5 Written questions
5 Matching questions
- State board of pharmacy.
- Orphan Drugs
- Food Drug and Cosmetic Act
- Pure Food and Drug Act of 1906
- a Body established to ensure that the public is well served professionally by pharmacist.
- b Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)
- c 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.
- d Patient Package Inserts FDA requires to distribute PPI's to educate the pt about proper care and dangers of prescription drugs.
- e This law was passed by congress because of the concern about the risks to public health and safety associated with unsanitary and poorly labeled foods and drugs.
5 Multiple choice questions
- Promulgates rules and regulation and standards; inspects drug and food facilities to ensure public safety regarding drug products.
- An amendment to the federal food and cosmetic act that required all new drugs marketed in the united states to be shown to not only safe, but effective.
- Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.
- A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
- 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.
5 True/False questions
The Joint Commission → "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 "
NDC → 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.
Food and drug Administration modernization Act of 1997. (FDAMA) → 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.
The Orange Book → FDA published the Approved Drug Products with Therapeutic Equivalence Evaluations
Prospective Drug Review → 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.