5 Written Questions
5 Matching Questions
- Food, Drug, and Cosmetic Act of 1938.
- The Joint Commission
- a a federal insurance program for persons over the age of 65 and qualified disabled or blind persons regardless of income
- b 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.
- c "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 "
- d Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.
- e Patient Package Inserts FDA requires to distribute PPI's to educate the pt about proper care and dangers of prescription drugs.
5 Multiple Choice Questions
- 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.
- Law regulating the manufacture, distribution, and sale of certain drugs or substances that have potential for abuse or physical and psychological dependence
- Used to help manufacturers to quickly get their drugs to market. Encourage manufacturers to conduct research for new uses of drugs and to submit new drug applications. (NDAs). To encourage drug manufacturers to perform pediatric studies of drugs.
- A record maintained by the nursing staff containing information about the patients medication and it's frequency of administration.
- A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
5 True/False Questions
Orphan Drugs → 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.
Drug Enforcement Agency → A federal agency established to implement the rules and regulations to enforce the Controlled Substances Act(CSA). To combat controlled substance abuse.
DEA-222 → Form required to order c-s I and II. Also need to transfer c-s I and II between pharmacies, and to returns to wholesaler or manufacturer. all DEA-222 come in triplicate.
OBRA → 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.
Kefauver-Harris Amendment → established two classes of drugs, over the counter (OTC) and prescription. And mandated that labels of prescription, drugs include the legend. Caution Federal Law Prohibits dispensing without a prescription.