Pharmacy Law Flashcards
Pure Food and Drug Act of 1906
To prohibit the interstate transportation or sale of adulterated and misbranded food or drugs.
Food, Drug, and Cosmetic Act of 1938 (FDCA 1938)
U.S. Food and Drug Administration (FDA) was created under FDCA; required that all new drug applications be filed with the FDA.
Adulteration
- Consisting “in whole or in part of any filthy, putrid, or decomposed substance”
- Prepped, packed, or held in unsanitary conditions
- Containing unsafe color additives
- Claimed to be or represented as drugs recognized in “an official compendium” but differing in strength, quality or purity
Misbranding
- Labeling that is false or misleading
- Packaging that doesn’t have a label containing name and place of business of the manufacturer, packer, distributor or an accurate quantity of content or not clearly labeled with info required by law
- Failure to indicate if product is habit forming on label if it is
- Failure to label adequate directions for use
Durham-Humphrey Act of 1951
All products must have adequate directions for use.
Drugs are separated into 2 categories: legend (prescription) and nonlegend (OTC).
Allows verbal prescriptions over phone
Allows refills to be called in from physician’s office
Kefauver-Harris Amendment of 1962
Requires all medication in US to be pure, safe, and effective
Comprehensive Drug Abuse Prevention and Control Act of 1970
DEA placed under the supervision of the Department of Justice. Controlled substances placed in 1 of 5 schedules based on abuse and accepted medical use
Schedule I
No accepted medical use, extremely high potential for abuse.
Crack, crystal meth, ex, hash, heroin, LSD, weed, mescaline, opium, PCP, peyote, psilocybin, roofies
Schedule II
Has a medical use but has a high abuse potentiality severe psych or physical dependency
Schedule III
Has accepted medical use, and the abuse potential is less than schedule I and II drugs
Schedule IV
Abuse potential is less than schedule III but administration may lead to limited physical or psych dependency
Schedule V
Abuse potential is less than Schedule IV drugs; schedule includes exempt narcotics
Drug Enforcement Agency Registration
Every facility that dispenses controlled drugs must register with DEA by submitting DEA Form 224. Renew every 3 years.
Schedule II Refills:
May be filled partially for up to 60 days from date of issue on the prescription unless discontinued sooner.
Schedule III to V Refills:
Patient may receive up to 5 refills within 6 months on prescription if authorized.
Exempt Narcotics
Select cough and antidiarrheal meds can be purchase if individual is 18yo. Limit on one container in 48hr period.
Poison Prevention Packaging Act of 1970
To reduce accidental poisoning in children
Occupational Safety and Health Act (OSHA) of 1970
Created Occupational Safety and Health Administration (OSHA). Developed to ensure job safety and health standards for employees. Requires usage of MSDS (Material Safety Data Sheets)
Drug Listing Act of 1972
Each drug is assigned 11-digit # to identify it. Known as NDC (National Drug Code). First 5 # identify manufacturer, next 4 # identify drug product, Last 2# represent package size and packaging.
Orphan Drug Act of 1983
Meds for diseases or conditions of which there are fewer than 200,000 cases in the world.
Drug Price Competition and Patent Term Restoration Act of 1984
Encouraged creation of both generic and new medication by streamlining process for generic drug approval and extending patent licenses.
Prescription Drug Marketing Act of 1987
Prohibits reimportation of drug into US by anyone but manufacturer.
Omnibus Budget Reconciliation Act of 1987 (OBRA-87)
Extensive revisions to Medicare and Medicaid Conditions of Participation regarding long-term care facilities and pharmacy
Anabolic Steroid Control Act of 1990
Harsher penalties for the abuse of anabolic steroids and their misuse by athletes
Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
- Requires manufacturers to provide lowest price to Medicaid customers by rebates.
- Requires an “offer to counsel” be made to every patient along with DUR.
Americans With Disabilities Act (ADA) of 1990
Prevents discrimination against potential employees who may possess a disability
Resource Conservation and Recovery Act
Environmental Protection Agency (EPA) made federal guidelines regarding hazardous waste (controlled substances) disposal. Flushing is illegal
FDA Modernization Act
Rx= federal law prohibits the dispensing of this medication without a prescription
Dietary Supplement Health and Education Act (DSHEA) of 1994
Herbal products are dietary supplements. Manufacturers are allowed to claim general health promotion but not disease claims.
Health Insurance Portability and Accountabiloty Act (HIPAA) of 1996
Improve portability and continuity of health coverage. Requires health care providers to ensure that patient confidentiality be maintained.
Title I- Insurance Reform: protects health insurance coverage for workers and fam when change or lose jo
Isotretinoin Safety and Risk Management Act of 2004
(Accutane) for acne. Has been known to cause severe birth defects, have adverse psychiatric effects, (depression, psychosis, suicide)
Patients must be educated about ADR. 30days prescription allotments. Appropriate blood testing must be performed
Anabolic Steroid Control Act of 2004
59 anabolic steroids listed. Amendment provided requirements for handling steroids including registration, security, labeling and packaging, inventory, record maintenance, prescriptions, disposal, importation and exportation, and criminal liability
Any Willing Provider Law
Any pharmacy to participate in a prescription drug benefit plan
Freedom of Choice Law
Allows a member of a prescription drug plan to select any pharmacy benefit
Freedom of Choice With Regard to Long-term Care
Long-term care residents may choose an outside pharmacy for their medications of pharmaceutical service is not provided by contract. Facility may refuse admission to resident if resident refuses drug distribution system already in place.
Medicare Drug, Improvement and Modernization Act (MPDIMA) of 2003
-Adds preventive medical benefits for seniors.
Lowers reimbursement rates for Medicare.
Changed the way Medicate pays for outpatient drugs.
Medicare Part D plan allows beneficiaries to enroll in either regional or national insurance plans
Combat Methamphetamine Epidemic Act of 2005
Federal law that placed ephedrine, pseudoephedrine, and phenylpropanolamine in Controlled Substances Act. 3.6g/day & 9g/30 days base product sales limit. Logbook required
Medicaid Tamper-Resistant Prescription Act
Prescription pad should have all of the following:
Industry-recognized features to prevent unauthorized copying, the erasure or modification of information, and the use of counterfeit forms
USP
Designed to cut down on infection transmitted to patient through pharmaceutical products by sterilization
ATF
Bureau of Alcohol, Tobacco, and Firearms.
DEA
Drug Enforcement Agency.
Overseen by Department of Justice. Enforces compliance with Controlled Substances Act, registers pharmacies, monitors destruction of controlled substances
EPA
Environmental Protection Agency
Sets guidelines for the disposal of hazardous waste.
FDA
Food and Drug Administration
Ensures that all pharmaceutical products are pure safe and effective.
Institutional Review Board
Group designated to approve biomedical research
TJC
The Joint Commission.
Addresses quality of patient care and patient safety in health care providers.
NABP
National Association of the Boards of Pharmacy.
Has no regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharm
BOP
State Boards of Pharmacy.
Oversees the practice of pharmacy in a given state.
USP
United States Pharmacopeia
Sets authority for all prescription and OTC meds and other health care products
Therapeutic Equivalence
Two drugs are therapeutically equivalent if they contain the same active ingredients, strength or concentration, dosage form, route of administration, clinical effect and safety profile.
Therapeutic Interchange
Substitution of one med for another med that is not generically equal but provides the same therapeutic effect
Recall Class 1
Strong likelihood that the product will cause serious adverse effects or death.
Recall Class 2
May cause temporary but reversible adverse effects.
Recall Class 3
Product will not likely cause adverse effects.
ASHP
American Society of Health-System Pharmacists. Accrediting organization for pharmacists and pharmtechs.
USP
United States Pharmacopeia. Sets standards for the manufacture and distribution of drugs in US.
JCAHO
Establishes standards and monitors compliance for health care programs in US.
ASCP
The American Society for Consultant Pharmacists. Sets standards for practice for pharmacists who provide medication distribution and consultation to nursing homes.
