Pharmacy Law and Regulations Flashcards
HIPAA stands for
Health Insurance Portability and Accountability Act of 1996
Examples of PHI
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
Federal Law
FDA
DEA
Patient privacy and rights
HIPAA
State Law
Licensing all prescribers and dispensers
stricter than federal
follow both state and federal
Liability
negligence
incorrectly labeling no PHI incorrect filling calculation errors expired drugs not recognized controlled substance mishandling
ASHP
American Society of Health-System Pharmacists
USP
United States Pharmacopeia
sets standards for manufacture and distribution of drugs
United States Pharmacopeia and the National Formulary
JCAHO
Joint Commission on the Accreditation of Health Care Organizations
Establishes standards and monitors compliance
ASCP
American Society for Consultant Pharmacists
Sets standards for those who dispense medications in nursing homes
Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs.
Government pre-approval of drugs is required
Food and Drug Act of 1906
1950 Alberty Food Products v. US
Purpose of drug needs to be on label
1914 Harrison Tax Act
doctors prescribing C2 meds need to be licensed and pay a tax
New drugs need to be proven safe before manufacturing
1938 Food, Drug and Cosmetic (FDC) Act
1951 Dunham-Humphrey Amendment
legend needs to be on label
Drug manufacturers need to prove safety AND effectiveness before manufacturing drug
1962 Kefauver-Harris Amendment
1966 Fair Packaging and Label Act
Requires all consumer products to be honestly and informatively labeled
1970 CSA
Classifies 5 levels of drugs
DEA established
1976 Medical Device Amendment
Requires pre-market approval for safety and effectiveness of medical devices
1970 Poison prevention packaging act
child proof caps
1983 orphan drug act
incentives to promote research to find cures for rare diseases
1984 Hatch-Waxman
quicker introduction of lower-cost generic medications
Extension of drug patent terms
1987 Prescription drug marketing act
requires drug wholesalers to be licensed by the states
1990 OBRA
pharmacists need to counsel medicaid patients
Testing on children
only after animals and adults
testing phases in humans
3 phases
phase 1
20-100 patients
several months
mainly safety
phase 2
several hundred patients
several months- 2 years
short-term safety and effectiveness
phase 3
several thousand
1-4 years
safety, dosage, and effectiveness
