Successful completion of “The emergence of REMS and its impact on specialty pharmacy” (401-000-10-001-H03-P) is worth one contact hour of credit. Mail completed answer sheet found in this issue to DrSN/Pharmacy Practice, P.O. Box 31180, Tampa, FL 33631-3180. For faster service, fax to (813) 626-7203. For fastest service, visit our Web site at CEdrugstorenews.com.

1. What does the acronym REMS
stand for?
a. Risk evaluation and
management systems
b. Risk emerging
management systems
c. Relative emerging
medical systems
d. Risk evaluation and
mitigation strategies

2. What is the name of the federal law granting REMS authorities to the Food and Drug Administration? a. OBRA-90

b. Federal Food, Drug and Cosmetic Acts (FFDCA)

c. ICH-2004

d. Food and Drug Administration Amendments Act of 2007 (FDAAA)

3. REMS can only be applied to drugs
approved after 2007.
a. True
b. False

4. What is the name of one drug
governed by REMS?
a. Crixivan
b. Prilosec
c. Tysabri
d. None of the above

5. RiskMAPs replaced REMS under
the FFDCA.
a. True
b. False

6. What element noted below is not part of federally mandated REMS? a. Medication guide b. Communication plan c. Elements to assure safe use d. Package insert

7. Medication guides are extensions of the directions in the package insert that seek to address: a. Dosing and administration b. Potential adverse events c. Safe use of the drug d. All of the above

8. A performance linked access system often is required under what element of REMS? a. Medication guide b. Communication plan c. Elements to assure safe use d. Package insert

9. Distribution and dispensing is monitored MOST often through: a. Medication guide use b. Communication plans c. Implementation systems d. The FDAAA

10. Restricted distribution is MOST often used for what type of drugs under REMS?

a. Oral medications for peptic ulcer
b. Oral medications used for
treatment of cancers
c. Parenteral medications used for
treatment of cancers
d. Parenteral medications requiring a
patient registry