HSC 343 1 Exam Questions and Answers| New Update with 100% Correct Answers
evidence-based practice 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 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 United States Pharmacopeia
NF National Formulary
Harrison Narcotic Act of 1914 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 repealed and superseded by Controlled Substances Act (1970)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 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 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 Example of over the counter
, Legend prescription medication
Nonlegend nonprescription medication (over the counter)
Kefauver-Harris Amendment 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 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 Number given to healthcare providers to be able to prescribe medication. Tracking
systems for prescribers and users
Controlled substances 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) 1. "It helps me (ex. adderall)
2. physically addicting
3. psychologically addicting
evidence-based practice 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 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 United States Pharmacopeia
NF National Formulary
Harrison Narcotic Act of 1914 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 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 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 Example of over the counter
, Legend prescription medication
Nonlegend nonprescription medication (over the counter)
Kefauver-Harris Amendment 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 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 Number given to healthcare providers to be able to prescribe medication. Tracking
systems for prescribers and users
Controlled substances 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) 1. "It helps me (ex. adderall)
2. physically addicting
3. psychologically addicting
