Term
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Definition
| Food and Drug Administration is the leading enforcement agency for drug product regulations at the federal level |
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Term
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Definition
| Drug Enforcement Administration is the agency that enforces controlled substances law and regulations |
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Term
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Definition
| American Society for Consultant Pharmacists sets standards for pharmacists who provide medical distribution and consultant services to nursing homes |
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Term
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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 |
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Term
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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. |
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Term
| 1996 Health Insurance Portability and Accountability Act |
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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 |
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Term
| 1976 Medical Device Amendment |
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Definition
| Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting devices |
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Term
| Food and Drug Act of 1906 |
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Definition
| Prohibits interstate commerce in adulterates food, drinks, and drugs. Gov approvals of drugs is required. |
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Term
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Definition
| Manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax |
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Term
| 1938 Food, Drug and Cosmetic (FDC) Act |
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Definition
| New drugs must be shown to be safe before marketing |
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Term
| 1950 Alberty Food Products v. U.S. |
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Definition
| Purpose of drug must be on the label |
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Term
| 1951 Durham-Humphrey Amendment |
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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" |
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Term
| 1962 Kefauver-Harris Amendment |
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Definition
| Requires drug manufacturers to provide proof of safety and effectiveness before marketing |
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Term
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Definition
| Establishes the Medicare program |
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Term
| 1966 Fair Packaging and Labeling Act |
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Definition
| Requires all consumer products in interstate commerce to be honestly and informatively labeled |
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Term
| 1970 Poison Prevention Packaging Act |
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Definition
| Requires childproof caps on medications |
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Term
| 1970 Controlled Substances Act (CSA) |
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Definition
| Classifies five levels of controlled substances that have potential for abuse and restrict their distribution. Creates DEA |
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Term
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Definition
| Provides incentives to promote research, approval and marketing of drugs needed for the treatment of rare diseases. |
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Term
| 1984 Drug Price Competition and Patent Terms Restoration Act (Hatch-Waxman) |
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Definition
| Alows for both extension of drug patents and quicker introduction of lower-cost generic drugs |
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Term
| 1987 Prescription Drug Marketing Act |
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Definition
| Restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states |
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Term
| 1990 Omnibus Budget Reconciliation Act (OBRA) |
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Definition
| Requires Pharmacists to offer counseling to Medicaid patients regarding medications |
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Term
| 1990 Anabolic Steroid Control Act |
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Definition
| Passed to "address the abuse of steroids by athletes, teens and youngsters." |
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Term
| 2003 Medicare Modernization Act |
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Definition
| Establishes optional Medicare Part D to provide coverage for prescription drugs and Medication Therapy Management |
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Term
| 2005 Combat Methamphetamine Epidemic Act |
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Definition
| Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine |
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Term
| 2010 Patient Protection and Affordable Care Act |
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Definition
| Health-care reform legislation of the 111th United States Congress intended to expand health insurance access for uninsured Americans. |
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Term
| 2012 FDA Safety and Innovation Act |
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Definition
| Establishes user fees to enhance access to medications and medical devices and made provisions and addressing drug product shortages in the USA |
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Term
| Pharmaceutical equivalent |
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Definition
| drug products that contain identical amounts of the same active drug in the same dosage form |
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Term
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Definition
| Important drug information that is not on the label but in an attached brochure |
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Term
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Definition
| Pharmaceutical equivalents that produce the same effects in patients |
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Term
| Combat Methamphetamine Epidemic Act (CMEA) |
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Definition
| Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine |
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Term
| Controlled Substances Mark |
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Definition
| (CII-CV) indicates control category of a drug and its potential for abuse |
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Term
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Definition
| Five groups identified and controlled by the Controlled Substances Act |
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Term
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Definition
| Court order preventing a specific action, sch as the distribution of a potentially dangerous drug |
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Term
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Definition
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Term
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Definition
| Legal costs or damages arising from misconduct or negligence |
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Term
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Definition
Three trials
1: safety
2: short-term safety and effectiveness
3: safety, dosage and effectiveness |
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Term
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Definition
| High potential for abuse with no accepted medical use. EX: Heroin, opium deviants |
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Term
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Definition
| High potential for abuse but have an accepted medical use. EX: amphetamines,opium |
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Term
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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 |
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Term
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Definition
| Low potential for abuse as related to schedule III. Have accepted medical uses. EX: Phenobarbital, chloral hydrate |
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Term
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Definition
| Low potential for abuse as related to schedule IV. Have accepted medical uses. EX: compounds with limited amounts of codeine |
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Term
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Definition
| Strong likelihood that product will cause adverse effects or death |
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Term
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Definition
| Product may cause temporary but reversible adverse effects |
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Term
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Definition
| Product is not likely to cause adverse effects |
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