[U.S. Food and Drug  Administration]

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Clinical Impact of Adverse Event Reporting

This program is sponsored by the Center for Drug Evaluation and Research (CDER), Food and Drug Administration. CDER is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing medical education for physicians. The Center designates this program for 2 credit hours in Category 1 of the Physician's Recognition Award of the American Medical Association.

CDER is approved by the American Council on Pharmaceutical Education as a provider of continuing pharmaceutical education (ACPE Universal Program No. 601-000-96-091-H01). This program meets the ACPE criteria for .2 continuing education units (2 contact hours) in pharmaceutical education.

To receive certification on continuing medical education or pharmaceutical education credit, the participant must:

NOTE: This program expires on March 31, 1998

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Application For Continuing Education Credit

Name (including degree)
Type of Health Professional
City State Zip
Phone Number E-Mail

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Self Assessment Questions

Note: Do not submit this answer sheet if it was previously mailed or faxed. Continuing education credit for this article can be awarded only once. To check the status of your certificate, call or e-mail Gale White at (301) 443-0117.

1. Which of the following is not a known limitation of premarketing clinical trials?

a. Narrow population

b. Ability to detect common adverse events

c. Short duration

d. Small size

e. Narrow set of indications

2. Which of the following statements is FALSE?

a. Once a new medical product is marketed, the number of patients exposed to the product greatly increases

b. Premarketing clinical trials are conducted under controlled conditions in defined populations

c. The capability to detect adverse interactions with other medical products is generally enhanced once a new medical product is marketed

d. Once a new medical product is marketed, its initial labeling/product information remains unchanged

e. Differences between the premarketing and postmarketing environments make adverse event detection and reporting by health professionals very important

3. Which of the following statements is FALSE with regard to MedWatch?

a .Causality is a prerequisite for reporting an adverse event to MEDWATCH

b. Any adverse event that is fatal, life-threatening or requires intervention to prevent permanent impairment or damage meets MedWatch criteria for being considered serious

c. An increase in the reporting of serious adverse events is a MedWatch goal

d. The voluntary MedWatch form is to be used by health professionals in reporting adverse events related to all FDA-regulated medical products, except vaccines

e. Increasing understanding/awareness of health professionals regarding medical product-induced disease is a MedWatch goal

4. Which of the following products does NOT require FDA safety and efficacy review prior to marketing:

a. Prescription drugs

b. Biologics

c. Dietary Supplements

d. Over-the-counter (OTC) drugs

e. None of the above - they ALL require FDA safety and efficacy review prior to marketing

5. Which of the following represents an example of voluntary adverse event reporting?

a. User facility report of serious injury in a patient using a medical device

b. Quarterly periodic report from a manufacturer regarding a drug approved less than three years ago

c. Health professional report of a serious adverse event in a patient taking several different drugs

d. Manufacturer report of a serious and unexpected adverse event in a patient using a biologic

e. Health professional report of paralytic poliomyelitis occurring in a patient following vaccination against polio

6. All of the following are known limitations of spontaneous reports data EXCEPT:

a. Very costly to obtain

b. Lack of denominator data

c. Biases

d. Subjectivity of adverse event recognition

e. Underreporting

7. Which of the following statements is FALSE?

a. The importance of adverse event reports evaluation derives from the uncontrolled nature of spontaneously reported information

b. Literature searches and use of medical product utilization databases can be part of the adverse event reports evaluation process

c. Awareness of the limitations of spontaneous data is important in adverse event reports evaluation

d. Biological plausibility and strength of association are unimportant in adverse event reports evaluation

e. Full assessment of reported unlabeled serious adverse events is an important aspect of adverse event reports evaluation

8. All of the following are FDA actions that can result from careful analysis of spontaneous adverse event reports EXCEPT:

a. Conducting of further epidemiologic investigations

b. Requesting manufacturer-sponsored postmarketing studies

c. Changing labeling/product information

d. Working with the manufacturer on the issuance of a "Dear Health Professional" letter that outlines the serious safety issue involved

e. None of the above - ALL are actions the FDA can initiate in this regard

9. All of the following are known strengths of postmarketing surveillance systems based on spontaneous reports EXCEPT:

a. Hypothesis generation (signaling function)

b. Relatively immune to bias

c. Ongoing potential monitoring of all patients

d. Allow for major contributions by clinicians

e. Cost-effective in detecting rare, serious adverse events

10. All of the following are methods by which the FDA disseminates safety-related information to health professionals EXCEPT:

a. Work with manufacturers on the issuance of "Dear Health Professional" letters, Safety Alerts and Urgent Notices

b. Use of the MedWatch Partner program

c. Publications in the scientific literature

d. The MedWatch column in the FDA Medical Bulletin

e. None of the above - ALL are used by the FDA to inform health professionals of new safety information

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Program Evaluation

The article met the stated learning objectives:

Strongly Agree Agree Disagree Strongly Disagree Cannot Decide

The information presented is relevant to my clinical practice:

Agree Disagree

Please send me a free copy of The FDA Desk Guide for Adverse Event and Product Problem Reporting
(contains forms and instructions)

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