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Chapter 3: Drug Regulation and Control
Vocabulary
44
Pharmacology
Undergraduate 1
01/26/2014

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Term
FDA
Definition
Food and Drug Administration is the leading enforcement agency for drug product regulations at the federal level
Term
DEA
Definition
Drug Enforcement Administration is the agency that enforces controlled substances law and regulations
Term
ASCP
Definition
American Society for Consultant Pharmacists sets standards for pharmacists who provide medical distribution and consultant services to nursing homes
Term
USP
Definition
The United States Pharmacopoeia non-gov, nonprofit, org that sets standards for manufacturing and distribution of drugs and related products standards directly referred to by state and federal laws and published in US Pharmacopoeia and National Formulary
Term
7 Parts of Prescriptions
Definition
1) Name of patient
2) Name of drug
3) Dose of drug
4) Route drug takes
5) How drug is to be taken
6) Date was written
7) Signature of Dr.
Term
1996 Health Insurance Portability and Accountability Act
Definition
(HIPAA) Defined the scope of health information that may and may not be shared among health care providers w/o patients' consent. Provided strict regulations to protect patients right to privacy
Term
1976 Medical Device Amendment
Definition
Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting devices
Term
Food and Drug Act of 1906
Definition
Prohibits interstate commerce in adulterates food, drinks, and drugs. Gov approvals of drugs is required.
Term
1914 Harrison Tax Act
Definition
Manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax
Term
1938 Food, Drug and Cosmetic (FDC) Act
Definition
New drugs must be shown to be safe before marketing
Term
1950 Alberty Food Products v. U.S.
Definition
Purpose of drug must be on the label
Term
1951 Durham-Humphrey Amendment
Definition
Defines which drugs require a prescription by a licensed practitioner and requires them to include a legend: "Caution: Federal Law prohibits dispensing w/o a prescription" or "Rx only"
Term
1962 Kefauver-Harris Amendment
Definition
Requires drug manufacturers to provide proof of safety and effectiveness before marketing
Term
1965 Social Security Act
Definition
Establishes the Medicare program
Term
1966 Fair Packaging and Labeling Act
Definition
Requires all consumer products in interstate commerce to be honestly and informatively labeled
Term
1970 Poison Prevention Packaging Act
Definition
Requires childproof caps on medications
Term
1970 Controlled Substances Act (CSA)
Definition
Classifies five levels of controlled substances that have potential for abuse and restrict their distribution. Creates DEA
Term
1983 Orphan Drug Act
Definition
Provides incentives to promote research, approval and marketing of drugs needed for the treatment of rare diseases.
Term
1984 Drug Price Competition and Patent Terms Restoration Act (Hatch-Waxman)
Definition
Alows for both extension of drug patents and quicker introduction of lower-cost generic drugs
Term
1987 Prescription Drug Marketing Act
Definition
Restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states
Term
1990 Omnibus Budget Reconciliation Act (OBRA)
Definition
Requires Pharmacists to offer counseling to Medicaid patients regarding medications
Term
1990 Anabolic Steroid Control Act
Definition
Passed to "address the abuse of steroids by athletes, teens and youngsters."
Term
2003 Medicare Modernization Act
Definition
Establishes optional Medicare Part D to provide coverage for prescription drugs and Medication Therapy Management
Term
2005 Combat Methamphetamine Epidemic Act
Definition
Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine
Term
2010 Patient Protection and Affordable Care Act
Definition
Health-care reform legislation of the 111th United States Congress intended to expand health insurance access for uninsured Americans.
Term
2012 FDA Safety and Innovation Act
Definition
Establishes user fees to enhance access to medications and medical devices and made provisions and addressing drug product shortages in the USA
Term
Pharmaceutical equivalent
Definition
drug products that contain identical amounts of the same active drug in the same dosage form
Term
Product Labeling
Definition
Important drug information that is not on the label but in an attached brochure
Term
Therapeutic equivalent
Definition
Pharmaceutical equivalents that produce the same effects in patients
Term
Combat Methamphetamine Epidemic Act (CMEA)
Definition
Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine
Term
Controlled Substances Mark
Definition
(CII-CV) indicates control category of a drug and its potential for abuse
Term
Controlled Substances
Definition
Five groups identified and controlled by the Controlled Substances Act
Term
Injunction
Definition
Court order preventing a specific action, sch as the distribution of a potentially dangerous drug
Term
Compliance
Definition
Doing what is required
Term
Liability
Definition
Legal costs or damages arising from misconduct or negligence
Term
Human Testing
Definition
Three trials
1: safety
2: short-term safety and effectiveness
3: safety, dosage and effectiveness
Term
Schedule I
Definition
High potential for abuse with no accepted medical use. EX: Heroin, opium deviants
Term
Schedule II
Definition
High potential for abuse but have an accepted medical use. EX: amphetamines,opium
Term
Schedule III
Definition
Less potential for abuse than schedules I and II, but may lead to low physical and psychological dependence. Have accepted medical use. EX: steroids, drugs with a limited amount of codeine
Term
Schedule IV
Definition
Low potential for abuse as related to schedule III. Have accepted medical uses. EX: Phenobarbital, chloral hydrate
Term
Schedule V
Definition
Low potential for abuse as related to schedule IV. Have accepted medical uses. EX: compounds with limited amounts of codeine
Term
Recall Class I
Definition
Strong likelihood that product will cause adverse effects or death
Term
Recall Class II
Definition
Product may cause temporary but reversible adverse effects
Term
Recall Class III
Definition
Product is not likely to cause adverse effects
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