Is that Adverse Experience Really Expected? Guidelines for Interpreting and Formatting Adverse Experience Information in
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Drug Information Journal, Vol. 35, pp. 269-284, 2001 Printed in the USA. All rights reserved.
IS THAT ADVERSE EXPERIENCE REALLY EXPECTED? GUIDELINES FOR INTERPRETING AND FORMATTING ADVERSE EXPERIENCE INFORMATION IN THE UNITED STATES KRISTINA
BROWN,RPH
Safety Policy Consultant
R. SCOTTSYKES,MD Vice President
GEORGEPHILLIPS, PHARMD Director, Product Surveillance Operations North American Product Surveillance, Glaxo Wellcome, Inc., Research Triangle Park, North Carolina
What is an “expected” or “labeled” adverse reaction versus an “unexpected” or “unlabeled” adverse event or experience? Unfortunately, present guidelines that assist with this assessment are not well defined, thus creating ambiguity in their interpretation and application. In an attempt to establish a definitive framework for assessing “expectedness ” or “labeledness,“formalized guidelines for interpreting and formatting safe9 information have been drufied. Although this article is written from a United States regulatory perspective. many of the guidelines can be applied globally. Key Words: Adverse experience; Adverse reaction; Drug safety; Expected experience; Labeled experience
INTRODUCTION UNITED STATES REGULATIONS and guidelines provide some assistance to the health care professional toward determining whether a given adverse experience is “expected” or “unexpected” when compared against the appropriate reference document. However, much of the assessment is left to individual judgment or personal opinion. The Food and Drug Administration (FDA) also
Reprint address: George Phillips, Glaxo Wellcome, Five Moore Drive, Po Box 13398, Research Triangle Park, NC 27709-3398, E-mail:gcp2818@glaxowellcome.
com.
recognizes the lack of a standardized approach in making the assessment of “expectedness.” In the 1997 amendment to the United States expedited safety reporting regulations for human drugs and biological products, the following citation from the International Conference on Harmonization (ICH) E2A guideline appears: The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of new, important information on serious reactions. Therefore, such reporting will generally involve events previously unobserved or undocumented, and a guideline is needed on how to define an event as “unexpected” or “ex-
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pected” (expectedunexpected from the perspective of previously observed, not on the basis of what might be anticipated from the pharmacological properties of a medicinal product) (1).
This article will hopefully be of value with regards to the interpretation and formatting of adverse experience information in reference documents such as clinical investigator’s brochures, company core safety information (CCSI), or local prescribing information. The overall objective is to encourage companies to establish a defensible approach, and achieve a greater degree of consistency in determining the “expectedness” or “unexpectedness” of a given adverse
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