Exam 1 Flashcards
(128 cards)
What is the definition of a drug?
ANY substance, that when administered to living organisms, produces a change in function.
What is toxicology?
The study of the adverse effects of chemical, physical or biological agents on living organisms and the ecosystem.
What is pharmacology?
The study of the uses, effects, and modes of action of drugs.
What was the 1906 pure food and drug act?
First attempt to protect consumers in manufacture of drugs and foods.
Drugs must label dangerous ingredients.
Drugs must meet minimal standards of strength, purity, and quality.
Established two references of officially approved drugs (US Pharmacopeia ‘USP’, National formulary ‘NF’).
What was the 1938 federal food, drug, and cosmetic act?
Passed after a drug company distributed a sulfa (very similar to antifreeze) to pediatric patients, icing those kids. This authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
What was the 1951 Durham-Humphrey Amendment?
Defined drugs that could only be purchased if the patient had a prescription from a licensed practitioner.
What was the 1958 Food Additives Amendment?
Approval of new food additives was required and safety determined by manufacturer before they could be marketed.
What are some of the Food Additive Amendment exemptions?
GRAS substances (deemed safe by experts).
Substances that were approved for use PRIOR to the passage of the amendment.
What was the FD&C Kefauver-Harris Amendment?
Required drug manufacturers to use standard labeling, listing adverse reactions and contraindications.
Required drug companies to prove their drugs safety and effectiveness.
What was the 1970 Drug Abuse Prevention and Control Act?
AKA “controlled substances act”
Regulation of drugs with “abuse potential” (controlled substances)
Substances categorized into 5 “schedules”
What was the 1994 Dietary Supplements Health and Education Act?
FDA responsible for taking action against any unsafe dietary supplement.
Generally, manufacturers are NOT required to register their products with FDA or get FDA to approve them.
What was the 1996 Food Quality Protection Act?
Reinvestigated pesticide tolerance levels
Development of stricter pesticide safety standards.
Who is the FDA and what do they oversee?
Food and Drug Administration.
Food labeling/nutrition, food ingredients/ packaging, pharmaceuticals, supplements, medical devices, vaccines, animal foods, tobacco, cosmetics
Who is the DEA and what do they oversee?
Drug Enforcement Administration
Controlled substances only, enforces laws against drug activity, changes schedules of abused drugs
Who is the USDA and what do they oversee?
US Department of Agriculture
Food distribution, school lunch programs.
Who is the EPA and what do they oversee?
Environmental Protection Agency
Agriculture and industrial chemicals, water.
Who is OSHA and what do they oversee?
Occupational Safety and Health Administration
Workplace chemical exposure
What are the 6 sources of drugs?
Plants Minerals Animals Microorganisms Synthetic/chemical Recombinant DNA
What are the 3 aspects of drug nomenclature?
Chemical name (e.g. N-acetyl-p-aminophenol)
Generic (e.g. acetominophen)
Brand or Trade (e.g. Tylenol)
What is the therapeutic affect of a drug?
The intended physiological effect of the drug
What does “indication” refer to?
Medical conditions or diseases for which the drug is meant to be used.
What does “contraindication” refer to?
Conditions/circumstances for which the drug should not be used
What does “caution” refer to?
Conditions or types of patients that warrant closer observation for specific side effects
What is a side effect?
Unintended effects other than therapeutic effect (may or may not be negative).