MA MPJE 2024 Flashcards
What is the Pure Food and Drug Act of 1906?
Prohibited misbranding and adulteration of drugs distributed through interstate commerce
No requirement for ingredients or directions on manufacturer label
Did not include cosmetics or medical devices
Which act was enacted d/t the sulfanilamide accident?
Food, Drug, and Cosmetic Act of 1938
What is the Food, Drug, and Cosmetic Act of 1938?
Enacted d/t the sulfanilamide accident (Antifreeze used in a product killed 107 people)
Required that a drug must be proven to be safe when using directions on the label
Label must provide adequate directions for use and warning of habit-forming ingredients
Cosmetics and medical devices included
Drugs marketed before 1938 were grandfathered in without need for above requirements (Includes levothyroxine, digoxin, and others)
What is the Durham-Humphrey Amendment of 1951?
Established 2 drug classes: “Legend” vs “OTC”
What was required for “Legend” drug labeling under the Durham-Humphrey Amendment of 1951?
“Caution: Federal law prohibits dispensing without a prescription” on manufacturer label – Later shortened to “Rx only” in 1997
No longer needed adequate directions for use on manufacturer label since pharmacist would be required to add a label with directions for use
What was required for OTC drug labeling under the Durham-Humphrey Amendment of 1951?
Adequate directions for use on label
Which act was enacted d/t the thalidomide concern?
Kefauver-Harris Amendment of 1962 (Drug Efficacy Amendment)
What is the Kefauver-Harris Amendment of 1962?
Drugs had to be proven both safe AND effective before marketing (Any drugs marketed from 1938 and beyond)
Put the FDA in charge of prescription drug advertising - Office of Prescription Drug Promotion (OPDP)
Put Federal Trade Commission (FTC) in charge of OTC medication advertising
Added informed consent for drug trials and Good Manufacturing Practices (GMPs)
What is the Medical Device Amendement of 1976?
Better classification and regulation of medical devices
What is the Federal Anti-Tampering Act of 1982?
Tamper-evident packaging required for OTC products
Label must indicate (on somewhere other than the tamper-evident closure itself) that the packaging is tamper-evident
What is the Orphan Drug Act of 1983?
Incentives for creating drug for rare diseases affecting <200,000 people in the US
What is the Drug Price Competition and Patent-Term Restoration Act of 1984 (Hatch-Waxman Amendment)
Created abbreviated new drug application (ANDA) for generic medication approval
Only need bioequivalence proof for generics
Brand name drug manufacturers get up to 5 years added to patent
What is the Prescription Drug Marketing Act of 1987?
Stricter regulations on drug product and sample distribution
Banned re-importation of prescription drug products
Banned sale, trade, or purchase of drug samples
Specified storage, handling, recordkeeping for samples
Barred retail pharmacies from receiving drug samples
– Retail pharmacies may instead utilize manufacturer vouchers/coupons or starter packs
What is the FDA Modernization Act of 1997?
New Drug Application (NDA) Fast Track - Expedited approval of new drugs for serious conditions
Clarified some compounding regulations
“Rx only” replaced old language
“Warning - may be habit forming” language eliminated
Encouraged supplemental NDAs – Add new indications for existing drug products
6 additional patent months for pediatric drugs
What is the Medicare Prescription Drug Improvement and Modernization Act of 2003?
Medicare Part A to D
A - hospitalization
B - physician services
C - Medicare Advantage
D - prescription meds
Cannot force pts to use mail order, must allow 90-day supply at local pharmacies
Medication Therapy Management (MTM)
- Part D sponsors automatically enroll targeted pts with chronic disease on many meds
- Pharmacists help manage those conditions by going over medications and making recommendations to providers
- Done quarterly for participants
When is an Investigational New Drug Application (IND) submitted?
After animal studies, you submit IND to FDA before you can begin human trials
How long does the FDA have to approve or decline an IND?
30 days
Describe Clinical Trial Phase 1
- Healthy subjects
- Safety, evaluate drug properties
- Small size
Describe Clinical Trial Phase 2
- Subjects with disease
- Effectiveness, dosing, adverse effects
- 100 + subjects
Describe Clinical Trial Phase 3
- Subjects with disease
- Usually blinded (some pts given placebo for comparison)
- Efficacy
- Can be 1000s of subjects at multiple sites around the globe
Describe Clinical Trial Phase 4
- Post marketing surveillance for more rare adverse effects
What are treatment INDs?
Drug given to pts with life-threatening illness that are not in the trial
When are New Drug Applications (NDAs) submitted?
Submitted after trials Phase 1-3 are completed
Takes FDA a long time (6 months+) to review
Once approved drug can go to market and Phase 4 begins
What is an Abbreviated NDA (ANDA)?
For generics
Must prove bioequivalence only
Do not need to repeat safety and efficacy trials
What is a Supplemental NDA (SNDA)?
Any change other than creating a generic
Can be used to add a new indication or dosage form
Describe Adulteration
Consists in whole or in part of any filthy, putrid, or decomposed substance
Has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth
Strength, quality, or purity differs from official compendium
Contains unsafe color additive
Describe Misbranding
Labeling proves false or misleading in any way
Labeling missing any required elements
Ex: missing the name and place of business of the manufacturer, packer, or distributor, or missing an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count
Describe Recall Class I
Most serious
Reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death
Pharmacies AND pts must be notified
Must send written notice
Describe Recall Class II
May cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy level recall
Must send written notice
Describe Recall Class III
Not likely to cause adverse health consequences
If a drug is A rated in the orange book, can a pharmacist substitute with that drug?
Yes
A rated = bioequivalent (may be substituted)
If a drug is B rated in the orange book, can a pharmacist substitute with that drug?
No
B rated = NOT bioequivalent (may NOT be substituted)
If a drug is AB rated in the orange book, can a pharmacist substitute with that drug?
Yes
AB rated = meets necessary bioequivalence standards (may be substituted)
Note: When there are multiple sources designated (AB1, AB2, AB3, etc.), AB1 can only be substituted with another AB1 rated medication, etc.
T/F: All generics, including authorized generics, are included in the Orange book and it is a great resource for pharmacists to know which generics can substitute brand name products
False - Authorized generics (approved brand name drugs that are marketed without the brand name on their label) do not appear in the Orange Book, however a pharmacist may interchange a prescription written for a brand name drug with its authorized generic version provided the prescriber did not indicate “no substitution” on the prescription
T/F: HIPAA notices should be provided to patients every time they refill
False
Must provide pt with a notice when first providing service
No need for new notice for repeat service
Requirements on manufacturer containers for prescription medications
Name and address of the manufacturer, packer, or distributor
Established name of the drug
Quantity (weight, quantity, dosage units)
Amount of active ingredient
“Rx Only”
Route if not taken orally
Special storage instruction if needed
Lot number
Expiration date
NDC code is requested but NOT required
Inactive additives should be listed alphabetically and separate from active ingredients
Labeling Requirements for Unit Dose Packaging
Name of drug
Quantity
Name and address of manufacturer, packer, or distributor
Lot number
Expiration date
OTC Product labels require content per dosage unit (e.g. tab, tsp) if single maximum recommended dose of the product is ___mg or more of calcium
20mg or more
OTC Product labels require content per dosage unit (e.g. tab, tsp) if single maximum recommended dose of the product is ___mg or more of magnesium
8mg or more
