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Chap 3 notes
Chapter 3 Notes
| Term | Definition/answer |
|---|---|
| Legend drug | any drug that requires a prescription and either of these legends on the label: Rx only or Caution: federal law prohibits dispensing without a prescription |
| Food and Drug act of 1906 | Prohibited interstate commerce in adulterated or misbranded food, drinks and drugs. Government requires pre approval of drugs |
| 1914 Harrison Tax Act | Established manufacturers, pharmacists, importers and physicians prescribing narcotics should be licensed and required to pay a tax |
| 1938 Food, Drug and cosmetic act (FDC) | Requires new drugs to be shown safe before markting |
| 1927 Food, Drug and Insecticide Administration | The law enforcement agency is formed that would be renamed in 1930 as the Food and drug administration |
| 1950 Alberty Food Products vs. US | US court of appeals rules that the purpose for which a drug is to be used must be included on the label |
| 1951 Durham-Humphrey Amendment | Defines which drugs require a prescription by a licensed practitioner and require them to include this legend on the label: Caution federal law prohibits dispensing without a prescription or Rx only |
| 1962 Kefauver-Harris amendment | Requires drug manufacturers to provide proof of safety and effectiveness before marketing |
| 1966 fair packaging and labeling act | requires all products to be honestly and informatively labeled |
| 1970 poison prevention act | requires child proof packaging on all controlled substance and most prescription drugs |
| 1970 Controlled Substances act (CSA) | Classifies 5 levels of drugs that have potential for abuse and restricts heir distribution. the DEA was established by this act |
| 1976 Medical device amendment | Requires pre market approval for safety and effectiveness of life sustaining and life supporting medical devices |
| 1983 Orphan drug act | provides incentives to promote research, approval and marketing of drugs needed for the treatment of rare diseases |
| 1984 Hatch Waxman / Drug price and patent term restoration act | this act allowed for both the extension of drug patent terms and quicker introduction of lower cost generic drugs |
| 1987 prescription drug marketing act | restricts distribution of prescription drugs to legitimate commercial channels and requies drug wholesalers to be licensed by the state. |
| 1990 Anabolic steroid control act | this act was passed to address abuse of steroids by athletes, and especially teenagers and youngsters |
| CDER | Center for drug evaluation and research |
| what are the 3 stages of trials? | Chemical, Animal and Clinical |
| Placebo | an inactive substance given in place of medicine |
| Pediatric | having to do with the treatment of children |
| Phase 1 of clinical testing | 20-100 people, several months, purpose: mainly safety |
| Phase 2 of clinical testing | up to several hundred people, lasts several months to 2 yrs, purpose: short term safety and effectiveness |
| Phase 3 of clinical testing | several hundred to several thousand, lasts one to four years, purpose: safety, dosage and effectiveness |
| IND | Investigational new drug, only used in trial groups unless granted special treament |
| CDRH | Center for devices and radiological heath |
| CBER | Center for biologics evaluation and research |
| Schedule 1 | Each drug has a high potential for abuse and no accepted medical use in the US. It may not be prescribed. ie. Heroin, various opium derivatives , and hallucinogenic substances |
| Schedule 2 | Each drug has a high potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US. ie. Amphetamines, opium, cocaine, methadone, and various opiates |
| schedule 3 | Each drugs potential for abuse is less than class 1 or 2 and there is urgently medical use in the US, but abuse may lead to mild or moderate dependence. ie. Anabolic steroids, various compounds containing quantities of narcotic substances, codeine |
| schedule 4 | each drug has a low potential for abuse relative to schedule 3 drugs, and there is current accepted medical use in the US |
| schedule 5 | Each drug hs low potential or buse relative to schedule 4 drugs and there is current accepted medical use in the US. Abuse may lead to physical or psychological dependence |
| DEA number | All prescribers of controlled substances must be an authorizd DEA dealer and are assigned a number to put on all prescriptions |
| DEA form 222 | Used to order C-I and C-II substances. must be filled out in pen, typewriter or indelible pencil and be signed by n authorized person in triplicate |
| DEA form 224 | Application for new registration |
| DEA form 224-a | Renewal application for registration |
| DEA form 224-b | retail pharmacy registration affidavit for chain renewal |
| DEA form 41 | registrants inventory of drugs surendered |
| DEA form 106 | Report of theft or loss of controlled substances |
| DEA form 363 | New application registration- narcotic treatment program |
| DEA form 363-a | Application for DEA registration- NTP renewal registration |
| DEA 510 | Application for registration- for chemical registration |
| Medwatch | a program run by the FDA to catch adverse side effects or problems in Prescription drug |
| Class 1 recall | Where there is a strong likelihood that the product will cause serious averse effects or death |
| Class 2 recall | Where a product may cause temporary but eversable adverse reactions or in which there is little likelihood of serious adverse effects |
| Class 3 recall | Where a product is not likely to cause any adverse reaction or effect |
| FDA Enforcement Report | Where recalls are listed publicly weekly |
| 3 steps of recalls | Report of adverse effects, Manufacturer agrees to recall, Consumers contacted and meds recalled |
| USP | United States Pharmacopeia- a voluntary, not for profit organization that sets standards for the manufacturer and distribution of drugs and related products in the US |
| JCAHO | Joint Commission on Accreditation of Health Care Organizations |
| CMEA |
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