Pharmacy Law and Regulations

Question 1

HIPAA stands for

Answer 1

Health Insurance Portability and Accountability Act of 1996

Question 2

Examples of PHI

Answer 2

name
address
date of birth
social security number
payment history
account number
name and address of health care provider
health plan
medical/prescription drug histories

Question 3

Federal Law

Answer 3

FDA
DEA
Patient privacy and rights
HIPAA

Question 4

State Law

Answer 4

Licensing all prescribers and dispensers
stricter than federal
follow both state and federal

Question 5

Liability

Answer 5

negligence

incorrectly labeling
no PHI
incorrect filling
calculation errors
expired drugs not recognized
controlled substance mishandling

Question 6

ASHP

Answer 6

American Society of Health-System Pharmacists

Question 7

USP

Answer 7

United States Pharmacopeia

sets standards for manufacture and distribution of drugs

United States Pharmacopeia and the National Formulary

Question 8

JCAHO

Answer 8

Joint Commission on the Accreditation of Health Care Organizations

Establishes standards and monitors compliance

Question 9

ASCP

Answer 9

American Society for Consultant Pharmacists

Sets standards for those who dispense medications in nursing homes

Question 10

Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs.

Government pre-approval of drugs is required

Answer 10

Food and Drug Act of 1906

Question 11

1950 Alberty Food Products v. US

Answer 11

Purpose of drug needs to be on label

Question 12

1914 Harrison Tax Act

Answer 12

doctors prescribing C2 meds need to be licensed and pay a tax

Question 13

New drugs need to be proven safe before manufacturing

Answer 13

1938 Food, Drug and Cosmetic (FDC) Act

Question 14

1951 Dunham-Humphrey Amendment

Answer 14

legend needs to be on label

Question 15

Drug manufacturers need to prove safety AND effectiveness before manufacturing drug

Answer 15

1962 Kefauver-Harris Amendment

Question 16

1966 Fair Packaging and Label Act

Answer 16

Requires all consumer products to be honestly and informatively labeled

Question 17

1970 CSA

Answer 17

Classifies 5 levels of drugs

DEA established

Question 18

1976 Medical Device Amendment

Answer 18

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

Question 19

1970 Poison prevention packaging act

Answer 19

child proof caps

Question 20

1983 orphan drug act

Answer 20

incentives to promote research to find cures for rare diseases

Question 21

1984 Hatch-Waxman

Answer 21

quicker introduction of lower-cost generic medications

Extension of drug patent terms

Question 22

1987 Prescription drug marketing act

Answer 22

requires drug wholesalers to be licensed by the states

Question 23

1990 OBRA

Answer 23

pharmacists need to counsel medicaid patients

Question 24

Testing on children

Answer 24

only after animals and adults

Question 25

testing phases in humans

Answer 25

3 phases

Question 26

phase 1

Answer 26

20-100 patients
several months
mainly safety

Question 27

phase 2

Answer 27

several hundred patients
several months- 2 years
short-term safety and effectiveness

Question 28

phase 3

Answer 28

several thousand
1-4 years
safety, dosage, and effectiveness