Section 1
Preview this deck
Children- Poison Prevention Packaging Act
Front
| 5 | 0 | ||
| 4 | 0 | ||
| 3 | 0 | ||
| 2 | 0 | ||
| 1 | 0 |
Active users
2
All-time users
3
Favorites
0
Last updated
1 year ago
Date created
Mar 1, 2020
Cards (123)
Section 1
(50 cards)
Children- Poison Prevention Packaging Act
80 % can't open the cap
Adults- Poison Prevention Packaging Act
90 % can open the cap
Conjugated estrogen in mnemomiuc dispenser
NMT 32 mg of the drug
Bioequivalence
Extent and Rate of the drug absorbed the same except if it 1. makes no medical difference 2. documented 3. not essential to effect
Poison Prevention Packaging Act of 1970
Requires use of child-resistant containers
Potassium supplements
NMT 50 meQ/dose
Components of REMS
1. Medication guides 2. Communication plans 3. Elements to assure safe use
Right to Try
1. Terminally ILL 2. Phase I trial 3. No FDA oversight 4.Manufacturer approval
Betamethasone
NMT 12.6 mg drug/pkg
Investigation New Drug used when
1. There is not comparable drug 2. There is no alternative drug 3. There is no controlled trials, or all trials completed
Waxman-Hatch Act
+Clinical studies are not needed for generics
Can physicians make blanket prescriptions?
No they can not
Prednisone
NMT 105 mg/pkg
Prescription refills in PA
1.Medication can not be substituted for another medication unless 1. Call pt and get approval 2. Call prescriber and get approval
Drugs products that have a _____ therapeutic window will not be considered therapeutically equivalent
narrow
Nitroglycerin
not required to be in CRC packaging
Methylprednisone Tablets
NMT 84 mg of drug/pkg
Hospitals
sometimes do not meet therapeutically equivalent products
Aerosol prepaations intenteded for inhalation
N/A
REMS
Risk Evaluation and Mitigation Strategy- the benefits of using it must outweigh risks
B in the Orange book
B means a documented or potential bioequivalence problem (does not mean it is worse than reference)
STEPS
Thialodmide
What does a generic drug need to prove for generic equivalence?
1. Bioequivalence 2. Bio availability 3. GMP
Anhydrous chloestyramine
N/A
Mebendazole
NMT 600 mg drug/pkg
can you reuse child-resistant packaging?
Only glass vials as long as new CRC cap is used
Erythromycin granules tablets
NMT 8 gm of erythromycin NMT 16 grams
What if I can't reach the doctor but can reach the patient?
Notify the doctor as soon as possible that you filled prescription from different manufacturer in emergency situation- legal
Can manufacturers produce one package that is not child resistant?
Yes, manufacturers can if they state on package is for households without young children or package not child resistant
Oral contracpetives
N/A
A in the Orange book
A means that a drug is therapeutically equivalent
General rule: CRC
all drugs must be in CRC
Sodium Flouride
NMT 110 mg of Sodium Flouridw per package ( 50 mg per package)- CRC
Therepeutic equivalents have the same
Active Ingredient Strength Dosage Form
isosorbide dinitrate SL or chewable
NMT 10 mg or less-CRC
Orange book is not federal law
drugs are substituted that sometimes that are not therapeutically equivalent; however, most states do this.
Medroxyprogestrone
N/A
Patent term extensions
2-5 years New indication can be marketed for three years no generic drug for five years
Pharmaceutical equivalents that are bio equivalent
assumed to be therapeutically equivalent
Pancrealipase preparations
N/A
REMS safe use
1. Special training or certification 2. Restricting distribution 3. Dispensing based on evidence safe conditions 4. Pt monitoring One or more
Waxman- Hatch Amendments
how generic drugs get approved
OTC
Are mostly approved through monograph
Colespitol
up to 5 gm
FTC comission monitors
marketing of OTC drugs
Therepeutic equivalents are Pharmceutical equivalents but with
same ClinicaL EFFECT and efficacy
Poison Prevention Packaging Act of 1970- enforced by
Consumer Product Safety
Unit dose- Under Poison Prevention Packaging Act
can't open more than eight doses or toxic amount, whichever is less
How to define a narrow therapeutic window drug?
1. Less than a two fold difference between toxic dose and effective dose 2. Less than a two fold difference between lethal dose and effective dose 3. Carbamezepine, Phenyotin, warfarin, lithium, clonidine, levothyroxine
FDA monitors
marketing of prescription drugs
Section 2
(50 cards)
Injunctive
bring manufacturer to court
In case of antibiotic drugs being provided for the manufacturer in granular form to be reconstituted by pharmacist, whose responsibility is it to provide child-resistant packaging?
the pharmacist and manufacturer
Whose responsibility maintains PPA?
it is the dispensing pharmacist
Good Manufacturing Practices
Federal guidelines that must be followed by all entities that prepare and package medication or medical devices ( manufacturing, processing, packaging holding)
If you think you have package site ,that is not susceptible to wear?
Get information from manufacturer it is not susceptible to wear
Sacrosidise in glycerol and water
N/A
Class I Recall
Recall class where there is a reasonable possibility that the use/exposure to a violative product will cause serous adverse effects on health or death
Dotterwich Case
mislabeled information by accident
Adulteration and Misbranding
Most all violations of the FDCA are either ____ or ____, or both.
Can I dispense easy open to nursing home?
Yes, traditional nursing home where nurse can give med= institutions not needed.
Adulteration
making unpure poorer in quality
Child resistant
80 percent can't get acess to meds children less than 5 90 percent of adults can open it
Who is ultimately responsible something complies with the PPPA of 1970?
the pharmacist
Class III recall definition
Unlikely to cause adverse health consequences * typo)
Poison Prevention Packaging Act of 1970- dosage form
This is only for oral medications
Park Case
Acme put food in bad places and unsanitary places
Can a physcian make a blanket waiver?
No physician can not- only prescription can be filled this way
drug recall: good faith defense?
No, you did not check mail
Seizure
seize drugs off the shelf
Items that don't need to be in tamper evidence packaging
Dermatological Dentrifice Insulin Lozenge
Park Doctrine
Park Case and Dottewich Case
May the individual request that all of his/ her prescriptions be filled in conventional ( non-special packaging)?
Yes; however one request is not a blanket waiver
If a pt calls for information for poisoning?
If you do not have emergency info needed, then call poison control center 1-800-222-1222
F & D C 301 Prohibitions
Adulteration and Misbranding
Pudue Pharma
downplayed oxycontin marketed as misbranding
FDA: can it order removal of device off market
YES it can
FDA: can it order a drug off market
No it can't
Class II Recall
The probability of serious harm is not likely and the effects may be temporary or reversable. This recall does not go to the customer level and is usually due to problems with consistency of potency ( remote probability of serious adverse effect)
FDA can't directly order
a drug to be removed from market
Non-prescription packaging one size that does not comply
is applicable
Norethindrone
50 mg of drug
prescription vial failure
if child gains acess to mes
Where all the expemptions listed for the PPPA?
PPPA regulations 16 CFR 1700 .14
Unit dose packaging failure
child gains access to those that have 8 or more pills or toxic dose
PACKAGING PPPA VIOLATION
CIVIL CRIMINAL ADMINISTRATIVE PENALTIES
Mislabeling: good faith defense?
Yes
FDA enforcement act
Injuctive relief ( seek court action) Seizure ( libel action)- take drugs off shelf Criminal proceedings- (fines and imprisonments) Warning letter
What is the responsbility of the pharmacist under PPPA?
Poison Prevention packaging ACT- To dispense medication in poison control container unless patient, prescriber, or exceptions
Must the customer make the choice for the conventional packaging in writing?
No; however to protect yourself you might want to
Did not catch recall?
Civil liability
Are IND susceptible to PPPAs standard?
Yes
FDA will inspect blank to determine_______ Adulteration
1. The plant not every product 2. Health and safety better for community if FDA can monitor
HRT that relies on progesterone and estrogen
N/A
What if you violate the PPPA?
YOU CAN GO TO JAIL FOR A YEAR AND FINED UP TO 250,000 500,000 FINED ORGANIZATION AND CIVILLY PROSECUTED IF HURT SOMEONE
Prescription packaging one size that does not comply
is not applicable
Can a physician check a box to do this easy open waiver?
Yes, prescribe can do this however not encouraged due to over non-child resistant caps
Criminal proceedings
against manufacturer
Can I dispense easy open containers in hopsital?
Yes, as long as patient is confined to hospital; however not in patient going out of hospital.
Misbranding/ Adulteration- Ask youself?
Strength, Quality, Purity
warning letter
to manufacturer
Section 3
(23 cards)