NOTE: This program expires on December 31, 1996

Self-Assessment Questions

1. Postmarketing drug surveillance is important because premarketing clinical trials are

a. not able to detect ADEs that occur rarely

b. not able to detect ADEs with long latency periods or those that occur with chronic therapy

c. not able to predict all potential drug-drug interactions

d. all of the above

2. In most cases premarketing clinical trials cannot detect adverse drug events that occur less frequently than

a. 1 case in 10 patients (10% incidence rate)

b. 1 case in 100 patients (1% incidence rate)

c. 1 case in 1,000 patients (0.1% incidence rate)

d. 1 case in 10,000 patients (0.01% incidence rate)

3. Which of the following statements about the clinical pharmacology of ADEs are false:

a. if rechallenge with a drug suspected of having caused an ADE does not produce the ADE in question, it is safe to conclude that the ADE and drug are not associated

b. an ADE can result when two drugs used for two different indications compete for the same metabolic pathway, such as terfenadine and ketoconazole

c. patient factors such as renal or hepatic function can have major impact on the development of an ADE

d. an ADE can result at the same dose in one patient and not in another because of genetic differences in the rate of metabolism

4. Which of the following does NOT represent pharmacokinetic variation among individuals?

a. differences in the rate of absorption

b. differences in the distribution of a drug

c. differences in the elimination rate

d. differences in response at a given drug plasma level

5. Which of the following represents an example of pharmacodynamic variation among individuals?

a. there may be anywhere from a 10-30 fold interindividual difference in the serum blood levels achieved with the same dose of a drug

b. elderly patients can often be more sensitive to adverse events, even at the same steady-state blood levels for a drug, than younger patients

c. differences in creatinine clearance between individuals may necessitate use of different doses of a renally-cleared drug to achieve the same steady-state blood level

d. differences in the rate of drug metabolism between fast and slow metabolizers in the hepatic P450 (CPY2D6) system

6. Which of the following describes a Type A (predictable) adverse drug event?

a. usually dose-dependent and an extension of the known pharmacology of the drug

b. high incidence

c. most are identified prior to marketing and listed in a product's labeling

d. all of the above

7. Which of the following does NOT describe a Type B (unpredictable) adverse drug event?

a. frequently detected during premarketing clinical trials

b. occur rarely and are usually unavoidable

c. generally independent of dose and route of administration

d. usually the most serious and life-threatening of all ADEs

8. Which of the following rare events are known to often be drug-induced?

a. hepatic failure

b. thrombocytopenia, hemolytic anemia, agranulocytosis, and aplastic anemia

c. erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis

d. all of the above

9. Of the following, which would be of important consideration in assessing a patient for an ADE?

a. time course on the suspected agent

b. knowledge of the patient's complete drug history, including nonprescription drugs

c. previous exposure to the suspected agent

d. all of the above

10. Which of the following does NOT apply when reporting ADEs to the FDA MEDWATCH program?

a. Only serious ADEs should be reported [i.e., if the patient outcome is death, life-threatening, hospitalization (initial or prolonged), disability, congenital anomaly, or if medical or surgical intervention was required to prevent permanent damage]

b. causality need not be proved before submitting a report to the FDA

c. all ADEs, serious or otherwise, detected through a JCAHO required hospital ADE monitoring system should be reported to the FDA

d. ADEs may be reported to the FDA through the manufacturer who is required by federal regulation to send them to the Agency

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)

Yes No

Your comments, please

Or mail a hard-page copy to:

or Fax to: