Pharmacy Law

Question 1

The Joint Commission (TJC)

Answer 1

Accredits and certifies healthcare organization in U.S

• it is an independent, not-for-profit
• works to increase pt safety

Question 2

United States Pharmacopeia Act (USP)

Answer 2

Sets standard for all prescriptions, OTC’s, and dietary supplements sold in U.S
-in quality, purity, strength, and consistency

Question 3

Combat Methamphetamine Epidemic Act

Answer 3

2005: Intended to stop the use of the illegal drug methamphetamines.
- such as ephedrine and pseudoephedrine
- being locked with the pharmacies
- limit amount available for purchase: 3.6 grams per person at a time and 7.5 grams per month
- ID needed for purchase

Question 4

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Answer 4

AKA Medicare Modernization Act (MMA): provided voluntary prescription drug drug benefits to pt’s eligible for medicare through part D

Question 5

FDA Modernization Act

Answer 5

1997: Designed to reform the regulation of cosmetics, food, and medical products.
- especially in compounding pharmacies
- every legend has to have ‘RX only’
- improved FDA’s regulation of medications

Question 6

Pure Food and Drug Act

Answer 6

1906: Prohibits the distribution or sale of adulterated drugs (made less pure) or misbranded (incorrect)
- replaced by Food, Drug, and Cosmetic Act

Question 7

Food, Drug, and Cosmetic Act

Answer 7

1938: Antifreeze as a sweetener in Massengill. New law requires all drug manufactures to file New Drug Application (NDA) with FDA for approval.
- Includes correct and safe labeling.

Question 8

Durham - Humphrey Amendment

Answer 8

1951: Created internal classification of prescriptions.
- prohibited dispensing legend drugs without prescriptions
- bottle need to have ‘Federal law prohibits this medication to be dispensed with out an prescription’
- allowed verbal prescriptions to be taken with refills

Question 9

Kefauver - Harris Amendment

Answer 9

1963: Enacted because of the thalidomide tragedy(1950) caused 10,000 - 20,000 birth defects. It was used to help pregnant with nausea.
- requires all medication to be pure, effective and safe on humans
- put drugs under FDA supervision
- requires manufactures to register to allow inspection

Question 10

Controlled Substance Act (CSA)

Answer 10

1970: AKA Comprehensive Drug Abuse Prevention and Control Act
- pharmacies must retain records for controlled substances
- division of controlled from I to V
- allows petitions for changes
- DEA enforces this shit
- Form 222 to order with date and signature
- Form 41 for expired and damaged controlled medication
- Form 106 for theft of controlled medication

Question 11

Poison Prevention Packaging Act (PPPA)

Answer 11

1970: Created standard for child proof packing. 80% of age of 5 or younger cannot open but 90% of adults can.
- pt can ask for non child safety caps

Question 12

Occupational Safety and Health Act (OSHA)

Answer 12

1970: Created OSHAdmin. Established to prevent illness and injury in work place.
- regulation of Material Safety Data Sheets (MSDS): what is in it, warnings, and disposable
- pharmacy workplace safety: hazardous waste

Question 13

Federal Hazardous Substance Act

Answer 13

1960: Involves the use and disposal of hazardous material in pharmacy hospital settings
- mostly IV’s
- human blood, cancer treatments and PPE used must be disposed in labeled bag

Question 14

Drug Listing Act

Answer 14

1972: Signs every drug a unique and permanent drug code

- National Drug Code (NDC): identifies manufacturers, product and strength, and bottle count

Question 15

Orphan Drug Act

Answer 15

1983: Financial incentives to organizations that develops and market drugs that are for rare diseases (20,000 people or less).
- offers tax breaks and 7 year patent

Question 16

Drug Price Competition and Patent Term Restoration Act

Answer 16

1984: Encouraged the creation of new medications by extending patents.
- increases the cost of drug prices by streaming the generic drug approval process

Question 17

National Association of the Boards of Pharmacy (NABP)

Answer 17

In each state to protect public health and develops uniformity

Question 18

USP-797 Act

Answer 18

Sets standard for sterile compounding and it’s essential for protecting pt’s against infections

Question 19

Anabolic Steroids Control Act

Answer 19

1990: Allows the CSA to regulate anabolic steroids
- anabolic steroids became a CIII
- raises penalties for illegal distribution
- important verification of anabolic steroids

Question 20

Health Insurance Portability and Accountability Act (HIPAA)

Answer 20

1996: Improve continuity and portability of health INS for pt’s
- 1st: Privacy Right - pt’s rights to their own records
- 2nd: Security Regulations - ensure Protected Health Information (PHI)
- 3rd: Transaction Regulations - record HIPAA acknowledgment

Question 21

Omnibus Budget Reconciliation Act (OBRA)

Answer 21

1990: Effects medicare and medicaid
- requires pharmacy to maintain files for medicaid pt’s
- Pharmacist must offer DUR (consuls)

Question 22

State Law Labeling

Answer 22

Single - Use: medication name, route, strength, lot #, expiration date, repackages name, special storage info, bar code
Outpatients: name and address of pharmacy, pt’s name, prescribers info, direction, dispense date, caution, rx #, and pharmacist name