Pharmacy Law Flashcards
Pure Food and Drug Act 1906
Prior: Products were contaminated, poorly labeled, and inconsistent
Manufactures did not have to list ingredients
-prohibited adulterated and misbranded drugs
-amended in 1912
Food, Drug, and Cosmetic Act 1938
-result of 107 deaths from automobile antifreeze in antibiotic elixir
-requires that new drugs are proven safe (not effective)
-required labeling with directions for use and warnings
-Drugs prior to 1938 were exempt (Levothyroxine, Digoxin, NTG, Phenobarbital)
Misbranded Product
product with non-compliant labeling
Adulterated Product
Issue with product itself
Durham Humphrey Amendment 1951
-Amendment to Food, Drug, and Cosmetic act
-established prescription and OTC classes of medications
-authorized verbal prescriptions and refills (refills not allowed before 1951)
Kefauver-Harris Amendment 1962
-Amendment to Food, Drug, and Cosmetic act
-result of concern over Thalidomide
-required not only safety but also efficacy
-informed consent in research studies
-Good Manufacturing Practice (GMP) requirements
Controlled Substance Act (CSA) 1970
-identified 5 schedules of drugs (I-V)
-Schedule I are very highly addictive and not currently used
-prescribers must use DEA numbers & pharmacies DEA licenses
DEA Numbers
-valid for 3 years
-2 letters & 7 numbers
-First letter denotes practitioner type
-second letter is last name initial
-sum of 1,3,5 digits + 2(2,4,6 digits) must equal a number with a last digit that is the same as the 7th digit
Prescription Drug Monitoring Program (PDMP)
-2005
-curb controlled drug abuse
-electronic reporting of controlled drugs
Ordering controlled drugs
-CII 222 Form
-Copy 1 (brown) -> supplier
-Copy 2 (green)-> supplier the DEA
-Copy 3 (blue) -> purchaser
-CIII-V with non-controlled drugs but separate invoices
Disposal of Controlled Substances
-only BoP member
-DEA form 41
-meds should be mixed in kitty litter or coffee
-do not flush or put in sink
Theft of Controlled Substances
-Notify DEA and form 106
-Notify police
-Notify BoP
-Call insurance company
Omnibus Budget Reconciliation Act (OBRA) 1990
-first federal law to mandate pharmacy
-improve medication understanding and decrease cost
-DUR was created
-required patient counseling
-federal laws cannot be used in lawsuit
-state laws determine pharmacy practice laws
-public trust in pharmacist
Health Insurance Portability & Accountability Act (HIPAA) 1996
-4 targets: transaction and code sets, NPI, security, privacy
-Prior: no shredding, no removing names, throw in trash
-only for electronic records
-large gap from when it was created and when it was implemented completely (1996-2005)
-cannot sue based on HIPAA because it is federal
Tamper Resistant Prescription Pads
-decrease # of unauthorized, improperly altered, and counterfeit prescriptions
-prevent unauthorized copying
-prevent eraser or modification
-prevent use of fake Rx forms
