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PharmacyLaw&Ethics
| Question | Answer |
|---|---|
| statutes | laws passed by federal, state, or local legislatures |
| regulations | clarify and explain statutes. must be consistent with statute. have the same power and authority as statute. |
| legislative intent | the meaning of a law is based on its intent |
| criminal laws | crimes are considered harmful actions against society rather than an individual. (ex. State vs John Smith) |
| civil laws | plaintiff brings charges against defendant. parties in civil case may be individuals, corporations, or the state itself. harm Is caused to an individual, not society. |
| IRS | internal revenue service |
| OSHA | occupational safety and health administration |
| CMS | centers for medicare and Medicaid services |
| SSA | social security administration |
| misdemeanor | considered less serious in nature, punishable by community service, parole, a fine, or imprisonment for 12 months or less |
| felony | determined to be more serious; punishable by at least one year of imprisonment |
| DEA | drug enforcement administration |
| JCAHO | joint commission on accreditation of healthcare organization |
| HIPAA | health insurance portability and accountability act |
| CLIA | clinical laboratory improvement amendments |
| FBI | federal bureau of investigation |
| FDA description | reviews/approves new drugs and therapeutic indications for existing medications. responsible for protection public health. |
| FDA assures safety, efficacy and security of | drugs, biological products, medical devices, food, and cosmetics |
| JCAHO description | evaluates and accredits nearly 15000 healthcare organizations and programs. establishes and enforces standards that improve quality and safety of healthcare organizations. |
| JCAHO evaluates and accredits | hospitals, hospice facilities, nursing homes, long term care facilities, rehabilitation centers, and other health care organizations |
| CMS | centers for medicare and Medicaid services |
| OSHA description | assures the safety and health of American workers by setting and enforcing protective standards |
| SBOP | state board of pharmacy. |
| Pure Food and Drug Act of 1906 | provided for federal inspection of meat products. forbade the manufacture, sale, or transport of imure food products or poisonous patent medicines |
| Pure food and drug act failed because it didnt | cover cosmetics, provide the authority to ban unsure drugs, prohibit false statements about drugs, require labeling to identify product contents |
| food, drug and cosmetic act of 1938 | prompted by the sulfanilamide disaster of 1937. established the FDA |
| Durham-Humphrey amendment of 1951 | aka the prescription drug amendment. requires drugs to bear the legend "Caution: Federal law prohibits dispensing without a prescription" later Rx only |
| Kefauver-Harris amendment of 1962 | prompted by the thalidomide disaster of 1962. aka drug efficacy amendments. focused on accountability of drug manufacturers. established procedures for new drug applications. |
| Comprehensive drug abuse prevention and control act of 1970 | aka controlled substances act of 1970. established the DEA. established the five classes. narcotics, stimulants, depressants, and abused designer drugs |
| occupational safety and health act of 1970 | ensures workers and workplace safety |
| drug listing act of 1972 | requires drug establishments to register their products with the FDA. National drug code |
| medical device amendment of 1976 | medical devices must have premarket approval by the FDA |
| orphan drug act of 1983 | stimulate the development of rare diseases. |
| rare disease | affects 200000 people or fewer |
| orphan drug act of 1983 three incentives | seven-year market exclusivity, tax credit of 50%, and federal research grants |
| drug price competition and patent term restoration act of 1984 | aka hatch-Waxman act. established modern system of generic drugs |
| prescription drug marketing act of 1987 | free samples, coupons, deeply discounted drugs |
| grey market | unofficial or unregulated market |
| anabolic steroid act of 1990 | any drug or hormonal substance chemically related to testosterone that promotes muscle growth |
| omnibus budget reconciliation act of 19990 (OBRA '90) | federal funding of medicare and Medicaid. increased necessity for pharmacy techs. |
| DURs | drug utilization reviews |
| dietary supplement health and education act of 1994 | required ingredient and nutrition labeling |
| GMP | good manufacturing practice |
| combat methamphetamine epidemic act of 2005 (CMEA) | regulates over-the-counter sales. daily sales limits, 30 say purchase limits, placement of product out of direct customer access, sales logbooks, customer ID verification, employee training |
| monograph | package inserts. description, warnings, dosage clinical pharmacology, precautions, how supplied, indications and usage, drug abuse and dependence, contraindications, and adverse reactions. |
| fidelity | keeping a promise |
| veracity | telling the truth |
| beneficence | bringing about good |
| justice | acting with fairness or equity within the law |
| autonomy | acting with self reliance |
| consequentialism | all actions should bring about the greatest good to the greatest number of people |
| nonconsequentialism | some actions cannot be justified because they are inherently wrong, regardless of the outcome |
Created by:
SpecialK1942
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