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PharmacyLaw&Ethics

QuestionAnswer
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