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
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 potassium
5mg 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 sodium
5mg or more
If the amount of sodium present in the labeled maximum daily dose of the product is more than ___ mg: “Ask a doctor before use if you have a sodium-restricted diet” is required on the OTC label
> 140mg of sodium
Special Label Warning Requirement for FD&C Yellow No. 5 (tartrazine)
Shall bear a statement such as “Contains FD&C Yellow No. 5 (tartrazine) as a color additive”
Special Label Warning Requirement for Aspartame
Shall bear a statement to the following effect: “Phenylketonurics: Contains Phenylalanine (X) mg per (dosage unit)”
Special Label Warning Requirement for Sulfites
Shall bear the warning statement “Contains (name of sulfite, e.g. sodium metabisulfite), a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people”
Special Label Warning Requirement for Mineral Oil
Shall bear a warning such as “Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician”
Should also discourage use in pregnancy
Special Label Warning Requirement for Wintergreen oil (Methyl salicylate)
> 5% shall warn that use otherwise than as directed may be dangerous and that the article should be kept out of reach of children to prevent accidental poisoning
Special Label Warning Requirement for sodium phosphate
Shall contain the sodium content per dose if the sodium content is 5 mg or more
The FDA limits the amount of sodium phosphates oral solution to not more than 90mL (3 oz) per OTC container
The FDA limits the amount of sodium phosphates oral solution to not more than ___ mL per OTC container
90mL (3 oz)
Special Label Warning Requirement for Ipecac Syrup
A statement conspicuously boxed and in red letters, to the effect: “For emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice”
A warning to the effect: “Warning - keep out of reach of children. Do not use in unconscious persons”
Usual dosage: 1 tablespoon (15mL) in persons over 1 yo
Special Label Warning Requirement for salicylates
Warning about Reye’s syndrome
Special Label Warning Requirement for Alcohol Warnings (analgesics)
The labeling for all OTC drug products containing any internal analgesic/antipyretic active ingredients (including, but not limited to, acetaminophen, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate) alone or in combination must bear a warning about use if you consume more than 3 alcoholic beverages a day
Which medications require patient package inserts (PPIs) to be provided?
Must be provided for Accutane, statins, estrogen, or progesterone containing medications
For inpatients, provide at initial dispensing and every 30 days
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for acetaminophen packages > ____
1 gram
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for aspirin ___
All oral dosage forms except effervescent tablets
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for dibucaine packages > ____
0.5 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for diphenhydramine packages > ____
> 66 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for ibuprofen packages > ____
> 1 gram
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for iron packages > ___
> 250 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for ketoprofen packages > ___
> 50 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for lidocaine packages > ___
> 5 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for loperamide packages > ___
> 0.045 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for minoxidil packages > ____
> 14 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for mouthwash packages > ___ of ethanol
> 3 grams ethanol
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for naproxen package > ___
> 250 mg
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for which controlled substances?
All oral dosage forms
Poison Prevention Packaging Act (PPPA) requires child-resistant closures for which nonprescription drugs that was one prescription only?
All oral dosage forms
Controlled Substance Registration is valid for ___ from issue
3 years
Renewal of Controlled Substance Registration may be processed a maximum of ___ prior to expiration
60 days
Which DEA form needs to be submitted for a Controlled Substance Registration for pharmacies?
224 for initial registration (online), 224a for renewal
Note: individual pharmacists do NOT need to register with DEA to work in a pharmacy
Applicant for pharmacy DEA registration does not need to be a pharmacist
Which DEA form needs to be submitted for a Controlled Substance Registration for manufacturers, distributors, importers, exporters, and researchers?
Form 225
In what situations can a Controlled Substance Registration be suspended or revoked?
If applicant:
Falsifies application
Has been convicted of a drug related felony
Has a state license suspended, revoked, or denied
T/F: If the Controlled Substance Registration applicant moves locations, the DEA license remains valid
False - every location needs its own DEA license
If you are moving locations, you need to request a modification to your license
What is DEA Form 222 used for?
Used to purchase or transfer CI and CII
Purchase from wholesaler
Return to supplier
Transfer CII from pharmacy that is closing
Transfer CII to a reverse distributor for destruction
When purchasing CI or CII, who keeps the original DEA Form 222?
The purchaser must make a copy of the original DEA form 222 for its records and then submit the original to the supplier
The purchaser does not have the option of retaining the original
When the items are received, the purchaser must document on the purchaser’s copy the actual number of commercial or bulk container received and the date received
When is the Controlled Substance Ordering System (CSOS) used?
electronic substitute for DEA Form 222 when ordering CI or CII substances online
Uses digital signature
DEA Form 222 must be signed by ____
Must be signed by the person who signed the most recent DEA application or by a person authorized to sign by a Power of Attorney
What is required to grant Power of Attorney (POA) for DEA forms?
Must be signed by the same person who signed the most recent application for registration or renewal registration of the CSR, the individual being given POA, and 2 additional witnesses
May be revoked at any time by the person who granted the POA and 2 witnesses
If someone else signs a registration renewal, need to create a new POA
T/F: If DEA 222 form is incorrect, the supplier can refuse to fill and the purchaser can resend corrections of the defective order
False - Supplier nor purchaser can correct defective order, a new order is needed
Supplier may reject and return paper form to purchaser with a written notice of rejection or send this notice digitally for CSOS order
Purchaser must keep unaccepted or defective forms with a statement attached
Whenever any used or unused order forms are stolen or lost, this must be reported immediately to ____
the Special Agent in charge of the DEA
What should you do with unused DEA order forms that you do not need?
Unused order forms must be returned to the DEA if not needed
T/F: DEA Form 222 is needed for CI-CIV meds
False - only for CI and CII
Not needed for CIII-V
Controlled substance prescriptions must be kept for (at least) ___per federal law
2 years
What is the SUPPORT for Patients and Communities Act of 2018?
Allows pharmacy to deliver a controlled substance to a practitioner for the purpose of administering it by the practitioner if 1) delivered by pharmacy to location listed on practitioner’s certificate of registration 2) med is used for maintenance or detox treatment and prescriber is “Qualifying Practitioner” or “Qualifying Other Practitioner” and administered by injection or implantation 3) prescription is NOT issued to supply any practitioner with stock of controlled substances for general dispensing to patients
Restrictions for verbal prescription for CII
For emergency situation only
Limited to amount of medication needed to cover emergency
Within 7 days of emergency prescription, prescriber must deliver a written prescription to the pharmacist stating “Authorization for Emergency Dispensing” and the date of the oral order
Must notify the DEA if the prescriber fails to deliver the written follow up
Restrictions for faxed prescription for CII
Fax can be sent to expedite filling but the original schedule II written prescription must be presented to the pharmacist and verified against the facsimile at the time the controlled substance is actually dispensed (if written prescription is allowed by state law)
In which situations are faxed prescriptions for CII considered as written prescriptions under federal law?
Federally legal for home infusion pharmacies receiving prescriptions for parenteral administration, long term care facility prescriptions, hospice patient prescriptions including home hospice to use faxed CII as the written prescription
What is the Comprehensive Addiction and Recovery Act of 2016 (CARA)?
Permits the partial dispensing of CII prescriptions at the request of the patient or the prescribing practitioner if all the following criteria are met:
1) Partial filling is not prohibited by state law
2) The prescription is written and filled in accordance with the CSA, DEA regulations, and state law
3) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and
4) The remaining portions of a partially filled prescription shall be filled not later than 30 days after the date on which the prescription was written
Restrictions for partial filling CIII-V
None, federally legal to partial fill CIII-V
Restrictions for refill for CII
No refills allowed but prescriber can send multiple prescriptions up to 90 day supply with instructions stating earliest fill date on each separate prescription
Restrictions for refill for CIII and CIV
Federal law: Max 5 refills in a 6 month period if authorized by the prescriber
MA: exceptions for out-of-state providers (covered later)
What do pharmacists need to record (electronically or on the back of script) for controlled refills?
The name of the controlled substance
The date of refill
The quantity dispensed
The dispensing pharmacist’s identification code or name/initials for each refill
Total number of refills dispensed to date for that prescription
Labeling requirement for CII-CIV
“Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
If prescription is filled at a central fill pharmacy, the central fill pharmacy must affix to the package a label showing the retail pharmacy name and address and a unique identifier (i.e.: central fill pharmacy’s DEA number) indicating the script was filled at the central fill pharmacy
If a registrant is transferring business to another registrant, how many days in advance do they need to notify DEA?
At least 124 days in advance of the date of the proposed transfer
If a registrant is transferring business to another registrant and complete inventory is taken the day of transfer, what are next steps?
Not necessary to send copy of the inventory to the DEA unless requested but both parties must keep copy for at least 2 years
When you transfer CIIs to a reverse distributor for destruction, what DEA forms are filled and by whom?
Form 222 by pharmacy to transfer CII to reverse distributor
Form 41 by reverse distributor when the controlled substances have been destroyed
When distributing controlled stock between pharmacies, what is the 5% rule?
Total number of dosage units of all controlled substances distributed by a pharmacy may not exceed 5% of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed 5%, the pharmacy is required to register as a distributor
Compare CI-II vs CIII-V inventory
CI-II: record exact count of each substance
CIII-V - estimated count for open bottles unless container holds > 1000 tabs or caps in which you need to do exact count
