Pharmacology Chapter 2 – The Drug Approval Process – Flashcards
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U.S. Food and Drug Administration (FDA)
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approves new drugs
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drug discovery and manufacturing
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takes 12 to 20 years combined with a cost of more than $1 billion
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The United States Pharmacopeia of 1820
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set of drug standards
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The United States Pharmacopeia National Formulary (USP-NF)
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- annual publication - drugs included in this have met high standards - drugs meeting these standards have the initials USP
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International Pharmacopeia (1951)
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- by the WHO - basis for standards in strenght and composition of drugs for use throughout the world
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federal legislation
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through this the public is protected and safety is ensured
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The Food, Drug, and Cosmetic Act of 1938
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- empowered the FDA to ensure drug safety by monitoring and regulation the manufacture and marketing of drugs - it is FDA's responsibility to ensure testing, having accurate labels and explain adverse effects - Only drugs considered safe by FDA are approved for marketing
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1952: The Durham-Humphrey Amendment to the 1938 Act
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distinguished between drugs that can be sold with or without prescription and those that shouldn't be refilled without a new prescription
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1962: The Kefauver-Harris Amendment to the 1938 Act
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- resulted from the thalidomide tragedy of the 1950s - tightened controls on drug safety (especially experimental drugs) - required that adverse reactions and contradictions must be labeled and included in literature - included provisions for the evaluation of testing methods, process for withdrawal of approved drugs when safety and effectiveness were in doubt, and establishment of effectiveness before marketing
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1970: The Controlled Substances Act
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- designed to remedy drug abuse 1) promotion of drug education and research into prevention and treatment of drug dependence 2) strengthening of enforcement authority 3) establishment of treatment and rehabilitation facilities 4) designation of schedules or categories
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Controlled substances
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- in 5 schedules or categories - Schedule I drugs are not approved for medical use - dependency decreases as you move from I to V
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1978: Drug Regulation Reform Act
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shortened the time in which new drugs could be developed and marketed - protected patients' rights and facilitates investigational processes and promotes research
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1983: The Drug Enforcement Administration
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role of being the nation's sole legal drug enforcement agency
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1938: Orphan Drug Act
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- designed to promote the development and manufacture of orphan drugs (those used in rare diseases) - 3 primary incentives 1) federal funding of grants and contracts 2) 50% tax credit for costs of clinical testing 3) exclusive right to market the drug for 7 years from marketing approval date
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2002: Best Pharmaceuticals for Children Act
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gives manufactures extension of patents to evaluate drugs on the market for their safety and efficacy to children
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2003: Health Insurance Portability and Accountability Act
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- patient history can be released only to patient - pharmacist must provide private area for consultation - all patients sign a statement that they have received a copy of the privacy statement
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2003: Pediatric Research Equity Act
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authorizes FDA to require that drug manufacturers test drugs and biologic products for their safety and effectiveness in children "children are not small adults"
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2007: Food and Drug Administration Amendments Act
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FDA can interfere after postmarking
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2009: Family Smoking Prevention and Tobacco Control Act
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FDA regulates cigarettes
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Nurses who administer a drug without a licensed health care provider's order are in violation of ___________
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The Nurse Practice Act
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Misfeasance
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negligence, giving the wrong drug or drug dose that results in patient's death
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Nonfeasance
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omission; omitting a drug dose that results in the patients death
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Malfeasance
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giving the correct drug but by the wrong rout resulting in patient's death
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Verified Internet Pharmacy Practice Site (VIPPS)
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reputable online pharmacies have this
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chemical name
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describes the drug's chemical structure
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generic name
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official nonproprietary name for the drug - this name is not owned and universally accepted - usually less expensive , have inert fillers and binders that may result in variations of drug effectiveness
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brand (trade) name
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- proprietary name - chosen by the drug company and is usually a registered trademark owned by said company
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When are brand named drugs preferred?
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when ordering anticonvulsants for seizures; anticoagulants' medication for heart failure; and aspirin in large doses for rheumatoid arthritis
