An Algorithmic Approach to Incorporating the Ich E2A Guidelines Into Safety Department ADR Reporting in the United State
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Drug I n f o m i i o n Journal. Vol. 33. pp. 817-885. 1999 Printed in the USA. All rights reserved.
Copyright 0 199Y Drug Information Association Inc.
AN ALGORITHMIC APPROACH TO INCORPORATING THE ICH E2A GUIDELINES INTO SAFETY DEPARTMENT ADR REPORTING IN THE UNITED STATES STEPHEN L.
KLINCEWICZ,
DO, MPH, JD
Medical Director, Zeneca, Inr.. Wilmington, Ilelaware
NANCYA. WOOLPERT Quality Assurance Analyst. Zeneca, Inc., Wilmington, Delaware
MARKK. BLAKE Manager. Drug Safety and Ilata Systems. Zrneca. Inc.. Wilmington, Delaware
BARKYD. C. ARNOLD,MD Global Head. Drug Safety, Zeneca, PLC. Alderly Park. United Kingdom
JOHN A. CLARK, RPH, MD, MSPH Medical Director. Stuart Disease Management Services, Wilmington. Delaware
Multiple reudings of rhe hiternationol Conference on Harmonizution (ICH) guidelines f o r the reporting vf udverse drug reuctions, the current United States regulations, and the recent Food arid Drug Administratin ( F D A ) guidunce f o r i n d u s t v may provide more questions thun nnswers. In an attempt t o provide some structure into operating under the new adverse event reporting requirements. Zpnecu has prepared n series of algorithms to assist in processiti~qsuspected adverse drug reaction reports. These ulgorithms should be used for guidance purposes only. Key Words: Adverse drug reactions; Algorithms; Reporting requirements
WITH THE IMPLEMENTATION of the recent International Conference on Harmonisation (ICH) guidelines for the reporting of adverse drug reactions (ADR). many companies continue to change their standard operating procedures (SOPS)and training to incorporate these new guidelines. While the harmonization efforts progress on a de facto
Reprint address: Stephen I.. Klincewicz. Zeneca Pharrnaceuticals. 1800 Concord Pike. P.O. Box 15-137. Wilmington DE 19850-5437.
basis, reporting requirements in the United States continue to be governed by the Food and Drug Administration (FDA) regulations which are primarily found in 21 C.F.R. 314. 80 and 3 12.32. Multiple readings of the ICH guidelines, the current United States regulations, and the recent FDA guidance for industry (1) may provide more questions than answers. Nevertheless, in an attempt to provide some structure into Operating under the new adverse event reporting requirements, Zeneca has prepared a series of algorithms to assist in
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S. Id. Klincewicz, N. A. Woolpert, M. K. Blake. R. D. C. Arnold, and J . A. Clark
processing suspected ADR reports (Figures 1-7). Many of these algorithms are based on the original reporting algorithms prepared by the FDA in 1988 (2) which were useful in the decision making process to determine event reportabil i ty. We have found these algorithms to be helpful during orientation of new staff mem-
bers in the Drug Safety Department and for communicating reporting requirements to investigators and other staff whose job functions do not directly involve safety reporting responsibilities. Where appropriate, annotat
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