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1. Which of the following federal laws required drug manufacturers to show that drugs were safe prior to market entry:

A. Kefauver-Harris Amendments B. Federal Food, Drug, and Cosmetic Act C. Pure Food and Drug Act D. Federal Anti-Tampering Act

2. Which of the following laws gave the U.S. Food and Drug Adminstration (FDA) the authority to enforce Risk Evaluation Mitigation Strategy (REMS) programs:

A. Pure Food and Drug Act B. MedWatch C. FDA Amendments D. Fair Packaging and Labeling Act

3. Which of the following statements is NOT correct concerning medications requiring a MedGuide:

A. A MedGuide is required to be given to hospitalized patients each time the drug is dispensed B. A MedGuide is required if a patient requests one, regardless of the patient's location C. A MedGuide is not required every time a drug is dispensed to personnel in outpatient clinics D. A MedGuide is required to be given to a patient in the retail setting if the content of the medication guide is updated

4. Which of the following elements of a REMS program is designed for health care practitioners only:

A. MedGuide B. Communication plan C. Elements to Assure Safe Use (ETASU) D. Implementation plan

5. Which of the following elements may be part of an ETASU:

A. Communication plan B. Pharmacy registration C. Modification plan D. National Drug Codes

6. All of the following medications require prescriber registries, EXCEPT:

A. Accutane B. Clozaril C. Thalomid D. Plan B

7. All of the following statements regarding pseudoephedrine are true, EXCEPT:

A. It must be kept behind the counter in retail pharmacies B. 3.6 grams is the 24-hour limit for a single purchaser C. 10 grams is the 30-day limit for a single purchaser D. Some state laws require a prescription for pseudoephedrine

8. REMS programs are required to be assessed according to which of the following timetables:

A. 2 months, 12 months, 8 years B. 3 months, 16 months, 5 years C. 18 months, 3 years, 7 years D. 12 months, 4 years, 10 years

9. All of the following were recommendations made by American Pharmacists Association (APhA) stakeholders regarding improvements in REMS programs, EXCEPT:

A. Standardize REMS programs B. Incorporate REMS training into continuing education programs C. Maintain REMS programs that are inflexible D. Compensate REMS-required services

10. Manufacturers do which of the following to remind health care practitioners of MedGuide dispensing requirements:

A. Place bold lettering on the stock bottle B. Place colored symbols on the stock bottle C. Include MedGuides with the product packaging D. All of the above

Evaluation Questions

11. To what extent did the program meet objective #1?

A. Excellent B. Very Good C. Good D. Fair E. Poor

12. To what extent did the program meet objective #2?

A. Excellent B. Very Good C. Good D. Fair E. Poor

13. To what extent did the program meet objective #3?

A. Excellent B. Very Good C. Good D. Fair E. Poor

14. To what extent did the program meet objective #4?

A. Excellent B. Very Good C. Good D. Fair E. Poor

15. Rate the effectiveness of how well the program related to your educational needs:

A. Excellent B. Very Good C. Good D. Fair E. Poor

16. Rate how well the active learning strategies (questions, cases, discussions) were appropriate and effective learning tools:

A. Excellent B. Very Good C. Good D. Fair E. Poor

17. Rate the quality of the faculty:

A. Excellent B. Very Good C. Good D. Fair E. Poor

18. Rate the effectiveness and the overall usefulness of the material presented:

A. Excellent B. Very Good C. Good D. Fair E. Poor

19. Rate the appropriateness of the examination for this activity:

A. Excellent B. Very Good C. Good D. Fair E. Poor

20. Rate the effectiveness of how well the activity related to your practice needs:

A. Excellent B. Very Good C. Good D. Fair E. Poor

21. Rate the effectiveness of how well the activity will help you improve patient care:

A. Excellent B. Very Good C. Good D. Fair E. Poor

22. Will the information presented cause you to change your practice?

A. Yes B. No

23. Are you committed to making these changes?

A. Yes B. No

24. As a result of this activity, did you learn something new?

A. Yes B. No

25. What is your practice setting or area of practice?

A. Community Pharmacy/Independent B. Community Pharmacy/Chain C. Hospital/Health Systems D. Administrative/Pharmacy Director E. Critical Care Pharmacy F. Long-term Care G. Managed Care/PBM H. Oncology/Specialty Pharmacy I. Industry/Manufacturing

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