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Pharmacy Law/Ethics
MxrI Chpt 2
| Question | Answer |
|---|---|
| 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 |