5 Written questions
5 Matching questions
- Food, Drug, and Cosmetic Act of 1938.
- Federal versus state drug control laws.
- The patients Bill of Rights
- The Controlled Substances Act of 1970
- The Orange Book
- a The federal statute through which the FDA promulgates its rules and regulations. No new drug could be marketed unless it was proven safe for use.
- b A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
- c Pharmacist are equally responsible for compliance with both Federal and State laws. If the federal law or regulation is more stringent then comparable state law, the more stringent law must be followed.
- d FDA published the Approved Drug Products with Therapeutic Equivalence Evaluations
- e Law regulating the manufacture, distribution, and sale of certain drugs or substances that have potential for abuse or physical and psychological dependence
5 Multiple choice questions
- Are used to treat relatively rare diseases. A rare disease is one that effects less then 200,000 persons or that the cost of developing it could not be made back from sales of the drug.
- A voluntary prescription drug benefit to medicare.
- "A private, voluntary, not-for-profit organization that evaluates and accredits hospitals and other healthcare organizations on the basis of predefined performance standards; formerly known as The Joint Commission on Accreditation of Healthcare Organizations or JCAHO "
- National Drug Code Number is required on all o-t-c and prescription drug labels. 11 numbers. The first 5 id the manufacturer or distributor. The last 6 id the drug name package size and type of drug.
- Recognized standards that are similar to laws.
5 True/False questions
OSHA → Omnibus Budget Reconciliation Act of 1990. Mandated three main provisions. Drug manufacturers provide the lowest price to medicaid patients. That drug review and patient counseling are now mandated.
Drug Enforcement Agency → Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)
Food Drug and Cosmetic Act → The federal statute through which the FDA promulgates its rules and regulations. No new drug could be marketed unless it was proven safe for use.
PHI → Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.
OBRA → Occupational Safety and Health Administration (1970). Was created to decrease hazards in the work place.