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gapcom 4/14 Drug Laws (X)


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describe major legislation affecting FDA regulation
1. controlled substances act (CSA)
2. dietary supplement and health education act of 1994
discuss the stages of new drug devt and the approval process, patent protection, and generic competition
1. drug discovery (2-5 yrs) -compound identification and optimization and patent application.
2. drug devt (5-9 yrs) - biological characterization, toxicology studies, Phase I,II,III trials, FDA approval
3. post-approval regulation -phase IV - Medwatch monitors lifespan of drug for reported ADR/ADE.
describe what information a drug package insert contains
mandated sections include: 1. trade name
2. chemical name
3. description (includes molecular struct)
4. clinical pharmacology
5. indications and usage
6. contraindications
7. warnings
8. precautions
9. adverse reactions
10.drug abuse/dependence
12.dosage and administration drug is supplied (e.g. tablet, liquid, etc.)
explain what is meant by FDA approved uses for a drug
the FDA approved uses of a drug are those that have been researched by the numerous clinical trials to prove safety and efficacy in treating a given dx or condition. The drug manufacturer with the FDA agree on specific language to describe dosage, route, and other information to be included on the drug's label. Approximately 23% of scripts written in the US are for 'off-label' uses of drugs (wikipedia site)
discuss the different types of drug recall
Class I - reasonable probability use/exposure to product cause serious adverse health consequences or death. ex. microbial contaminations of an injectable drug.
Class II - use/exposure cause temporary/medically reversible adverse health consequences. probability of serious adverse health consequences is remote.
Class III - use/exposure is not likely to cause adverse health consequences (ex. quantity packaging error)
Pure Food and Drug Act
1906. prohibited mislabeling and adulteration of drugs.
Harrison Narcotic Act
1914. established regulations for use of opium, opiates, and cocaine (marijuana added in 1937)
Food, Drug, and Cosmetic Act
1938. Required new drugs be safe as well as pure (but did not require proof of efficacy). enforcement by FDA
Kefauver-Harris Amendments
1962 to the Food, Drug, and Cosmetic Act. required proof of efficacy as well as safety for new drugs and for drugs released since 1938. established guidelines for reporting information about ADR, clinical testing, and advertising of new drugs
Comprehensive Drug Abuse Prevention and Control Act
1970. Outlined struct control in the manufacture, distribution and prescribing of habit-forming drugs; established programs to prevent and treat drug addiction. important to drug schedules
Orphan Drug Amendments
1983. Amended 1938 act to provide incentives for devt drugs that treat diseases with less than 200,000 patients in USA
Drug Price Competition and Patent Restoration Act
1984. abbreviated new drug applications for generic drugs. required bioequivalence data.
Diety Supplement Health and Education Act
1994. amended 1938 to establish standards with respect to dietary supplements. establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply.
explain the five drug groups regulated by the CSA
C-I abuse potential hi, no medical use (ex. heroin)
C-II no refills, has medical uses (ex. morphine, ampethamine, ritalin), NO refills(emergency scheduling possible through pharmacists)
C-III abuse potential moderate, (ex. doriden) refill restricted 5X or 6mo.
C-IV lo abuse potential (ex. valium, librium, darvon)
C-V lowest abuse potential, OTC drugs with limited amt narcotics for antitussive, antidiarrheal. exception is Lomotil (requires Rx)
explain the phases of clinical drug testing in humans
phase I (20-100 normal people) several months. purpose:mainly safety
phase II (several hundred patients) several months-2yrs. purpose:effectiveness and short-term safety
phase III (several 100-1000 patients) 1-4 years. purpose: safety, dosage, effectiveness.
what info should be included on a prescription
date, patient, address
rx: drug name and strength, quantity to be dispensed, patient instructions
refill times, no safety cap, DEA No., and LEGIBLE doc sig

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