The Role of Systematic Reviews in Pharmacovigilance: A Case Study of Granulocyte-Macrophage Colony Stimulating Factor in
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THE ROLE OF SYSTEMATIC REVIEWS IN PHARMACOVIGILANCE: A CASE STUDY OF
GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR IN AIDS* SUSANDICKINSON Ross, MD, FRCPC MetaWorks Inc.. Boston, Massachusetts
Objective: To present a case study of the application of systematic review methods to the pharmacovigilance of drugs post-marketing. Background: The methods of systematic review are evolving as a tool for health care decision makers to assist with the comprehensive assessment of large amounts of information. As the methods have evolved, so have the applications increased. This paper covers an application of systematic review methods to the field of pharmacovigilance of drugs in the postmarketing phase. Methods: A systematic review of published literature addressing the safety of granulocyte-macrophage colony stimulating factor (GM-CSF) when used off-label in patients with HIV infection or AIDS is used. The methods applied to each step in the review are described to illustrate the general approach. Problems specific to this project, and those which are shared by all reviewers, are discussed along with the solutions. Conclusion: This case study serves: 1. Other reviewers, by sharing this experience with a relatively new application of systematic review methods; 2. Readers of reviews, by highlighting the pros and cons of these review methods in the context of a real application, and 3. Industry and regulatory decision makers, by demonstrating another approach to enhancing pharmacovigilance of new drugs post-marketing. Key Words: Systematic review; AIDS; GM-CSF; Adverse drug reaction reporting schemes; Postmarketing surveillance
occurrence of infrequently occurring adverse events. Such events are typically only recogto Food and nized after drugs are marketed in much larger Drug Administration (FDA) approval of new and more diverse populations of patients. drugs typically involve patient populations Furthermore, adverse events in patients rewhich are not representative of general popuceivmg drugs for unapproved ("off label") lations, and employ sample sizes which are indications may not be recognized as drugnearly always underpowered to detect the related at all, if not previously encountered in approved, labeled indications. The limitations of premarket safety data *Funded by Immunex Corporation, Seattle, WA. Meta- as well as the existing surveillance methods ad&ess: s, D, Ross, MD, FRcpc, works Inc.. 470 Atlantic Avenue, Boston, MA 02210. are apparent in the delays in risk detection E-mail: [email protected] which have been documented for several
INTRODUCTION
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cutaneous syndrome), phenformin (lactic acidosis), isoniazid (hepatitis), and recently, terfenadine (QT prolongation and ventricular arrhythmias when given in combination with itraconazole, ketoconazole, or erythromycin). It has been stated that the current system of reporting adverse events to the FDA (via FDA’s MedWatch
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