Globalization of the Safety Sections of the Periodic Safety Update Report
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0092-8615/99 Copyright G 1999 Drug Inforniation Association Inc.
GLOBALIZATION OF THE SAFETY SECTIONS OF THE PERIODIC SAFETY UPDATE REPORT STEPHENL. KLINCEWICZ, DO, MPH, JD Medical Director, Zeneca Inc., Wilmington. Delaware
JOHN A. CLARK,RPH, MD, MSPH Vice President. Medical Informatics, MicroAnalytica,
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BAKRYD. C. ARNOLD,MD Head. Drug Safety. 7xneca PLC. Alderly Park. United Kingdom
EDMUNDO N. MUNIZ,MD, PHD Director. Global Pharmacovigilance. Eli Lilly and Company. Indianapolis, Indiana
MARKK. BLAKE,MS Manager. Drug Safety Data Systems. Zeneca Inc.. Wilmington. Delaware
The recent implementation qf the International Conference on Harmonization S E2C Guidelines was c m important step towcird globalizing the activities gf drug safety departments. While many details have trot yet been addressed, the prirnary objective of this initiative is clear: the preporation and worldwide submission of standardized periodic reviews of a marketed product S sqfety record. This article presents a strategy f o r integrating surveillance ac'tilities and epidemiological principles into periodic safety update reporting (PSUR), while l i t the same time meeting the regulatop requirements set forth in the ICH E2C Guidelines. A stepwise approach to PSUR compilation. interpretations of critical subsections qf the ICH E2C Guidelines, and issues unique to the United States reporting ent!ironment are discussed. Kev Words: Periodic safety update reports: International Conference on Harmonization; Pharmacoepidemiology: Adverse event signaling; Postmarketing surveillance
INTRODUCTION AS A RESULT OF RECENT initiatives by the International Conference on Harmonization (ICH), many regulatory authorities have agreed in principle to accept identically formatted information about the safety of marketed pharmaceuticals. The precepts embod-
Reprint address: Stephen L. Klincewicz. Zeneca Pharnlaceuticals, 1800 Concord pike, PO B~~ 153.77. wil. rnington. DE 198XL5437.
ied in one such harmonized document, the ICH E2C Guidelines (l), suggest that in the future, periodic safety update report preparation will play an expanded role in the drug surveillance process. As discussed below, use of the PSUR as an instrument for focusing globally-oriented, drug-specific adverse event (AE) surveillance programs can improve resource allocation for significant issues, can create a coherent structure for safety reviews, and can provide a coordinated framework for labeling initiatives.
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S. I.. Klincewicz. J . A. Clark, B. I). C. Arnold, E. N. Mioiiz. cind M. K . Blake
For PSUR-focused AE surveillance to be effective, the PSUR compilation process will need to integrate several sometimes conflicting perspectives: public health surveillance principles, pharmacoepidemiologic analysis, specialized medical judgment, data management skills. regulatory decision making and legal considerations. As a result, from the United States viewpoint in particular, adoption of the ICH E2C Guidelines implies a change from an historically narrow set of data-driven procedur
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