Law Flashcards
Four Types
Legislative (Congress), Constitutional (bill of rights), Administrative (executive branch), Common/Case law (courts)
Divisions of Law
criminal, civil, contract
Civil law is also known as?
torts
What association has its own code of ethics?
American Association of Pharmacy Technicians
Steps to an ethical decision
Identify the problem gather data analyze data create an action plan asses the results
pure food and drug act
prohibited the interstate distribution or sale of adulterated or misbranded food/drugs
Food, Drug, and Cosmetic Act
all drug manufacturers to file a New Drug Application (NDA) with the FDA before any drug could be put on the market
Durham-Humphrey Amendment
prohibited dispensing legend drugs without a prescription
Kefauver-Harris Amendment
required that all medications be pure, effective and safe for use on humans
Controlled Substance Act (CSA)
requires pharmaceutical industry to keep records and maintain security measures for certain medications; five class schedules
Schedule I
drugs having no accepted medical use in the United States, with high abuse potential
Schedule II
drugs having an accepted medical use and high abuse potential
Schedule III
drugs having an accepted medical use and an abuse potential less than II and III
Schedule IV
drugs having an accepted medical use and an abuse potential less than III
Schedule V
drugs having an accepted medical use and an abuse potential less than IV
Poison Prevention Packaging Act
created standards for child-resistant packaging
Occupational Safety and Health Act
prevent workplace disease and injuries
Drug Listing Act
assigns a unique a permanent code to each medication; National Drug Code (NDC)
National Drug Code meaning of numbers
first 5 - manufacturer
next 4 - product and strength
last 2 - container size
Federal Hazardous Substance Act
use and disposal of hazardous material; anything with blood/cancer must say “hazardous substances”
Orphan Drug Act
offers financial incentives to organizations that develop and market medications that were not previously available in the united states
Orphan Drug Definition
medications that treat a small part of the population are often not cost-effective to develop and market
Omnibus Budget Reconciliation Act
requires pharmacies that fil prescription orders for medicaid patients to obtain, record and maintain basic patient information
Anabolic Steroids Control Act
allows CSA to regulate anabolic steroids. Schedule III
Health Insurance Portability and Accountability Act
HIPAA; improve continuity and portability of health insurance for patients
HIPAA regulation divisions
Privacy, security and transactions
FDA Modernization Act
reform the regulation of cosmetics, food and medical products; legend meds must bear “Rx Only”
Combat Methamphetamine Epidemic Act
intended to stop the use of methamphetamine; regulates drug trafficking; limits amount of ephedrine or pseudo ephedrine
State Board of Pharmacy
BOP; designed to establish state-specific pharmacy laws and regulations; responsible for licensure/certification
Drug Enforcement Agnecy
DEA; responsible for enforcing controlled substance legislation
Food and Drug Administration
enforce the safety and effectiveness of foods, medications, biological products, cosmetics and radioactive substances.; utilizes system called MedWatch
Joint Commission on Accreditation of Healthcare Organizations
JCAHO; accredits and certifies healthcare organizations in the United States
National Association of the Boards of Pharmacy
assists the boards in each state
Processing a Prescription
Check for validity Verify name record DOB record Address record Phone number verify any patient allergies record insurance info
Counting, Measuring, Pouring, and Labeling
verify name on label matches prescription
verify drug on label matches prescription
count pills, match NDCs
place medication in vial, attach label
