Fulcher: Pharmacology, 2nd Edition

Chapter 1: Legal and Ethical Aspects of Pharmacology

Test Bank

MULTIPLE CHOICE

	1.	The government agency that regulates the development of drugs is the
a.	Drug Enforcement Agency	
b.	World Health Organization	
c.	Food and Drug Administration	
d.	Bureau of Dangerous Drugs	

ANS:	C

	2.	What government agency or agencies control(s) prescription or legend medications?
a.	Drug Enforcement Agency	
b.	Bureau of Dangerous Drugs	
c.	Food and Drug Administration	
d.	a and c	
e.	all of the above	

ANS:	D

	3.	The overuse or misuse of drugs is considered
a.	drug abuse	
b.	drug dependence	
c.	drug addiction	
d.	none of the above	

ANS:	A

	4.	The agency responsible for the efficacy, purity, and safety of medications is the
a.	DEA	
b.	FDA	
c.	BNDD	
d.	none of the above	

ANS:	B

	5.	The FDA is a division of the
a.	Department of Justice	
b.	Department of Health and Human Services	
c.	Department of Social Services	
d.	Bureau of Narcotics and Dangerous Drugs	

ANS:	B

	6.	Standardization of drugs began
a.	in the nineteenth century	
b.	in the twentieth century	
c.	after 1950	
d.	Drugs have always been standardized.	

ANS:	B

	7.	Consumer safety became an important issue during the latter part of the twentieth century because of the
a.	increased use of drugs by the public	
b.	need to be sure that drugs have the expected therapeutic properties	
c.	increased numbers of OTC medications	
d.	a and c	
e.	all of the above	

ANS:	D

	8.	The act that placed dangerous drugs into schedules is the
a.	Kefauver-Harris Amendment	
b.	Federal Food, Drug, and Cosmetic Act of 1938	
c.	Controlled Substances Act of 1970	
d.	Harrison Narcotic Act of 1914	

ANS:	C

	9.	The formulary for medications is approved by the
a.	USP	
b.	NF	
c.	FDA	
d.	DEA	

ANS:	B

	10.	The FDA regulates the following areas concerning drugs:
a.	purity and quality	
b.	identity	
c.	strength	
d.	a and c	
e.	all of the above	

ANS:	E

	11.	Drug testing is done on which of the following before being named an Investigational New Drug?
a.	animals	
b.	humans	
c.	a and c	
d.	none of the above	

ANS:	A

	12.	The physician must keep which of the following records when using drugs found on the DEA list of scheduled medications?
a.	a log of all scheduled medications given	
b.	copies of the supplier’s invoices showing the receipt of the drug	
c.	a copy of a BNDD number for each place where the physician administers Schedule II medications	
d.	b and c	
e.	all of the above	

ANS:	E

	13.	The act that allows drug manufacturers to find new uses in rare medical conditions for medications previously found to be dangerous is the
a.	Controlled Substances Act of 1970	
b.	Omnibus Reconciliation Act of 1990	
c.	Orphan Drug Act of 1983	
d.	Kefauver-Harris Amendment	

ANS:	C

MATCHING

Match the following terms with their descriptions below:
a.	potency	
b.	quality	
c.	efficacy	
d.	purity	
e.	placebo	

	1.	A drug that has no therapeutic effect

	2.	The concentration of active ingredients in a drug preparation

	3.	The ability of a drug to produce the desired effect

	4.	The standard that specifies the type and concentration of a substance in a drug

	5.	The fact that the consumer will receive the same standard of medication with each prescription

	1.	ANS:	E

	2.	ANS:	A

	3.	ANS:	C

	4.	ANS:	D

	5.	ANS:	B

Match the following schedules to the drugs described below that may be abused:
a.	Schedule I	
b.	Schedule II	
c.	Schedule III	
d.	Schedule IV	
e.	Schedule V	

	6.	A drug that requires a written prescription because of its high potential for abuse

	7.	A prescription that may be phoned to the pharmacist because of the lower potential for abuse and limited psychological/ physical dependence

	8.	A drug with no medical indication

	9.	A drug that has a low abuse indication and may be bought OTC

	10.	A drug with moderate potential for abuse but may have a prescription phoned to the pharmacist with five refills in 6 months

	6.	ANS:	B

	7.	ANS:	D

	8.	ANS:	A

	9.	ANS:	E

	10.	ANS:	C

TRUE/FALSE

	1.	A physician may prescribe medications without a license because he or she has the necessary education.

ANS:	F

	2.	Drug standards are the same in all states and countries.

ANS:	F

	3.	OTC drugs are not regulated by the FDA.

ANS:	F

	4.	The USP is issued every 5 years with supplements as needed to provide formulas of medications and information on how medications are prepared.

ANS:	T

	5.	The first regulation on importation, manufacture, sale, and use of narcotics and their derivatives was found in the Harrison Narcotic Act of 1914.

ANS:	T

	6.	For a drug to be classified as OTC, it must be safe for use when the pharmacist suggests its use.

ANS:	F

	7.	If an adverse reaction occurs during the use of a drug, that information should be reported to the FDA on the MedWatch form.

ANS:	T

	8.	All drugs with the potential for abuse, as found under the auspices of the Controlled Substances Act of 1970, are followed by the DEA from manufacture to sale in a pharmacy or use by the physician.

ANS:	T

	9.	Controlled substances should be kept separate from other drugs and in a securely locked area.

ANS:	T

	10.	An inventory of controlled substances must be taken in a physician’s office every 5 years.

ANS:	F

	11.	If controlled substances are administered but not dispensed in a physician’s office, the medical record may be used as the documentation of the use of the controlled substance.

ANS:	T

	12.	If medications are administered and dispensed in a physician’s office, separate records (other than the patient record) must be kept showing where the medications have been used.

ANS:	T

	13.	The physician must have permission from the DEA to dispose of outdated controlled substances.

ANS:	T

	14.	The physician must have permission from the FDA to dispose of any outdated medications.

ANS:	F

	15.	Prescription pads should be left on the physician’s desk in each exam room for ease in writing prescriptions.

ANS:	F

	16.	A good safeguard in preventing forgery of prescriptions is to photocopy all prescriptions leaving the office.

ANS:	T

	17.	A drug sample must be signed for by the physician before a drug sales representative leaves the sample.

ANS:	T

	18.	The medical assistant should allow the drug sales representative to leave any medication that might be used in the office for patient care.

ANS:	F

	19.	Drug dependence is always unethical.

ANS:	F

	20.	A terminally ill patient should be kept as free of pain as possible by administering as many medications as necessary to allow him or her to be comfortable.

ANS:	T

	21.	Prescription pads make wonderful notepads and paper for ordering blood tests and x-rays.

ANS:	F

	22.	It is ethical and legal to charge for drug samples in a physician’s office.

ANS:	F