evidence-based practice - Answers clinical decision making that integrates the best available
research with clinical expertise and patient characteristics and preferences, example: Opium is
both good and bad for patients
Pure Food and Drug Act of 1906 - Answers 1. The federal government (FDA) enforcing
standards of drug strength and purityas officially designated by the USP and NF
2. prohibits mislabeling and adulteration (contamination) of drugs
USP - Answers United States Pharmacopeia
NF - Answers National Formulary
Harrison Narcotic Act of 1914 - Answers 1. regulated importation, manufacture, sale, and use of
opium, cocaine, and marijuana
2. repealed and superseded by Controlled Substances Act (1970)
Food, Drug, and Cosmetic Act of 1938 - Answers 1. enforced by the FDA through registration of
all parties involved in the manufacture, sale, and distribution of drugs
2. required adequate testing of a compound to prevent marketing of a possibly toxic substance.
New drugs must be safe as well as pure in order to be introduced into interstate commerce. But
this law still did not require proof of effectiveness
Durham-Humphrey Amendment of 1951 - Answers 1. seperated drugs into LEGEND(prescription)
and NONLEGEND(nonprescription)
2. the legend must appear on every commercial container of legend drugs "caution: federal law
prohibits dispense without prescription
Tylenol - Answers Example of over the counter
Legend - Answers prescription medication
Nonlegend - Answers nonprescription medication (over the counter)
Kefauver-Harris Amendment - Answers 1. required proof of efficacy: all medications
prescription and OTC be pure, effective, and safe to use on humans
2. place prescription drug advertising under the supervision of the FDA
3. Guidlines for clinical trials-How risky is it, are the side effects fatal?
4. Response to Thalidomide disaster
, 5. established by Druh Efficacy study Implementation (DESI)
Comprehensive Drug Abuse Prevention and Control Act of 1970 - Answers Controlled
Substances Act
1. established rehab programs for drug users
2. established control (registration) and enforcement (DEA)
3. regulates export and import of controlled substances
DEA - Answers Number given to healthcare providers to be able to prescribe medication.
Tracking systems for prescribers and users
Controlled substances - Answers 1. Prescription
2. Potentially addictive
3. Drugs use is controlled by the federal government and monitored by federal and state
government
Types of drug addictions(controlled substances) - Answers 1. "It helps me (ex. adderall)
2. physically addicting
3. psychologically addicting
Controlled substances Schedule 1 - Answers High abuse potential, No accepted medical use in
the US
1. Investigational Drugs
2. Opiates: Heroin, many synthetic derivatives
3. hallucinogens: LSD, mescaline, peyote, bath salts
4. Marijuana: (medical mari in 21 states is an exception) spice
5. Methaqualone: qualudes
Controlled substances Schedule 2 - Answers Currently accepted medical use in the US with high
abuse potential resulting in severe physical or psychological dependence. ex; adhd meds
1. rules for prescriptions
-written prescriptions required with prescribers actual (legal) signature. Electronic prescriptions
are allowed (preffered,required)
-must be dated the dame day as signed