Pharmacy Law Flashcards
The Joint Commission (TJC)
Accredits and certifies healthcare organization in U.S
- it is an independent, not-for-profit
- works to increase pt safety
United States Pharmacopeia Act (USP)
Sets standard for all prescriptions, OTC’s, and dietary supplements sold in U.S
-in quality, purity, strength, and consistency
Combat Methamphetamine Epidemic Act
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
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
AKA Medicare Modernization Act (MMA): provided voluntary prescription drug drug benefits to pt’s eligible for medicare through part D
FDA Modernization Act
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
Pure Food and Drug Act
1906: Prohibits the distribution or sale of adulterated drugs (made less pure) or misbranded (incorrect)
- replaced by Food, Drug, and Cosmetic Act
Food, Drug, and Cosmetic Act
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.
Durham - Humphrey Amendment
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
Kefauver - Harris Amendment
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
Controlled Substance Act (CSA)
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
Poison Prevention Packaging Act (PPPA)
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
Occupational Safety and Health Act (OSHA)
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
Federal Hazardous Substance Act
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
Drug Listing Act
1972: Signs every drug a unique and permanent drug code
- National Drug Code (NDC): identifies manufacturers, product and strength, and bottle count
Orphan Drug Act
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
Drug Price Competition and Patent Term Restoration Act
1984: Encouraged the creation of new medications by extending patents.
- increases the cost of drug prices by streaming the generic drug approval process
National Association of the Boards of Pharmacy (NABP)
In each state to protect public health and develops uniformity
USP-797 Act
Sets standard for sterile compounding and it’s essential for protecting pt’s against infections
Anabolic Steroids Control Act
1990: Allows the CSA to regulate anabolic steroids
- anabolic steroids became a CIII
- raises penalties for illegal distribution
- important verification of anabolic steroids
Health Insurance Portability and Accountability Act (HIPAA)
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
Omnibus Budget Reconciliation Act (OBRA)
1990: Effects medicare and medicaid
- requires pharmacy to maintain files for medicaid pt’s
- Pharmacist must offer DUR (consuls)
State Law Labeling
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
