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107 Cards in this Set
- Front
- Back
Which part of the government appoints the administrative agency (DEA, Board of Pharmacy)?
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Legislative branch
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What are the three different types of laws?
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Criminal law
Civil law Administrative law |
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Which laws, if broken, can lead to jail?
Which laws, if broken, do not lead to jail? |
Jail - Criminal, Civil laws
No jail - administrative law |
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In the case of pharmacy, the state Board of Pharmacy is the _______ agency
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Administrative
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What functions of the Board of Pharmacy include enforcement responsibilities for inspections of pharmacies?
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Executive
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What functions of the Board of Pharmacy include enacting regulations?
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Legislative
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What functions of the Board of Pharmacy act to interpret violations of the statues and regulations?
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Judicial
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What is the statute of limitations for negligence?
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Two years
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What does CFR stand for?
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Code of Federal Regulations
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CFR21 is an act by which agency of the government?
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FDC
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Under Georgia Laws - OCGA, what Title deals with Food, Drugs, and Cosmetics?
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Title 26
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Under Georgia Laws - OCGA, what Title deals with Crimes and Offenses?
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Title 16
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True or False - Your license is a revocable privilege
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True
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How long can a pharmacist be imprisoned for pleading guilty to one count of felony insurance fraud and felony theft?
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Six months
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When was the FDA established?
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1906
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When was the 16th amendment passed?
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1913
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What was the 16th amendment?
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Income taxes
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The establishment of the FDA was also known as what act?
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Wiley Act
(first chemist employed by the FDA) |
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What is a patent medicine?
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Trademarked medicine
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What was the act with the basic premise of "Unlawful for any person to manufacture any article of food or drug which is adulterated or misbranded"?
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Food and Drug Act of 1906
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What is the term for adding extraneous, improper, or inferior ingredients?
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Adulterated
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What is the term for misleading label or fraudulent?
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Misbranded
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A violation of the Food and Drug Act of 1906 is a (misdemeanor/felony)
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Misdemeanor
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What were the fines/punishments for violation of the Food and Drug Act of 1906?
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Up to $500 or one year's imprisonment
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What two things did the Food and Drug Act of 1906 fail to require for medicinal product labeling?
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Did not require ingredient listing or directions
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What medication and vehicle combination prompted the Food, Drug, and Cosmetic Act of 1938?
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Sulfanilamine (diethylene glycol)
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When was the Food, Drug, and Cosmetic Act enacted?
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1938
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The Food, Drug, and Cosmetic Act did NOT require what?
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Proof of effectiveness
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True or False - All medications required proof of safety after the Food, Drug, and Cosmetic Act was passed
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False - Grandfathering of currently available medications was allowed
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Which Act established the FDA?
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Food and Drug Act of 1906
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What were three requirements of the Food, Drug, and Cosmetic Act of 1938?
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New drugs had to be proven safe
Labels must contain directions Warnings about habit-forming drugs |
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In 1939, the Georgia General Assembly passed what act?
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Dangerous Drug Act
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Which Act is the basis for the Dangerous Drug Act (in Georgia) of 1939?
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Food, Drug, and Cosmetic Act
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What court case held that because the Sulfathiazole product of 1948 had been in interstate commerce that the provisions of the Food, Drug, and Cosmetic Act of 1938 applied?
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US v. Sullivan
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Which act requires the following three things:
1) Internet pharmacy websites must display information identifying the business, pharmacist, and physician associated with the website 2) The bill bars the selling or dispensing of a prescription drug via the internet when the website has referred the customer to a doctor who then writes a prescription without ever seeing the patient 3) The bill provides states with new enforcement authority modeled on the Federal Telemarketing Sales Act that will allow a state attorney general to shut down a rogue site across the country, rather than only bar sales to consumers of his or her state |
Haight Act of 2008
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What primary thing did the Durham-Humphrey Amendment of 1951 establish?
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Two classes of drugs
1) Legend drugs 2) Non-prescription drugs |
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What were additional components of the Durham-Humphrey Amendment of 1951?
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Directions required
Oral prescriptions Prescription refill regulation |
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The Thalidomide disaster prompted what legislation?
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Kefauver-Harris Amendment of 1962
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What did the Kefauver-Harris Amendment of 1962 require proof of?
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Efficacy
(in addition to safety) |
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Which amendment was retroactive in regards to drug safety and efficacy?
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Kefauver-Harris Amendment of 1962
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What 6 things did the Kefauver-Harris Amendment of 1962 require?
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1) Efficacy (in addition to safety)
Retroactive 2) Prescription drug advertising regulated by FDA 3) Informed consent for clinical studies 4) Reporting of ADRs 5) Creating of Good Manufacturing Principles 6) NDA established |
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When was the NDA process established?
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Kefauver-Harris Amendment of 1962
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True or False - Thalidomide is banned in the United States
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False - in 1998, the FDA approved thalidomide for limited use in the US (two forms of contraception and to submit to biweekly pregnancy tests)
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Which act provided tax and licensing incentives to manufacturers for drugs used to treat rare diseases?
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Orphan Drug Act of 1983
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What population is defined by the Orphan Drug Act?
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< 200,000 people in the US
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Which piece of legislation provided generic companies with the option of an ANDA?
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Waxman-Hatch Amendment of 1984
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The Waxman-Hatch Amendment of 1984 assured innovater companies of ___ years of exclusive marketing after the approval process, and exclusive rights to marketing for ___ years after patent REGISTRATION
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5 years of exclusive marketing after approval process
Exlusive rights to marketing for 17 years after patent registration, not approval |
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Which bill removed samples from community pharmacies?
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Prescription Drug Marketing Act of 1987 (Dingell Bill)
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The Prescription Drug Marketing Act of 1987 is also known as what?
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Dingell Bill
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What did the Prescription Drug Marketing Act of 1987 establish for drug wholesalers?
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Wholesaler licensure requirements
Security of drug stocks Record-keeping including drug lot number tracking for all drug distribution |
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What three primary components were required with OBRA 90?
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Patient information
Prospective DUR Patient counseling |
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What is defined as "the watchfulness, attention, caution, and prudence that a reasonable person in the circumstances would exercise"?
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Standard of care
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What act updated many FDA activities?
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FDA Modernization Act of 1997
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What did the FDA Modernizzation Act of 1997 update?
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1) Fast-track review of some NDAs
2) Clarification of pharmacy compounding 3) Legend --> Rx only 4) Elimination of "Warning - may be habit forming" 5) Supplemental NDA for new uses of existing drugs 6) Pediatric studies - 6 month extension of exclusivity |
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What act established Medicare Part D?
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Medicare Prescription Drug Improvements and Modernization Act of 2003
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True or False - Mail order may be required for some Medicare Part D programs
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False - mail order may NOT be required
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True or False - Importation of drugs from Canada and elsewhere is allowed for Medicare Part D
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True
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The reimbursement for Medicare Part D prescriptions changed from ____ to ____
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From AWP to ASP
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What drug categories must have multiple drug options for Medicare Part D? (6)
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Anticonvulsants
Antineoplastic Antiretrovirals Antidepressants Antipsychotics Immunosuppressants |
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What was the cost to bring a drug to market as of 2005?
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$250 billion
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What is required before a drug can proceed with clinical trials on humans?
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IND
(Investigational New Drug Application) |
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Which phase of Clinical Trials makes sure a drug is safe at projected dosages, determines route of administration, and is tested on normal healthy adults?
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Phase 1
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Which phase of Clinical Trials studies patients with the disease/condition to be treated and assesses efficacy?
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Phase 2
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Which phase of Clinical Trials studies widespread groups, does double-blind studies, compares the drug to placebo, and is the most costly and time consuming?
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Phase 3
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What special type of IND is for use of a non-approved drug, for patients not enrolled in the clinical trials, and for patients in an imminent life-threatening stage?
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Treatment IND
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What is submitted after Phase 3 Clinical Trials are complete?
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NDA
(New Drug Application) |
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A fast track drug is requested by the applicant to who?
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Secretary of Health and Human Services
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What must generic drugs submit for approval?
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ANDA
(Abbreviated New Drug Application) |
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An ANDA (abreviated new drug application) requires proof of what?
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Bioavailability and chemical activity
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If a manufacturer wants to change a drug already on the market (i.e. formulation, dosage form, strength, packaging, indication), what must it submit for approval?
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SNDA
(Supplemental New Drug Application) |
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What are the two therapeutic classifications for NDAs?
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Type P (Priority)
Type S (Standard) |
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The Orphan Drug Act of 1983 extends exclusivity of a drug by how many years over the patent limit?
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7 years
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When a generic challenges the patent of a brand medication, what is the exclusivity period?
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180 days
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What do the NDC numbers stand for?
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First 5 digits - manufacturer
Middle 4 digits - drug Last 2 digits - package type/size |
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What is required on labeling for manufacturer containers that are supplied to hospitals?
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Bar codes
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Bar codes on products supplied to hospitals must contain what?
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NDC number, not a UPC code
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True or False - Listing of therapeutically inactive ingredients is a GMP requirement
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True
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The new package inserts contain a _______ section as part of their new "streamlined" design since 2006?
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Highlights
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True or False - Only Rx medications require drug imprints
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False - Rx and OTC medications require drug imprints for ID purposes
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What is the expiration date for repackaging items?
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25% of remaining expiration time or 6 months (whichever is less)
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Bar coding is only required on packages for what types of institutitons?
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Only required on hospital product packages (by FDA)
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What program is for monitoring and reporting of adverse drug events?
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MedWatch Program
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What adverse drug event initiative is hospital based?
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MedMARx
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What adverse drug event initiative is for reporting of device problems?
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Safe Medical Device Act (SMDA)
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What Class of recall occurs because of risk of serious effects or death?
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Class I
(recall stock, notify patients) |
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What Class of recall occurs because of risk of temporary or reversible adverse effects?
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Class II
(recall stock) |
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What Class of recall occurs even if there is little risk of adverse effects?
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Class III
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What are the expiration dates for compounds of solids and non-aqueous liquids?
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NMT 25% of remaining expiration date with a maximum of 6 months
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What are the expiration dates for compounds of non-aqueous solutions with solid drugs?
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NMT 14 days under refrigeration
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What are the expiration dates for miscellaneous compounds?
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30 days or the duration of therapy
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What types of compounds are exempt from compounding standards?
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Radiopharmaceuticals (including PETs)
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Sterile products follow what USP guidelines?
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797
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What is the term for anything that includes "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man and other animals"?
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Drug
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What is the term for anything that includes "articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article"?
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Food
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What characteristics differentiate a dietary supplement from food? (6)
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1) vitamin
2) mineral 3) herb or botanical 4) amino acid 5) supplement the diet by increasing dietary uptake 6) concentrate, metabolite, extract, or combination of any ingredient described |
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What is the term for "articles intended to be rubbed, poured, spinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of any such articles; except that such term shall not include soap"
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Cosmetic
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What acronym/organization describes federal law and is specific for the state as well?
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MPJE
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True or False - According to Georgia law, you may not compound products that are available commercially
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False - Georgia law says you may compound products which are and are not available as commercial products (federal law says you may NOT)
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What are the four "practitioner" or "practitioner of the healing arts" professions?
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Physician
Dentist Podiatrist Veterinarian |
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True or False - Chiropracters are not allowed to prescribe or administer medications
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True
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What are the limits for prescribing controlled medications for optometrists?
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Non-narcotic oral analgesics
Schedule III or IV controlled substances for ocular pain, with NMT 72 hours without talking to physician |
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If a patient has what disease state, he/she must be referred to an ophthamologist immediately?
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Closed angle glaucoma
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True or False - You can receive C-IIs by both e-RX and fax
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False - Can NOT get controlled medications by e-prescribing in Georgia
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What are the only three acceptable circumstances for filling a C-II fax as an original?
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Terminally ill patients
LTCF Hospice |
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What three things can be changed to a CII prescription?
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strength
quantity directions (talk directly to prescriber, note on prescription) |
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True or False - It is required that a pharmacist put his/her initials and license number on a CII prescription upon filling it
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False - NOT initials, license # not required
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What three pharmacist requirements must be placed on a controlled medication?
How do CIIs differ from CIIIs, CIVs, and CVs? |
All controls - dispensing date and prescription/serial number
CIIs - pharmacist SIGNATURE CIIIs-CVs - pharmacist INITIALS |