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law and ethics
| Question | Answer |
|---|---|
| constitutional law | outlines the organization of federal govt, all states must comply with this law |
| statutes | laws passed by federal, state, or local legislatures |
| regulations | clarify and explain statutes |
| what does CMS stand for? | centers for medicare and medicaid services |
| what does FDA stand for? | food and drug administration |
| what does JCAHO stand for? | joint commission on accreditation of healthcare organization |
| what does OSHA stand for? | occupational safety and health administration |
| what does SBOD stand for? | state board of pharmacy |
| what was centers for medicare and medicaid services formerly known as | health care financing administration (hcfa) |
| what does cms do? | regulates the administration of federal healthcare programs and laws & conducts inspections to ensure compliance with guidelines |
| what does SCHIP stand for? | state children's health insurance program |
| what does HIPAA stand for? | health insurance portability and accountability act |
| what does CLIA stand for? | clinical laboratory improvement amendments |
| what does the DEA do? | regulates legal trade in narcotic and dangerous drugs, manages national narcotics intelligence system, and works with other agencies to support drug traffic prevention |
| who does the DEA share jurisdiction over drug offenses with? | federal bureau of investigation |
| what does the FDA do? | reviews/approves new drugs, generic equivalents, and therapeutic indications for existing medications; is responsible for the public health |
| what does the FDA assure safety of? | drugs, biological products, medical devices, food, and cosmetics |
| what does JCAHO do? | evaluates and accredits nearly 15,000 healthcare organizations and programs & establishes standards that improve quality and safety of healthcare organization |
| what does JCAHO evaluate and accredit? | hospitals, hospice facilities, nursing homes, long term care facilities, rehabilitation centers, and other healthcare organizations |
| what does OSHA do? | assures the safety and health of American workers by setting and enforcing protective standards; is a division of the US dept of labor |
| what is the state board of pharmacy | state agency that registers and regulates pharmacy facilities, pharmacists, and pharmacy technicians; is responsible for the actual practice of pharmacy within state domain and granted authority to take away licenses |
| what did the pure food and drug act of 1906 do? | provided for federal inspection of meat products, forbade the manufacture, sale, or transport of adulterated food products or poisonous plant medicine |
| why did the pure food and drug act of 1906 prove inadequate? | did not: cover cosmetics, provide the authority to ban unsafe drugs, prohibit false statements about drugs, and require labeling to identify product contents |
| what was the food, drug, and cosmetic act of 1938? | prompted by the sulfanilmide disaster of 1937, limited interstate commerce in drugs to those that are safe and effective, established the FDA, regulated labeling of drugs, and regulated who could prescribe legend drugs |
| durham-humphrey amendment of 1951 | aka the prescription drug amendment, required prescription drugs to bear the legend "caution: federal law prohibits dispensing without a prescription", later amendments substituted it to Rx only |
| kefauver-harris amendment of 1962 | prompted by the thalidomide disaster of 1962, aka the drug efficacy amendment, focused on accountability from drug manufacturers for the effectiveness of drugs |
| what also came from the kefauver-harris amendment of 1962? | manufacturers required to supply proof of effectiveness and safety, advertising of prescription drugs placed under supervision of the FDA, and established procedures for new drug applications |
| comprehensive drug abuse prevention and control act of 1970 | aka controlled substances act of 1970; combined all federal laws dealing with narcotics, stimulants, depressants, and abused designer drugs; established the DEA, and established the five classes for controlled drugs |
| occupational safety and health act of 1970 | ensures worker and workplace safety, requires employers to provide a workplace free from hazard such as: exposure to toxic chemicals, excessive noise levels, mechanical dangers, heat or cold stress, and unsanitary conditions |
| drug listing act of 1972 | amended the federal food, drug, and cosmetic act of 1938; required drug establishments to register their products with the FDA, assigned the national drug code |
| medical device amendment of 1976 | requires life-sustaining and life-supporting devices to have pre-market approval from the FDA |
| orphan drug act of 1983 | intended to stimulate the development of drugs for rare diseases (rare = 200,000 or fewer) |
| 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 | enacted to address certain prescription drug marketing practices |
| what do prescription drug marketing practices include? | distribution of free samples, use of coupons redeemable for drugs at no cost or low cost, and sale of deeply discounted drugs to hospitals and healthcare entities |
| what is a grey market? | an unofficial or unregulated market |
| anabolic steroid control act of 1990 | placed anabolic steroids into schedule III of the controlled substances act |
| what is an anabolic steroid as defined by the CSA? | any drug or hormonal substance chemically or pharmacollogically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth |
| what does OBRA '90 stand for? | omnibus budget reconciliation act of 1990 |
| what did OBRA '90 do? | focused on federal funding of medicare and medicaid, increased necessity for pharmacy technicians, and mandated that pharmacists perfrom drug utilazation reviews (DURs) and offer counseling to patients |
| dietary supplement health and education act of 1994 | defined dietary supplement and dietary ingredient, safety guidelines, ingredient and nutrition labeling, and granted FDA authority to est. good manufacturing price regulation |
| health insurance portability and accountabilty act of 1996 | ensure patient confidentiallity and privacy, patient right to view medical records, requires patient consent for transfer of records |
| what does HIPAA define protected health information as? | any info created or recieved by pharmacy, info relating to patient's health, info that may identify a patient |
| cmea | combat methamphetamine epidemic act of 2005; regulates retail OTC sales of ephedrine, psuedoephedrine, and phenylpropanolamine products |
| What is put into place in CMEA? | daily sales limits, 30 day purchase limits, placement of product out of direct customer access, sales logbooks, customer ID verification, and employee training |
| monographs | package inserts, necessary component of drug labeling, provides all clinical info required by FDA |
| components of a monograph | description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, drug abuse and dependence, adverse reactions, dosage, and how supplied |
| pharmacy techinican code of ethics | health and safety, respect and integrity, and profressional development |
Created by:
caseytessmer