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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
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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
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1962 Kefauver-Harris Amendment
- Tightened control on drug safety
- Required labels listing adverse reactions and contraindications
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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
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Source of drugs
plants, animals, minerals, synthetic/chemical derivatives, herbals
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Drug names
- Chemical (N-acetyl-p-aminophenol)
- Generic (acetaminophen)
- Brand/trade (Tylenol)
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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)
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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
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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
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Human testing phases
- Phase I: Initial pharmacological evaluation
- Phase II: Limited controlled evaluation
- Phase III: Extended clinical evaluation
- Phase IV: post-marketing follow-up
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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
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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
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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
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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
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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
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Five Rights of drug administration
- Right Patient
- Right Drug
- Right Dose
- Right Time
- Right Route
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Other rights
- Right to Refuse
- Right to More Education
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