3 Drug Regulation & Control

Question 1

Placebo

Answer 1

an inactive substance given in place of medication

Question 2

Pediatric

Answer 2

having to do with the treatment of children

Question 3

pharmaceutical equivilent

Answer 3

drug products that contain identical amounts of the same active ingredients in the same dosage form

Question 4

therapeutic equivalent

Answer 4

pharmaceutical equivalents that produce the same effect in patients

Question 5

legend drug

Answer 5

any drug which requires a prescription

Question 6

product labeling

Answer 6

important associated information that is not on the label of a drug product itself, but is provided with the product in the form of an insert, brochure, or other document

Question 7

CMEA

Answer 7

Combat Methamphetamine Epidemic Act - Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine

Question 8

Exempt narcotics

Answer 8

medications with habit-forming ingredients that could be dispensed by a pharmacist without a prescription to persons at least eighteen years of age

Question 9

dual marketing

Answer 9

status of medications like Plan B that are classified as both prescription drugs and OTC drugs

Question 10

controlled substances

Answer 10

five groups of drugs identified by the 1970 CSA as having potential for abuse and whose distribution is therefor strictly controlled

Question 11

adverse effect

Answer 11

an unintended side effect of a medication that is negative or in some way injurious to a patient’s health

Question 12

injunction

Answer 12

a court order preventing a specific action, such as the distribution of a potentially dangerous drug

Question 13

recall

Answer 13

the action taken to remove a drug from the market and have it returned to the manufacturer

Question 14

protocol

Answer 14

specific guideline for practice

Question 15

compliance

Answer 15

doing what is required

Question 16

negligence

Answer 16

failing to do something that should or must be done

Question 17

FDA

Answer 17

Food and Drug Administration - the leading federal enforcement agency for regulations concerning drug products (Originally Named in 1927 The Food, Drug and Insecticide Administration

Question 18

DEA

Answer 18

Drug Enforcement Agency - (Justice Department) controls the distribution of drugs that may be easily abused

Question 19

Food and Drug Act of 1906

Answer 19

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

Question 20

1914 Harrison Tax Act

Answer 20

established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax

Question 21

FDC

Answer 21

1938 Food, Drug and Cosmetic Act - requires new drugs to be shown to be safe before marketing. (In response to poisoning by sulfanilamide concotion)

Question 22

1950 Alberty Food Products v U.S.

Answer 22

The US Court of Appeals rules the purpose for which a drug is to be used must be included on the label.

Question 23

1951 Durham-Humphery Admendment

Answer 23

This law defines what drugs require a prescription by a licensed practitioner and requires them to include an RX Only label

Question 24

1962 Kefauver-Harris Amendment

Answer 24

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

Question 25

1966 Fair Packaging and Labeling Act

Answer 25

this requires all consumer products in interstate commerce to be honestly and informatively labeled.

Question 26

1970 Poison Prevention Packaging Act

Answer 26

Requires child-proof packaging on controlled and most prescription drugs dispensed by pharmacies.

Question 27

CSA

Answer 27

1970 Controlled Substances Act - The CSA classifies five levels of drugs (controlled substances) that have potential for abuse and therefore restricts their distribution.

Question 28

1976 Medical Device Amendment

Answer 28

Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices

Question 29

1983 Orphan Drug Act

Answer 29

Provides incentives to promote research, approval, and marketing of drugs needed for treatments of rare diseases

Question 30

1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)

Answer 30

This act allowed for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs

Question 31

1987 Prescription Drug Marketing Act

Answer 31

Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states.

Question 32

1990 Omnibus Budget Reconciliation Act (OBRA)

Answer 32

Among other things, this act requires pharmacists to offer counseling to Medicaid patients regarding medication

Question 33

1990 Anabolic Steriod Control Act

Answer 33

This act was passed to “address the abuse of steroids by athletes, and, especially, youngsters and teenagers”

Question 34

HIPAA

Answer 34

1996 Health Insurance Portability and Accountability Act - among other things, defined the scope of health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients privacy