| A | B |
|---|
| contraindication | reason or condition that renders a treatment improper or undesirable |
| controlled substance | drugs whose dispension is regulated by federal law due to dependency or abuse potential |
| Food and Drug Administration (FDA) | responsible for monitoring drug development,manufacturing,marketing |
| indication | condition or reason to prescribe medication or perform a procedure |
| narcotics | drugs that produce insensibility or stupor |
| OTC | over-the-counter drugs, sold without a presecription |
| Physician's Desk Reference (PDR) | indepth resource to information about drugs used in medical and surgical practice |
| prescription drugs | drugs requiring a physician's order to dispense |
| United States Pharmacopoeia & National Formulary (USP/NF) | official drug list recognized by the U.S. govt |
| Pure Food and Drug Act | set standards for quality, required proper labeling of drugs (1906) |
| Food, Drug, and Cosmetic Act | address drug effectiveness, required animal testing of drugs (1938) |
| Durham-Humphrey Amendments to the Food, Drug, and Cosmetic Act | establishment of prescription drugs and OTC category of drugs (1951) |
| Controlled Substance Act | designated certain drugs as controlled substances based upon potential for abuse (1970) |
| C-I of Controlled Substances | high abuse potential, no accepted medical use: heroin, LSD, PCP, marijuana |
| C-II of Controlled Substances | high abuse potential,have acccepted medical uses:Alfentanyl, opium, cocaine, codeine, morphine |
| C-III of Controlled Substances | moderate abuse potential: anabolic steroids, products with low amts of codeine |
| C-IV of Controlled Substances | low abuse potential: diazepam, lorazepam, phenobarbital |
| C-V of Controlled Substances | low abuse potential: many antitussives & antidiarrheal agents |
| Drug Enforcement Agency (DEA) | enforces Controlled Substances Act; sets & enforces standards |
| State Practice Acts | govern ordering, dispensing, & administration of meds |
| Institutional Policies | local authority determining scope of practice when not addressed by fed or state laws |
| Federal Dood and Drug Administration (FDA) | regulates pharmaceutical industry, ensures standards are met |
| Phase I: Clincial Pharmacology (1st phase human testing) | health volunteers, determine toxicity levels |
| Phase II: Clinical Investigation (2nd phase of human testing) | limited # of patients presenting with disease/condition;effectiveness, dosage and range |
| Phase III: Clinical Trials (3rd phase of human testing) | 100s to 1000s of patients for effectiveness, safety, side effects |
| Phase IV: Post-marketing Study (4th phase of human testing) | continued study/documentation after release for treatment |
