We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Commentary |

Drug-Related Adverse Events A Readers' Guide to Assessing Literature Reviews and Meta-analyses

Susan D. Ross, MD, FRCPC
Arch Intern Med. 2001;161(8):1041-1046. doi:10-1001/pubs.Arch Intern Med.-ISSN-0003-9926-161-8-icx00012.
Text Size: A A A
Published online


IN THE SETTING of increasing concern about drug safety and a burgeoning literature on the subject, the objective of this article is to provide readers with a practical guide to critically appraising reviews and meta-analyses of source studies of drug-related adverse events. A critique of a recent highly publicized meta-analysis of adverse drug reactions is used as a case study here to highlight several contentious issues. The published literature on drug-related adverse events is fraught with problems, starting with the original reports and extending to systematic reviews and meta-analyses thereof. A fundamental and universal taxonomy does not exist. For original reports, prospective protocols are missing; event ascertainment is poorly described and executed; and analytic methods are questionable and lead to problems of imprecise estimates, multiple correlations, and generalizability of results. It is recommended that for reviews and syntheses of original reports, explicit search methods and study selection criteria are needed. Special attention must be paid to choice of analytic methods; to approaches to inconsistent reporting formats and heterogeneity and bias in the selected studies; and to problems of imprecise estimates, multiple correlations, and interpretation and generalizablility of results. In conclusion, systematic reviews and meta-analyses of reports of drug-related adverse events must be considered, with special attention to source materials and methods. It is well worth the effort to do so, since, on balance, systematic review and meta-analytic techniques hold great promise for pharmacovigilance efforts.

Figures in this Article

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview


Place holder to copy figure label and caption

MEDLINE citation counts.

Graphic Jump Location




Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

27 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles

The Rational Clinical Examination: Evidence-Based Clinical Diagnosis
Original Article: Does This Patient Have Bacterial Peritonitis or Portal Hypertension? How Do I Perform a Paracentesis and Analyze the Results?

The Rational Clinical Examination: Evidence-Based Clinical Diagnosis
Make the Diagnosis: Lumbar Puncture to Diagnose Bacterial Meningitis