Unit 1 Flashcards
(37 cards)
pharmaceutics (definiton)
drug formulating
Pharmacotherapeautics (definition)
clinical; study of drugs in humans
Pharmacodynamics (definition)
mechanism of action of drugs (how and why they act on the body)
Pharmacokinetics (definition)
what the body does to the drug
Toxicology (definition)
study of toxic effects of the drug (the beneficial effects outweigh the bad effects)
Pharmacogenomics (definition)
genomic testing to predict how a patient will respond to a drug based on genetic makeup
therapeutic effect (definition)
the effect for which the drug is administered
side effect (definition)
any effect other than the one for which the drug is administered (often are predictable)
toxic/untoward, adverse effect (definition)
regarded as harmful or unpleasant; often worse than side effects
three cardinal rules for drug action
- all drugs are potential poison
- all drugs have more than one effect
- drugs do not cure disease, they relieve symptoms
What happened in 1848?
The drug importation act requires all drugs entering the US must be analyzed and inspected for “quality, purity and fitness for medical purposes”
What happened in 1901?
death of a group of children in St. Louis who were given diptheria antitoxin contaminated with tetanus
What happened in 1906?
Pure Food and Drug Act: required drugs to be labeled and manufactured according to standards set in USP and NF
Listed 11 narcotic and habit forming drugs and required they be labeled
Too many loopholes- drugs did not have to be safe or effective
What happened in 1937?
- elixir of sulfanilamide
- 107 deaths due to antifreeze being an elixir for sulfanilamide
- The only law broken was the mislabeling (elixir implied alcohol)
What happened in 1938?(federal food, drug and cosmetic act)
- federal food, drug and cosmetic act
- Safety insured: tests required before petitioning FDA for approval to market the drug
- Toxicity in animals
- Human clinical trials
- Quality and purity or origin assured
- Must conform to standards in USP and NF
- Labeling improved
- Habit forming label warning
- Directions for use
What happened in 1952? (durham-humphrey amendment)
Distinguishes between Rx vs OTC
Expanded dispensing laws for prescription drugs
Oral or telephone prescriptions
Refills
State-controls Physcians license to prescribe non-controlled legend drugs
What happened in 1962? (Kefauver-harris drug amendments)
- Drugs must be affective and safe
- Senator-kefauver started investigating started investigating the drug industry in 1958
- Thalidomide incident helped pass legislation
- Safety also improved
- Need more animal testing
- Pregnant animals tested
- drug usefulness must outweigh dangers
What happened in 1970? (drug abuse prevention act)
- AKA controlled substances act
- Obtainable by prescription or federal permission not simple
- Applies to all habit forming drugs, not just narcotics
What are controlled substances and how do they differ from regular prescription drugs?
- Controlled substances are based on medical usefulness and potential abuse
- They are placed by the attorney general
Schedule I drugs
- All drugs begin here whether destined to become OTC, legend drugs, or controlled substances
- Drugs remain here if there is no therapeautic use even with medical supervision
- Use is forbidden except for research
Schedule II-IV drugs
- Ordered with prescription
- Records kept for two years
- DEA sets quotas for amount manufactured/ distributed
Schedule V Drugs
- No prescription necessary (still federally controlled)
- Pharmacy keeps record of purchaser for two years
Form for writing prescriptions for scheduled drugs
Tamper- resistant security prescriptions forms required for schedule II-V
How are drugs placed on the schedule?
A balance of both usefulness and potential for abuse
