Section 1
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Special pharmacy
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Last updated
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Cards (513)
Section 1
(50 cards)
Special pharmacy
"community Special limited pharmacy. Pharmacy services provided to employees, ER, pts, and pts of hospital
Can Unused unit dose drugs be returned?
Yes, RPh must maintain records for returned or unused drugs
Verbal C2s limit
72 hrs In fl
Pain meds in fl
Verify with MD, if MD can't be reached dispense 72 hr supply, with photo ID, document ID or. Copy it
Butorphanol
Stadol C-iv analgesic
Dispensing w/o prescription
Schedule 5, must have to be 18 yo and have ID, Rx below must not exceed more than 48 hours in these amounts 2 40mg opium 120 mg codeine 60 mg dihydrocodeine 30 mg ethyl morphine
Rph checks
Initial or sign Rx face and write date filled Conduct drug use review (sutibality of Rx) MUST COUNSEL PT ON MEDICATION Must make drug pricing upon request Remains available during meal breaks
Vet drugs exempt from counterfeit proof blanks?
Yes
Do hospitals report to eforsce
No
9 members bust live in
Florida and practiced for over 4 years 1 member 60 yo age Must serve 4 year terms
Technician hours
20 CE, twice a year 4 livs 2 med error
RPh hours
10 live 2 med error
Technician 20 ce
Twice a year 17
Immunization records kept for
5 years
DAMP
Drugs/Alcohol mental physical condition Program for RPh who has an impairment and fulfills program requirements, RPh has to pay own expense
Technicians can
Accept authorization to dispense rx to a prescribing practitioners authorization of EXISTING rx with no refill remaining (prescription authorizations)
Can techs Receive diagnostic orders in a nuclear pharmacy
Yes
Consultant pharmacists may hire other consultants to
Do work
Vetinary pedigree papers
No
9 members total
3 a combo of everything they want to be (in pharmacy) 2 community 2 hospital 2 who have nothing to do with pharmacy
CE or not
Q2 years= 30 hrs CE <12 mo- none 12-24=15 hrs CE
Compounded tablets, radio pharmaceuticals,investigational drugs
Don't need to have to have imprints,
May never prescribe
Anesthesiologist assistants Doctors of Oriental medicine Nurses Respiratory therapist Psychologists - CAN'T PRESCRIBE
PSE LESS THAN 60 MG
Are exempt from logbook!!!!!
Fl weed given for compassionate use
>10% cbd, < than equal 0.8% thc
Office use labeled controls
Can't prescribe
Length of medicaid/medicare records kept
10 years
Theft or significant loss
Notify DEA,POLICE, WITHIN 1 BUSINESS DAY AFTER DISCOVERY , and complete form 106,
Rph dispensing emergency rx INCLUDING c2s
May dispense ONE TIME EMERGENCY REFILL IF MD unavailable
Nursing homes
No
Prescriber care plan
Gives right to order lab tests "need 3 hour course"
Are partial fills considered refills
No
Controlled prescriptions must have RPh fill
Practitioners DEA Registration Initial the prescription Write date filled Note controlled rx number
Records kept at central fill for how lomgth
2 years not 4 like community pharmacy
Techs may not
Transfer a rx
Hard copy reproduced within
72 hours of 60 day period
Consultant pharmacacists
54 CE total q 2 years MUST receive 3 hours of CE lab & clinical testing Counseling not required for inputs of hospital
Only 7 prescribers in Fl
OPPP, VAD Optometrists - only tylenol/codeine /#3 ocular and systemic drugs in practice Podiatrist Physician (MD, DO) Physician assistant - STILL CAN'T PRESCRIBE CONTROLS UNDER PHYSCIAN only under physicans (No controls) Vetniranian ARNP Dentist
Pharmacy hours
5 days a week 40 hours
After dispensing rph must
Date and sign hardcopy within 7 days of date dispensed
Can techs provide a copy of rx or tell rx to someone besides pt
No
Emergency C2 prescribing
One time 72 hr SUPPLY, AFTER 73RDHR YOU VOID REMAINDER OF RX IT'S (MD RESPONSIBILITY TO MAIL PRESCRIPTION WITHIN 7 DAYS)
Can techs monitor drug usage
No
Rph CV renewed q
2 years
Can u prescribe Different schedules of drugs on same rx blank?
i.e C3-C4
Eforsce
For all controls yes ope c2-4
Out of country Rx ok to fill if
Valid Reputable MD liscenced in jurisdiction Chronic or recurrent condition
Hospice do eforsce
No
CE first time
1hr HIV 2hr med errors 10 hr live,video, or interactive
Correctional facilities, and ambulatory centers do eforsce?
No
Section 2
(50 cards)
C5s typically
No more than 200 mg of codeine per , 100 mg or grams
C2 90 day supply
Not 30 day like Brian said, Each must be in a separate rx blank
Max ORAL dispense by a RPh for C3
30 days in Florida
CS substance inventory conducted q
2 years
DEA 222
Only orders C1 & C2 drugs
C3-5 faxes
Equal to original rx
Prescription drug distributions
Four years
Heroin
C1
Transfer protocol
Dispensing RPh must tell pt rx at other pharmacy is cancelled, and now mist get correct valid rrfills
Wholesale records
The longer if two years following disposition of drug or three years from creation of record
Lysergic acid
C1 it's lsd
Modified Class iia
Methadone clinic Not more than 15 medicinal drugs
Ketamine
C3
DEA 224
To dispense controls, register at deaadiversion
Drug samples records kept for
3 years
Exceptions to C2 faxes
If it is COMPOUNDED UNDER for direct parental iv, im, INFUSION, it will count as a "written rx"
Mds prescribe for family friend
Yes, within scope of practice
Compounded drugs included in Eforsce
Yes
Chiropractors, naturopaths
Can't prescribe
Any controlled 3-4 may be orally dispensed if BECOMES FILLING RPh reduces it to
Writing or records in computer along with date of authorization
Techs do data entry?
Yes
Salvia schedule
C1
Marijuana
C1
Giving transfer
RPh must cancel electronic prescription and or void written prescription
Can techs retrieve rx files pt files and similar records
Yes
C2s expire preaxrip
1 year
Can techs remove detraioated products from quarantine area
Yes
C3s typically contain
Combination products containing Less than 15 mg hydrocodone per unit And not more than 90 mg of codeine per dosage unit
Any RPh may dispense a mail c2-4 without getting suitable identification if already obtained
Pt info through prescription benefit plan
Max scopilamine per dermal patch ordered by rph
1.5 mg per parch
Modified Class iib
Specific Bulk drugs Expanded formulary
If missing med guide
Misbranded!!
Exctasy 3,4 methylenedioxysamptheamine
C1
Clerkship of consultant rph
Must undergo 40 hrs under consult RPh preceptor within 1 year of course completion, must complete over 3 months 60% in on site pharmacy permit holding institution
Can techs perform data entry
Yes
Can techs receive therapy or blood product procedures in nuclear pharmacy
No
DEA 224a
Once u successfully are approved for 224 u must renew every 3 years with 224a
Can techs engage in drug review
No
Internet pharmacy
Open 6 days a week, 40 hrs a week, with toll free number on label of each rx filled
Negative formulary
Drugs which CAN'T be substituted Digitoxin Controlled release theophylline (even regular) Dicumarol Chlorpromazine Prancelipase
Pharmacy permits
Expire ever did years on Feb 28
Can techs monitor rx usage
No
Can techs Receive new non written rx or receive any change in medication strength or directions to existing rx
No
Inventory records maintained q
2 years
If not written down assume it's
4 years ope
Can techs engage in rx drug review
No
Methaqualone
C1
Records and sales of either by manufaurers distributors or dealers
5 years
Oxandrolone
C3
6:1 ratio
Allowed if not INVOLVING sterile compounding or dispensing
Section 3
(50 cards)
Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include a numerical notation of the quantity of the controlled substance prescribed on the face of the prescription. T/F
False, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.04(2),(d)]. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include BOTH a written and a numerical notation of the quantity of the controlled substance prescribed on the face of the prescription (not just the numeric quantity) and and a notation of the date in numerical, month/day/year format, or with the abbreviated month written out, or the month written out in whole. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. If the prescriber is not available to verify a prescription, the pharmacist may dispense the controlled substance but may insist that the person to whom the controlled substance is dispensed provide valid photographic identification. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not include the quantity or date written out in textual format, the pharmacist may dispense the controlled substance without verification by the prescriber of the quantity or date if the pharmacy previously dispensed another prescription for the person to whom the prescription was written.
The delivery of a filled prescription by a central fill pharmacy to the ultimate consumer or the consumer's agent pursuant to a contract with an originating pharmacy shall be considered dispensing under the Florida State Pharmacy Law. T & F
False, [Florida Administrative Code 64B16-28.450]. (a). The term "originating pharmacy" means a pharmacy wherein the prescription which will be filled by the central fill pharmacy is initially presented; and (b). The term "central fill pharmacy" means a pharmacy which performs centralized prescription filling, delivering, and returning for one or more originating pharmacies. (c). Delivery of medications must be made in a timely manner. The originating and central fill pharmacies shall each be identified on the prescription container. (d). Delivery by central fill pharmacy to ultimate consumer. A central fill pharmacy may deliver medications for an originating pharmacy to the ultimate consumer or the consumer's agent under the following conditions: 1. The pharmacies are under the same ownership or have a written contract specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which each pharmacy will comply with federal and state laws, rules and regulations. 2. The pharmacies shall have a pharmacist available 40 hours a week, either in person or via two-way communication technology, such as a telephone, to provide patient counseling. 3. The pharmacies shall include a toll-free number that allows the patient to reach a pharmacist for the purposes of patient counseling. 4. The pharmacies shall each be identified on the prescription container label. The originating pharmacy shall be identified with pharmacy name and address. The central fill pharmacy may be identified by a code available at the originating pharmacy. 5. The central fill pharmacy shall only deliver via carrier to the ultimate consumer or the consumer's agent those medications which could have been delivered via carrier by the originating pharmacy. 6. The central fill pharmacy shall not deliver to the ultimate consumer or consumer's agent substances listed as controlled substances. 7. The delivery of a filled prescription by a central fill pharmacy to the ultimate consumer or the consumer's agent pursuant to a contract with an originating pharmacy shall not be considered dispensing. 8. Each pharmacist that performs a specific function within the processing of the prescription shall be responsible for any errors or omissions committed by that pharmacist during the performance of that specific function.
Bill's father comes to your pharmacy and asks for the medication records of his son who is a minor. The pharmacist gives him the medication records of his son. The pharmacist was in accordance with the Florida State Pharmacy Law. T/F
True. According to HIPAA, a healthcare provider cannot disclose medication records or the history of patients without prior approval of patients or otherwise permitted by the law. The only exception under this law is when the patient is designated a minor by the court [Public Law 104-191].
Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier. t/f
True, [Florida Statues, Chapter 499, Section 499.0121(5)(a)(1)]. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier. A quarantine section must be separate and apart from other sections where prescription drugs are stored so that prescription drugs in this section are not confused with usable prescription drugs.
Which of the following requires a tamper-evident packaging? Cold EZ lozenges Tolnaftate cream Prilosec capsules Sensodyne fluroide tooth paste
Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.
Can prescriber dispense drugs in fl
Yes, if in their regular course of practice, they will have to register as a dispenser,
Pt ran out of C2 can u give emergency 72 hr SUPPLY
No, not for c2, ONLY can fill IF PRESCRIBER CALLS IN ORAL C2 FOLLOWED WITH A WITHIN RX IN 7DAYS 465.0275
Which of the following is/are NOT TRUE regarding dispensing in an institutional pharmacy to outpatients? I. Medicinal drugs shall be dispensed in an institutional pharmacy to outpatients only when that institution has secured a community pharmacy permit from the department. II. In case of emergency, a licensed prescriber may dispense up to a 48-hour supply of a medicinal drug to any outpatient. III. For any such outpatient for whom a medicinal drug is warranted for a period to exceed 48 hours, an individual licensed to prescribe such drug must dispense a 48-hour supply of such drug to the patient and must provide the patient with a prescription for such drug for use after the initial 48-hour period. I III II and III All
II and III are NOT TRUE, [Florida Pharmacy Act 465.019(4)]. 1). Medicinal drugs shall be dispensed in an institutional pharmacy to outpatients only when that institution has secured a community pharmacy permit from the department. However, an individual licensed to prescribe medicinal drugs in this state may dispense up to a 24-hour supply of a medicinal drug to any patient of an emergency department of a hospital that operates a Class II institutional pharmacy, provided that the physician treating the patient in such hospital's emergency department determines that the medicinal drug is warranted and that community pharmacy services are not readily accessible, geographically or otherwise, to the patient. 2). Such dispensing from the emergency department must be in accordance with the procedures of the hospital. For any such patient for whom a medicinal drug is warranted for a period to exceed 24 hours, an individual licensed to prescribe such drug must dispense a 24-hour supply of such drug to the patient and must provide the patient with a prescription for such drug for use after the initial 24-hour period.
A pharmacist who is authorized by Florida State Board of Pharmacy to dispense as well as to prescribe medicinal drugs can prescribe and dispense naproxen sodium to patients provided that the dispensing quantity of naproxen sodium should be limited to: 10 day, 3 day, 6 day, 7 day
6-day supply, [Florida Administrative Code 64B16-27.220(A)(1)]. A pharmacist who is authorized by Florida State Board of Pharmacy to dispense as well as to prescribe medicinal drugs can prescribe and dispense naproxen sodium to patients provided that the dispensing quantity of naproxen sodium should be limited to 6-day supply. A Pharmacist may order and dispense from the following formulary, within their professional judgment, subject to the stated conditions. (1). Oral analgesics for mild to moderate pain. The pharmacist may order these drugs for minor pain and menstrual cramps for patients with no history of peptic ulcer disease. The prescription shall be limited to a six (6) day supply for one treatment. If appropriate, the prescription shall be labeled to be taken with food or milk. (a). Magnesium salicylate/phenyltoloxamine citrate. (b). Acetylsalicylic acid (Zero order release, long acting tablets). (c). Choline salicylate and magnesium salicylate. (d). Naproxen sodium. (e). Naproxen. (f). Ibuprofen.
Any pharmacist who dispenses by mail a controlled substance listed in Schedule II, Schedule III, or Schedule IV is exempt from the requirement to obtain suitable identification for the prescription dispensed by mail if the pharmacist has obtained the patient's identification through the patient's prescription benefit plan. T or F
True, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.04(2),(b)]. In Florida, any pharmacist who dispenses by mail a controlled substance listed in Schedule II, Schedule III, or Schedule IV is exempt from the requirement to obtain suitable identification for the prescription dispensed by mail if the pharmacist has obtained the patient's identification through the patient's prescription benefit plan.
A pharmacist is conducting an inventory for Provigil. Which of the following shall be applied? I. An exact count is required. II. An estimate count is required if the drug is available in 100-tablet manufacturer bottle. III. An exact count is required if the drug is available in 1500-tablet manufacturer bottle. IV. It is not a controlled substance therefore no controlled-substance inventory is required. I I,II,III II,III IV
II and III only, [Florida Administrative Code 64B16-28.203(4)]. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the prescription drug outlet shall do as follows: (1). If the drug is a schedule II drug, an exact count of the contents shall be made. (2). If the substance is listed in schedule III, IV, or V, and estimated count of the measure of the contents may be made, unless the container holds more than 1,000 tablets or capsules, in which case an exact count of the contents must be made. Modafinil (Provigil) is a wakefulness-promoting agent for oral administration. It is a schedule IV controlled substance. It is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.
A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented.
True, [Florida Administrative Code, 64B16-27.820(3) and OBRA 90]. A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented.
Pt ran out of C2 can u give emergency 72 hr SUPPLY
No ONLY can fill IF PRESCRIBER CALLS IN ORAL C2 FOLLOWED WITH A WITHIN RX IN 7DAYS
The automated pharmacy system dispensing a drug, located within a Hospice facility, shall identify at minimum: I. The name of the dispensing pharmacy. II. The name of the patient. III. The name of the prescribing practitioner.
All, [Florida Pharmacy Act 465.0235(5)(c)]. 5. The board has adopted rules governing the use of an automated pharmacy system. It specifies: (a). Recordkeeping requirements; (b). Security requirements; and (c). Labeling requirements that permit the use of unit-dose medications if the facility, hospice, or institution maintains medication-administration records that include directions for use of the medication and the automated pharmacy system identifies: 1. The dispensing pharmacy; 2. The prescription number; 3. The name of the patient; and 4. The name of the prescribing practitioner.
Which of the following should be done by a permitee prior to closure of the pharmacy at the specific location? I. The permittee shall notify the Board of Pharmacy in writing with the effective date of closing of the pharmacy. II. The permitee shall return the pharmacy permit to the Board of Pharmacy office. III. The permitee shall advise the Board of Pharmacy which permittee is to receive the prescription files. I I& II only II and III only All
All, [Florida Administrative Code 64B16-28.202(3),(4),(5),and (6)]. Prior to closure of a pharmacy the permittee shall notify the Board of Pharmacy in writing as to the effective date of closure, and shall: (3).(a). Return the pharmacy permit to the Board of Pharmacy office or arrange with the local Bureau of Investigative Services of D.P.R. to have the pharmacy permit returned to the Board of Pharmacy; (b). Advise the Board of Pharmacy which permittee is to receive the prescription files; (4). On the date of closure the former permittee shall physically deliver the prescription files to a pharmacy operating within reasonable proximity of the pharmacy being closed and within the same locality. This delivery of prescription files may occur prior to the return of the pharmacy permit to the Board of Pharmacy office. (5). Affix a prominent sign to the front entrance of the pharmacy advising the public of the new location of the former permittee's prescription files or otherwise provide a means by which to advise the public of the new location of their prescription files. (6). A pharmacy receiving custody of prescription files from another pharmacy shall maintain the delivered prescriptions in separate files so as to prevent intermingling with the transferee pharmacy's prescription files.
Manan Care Pharmacy wants to transfer 30 tablets of Oxycontin 10 mg to High Yield Care Pharmacy. The correct way to do this transfer is: I. By filling a DEA 222 order form. II. By taking verbal authorization and all necessary information from the pharmacist where Oxycontin is being transferred. III. It cannot be transferred between pharmacies.
I only, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.06(1)]. Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to a DEA 222 order form. Oxycontin is a schedule II controlled drug. It can only be transferred between pharmacies by filling a DEA 222 order form.
In which type of an institutional pharmacy is dispensing prohibited? I. Class I institutional pharmacies II. Class II institutional pharmacies III. Modified Class II institutional pharmacies
I only, [Florida Pharmacy Act 465.019(2)(a),(b),(c)]. Class I institutional pharmacies are those institutional pharmacies in which all medicinal drugs are administered from individual prescription containers to the individual patient and in which medicinal drugs are not dispensed on the premises, except that licensed nursing homes may purchase medical oxygen for administration to residents. No medicinal drugs may be dispensed in a Class I institutional pharmacy. "Class II institutional pharmacies" are those institutional pharmacies which employ the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, shall provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution. "Modified Class II institutional pharmacies" are those institutional pharmacies in short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements.
Appropriate to use DEA number on NON controlled substanced
No,
A patient brings a new prescription for Alprazolam with 5 eligible refills. The prescription is written on April 1, 2014. The prescription reads: Alprazolam 1 mg: 1 tablet by mouth at bed time x 30 days. Refills: 5 times A patient has requested medication to be partially filled. Below is the list of partially filled transactions: 1. 04/04/2014: 20 tablets 2. 05/05/2014: 40 tablets 3. 05/25/2014: 18 tablets 4. 06/09/2014: 23 tablets 5. 06/21/2014: 5 tablets 6. 08/11/2014: 35 tablets 7. 09/05/2014: 11 tablets 8. 10/11/2014: 36 tablets 9. 10/28/2014: 21 tablets 10. 11/05/2014: 6 tablets Based on above information what shall be the dispensed quantities (legally)?
152 tablets, [http://www.deadiversion.usdoj.gov/faq/general.htm]. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue. In above example, the prescription expires on 10/01/2014 (six months from an issue date of 04/01/2014). Therefore, all partial filling before this date should be considered legal. The second thing the pharmacist has to observe that the total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed. The prescription is written for 180 tablets, 1 tablet by mouth qd x 30 days with additional 5 refills. When adding all the partial filling starting from 04/04/2014 to 09/05/2014, the total quantities that the pharmacist can dispense legally come about 152 tablets.
Pt ran out of C2 can u give emergency 72 hr SUPPLY
No ONLY can fill IF PRESCRIBER CALLS IN ORAL C2 FOLLOWED WITH A WITHIN RX IN 7DAYS
Which of the following is/are TRUE about labeling the dispensing container by the practitioner who dispenses complimentary packages of medicinal drugs to his/her own patients in the regular course of his or her practice? I. May dispense such drugs in the manufacturer's labeled package with the practitioner's name, patient's name, and date dispensed. II. If such drugs are not dispensed in the manufacturer's labeled package, they must be dispensed in a container which bears at least patient's name. III. Shall only be dispensed such drugs in the manufacturer's labeled package. I II III
I only, [Florida Pharmacy Act 465.0276(5)]. A practitioner who confines her or his activities to the dispensing of complimentary packages of medicinal drugs to the practitioner's own patients in the regular course of her or his practice, must dispense such drugs in the manufacturer's labeled package with the practitioner's name, patient's name, and date dispensed, OR If such drugs are not dispensed in the manufacturer's labeled package, they must be dispensed in a container which bears the following information: (a). Practitioner's name; (b). Patient's name; (c). Date dispensed; (d). Name and strength of drug; and (e). Directions for use.
Prescription
Is NOT AN ORDER FOR MEDS DISPENSED FOR IMMEDIATE ADMINISTRATION TO ULTIMATE USER (hospital order)
Slep
Product containing ephedrine, psuedoephrine, or phenylephrine
In which of the following instances, a pharmacist or health care practitioner is an EXEMPT from reporting requirement of the prescription drug monitoring program? I. A practitioner when administering or dispensing a controlled substance in the health care system of the Department of Corrections. II. A practitioner when administering a controlled substance in the emergency room of a licensed hospital. III. A health care practitioner when administering or dispensing a controlled substance to a person under the age of 16. I III II,III All
All, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.055(5)] When the following acts of dispensing or administering (controlled substances) occur, the following are exempt from reporting under the prescription drug monitoring program for that specific act of dispensing or administration: (a). A health care practitioner when administering a controlled substance directly to a patient if the amount of the controlled substance is adequate to treat the patient during that particular treatment session. (b). A pharmacist or health care practitioner when administering a controlled substance to a patient or resident receiving care as a patient at a hospital, nursing home, ambulatory surgical center, hospice, or intermediate care facility for the developmentally disabled which is licensed in this state. (c). A practitioner when administering or dispensing a controlled substance in the health care system of the Department of Corrections. (d). A practitioner when administering a controlled substance in the emergency room of a licensed hospital. (e). A health care practitioner when administering or dispensing a controlled substance to a person under the age of 16. (f). A pharmacist or a dispensing practitioner when dispensing a one-time, 72-hour emergency supply of a controlled substance to a patient.
Return unused control medication to pharmacy
...
A pharmacist who is authorized by Florida State Board of Pharmacy to dispense as well as to prescribe medicinal drugs can prescribe and dispense phenazopyridine to patients provided that the dispensing quantity of phenazopyridine should be limited to: 2day,3day,6day,7day,
2-day supply, [Florida Administrative Code 64B16-27.220(A)(2)]. A pharmacist who is authorized by Florida State Board of Pharmacy to dispense as well as to prescribe medicinal drugs can prescribe and dispense phenazopyridine to patients provided that the dispensing quantity of phenazopyridine should be limited to 2-day supply. The prescriptions shall be labeled about the tendency to discolor urine. If appropriate, the prescription shall be labeled to be taken after meals.
rph adding 1000mg of pure codeine powder to 100 cc of tylenol with codeine elixer (120/12mg/5cc) the resultant mixture is what class
The compounded mixture should be classified as a Schedule III controlled drug. The amount of Codeine present in the final mixture is 1.24 gms (1000 mg plus 240 mg). It has been stated under CSA that if a mixture contains less than 1.8 gms of Codeine per 100 cc, it should be classified as a Schedule III controlled substance, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.03(3)(c)(2)].
Pt ran out of C2 can u give emergency 72 hr SUPPLY
No ONLY can fill IF PRESCRIBER CALLS IN ORAL C2 FOLLOWED WITH A WITHIN RX IN 7DAYS
Can u refill a c3-5 after 6 months of original fill
No
Pt ran out of C2 can u give emergency 72 hr SUPPLY
Probably definitely ** no
Faxing a prescription for Schedule II controlled drugs may serve as the original prescription only if: I. A prescription written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral route. II. A prescription written for Schedule II substances for a resident of a long-term care facility. III. A prescription written for Schedule II substances for a resident of Hospice care certified by Medicare. I I,II II,III All look
All, [Florida Pharmacy Act 465.035(2)]. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the agent of the practitioner, but not by the patient or patient's agent, to a pharmacy via facsimile equipment, provided the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. Faxing a prescription for Schedule II controlled drugs may serve as the original prescription only if: 1. A prescription is written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. 2. A prescription is written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. 3. A prescription is written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient.
Pt ran out of C2 can u give emergency 72 hr SUPPLY
No not c2s ONLY can fill IF PRESCRIBER CALLS IN ORAL C2 FOLLOWED WITH A WITHIN RX IN 7DAYS
cGMPs
Current good manufacturing practices for human pharmaceuticals
Prescribe methadone for pain?
Sure as long as medically necessary
Which of the following is/are TRUE regarding Internet Pharmacy Permit and its function? I. The permittee shall notify the department within 30 days after any change of the licensed pharmacist responsible for function of Internet Pharmacy. II. Internet Pharmacy shall be open for a minimum of 40 hours per week. III. A toll-free telephone service shall be provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. I I and II II & III All
All, [Florida Statues Chapter 465, 465.0197]. 1). Any person desiring a permit to operate an Internet pharmacy shall apply to the department for an Internet pharmacy permit. If the board certifies that the application complies with the applicable laws and rules of the board governing the practice of the profession of pharmacy, the department shall issue the permit. 2). A permit may not be issued unless a licensed pharmacist is designated as the prescription department manager for dispensing medicinal drugs to persons in this state. 3). The permittee shall notify the department within 30 days after any change of the licensed pharmacist responsible for such duties. 4). The location, names, and titles of all principal corporate officers and the pharmacist who serves as the prescription department manager for dispensing medicinal drugs to persons in this state. This disclosure shall be made within 30 days after any change of location, principal corporate officer, or pharmacist serving as the prescription department manager for dispensing medicinal drugs to persons in this state. 5). During its regular hours of operation but not less than 6 days per week, for a minimum of 40 hours per week, a toll-free telephone service shall be provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll-free number must be disclosed on the label affixed to each container of dispensed medicinal drugs.
Cam prescriber dispense c2 or 3
Max is 14 DAY SUPPLY Yes as long as it is connected to surgical procedure Clinical trial Methadone facility
Ltcf
Nursing home, retirement care, mental facility, or institution, providing to resident patients
DEA 222 info
Schedules I and II, should are in a form with 3 copies, the pruchaser (Kmart) compeltes the form and submits the copy 1 and 2 to the SUPLLIER (CARDINAL) and keeps copy 3 (brown copy next to pink envelope) for kmarts record. A partially filled order must be filled within 60 days of date of issuance
Prescription
An order for medication which is dispensed to or for an ultimate user
A 45-year-old patient comes to the pharmacy and presents a prescription for Alprazolam written by his podiatrist. A pharmacist shall:
A pharmacist shall not fill the prescription. For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but the pharmacist is responsible for the proper filling of the prescription drug order. A registered physician, dentist, veterinarian, or podiatrist authorized by this state to prescribe controlled substances can issue a prescription for controlled substances only in the usual course of his or her professional practice. Therefore, a pharmacist shall question the prescription for sleeping pill (Alprazolam) prescribed by a registered podiatrist.
A vendor pharmacy may transmit a starter dose prescription to a starter dose pharmacy if the vendor pharmacy: I. Has written authorization from the facility to utilize a starter dose pharmacy. II. Has a written contract with the starter dose pharmacy. III. Has written authorization from a prescribing practitioner to act as the practitioner's agent for the purpose of transmitting a starter dose prescription. I I and II II and III All
All, [Florida Administrative Code 64B16-28.503(2)]. (a). "Vendor pharmacy" means a community pharmacy or special closed system pharmacy which has a contract to dispense a medicinal drug to a patient in a facility holding a Class I Institutional Permit or Modified II B Permit. (b). "Starter dose pharmacy" means a pharmacy that dispenses a medicinal drug pursuant to a starter dose prescription to a patient in a facility served by the vendor pharmacy. (c). "Starter dose prescription" means a prescription transmitted by a vendor pharmacy to a starter dose pharmacy for the purpose of initiating drug therapy for a patient in a facility served by the vendor pharmacy. (2). A vendor pharmacy may transmit a starter dose prescription to a starter dose pharmacy if the vendor pharmacy: (a). Has written authorization from the facility to utilize a starter dose pharmacy. (b). Has a written contract with the starter dose pharmacy. (c). Has written authorization from a prescribing practitioner to act as the practitioner's agent for the purpose of transmitting a starter dose prescription. (d). Possess a valid prescription from the prescribing practitioner prior to transmitting the starter dose prescription. (e). Maintains a record of each starter dose prescription. (f). Maintains a policy and procedure manual that references starter dose prescriptions.
Which of the following is/are TRUE about dispensing of medicinal drugs pursuant to facsimile prescription? I. At the time of the delivery of the medicinal drugs, the pharmacy has in its possession the original prescription for the medicinal drug present in facsimile transmission. II. The recipient of the prescription shall sign a log and shall indicate the name and address of both the recipient and the patient for whom the medicinal drug was prescribed. III. The Florida Pharmacy Law does not allow to fill the medicinal drug pursuant to facsimile transmission. I II III I, II
I and II are TRUE, [Florida Pharmacy Act 465.035]. It is lawful for a pharmacy to dispense medicinal drugs, including controlled substances authorized under subsection (2), based on reception of an electronic facsimile of the original prescription if all of the following conditions are met: a). At the time of the delivery of the medicinal drugs, the pharmacy has in its possession the original prescription for the medicinal drug involved. b). The recipient of the prescription shall sign a log and shall indicate the name and address of both the recipient and the patient for whom the medicinal drug was prescribed. c). Controlled substances listed in Schedule II as defined in s. 893.03(2) may be dispensed as provided in this section to the extent allowed by 21 C.F.R. s. 1306.11.
A patient's medical and dispensing records shall not be furnished to any person other than: I. to the patient for whom the drugs were dispensed. II. a patient's legal representative. III. a patient's spouse.
I and II only, [42 C.F.R. Part 3 and Public Law 104-191]. A patient's medical and dispensing records shall not be furnished to any person other than: 1. to the patient for whom the drugs were dispensed. 2. a patient's legal representative. 3. a patient's spouse only if the spouse has written authorization from the patient.
Phenergan with Codeine syrup is classified as:
Phenergan with Codeine syrup is classified as a Schedule V controlled drug, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.03(5)(a)]. List of Schedule V controlled drugs: ______________________________ Codeine preparations - 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine) Difenoxin preparations - 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen) Dihydrocodeine preparations 100 mg per 100 ml or 100 gm Diphenoxylate preparations- 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen) Ethylmorphine preparations 100 mg per 100 ml or 100 gm Opium preparations - 100 mg per 100 ml or gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.) Lyrica - Pregabalin Lacosamide - Vimpat Ezogabine - Potiga
A partially filled DEA 222 order must be filled within
60 days of date of issuance
In the case of an emergency oral schedule II prescription, the dispensed quantity of the emergency C II drug should be limited to a:
Three day supply, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.04(1)(f)]. A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written prescription of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such controlled substance may be dispensed upon oral prescription but is limited to a 72-hour supply. A prescription for a controlled substance listed in Schedule II may not be refilled.
Which of the following is/are TRUE about filling or refilling a valid prescription which is on file in a pharmacy located in another state and has been transferred from one pharmacy to another by any electronic means? I. Prior to dispensing any transferred prescription, the dispensing pharmacist must advise the patient that the prescription on file at the other pharmacy must be canceled before it may be filled or refilled. II. Prior to dispensing any transferred prescription, the dispensing pharmacist must obtain the consent of the prescriber to the refilling of the prescription when the prescription, in the dispensing pharmacist's professional judgment, so requires. III. If a transferred prescription is not dispensed within a reasonable time, the pharmacist shall so notify the transferring pharmacy to revalidate the canceled prescription. I I and II II and III All
All, [Florida Pharmacy Act 465.026]. A pharmacist licensed in Florida may fill or refill a valid prescription which is on file in a pharmacy located in this state or in another state and has been transferred from one pharmacy to another by any means, including any electronic means, under the following conditions: (1). Prior to dispensing any transferred prescription, the dispensing pharmacist must, either verbally or by any electronic means, do all of the following: (a). Advise the patient that the prescription on file at the other pharmacy must be canceled before it may be filled or refilled. (b). Determine that the prescription is valid and on file at the other pharmacy and that the prescription may be filled or refilled, as requested, in accordance with the prescriber's intent expressed on the prescription. (c). Notify the pharmacist or pharmacy where the prescription is on file that the prescription must be canceled. (d). Record in writing, or by any electronic means, the prescription order, the name of the pharmacy at which the prescription was on file, the prescription number, the name of the drug and the original amount dispensed, the date of original dispensing, and the number of remaining authorized refills. (e). Obtain the consent of the prescriber to the refilling of the prescription when the prescription, in the dispensing pharmacist's professional judgment, so requires. Any interference with the professional judgment of the dispensing pharmacist by any pharmacist or pharmacy permittee, or its agents or employees, shall be grounds for discipline. (3). If a transferred prescription is not dispensed within a reasonable time, the pharmacist shall, by any means, so notify the transferring pharmacy. Such notice shall serve to revalidate the canceled prescription. The pharmacist who has served such notice shall then cancel the prescription in the same manner as set forth in paragraph (2)(c). (4). In the case of a prescription to be transferred from or to a pharmacy located in another state, it shall be the responsibility of the pharmacist or pharmacy located in the State of Florida to verify, whether by electronic means or otherwise, that the person or entity involved in the transfer is a licensed pharmacist or pharmacy in the other state.
Which of the following is/are required on the face of the controlled substance prescription? I. The full name and address of the person for whom the controlled substance is dispensed. II. The full name and address of the prescribing practitioner and the practitioner's federal controlled substance registry number. III. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. I III II,III, All
All, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.04]. A pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances upon a written or oral prescription of a practitioner, under the following conditions: (1). Oral prescriptions must be promptly reduced to writing by the pharmacist. (2). The written prescription must be dated and signed by the prescribing practitioner on the day when issued.
Records in a central fill pharmacy
Must be maintained he both central and retail of all controlled substance prescriptions dispensed Central fill pharmacies are permitted to prepare initial and refill prescriptions
A practitioner authorized by the law to prescribe drugs may dispense a controlled substance listed in Schedule II or Schedule III to her or his patients in the regular course of her or his practice. T/F
False, [Florida Pharmacy Act 465.0276]. MAX 14 DAYS FOR C2 & 3 FILLING NOT ROUTINE FILLING A person may not dispense medicinal drugs unless licensed as a pharmacist or otherwise authorized under this chapter to do so, except that a practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with this section. A practitioner registered under this section MAY NOT dispense a controlled substance listed in Schedule II or Schedule III as provided in s. 893.03. This paragraph DOES NOT apply to:
Section 4
(50 cards)
A registered pharmacy intern may: I. Receive verbal prescriptions from a practitioner. II. Supervise and be responsible for the controlled substance inventory. III. Advise or consult with a patient, both as to the prescription and the patient profile record. I I,II II,III All
All, [Florida Administrative Code 64B16-27.1001(1)]. (1). A pharmacist or registered pharmacy intern must: (a). Supervise and be responsible for the controlled substance inventory. (b). Receive verbal prescriptions from a practitioner. (c). Interpret and identify prescription contents. (d). Engage in consultation with a practitioner regarding interpretation of the prescription and date in patient profile. (e). Engage in professional communication with practitioners, nurses or other health professionals. (f). Advise or consult with a patient, both as to the prescription and the patient profile record.
Prospective DUR means the part of the drug utilization review program that: I. is to occur before the drug is dispensed. II. is designed to screen for potential drug therapy problems based on explicit and predetermined criteria and standards that are developed on an ongoing basis with professional input. III. is to provide for the counseling of recipients about the proper use of drugs. I, I,II II,III All
All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. Prospective DUR means the part of the drug utilization review program that: I. Is to occur before the drug is dispensed. II. Is designed to screen for potential drug therapy problems based on explicit and predetermined criteria and standards that are developed on an ongoing basis with professional input. III. Is to provide for the counseling of recipients about the proper use of drugs. Whereas Retrospective DUR means the part of the drug utilization review program that assesses or measures drug use based on an historical review of drug use data against predetermined and explicit criteria and standards that are developed on an ongoing basis with professional input.
A prescription for Tramadol (Ultram) can be refilled how many times? cant be, 5 times, as needed within 1 year, max 10 times
5 times within a period of 6-months. Under a final rule (PDF) published in the Federal Register, the pain reliever tramadol is now classified as a Schedule IV controlled substance (CS). Starting August 18, 2014, Drug Enforcement Administration (DEA) will require manufacturers to print the "C-IV" designation on all labels that contain 2- [(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol), including its salts, isomers, and salts of isomers. The agency notes that every "DEA registrant who possesses any quantity of tramadol on the effective date of this final rule must take an inventory of all stocks of tramadol on hand as of August 18, 2014, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03,1304.04, and 1304.11 (a) and (d)." In addition, all "prescriptions for tramadol or products containing tramadol must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as of August 18, 2014." National Association of State Controlled Substances Authorities notes (PDF) that several states have already classified tramadol as a CS. To "provide a reasonable time for registrants to comply with the handling requirements" for a Schedule IV CS, DEA established the effective date of the final rule as 45 days from the date of publication.
In Florida, a registered pharmacy technician shall complete 30 hours biennially of continuing education courses approved by the board or the Accreditation Council for Pharmacy Education.
False, [Florida Pharmacy Act 465.014(6)]. As a condition of registration renewal, a registered pharmacy technician in Florida shall complete 20 hours biennially of continuing education courses approved by the board or the Accreditation Council for Pharmacy Education, of which 4 hours must be via live presentation and 2 hours must be related to the prevention of medication errors and pharmacy law.
Which of the following information is/are TRUE about ordering and dispensing approved medicinal drug products by a pharmacist? I. Injectable products shall not be ordered by the pharmacist. II. No oral medicinal drugs shall be ordered by a pharmacist for a pregnant patient or nursing mother. III. The amount or quantity of drug dispensed shall not exceed a 34-day supply or standard course of treatment. I I,II II,III All
All, [Florida Administrative Code 64B16-27.210]. A pharmacist may order the medicinal drug products listed in Rule 64B16-27.220, F.A.C., subject to the following terms and limitations: (1). Injectable products shall not be ordered by the pharmacist. (2). No oral medicinal drugs shall be ordered by a pharmacist for a pregnant patient or nursing mother. (3). In any case of dispensing hereunder, the amount or quantity of drug dispensed shall not exceed a 34-day supply or standard course of treatment unless subject to the specific limitations in this rule. Patients shall be advised that they should seek the advice of an appropriate health care provider if their present condition, symptom, or complaint does not improve upon the completion of the drug regimen. (4). The directions for use of all prescribed medicinal drugs shall not exceed the manufacturer's recommended dosage. (5). The pharmacist may only perform the acts of ordering and dispensing in a pharmacy which has been issued a permit by the Board of Pharmacy. (6). The pharmacist shall create a prescription when ordering and dispensing medicinal drug products which shall be maintained in the prescription files of the pharmacy. The pharmacist shall place the trade or generic name and the quantity dispensed on the prescription label, in addition to all other label requirements.
If a prescription is written for an Atrovent inhaler WITHOUT indicating "Brand Medically Necessary," and if both Atrovent and Ipratropium are included in State formulary, the pharmacist should dispense: Atrovent Ipratropium Either one
Atrovent. Under Florida State Pharmacy Law, no pharmacist shall substitute a generically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type drug product is included in the said formulary, [Florida Pharmacy Act 465.025(6)(b)].
The Tripartite Continuing Education Committee is composed of: I. Members from the Florida Board of Pharmacy II. Representatives from each College or School of Pharmacy in Florida III. Practicing pharmacists within Florida I I,II II,III All
All, [Florida Administrative Code 64B16-26.600]. (1). The Tripartite Continuing Education Committee will be composed of equal representation from the Board of Pharmacy, each College or School of Pharmacy in the State, and practicing pharmacists within the State. The members of the Committee shall be selected by the Board of Pharmacy and shall serve for a period of two years. The chairman of the committee shall be selected by the Chair of the Board. (2). The Tripartite Continuing Education Committee shall perform the following duties pursuant to Rule 64B16-26.601, F.A.C.: (a). Review continuing education providers and make recommendations to the Board; (b). Approve continuing education course or program for approved providers or individuals that are non-approved providers for the following: 1. General; 2. Initial Consultant Pharmacist Certification; 3. Consultant Recertification; 4. Nuclear Recertification; 5. Medication Errors; 6. HIV/AIDS; 7. Laboratory Tests; 8. Laws and Rules; 9. Quality Related Events.
The originating pharmacy transmitting the prescription information must: I. write the word "central fill" on the face of the original prescription. II. record the name, address, and DEA registration number of originating pharmacy if a prescription is for a controlled substance. III. the name of the originating pharmacy's pharmacist transmitting the prescription. I I,II II,III All
All, [Florida Administrative Code 64B16-28.450]. (a). Prescriptions may be transmitted electronically from an originating pharmacy to a central fill pharmacy including via facsimile. The originating pharmacy transmitting the prescription information must: 1. Write the word "central fill" on the face of the original prescription and record the name, address, and DEA registration number of the originating pharmacy if a prescription is for a controlled substance. 2. The name of the originating pharmacy's pharmacist transmitting the prescription, and the date of transmittal; 3. Ensure all the information required to be on a prescription pursuant to Sections 456.0392 and 893.04, F.S., is transmitted to the central fill pharmacy either on the face of the prescription or in the electronic transmission of information; 4. Indicate in the information transmitted the number of refills already dispensed and the number of refills remaining; 5. Maintain the original prescription for a period of two years from the date the prescription was last refilled. 6. Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the originating pharmacy's employee accepting delivery.
In Florida, drug therapy management services for a patient by a pharmacist shall be executed under the: Qualifying physican plan, prescriber care plan, pharmacist dispensing plan, pharmacist care plan
Prescriber Care Plan, [Florida Administrative Code 64B16-27.830] Prescriber Care Plan means an individualized assessment of a patient and orders for specific drugs, laboratory tests, and other pharmaceutical services intended to be dispensed or executed by a pharmacist. The Prescriber Care Plan shall be written by a licensed physician. The Prescriber Care Plan shall specify the conditions under which a pharmacist shall order laboratory tests, interpret laboratory values ordered for a patient, execute drug therapy orders for a patient, and notify the physician. A pharmacist who provides Drug Therapy Management services for a patient shall comply with orders in a Prescriber Care Plan, insofar as they specify: (a). Drug therapy to be initially dispensed to the patient by the pharmacist; or (b). Laboratory values or tests to be ordered, monitored and interpreted by the pharmacist; or (c). The conditions under which the duly licensed practitioner authorizes the execution of subsequent orders concerning the drug therapy for the patient; or (d). The conditions under which the pharmacist shall contact or notify the physician.
The activities of registered pharmacy technicians during a pharmacist's meal break shall be considered to be under the direct and immediate personal supervision of a pharmacist if the pharmacist is available on the premises during the meal break. T,F
True, [Florida Administrative Code 64B16-27.1001(6)(c)]. (6). The pharmacist may take a meal break, not to exceed 30 minutes in length, during which the pharmacy department of a permittee shall not be considered closed, under the following conditions: (a). The pharmacist shall be considered present and on duty during any such meal break if a sign has been prominently posted in the pharmacy indicating the specific hours of the day during which meal breaks may be taken by the pharmacist and assuring patients that a pharmacist is available on the premises for consultation upon request during a meal break. (b). The pharmacist shall be considered directly and immediately available to patients during such meal breaks if patients to whom medications are delivered during meal breaks are verbally informed that they may request that a pharmacist contact them at the pharmacist's earliest convenience after the meal break, and if a pharmacist is available on the premises during the meal break for consultation regarding emergency matters. Only prescriptions with the final certification by the pharmacist may be delivered. (c). The activities of registered pharmacy technicians during such a meal break shall be considered to be under the direct and immediate personal supervision of a pharmacist if the pharmacist is available on the premises during the meal break to respond to questions by the technicians, and if at the end of the meal break the pharmacist certifies all prescriptions prepared by the registered pharmacy technicians during the meal break.
It is a misdemeanor of the first degree if any pharmacist knowingly fail to report to the sheriff or other chief law enforcement agency of the county where the pharmacy is located within 24 hours after learning of any instance in which a person obtained or attempted to obtain a controlled substance from the pharmacy at which the pharmacist practiced pharmacy. T/F
True, [Florida Statues Chapter 465, 465.015(3) and Chapter 775 775.082, 775.083]. 1). It is unlawful for any pharmacist to knowingly fail to report to the sheriff or other chief law enforcement agency of the county where the pharmacy is located within 24 hours after learning of any instance in which a person obtained or attempted to obtain a controlled substance or at the close of business on the next business day, whichever is later, that the pharmacist knew or believed was obtained or attempted to be obtained through fraudulent methods or representations from the pharmacy at which the pharmacist practiced pharmacy. 2). Any pharmacist who knowingly fails to make such a report within 24 hours after learning of the fraud or attempted fraud or at the close of business on the next business day, whichever is later, commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083. 3). A sufficient report of the fraudulent obtaining of controlled substances under this subsection must contain, at a minimum, a copy of the prescription used or presented and a narrative, including all information available to the pharmacist concerning the transaction, such as the name and telephone number of the prescribing physician; the name, description, and any personal identification information pertaining to the person who presented the prescription; and all other material information, such as photographic or video surveillance of the transaction. Fines under Title XLVI, Chapter 775: A person who has been convicted of a noncriminal violation may be sentenced to pay a fine. Fines for designated crimes and for noncriminal violations shall not exceed: (a). $15,000, when the conviction is of a life felony. (b). $10,000, when the conviction is of a felony of the first or second degree. (c). $5,000, when the conviction is of a felony of the third degree. (d). $1,000, when the conviction is of a misdemeanor of the first degree. (e). $500, when the conviction is of a misdemeanor of the second degree or a noncriminal violation.
Which of the following is/are the minimum requirement(s) to work as a certified pharmacy technician? I. An applicant is at least 17 years of age. II. An applicant has completed a pharmacy technician training program approved by the Board of Pharmacy. III. An applicant must have a college degree from an approved college. I, I,II, II,III All
I and II only, [Florida Pharmacy Act 465.014(1)(2)]. Any person who wishes to work as a pharmacy technician in this state must register by filing an application with the board on a form adopted by rule of the board. The board shall register each applicant who has remitted a registration fee set by the board, not to exceed $50 biennially; has completed the application form and remitted a nonrefundable application fee set by the board, not to exceed $50; is a). at least 17 years of age; and b). has completed a pharmacy technician training program approved by the Board of Pharmacy. Notwithstanding any requirements in this subsection, any registered pharmacy technician registered pursuant to this section before January 1, 2011, who has worked as a pharmacy technician for a minimum of 1,500 hours under the supervision of a licensed pharmacist or received certification as a pharmacy technician by certification program accredited by the National Commission for Certifying Agencies is exempt from the requirement to complete an initial training program for purposes of registration as required by this subsection.
Under Florida State Pharmacy Law, the total quantity of controlled substance listed in Schedule V which may be sold to any one purchaser within a given 48-hour period shall not exceed 200 milligrams of codeine. T,F
False, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.08(3)(c)]. Under Florida Comprehensive Drug Abuse Prevention and Control Act, the total quantity of controlled substance listed in Schedule V which may be sold to any given purchaser within a given 48-hour period without a prescription shall not exceed 120 milligrams of codeine, 60 milligrams dihydrocodeine, 30 milligrams of ethyl morphine, or 240 milligrams of opium.
A prescription for Cephalexin 500 mg has been prescribed and presented by Dr. Shah on January 20, 2015 with the direction: 1 cap po qid x 10 days. If the bulk bottle of Cephalexin has an expiration date of Jan/15, what would be the minimum quantity that should be dispensed by the pharmacist? 40,0,28,14
40. The bulk bottle of Cephalexin has an expiration date of Jan/15, which indicates that the drug will be expiring on January 31, 2015. The prescription is presented on January 20 and is written for 10 days, therefore the pharmacist can fill the whole supply of the drug.
Each pharmacist certified to administer a vaccine or epinephrine autoinjection must complete a 6-hour continuing education course on the safe and effective administration of vaccines and epinephrine autoinjection as part of biennial relicensure or recertification. T,F
False, [Florida Statues Chapter 465, 465.009(6)(a)]. Each pharmacist certified to administer a vaccine or epinephrine autoinjection must complete a 3-hour (NOT 6 hours) continuing education course, which shall be offered by a statewide professional association of physicians in this state accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award (AMA PRA) Category I credit, on the safe and effective administration of vaccines and epinephrine autoinjection as part of biennial relicensure or recertification. This course may be offered in a distance-learning format and must be included in the 30 hours of continuing professional pharmaceutical education.
A pharmacy permit may be issued to a partnership if at least one person of said partnership is at least 18 years of age or older. T/F
False, [Florida Statues Chapter 465, 465.022]. 1). A pharmacy permit may be issued only to a natural person who is at least 18 years of age, to a partnership comprised of at least one natural person and all of whose partners are at least 18 years of age, to a governmental agency, or to a business entity that is properly registered with the Secretary of State, if required by law, and has been issued a federal employer tax identification number. 2). Permits issued to business entities may be issued only to entities whose affiliated persons, members, partners, officers, directors, and agents, including persons required to be fingerprinted under subsection (3), are not less than 18 years of age. 3). An application for a pharmacy permit must include a set of fingerprints from each person having an ownership interest of 5 percent or greater and from any person who, directly or indirectly, manages, oversees, or controls the operation of the applicant, including officers and members of the board of directors of an applicant that is a corporation. 4). For corporations having more than $100 million of business taxable assets in this state, in lieu of these fingerprint requirements, the department shall require the prescription department manager or consultant pharmacist of record who will be directly involved in the management and operation of the pharmacy to submit a set of fingerprints.
Which of the following is/are true about destroying controlled substances in Class I institutional pharmacies located in Nursing Homes? I. Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed. II. A document must be completed showing the name and quantity of the drug, strength and dosage form, patient's name, prescription number and name of the nursing home. III. The filled document, at the time of destruction, shall be witnessed and signed ONLY by the DEA officer. I I,II II,III All
I and II, [Florida Administrative Code 64B16-28.301(1)(2)]. The destruction of controlled substances in Class I institutional pharmacies located in nursing homes can be done by following ways: 1. Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed. 2. A document must be completed showing the name and quantity of the drug, strength and dosage form, patient's name, prescription number and name of the nursing home. 3. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee, which may include a licensed physician, mid-level practitioner, nurse, another pharmacist, or a sworn law enforcement officer.
Which of the following information about Plan-B One Step is/are TRUE? I. It is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. II. With Plan B One-Step, a patient has up to 72 hours to prevent a pregnancy. III. If a patient is 15 or older, Plan B One-Step is available ONLY through a prescription. I I,II II,III All
I and II are true. Plan B One-Step is a backup plan that helps prevent pregnancy after birth control failure. The sooner a patient takes an emergency contraception, the better it works. Plan B One-Step requires just one pill. Other emergency contraception requires two pills, 12 hours apart. With Plan B One-Step, a patient has up to 72 hours (3 days) to prevent a pregnancy. It is not the abortion pill and it isn't a substitute for routine birth control. Plan B is available to all Over-The-Counter without the prescription or presenting an id. A patient is required to take a single pill, as soon as possible within 72 hours, after an unprotected intercourse or a contraceptive failure.
If a pharmacy permit is revoked the person owning or operating the establishment shall not be entitled to make application for a permit to operate a pharmacy for a period of at least 2 years from the date of such revocation. T,F
False, [Florida Statues Chapter 465, 465.023(2)]. 1). If a pharmacy permit is revoked or suspended, the owner, manager, or proprietor shall cease to operate the establishment as a pharmacy as of the effective date of such suspension or revocation. 2). In the event of such revocation or suspension, the owner, manager, or proprietor shall remove from the premises all signs and symbols identifying the premises as a pharmacy. The period of such suspension shall be prescribed by the Board of Pharmacy, but in no case shall it exceed 1 year. 3). In the event that the permit is revoked, the person owning or operating the establishment shall not be entitled to make application for a permit to operate a pharmacy for a period of 1 year from the date of such revocation. 4). Upon the effective date of such revocation, the permittee shall advise the Board of Pharmacy of the disposition of the medicinal drugs located on the premises. Such disposition shall be subject to continuing supervision and approval by the Board of Pharmacy.
A pharmacist may administer which of the following vaccines to an adult? I. Influenza vaccine II. Pneumococcal vaccine III. MMR vaccine I I,II II,III Alll
All, [Florida Statues Chapter 465, 465.189]. (1). In accordance with guidelines of the Centers for Disease Control and Prevention for each recommended immunization or vaccine, a pharmacist, or a registered intern under the supervision of a pharmacist who is certified, may administer the following vaccines to an adult within the framework of an established protocol under a supervising physician licensed: (a). Immunizations or vaccines listed in the Adult Immunization Schedule as of February 1, 2015, by the United States Centers for Disease Control and Prevention. The board may authorize, by rule, additional immunizations or vaccines as they are added to the Adult Immunization Schedule. (b). Immunizations or vaccines recommended by the United States Centers for Disease Control and Prevention for international travel as of July 1, 2015. The board may authorize, by rule, additional immunizations or vaccines as they are recommended by the United States Centers for Disease Control and Prevention for international travel. (c). Immunizations or vaccines approved by the board in response to a state of emergency declared by the Governor pursuant to s. 252.36. A registered intern who administers an immunization or vaccine under this subsection must be supervised by a certified pharmacist at a ratio of one pharmacist to one registered intern. (2). In order to address any unforeseen allergic reaction, a pharmacist may administer epinephrine using an autoinjector delivery system within the framework of an established protocol under a supervising physician. (3). A pharmacist may not enter into a protocol unless he or she maintains at least $200,000 of professional liability insurance and has completed training in administering vaccines authorized under this section. (4). A pharmacist administering vaccines under this section shall maintain and make available patient records for a minimum of 5 years. (5). Any pharmacist or registered intern seeking to administer vaccines to adults under this section must be certified to administer such vaccines pursuant to a certification program approved by the Board of Pharmacy in consultation with the Board of Medicine and the Board of Osteopathic Medicine. The certification program shall, at a minimum, require that the pharmacist attend at least 20 hours of continuing education classes approved by the board and the registered intern complete at least 20 hours of coursework approved by the board. (6). The pharmacist shall submit to the Board of Pharmacy a copy of his or her protocol or written agreement to administer vaccines under this section.
Which of the following drug(s) is classified as a controlled substance? Cipro,Vibramycin,Lyrica,Antara
yrica (Pregabalin) is classified as a Schedule V controlled substance, [Florida Pharmacy Statues DRUG ABUSE PREVENTION AND CONTROL 893.03 Schedule V].
A pharmacist who fills, compounds, or dispenses prescriptions without holding an active license as a pharmacist shall be considered committing a misdemeanor of the: First degree, 2nd degree,3rd,4th
Third degree, [Florida Statues Chapter 465, 465.015(2)(b), (5)]. Misdemeanor of the Third Degree (a). To make a false or fraudulent statement, either for herself or himself or for another person, in any application, affidavit, or statement presented to the board or in any proceeding before the board. (b). To fill, compound, or dispense prescriptions or to dispense medicinal drugs if such person does not hold an active license as a pharmacist in this state, is not registered as an intern in this state, or is an intern not acting under the direct and immediate personal supervision of a licensed pharmacist. (c). To sell or dispense drugs as defined in s. 465.003(8) without first being furnished with a prescription. (d). To sell samples or complimentary packages of drug products. Misdemeanor of the First Degree 1). To own, operate, maintain, open, establish, conduct, or have charge of, either alone or with another person or persons, a pharmacy: (a). Which is not registered under the provisions of this chapter. (b). In which a person not licensed as a pharmacist in this state or not registered as an intern in this state or in which an intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist fills, compounds, or dispenses any prescription or dispenses medicinal drugs. 2). To use the title "pharmacist" or "druggist" or otherwise lead the public to believe that she or he is engaged in the practice of pharmacy. 3). To use the title "pharmacist" or "druggist" (other than an owner of a pharmacy registered) or otherwise lead the public to believe that she or he is engaged in the practice of pharmacy. 4). Use a trade name, sign, letter, or advertisement any term, including "drug," "pharmacy," "prescription drugs," "Rx," or "apothecary," (by a a person, firm, or corporation that is not licensed or registered) which implies that the person, firm, or corporation is licensed or registered to practice pharmacy in this state. 5). To perform the functions of a registered pharmacy technician without being registered as a pharmacy technician.
Oxygen is a drug and therefore requires prescribing in all but emergency situations. T/F
True. Oxygen is a drug and therefore requires prescribing in all but emergency situations. In the emergency situation oxygen prescription is not required. Before oxygen therapy is prescribed there are guidelines or criteria that must be met. These criteria involve a blood test. (These blood test criteria must also be met for Medicare and other insurers to pay for the oxygen costs.) Medical experts produced the criteria. They establish what the levels of oxygen in the blood must be for oxygen therapy to be needed. These guidelines describe three conditions that require the use of oxygen therapy: 1. PaO2 is less than or equal to 55 mmHg. Or hemoglobin oxygen saturation (SaO2) measured by pulse oximeter is less than or equal to 88 percent when breathing room air at rest. 2. PaO2 of 56-59 mmHg. Or if the hemoglobin oxygen saturation (SaO2) is equal to or greater than 89 percent when linked to specific conditions. These may include Cor Pulmonale, congestive heart failure or erythrocytosis. (With a hematocrit of greater than 56 percent.) (Erythrocytosis means there are more red cells in the blood than normal. Hematocrit measures the percentage of cells in a sample of blood.) 3. Some individuals do not qualify for oxygen therapy while at rest. But they may require oxygen while walking, exercising or during sleep. Oxygen therapy is needed in these cases when the hemoglobin oxygen saturation (SaO2) falls to less than or equal to 88 percent. Also, for the costs of oxygen to be covered by insurance there must be proof that the oxygen therapy used during exercise or sleep improves the individual's hypoxemia. A physician must write a prescription for oxygen therapy prior to delivery. The prescription will indicate the flow rate, how much oxygen you need per minute -- referred to as liters per minute (LPM) -- and when a patient needs to use oxygen. Also necessary is Diagnosis, portability (if needed), and length of need. Some people use oxygen therapy only while sleeping, others only while exercising, and still others need oxygen continuously. The physician will order a blood test or oximetry test that will indicate what the patient's oxygen level is and help determine what his/her needs are. A written prescription is required prior to delivery. Certain insurance polices may pay for all your oxygen, but payment is based on laboratory results, diagnosis, and other information. The information listed below will help to determine insurance coverage. Medicare - In addition to a prescription, Medicare requires a Certificate of Medical Necessity (CMN) to be filled out by your physician. CMN Oxygen requirements are as follows: 1. Length of need 2. Diagnosis, a respiratory ailment showing the need for oxygen 3. Oxygen Blood Gas to be 56-59 or below, or Oxygen Saturation level to be 89 or below 4. How the test was taken, room air, during exercise, or while sleeping 5. The testing facility where blood gasses or oximetry was performed 6. Portability if needed 7. Liter flow prescribed 8. Physicians Signature 9. Date
Who can be witnesses for destruction of controlled substances in Class I Institutional Pharmacies located in Nursing Homes? I. The nursing home administrator II. The licensed consultant pharmacist III. The director of nursing I, I,II II,III All
All, [Florida Administrative Code 64B16-28.301(1)(2)]. Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed. A document must be completed showing the name and quantity of the drug, strength and dosage form, patient's name, prescription number and name of the nursing home. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee, which may include a licensed physician, mid-level practitioner, nurse, another pharmacist, or a sworn law enforcement officer.
In Florida, only a pharmacist or pharmacy-intern may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy. T,F
False, [Florida Administrative Code 64B16-27.1001(3)]. In Florida, only a PHARMACIST may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy.
Which of the following can keep drug samples? I. Saint Agnes Hospital II. Dr. Bernard's office III. Rite-Aid Pharmacy I I,II II,III All
I and II only, [Florida Administrative Code 64B16-27.615, Florida Drug and Cosmetic Act 499.028(3)(e), 21CFR203.20]. The hospital and prescriber offices can keep drug samples. Pharmacies (e.g. Rite Aid) may not be in possession of sample medicinal drugs except: (a). Pharmacies may possess the sample medicinal drugs that are listed within Rule 64B16-27.220, F.A.C., Medicinal Drugs That May be Ordered by Pharmacists. (b). Institutional pharmacies may possess sample medicinal drugs upon the written request of the prescribing practitioner. Such possession must be in accordance with the provisions of Section 499.028(3)(e)2., F.S. (c). Those community pharmacies that are pharmacies of health care entities, as defined by Sections 499.003(3) and (14), F.S., may possess sample medicinal drugs upon the written request of the prescribing practitioner. Such possession must be in accordance with the provisions of Section 499.028(3)(e)2., F.S.
Registered Pharmacy technicians shall NOT: I. Receive new verbal prescriptions II. Engage in prospective drug review III. Initiate communication to confirm the patient's name, medication, strength, quantity, directions and date of last refill I I,II II,III All
I and II only, [Florida Administrative Code 64B16-27.420]. (1). Registered pharmacy technicians may assist the pharmacist in performing the following tasks: (a). Retrieval of prescription files, patient files and profiles and other such records pertaining to the practice of pharmacy; (b). Data Entry; (c). Label preparation; (d). The counting, weighing, measuring, pouring and mixing of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system; (e). Initiate communication to a prescribing practitioner or their medical staffs (or agents) regarding patient prescription refill authorization requests; (f). Initiate communication to confirm the patient's name, medication, strength, quantity, directions and date of last refill; (g). Initiate communication to a prescribing practitioner or their medical staff (or agents) to obtain clarification on missing or illegible dates, prescriber name, brand/generic preference, quantity, DEA registration number or license numbers; and (h). May accept authorization for a prescription renewal. For the purposes of this section, "prescription renewal" means the dispensing of medications pursuant to a practitioner's authorization to fill an existing prescription that has no refill remaining. (2). Registered Pharmacy technicians shall not: (a). Receive new verbal prescriptions or any change in the medication, strength or directions; (b). Interpret a prescription or medication order for therapeutic acceptability and appropriateness; (c). Conduct a final verification of dosage and directions; (d). Engage in prospective drug review; (e). Provide patient counseling; (f). Monitor prescription usage; and (g). Override clinical alerts without first notifying the pharmacist.
The pharmacist shall maintain patient profiles for all patients for whom the pharmacist orders and dispenses medicinal drug products for a period of: 3 months,4yrs,3yrs,5yrs
4 years, [Florida Administrative Code 64B16-27.210 (7) to (10)]. The pharmacist shall maintain patient profiles, separate from the prescription order, for all patients for whom the pharmacist orders and dispenses medicinal drug products and shall initial and date each profile entry. Such profiles shall be maintained at the pharmacy wherein the ordering and dispensing originated for a period of 4 years. In the patient profiles, the pharmacist shall record as a minimum the following information if a medicinal drug product is ordered and dispensed. (a). Patient's chief complaint or condition in the patient's own words. (b). A statement regarding the patient's medical history. (c). A statement regarding the patient's current complaint which may include, onset, duration and frequency of the problem. (d). The medicinal drug product ordered and dispensed. (e). The pharmacist ordering and dispensing the medicinal drug product shall initial the profile. (f). The prescription number shall be recorded in the patient's profile. A medicinal drug product may be ordered, and dispensed only by the pharmacist so ordering. Only legend medicinal drugs may be prescribed by a pharmacist. Over-the-counter drugs are exempt from the requirements of this rule and shall be recommended as over-the-counter products.
Who may counsel a patient under the Florida State Pharmacy Law? I. a licensed pharmacist II. a registered pharmacy intern III. a certified pharmacy technician I, I,II II,III All
I and II only, [Florida Administrative Code 64B16-27.820(1)]. Upon receipt of a new or refill prescription, the pharmacist shall ensure that a verbal and printed offer to counsel is made to the patient or the patient's agent when present. If the delivery of the drugs to the patient or the patient's agent is not made at the pharmacy the offer shall be in writing and shall provide for toll-free telephone access to the pharmacist. If the patient does not refuse such counseling, the pharmacist, or the pharmacy intern, acting under the direct and immediate personal supervision of a licensed pharmacist, shall review the patient's record and personally discuss matters which will enhance or optimize drug therapy with each patient or agent of such patient. Such discussion shall be in person, whenever practicable, or by toll-free telephonic communication and shall include appropriate elements of patient counseling.
Consultant pharmacists and pharmacists holding the Doctor of Pharmacy degree may order and evaluate laboratory tests under the Florida State Pharmacy Law. T/F
True, [Florida Administrative Code 64B16-27.120]. Those consultant pharmacists and pharmacists holding the Doctor of Pharmacy degree that meet the continuing education requirements of Rule 64B16-26.320, F.A.C., may order and evaluate laboratory tests to the extent allowed by the provisions of Section 465.0125, F.S. Evidence of such training and authorization to perform these tasks shall be furnished to the board, the patient, or the patient's physician upon request.
Which of the following shall be present on a prescription container label if the medication were filled by using centralized prescription filling services? I. The name and address of the originating pharmacy. II. The name and address of both originating as well as central filled pharmacy. III. The name and address of only central filled pharmacy. I II III All
I only, [Florida Administrative Code 64B16-28.450(4)]. 1). The central fill and originating pharmacy shall each be identified on the prescription container label. 2). The originating pharmacy shall be identified with pharmacy name and address. 3). The central fill pharmacy may be identified by a code (Name and Address are not required) available at the originating pharmacy.
In order to compliant with the Law, a non-resident pharmacy shall be opened: I. Not less than 6 days per week II. Not less than 40 hours per week III. At least two Sunday of a calendar month. I I,II II,III All
I and II are required, [Florida Statues Chapter 465, 465.0156(1)(e)]. 1). Any pharmacy which is located outside this state and which ships, mails, or delivers, in any manner, a dispensed medicinal drug into this state shall be considered a nonresident pharmacy. It shall disclose to the board the following specific information: (a). That it maintains at all times a valid, unexpired license, permit, or registration to operate the pharmacy in compliance with the laws of the state in which the dispensing facility is located and from which the medicinal drugs shall be dispensed; (b). The location, names, and titles of all principal corporate officers and the pharmacist who serves as the prescription department manager for dispensing medicinal drugs to residents of this state. This disclosure shall be made within 30 days after any change of location, corporate officer, or pharmacist serving as the prescription department manager for dispensing medicinal drugs to residents of this state; (c). That it complies with all lawful directions and requests for information from the regulatory or licensing agency of all states in which it is licensed as well as with all requests for information made by the board pursuant to this section. It shall respond directly to all communications from the board concerning emergency circumstances arising from errors in the dispensing of medicinal drugs to the residents of this state; (d). That it maintains its records of medicinal drugs dispensed to patients in this state so that the records are readily retrievable from the other business records of the pharmacy and from the records of other medicinal drugs dispensed; and (e). That during its regular hours of operation but not less than 6 days per week, for a minimum of 40 hours per week, a toll-free telephone service shall be provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll-free number must be disclosed on the label affixed to each container of dispensed medicinal drugs.
A Consultant Pharmacist License Renewal Continuing Education Program must contain at least 3 hours of training in: I. Drug Therapy Management and Monitoring II. Committee Responsibilities III. The Joint Commission on the Accreditation of Healthcare Organizations I I,II II,III I, or II or III or Alll
I or II or III or All, [Florida Administrative Code 64B16-26.302]. A Consultant Pharmacist License Renewal Continuing Education Program must contain at least three (3) hours of training in any of the subjects specified below. Duplicate courses are not acceptable. (1). Drug Therapy - Disease State. Patient Drug Therapy - management and monitoring. (a). Drug, Disease State Information - In-depth disclosure of the drug or therapeutic class of drugs or disease state including pharmacology, side effects and interaction. (b). New Therapeutic Modalities: Expansion of current drug therapy or treatment. (c). Patient Assessment: Assessment techniques by consultant pharmacist to determine the need and effectiveness of indicated drug therapy along with identification and assessment of side effects on patient's well-being. (d). Pertinent Laboratory Tests. (e). Therapeutic Dosing. (2). Administrative Responsibilities. (a). Update on Administrative Responsibilities. 1. Legal requirements including statutes, rules and regulation (Federal and State). 2. The Joint Commission on the Accreditation of Healthcare Organizations. 3. Personnel requirements. 4. Health Insurance Portability and Accountability. (b). Focus on Consultant Pharmacist Practice Issues/Concerns. 1. How to get things accomplished in complex organizations. 2. Key contacts to be effective as a consultant pharmacist. 3. Considerations and preparation for site inspections. (3). Consultant Pharmacist Facility Responsibilities. This segment details the requirements in one of the facility types for which a consultant pharmacist is required. Only one practice setting may be included in each program. (a). Pharmacist-Medication Responsibilities - Assessment mechanism for delivery system, review procedures and monitoring processes. (b). Pharmacist-Patient Responsibilities - Patient assessment, laboratory test monitoring and therapeutic dosing. (c). Committee Responsibilities - Make-up and responsibilities for various facility committees. (d). Reporting requirements.
A pharmacist may not dispense more than a 30-day supply of Tylenol No.3 upon an oral prescription issued in this state. T/F
True, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.04 (2),(e)]. A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III (e.g. Tylenol No.3) upon an oral prescription issued in this state.
According to Florida Comprehensive Drug Abuse Prevention and Control Act, the record of Schedule III, IV, or V controlled substances shall be made available for a period of at least 2 years for inspection and copying by law enforcement officers.
True, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.07(4)(a)(b)]: Every inventory or record required by this chapter, including prescription records, shall be maintained: (a). Separately from all other records of the registrant, or (b). Alternatively, in the case of Schedule III, IV, or V controlled substances, in such form that information required by this chapter is readily retrievable from the ordinary business records of the registrant. In either case, records shall be kept and made available for a period of at least 2 years for inspection and copying by law enforcement officers whose duty it is to enforce the laws of this state relating to controlled substances. Law enforcement officers are not required to obtain a subpoena, court order, or search warrant in order to obtain access to or copies of such records.
Which of the following is/are TRUE about Fluoride supplement treatment by a pharmacist under the Florida State Pharmacy Law? I. Oral medicinal drug products containing fluoride may be ordered by pharmacists for their patients who do not have fluoride supplement in their drinking water. II. Once a fluoride treatment has been initiated with one specific fluoride medicinal drug product it should not be interchanged with a product of a different manufacturer for the course of the treatment. III. No more than 500 mg of sodium fluoride may be dispensed at any one time to a patient. I I,II II,III All
I and II are true, [Florida Administrative Code 64B16-27.230]. Oral medicinal drug products containing fluoride may be ordered by pharmacists for their patients who do not have fluoride supplement in their drinking water, pursuant to the following limitations: (1). The fluoride content of drinking water does not exceed 0.5 ppm. (2). Once a fluoride treatment has been initiated with one specific fluoride medicinal drug product it should not be interchanged with a product of a different manufacturer for the course of the treatment. No more than 264 mg. of sodium fluoride (NOT 500 mg) may be dispensed at any one time to a patient. A pharmacist may continue a course of therapy with fluoride products until appropriate referral to another health care practitioner is indicated or in no event shall the course of therapy be more than one (1) year.
The stocking or restocking of a medicinal drug for an Automated Pharmacy System in a Community Pharmacy shall only be completed by a Florida licensed pharmacist.
True, [Florida Administrative Code 64B16-28.141(3)(b)(c)(d)]. "Automated pharmacy system" means a mechanical system, located within or adjacent to the prescription department, that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all transaction information. A pharmacy may use an automated pharmacy system provided that: (a). The pharmacy develops and maintains a policy and procedure manual that includes: 1. The type or name of the system including a serial number or other identifying nomenclature. 2. A method to ensure security of the system to prevent unauthorized access. Such method may include the use of electronic passwords, biometric identification (optic scanning or fingerprint) or other coded identification. 3. A process of filling and stocking the system with drugs; an electronic or hard copy record of medication filled into the system including the product identification, lot number, and expiration date. 4. A method of identifying all the registered pharmacy interns or registered pharmacy technicians involved in the dispensing process. The stocking or restocking of a medicinal drug shall only be completed by a Florida licensed pharmacist, except as provided in paragraph (c) below. (c). If the automated pharmacy system uses removable cartridges or container to store the drug, the stocking or restocking of the cartridges or containers may occur at a licensed repackaging facility and be sent to the provider pharmacy to be loaded by personnel designated by the pharmacist if: 1. A Florida pharmacist verifies the cartridge or container has been properly filled and labeled. 2. The individual cartridge or container is transported to the provider pharmacy in a secure, tamper-evident container. 3. The automated pharmacy system uses a bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the cartridge or container is accurately loaded into the automated pharmacy system. 4. The Florida pharmacist verifying the filling and labeling is responsible if the cartridge or container is stocked or restocked incorrectly by the personnel designated to load the cartridges or containers. (d). The automated pharmacy system must use at least two separate verifications, such as bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the proper medication is being dispensed from the automated system.
Which of the following is/are TRUE about Pharmacy Intern hours under the Florida State Pharmacy Law? I. All internship hours may be obtained prior to the applicant's graduation. II. Proof of completion of an internship program shall consist of a certification that the applicant has completed 2080 internship hours. III. Hours worked in excess of 50 hours per week prior to the applicant's graduation or in excess of 60 hours per week after an applicant's graduation, will not be credited toward meeting the required internship hours. I I,II II,III All
All, [Florida Administrative Code 64B16-26.2032(8),(9),(10),(11) and 64B16-26.2033(8),(9),(10),(11)]. US Graduates: 1. All internship hours may be obtained prior to the applicant's graduation. 2. Proof of completion of an internship program shall consist of a certification that the applicant has completed 2080 internship hours. 3. Hours worked in excess of 50 hours per week prior to the applicant's graduation or in excess of 60 hours per week after an applicant's graduation, will not be credited toward meeting the required internship hours. Foreign Graduates: 1. All internship hours may be obtained prior to the applicant's graduation. 2. Proof of completion of an internship program shall consist of a certification that the applicant has completed 1580 internship hours. 3. Hours worked in excess of 50 hours per week prior to the applicant's graduation or in excess of 60 hours per week after an applicant's graduation, will not be credited toward meeting the required internship hours. 4. All foreign pharmacy graduates must complete 500 hours of supervised work activity within the state of Florida as provided by Section 465.007(1)(b)2., F.S. Further, these 500 hours of work activity program shall not be recognized for any applicant until said applicant has obtained the passing score on the Foreign Pharmacy Graduate Equivalency Exam.
The prescription department manager or consultant pharmacist of record is required to submit a written request and receive approval prior to the pharmacy's allowing a pharmacist to supervise more than one registered pharmacy technician at any given time as permitted by law. True,False
True, [Florida Administrative Code 64B16-27.410]. Registered pharmacy technicians may assist a pharmacist in performing professional services within a pharmacy environment provided that no pharmacist shall supervise more than one registered pharmacy technician unless otherwise permitted by the Florida Board of Pharmacy. The prescription department manager or consultant pharmacist of record is required to submit a written request and receive approval prior to the pharmacy's allowing a pharmacist to supervise more than one registered pharmacy technician as permitted by law. Such requests shall be reviewed and pre-approved by Board staff according to the guidelines adopted herein, and submitted to the Board for ratification. The request to practice with a ratio greater than 1:1 shall include a brief description of the workflow needs that justify the ratio request. The brief description of workflow needs shall include the operating hours of the pharmacy, number of pharmacists, registered interns, and registered pharmacy technicians employed.
Every person who engages in the dispensing shall notify the theft or significant loss of controlled substances to the sheriff of that county within 24 hours after discovery. T & F
True, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.07(5)(b)]. Every person who engages in the manufacture, compounding, mixing, cultivating, growing, or by any other process producing or preparing, or in the dispensing, importation, or, as a wholesaler, distribution, of controlled substances shall: (a). Maintain a record which shall contain a detailed list of controlled substances lost, destroyed, or stolen, if any; the kind and quantity of such controlled substances; and the date of the discovering of such loss, destruction, or theft. (b). In the event of the discovery of the theft or significant loss of controlled substances, report such theft or significant loss to the sheriff of that county within 24 hours after discovery. A person who fails to report a theft or significant loss of a substance listed in III, IV or V within 24 hours after discovery as required in this paragraph commits a misdemeanor of the second degree. A person who fails to report a theft or significant loss of a substance listed in Schedule II within 24 hours after discovery as required in this paragraph commits a misdemeanor of the first degree. *Please Note*: Under Florida Pharmacy Act 465.022 (10)(11)(c): The prescription department manager must notify the BOARD of any theft or significant loss of any controlled substances within 1 business day after discovery of the theft or loss.
Ownership of medicinal drugs may be transferred to a new owner upon the change of ownership of a pharmacy. In this regard, the transferor pharmacy shall provide the Florida Board of Pharmacy with which of the following information? I. The name, address, pharmacy permit number and D.E.A. registration number of the transferor pharmacy. II. The name, address, pharmacy permit number and D.E.A. registration number of the transferee entity. III. The date on which the transfer will occur. I I,II II,III All
All, [Florida Administrative Code 64B16-28.203(5)]. Ownership of medicinal drugs may be transferred to a new owner upon the change of ownership of a pharmacy. In this regard, the transferor pharmacy shall provide the Florida Board of Pharmacy with the following information: 1. The name, address, pharmacy permit number and D.E.A. registration number of the transferor pharmacy. 2. The name, address, pharmacy permit number and D.E.A. registration number of the transferee entity. 3. The date on which the transfer will occur. 4. Unless the permittee-transferor is informed by the Board of Pharmacy or the regional D.E.A. Administrator prior to the date on which the transfer was stated to occur, that the transfer may not occur, the permittee-transferor may proceed with the transfer. 5. A complete inventory of all medicinal drugs on the date of transfer. If the medicinal drug is listed in Schedule II, the transferor shall make an exact count or measure of the contents. If the medicinal drugs are listed in Schedule III, IV, or V, the transferor shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules, in which case an exact count of the contents shall be made. This inventory shall serve as the final inventory of the permittee transferor and the transfer inventory of the transferee entity. The transferor and transferee shall retain a copy of the inventory in their records and shall provide the Board of Pharmacy with a copy of such inventory. 6. Transfer of any controlled substance in Schedule II shall require the use of order form, D.E.A. form number 222. 7. It is the responsibility of the permittee-transferor to return all unused Schedule II order forms (D.E.A. form no. 222) to the regional D.E.A. office.
Which of the following are TRUE about prescription blanks under Florida State Pharmacy Law? I. Counterfeit-resistant prescription blanks shall be used for prescribing controlled substances listed in Schedule II, III, IV or V. II. The Department of Health may require the prescription blanks to be printed on distinctive, watermarked paper. III. The prescription blanks may be transferred to another licensed registrant upon authorization from the Board under Florida Comprehensive Drug Abuse Prevention and Control Act. I I and II II,III All
I and II only, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.065]. The Department of Health shall develop and adopt by rule the form and content for a counterfeit-resistant prescription blank which may be used by practitioners for the purpose of prescribing a controlled substance listed in Schedule II, III, IV or V. The Department of Health may require the prescription blanks to be printed on distinctive, watermarked paper and to bear the preprinted name, address, and category of professional licensure of the practitioner and that practitioner's federal registry number for controlled substances. The prescription blanks may NOT be transferred.
In which of the following instances, a dispensing of a drug shall be classified as misbranded? 1tablet falls to floor dispensed by rph 2spider found in orignal manufacturer container 3 a returned drug is mixed with the drug containing a different lot number 4 drug is compounded without properly sanitizing the compounding area
Misbranded, [Food, Drugs And Cosmetics 53-1-109]. The choices a, b and d are considered to be adulterated. A drug shall be classified as misbranded if: (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.
A pharmacist administering influenza virus immunizations shall maintain patient records for: 2years,3years,5years,
5 years, [Florida Pharmacy Act 465.189(4)]. (1). Pharmacists may administer influenza virus immunizations to adults within the framework of an established protocol under a supervisory practitioner who is a physician licensed under chapter 458 or chapter 459 of Florida State Law. Each protocol shall contain specific procedures for addressing any unforeseen allergic reaction to influenza virus immunizations. (2). A pharmacist may not enter into a protocol unless he or she maintains at least $200,000 of professional liability insurance and has completed training in influenza virus immunizations as provided in this section. (3). A pharmacist administering influenza virus immunizations shall maintain and make available patient records using the same standards for confidentiality and maintenance of such records as those that are imposed on health care practitioners under s. 456.057. These records shall be maintained for a minimum of 5 years. (4). The decision by a supervisory practitioner to enter into a protocol under this section is a professional decision on the part of the practitioner, and a person may not interfere with a supervisory practitioner's decision as to entering into such a protocol. A pharmacist may not enter into a protocol that is to be performed while acting as an employee without the written approval of the owner of the pharmacy. Pharmacists shall forward immunization records to the department for inclusion in the state registry of immunization information. (5). Any pharmacist seeking to administer influenza virus immunizations to adults under this section must be certified to administer influenza virus immunizations pursuant to a certification program approved by the Board of Pharmacy in consultation with the Board of Medicine and the Board of Osteopathic Medicine. The certification program shall, at a minimum, require that the pharmacist attend at least 20 hours of continuing education classes approved by the board. The program shall have a curriculum of instruction concerning the safe and effective administration of influenza virus immunizations, including, but not limited to, potential allergic reactions to influenza virus immunizations.
Which of the following is/are TRUE regarding the prescription department manager? I. A permittee must notify the department of the identity of the prescription department manager within 10 days after employment. II. The prescription department manager must notify the board of any theft or significant loss of any controlled substances within 1 business day after discovery of the theft or loss. III. A registered pharmacist may not serve as the prescription department manager in more than two locations at one time. I, I,II II,III All
I and II are true, [Florida Statues Chapter 465, 465.022(10),(11)(c)]. 1). A permittee must notify the department, on a form approved by the board, within 10 days after any change in prescription department manager or consultant pharmacist of record. A permittee must notify the department of the identity of the prescription department manager within 10 days after employment. 2). The prescription department manager must comply with the following requirements: (a). The prescription department manager of a permittee must obtain and maintain all drug records required by any state or federal law to be obtained by a pharmacy, including, but not limited to, records required by or under this chapter, chapter 499, or chapter 893. The prescription department manager must ensure the permittee's compliance with all rules adopted under those chapters as they relate to the practice of the profession of pharmacy and the sale of prescription drugs. (b). The prescription department manager must ensure the security of the prescription department. The prescription department manager must notify the board of any theft or significant loss of any controlled substances within 1 business day after discovery of the theft or loss. (c). A registered pharmacist may not serve as the prescription department manager in more than one location (NOT two locations) unless approved by the board.
Under Florida State Pharmacy Law, no person shall knowingly deliver in any single day, any number of packages that contain a total in excess of 3.6 grams of ephedrine or related compounds.
True, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.1495(1),(2)]. 1). A person may not knowingly obtain or deliver to an individual in any retail over-the-counter sale any nonprescription compound, mixture, or preparation containing ephedrine or related compounds in excess of the following amounts: (a). In any single day, any number of packages that contain a total of 3.6 grams of ephedrine or related compounds; (b). In any single retail, over-the-counter sale, three packages, regardless of weight, containing ephedrine or related compounds; or (c). In any 30-day period, in any number of retail, over-the-counter sales, a total of 9 grams or more of ephedrine or related compounds. 2). Any person purchasing, receiving, or otherwise acquiring any nonprescription compound, mixture, or preparation containing any detectable quantity of ephedrine or related compounds must: 1. Be at least 18 years of age. 2. Produce a government-issued photo identification showing his or her name, date of birth, address, and photo identification number or an alternative form of identification acceptable under federal regulation 8 C.F.R. s. 274a.2(b)(1)(v)(A) and (B). 3. Sign his or her name on a record of the purchase, either on paper or on an electronic signature capture device.
A pharmacist who is reconstituting the Amoxicillin Suspension adds 75cc of distilled water to reconstitute the suspension. However, the label instruction on Amoxicillin bottle suggests to add 125cc. The resultant compounding shall be classified as: Adulterated Misbranded
Misbranded, [(U.S.C.) Title 21, Chapter 9, Subchapter V, 502,352]. A drug shall be classified as misbranded if: ____________________________________ (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.
How many hours of study are required by a pharmacist to obtain an initial certification to administer an influenza vaccine to patients? 3hours,7,10,20
20 hours, [Florida Administrative Code 64B16-26.1031]. The Board shall approve for initial certification of pharmacist administration of influenza immunizations, programs of study not less than 20 hours that includes coursework covering all of the following: (1). Mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after vaccine administration; (2). Immunization Schedules; (3). Immunization screening questions, provision of risk/benefit information, informed consent, recordkeeping, and electronic reporting into the statewide immunization registry; (4). Vaccine storage and handling; (5). Bio-Hazardous waste disposal and sterile techniques; (6). Entering, negotiating and performing pursuant to physician oversight protocols; (7). Community immunization resources and programs; (8). Identifying, managing and responding to adverse incidents including but not limited to potential allergic reactions associated with vaccine administration; (9). Procedures and policies for reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS); (10). Reimbursement procedures and vaccine coverage by federal, state and local governmental jurisdictions and private third party payers; (11). Administration techniques; (12). The current influenza immunization guidelines and recommendations of the United States Department of Health Centers for Disease Control and Prevention; (13). Cardiopulmonary Resuscitation (CPR) training.
Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to the: American Medical Board of Association Dpartment of Health DEA Medical Board of Florida
Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to the Department of Health, [Florida Administrative Code 64B16-27.831 (5)].
Which of the following is/are TRUE about reactivating of pharmacist license under the Florida State Pharmacy law? I. The continuing education requirements for reactivating a license shall be at least 15 classroom hours for each year the license was inactive in addition to completion of the number of hours required for renewal on the date the license became inactive. II. An applicant may need to pay an application fee for inactive status, a renewal fee for inactive status, a delinquency fee, and a fee for the reactivation of a license. III. An applicant whose licensed is inactive for more than 2 years must pass MPJE as a part of reactivating his/her license. I I,II II,III All
I and II are true, [Florida Statues Chapter 465, 465.012]. 1). The board shall prescribe by rule continuing education requirements as a condition of reactivating a license. The continuing education requirements for reactivating a license shall be at least 15 classroom hours for each year the license was inactive in addition to completion of the number of hours required for renewal on the date the license became inactive. 2). The board shall adopt rules relating to application procedures for inactive status, to the biennial renewal of inactive licenses, and to the reactivation of licenses. 3). The board shall prescribe by rule an application fee for inactive status, a renewal fee for inactive status, a delinquency fee, and a fee for the reactivation of a license. None of these fees may exceed the biennial renewal fee established by the board for an active license. 4). The department may not reactivate a license unless the inactive or delinquent licensee has paid any applicable biennial renewal or delinquency fee, or both, and a reactivation fee.
Section 5
(50 cards)
Which of the following is/are TRUE regarding writing a prescription for a controlled substance listed in Schedule II, Schedule III, or Schedule IV? I. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include both a written and a numerical notation of the quantity of the controlled substance prescribed on the face of the prescription. II. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include a notation of the date in numerical, month/day/year format, or with the abbreviated month written out, or the month written out in whole. III. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not include the quantity or date written out in textual format, the pharmacist may dispense the controlled substance without verification by the prescriber of the quantity or date if the pharmacy previously dispensed another prescription for the person to whom the prescription was written. I, I,II II,III All
All, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.04(2)(d)]. 1. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include both a written and a numerical notation of the quantity of the controlled substance prescribed and a notation of the date in numerical, month/day/year format, or with the abbreviated month written out, or the month written out in whole. 2. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. 3. If the prescriber is not available to verify a prescription, the pharmacist may dispense the controlled substance but may insist that the person to whom the controlled substance is dispensed provide valid photographic identification. 4. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not include the quantity or date written out in textual format, the pharmacist may dispense the controlled substance without verification by the prescriber of the quantity or date if the pharmacy previously dispensed another prescription for the person to whom the prescription was written.
All of the following are required on an OTC medication label EXCEPT: Inactive ingredients, Directions, Expiration date, NDC number
The following information is required on any OTC medication label, [21CFR201.2, 21CFR207.35, 21CFR201.6-201.63 and 21CFR201.1-201.55]: 1. Drug Facts - title 2. Active ingredient(s)-including amount in each dosage unit 3. Purpose - pharmacologic class 4. Use(s) - indications 5. Warnings 6. Do not use - absolute contraindications, when the product should not be used under any circumstances 7. Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms 8. Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions 9. When using this product - side effects that could occur and substances or activities to avoid 10. Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately 11. Pregnancy/breast-feeding warning 12. Keep out of reach of children/Accidental overdose warnings 13. Direction - dosage and when, how, or how often to take 14. Other information 15. Inactive ingredients 16. Questions? (Optional) - followed by telephone number 17. Lot number 18. Expiration date 19. Name and addresses of manufacturer or distributor The National Drug Code (NDC) number is requested but NOT required to appear on all drug labels (prescription as well as OTC) and in all drug labeling, including the label of any prescription drug container furnished to a consumer. If the NDC number is shown on a drug label, it shall be displayed as required in [21CFR207.35(b)(3)].
A practitioner registered with a narcotic treatment program pursuant to the Narcotic Addict Treatment Act of 1974 may administer, dispense and prescribe scheduled narcotic drugs that are approved by the FDA for the treatment of narcotic addiction. T,F
True, [21CFR1306.07(a)(1), 21CFR1306.07(b) and http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section6.htm]. 1. Practitioners wishing to administer and dispense approved Schedule II controlled substances (that is, Methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program. Application for registration as a Narcotic Treatment Program is made using DEA Form 363. 2. In addition to obtaining this separate DEA registration, this type of activity also requires the approval and registration of the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS), as well as the applicable state methadone authority. 3. If a practitioner wishes to prescribe, administer, or dispense Schedule III, IV, or V controlled substances approved for addiction treatment (i.e., buprenorphine drug products), the practitioner must request a waiver (Form SMA-167) and fulfill the requirements of CSAT. CSAT will then notify DEA of all waiver requests. DEA will review each request. If DEA approves this waiver, the practitioner will receive a Unique Identification Number. 4. If a practitioner chooses to dispense controlled substances, the practitioner must maintain, separate from all other records, for a period of at least two years, all required records of receipt, storage, and distribution. If a practitioner chooses to prescribe these controlled substances, the practitioner must utilize their Unique Identification Number on the prescription in addition to his/her regular DEA registration number. 5. An exception to the registration requirement, known as the "three day rule" (21CFR1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient's referral for treatment, under the following conditions: I. Not more than one day's medication may be administered or given to a patient at one time; II. This treatment may not be carried out for more than 72 hours and; III. This 72-hour period cannot be renewed or extended. 6. The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. It should be noted that although Buprenex, a Schedule III controlled substance, is currently approved for the treatment of pain, it may not be prescribed or dispensed for use in narcotic addiction treatment, including the treatment of withdrawal symptoms as provided above under the three-day rule.
Which of the following forms is required to change the name of person or establishment on already issued pharmacy permit? Form DH-MQA 1227 Form DH-MQA 1214 Form DH-MQA PH10 Form DH-MQA PH10
Form DH-MQA 1227, [Florida Administrative Code 64B16-28.100]. A permit is valid only for the name and address to which it is issued. The name in which the permit is issued must be the name in which the company is doing business, i.e., the name that appears on purchase and sales invoices. A permit shall be issued only to a single entity at a single location. The name in which a permit is issued may be changed upon notification to the board. To change the name in which a permit is issued the person or establishment must file with the board an original Form DH-MQA 1227 "Pharmacy Permit Name Change Form". Form DH-MQA 1214: Applicants for a community pharmacy permit must complete an application for a permit using an original Form DH-MQA 1214, "Community Pharmacy Permit Application and Information." Form DH-MQA PH10: The permittee and the newly designated prescription department manager shall notify the board within 10 days of any change in the prescription department manager using an original Form DH-MQA PH10, "Prescription Department Manager Change." Form DH-MQA 1215: Applicants for a Institutional Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1215, "Institutional Pharmacy Permit Application and Information". Form DH-MQA 1184:The Board shall be notified in writing within 10 days of any change in the consultant pharmacist of record using an original Form DH-MQA 1184, "Change of Consultant Pharmacist of Record". Form DH-MQA 1218: Applicants for a Nuclear Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1218, "Nuclear Pharmacy Permit Application and Information." Form DH-MQA 1220: Applicants for a Special-Limited Community, Special - Parenteral and Enteral, Special - Closed System Pharmacy, Special - End Stage Renal Disease (ESRD), Special - Parenteral/Enteral Extended Scope, and Special - Assisted Living Facility (ALF) permits must complete an application for a permit using an original Form DH-MQA 1220, "Special Pharmacy Permit Application and Information." Applicants for an Internet Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1220. Form DH-MQA 1217: Applicants for a Non-Resident Registration must complete an application for a registration using an original Form DH-MQA 1217, "Non-Resident Pharmacy Permit Application and Information."
If a pharmacy technician, an accidentally, mixes two bottles of Tylenol syrup with the same strength but different lot numbers and expiration dates, the resultant mixture should be classified as a(n): adulterated,misbranded
Misbranded, [Food, Drugs And Cosmetics 53-1-109]. A drug shall be classified as misbranded if: (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.
Who may prescribe non-controlled substances under the Florida State Pharmacy Law? I. a licensed prescriber II. a registered nurse practitioner III. a licensed physician assistant I, I,II II,III All
All, [Florida Health Professions and Occupations, Chapter 456, Section 456.0392]. (1). A prescription written by a practitioner who is authorized under the laws of Florida state to write prescriptions for drugs that are not listed as controlled substances but who is not eligible for a federal Drug Enforcement Administration number shall include that practitioner's name and professional license number. The pharmacist or dispensing practitioner must include the practitioner's name on the container of the drug that is dispensed. (2). A prescription for a drug that is not listed as a controlled substance which is written by an advanced registered nurse practitioner certified is presumed to be valid and within the parameters of the prescriptive authority delegated by a practitioner licensed under chapter 458, chapter 459, or chapter 466. (3). A prescription for a drug that is not listed as a controlled substance which is written by a licensed physician assistant is presumed to be valid and within the parameters of the prescriptive authority delegated by the physician assistant's supervising physician.
The compounding of Cisplatin shall be performed under: Vertical Laminar flow, Horizontal laminar flow,
Vertical laminar flow, [Florida Administrative Code 64B16-27.797(6)(a)]. (1). All anti-neoplastic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet, or similar preparation area. (2). Protective apparel shall be worn by personnel compounding anti-neoplastic drugs. (3). Prepared doses of anti-neoplastic drugs must be dispensed, labeled with precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container. (4). Disposal of cytotoxic waste shall comply with all applicable federal, state, and local requirements. (5). A "Chemo Spill Kit" shall be readily available in the work area, and shall consist of appropriate materials needed to clean up spills of hazardous drugs. Personnel shall be trained in its appropriate use for handling both minor and major spills of cytotoxic agents.
According to Florida Pharmacy Law, which of the following is/are included in a negative drug formulary? I. Theophylline II. Conjugated estrogen III. Dicumarol I, I,II II,III All
All, [Florida Administrative Code 64B16-27.500]. The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Florida Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. The following are included on the negative drug formulary: (1). Digitoxin. (2). Conjugated Estrogen. (3). Dicumarol. (4). Chlorpromazine (Solid Oral Dosage Forms). (5). Theophylline (Controlled Release). (6). Pancrelipase (Oral Dosage Forms). Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a brand name equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is non-applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements.
A change in the company or person who leases the building where the permit is housed or a change in the management company which contracts with the owner of the permit for the operation of the permit does not constitute a change in ownership (and issuance of a new permit number). T,F
True, [Florida Administrative Code 64B16-28.2021]. (1). A pharmacy permit is not transferable. Upon the sale of an existing pharmacy, a new application must be filed. In those cases where the permit is held by a corporation, the transfer of all the stock of said corporation to another person or entity does not constitute a change of ownership, provided that the initial corporation holding the permit continues to exist. (2). A change in ownership (and issuance of a new permit number) requires that new records be started and old records closed. The process for closing a pharmacy, including the transfer of prescription files and medicinal drugs, as outlined in Rules 64B16-28.202 and 64B16-28.203, F.A.C., must be followed for the old permit. If the old permit has controlled substances, the new permit must record an "opening inventory" for DEA purposes. Both the new permit and the old permit must keep appropriate records for 4 years for the transfer of legend drugs and controlled substances. (3). A change in the company or person who leases the building where the permit is housed or a change in the management company which contracts with the owner of the permit for the operation of the permit does not constitute a change in ownership.
Which of the following criteria shall cause a pharmacist to question whether a prescription for a controlled substance was issued for a legitimate medical purpose? I. One person presents controlled substance prescriptions with different patient names. II. Same or similar controlled substance medication is prescribed by two or more prescribers at same time. III. Patient always pays cash and always insists on brand name product. I, I,II II,III All
All, [Florida Administrative Code 64B16-27.831 (2)]. (2). The following criteria shall cause a pharmacist to question whether a prescription was issued for a legitimate medical purpose: (a). Frequent loss of controlled substance medications, (b). Only controlled substance medications are prescribed for a patient, (c). One person presents controlled substance prescriptions with different patient names, (d). Same or similar controlled substance medication is prescribed by two or more prescribers at same time, (e). Patient always pays cash and always insists on brand name product. If any of the criteria in (2) is met, the pharmacist shall: (a). Require that the person to whom the medication is dispensed provide picture identification and the pharmacist should photocopy such picture identification for the pharmacist's records. (b). If a photocopier is not available, the pharmacist should document on the back of the prescription complete descriptive information from the picture identification. (c). If the person to whom medication is dispensed has no picture identification, the pharmacist should confirm the person's identity and document on the back of the prescription complete information on which the confirmation is based.
Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility are considered to be the part of the inventory of that LTCF. T,F
False, [Florida Pharmacy Act 465.0235(2)]. Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution are part of the inventory of the pharmacy (NOT of LTCF since LTCF does not have its own pharmacy) providing pharmacy services to that facility, hospice, or institution, and drugs delivered by the automated pharmacy system are considered to have been dispensed by that pharmacy. The operation of an automated pharmacy system must be under the supervision of a Florida-licensed pharmacist. To qualify as a supervisor for an automated pharmacy system, the pharmacist need not be physically present at the site of the automated pharmacy system and may supervise the system electronically.
A prescription for Vicodin can be refilled how many times? cannot be refilled, 5 times, as needed within 1 year, maximum 10 times
Cannot be refilled, [http://www.nabp.net/news/dea-reschedules-hydrocodone-combination-products-as-schedule-ii]. Drug Enforcement Administration (DEA) has published its final rule rescheduling hydrocodone combination products from Schedule III to Schedule II in the Federal Register. The change imposes Schedule II regulatory controls and sanctions on anyone handling hydrocodone combination products, effective October 6, 2014. DEA first published the proposed rules in March 2014, in response to a Food and Drug Administration recommendation. DEA received almost 600 public comments regarding the proposed rules after they were published, with a small majority of the commenters supporting the change, a DEA press release notes.
Which of the following drugs is classified as a Schedule III drug? Fioricet, Fiornal, Codeine, Lorazepam
Fiorinal (Butalbital with Aspirin) is classified as a Schedule III drug under Florida Pharmacy Law, [Section 811(g) (3) (A) of the Controlled Substances Act]. Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine. Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine. The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. Interesting to note that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg. The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.
To obtain the compounds, mixtures, or preparations containing Schedule V controlled substances without a prescription, the patient must be age 21 or older. T,F
False, [Florida Drug Abuse prevention and Control Chapter 893, Section 893.08 (3)]. To obtain the compounds, mixtures, or preparations containing Schedule V controlled substances without a prescription, the patient must be age 18 or older. A bound volume must be maintained as a record of sale at retail of excepted compounds, mixtures, and preparations, and the pharmacist must require suitable identification from every unknown purchaser. Such compounds, mixtures, and preparations shall be sold ONLY by the pharmacist (NOT by intern or technician) in good faith as a medicine and not for the purpose of evading the provisions of this chapter. The total quantity of controlled substance listed in Schedule V which may be sold to any one purchaser within a given 48-hour period shall not exceed 120 milligrams of codeine, 60 milligrams dihydrocodeine, 30 milligrams of ethyl morphine, or 240 milligrams of opium. The pharmacist may, in his or her discretion, withhold sale to any person whom the pharmacist reasonably believes is attempting to purchase excepted compounds, mixtures, or preparations for the purpose of abuse.
A prescription stamped with red color ink indicating "BRAND MEDICALLY NECESSARY" SHALL NOT be substituted by a dispensing pharmacist. True,False
False, [Florida Pharmacy Act 465.025(2)]. A prescriber shall write the words "BRAND MEDICALLY NECESSARY," in her or his own handwriting (Stamping is NOT Allowed). In the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with the electronic transmission of the prescription, the prescriber's overt act indicates to the pharmacist that the brand name drug prescribed is medically necessary. Any pharmacist who substitutes any drug shall notify the person presenting the prescription of such substitution, together with the existence and amount of the retail price difference between the brand name drug and the drug substituted for it, and shall inform the person presenting the prescription that such person may refuse the substitution.
Under the Prescription Monitoring Program, each time a controlled substance is dispensed to an individual, the controlled substance shall be reported to the department through the system as soon thereafter as possible, but not more than 72 hours after the date the controlled substance is dispensed unless an extension is approved by the department for cause as determined by rule. T,F
False, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.055(4)]. "Patient advisory report" or "advisory report" means information provided by the department in writing, or as determined by the department, to a prescriber, dispenser, pharmacy, or patient concerning the dispensing of controlled substances. Each time a controlled substance is dispensed to an individual, the controlled substance shall be reported to the department through the system as soon thereafter as possible, but not more than 7 days after the date the controlled substance is dispensed unless an extension is approved by the department for cause as determined by rule. A dispenser must meet the reporting requirements of this section by providing the required information concerning each controlled substance that it dispensed in a department-approved, secure methodology and format. Such approved formats may include, but are not limited to, submission via the Internet, on a disc, or by use of regular mail.
Which of the following should be part of Drug Utilization Review? I. Drug-food interaction. II. Duplication of therapy. III. Direction for use. I I,II, II,III All
All. [Florida Administrative Code 64B16-27.810]. A Drug Utilization review may include: 1. known allergies. 2. rational therapy-contraindication. 3. reasonable dose, direction for use and route of administration. 4. duplication of therapy. 5. drug-drug, drug-food and drug-disease interactions. 6. adverse drug reactions. 7. overutilization or underutilization of prescribed drugs.
Which of the following reference materials shall be kept in a pharmacy? I. Florida Pharmacy Law related statues and administrative codes II. United States Pharmacopeial Drug Information III. The Remington Practice of Pharmacy I, I,II II,III All
All, [Florida Administrative Codes 64B16-28.102]. A current pharmacy reference compendium such as the United States Pharmacopoeia/National Formulary, the U.S. Dispensatory, USP DI, (United States Pharmacopeial Drug Information), the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent thereof sufficient in scope to meet the professional practice needs of that pharmacy, and A current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format.
Each pharmacy performing or contracting for the performance of centralized prescription filling pursuant to Florida State Pharmacy Law must maintain a policy and procedures manual. The policy and procedures manual shall include: I. A description of how each pharmacy will comply with federal and state laws, rules, and regulations. II. The procedure for tracking the prescription during each stage of the filling and dispensing process. III. The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information. I I,II II,III All
All, [Florida Pharmacy Act 465.0265]. (1). A pharmacy licensed under this chapter may perform centralized prescription filling for another pharmacy, provided that the pharmacies have the same owner or have a written contract specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which the pharmacies will comply with federal and state laws, rules, and regulations. (2). Each pharmacy performing or contracting for the performance of centralized prescription filling pursuant to this section must maintain a policy and procedures manual, which shall be made available to the board or its agent upon request. The policy and procedures manual shall include the following information: (a). A description of how each pharmacy will comply with federal and state laws, rules, and regulations. (b). The procedure for maintaining appropriate records to identify the pharmacist responsible for dispensing the prescription and counseling the patient. (c). The procedure for tracking the prescription during each stage of the filling and dispensing process. (d). The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription. (e). The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information. (f). The procedure to be used by the pharmacy in implementing and operating a quality assurance program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of patient care. (3). The filling, delivery, and return of a prescription by one pharmacy for another pursuant to this section shall not be construed as the filling of a transferred prescription as set forth in s. 465.026 or as a wholesale distribution as set forth in s. 499.003(53).
In which of the following situations is a PDR not required? I. A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy. II. A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee. III. A pharmacist fills a prescription for a patient who lives in a personal care home. IV. A pharmacist fills a prescription for a patient in a nursing home. I, II, III, IV,
The PDR is required for retail or outpatient prescriptions, [Florida Administrative Code 64B16-27.810, OBRA-90, 42USC1396r-8(g)(2)(B)] . The PDR does not extend to the following: ____________________________________ (1). An order for a drug for an inpatient of an institution. (2). A drug dispensed in an emergency room. (3). A drug dispensed by a medical practitioner. (4). A drug dispensed by a pharmacist to a medical practitioner who will administer it to a patient. The following are examples of situations in which a PDR is required: _________________________________________________________ (1). A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy. (2). A pharmacist fills a prescription for a patient who lives in a personal care home. (3). A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee. (4). A patient is treated on a non-emergency basis in an outpatient clinic of a hospital and is given a prescription. (5). The patient has the prescription filled either in the hospital pharmacy or in a retail pharmacy. The following are examples of situations in which a PDR is not required: ____________________________________________________________ (1). A pharmacist fills a prescription for a patient in a nursing home. (2). A pharmacist in a hospital dispenses a drug that will be administered to a patient in the hospital. (3). A physician dispenses a drug to a patient being treated in the emergency room. (4). A pharmacist dispenses a radiopharmaceutical to a physician who will administer it to a patient.
In Florida, a pharmacist should not dispense any drug or device if the prescription is presented: More than 180 days after date of issuance, 90 days after date of issuance, 365,30
In Florida, a pharmacist should not dispense or refill any drug or device if the prescription is presented more than 365 days or 1 year after the date of issuance, [Florida Administrative Code 64B16-27.211]. 1. No prescription may be filled or refilled in excess of one (1) year from the date of the original prescription was written. 2. No prescription for a controlled substance listed in Schedule II may be refilled. 3. No prescription for a controlled substance listed in Schedules III, IV, or V may be filled or refilled more than five (5) times within a period of six (6) months after the date on which the prescription was written. Chapter 893 Section 893.07(4)(a)(b): Also, all prescription records shall be kept and made available for a period of at least 2 years for inspection and copying by law enforcement officers.
In order to act as a consultant pharmacist preceptor, a person shall: I. Be a consultant pharmacist of record at an institutional pharmacy. II. Have a minimum of one year of experience as a consultant pharmacist of record. III. Not act as a preceptor to more than one applicant at the same time. I, I,II II,III All
I and II only, [Florida Administrative Code 64B16-26.300(4)(a) to (d)]. In order to act as a preceptor, a person shall: (1). Be a consultant pharmacist of record at an institutional pharmacy which is required to have a consultant pharmacist under the provisions of Chapter 465, F.S., and these rules. (2). Have a minimum of one (1) year of experience as a consultant pharmacist of record. (3). Maintain all pharmacist licenses in good standing with the Board. (4). Not act as a preceptor to more than two (2) applicants at the same time.
How many hours of continuing education are required for pharmacists under Florida State Pharmacy Law? 30 hours, 15 hours, 22 hours, 7 hours
30 hours, [Florida Administrative Code 64B16-26.103(1)]. Prior to renewal, a licensee shall complete no less than 30 hours of approved courses of continued professional pharmaceutical education within the 24 month period prior to the expiration date of the license. (a). Upon a licensee's first renewal of licensure, the licensee must document the completion of one (1) hour of board approved continuing education which includes the topics of a. Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome; b. the modes of transmission, including transmission from a healthcare worker to a patient and the patient to the healthcare worker; c. infection control procedures, including universal precautions; d. epidemiology of the disease; related infections including tuberculosis (TB); e. clinical management; prevention; and f. current Florida law on AIDS and its impact on testing, confidentiality of test results, and treatment of patients. In order to meet this requirement, licensees must demonstrate that the course includes information on the State of Florida law on HIV/AIDS and its impact on testing, reporting, the offering of HIV testing to pregnant women, and partner notification issues pursuant to Sections 381.004 and 384.25, F.S. Any HIV/AIDS continuing education course taken during the second or subsequent renewal of licensure may be applied to satisfy the general continuing education hours requirement. (b). The initial renewal of a pharmacist license will not require completion of courses of continued professional pharmaceutical education hours if the license was issued less than 12 months prior to the expiration date of the license. If the initial renewal occurs 12 months or more after the initial licensure, then 15 hours of continued professional pharmaceutical education hours shall be completed prior to the renewal of the license but no earlier than the date of initial licensure (c). Prior to renewal a licensee must complete, within the 24 month period prior to the expiration date of the license, a two-hour continuing education course approved in advance by the Board or the Accreditation Council for Pharmacy Education (ACPE) on medication errors that covers the study of: a. root-cause analysis, b. error reduction and prevention, and c. patient safety. Hours obtained pursuant to this section may be applied by the licensee to the requirements of subsection (1). (d). Five hours of continuing education in the subject area of risk management may be obtained by attending one full day or eight (8) hours of a board meeting at which disciplinary hearings are conducted by the Board of Pharmacy in compliance with the following: 1. The licensee must sign in with the Executive Director or designee of the Board before the meeting day begins; 2. The licensee must remain in continuous attendance; 3. The licensee cannot receive continuing education credit for attendance at a board meeting if required to appear before the board; and 4. The maximum continuing education hours allowable per biennium under this paragraph shall be ten (10). (e). Up to five hours per biennium of continuing education credit may be fulfilled by the performance of volunteer services to the indigent as provided in Section 456.013(9), F.S., or to underserved populations, or in areas of critical need within the state where the licensee practices. One hour credit shall be given for each two hours volunteered in the 24 months prior to the expiration date of the license. (f). Continuing education credit shall be granted for completion of post professional degree programs provided by accredited colleges or schools of pharmacy. Credit shall be awarded at the rate of 5 hours of continuing education credit per semester hour completed within the 24 months prior to the expiration date of the license. (g). The presenter of a live seminar, a live video teleconference or through an interactive computer-based application shall receive 1 credit for each course credit hour presented, however presenter will not receive additional credit for multiple same course presentations. (h). At least ten (10) of the required 30 hours must be obtained either at a live seminar, a live video teleconference, or through an interactive computer-based application.
The pharmacy compounding parenteral and sterile preparation shall have which of the following? I. Laminar airflow hoods II. Hand washing materials with bactericidal properties III. Zonal laminar flow of HEPA filtered air I, I,II, II,III All
All. The pharmacy compounding parenteral and sterile preparation shall have the following: 1. Appropriate environmental control devices capable of maintaining at least class 100 conditions in the work place where critical objects are exposed and critical activities are performed; furthermore, these devices must be capable of maintaining class 100 conditions during normal activity. Examples of appropriate devices include laminar airflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air; 2. Appropriate disposal containers for used needles, syringes, and if applicable, for antineoplastic waste from the preparation of chemotherapy agents; 3. Appropriate environmental control including approved biohazard cabinetry when antineoplastic drug products are prepared; 4. Appropriate temperature and transport containers; 5. Infusion devices and equipment, if appropriate. (c). The pharmacy shall maintain and use supplies adequate to preserve an environment suitable for the aseptic preparation of sterile preparations, such as: 1. Gloves, masks, shoe covers, head and facial hair covers, and non-shedding gowns; 2. Needles and syringes of various standard sizes; 3. Disinfectant cleaning agents; 4. Clean towels; 5. Hand washing materials with bactericidal properties; 6. Vacuum containers and various transfer sets; 7. "Spill kits" for antineoplastic agent spills.
In a closed drug delivery system, the unused unit dose or customized patient medication packages medication may be returned to a pharmacy for redispensing.
True, [Florida Administrative Code 64B16-28.118(1)]. In a closed drug delivery system in which unit dose or customized patient medication packages are dispensed to in-patients, the unused medication may be returned to the pharmacy for redispensing only if each unit dose or customized patient medication package is individually sealed and if each unit dose or the unit dose system, or the customized patient medication package container or the customized patient medication package unit of which it is clearly a part is labeled with the name of the drug, dosage strength, manufacturer's control number, and expiration date, if any. (1). In the case of controlled substances, as it is allowed by Federal Law. (2). A "unit dose system" to which this rule applies means a system wherein all individually sealed unit doses are physically connected as a unit. For purpose of this section, a product in an unopened, sealed, manufacture's container is deemed to be a unit dose package. (3). A "customized patient medication package" to which this rule applies means a system wherein all USP approved multi-dose units are physically connected and are referred to as a container. The use of customized patient medication packages must comply with the provisions of subsection 64B16-28.108(5), F.A.C. (4). A "closed drug delivery system" to which this rule applies is a system in which the actual control of the unit dose or customized patient medication package is maintained by the facility rather than by the individual patient. (5). All pharmacies utilizing unit dose or customized patient medication packages shall address specific policies and procedures regarding their preparation and use in their Policy and Procedures Manual.
Under CSA, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. T,F
True, [21CFR1306.12(a)(b)]. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met: (i). Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; (ii). The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; (iii). The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; (iv). The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and (v). The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
Under Florida State Pharmacy Law, a consultant pharmacist or a doctor of pharmacy may order or evaluate any laboratory or clinical testing for persons only if: I. in the judgment of the consultant pharmacist or doctor of pharmacy, such activity is necessary for the proper performance of his or her responsibilities. II. he or she receives 3 hours of continuing education relating to laboratory and clinical testing as established by the board. III. Such action shall not be permitted. I, III I,II Alll
I and II only, [Florida Pharmacy Act 465.0125(2), Florida Administrative Code 64B16-26.320(1)(2)(3)]. A consultant pharmacist or a doctor of pharmacy licensed in this state may also be responsible for ordering and evaluating any laboratory or clinical testing for persons under the care of a licensed home health agency when, in the judgment of the consultant pharmacist or doctor of pharmacy, such activity is necessary for the proper performance of his or her responsibilities and only when authorized by a licensed practitioner. In order for the consultant pharmacist or doctor of pharmacy to qualify and accept this authority, he or she must receive continuing education course at least three (3) hours in duration for initial certification and at least one (1) hour for recertification, and shall cover the following subjects: (a). Requirements for monitoring laboratory values, (b). Interpretation of laboratory values, (c). Use of laboratory data to monitor and improve drug therapy, (d). Legal aspects, restrictions, and requirements for obtaining laboratory studies, (e). Use of laboratory data and therapeutic outcomes, (f). Documentation of interventions, and (g). Laboratory studies as an element of complete patient care.
Which of the following is/are TRUE about displaying the current license of pharmacist under Florida State Pharmacy Law? I. The current license of each pharmacist engaged in the practice of the profession of pharmacy in any pharmacy shall be displayed in a conspicuous place in or near the prescription department. II. Pharmacists employed in secondary practice sites shall present a valid wallet license as evidence of licensure upon request. III. No pharmacist shall display, cause to be displayed or allow to be displayed, their license in any pharmacy where said pharmacist is not engaged in the practice of the profession. I, II,III I,III All
All, [Florida Administrative Code 64B16-27.100]. (1). The current license of each pharmacist engaged in the practice of the profession of pharmacy in any pharmacy shall be displayed, when applicable, in a conspicuous place in or near the prescription department, and in such manner that said license can be easily read by patrons of said establishment. Pharmacists employed in secondary practice sites shall present a valid wallet license as evidence of licensure upon request. (2). No pharmacist shall display, cause to be displayed or allow to be displayed, their license in any pharmacy where said pharmacist is not engaged in the practice of the profession. (3). A pharmacist and registered pharmacy intern must be clearly identified by a means such as an identification badge or monogrammed smock showing their name and if they are a pharmacist or a registered pharmacy intern. (4). The current registration of each registered pharmacy technician shall be displayed, when applicable, in a conspicuous place in or near the prescription department, and in such a manner that can be easily read by patrons of said establishment. Registered pharmacy technicians employed in a secondary practice site shall present a valid wallet registration as evidence of registration upon request.
According to Florida Pharmacy Law, duly authorized agents and employees of the Department of Health shall have the power to inspect in a lawful manner at any pharmacy. T,F
True, [Florida Pharmacy Act 465.017(1)]. According to Florida Pharmacy Law, duly authorized agents and employees of the department shall have the power to inspect in a lawful manner at all reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician's office, or any other place in the state in which drugs and medical supplies are manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale.
The Department of Health may suspend a pharmacist license if he/she fails to repay a student loan or comply with scholarship service obligations under the Florida Law. T,F
True, [Florida Health Professions and Occupations, Chapter 456, Section 456.0721 and 456.072(1)(k)]. 1. The Department of Health shall obtain from the United States Department of Health and Human Services information necessary to investigate and prosecute health care practitioners for failing to repay a student loan or comply with scholarship service obligations pursuant to s. 456.072(1)(k). 2. The department shall obtain from the United States Department of Health and Human Services a list of default health care practitioners each month, along with the information necessary to investigate a complaint in accordance with s. 456.073. 3. The department may obtain evidence to support the investigation and prosecution from any financial institution or educational institution involved in providing the loan or education to the practitioner. 4. The department shall report to the Legislature as part of the annual report required by s. 456.026, the number of practitioners in default, along with the results of the department's investigations and prosecutions, and the amount of fines collected from practitioners prosecuted for violating s. 456.072(1)(k). 456.072(1)(k): Failing to perform any statutory or legal obligation placed upon a licensee. For purposes of this section, failing to repay a student loan issued or guaranteed by the state or the Federal Government in accordance with the terms of the loan or failing to comply with service scholarship obligations shall be considered a failure to perform a statutory or legal obligation, and the minimum disciplinary action imposed shall be a suspension of the license until new payment terms are agreed upon OR the scholarship obligation is resumed, followed by probation for the duration of the student loan or remaining scholarship obligation period, and a fine equal to 10 % of the defaulted loan amount. Fines collected shall be deposited into the Medical Quality Assurance Trust Fund.
Which of the following is/are TRUE regarding destruction of controlled substances by using authorized reverse distributors? I. A pharmacy may at any time forward controlled substances to DEA registered reverse distributors who handle the disposal of drugs. II. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy. III. A DEA Form-41 along with DEA Form-222 should be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor. I I,II II,III All
I and II only. A pharmacy may at any time forward controlled substances to DEA registered reverse distributors who handle the disposal of drugs. The pharmacist may contact their local DEA Diversion Field Office for an updated list of those reverse distributors in their area. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy. When Schedule III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy should document in writing the drug name, dosage form, strength, quantity and date transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form-41 to the DEA when the drugs have been destroyed. A DEA Form-41 should not be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor, [21CFR1300, 1301, 1304, 1305, and 1307].
In Florida, a physician may prescribe Vicodin and Valium on the same prescription blank. T,F
False, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.02, Definition (22)]. A prescription order for a controlled substance shall not be issued on the same prescription blank with another prescription order for a controlled substance which is named or described in a different schedule, nor shall any prescription order for a controlled substance be issued on the same prescription blank as a prescription order for a medicinal drug, as defined in 1s. 465.031(5), which does not fall within the definition of a controlled substance as defined in this act.
In Florida, the inventory of controlled substances should be done every: year, 2 years, 3 years, 5 years
In Florida, the inventory of controlled substances should be done every two years, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.07(1)(a)]. On January 1, 1974, or as soon thereafter as any person first engages in a controlled substance activity, and every second year thereafter, make a complete and accurate record of all stocks of controlled substances on hand. The inventory may be prepared on the regular physical inventory date which is nearest to, and does not vary by more than 6 months from, the biennial date. (2). The record of controlled substances received shall in every case show: (a). The date of receipt. (b). The name and address of the person from whom received. (c). The kind and quantity of controlled substances received. (3). The record of all controlled substances sold, administered, dispensed, or otherwise disposed of shall show: (a). The date of selling, administering, or dispensing. (b). The correct name and address of the person to whom or for whose use, or the owner and species of animal for which, sold, administered, or dispensed. (c). The kind and quantity of controlled substances sold, administered, or dispensed. (4). Every inventory or record required by this chapter, including prescription records, shall be maintained: (a). Separately from all other records of the registrant, or (b). Alternatively, in the case of Schedule III, IV, or V controlled substances, in such form that information required by this chapter is readily retrievable from the ordinary business records of the registrant. In either case, records shall be kept and made available for a period of at least 2 years for inspection and copying by law enforcement officers whose duty it is to enforce the laws of this state relating to controlled substances.
The pharmacy dispensing the controlled substance and each prescriber who directly dispenses a controlled substance shall submit to the electronic system, by a procedure and in a format established by the department and consistent with an ASAP-approved format, the following information for inclusion in the database: I. the practitioner's federal Drug Enforcement Administration registration number. II. the date the prescription was filled and the method of payment. III. the practitioner's National Provider Identification (NPI) I I,II II,III All
All, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.055(3)]. The pharmacy dispensing the controlled substance and each prescriber who directly dispenses a controlled substance shall submit to the electronic system, by a procedure and in a format established by the department and consistent with an ASAP-approved format, the following information for inclusion in the database: (a). The name of the prescribing practitioner, the practitioner's federal Drug Enforcement Administration registration number, the practitioner's National Provider Identification (NPI) or other appropriate identifier, and the date of the prescription. (b). The date the prescription was filled and the method of payment, such as cash by an individual, insurance coverage through a third party, or Medicaid payment. This paragraph does not authorize the department to include individual credit card numbers or other account numbers in the database. (c). The full name, address, and date of birth of the person for whom the prescription was written. (d). The name, national drug code, quantity, and strength of the controlled substance dispensed. (e). The full name, federal Drug Enforcement Administration registration number, and address of the pharmacy or other location from which the controlled substance was dispensed. If the controlled substance was dispensed by a practitioner other than a pharmacist, the practitioner's full name, federal Drug Enforcement Administration registration number, and address. (f). The name of the pharmacy or practitioner, other than a pharmacist, dispensing the controlled substance and the practitioner's National Provider Identification (NPI). (g). Other appropriate identifying information as determined by department rule.
What are requirements to be licensed as a consultant pharmacist? I. Hold a license as a pharmacist which is active and in good standing. II. Successfully complete a consultant pharmacist course of no fewer than twelve hours, sponsored by an accredited college of pharmacy located within the State of Florida. III. Successfully complete a period of assessment and evaluation under the supervision of a preceptor within one year of completion of the course. I I,II II,III All
All, [Florida Administrative Code 64B16-26.300]. (1). No person shall serve as consultant pharmacist unless that person holds a license as a consultant pharmacist. (2). Application for consultant pharmacist licensure shall be made on form DOH-MQA 1109, 02/09. (3). In order to be licensed as a consultant pharmacist, a person must meet the following requirements: (a). Hold a license as a pharmacist which is active and in good standing, (b). Successfully complete a consultant pharmacist course of no fewer than twelve (12) hours, sponsored by an accredited college of pharmacy located within the State of Florida, and approved by the Florida Board of Pharmacy Tripartite Continuing Education Committee which is based on the Statement of the Competencies Required in Institutional Pharmacy Practice. The course shall be instructionally designed to include a cognitive test on which the applicant must score a passing grade for certification of successful completion of the course. (c). Successfully complete a period of assessment and evaluation under the supervision of a preceptor within one (1) year of completion of the course. This period of assessment and evaluation shall be completed over no more than three (3) consecutive months and shall include at least 40 hours of training in the practice areas, 60% of which shall occur on-site at an institution that holds a pharmacy permit. (4). After licensure a consultant pharmacist's license shall be renewed biennially upon payment of the fee, and upon completing twenty-four (24) hours of board approved continuing education. (5). The number of hours earned in recertification programs by a consultant pharmacist, if applied to the twenty-four (24) hours required for consultant pharmacist license renewal, may not be used toward the thirty (30) hours of continued professional pharmaceutical education credits.
A pharmacy technician may perform all of the following duties EXCEPT: Initiating and receivnig refill authorozation requests, entering prescreiption data into a data processing system, taking a stock botle from the shelf for a prescritpion, taking a new order from a prescriber
Pharmacy technicians may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs, including but not limited to the following, [Florida Pharmacy Act 465.014(1)]: (1). initiating and receiving refill authorization requests; (2). entering prescription data into a data processing system; (3). taking a stock bottle from the shelf for a prescription; (4). preparing and packaging prescription drug orders (i.e. counting tablets/capsules, measuring liquids and placing them in the prescription container); (5). affixing prescription labels and auxiliary labels to the prescription container provided by the pharmacy technician; (6). reconstituting medications; (7). prepackaging and labeling prepackaged drugs; (8). compounding non-sterile prescription drug orders; and (9). bulk compounding.
According to Florida State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substance in the course of their professional practices? I. Animal shelters II. Nurse practitioner III. Physicians assistant I, I,II II,III All
I only, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf]. Pursuant to Title 21, Code of Federal Regulations, Section 1300.01(b28), the term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice. 1. AMB (Ambulance Service) 2. AS (Animal Shelters) 3. DOM (Doctors of Oriental Medicine) 4. ET (Euthanasia Technicians) 5. HMD (Homeopathic Physician) 6. MP (Medical Psychologists) 7. ND (Naturopathic Physician) 8. NP (Nurse Practitioners) 9. NH (Nursing Homes) 10. OD (Optometrists) 11. PA (Physician Assistants) 12. RPH (Registered Pharmacists) For the State of Florida, only following mid level practitioners can either prescribe or administer or both, schedule controlled substances. 1. AS (Animal Shelters): Schedule II and III narcotics, sodium pentobarbital and sodium pentobarbital with lidocaine. 2. OD (Optometrists): Tylenol with Codeine No. 3 administer, prescribe. Requires 20 CME hours.
Which of the following should be part of a patient's counseling? I. The name and description of the drug. II. Techniques for self-monitoring of therapy. III. Action to be taken in the event of a missed dose. I I,II II,III All
All. To optimize drug therapy, a pharmacist shall counsel the patient or patient's agent regarding, [Florida Administrative Code 64B16-27.820(1)(2)(3)]: 1. the name and description of the drug or device. 2. dosage form, dosage, route of administration, and duration of drug therapy. 3. special direction and precautions for preparation, administration, and use by the patient. 4. common severe side or adverse effects or interactions and therapeutic contraindications that may occur with the therapy. 5. techniques for self-monitoring of drug therapy. 6. proper storage of medication. 7. refill information. 8. action to be taken in the event of a missed dose.
Which of the following acts emphasizes the security and safety of health related information? FTC, HIPPA,OBRA,FDA Moderization Act
HIPAA is known as the Health Insurance Portability and Accountability Act, [Public Law 104-191]. It emphasizes the security and safety of health related information. It was issued in 1996. The major objectives of the HIPAA are: I. To assure health insurance portability. This will help a person who has preexisting health conditions and wants to change jobs. Before the HIPPA, a person would think twice before changing jobs, if they had preexisting health conditions, because of insurance problems. II. To prevent or reduce healthcare related fraud and abuse. III. To ensure the safety and security of each patient's health related information. This will help to keep a patient's condition confidential. IV. To enforce the standard for health.
Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record shall be made available within 48 hours following a request for it by any law enforcement personnel. T,F
False, [Florida Administrative Code 64B16-27.831(4)]. Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary under authority of Section 465.017(2), F.S.
What are requirement(s) to become a licensed nuclear pharmacist? I. A pharmacist seeking licensure as a nuclear pharmacist in this state shall submit to the Board of Pharmacy a certificate of training which provides a minimum of 200 clock hours of formal didactic training. II. The minimum on-the-job training which shall be included in a radiopharmacy internship is 500 hours of training and experience in the handling of unsealed radioactive material under the supervision of a licensed nuclear pharmacist. III. If the didactic and experiential training required in this section have not been completed within the last seven (7) years, the applicant must have been engaged in the lawful practice of nuclear pharmacy in another jurisdiction at least 1080 hours during the last seven (7) years. I, I,II II,III All
All, [Florida Administrative Code 64B16-26.303]. (1). A pharmacist licensed to practice pharmacy in this state who performs a radiopharmaceutical service shall, prior to engaging in such specialized practice, be actively licensed as a nuclear pharmacist. (2). A pharmacist seeking licensure as a nuclear pharmacist in this state shall submit to the Board of Pharmacy a course outline from an accredited college of pharmacy or other program recognized by the Florida Department of Health and the Florida Board of Pharmacy (a program comparable to those offered by accredited colleges of pharmacy for the training of nuclear pharmacists), and a certificate of training which provides a minimum of 200 clock hours of formal didactic training, which includes: (a). Radiation physics and instrumentation (85 hours). (b). Radiation protection (45 hours). (c). Mathematics pertaining to the use and measurement of radioactivity (20 hours). (d). Radiation biology (20 hours). (e). Radiopharmaceutical chemistry (30 hours). (3). Such academic training programs will be submitted to the Board of Pharmacy for approval by an accredited educational institution which operates under the auspices of or in conjunction with an accredited college of pharmacy. (4). The minimum on-the-job training which shall be included in a radiopharmacy internship is 500 hours of training and experience in the handling of unsealed radioactive material under the supervision of a licensed nuclear pharmacist. The training and experience shall include but shall not be limited to the following: (a). Ordering, receiving and unpackaging in a safe manner, radioactive material, including the performance of related radiation surveys. (b). Calibrating dose calibrators, scintillation detectors, and radiation monitoring equipment. (c). Calculating, preparing and verifying patient doses, including the proper use of radiation shields. (d). Following appropriate internal control procedures to prevent mislabeling. (e). Learning emergency procedures to safely handle and contain spilled materials, including related decontamination procedures and surveys. (f). Eluting technetium-99m from generator systems, assaying the eluate for technetium-99m and for molybdenum-99 contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals. (g). Clinical practice concepts. (5). If the didactic and experiential training required in this section have not been completed within the last seven (7) years, the applicant must have been engaged in the lawful practice of nuclear pharmacy in another jurisdiction at least 1080 hours during the last seven (7) years.
Prescriptions that are unclaimed may be retained by a pharmacy and reused for a period up to one year from the date of filling or product expiry date whichever comes the first. T,F
True, [Florida Administrative Code 64B16-28.1191]. Prescriptions that are unclaimed may be retained by a pharmacy and reused for a period up to one year from the date of filling; however, any product reaching the product's expiration date prior to one year or any product subject to a recall shall not be reused.
Which of the following is/are alternative form of counseling? I. information leaflets II. pictogram labels III. video programs I, I,II II,III All
All, [OBRA 90]. Alternative forms of patient information may be used to replace patient counseling in an emergency situation when verbal face-to-face counseling is not possible. Alternative forms of patient information may be used to supplement patient counseling when appropriate. Examples include written information leaflets, pictogram labels, video programs, etc.
If the prescription is written for an animal, which of the following shall be required on the prescription? I. Name of an animal II. The species of animal III. The full name and address of the owner of the animal I I,II, II,III All
II and III only, Florida Comprehensive Drug Abuse Prevention and Control Act 893.04(1)(c)(1 and 3). If the prescription is for an animal, the prescription shall state the species of animal for which the drug is prescribed and the full name and address of the owner of the animal.
When should a pharmacist offer patient counseling? I. Upon a new prescription drug order. II. Upon refill of a prescription drug order. III. Once yearly on maintenance drugs. I, I,II II,III All
All, [Florida Administrative Code 64B16-27.820(1)(2)(3)]. A pharmacist should offer patient counseling on new prescription drug orders, refill orders and once yearly on maintenance drugs (maintenance medications are defined as any medication the patient has taken for one year or longer).
In Florida, who may audit pharmacists' continuing education records requirements? I. Representatives from the regional DEA office II. Representatives from the Department of Health III. Representatives from the Florida State Pharmacy Board I I,II II,III, All
II and III only, [Florida Administrative Code 64B16-26.603]. Each pharmacist shall retain documentation of participation in continuing education programs required for license renewal for not less than TWO years after the license is renewed for audit purposes if and when such audit is undertaken by the Department of Health and the Board of Pharmacy. Such documentation shall consist of statements of credit for lecture attendance, certification forms from instructors, or course completion slips from correspondence courses.
In Florida, a beyond use date for the customized patient medication package shall not be more than 30 days from the date of preparation of the customized patient medication package. T,F
False, [Florida Administrative Code 64B16-28.108(6)(b)(9)]. 6. A customized patient medication package may be utilized if: (a). The consent of the patient or the patient's agent has been secured, and (b). The label includes: 1. Name, address and telephone number of the pharmacy. 2. Serial number for the customized medication package and a separate serial number for each medicinal drug dispensed. 3. Date of preparation of the customized patient medication package. 4. Patient's name. 5. Name of each prescriber. 6. Directions for use and any cautionary statements required for each medicinal drug. 7. Storage instructions. 8. Name, strength, quantity and physical description of each drug product. 9. A beyond use date that is not more than 60 days from the date of preparation of the customized patient medication package but shall not be later than any appropriate beyond use date for any medicinal drug included in the customized patient medication package.
According to Florida State Pharmacy Law, prescription drugs must be examined at least every 3 months, and drugs for which the expiration date has passed must be removed and quarantined. T,F
False, [Florida DRUG, COSMETIC, AND HOUSEHOLD PRODUCTS 499.0121 5(a), (1),(2)]. 1. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier. A quarantine section must be separate and apart from other sections where prescription drugs are stored so that prescription drugs in this section are not confused with usable prescription drugs. 2. Prescription drugs must be examined at least every 12 months (not 3 months), and drugs for which the expiration date has passed must be removed and quarantined. *Please Note: According to Florida Administrative Code 64B16-28.110 ]* Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of FOUR months, and shall remove all deteriorated pharmaceuticals, or pharmaceuticals which bear upon the container an expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon the container an expiration date which has been reached be sold or dispensed to the public. **
The dispensing container shall bear a label with all of the following EXCEPT: name, address and phone number of the manufacturer, unique identification number of the prescription, name of the prescribing practitioner, initials or an identification code of the dispensing pharmacist
At the time of delivery of the drug, the dispensing container shall bear a label with at least the following information, [Florida Administrative Code 64B16-28.108(2)]: (1). name, address and phone number of the pharmacy (not the manufacturer); (2). unique identification number of the prescription; (3). date the prescription is dispensed; (4). initials or an identification code of the dispensing pharmacist; (5). name of the prescribing practitioner; (6). name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner; (7). instructions for use; (8). quantity dispensed; (9). appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effects of combining the drug product with any product containing alcohol; (10). if the prescription is for a Schedule II - IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"; (11). if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed; (12). the name of the advanced practice nurse or physician assistant, if the prescription is carried out or signed by an advanced practice nurse or physician assistant in compliance; (13). the name and strength of the actual drug product dispensed, unless otherwise directed by the prescribing practitioner.
Which of the following is/are TRUE regarding Electronic Recordkeeping System to track OTC sales of ephedrine or related compounds? I. A pharmacy or retailer may request an exemption from electronic reporting system if such pharmacy or retailer maintains a sales volume of less than 100 grams of ephedrine or related compounds in a 30-day period. II. The data submitted to the electronic recordkeeping system must be retained within the system for no less than 2 years following the date of entry. III. Physicians' offices are exempt from the requirements of Electronic Recordkeeping System. I, I,II II,III All
II and III are true, [Florida Statues Chapter 893, 893.1495]. 1). The Department of Law Enforcement shall approve an electronic recordkeeping system for the purpose of recording and monitoring the real-time purchase of products containing ephedrine or related compounds and for the purpose of monitoring this information in order to prevent or investigate illegal purchases of these products. 2). The approved electronic recordkeeping system shall be provided to a pharmacy or retailer without any additional cost or expense. 3). A pharmacy or retailer may request an exemption from electronic reporting from the Department of Law Enforcement if the pharmacy or retailer lacks the technology to access the electronic recordkeeping system and such pharmacy or retailer maintains a sales volume of less than 72 grams (NOT 100 grams) of ephedrine or related compounds in a 30-day period. The electronic recordkeeping system shall record the following: 1. The date and time of the transaction. 2. The name, date of birth, address, and photo identification number of the purchaser, as well as the type of identification and the government of issuance. 3. The number of packages purchased, the total grams per package, and the name of the compound, mixture, or preparation containing ephedrine or related compounds. 4. The signature of the purchaser, or a unique number relating the transaction to a paper signature maintained at the retail premises. 4). The electronic recordkeeping system shall provide for: 1. Real-time tracking of nonprescription over-the-counter sales under this section. 2. The blocking of nonprescription over-the-counter sales in excess of those allowed by the laws of this state or federal law. 5). Prior to completing a transaction, a pharmacy or retailer distributing products containing ephedrine or related compounds to consumers in this state shall submit all required data into an electronic recordkeeping system approved by the Department of Law Enforcement at the point of sale or through an interface with the electronic recordkeeping system, unless granted an exemption by the Department of Law Enforcement pursuant to paragraph (5)(b). 6). The data submitted to the electronic recordkeeping system must be retained within the system for no less than 2 years following the date of entry. 7). This section does not apply to: (a). Licensed manufacturers manufacturing and lawfully distributing products in the channels of commerce. (b). Wholesalers lawfully distributing products in the channels of commerce. (c). Health care facilities licensed under chapter 395. (d). Licensed long-term care facilities. (e). Government-operated health departments. (f). Physicians' offices. (g). Publicly operated prisons, jails, or juvenile correctional facilities or private adult or juvenile correctional facilities under contract with the state. (h). Public or private educational institutions maintaining health care programs. (i). Government-operated or industry-operated medical facilities serving employees of the government or industry operating them.
Section 6
(50 cards)
Acme wholesalers DEA number first number
P
Can practitioner issue multiple rx for multiple pts with a single signature
No not for multiple patient, but he can sign multiple rx for a single pt at one time
CE hours for out of state RPh practicing for 5 years
30 CE hours for the preceding, 2 years
DEA requirements of electronic records
Kept for 2 years, once created
Which of the following is/are TRUE regarding pharmacy technicians under Florida State Pharmacy Law? I. A licensed pharmacy technician may take a verbal order from a licensed practitioner. II. A licensed pharmacist can supervise up to three pharmacy technicians at any given time without prior approval from the Board. III. A pharmacy technician may initiate or receive communication from a practitioner or his or her agent, on behalf of a patient, regarding refill authorization requests. I II, III, II,III
III only, [Florida Pharmacy Act, 465.014(1),(6)]. 1). A pharmacy technician, under the supervision of a pharmacist, may initiate or receive communication from a practitioner or his or her agent, on behalf of a patient, regarding refill authorization requests. 2). No licensed pharmacist shall supervise more than one registered pharmacy technician unless otherwise permitted by the guidelines adopted by the board. 3). The board shall establish guidelines to be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than one pharmacy technician. 4). A licensed pharmacy technician cannot take a verbal order from a licensed practitioner; this is only allowed for a licensed pharmacist or a licensed registered intern under the direct supervision of a licensed pharmacist. 5). As a condition of registration renewal, a registered pharmacy technician shall complete 20 hours biennially of continuing education courses approved by the board or the Accreditation Council for Pharmacy Education, of which 4 hours must be via live presentation and 2 hours must be related to the prevention of medication errors and pharmacy law.
Opium 8oz
Not more than 8oz in 48 hrs
Internet pharmacy distributing medicinal drugs without permit
Is a 2nd degree felony
Which of the following requires a DEA 222 form for purchase? Marijuana,Pemoline,Modafinil,Clonazepam
Marijuana is classified as Schedule I controlled drug. It requires a DEA 222 order form for purchase, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.06(1)]. List of Schedule I controlled drugs: _____________________________ Difenoxin (Lyspafen) Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote
DEA and electronic controlled substances prescriptions
It revises it's previous regulations by giving practitioners with the options for electronic sendjnf
C2 and LTCF
Shouldn't exceed 60 days, may be filled in partial quantities
Benefits of having a pdmp
A tool used by States to adress drug abuse and diversion
Does breakage or spillage or damage constitute as a loss of controlled substance
No, so u don't do a 106 form for this, but any recoverable controlled substance must be disposed of through DEA requirements
Is the DEA involved with pdmps
Nope
A pharmacist who believes a prescription for a controlled substance medication to be valid, but who has not been able to verify it with the prescriber, may dispense a partial supply, not to exceed a 72 hour supply under the Florida State Pharmacy Law. T,F
True, [Florida Administrative Code 64B16-27.831(3)(b)]. According to Florida Pharmacy Law, a pharmacist who believes a prescription for a controlled substance medication to be valid, but who has not been able to verify it with the prescriber, may determine not to supply the full quantity and may dispense a partial supply, not to exceed a 72 hour supply. After verification by the prescriber, the pharmacist may dispense the balance of the prescription within a 72 hour time period following the initial partial filling, unless otherwise prohibited by law. Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary under authority of Section 465.017(2), F.S. Such summary shall include information from which it is possible to determine the volume and identity of controlled substance medications being dispensed under the prescription of a specific prescriber, and the volume and identity of controlled substance medications being dispensed to a specific patient. Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to the Department of Health.
When can practitioner start issuing controlled electric rx
Only when electronic health record (EHR) application complies with interim final rule
Cqi program summarization document kept for
4 years
Can practitioner print copy of electronic rx for CS
Yes as long as it says copy only not valid for dispensing
Codeine 4oz
Not more than 4oz in 48hrs
Central fill eligible for emergency c2s?
No
Central fill eligible for emergency c2s?
No
Identity proofing electronic controlled substances
Required, using a two factor credential to sign a prescription Two factors being a knowledge factor or a hard token and something u are
The pharmacy engagement in which of the following acts may consider by the FDA the violation of the new drug, adulteration, or misbranding provisions of the Act? I. Compounding very large quantities of particular drug before receiving valid prescriptions. II. Compounding drug products that are commercially available in the marketplace. III. Compounding drugs that were withdrawn or removed from the market for safety reasons. I, I,II II,III All
All, [FDA Compliance Policy Guide Sec. 460.200 Pharmacy Compounding]. Generally, FDA will continue to defer to state authorities regarding less significant violations of the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases, cooperative efforts between the states and the Agency will result in coordinated investigations, referrals, and follow-up actions by the states. However, when the scope and nature of a pharmacy's activities raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the pharmacy engages in any of the following acts: 1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions. Compounding very large quantities of particular drug before receiving valid prescriptions is considered as manufacturing. 2. Compounding drugs that were withdrawn or removed from the market for safety reasons. Appendix A provides a list of such drugs that will be updated in the future, as appropriate. 3. Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312. 4. Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility. 5. Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements. 6. Using commercial scale manufacturing or testing equipment for compounding drug products. 7. Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale. 8. Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient. 9. Failing to operate in conformance with applicable state law regulating the practice of pharmacy.
Changing a C2 rx
Has been confusing due to * ** FDA. Majority of changes can be made AFTER TALKING TO MD, MAY CHANGE PT ADRESS DRUG STRENTGH, QUANTITY AND DIRECTIONS FOR USE, may change to generic substitution, then in 2007 the strength dosage..... Can't be changed orally In 2011 DEA said ** it PROFESIONAL JUDGEMENT
Can practitioner use his own digital signature to sign electronic CS
Yes,
Which of the following is/are classified as Schedule II controlled drug(s)? I. Heroin II. Morphine III. Pentobarbital I, I,II II,III All
Morphine sulfate and Pentobarbital are classified as Schedule II controlled drugs, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.03(2)(a) and 893.03(1)(a)]. Heroin is classified as a Schedule I controlled drug. List of Schedule II controlled drugs: _____________________________ Alfentanil (Alfenta) Amobarbital (Amytal, Tuinal) Amphetamine (Dexedrine, Biphetamine) Lisdexamfetamine (Vyvanse) Coca Leaves Cocaine Codeine Dextropropoxyphene, bulk (non-dosage forms) Dihydrocodeine (Didrate, Parzone) Diphenoxylate Diprenorphine Ecgonine (Cocaine precursor, in Coca leaves) Ethylmorphine (Dionin) Fentanyl (Innovar, Sublimaze, Duragesic) Glutethimide (Doriden, Dorimide) Hydrocodone (dihydrocodeinone) Hydrocodone and isoquinoline alkaloid Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia) Hydromorphone (Dilaudid, dihydromorphinone) Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate) Meperidine (Demerol, Mepergan, pethidine) Methadone (Dolophine, Methadose, Amidone) Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed) Methylphenidate (Ritalin) Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR) Opium poppy Opium tincture Opium, granulated Opium, powdered Opium, raw Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw Concentrate Remifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta) Tapentadol (Nucynta)
Official compendium under fdca
Homeopathic pharnaxopeia
PDMP acsess
Pharmacy, prescriber, or dispenser
DQSA
Florida department of healths Drug quality and safety act
Form DEA-41
The disposal or destruction of controlled substances should be done by filling out DEA form 41. Destruction of Controlled Substances - Class I Institutional Pharmacies - Nursing Homes, [Florida Administrative Code 64B16-28.301] . (1). Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed. (2). A document must be completed showing the name and quantity of the drug, strength and dosage form, patient's name, prescription number and name of the institution. (3). This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his designee, which may include a licensed physician, pharmacists, mid-level practitioner, or nurse. Destruction of Controlled Substances All Permittees (excluding Nursing Homes), [Florida Administrative Code 64B16-28.303]. (1). Controlled substances that cannot be retained as usable shall be securely stored in the prescription department of the permittee pharmacy until destroyed. (2). Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form 41. This form, at the time of destruction, shall be witnessed and signed by the prescription department manager or the consultant pharmacist of record and D.E.A. agent, or a Department inspector. This method of destruction requires that a copy of the completed and witnessed Form DEA 41 be mailed to the D.E.A. office in his/her area within one (1) business day after the destruction. (3). Another method of destruction shall be conducted by at least two persons: One will be the prescription department manager or the consultant pharmacist of record. The other will be one of the following: medical director or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. This method of destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to the D.E.A. office in the permittee's area within one (1) business day after destruction. (4). In lieu of destruction on the premises as outlined in subsections (2) and (3) above, controlled substances may also be shipped to reverse distributors for destruction in conformity with federal guidelines. (5). For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, the destruction method in subsection 64B16-28.301(2), F.A.C., must be followed.
Lyrica
Requires prescription
Do pharmacies have to accept electronic controlled rx
Voluntary for the pharmacy according to DEA
Centralized rx filling
Allows central fill to do duties such as drug utilization review, Therapeutic drug review, claims adjudication, and obtaining refill authorizations
Central fill eligible for emergency c2s?
NO
Partial c2 fulls
Must be done within 72 hrs if u do not have enough u have to tell the MD and no more can be given after 72
Which of the following is/are TRUE about refilling a prescription drug or device when the pharmacist fails to obtain authorization from the prescriber? I. A pharmacist can fill the prescription drug or device if he thinks that the drug or device is required for continuation of therapy for chronic conditions. II. A pharmacist can fill the prescription drug or device if he thinks that the interruption of the therapy may produce serious health consequences. III. A pharmacist can fill the prescription drug if the refill of the prescription is not for a controlled substance. I I,II II,III All
I and II only, [Florida Administrative Code 465.0275(1),(2),(3),(4) and (5)]. In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication, with the exception of those areas or counties included in an emergency order or proclamation of a state of emergency declared by the Governor, in which the executive order may authorize the pharmacist to dispense up to a 30-day supply, providing that: (1). The prescription is not for a medicinal drug listed in Schedule II (Schedule III, IV and V are permitted) appearing in chapter 893. (2). The medication is essential to the maintenance of life or to the continuation of therapy in a chronic condition. (3). In the pharmacist's professional judgment, the interruption of therapy might reasonably produce undesirable health consequences or may cause physical or mental discomfort. (4). The dispensing pharmacist creates a written order containing all of the prescription information required by this chapter and chapters 499 and 893 and signs that order. (5). The dispensing pharmacist notifies the prescriber of the emergency dispensing within a reasonable time after such dispensing.
What is a PDMP
Prescription drug monitoring program collecting designating data on substances dispensed in the state.
Damaged goods
May be disposed through shipment to reverse distributor or DEA approved process
Controlled substances stored in office of practitioner
All controlled substances should be stored in locked cabinet or other secure container accessible by office staff
If controlled substance spillage is not recoverable
Registrant must document the circumstances of breakage in inventory records, TWO WITNESSES MUST SIGN INVENTORY RECORDS, form 41 is not required
CV refill
No limit on refills, only 1 transfer permitted
Once electronic CS signed is it transmitted immediately
No, bcas other insurance info and pharmacy may be needed to be added to it
How often shall a pharmacist examine the stock of the prescription department of each pharmacy for deteriorated or expired pharmaceuticals? Monthly,Biwekly,Quarterly,Every four months
Every 4 months, [Florida Administrative Code 64B16-28.110 ]. Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of four months, and shall remove all deteriorated pharmaceuticals, or pharmaceuticals which bear upon the container an expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon the container an expiration date which has been reached be sold or dispensed to the public.
A central fill pharmacy's pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing: I. the originating pharmacy's name and address II. the name of the prescribing practitioner III. the central fill pharmacy's DEA registration number I I,II II,III All
All, [Florida Administrative Code 64B16-28.450(4)(b)(4)]. The central fill pharmacy receiving the transmitted prescription must: 1. Keep a copy of the prescription if sent via facsimile, or an electronic record of all the information transmitted by the originating pharmacy, including the name, address, and DEA registration number, if a controlled substance, of the originating pharmacy transmitting the prescription; 2. Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription; 3. Keep a record of the date the filled prescription was delivered to the originating pharmacy and the method of delivery (private, common or contract carrier). 4. A central fill pharmacy's pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing: a). the date of filling, b). the originating pharmacy's name and address, c). a unique identifier (i.e. the central fill pharmacy's DEA registration number) indicating the prescription was filled at the central fill pharmacy, d). the serial number of the prescription, e). the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. *Please note according to 21 Code of Federal Regulation 1306, Section 1306.11(d)(5): Central fill pharmacies shall not be authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.*
All of the following are Schedule I controlled drugs EXCEPT: Heroin,LSD,Marijuana,Methylphenidate,
Methylphenidate(Ritalin) is a Schedule II controlled drug, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.03(1)(a) and 893.03(2)(a)]. List of Schedule I controlled drugs: ____________________________ Difenoxin(Lyspafen) Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote
Can medicinal drugs be dispensed in class 1
No, only medicinal drugs administered are from individual prescription containers to individual patients
NSCP
nonresident sterile compounding permit from Florida board of pharmacy along with Nonresident pharmacy permit. Nonresident pharmacies and outsourcing facilities need this to ship sterile pharmaceuticals due to fungal meningitis outbreak
Can a staff person in practitioner office complete all required info for CS and have practitioner sign and authorize
Yes, but practitioner is responsible
Central fill eligible for emergency c2s?
No, not oral ones or emergency ones
Which of the following is/are classified as Schedule IV controlled drug(s)? I. Oxazepam II. Zaleplon III. Butorphanol I, I,II II,III All
All, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.03(4)(a)]. List of Schedule IV controlled drugs: ______________________________ Tramadol (Ultram) Carisoprodol (Soma) Alprazolam (Xanax) Barbital(Barbitone) Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol) Chloral hydrate (Noctec) Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen) Clonazepam (Klonopin, Clonopin) Clorazepate(Tranxene) Dexfenfluramine (Redux) Propoxyphene (dosage forms) Diazepam (Valium, Valrelease) Dichloralphenazone (Midrin) Difenoxin 1 mg/ Atropine 25 mcg (Motofen) Estazolam (ProSom, Domnamid, Eurodin, Nuctalon) Ethchlorvynol (Placidyl) Fenfluramine (Pondimin, Ponderal) Flurazepam (Dalmane) Lorazepam (Ativan) Mazindol (Sanorex, Mazanor) Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan) Midazolam (Versed) Modafinil (Provigil) Oxazepam (Serax, Serenid-D) Pemoline (Cylert) Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound) Phenobarbital (Luminal, Donnatal, Bellergal-S) Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl) Prazepam (Centrax) Quazepam (Doral, Dormalin) Sibutramine (Meridia) Temazepam (Restoril) Triazolam (Halcion) Zaleplon (Sonata) Zolpidem (Ambien) Zopiclone (Imovane) Eszopiclone (Lunesta)
Readily retrievable
Records kept and maintained such that it can be separated from other records easily from other records
Section 7
(50 cards)
An inspector from the FDA enters your community pharmacy. For which of the following the inspector may issue citations? I. Samples stored in the drug stock II. Recall prescription drugs among the drug stock III. Drug samples being sold/dispensed pursuant to a prescription I only III only I & II only II & III only I,II, & III
All
Revocation of digital certificates for electronic ordering may occur under which of the following circumstances? I. Registrant has changed his/her business address II. A Notice of Revocation has been signed and is on file III. Password has been forgotten I only III only I & II only II & III only I, II, & III
There are many circumstances that would require revocation of a digital certificate: The hardware storage device has been lost, stolen, or compromised in any fashion If any information in the certificate has changed ( i.e. his/her business address, new schedules added The password has been forgotten The private key can no longer be accessed Registrant's Power of Attorney has been revoked
If the pharmacy is unsure of a theft or a loss of controlled substance, what action should the pharmacy take? I. Notify the DEA within 1 business day II. Perform an internal investigation III. Wait 24 hours to determine if the drugs appear back again
I The pharmacy is responsible for notifying the DEA, the appropriate State agency, and the Local Police of any suspected theft or significant loss of any controlled substances immediately upon suspected theft or loss.
DEA registrants must maintain what controlled substance records? I. Purchased II. Received III. Destroyed I only III only I & II only II & III only I, II, & III
Purchasers are required to keep the complete and accurate records for each controlled substance manufactured, purchased, received, distributed, dispensed or disposed of for 2 years. I, II, & III (Correct)
Under what circumstances may the U.S federal government suspend revocation of DEA registration I. Registrant filed an application with falsified material II. Registrant had been excluded from participating in the Medicare program III. Registrant is convicted of a felony involving a controlled substance I only III only I & II only II & III only I, II, & III
The U.S federal government may suspend or revoke of DEA registration when: 1. Registrant filed an application with falsified material 2. Registrant had been excluded from participating in the Medicare program 3. Registrant is convicted of a felony involving a controlled substance 4. Registrant committed an act which would render the registration contrary to the public interest
Which DEA Form must a pharmacist complete to personally register with the DEA? There is no form to complete Form 222 Form 41 Form 224 Form 225 Show Answer
There is no form to complete (Correct) Explanation Pharmacist do not generally need to register with the DEA if they are working in a registered establishment.
Ephedra may no longer be present in which of the following products in a community pharmacy? I. Herbal teas II. Nonprescription drug products III. Dietary supplements I only III only II & III only I, II, & III
Explanation In 2004 the FDA banned the sales of all dietary supplements containing ephedra. This does not apply to ephedra prepared or used for prescription, non-prescription drug products or to conventional foods such as herbal teas as well as "Traditional Chinese Medicine." The label must not indicate that the product is a dietary supplement.
How many signatures are needed to validate the power of Attorney form? 0 1 2 4 5
2 (Correct) Registrants can utilize a Power of Attorney to authorize one or more individuals to obtain and execute Form 222 on behalf of the registrant. The power of Attorney requires two signatures for validation.
How many refills are allowed for a written prescription for a 30 day supply of alprazolam? No refills 1 refill 2 refills 3 refills 5 refills Explanation CII: no refills (no days supply specified in FL law) Non-oral CIII Rx: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner Oral CIII Rx: no more than a 30 day supply should be dispensed (893.04(1)e) CIV: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner CV: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner 893.04(1)g Pharmacist and practitioner.
5 refills (Correct) CII: no refills (no days supply specified in FL law) Non-oral CIII Rx: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner Oral CIII Rx: no more than a 30 day supply should be dispensed (893.04(1)e) CIV: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner CV: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner 893.04(1)g Pharmacist and practitioner.
Which organization is primarily responsible for evaluating safety of drugs used in veterinary practices? SPCA Animal rights organization FDA HCFA Vegan society
FDA (Correct) The FDA is responsible for evaluating safety and effectiveness of drugs used in veterinary practices. All adverse events and product problems that occur in animals should be reported to the FDA's Center for Veterinary Medicine.
Who can sell poisons
Pharmacies, must say poison
NDC required on drug label?
No
How can a registrant, who wants to grant authority for execution of the DEA Form 222s, give authority to someone else? Power of Attorney Revocation of Notice DEA Form 222 All of the above None of the above
Explanation The registrants can utilize a Power of Attorney to authorize one or more individuals to obtain and execute Form 222 on behalf of the registrant.
In which of the following circumstances prior authorization from the DEA to destroy controlled substances is not necessary? The local environmental authority is present during the destruction If the DEA has previously approved the destruction If state law enforcement is present during destruction If a licensed physician is present during destruction There is no waiver of the prior authorization allowed
If state law enforcement is present during destruction (Correct) The only exception to DEA authorization for destruction of controlled substances is when a authorized member of a state law enforcement or regulaturay agency witnesses the destruction.
What is the number of the clinical trial phase that is established as a post-marketing surveillance of a drug that was recently introduced onto the market? 1 2 3 4 5
Clinical trial have phases 1 to 4. 4 After phase 3 the drug is approved to be placed on the market then phase 4 will consist of post-marketing surveillance of the drug.
Ordering Schedule IV controlled substances is done utilizing which form? DEA Form 41 DEA Form 222 DEA Form 224 DEA Form 225 No DEA form is required
Purchasing Schedule I and II controlled substances is done using DEA form 222. Schedule III, IV, and V controlled substances do not require a special DEA ordering form
A pharmacist may fill prescriptions for and mail which of the following drugs through the US Postal Service? I. Schedule II narcotics II. Benzodiazepines III. Schedule III narcotics I only III only I & II only II & III only I, II, & III Explanation There are no restrictions on mailing prescription products via the United States Postal Service including controlled substances narcotics and non narcotics.
There are no restrictions on mailing prescription products via the United States Postal Service including controlled substances narcotics and non narcotics.
Which of the following personnel is responsible for a lost controlled substance drug: I. Prescription Drug Manager at time of incident II. Supervising pharmacist III. Store manager I only III only I & II only II & III only I,II, & III
I & II only (Correct) Explanation Prescription Drug Manager must report loss to the board within 1 business day Responsible for controlled substances: Every person who engages in preparing, dispensing, or importing the substance Anyone who fails to report theft to the sheriff within 24 hours of discovery 893.07(1) Records http://www.flsenate.gov/Laws/Statutes/2012/Chapter893/All
The term "donut hole" refers to a component of which one of the following? Medicare Part D Medication management Medicare Part B Drug packaging Prescription Drug marketing Explanation
The term "donut hole" refers to a dollar range in which the beneficiary of Medicare part D must pay for all prescription drugs because the plan pays 0%. "Donut hole" is also called "coverage gap" of the Part D Plan.
The term "grandfathered" refers to drugs that were marketed before which of the following? DSHEA Durham-Humphrey Amendment of 1951 FD & C Act of 1938 Kefauver-harris Amendment of 1962 Poison Prevention Act
FD & C Act of 1938 (Correct) Drug product marketed prior to 1938 are grandfathered and did not have to be labeled or proven safe under the grandfather clause; they were exempted from the requirements of therapeutic equivalence.
ABC pharmacy does not have enough carisoprodol to fill a patient's prescription, so the pharmacy decides to partially fill it. Which of the following is true? (Select all that apply) The pharmacy may partially fill it as long as the remaining quantity dispensed does not exceed the prescribed amount The pharmacy may partially fill it as long as the remaining quantity is filled within 48 hours The pharmacy may partially fill it as long as the remaining quantity is filled within 72 hours The pharmacy may partially fill it as long as it is recorded like a refill would be The pharmacy may not partially fill this prescription Show Answer Next >
ABC pharmacy does not have enough carisoprodol to fill a patient's prescription, so the pharmacy decides to partially fill it. Which of the following is true? (Select all that apply) The pharmacy may partially fill it as long as the remaining quantity dispensed does not exceed the prescribed amount (Correct) The pharmacy may partially fill it as long as the remaining quantity is filled within 48 hours The pharmacy may partially fill it as long as the remaining quantity is filled within 72 hours The pharmacy may partially fill it as long as it is recorded like a refill would be (Correct) The pharmacy may not partially fill this prescription Explanation Defer to DEA Code of Federal Regulations Title 21 §1306.23 Partial filling of prescriptions. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: (a) Each partial filling is recorded in the same manner as a refilling, (b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and (c) No dispensing occurs after 6 months after the date on which the prescription was issued. Carisoprodol is CIV substance.
Practitioners must use what form to obtain Schedule I controlled substances? None of the above DEA Form 222 (Correct) DEA Form 41 DEA Form 363 Prescription Explanation Purchasing Schedule I and II controlled substances is done using DEA form 222.
DEA Form 222 (Correct) Purchasing Schedule I and II controlled substances is done using DEA form 222.
The purchaser has to complete which of the following on the DEA Form 222? I. Supplier's address II. Purchaser's signature III. Number of lines completed by the order on the form I only III only I & II only II & III only I, II, & III
Explanation The purchaser will need to complete the following: 1. Name and address of the supplier 2. Number of lines completed by the order on the form 3. Purchaser's name 4. Date
CV expire in
6 months
Sell Syringes to minor
No
Which of the following statement(s) is FALSE about the requirements for compounding in pharmacies? All compounding pharmacies must follow current good manufacturing practices. Compounders may register with the FDA and become an outsourcing facility Must provide the FDA with certain information such as adverse events reported and specific information about their compounds. Compounds must be labeled with adequate directions for use May be exempted from complying with current good manufacturing practices in certain circumstances
May be exempted from complying with current good manufacturing practices in certain circumstances (Correct) Explanation Some requirements of compounding prescriptions: There should be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, and preparations. There shall be referenced written justification of the chosen beyond-use-dates for compounded products. A policy and procedure manual should be maintained for the compounding, dispensing, and delivery of sterile preparation prescriptions All compounding personnel are required to demonstrate competency by completing a media-filled test that represents low-level compounding annually 64B16-27.797 Standards of Practice for Compounding Sterile Preparations (CSPs) The preparation of drugs for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is NOT compounding and is not within the practice of the profession of pharmacy 64B16-27.700(2) Definition of Compounding. Source: http://www.ncsl.org/research/health/regulating-compounding-pharmacies.aspx#Table2 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm376732.htm
Which of the following can NOT prescribe controlled substances? (select all that apply) Registered Nurse Veterinarian Physician's assistant Primary Care Physician Psychologist
Which of the following can NOT prescribe controlled substances? (select all that apply) Registered Nurse (Correct) Physician's assistant (Correct) Psychologist (Correct) Explanation "Practitioners" have full prescriptive authority for CII-CV substances provided that they have a valid federal controlled substance registry number includes licensed physicians, dentists, veterinarians, osteopaths, naturopaths, and podiatrists 893.02(21) Definitions Mid-level providers (Nurse Practitioners, Physician's Assistants, Homeopathic Physicians, Medical Psychologists, etc) do not have prescriptive authority for any controlled substances Optometrists may prescribe/administer APAP w/ codeine (Schedule #) with 20 additional CME's http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf
Patient with a Medicare endorsed discount card can how frequently change his/her provider? Every month Every 3 months Every 6 months Once a year Never Explanation
Once a beneficiary has enrolled in Medicare, he/she may change plans only once a year unless he/she moves out of the plan's area, into a nursing home, or the plan stops service in the area.
Prescription labels are required to show in print which of the following according to the federal law? (Select ALL that apply) Strength of the drug Name of the drug Name of the prescriber Cautionary statements Name of the patient
By federal government: prescription labeling requires at least all of the following: Name of patient Name of drug Strength of drug Prescription number Dispensing date Direction of use Name of prescriber Name and address of the pharmacy Cautionary statements
When ordering Schedule I & II controlled substances which drugs must be ordered on a separate DEA Form 222 from all other Schedule I and II controlled substances? I. Marijuana II. Etorphine HCI III. Carfentanil I only III only I & II only II & III only I, II, & III only
II & III only (Correct) When Carfentanil, Etorphine HCL, or Diprenorphine are ordered for use in veterinary practice or exotic animal practice the order form should contain only these items on the form.
Which of the following tasks can a pharmacist with a Prescriber Care Plan agreement perform? I. Executing drug therapy orders II. Order labs III. Interpret labs I only III only I & II only II & III only I,II, & III
I,II, & III (Correct) Explanation There is a statute allowing pharmacists to carry out "Prescriber Care Plans" including ordering labs, interpreting them, executing drug therapy orders, and notifying the MD 64B16-27.830 Standards of Practice - Drug Therapy Management
A licensed pharmacy intern can: I. Make the final check of the completed prescription II. Review the benefits of the influenza vaccination with the patient III. Take a verbal prescription from a doctor's office I only III only I & II only II & III only I,II, & III
II & III only (Correct) Explanation Some tasks that a licensed pharmacy intern can perform are: Take a verbal prescription, counsel patients, data entry, inventory, fill prescriptions Source: Florida Administrative Code, Rule 64B16-27.1001(1) https://www.flrules.org/gateway/ChapterHome.asp?Chapter=64B16-27
How often does a pharmacy renew registration with the DEA? 1 year 2 years 3 years 4 years No need for renewal
3 years (Correct) Explanation Registration must be renewed every 3 years.
When a pharmacy transfers Schedule I & II controlled substances to a registered reverse distributor what form must the distributor issue to the pharmacy? (Select ALL that apply) DEA Form 41 DEA Form e222 DEA Form 224 DEA Form 225 DEA Form 222
DEA Form e222 (Correct) DEA Form 224 DEA Form 225 DEA Form 222 (Correct) Explanation When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent (DEA form e222) to the pharmacy.
Which of the following information is NOT required to be on the label of a dispensed prescription? The directions for use The initials or name of the dispensing pharmacy technician The expiration date or beyond-use date The name and strength of the prescription drug The name and address of the pharmacy
Which of the following information is NOT required to be on the label of a dispensed prescription? The initials or name of the dispensing pharmacy technician (Correct) Name and address of the pharmacy. Date of dispensing. Serial number. Name of the patient. Name of the prescriber. Name of the drug dispensed (unless prescriber specifically requests it to be withheld). Directions for use. An Expiration Date or Beyond-Use Date. Controlled Substance: a warning that it is a crime to transfer the drug to another person. 64B16-28.108(2) All Permits - Labels and Labeling of Medicinal Drugs
The primary objective for individual state board of pharmacy is which of the following? Protect the general public Protect the pharmacy profession Serve as an advocate for independent pharmacies Enforce federal laws Protect individual pharmacies
Protect the general public (Correct) The primary objective of individual state boards of pharmacy is to protect the general public.
The Food, Drug and Cosmetic Act has a special label warning for which of the following drugs and adjuvants? Lubricants Antioxidant Artificial flavoring Artificial coloring Wintergreen oil
The Food, Drug and Cosmetic Act has a special label warning for all of the following drugs and adjuvants: Tartrazine Aspartame Sulfite Mineral oil Wintergreen oil Sodium phosphate Ipecac syrup Isoproterenol inhalation products
Whose responsibility is it to keep records of a pharmacist's CE credits working in retail pharmacy? (select all that apply) Speaker at the approved CE course The pharmacist The pharmacy district manager The pharmacy manager The store manager
The regulations of records maintenance in the pharmacy are: CE: Each pharmacist must maintain their own CE records for 4 years from the program date. Source: 465.022(12) Pharmacies; general requirements; fees
If the DEA Form 222 order cannot be filled to completion, what happens to the order? The order becomes invalid The date form can be changed on the original form to extend the time period The form does not have an expiration date Supplier holds onto the form until the can fill the form to completion None of the above
The balance of the order must be supplied within 60 days of the original date of the order. Otherwise the order becomes invalid.
Within what period of time should a pharmacy notify the DEA of a suspected theft? Immediately upon discovery of the theft or loss Within 2 hours of the suspected theft or loss Within a day of the suspected theft or loss Within a month of the suspected theft or loss No need to report a suspected theft or loss Explanation
Immediately upon discovery of the theft or loss (Correct) The pharmacy is responsible for notifying the DEA, the appropriate State agency, and the Local Police of any suspected theft or significant loss of any controlled substances immediately upon suspected theft or loss.
All records associated with a theft or loss of controlled substances should be kept on file in the pharmacy for how long a period of time? 1 year 2 years 3 years 5 years 7 years
2 years (Correct) Explanation The pharmacy is responsible for notifying the DEA, the appropriate State agency, and the Local Police of any suspected theft or significant loss of any controlled substances immediately upon suspected theft or loss. DEA form 106 must be completed. 3 copies are needed; the original and a copy of it are sent to the DEA Diversion Field Office and the pharmacy retains a copy for its records for 2 years.
How long is a Notice of revocation kept on file? 6 months from date of execution 1 year from the date of execution 2 years from date of execution 3 years from date of execution 5 years from date of execution
2 years from date of execution (Correct) A Notice of revocation is kept on file 2 years and should be made available for inspection.
Which of the following must be registered with iPLEDGE to deal with isotretinoin products? I. Pharmacy II. Physician III. Patient I only III only I & II only II & III only I,II, & III
I,II, & III (Correct) Explanation According to the federal law - pharmacies must be registered and participating in IPLEDGE to be able to dispense Isotretinoin containing products
Which of the following students are allowed to have a pharmacy intern permit? I. Someone who just started his or her first professional year at an accredited ACPE pharmacy school II. Someone who just enrolled in an intern program at an accredited ACPE pharmacy school III. A graduate from an accredited ACPE pharmacy school from another state awaiting licensing in FL
II III To have a pharmacy intern license the person must be: Registration with the board Enrollment in an intern program at an accredited school of pharmacy or graduates who are not yet licensed in FL
Under which of the following circumstances would a purchaser return DEA Form 222 to the DEA? I. Purchaser's address on the form is incorrect II. Purchaser's DEA registration has been suspended III. Purchaser has died I only III only I & II only II & III only I, II, & III
I, II, & III (Correct) Explanation When a registrant's DEA is terminated, revoked, suspended, or the name or address changes, all unused forms must be returned to the nearest DEA office.
The first phase of a clinical trial which evaluates the efficacy of the drug is which of the following? Phase V Phase IV Phase III Phase II Phase I
Phase II (Correct) Phase I assesses safety in a small group of healthy individuals Phase II assesses safety and efficacy in a larger group of patients (100 or more) Phase III assesses efficacy compared to a control group on larger group of patients than phase 2 (1000)
The packaging of nonprescription products that prohibits anyone from adding foreign materials into the final product is best described as being which of the below? Sealed Child-resistant Tamper-evident Tamper-proof Tamper-resistant Explanation
Explanation It is required by law to have a temper-evident packaging of all drug products (Exemptions are available). Tamper-evident packaging will have many indicators or barriers for entry. If breached or missing the patient can have visible proof of tampering.
FDCA
Federal food drug & cosmetic act, that has had several amendments since then Durham Humphrey - otc and such Keauver-Harris ammendment -
How long must controlled substance inventory be maintained by the discontinuing business? 1 year 2 years 3 years 5 years No records must be kept since the business is discontinued
Brittney Rule-they inspect you every year so every record would make sense to be keep for 2 years 2 years (Correct) The records involving controlled substances must be kept available by the discontinuing business for two years.
Which of the following professions can possess and dispense prescription drugs: I. Pharmacist II. Infectious disease doctor III. Oncology physician I only III only I & II only II & III only I,II, & III
I,II, & III (Correct) Explanation Non controlled rx: pharmacy or it's agent, MD, DO, dentist, podiatrist, vet, PA, APN Controled rx: MD, DO, dentist, podiatrist, vet, pharmacy and pharmacist via pharmacy as a DEA registrant NABP 2014 Survey of Pharmacy Law
Section 8
(50 cards)
Which application should a drug company submit to market a generic form of a drug? Orphan drug application INDA SNDA ANDA NDA
ANDA (Correct) Explanation ANDA is Abbreviated new Drug Application that is submitted by secondary companies rather than submitting an NDA again when the patent of a drug from the innovator company will expire.
How many days of medication can a patient in a short term detoxification treatment take home? 30 7 3 1 0 (Correct) Explanation Patients in a short term detoxification are not eligible for take-home medication; However, long-term detoxification patients are eligible.
0 (Correct) Explanation Patients in a short term detoxification are not eligible for take-home medication; However, long-term detoxification patients are eligible.
Patients enrolled in the Drug Addiction treatment Act (DATA) for the first 90 days may receive what maximum quantity of take home medication? 45 days 30 days 7 days 2 days 1 day
Patients enrolled in the Drug Addiction treatment Act (DATA) for the first 90 days may receive what maximum quantity of take home medication? 45 days 30 days (Correct) 7 days 2 days 1 day Explanation Under the Drug Addiction treatment Act of 2000 (DATA) patients are allowed buprenorphine administration through pharmacies through monthly (30 days) prescriptions as opposed to daily visits to methadone clinics.
Which of the following drugs may NEVER be sold in a retail pharmacy? Schedule I Controlled substances Schedule II Controlled substances Schedule III Controlled substances Schedule IV Controlled substances Schedule V Controlled substances
I
Which of the following should a pharmacist do? (select all that apply) Reducing a verbal order to writing Numbering prescriptions numerically and consecutively and filing them appropriately Holding for sale adulterated drugs Dispensing misbranded drugs Filling a possible forged prescription without calling the prescriber
Drug samples should be stored in a place where drug integrity is maintained (Correct) Drug samples should be stored safely (Correct) Drug samples should be stored in accordance with the manufacturers' labeling in hospital pharmacies (Correct) All expired, damaged, or deteriorated drug samples should be immediately removed and disposed of properly (Correct) Explanation Drug sample should be safely stored and in accordance with the manufacturers' labeling. The following should never be placed in drug storage areas; drug delivery devices used for patient education and/or demonstration; placebo drugs; food; hazardous chemicals; and/or potential adulterants. All expired, damaged, or deteriorated drug samples should be immediately removed and disposed of properly. All drug sample storage areas should comply with safe storage practices, and be evaluated and inspected by appropriately trained staff for the potential for medication errors due to similar drug names, packaging or labeling. The Prescription Drug Marketing Act 1987 prohibits the sale, purchase, or trade of drug samples and restricts pharmacies from receiving any prescription drug samples. Sources: http://www.nccmerp.org/council/council2008-01.html http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987/ucm201702.htm
What controlled substance records must the purchaser maintain? I. Copy 2 of all DEA Form 222 II. All rejected DEA Form 222 received III. Receipts and invoices for Schedule III-V I only III only I & II only II & III only I, II, & III
II & III only (Correct) Explanation The purchaser must maintain the following controlled substances records: Copy 3 of all DEA Form 222 Power of Attorney authorization Receipts and invoices for Schedule III-V All inventory records for controlled substances Records of controlled substances distributed or dispensed All rejected DEA Form 222 received All statements associated with lost or stolen DEA Form DEA registration certificate Records of transfers of controlled substances
Which of the following is NOT a responsibility of the prescription drug manager of a retail pharmacy? Keep in proper form all records required relating to the purchase and dispensing of all prescription required drugs including controlled substance requirements Eliminate from stock all misbranded and adulterated drugs including outdated drugs and drugs not properly labeled Insure against unauthorized entry into the pharmacy's dispensing and compounding area and insure appropriate security Insure coverage of the entire retail store by licensed personnel Insure against unauthorized refills of prescriptions and unauthorized sale of legend drugs
INsure coverage of entire retail store by liscneced personalll
Companies that identify, patent, and produce a new drug are guaranteed exclusive marketing rights by the Marketing act of 1987 for up to how many years? 5 years 10 years 15 years 20 years 25 years
20 years (Correct) Explanation Prescription Drug Marketing Act of 1987: Typically for about 20 years a company may apply for a patent for the drug granting exclusivity rights depending on a number of considerations.
Which of the following statements is/are true regarding the storage of controlled substance medications? I. Controlled substance drugs may be dispersed through the pharmacy with non-controlled substances II. Controlled substances may be locked in a storage cabinet III. Controlled substances may NOT be placed on a single shelf alphabetically I only III only I & II only II & III only I,II, & III
I,II, & III (Correct) Explanation Conditions of controlled substance storage requirements are: Working stocks of controlled substances of a registered pharmacy may be dispersed throughout the stocks of noncontrolled substances in such a manner as to obstruct theft or diversion provided the conditions of section 80.6 of this Part are met and the pharmacy is locked when not in operation. If not dispersed, controlled substances in Schedules II, III and IV shall be kept in a stationary, securely locked cabinet of substantial construction. Source: no mention in FL state pharmacy law defer to DEA--http://www.cogan.com/documents/DEA_Controlled_Substances_Security_Manual.pdf
ABC pharmacy does not have enough oxycodone to fill a patient's prescription, so the pharmacy decides to partially fill it. How long must the remaining quantity be filled by? The pharmacy may partially fill it as long as the remaining quantity is filled within 24 hours The pharmacy may partially fill it as long as the remaining quantity is filled within 48 hours The pharmacy may partially fill it as long as the remaining quantity is filled within 72 hours The pharmacy may partially fill it as long as the remaining quantity is filled within one week The pharmacy may not partially fill this prescription Explanation
The pharmacy may partially fill it as long as the remaining quantity is filled within 72 hours (Correct) Defer to DEA Title 21 Code of Federal Regulations Title 21 Code of Federal Regulations §1306.13 Partial filling of prescriptions. Schedule II: permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_13.htm
The FDA does not regulate which of the following? (Select ALL that apply) Biologics Meat Chicken Cosmetics Drugs
Meat (Correct) Chicken (Correct) Explanation The FDA (Food and Drug Administration) is a public health agency. It enforces the regulations of the following: Food excluding meat and poultry Drugs Medical devices Blood Biologics Cosmetics
What are requirements to become a pharmacist intern? 17 years of age 18 years of age 19 years of age 21 years of age No age minimum
No age minimum (Correct) Explanation Requirements to become a pharmacist intern registration with the board enrollment in an intern program at an accredited school of pharmacy or graduates who are not yet licensed in FL 465.013 Registration of pharmacy interns
By FL law, a prescription drug manager must notify the Board within how many days of any pharmacy manager change? 24 hours 7 days 10 days 30 days 60 days Explanation
10 days (Correct) Requirements of PDM's Maintaining all drug records Providing for the security of the prescription department notify the board of any theft or significant loss of any controlled substances within 1 business day after discovery Following such other rules as related to the sale of prescription drugs and the "practice of the profession of pharmacy" (definition available in FL statute 2012 chapter 465) Notify the Board within 10 days of any pharmacy manager change Section 465.022(10) and s. 465.022(11), F.S.
An orphan drug is a drug that: Has been created for special markets in poor countries Has a low therapeutic index Has special economic incentives for the manufacturer who develop it Has been imported to a foreign country Has been discontinued because of proof that it is unsafe
Has special economic incentives for the manufacturer who develop it (Correct) Explanation Orphan drugs are drugs for rare diseases and small populations of patients. The government created marketing incentives for manufacturers to encourage them to develop those kinds of medications.
Which of the following professions have no quantity restrictions in dispensing a prescription drug? (Select all that apply) Pharmacist Opthamologist Veterinarian Psychologist Psychiatrist
Which of the following professions have no quantity restrictions in dispensing a prescription drug? (Select all that apply) Pharmacist (Correct) Veterinarian (Correct) Non control: pharmacy or it's agent, MD, DO, dentist, podiatrist, vet, PA, APN Control: MD, DO, dentist, podiatrist, vet, pharmacy and pharmacist via pharmacy as a DEA registrant NABP 2014 Survey of Pharmacy Law pg 96-100
Which of the following can administer a controlled medication? I. Midwife II. Nurse Practitioner III. Psychologist I only III only I & II only II & III only I,II, & III
I & II only (Correct) Explanation controlled substances: practitioner, licensed nurse, intern practitioner, veterinarian or their orderly (893.05(1) Practitioners and persons administering controlled substances in their absence)
Dr. Smith (an MD) wants to sell his patients prescription medications. Which of the following prescriptions would be legally allowed? (select all that apply) A prescription for a 30 day supply of lisinopril A prescription for a 2 day supply of amphetamine A prescription for a 10 days supply of Xanax A prescription for a 5 days supply of Norco A prescription for a 3 days supply of Xanax
Dr. Smith (an MD) wants to sell his patients prescription medications. Which of the following prescriptions would be legally allowed? (select all that apply) A prescription for a 30 day supply of lisinopril (Correct) A prescription for a 2 day supply of amphetamine A prescription for a 10 days supply of Xanax (Correct) A prescription for a 5 days supply of Norco A prescription for a 3 days supply of Xanax (Correct) Explanation Practitioners can register (and register ANP's and PA's underneath them) to dispense medications out of their office. Controlled substances that are Schedule II and III are NOT allowed for office dispensing (there are some exceptions--surgery, corrections...) Schedule IV and V are allowed for office dispensing with registration 465.0276 Dispensing practitioner http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0465/0465.html
Which of the following is required to be on the label of a dispensed prescription? (select all that apply) The initials or name of the dispensing pharmacist The initials or name of the dispensing pharmacy technician The initials or name of the dispensing pharmacy intern A controlled substance auxiliary label for a controlled substance prescription The name of the pharmacy
A controlled substance auxiliary label for a controlled substance prescription (Correct) The name of the pharmacy (Correct) Explanation Requirements for labeling dispensed prescriptions: Name and address of the pharmacy. Date of dispensing. Serial number. Name of the patient. Name of the prescriber. Name of the drug dispensed (unless prescriber specifically requests it to be withheld). Directions for use. An Expiration Date or Beyond-Use Date. Controlled Substance: a warning that it is a crime to transfer the drug to another person. 64B16-28.108(2) All Permits - Labels and Labeling of Medicinal Drugs
Which of the following vaccinations can a pharmacist administer based on a non-patient specific order ? I. Influenza II. Pneumococcal III. Zostavax I only III only I & II only II & III only I,II, & III
Which of the following vaccinations can a pharmacist administer based on a non-patient specific order ? I. Influenza II. Pneumococcal III. Zostavax I only III only I & II only II & III only I,II, & III (Correct) Explanation Pharmacists may get certified to administer vaccines or epinephrine autoinjections Flu, pneumococcal, shingles vaccines with protocol 3h CE course every 2 years 465.189 Administration of vaccines and epinephrine autoinjection 465.009(6)a Continuing professional pharmaceutical education July 1, 2015 update: Certified pharmacist can give all immunizations or vaccines listed in the U.S. Centers for Disease Control and Prevention's Adult Immunization Schedule in effect on February 1, 2015. http://floridaspharmacy.gov/latest-news/immunization-authority-expanded/
Which of the following are acceptable methods of disposal of controlled substances? I. Surrender to DEA via Form 41 II. Ship to reverse distributor for destruction III. Donation to a charitable organization for reuse I only III only I & II only II & III only I,II, & III
I & II only (Correct) The department shall keep a full and complete record of all controlled substances or listed chemicals received and of all controlled substances or listed chemicals disposed of, showing: The exact kinds, quantities, and forms of such controlled substances or listed chemicals The persons from whom received and to whom delivered By whose authority received, delivered, and destroyed The dates of the receipt, disposal, or destruction Destruction of controlled substances: complete DEA Form DEA-41 sighed by the PDM/consultant and a DEA agent or department inspector shipped to reverse distributors for destruction 893.12(1)d Contraband; seizure, forfeiture, sale. http://www.flsenate.gov/Laws/Statutes/2012/Chapter893/All 64B16-28.303 Destruction of Controlled Substances All Permittees
The Controlled Substances Act identifies a "Listed Chemical" as chemicals that are: Listed in the HPUS Listed in the USP DI Listed in the USP/NF Listed in the Orange Book Used in manufacturing a controlled substance
Used in manufacturing a controlled substance (Correct) Explanation The Controlled Substances Act identifies a "Listed Chemical" as chemicals that are used in manufacturing a controlled substance in violation of CSA and is important to the manufacture of a controlled substance. They are classified as List I and List II chemicals.
Which of the following statement(s) is/are required to be monitored during drug utilization review? (select all that apply) Over/under utlization Drug-disease contraindications Drug-drug interactions Clinical abuse/misuse Therapeutic duplication
Which of the following statement(s) is/are required to be monitored during drug utilization review? (select all that apply) Over/under utlization (Correct) Drug-disease contraindications (Correct) Drug-drug interactions (Correct) Clinical abuse/misuse (Correct) Therapeutic duplication (Correct) Explanation Pharmacists should review patient records at each new and refill prescription fill to promote therapeutic appropriateness Pharmacists should monitor: Over/under utilization Therapeutic duplication Drug-disease contraindications Drug-drug interactions Clinical abuse/misuse Upon recognition of the above, appropriate steps should be taken to avoid/resolve the potential problems, including consultation with the prescriber if necessary 64B16-27.810(1)- 64B16-27.810(2) Prospective Drug Use Review.
Dr. Smith (an MD) wants to buy medications from ABC pharmacy and resale them at his practice. Which medications may Dr. Smith legally buy from ABC pharmacy for RESALE? (select all that apply) Lisinopril Tramadol Norco 5/325 Xanax None, a pharmacist can not sell a practitioner a prescription drug for resale
Dr. Smith (an MD) wants to buy medications from ABC pharmacy and resale them at his practice. Which medications may Dr. Smith legally buy from ABC pharmacy for RESALE? (select all that apply) Lisinopril (Correct) Tramadol (Correct) Xanax (Correct) Complete a 222 to use the pharmacy as a supplier for controls (with DEA registration) or an invoice for legend drugs Practitioners can register (and register ANP's and PA's underneath them) to dispense medications out of their office. Controlled substances that are Schedule II and III are NOT allowed for office dispensing (there are some exceptions--surgery, corrections...) Schedule IV and V are allowed for office dispensing with registration 465.0276 Dispensing practitioner http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0465/0465.html
What are the requirements to work in FL as a pharmacy technician? (select all that apply) Completion of a board-approved PhT training program Pass a PTCB (Pharmacy Technician Certification Board) examination Registration through the board No certification is necessary Compounding certificaation
Completion of a board-approved PhT training program (Correct) Registration through the board (Correct) No certification is necessary (Correct) Explanation Requirements to become a pharmacy technician are: Registration with the state board At least 17 years old Completion of an approved pharmacy technician program 465.014(2) Pharmacy technician
How many pharmacy technicians are allowed per pharmacist? 1 pharmacy technician 2 pharmacy technicians 3 pharmacy technicians 4 pharmacy technicians Unlimited technicians
1
To transfer ownership, an application for the new registration should be received by the State Board of Pharmacy at least: One week prior to the proposed date of transfer Six weeks prior to the proposed date of transfer One week after the proposed date of transfer Six weeks after the proposed date of transfer None of the above Show Answer Next >
None of the above (Correct) Explanation Pharmacy permits are not transferable, upon a sale a new application has to be filed. Old records and drugs must be transferred and "new" records be started under the new permit. The new permit must record and opening inventory for the DEA New and old permits have to keep their appropriate records for 2 years for the transfer or legend and controlled drugs 64B16-28.2021 Change of Ownership.
Which of the following is a responsibility of a supervising pharmacist? I. Instruct ALL employees, either orally or in writing, at regular intervals relative to the appropriate activities in connection with the practice of pharmacy II. Be certain that the pharmacy is properly registered and operating in accordance with the present laws, rules and regulations III. Use "reasonable" means to determine that the drugs being held for sale meet only established federal standards I only III only I & II only II & III only I,II, & III
I & II only (Correct) Explanation The following are some responsibilities of the Prescription Department Manager: Keep in proper form all records required relating to the purchase and dispensing of all prescription required drugs including controlled substance requirements. Eliminate from stock all misbranded and adulterated drugs including outdated drugs and drugs not properly labeled. Provide for the proper storage of drugs in order to prevent loss or deterioration. Insure coverage of the pharmacy by licensed pharmacists. Insure against unauthorized refills of prescriptions and unauthorized sale of legend drugs. Source: Section 465.022(10) and s. 465.022(11), F.S. http://www.flsenate.gov/Laws/Statutes/2012/Chapter465/All
Which of the following is a valid Percocet prescription (assume no diagnostic codes)? (select all that apply) A written prescription for a 30 day supply of Percocet A written prescription for a 15 day supply of Percocet A faxed prescription for a 30 day supply of Percocet A verbal prescription for a 15 day supply of Percocet A written prescription for a 60 day supply of Percocet
Which of the following is a valid Percocet prescription (assume no diagnostic codes)? (select all that apply) A written prescription for a 30 day supply of Percocet (Correct) A written prescription for a 15 day supply of Percocet (Correct) A faxed prescription for a 30 day supply of Percocet A verbal prescription for a 15 day supply of Percocet A written prescription for a 60 day supply of Percocet (Correct) Explanation The requirements for acceptance of CII prescriptions are: Written Emergency oral prescription for 72 hour supply maximum promptly reduced to writing Must be on counterfeit-resistant blanks Source: 893.04(1)f Pharmacist and practitioner. http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0800-0899/0893/0893.html
Which of the following is required for the pharmacist to obtain for transferring a prescription refill to his pharmacy? (select all that apply) The Pharmacist's name transferring the information The original prescription number The date of the original prescription and most recent transfer The name of the patient The DEA number of the pharmacy it was transferred from
The Pharmacist's name transferring the information (Correct) The original prescription number (Correct) The date of the original prescription and most recent transfer (Correct) The name of the patient (Correct) Explanation The following is needed when transferring existing prescription information from one pharmacist to another: the prescription order, the name of the pharmacy at which the prescription was on file, the prescription number, the name of the drug and the original amount dispensed, the date of original dispensing, and the number of remaining authorized refills requesting pharmacy and pharmacist and the date of reques (CIII-V prescriptions may be transferred) 465.026(2) Filling of certain prescriptions
Which of the following patient consultation areas are acceptable in a pharmacy? I. Converted storage closet behind the counter II. Check-out counter with designated 5 foot buffer to checkout queue III. Check-out counter with privacy screen I only III only I & II only II & III only I,II, & III
III only (Correct) community pharmacies: provide a private consultation area in which the patient does not enter the dispensing or stock areas of the pharmacy.
Which of the following are examples of misbranding? I. Drug includes an ingredient that reduces its quality II. Failing to use the established name III. Product does not contain the product I only III only I & II only II & III only I,II, & III
II & III only (Correct) Misbranding refers to: Labeling is false or misleading Packaging contains incorrect information about the manufacturer, packer, distributor, and or content. Includes conspicuous information Fail to use the established name Fail to provide direction of use and warnings Drug that includes an ingredient that reduces its quality is an example of adulteration.
Which publication publishes the controlled substances schedule changes? Federal Register (Correct) USP/NF USP/DI orange Book AJHP Explanation The Federal Register is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations including changes in schedules of controlled substances.
Federal Register (Correct) Explanation The Federal Register is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations including changes in schedules of controlled substances.
The FDA ruled that the drug ingredient cascara sagrada belongs to OTC category II in 2002. The FDA considers products that contain cascara sagrada to be: Safe Toxic Effective Expired Misbranded
Misbranded (Correct) Explanation OTC Category II is the classification of OTC ingredients that are not recognized as safe and effective nor as having acceptable indications: Laxative products containing cascara sagrada are considered misbranded.
Which of the following is true regarding a practitioner's sale of prescription drugs? (select all that apply) He may sell a patient a 5 day supply of a non controlled drug He may sell a patient a 60 day supply of a CII drug without a diagnosis code He may sell a patient a 30 day supply of a CIV drug without a diagnosis code He may sell a patient a 15 day supply of a non controlled drug He may sell a patient a 180 day supply of a CIII drug with a diagnosis code
He may sell a patient a 5 day supply of a non controlled drug (Correct) He may sell a patient a 30 day supply of a CIV drug without a diagnosis code (Correct) He may sell a patient a 15 day supply of a non controlled drug (Correct) Explanation Practitioners can register (and register ANP's and PA's underneath them) to dispense medications out of their office. Controlled substances that are Schedule II and III are NOT allowed for office dispensing (there are some exceptions--surgery, corrections...) Schedule IV and V are allowed for office dispensing with registration 465.0276 Dispensing practitioner
Which of the following drugs may be sold in a pharmacy with a valid prescription? (select all that apply) A CI Controlled substance A CII Controlled substance Cocaine 4% Flunitrazepam A non-controlled substance Explanation
A CII Controlled substance (Correct) Cocaine 4% (Correct) A non-controlled substance (Correct) Explanation Drugs that are prohibited to be sold in retail pharmacy are: Controlled substances Schedule I flunitrazepam (Rohypnol) Sources: 893.04 Pharmacist and practitioner http://www.drugs-forum.com/forum/showwiki.php?title=Category:Benzodiazepines#ixzz31Sxw9tIx
A pharmacist must use the DEA Form 222 to transfer a CII prescription to: I. The original manufacturer II. Another pharmacy III. The patient I only III only I & II only II & III only I,II, & III
I & II only (Correct) Explanation For CIIs a DEA 222 (federal) form must be filled out and that pharmacist must be given power of attorney by the pharmacy registrant. Source: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.htm
Flunitrazepam is considered a: I. CI FLS II. CIV Federal III. CI Federal I only III only I & II only II & III only I, II, & III
I & II only (Correct) Explanation flunitrazepam (Rohypnol) is schedule IV per federal law, but schedule I in FL http://www.drugs-forum.com/forum/showwiki.php?title=Category:Benzodiazepines#ixzz31Sxw9tI
Which of the following information is required to be on a FDA approved OTC drug packaging box? (select all that apply) Listing of active ingredients Brand and generic name of the active ingredient Listing of inactive ingredients The statement "This product is not intended to diagnose, treat, cure, or prevent any disease" Statement of purpose
Which of the following information is required to be on a FDA approved OTC drug packaging box? (select all that apply) Listing of active ingredients (Correct) Listing of inactive ingredients (Correct) Statement of purpose (Correct) Explanation Section 201.66 requires that all OTC drug product labeling contain the following information about the drug product. 1.Title (Drug Facts or Drug Facts (continued)) 2.Active ingredient(s) 3.Purpose(s) 4.Use(s) 5.Warning(s) 6.Directions 7.Other information 8.Inactive ingredients 9.Questions? or Questions or comments? (optional) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078792.pdf
Which pharmacy references are inadequate for use in a FL pharmacy? USP-NF USP-DI hard copy of 2011 FL pharmacy law reference Electronic access to Facts and Comparisons None of the above
hard copy of 2011 FL pharmacy law reference (Correct) Requirements of a pharmacy: No specific requirements other than workable and easily accessible sink, sufficient shelf/drawer/cabinet space, adequate facilities for refrigeration of drugs community pharmacies: provide a private consultation area in which the patient does not enter the dispensing or stock areas of the pharmacy. A current pharmacy reference compendium such as the USPNF, USP DI, , the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent to meet the practice needs of that pharmacy, current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format. 64B16-28.102 Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment. 64B16-28.1035 Patient Consultation Area.
Which act or amendment established a fast track process for drug approval for use in serious cases? Grandfather Act FDA Durham-Humphrey FDA Modernization Act Pure Food and Drug Act
FDA Modernization Act (Correct) Explanation FDAMA (Food and Drug Administration Modernization Act) of 1997 addresses but not limited to all of the following Expanded Prescription Drug User Fee Act Implemented inactive ingredient labeling requirements for OTC products Established new prescription drug labeling requirements A fast track approval process was established for cases of serious or life-threatening conditions.
Which of the following staff members can NOT make an offer to have a patient counseled on their medications? Pharmacist Pharmacy intern Pharmacy technician Pharmacy cashier Any pharmacy staff member can make an offer to counsel
Any pharmacy staff member can make an offer to counsel (Correct) Explanation Pharmacists must offer to counsel patients verbally and by printed offer for each new or refill prescription Pharmacists may counsel the patient's agent in lieu of the patient Delivery: counseling offer must be in writing and must include toll-free phone access to the pharmacist Pharmacists or interns under direct pharmacist supervision may complete counseling which includes appropriate elements of patient counseling 64B16-27.820(1)- 64B16-27.820(3) Patient Counseling.
Which of the following can dispense a prescription drug? I. Physician's assistant II. Nurse Practitioner III. Nurse I only III only I & II only II & III only I,II, & III
I & II only (Correct) Explanation A FL licensed pharmacist 465.015(1)b Violations and penalties. Practitioners can register (and register ANP's and PA's underneath them) to dispense medications out of their office. Not CII or CIII's except: as a sample as necessary for a surgical procedure registered methadone clinics 465.0276 Dispensing practitioner
Which of the following is NOT a requirement to become a pharmacist in FL? The person must be of good moral character Must pass the NAPLEX exam Be a legal immigrant or citizen of the United States Completion of a pharmacy program at an accredited ACPE program Completed a pharmacy program which led to an associated degree
Completed a pharmacy program which led to an associated degree (Correct) Explanation Requirements to become a licensed pharmacist: Pass NABP and law licensure exams and proof of completion of approved internship program and degree from accredited school of pharmacy (license by examination) or submit proof of active licensed practice in at least 2 of the preceding 5 years (license by endorsement) at least 18 years old the state board may not issue a license by endorsement to an applicant whose practice has been suspended/revoked or is under disciplinary proceedings in another state 465.0075 Licensure by endorsement 465.007 Licensure by examination 64B16-26.203 Licensure by Examination
Which of the following drug substitution laws is allowed? (select all that apply) The pharmacy dispenses the brand name drug because the prescription says DAW with the brand name drug written on the prescription. The pharmacy dispenses the generic version of a drug because the prescription does not have DAW written on the face of the prescription. The pharmacy dispenses the brand name drug and charges the brand name price because they are out of stock of the generic even though DAW is NOT written on the face of the prescription. The pharmacy dispenses the generic drug and charges the generic price when the medication is on the Negative Drug Formulary because DAW is NOT written on the face of the prescription. The pharmacy dispenses the brand name drug and charges the brand drug price because they are out of stock of the generic without notification to the patient.
Which of the following drug substitution laws is allowed? (select all that apply) The pharmacy dispenses the brand name drug because the prescription says DAW with the brand name drug written on the prescription. (Correct) The pharmacy dispenses the generic version of a drug because the prescription does not have DAW written on the face of the prescription. (Correct) The pharmacy dispenses the brand name drug and charges the brand name price because they are out of stock of the generic even though DAW is NOT written on the face of the prescription. The pharmacy dispenses the generic drug and charges the generic price when the medication is on the Negative Drug Formulary because DAW is NOT written on the face of the prescription. The pharmacy dispenses the brand name drug and charges the brand drug price because they are out of stock of the generic without notification to the patient. Explanation Brands may be substituted for less expensive generic equivalent unless requested by prescriber or patient Patient must be notified of substitution, price difference, and their right to refuse the substitution Each community pharmacy must maintain a formulary of equivalent brand/generic drugs The sign must be posted: "CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW." 465.025 Substitution of drugs Drugs on the FL "Negative Drug Formulary" have inequivalent brand/generics and can NOT be substituted 64B16-27.500 Negative Drug Formulary
Which federal act prohibits pharmacies from selling drug samples? Drug Price Competition and Patent-Term Restoration Act FDA Modernization Act Patient Protection and Affordable Care Act Pure Food and Drug Act Prescription Drug Marketing Act
Prescription Drug Marketing Act (Correct) Explanation The Prescription Drug Marketing Act 1987 prohibits the sale, purchase, or trade of drug samples and restricts pharmacies from receiving any prescription drug samples.
The NDC number on a medication package has how many parts? 1 2 3 4 5
3 (Correct) Explanation The NDC or national drug code identifies a drug product. It has 3 parts totaling 10-11 digits:
Dr. Smith (an MD) wants to buy lisinopril from ABC pharmacy and resell them at his practice. How many lisinopril can Dr. Smith legally buy from ABC pharmacy for RESALE? (check all that apply) A 30 day supply of lisinopril A 100 count bottle of lisinopril A 60 day supply of lisinopril A 5 day supply of lisinopril None, a pharmacist can not sell a practitioner a prescription drug for resale
A 100 count bottle of lisinopril (Correct) A 60 day supply of lisinopril (Correct) A 5 day supply of lisinopril (Correct) Explanation 465.0276 Dispensing practitioner A practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with sections 465.0276 A practitioner registered under section 465.0276 may not dispense a controlled substance listed in Schedule II or Schedule III as provided in s. 893.03. This paragraph does not apply to: The dispensing of complimentary packages of medicinal drugs which are labeled as a drug sample or complimentary drug as defined in s. 499.028 to the practitioner's own patients in the regular course of her or his practice without the payment of a fee or remuneration of any kind, whether direct or indirect, as provided in subsection (5). The dispensing of controlled substances in the health care system of the Department of Corrections. The dispensing of a controlled substance listed in Schedule II or Schedule III in connection with the performance of a surgical procedure. Max:14-day supply and not more than 14 days after the performance of the surgical procedure. The dispensing of a controlled substance listed in Schedule II or Schedule III pursuant to an approved clinical trial. The dispensing of methadone in a facility licensed under s. 397.427 where medication-assisted treatment for opiate addiction is provided. Before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner's office or at any pharmacy. 465.0276 Dispensing practitioner http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0465/0465.html
Which of the following tasks can a pharmacy technician perform? (select all that apply) Take a verbal new prescription from a doctor's office Data entry a prescription into the computer system Talk to a patient about where an OTC product is located Counsel a patient on his or her new medication Operate the cash register in a pharmacy
Which of the following tasks can a pharmacy technician perform? (select all that apply) Take a verbal new prescription from a doctor's office Data entry a prescription into the computer system (Correct) Talk to a patient about where an OTC product is located (Correct) Counsel a patient on his or her new medication Operate the cash register in a pharmacy (Correct) Explanation Some tasks that can be performed by a technician in FL: (a) Data entry (b) Labeling of preparations and prescriptions; (c) Retrieval of records pertaining to the practice of pharmacy; (d) The counting, weighing, measuring, and pouring of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system (e) The initiation of communication to confirm the patient's name, medication, strength, quantity, directions, number of refills, and date of last refill; (f) The initiation of communication with a prescribing practitioner or their agents to obtain clarification on missing or illegible dates, prescriber name, brand or generic preference, quantity, license numbers or DEA registration numbers; (g) The acceptance of authorization to dispense medications pursuant to a prescribing practitioner's authorization to fill an existing prescription that has no refills remaining (refill authorization); The following tasks may not be delegated and the pharmacy technician shall not: (a) Receive new non written prescriptions or receive any change in the medication, strength, or directions of an existing prescription; (b) Interpret a prescription or medication order for therapeutic acceptability and appropriateness; (c) Conduct final verification of dosage and directions; (d) Engage in prospective drug review; (e) Monitor prescription usage; (f) Override clinical alerts without first notifying the pharmacist; (g) Transfer a prescription; (h) Prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning treatment of the person or animal for whom the prescription was written; (i) Engage in patient counseling; Florida Administrative Code, Rule 64B16-27.420(1) Registered Pharmacy Technician Responsibilities. https://www.flrules.org/gateway/ChapterHome.asp?Chapter=64B16-27
Which of the following prescriptions can be transferred? I. A written refill prescription for lisinopril II. A verbal refill prescription for amlodipine III. A written prescription with no refills for amoxicillin I only III only I & II only II & III only I,II, & III
I & II only (Correct) Explanation the prescription order, the name of the pharmacy at which the prescription was on file, the prescription number, the name of the drug and the original amount dispensed, the date of original dispensing, and the number of remaining authorized refills requesting pharmacy and pharmacist and the date of request (CIII-V prescriptions may be transferred) 465.026(2) Filling of certain prescriptions
How many hours are required to be completed by a pharmacist intern? 1600 intern hours, 500 extern hours 1000 intern hours, 1000 extern hours 2080 combined intern and extern hours 2080 intern hours 2100 intern hours
2080 intern hours (Correct) Explanation Internship hours are required by a pharmacist intern: 2080 hours 64B16-26.2032(8)b Pharmacy Intern Registration Internship Requirements
Section 9
(50 cards)
Who of the following must be registered by the DEA to possess controlled substances? I. Researchers II. Pharmacies III. Narcotic Treatment Programs I only III only I & II only II & III only I,II, & III (Correct) Explanation Anyone authorized to possess controlled substances must be registered by the DEA.
I,II, & III (Correct) Explanation Anyone authorized to possess controlled substances must be registered by the DEA.
DEA permits pharmies to take unused controlled narcotics
Yes
How many items may be ordered on each numbered line on the DEA Form 222? 7 5 3 2 1
Only one item (one or more commercial or bulk containers of the same substance) may be entered on each numbered line of the order form.
Which of the following vaccinations can a pharmacist administer? (select all that apply) Meningococcal Influenza Varicella Zostavax Polio
Meningococcal (Correct) Influenza (Correct) Varicella (Correct) Zostavax (Correct) Polio (Correct) Explanation Flu, pneumococcal, shingles vaccines with protocol 3h CE course every 2 years 465.189 Administration of vaccines and epinephrine autoinjection 465.009(6)a Continuing professional pharmaceutical education Florida law update July 1, 2015: registered pharmacist can give all immunizations or vaccines listed in the U.S. Centers for Disease Control and Prevention's Adult Immunization Schedule in effect on February 1, 2015.
Which of the following is true regarding a practitioner's sale of prescription drugs? (select all that apply) He may sell a patient a 5 day supply of a CIV drug He may sell a patient a 60 day supply of a CII drug without a diagnosis code He may sell a patient a 30 day supply of a CIII drug without a diagnosis code He may sell a patient a 15 day supply of a non controlled drug He may sell a patient a 180 day supply of a CIII drug with a diagnosis code Show Answer Next >
He may sell a patient a 5 day supply of a CIV drug (Correct) He may sell a patient a 15 day supply of a non controlled drug (Correct) Explanation Practitioners can register (and register ANP's and PA's underneath them) to dispense medications out of their office. Controlled substances that are Schedule II and III are NOT allowed for office dispensing (there are some exceptions--surgery, corrections...) Schedule IV and V are allowed for office dispensing with registration 465.0276 Dispensing practitioner http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0465/0465.html
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
When will a supplier reject an order form? I. Number of lines completed by purchaser is empty II. Form is illegible III. Erasure signs I only III only I & II only II & III only I,II, & III
When will a supplier reject an order form? I. Number of lines completed by purchaser is empty II. Form is illegible III. Erasure signs I only III only I & II only II & III only I,II, & III (Correct) Explanation If the supplier receives a defective order form he may correct an error and send the order only when the errors relate to the following: 1. Package size is missing where only one package size exists for the product 2. Misspelling of the drug name if there is no question about the identity of the drug 3. Date of order is missing provided that it not 60 days or more after the date of receipt 4. Strength of drug is missing where only one strength exists for the product 5. Incorrect placement of items on the order form only if there is no question as to what was ordered. On all other issues the copies 1 and 2 of the order form will be sent back to the purchaser with a statement of the reason the order was not filled.
DEA permits pharmies to take unused controlled narcotics
Yes
Which of the following DEA numbers is correct? (select all that apply) ME1178690 AD1447817 AL6379243 AP1564310 MS2178697
Which of the following DEA numbers is correct? (select all that apply) ME1178690 (Correct) AD1447817 (Correct) AP1564310 (Correct) Explanation Step 1: add the first, third, and fifth digits of the DEA number. Step 2: add the second, fourth, and sixth digits of the DEA number. Step 3: multiply the result of Step 2 by two. Step 4: add the result of Step 1 to the result of Step 3. Then, the last digit of this sum must be the same as the last digit of the DEA number. ME1178690: 1+7+6 = 14 2*(1+8+9) = 36 36+14 = 50 AD1447817: 1+4+8 = 13 2*(4+7+1) = 24 13+24 = 37 AP1564310: 1+6+3 = 10 2*(5+4+1) = 20 10+20 = 30
DEA permits pharmies to take unused controlled narcotics
Yes
The supplier records the number of bulk containers sent to the purchaser on which copy of the DEA Form 222 for its records? Copy 2 & Copy 3 Copy 1 & Copy 2 Copy 3 Copy 2 Copy 1 Explanation
Copy 1 (Correct) Explanation The purchaser sends to the supplier copies 1 and 2 of DEA form 222. Once received, the supplier fills the order and records on both copies the number of bulk containers supplied on each item and the date on which such containers are shipped to the purchaser. The supplier must retain copy 1 only of the order form for his record. The supplier forwards copy 2 to the Special Agent in Charge at the DEA office in the area where the supplier is located.
What can the purchaser do to receive the drugs ordered when he/she receives a rejected order form from the supplier? Correct the form and send it back to the supplier Send the rejected form to the DEA Send the rejected form to a different supplier Attach copies 1 and 2 of the rejected order to the other portion of DEA Form 222 (Copy 3) and retain them on file, then execute a new order Complete the number of lines section and resubmit
Attach copies 1 and 2 of the rejected order to the other portion of DEA Form 222 (Copy 3) and retain them on file, then execute a new order (Correct) Explanation When the purchaser receives a rejected order form from the supplier, he/she must attach copies of the rejected order to the other portion of DEA Form 222 and maintain with other DEA records, then process a new order and submit to the supplier
What action should the supplier take when he/she receives a DEA Form 222 and is concerned about the validity of the form? I. Notify the purchaser that the form is rejected II. Notify the DEA of the concern III. Notify the local police I only III only I & II only II & III only I,II, & III
Explanation If the supplier receives a defective order form he may correct an error and send the order only when the errors relate to the following: 1. Package size is missing where only one package size exists for the product 2. Misspelling of the drug name if there is no question about the identity of the drug 3. Date of order is missing provided that it not 60 days or more after the date of receipt 4. Strength of drug is missing where only one strength exists for the product 5. Incorrect placement of items on the order form only if there is no question as to what was ordered. On all other issues, the supplier should notify the purchaser that the form is rejected and the copies 1 and 2 of the order form will be sent back to the purchaser with a statement of the reason the order was not filled.
If the pharmacist fails to receive a follow-up prescription for an emergency supply of oxycodone what must he/she do? Notify the DEA within 72 hours of dispensing the prescription Notify the FL BOP within 72 hours of dispensing the prescription Notify the DEA within 7 days of dispensing the prescription Notify the FL BOP within 7 days of dispensing the prescription Does not have to notify anyone
Notify the DEA within 7 days of dispensing the prescription (Correct) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner. Source: http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm
When a DEA registration is terminated, what should the registrant do with unused DEA Form 222s? (Select ALL that apply) Destroy the forms Forward the forms to the location where the drugs are being stored Return the forms to the supplier Return the forms to the DEA Write void accross the forms Show Answer Next >
When a DEA registration is terminated, what should the registrant do with unused DEA Form 222s? (Select ALL that apply) Destroy the forms Forward the forms to the location where the drugs are being stored Return the forms to the supplier Return the forms to the DEA (Correct) Write void accross the forms Explanation When a registrant's DEA is terminated, revoked, suspended, or the name or address changes, all unused forms must be returned to the nearest DEA office. http://www.floridaspharmacy.gov/Forms/form-pharmacy-closing.pdf
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
Which of the following drug substitution laws is allowed? (select all that apply) The pharmacy dispenses the brand name drug because the prescription says DAW with the brand name drug written on the prescription. The pharmacy dispenses the generic version of a drug because the prescription does not have DAW written on the face of the prescription. The pharmacy dispenses the brand name drug and charges the brand name price because they are out of stock of the generic even though DAW is NOT written on the face of the prescription. The pharmacy dispenses the generic drug and charges the generic price when the medication is on the Negative Drug Formulary because DAW is NOT written on the face of the prescription. The pharmacy dispenses the brand name drug and charges the brand drug price because they are out of stock of the generic without notification to the patient.
Which of the following drug substitution laws is allowed? (select all that apply) The pharmacy dispenses the brand name drug because the prescription says DAW with the brand name drug written on the prescription. (Correct) The pharmacy dispenses the generic version of a drug because the prescription does not have DAW written on the face of the prescription. (Correct) The pharmacy dispenses the brand name drug and charges the brand name price because they are out of stock of the generic even though DAW is NOT written on the face of the prescription. The pharmacy dispenses the generic drug and charges the generic price when the medication is on the Negative Drug Formulary because DAW is NOT written on the face of the prescription. The pharmacy dispenses the brand name drug and charges the brand drug price because they are out of stock of the generic without notification to the patient. Explanation Brands may be substituted for less expensive generic equivalent unless requested by prescriber or patient Patient must be notified of substitution, price difference, and their right to refuse the substitution Each community pharmacy must maintain a formulary of equivalent brand/generic drugs The sign must be posted: "CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW." 465.025 Substitution of drugs Drugs on the FL "Negative Drug Formulary" have inequivalent brand/generics and can NOT be substituted 64B16-27.500 Negative Drug Formulary
Hydrocodone is considered a schedule ___ (select all that apply) FL CII Federal CIII FL CIII Federal CII Federal CV
FL CII (Correct) Federal CII (Correct) Explanation Hydrocodone is CII in FL and federal schedules starting October 6, 2014 Sources: 893.03 Standards and schedules
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
Under what circumstances may a supplier fill a defective order form? I. Number of lines completed by the purchaser is missing II. Strength of drug is missing where only one strength exists for the product III. Misspelling of the drug name if there is no question about the identity of the drug I only III only I & II only II & III only I,II, & III
II & III only (Correct) Explanation The supplier may correct an error on order form 222 and send the order only when the errors relate to the following: 1. Package size is missing where only one package size exists for the product 2. Misspelling of the drug name if there is no question about the identity of the drug 3. Date of order is missing provided that it not 60 days or more after the date of receipt 4. Strength of drug is missing where only one strength exists for the product 5. Incorrect placement of items on the order form only if there is no question as to what was ordered.
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
By FL law, a prescription drug manager must notify the Board within how many days of any pharmacy manager change? 24 hours 7 days 10 days 30 days 60 days Explanation
Requirements of PDM's Maintaining all drug records Providing for the security of the prescription department notify the board of any theft or significant loss of any controlled substances within 1 business day after discovery Following such other rules as related to the sale of prescription drugs and the "practice of the profession of pharmacy" (definition available in FL statute 2012 chapter 465) Notify the Board within 10 days of any pharmacy manager change Section 465.022(10) and s. 465.022(11), F.S.
How many refill(s) for a 15 day written prescription of modafinil is allowed? (select all that apply) 1 refill 3 refills 5 refills 6 refills 11 refills
1 refill (Correct) 3 refills (Correct) 5 refills (Correct) CII: no refills (no days supply specified in FL law) Non-oral CIII Rx: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner Oral CIII Rx: no more than a 30 day supply should be dispensed (893.04(1)e) CIV: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner CV: may not be filled/refilled more than 5 times within 6 months from the prescription's written date unless it is renewed by a practitioner Modafinil is a CIV substance. 893.04(1)g Pharmacist and practitioner.
If a DEA Form 222 is defective, what action will be necessary by the registrant? Get authorization from the DEA to correct the form Tear the defective form and start a new one Handwrite the correct information on top of the incorrect information Print the correct information on top of the erased incorrect information Send the form to the DEA and request that the DEA corrects it
Send the form to the DEA and request that the DEA corrects it (Correct) Explanation The DEA form 222 cannot be changed or altered by the recipient. If the information on the DEA form 222 is incorrect it must be sent back to the DEA for correction.
Which statement regarding the packaging of non liquid drugs regulated by the CMEA is TRUE? I. Blister pack packaging II. Unit dose packaging III. No more than two dosage units per blister I only III only I & II only II & III only I,II, & III
I,II, & III (Correct) Explanation The Combat Methamphetamine Epidemic Act (CMEA) regulates the non liquids packaging of ephedrine, pseudoephedrine, and phenylpropanolamine to blister packs containing no more two dosage units per blister. If blister packs are not convenient then the product must be packaged in unit dose packaging.
DEA permits pharmies to take unused controlled narcotics
Yes
Once received from the purchaser, what information does the supplier record on the DEA Form 222? (Select ALL that apply) Purchaser's name Purchaser's address Number of bulk containers supplied on each order to the purchaser Supplier's signature Date supplies are shipped
Number of bulk containers supplied on each order to the purchaser (Correct) Date supplies are shipped (Correct) Explanation The purchaser sends to the supplier copies 1 and 2 of DEA form 222. Once received, the supplier fills the order and records on both copies the number of bulk containers supplied on each item and the date on which such containers are shipped to the purchaser.
When filling out the DEA Form for a controlled substance order, what should the registrant complete? (Select ALL that apply) Date of order Name of all suppliers Number of lines completed on the order Signature of registrant Address of the supplier
Date of order (Correct) Number of lines completed on the order (Correct) Signature of registrant (Correct) Address of the supplier (Correct) To Purchase or transfer schedule I and/or II drugs between pharmacies, the pharmacist must use the DEA form 222. The form 222 is also used for returns of schedule I and/or II drugs to the supplier. DEA form 222 should be dated and signed. The total number of lines completed must be noted on that form in the space provided at the bottom of the form. The name and address of the supplier from whom Schedule II controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form this is why name of all suppliers is the wrong answer.
DEA permits pharmies to take unused controlled narcotics
Yes
What is NOT true about a drug? It is a substance intended to affect the structure or function of the body of man It is a substance intended for use in cure and treatment only It is a substance recognized by the USP/NF It is a substance recognized by the HPUS It is a substance that can be used in diagnosis
It is a substance intended for use in cure and treatment only (Correct) Explanation A drug is any of the below: Substance recognized by the USP/NF Substance recognized by the HPUS or Homeopathic Pharmacopoeia of the United States Substance intended for use in the cure, mitigation, treatment, diagnosis, and prevention of disease Substance intended to affect the structure or function of the body of man or other animals
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
Which of the following acts was the first to require pharmaceutical manufacturers to prove the safety of prescription drugs before marketing of the drug? FD & C Act of 1938 Durham-Humphrey Ammendments of 1951 Prescription Drug Marketing Act of 1987 Orphan Drug Act Pure Food and Drug Act
FD & C Act of 1938 (Correct) Explanation FD and C Act or Food, Drug and Cosmetic Act of 1938 was the first to require pharmaceutical manufactures prove the safety of prescription drugs before marketing of the drug.
DEA permits pharmies to take unused controlled narcotics
Yes
Which act or amendment was the first to recognize the USP/NF as an official compendium? Pure Food and Drug Act Food, Drug and Cosmetic Act Food, Drug and Insecticide Administration Drug Abuse Control Drug Importation Act
Pure Food and Drug Act (Correct) Explanation Pure Food and Drug Act prevents the manufacture, sale, or transportation of adulterated, misbranded, poisonous, or deleterious foods or drugs in interstate commerce. This act recognized the USP/NF as the official compendia for dug standards for misbranding and adulteration purposes.
Up to how many suppliers can be listed on each DEA Form 222? 1 2 3 4 5
1 To Purchase or transfer schedule I and/or II drugs between pharmacies, the pharmacist must use the DEA form 222. The name and address of the supplier from whom Schedule II controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any DEA form 222.
Which of the following is true regarding a practitioner's sale of prescription drugs? (select all that apply) He may sell a patient a 5 day supply of a non controlled drug He may sell a patient a 60 day supply of a CII drug without a diagnosis code He may sell a patient a 30 day supply of a CIV drug without a diagnosis code He may sell a patient a 15 day supply of a non controlled drug He may sell a patient a 180 day supply of a CIII drug with a diagnosis code
Which of the following is true regarding a practitioner's sale of prescription drugs? (select all that apply) He may sell a patient a 5 day supply of a non controlled drug (Correct) He may sell a patient a 60 day supply of a CII drug without a diagnosis code He may sell a patient a 30 day supply of a CIV drug without a diagnosis code (Correct) He may sell a patient a 15 day supply of a non controlled drug (Correct) He may sell a patient a 180 day supply of a CIII drug with a diagnosis code Explanation Practitioners can register (and register ANP's and PA's underneath them) to dispense medications out of their office. Controlled substances that are Schedule II and III are NOT allowed for office dispensing (there are some exceptions--surgery, corrections...) Schedule IV and V are allowed for office dispensing with registration 465.0276 Dispensing practitioner
Question 61 of 90 Which of the following is true regarding a CS prescription? I. A CII may have only one refill II. The quantity of dosage units must be written in both numerical and written form III. In an emergency, up to a 72 h supply may be dispensed for a CIII without a Rx I only III only I & II only II & III only I,II, & III
II & III only (Correct) Explanation CII: no refills (no days supply specified in FL law) CS must have written and numeric quantity notation 893.04(1)g Pharmacist and practitioner. The pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of non-Schedule II prescribed medications 465.0275 Emergency prescription refillS
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
Which copy of the DEA Form 222 is sent to the DEA by the pharmacy? Copy 1 Copy 2 Copy 3 Copy 1 and Copy 2 The pharmacy does not submit any copies to the DEA Show Answer Next >
Which copy of the DEA Form 222 is sent to the DEA by the pharmacy? Copy 1 Copy 2 Copy 3 Copy 1 and Copy 2 The pharmacy does not submit any copies to the DEA (Correct) Explanation The purchaser sends to the supplier copies 1 and 2 of DEA form 222 and retains copy 3 for his/her own records. Once received, the supplier fills the order and records on both copies the number of bulk containers supplied on each item and the date on which such containers are shipped to the purchaser. The supplier must retain copy 1 of the order form and forward copy 2 himself to the Special Agent in Charge at the DEA office in the area where the supplier is located. The pharmacy does not submit any copies to the DEA.
DEA permits pharmies to take unused controlled narcotics
Yes
Section 10
(50 cards)
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
DEA permits pharmies to take unused controlled narcotics
Yes
Section 11
(13 cards)