pharmacology pt. 1

pure food & drug act (1906)

forbade manufacture, sale & transportation of adulterated/mislabeled foods & drugs

shirley amendment of 1912

prevented fraudulent therapeutic claims by drug manufacturers

harrison act of 1914

established the word “narcotic” & required use of stamps on narcotic drug containers. regulated importation, manufacture, sale & use of opium, codeine, & their derivatives

food, drug & cosmetic act of 1938

new drug can’t be marketed until proven safe, tested for toxins, & required adverse drug effects to be reported

durham-humphrey amendment (1951)

replaced laws of 1938. required designation of whether not the drug was prescription or OTC

schedule I drug

no accepted use in the US. high potential for abuse

schedule II drug

accepted for medical uses with severe restrictions. high potential for abuse

schedule III drug

low potential for abuse, accepted medical use. prescription only.

schedule IV

abuse potential exists, less than II. ex: ambien, darvocel, and lorazepam

schedule V drug

lowest potential for abuse. may be sold OTC to people with ID

kefauver-harris amendment (1962)

requires proof of safety & efficacy of a drug for approval before marketing

controlled substances act (1970)

replaced all laws pass prior to it concerning drug control. 5 drug schedules put in place based on potential for abuse

poison prevention packaging act (1970)

implemented child restraint packaging

drug listing act of 1972

drugs must all have a national drug code number

drug regulation & reform act of 1978

quicker development & distribution of new drugs

orphan drug act of 1983

established funding for research of rare chronic illnesses for new & old drugs

drug price competition & patent term restoration act of 1984

eased requirements for marketing generic drugs

omnibus budget reconciliation act (OBRA 1990)

mandated that OTC drugs be documented

anabolic steroid control act of 1990

placed all into category III drugs (CSA)

prescription drug amendments of 1992

allowed rapid approval of drugs for life-threatening diseases

food & drug administration modernization act of 1997

allowed rapid approval of drugs by the FDA

pharmokinesis

movement of drugs through the body by absorption, distribution, metabolism, & excretion

drug blood level

amount of drug present in the blood

plasma binding

when proteins bind to drugs & decrease the amount of free-floating drug in the bloodstream, allowing drug to stay in the body for longer

examples of sulfonamides

sulfamethoxazole, sulfisoxazole, sulfadiazine