1. 1938 Food, Drug and Cosmetic Act
    • Provided control over pharmaceutical industry
    • Drugs must be proven safe before they can be sold
    • Inpections of drug manufacturing facilities
    • Safe tolerance levels must be identified
    • Cosmetic and therapeutic devices are now controlled
  2. 1952 Durham-Humphrey Amendment
    Certain drugs need a prescription from a physician to be purchased; injection, hypnotic, narcotic, habit-forming, new drugs, drugs that are unsafe unless administered under supervision
  3. 1962 Kefauver-Harris Amendment
    • Tightened control on drug safety
    • Required labels listing adverse reactions and contraindications
  4. 1970 Comprehensive Drug Abuse Prenvent and Control Act
    • Categorized controlled substances accroding to a schedule based on potential for abuse
    • Schedule I - most dangerous, no recognized medicinal use
    • Schedule II & III - high abuse potential w/acceptable medicinal use
    • Schedule IV & V - lower abuse potential w/accpetable medicinal use
  5. Source of drugs
    plants, animals, minerals, synthetic/chemical derivatives, herbals
  6. Drug names
    • Chemical (N-acetyl-p-aminophenol)
    • Generic (acetaminophen)
    • Brand/trade (Tylenol)
  7. Drug effects
    • Therapeutic - the intended physiological effect (the reason the drug is being given)
    • Side effect - physiologic effect that is not the intended action (drowsiness with antihistamine)
  8. Drug safety
    testing by FDA, initial testing done on animals to determine toxicity of the drug, then moves on to human studies in three phases
  9. Animal toxicity testing
    • Acute toxicity - dose that is lethal to 50% of animals tested.
    • Subchronic toxicity- in at least 2 animal species, daily administration of drugs up to 90 days
    • Chronic toxicity - 2 species, use three dose levels from nontoxic low-level to higher than expected and toxic, usually last for lifetime of animal
  10. Human testing phases
    • Phase I: Initial pharmacological evaluation
    • Phase II: Limited controlled evaluation
    • Phase III: Extended clinical evaluation
    • Phase IV: post-marketing follow-up
  11. Phase I: Initial pharmacological evaluation
    • Given to a small number of healthy volunteers to determine the dose level at which signs of toxicity first appear on humans, determine a safe tolerated dose and determine the pharmacokinetics of the drug
    • Requires permission from FDA to conduct
  12. Phase II: Limited controlled evaluation
    • Monitors drug effectiveness and any side effects
    • Done on individuals with the targeted disease
    • Number of partcipants is usually larger than Phase I but less than 100
  13. Phase III: Extended clinical evaluation
    • Includes many physicians and large groups of participants
    • When enough information to justify continued use of the drug, a New Drug Application (NDA) is filed with the FDA
  14. Phase IV: Post-marketing follow-up
    • Voluntarily conducted by the companies and continue after the FDA approval of drug
    • Include children, pregnant women and elderly
    • Allows manufacturers to find low-level side effects
  15. Drug effects on fetus
    • Four categories:
    • A - adequate and well-controlled studies indicate no risk in first trimester or later
    • B - animal reproduction studies indicate no risk to fetus, but there are no studies on pregnant women
    • C - animal reproduction studies reported adverse effects on fetus, no well-controlled studies in pregnant women but potential benefits may outweigh risks in pregnant women
    • D - positive human fetal risk reported - potential benefits may warrant the use in pregnant women in very select cases
    • X - fetal abnormalities reported and positive evidence of risk in humans is available. Risks clearly outweigh benefits and drug should not be used in pregnant women
  16. Five Rights of drug administration
    • Right Patient
    • Right Drug
    • Right Dose
    • Right Time
    • Right Route
  17. Other rights
    • Right to Refuse
    • Right to More Education
Card Set
powerpoint from pharma lecture 1 (excluding herbal)