Chapter 3 -- Drug Regulation and Control

Question 1

Food and Drug Administration

Answer 1

leading enforcement agency at federal leval for regulations involving drug products

Question 2

Drug Enforcement Administration

Answer 2

agency which controls distribution of drugs that can be easily abused

Question 3

Food and Drug Act of 1906

Answer 3

Prohibits interstate commerce in adulterated or misbranded food, drinks,and drugs. Government pre-aproval of drugs is required.

Question 4

1938 Food, Drug, and Cosmetic (FDC) Act

Answer 4

Comprehensive law requires new drugs be shown to be safe before marketing

Question 5

1951 Durham-Humphrey Amendment

Answer 5

law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: “Caution: Federal Law prohibits dispensing without a prescription.”

Question 6

1962 Kefauver-Harris Amendments

Answer 6

Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug

Question 7

1970 Poison Prevention Packaging Act

Answer 7

Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacists

Question 8

1970 Controlled Substances Act (CSA)

Answer 8

The CSA classifies drugs that may be easily abused and restrict their distribution. It is enforced by the Drug Enforecement Adminsitration (DEA) within the Justice Department

Question 9

1990 Omnibus Budget Reconciliation Act (OBRA)

Answer 9

Requires pharmacists to offer counseling to Medicaid patients regarding medications, effectively putting common practice into law

Question 10

1996 Health Insurance Portability and Accountability Act (HIPAA)

Answer 10

Provided broad and stringent regulations to protect patients’ privacy

Question 11

placebos

Answer 11

inactive substances, not real meds, used to test effectiveness of drugs

Question 12

prescription drug labels (minimum requirements)

Answer 12

minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements

Question 13

NDC (National Drug Code) number

Answer 13

number assigned by manufacturer
Three parts:
1. MANUFACTURER
2. MEDICATION, STRENGTH, DOSAGE FORM
3. PACKAGE SIZE

Question 14

DEA number/formula

Answer 14

number all prescribers of controlled substances are assigned which must be used on all controlled drug prescriptions.

Two letters folowed by seven single-digit numbers.

EXAMPLE: AB1234563

Formula for checking a DEA number on a prescription form is:

1. Sum of first, third, and fifth digit added to..
2. Twice the sum of second, forth, sixth digit
3. The total should be a number whose last digit is the same as the last digit of the DEA number.

Question 15

recalls

Answer 15

recalls are voluntary on the part of manufacturer. three classes of recalls.

1) where there is a strong likelihood that the product will cause serious adverse effects or death
2) where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects
3) where a product is not likely to cause adverse effects

Question 16

state regulation

Answer 16

state boards of pharmacy are responsible for licensing all prescribers and dispensers and administering regulations for the practice of pharmacy in the state

Question 17

liability

Answer 17

legal liability means you can be prosecuted for misconduct

Question 18

Schedule I

Answer 18

each drug has a high potential for abuse;
no accepted medical use in the U.S;
may not be prescribed;

Heroin
Opium derivatives
Hallucinogenic substances

Question 19

Schedule II

Answer 19

each drug has a high potential for abuse;
may lead to physical or psychological dependence;
has a currently accepted medical use in the U.S.

amphetamines
opium
cocaine
methadone
various opiates

Question 20

Schedule III

Answer 20

each drug’s potential for abuse is less than those in Schedules I and II;
may lead to moderate/low physical dependence or high psychological dependence;

anabolic steroids
various compounds containing lmited quantities of narcotic substances such as codeine are included on this schedule

Question 21

Schedule IV

Answer 21

each drug has a low potential for abuse relative to Schedule III drugs and there is a current accepted medical use in the U.S;
abuse may lead to limited physical dependnce or psychological dependence

phenoarbital
sedative chloral hydrate
anesthetic methonexital

Question 22

Schedule V

Answer 22

each drug has low potential for abuse;
limited physical dependence or psychological dependence

compounds containing limited amounts of narcotic such as codeine