study of drugs and their actions on living organisms
chemical substances that have an effect on living organisms
therapeutic drugs, used to prevent or treat diseases
treatment with natural physical forces such as water, light, and heat
Psychological therapy
identification of stressors and methods to reduce or eliminate stress and/or the use of drugs
generic name
first letter of name is not capitalized
official name
name of drug that is listed by U.S. Food and Drug Administration
trademark/brand/proprietary name
first letter is capitalized
U.S. Pharmacopiea/National Formulary
provides standards for identity,quality,strength, and purity of substances used in healthcare
Controlled Substances Act (1970)
divided potentially addictive drugs into five schedules
Schedule I
high abuse potential/no medical use; Ex: LSD, heroin,marijuana,mescaline,methaqualone,peyote,STP,hashish,psilocybin
Schedule II
high abuse potential/accepted medical use/no refills/phone orders in emergencies;Ex:Amphetamines,cocaine,codeine,dronabinol,methadone,methylphenidate,pentobarbital,Opium(morphine),meperidine,short-acting barbiturates(secobarbital)
Schedule III
less abuse than I & II/possible psychological dependence;Ex:Benzphetamine,butabarital,mixtures of codeine,Loratab,Fiorinal
Schedule IV
low abuse potential/phone orders permitted;Ex:Librium(chlordiazepoxide),Valium(diazepam),Chloral Hydrate,Darvon(propoxyphene),phenobarbital,flurazepam,temazepam
Schedule V
low abuse potential/may not need prescription;Ex:Lomotil,Robitussin A-C
Federal Food, Drug, and Cosmetic Act (1938)
moved burden of proof from government to manufacturer/FDA regulates
Federal Food, Drug, and Cosmetic Act (Durham-Humphrey Amendment 1952)
restricted the refilling of perscriptions
Federal Food, Drug, and Cosmetic Act (Kefauver-Harris Amendment 1962)
product has to be safe and effective/came after Thalidomide (drug used for pregnant woman's pain) tragedy
Harrison Narcotic Act (1914)
regulated narcotic sales (before act, could buy w/o prescription)
state of being free of contamination
rate and extent to which an active drug enters general circulation
ability to produce a desired effect
measures to prevent harm
extent, quality, or degree of being poisonous
Four stages of drug development
1)preclinical/stage where FDA has 30 days to determine if safe/only 20% go to clinical stage 2)clinical 3)New Drug Application (NDA) review 4)postmarking surveillance