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Pharmacy Law/Ethics

MxrI Chpt 2

QuestionAnswer
Adulteration mishandling of meds that can lead to contamination and or illness
Board Of Pharmacy state board that regulates pharmaceutical practices
Controlled Substance substances consisting of stimulants, depressants and hallucinogens
DEA federal agency enforcing laws against controlled substances
FDA federal agency regulating manufacturing and safeguard of meds
Health Insurance Portability and Accountability Act of 1996 protecting patients rights
Legend drug requires script for dispensing
Misbranding deceptive or misleading labeling of a product that may mislead consumer to think it will cure illness
Monograph med info sheet provided by manufacturer that includes side effects, dosage forms, indications
Narcotic drug that in moderate doses dulls senses, relieves pain, and induces sleep- in lg doses causes stupor, coma or convulsions
OTC meds meds that can be purchased without a script, nonlegend meds
Pharm Tech Cert Board National Board of certification
Physicians Desk Reference Reference book of meds
1906 Food and Drug act enacted to stop sale of inaccurately labeled drugs
1914 Harrison Narcotic act started due to large amt of opium addicts in the U.S
1938 Food, Drug and Cosmetic act enacted bc earlier act wasnt strict enough and didnt include cosmetics
1951 Durham Humphrey Amendment added more instructions for drug companies and required labeling to include "Caution" labels
1962 Kefauver-Harris Amendment enacted in an attempt to ensure safety of all new drugs on the market
1970 Comprehensive Drug Abuse prevention and control act formed to enforce the laws concerning controlled substances and their distribution
1970 Poison Packaging Prevention Act requires both manufacturers and pharmacies to place all medications in childproof caps
1983 Orphan Drug Act allowed companies to bypass lengthy time requirements of testing a new drug & the costs to provide meds to people with rare diseases
1987 Prescription Drug Marketing act requiring vets to write scripts for animals before owners could get the scripts
1990 Omnibus Budget Reconciliation Act pharmacist must offer to council at time of purchase to all patients that receive new meds
1996 Health Ins. portability and accountability act HIPPA privacy forms and requirements
2005 Combat Meth Act pseudoephederine not able to be sold OTC and only allowed to be purchased in now larger than 9g dose in a 30 day period or 7g if by mail
Tort causing injury to a person intentionally or due to negligence
C-I most addictive Ex. street drugs
C-II addictive EX. percocet,oxycodone,liquid cocaine
C-III combos EX. vicodin/acetemetophin, tyl/codeine
C-IV mentally addictive EX. valium,pheno,ativan
C-V not addictive EX. Robitussin with codeine
Created by: bryan6996
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