From Causality Assessment to Product Labeling
- PDF / 538,915 Bytes
- 8 Pages / 504 x 719.759 pts Page_size
- 108 Downloads / 181 Views
0092-8615197 Copyright 0 1997 Drug Information Association Inc.
FROM CAUSALITY ASSESSMENT TO PRODUCT LABELING MYLESDAVIDBUCKINGHAM STEPHENS, MD, FFPM, MRCGP, DRCOG, DMJ, DIP PHAM MED Pharmacovigilance Consultant, Hertfordshire, United Kingdom
Little is known about the process of converting the results of causality assessments of adverse medical events into labeling changes. A questionnaire was sent to heads of drug safety in 30 international pharmaceutical companies comprising 12 questions covering this area. There was a wide range of approaches to assessment and labeling decisions. Key Words: Causality assessment; Labeling; Signals; Data sheet
INTRODUCTION THERE HAVE BEEN MANY methods put forward for assessing adverse medical events associated with drugs (1). Some of these have been devised by practicing physicians, others by regulatory authorities, and several by those in the pharmaceutical industry. A survey carried out in 1989 showed how various regulatory authorities used a structured approach to causality assessment (2). Different groups use causality assessment methods for different purposes; but nothing has been published on how these assessments have been used to create signals, indicating that there is sufficient evidence for a labeling change.
METHODS A survey was carried out in 1995 of 30 major international pharmaceutical companies as to the methods that they used in this field. A questionnaire was sent to the companies and
Presented at the DIA Workshop ‘The Management of Adverse Drug Reactions-Diagnoses and Issues,” December 3-6, 1995, New Orleans, Louisiana. Reprint address: M.D.B. Stephens, 49, King’s Court, Bishop’s Stortford, Hertfordshire, CM23 2AB, United Kingdom.
if there was no reply a further questionnaire was sent. There were 25 questionnaires returned.
RESULTS Question #1: Are all adverse events (AE) assessed or only certain classes of AE? Eleven companies assessed all cases but one said that it did not assess AEs in a formal sense. Four companies only assessed cases when required by regulations. Individual comments include: 1. All serious AEs have a written assessment when required by regulations. All unlabeled events are scanned for pharmacological plausibility, 2. If there was an issue, for example, a cluster of events leading to an assessment for a label change (or not), 3. If a signal had been recognized, or 4.Not as a routine within the corporate safety division. 10 of the companies only certain classes of AEs were assessed: 1. serious unexpected AEs* 2. All postmarketing and serious AEs from
849 Downloaded from dij.sagepub.com at University of Manitoba Libraries on June 16, 2015
850
Myles David Buckingham Stephens
clinical trials. All AEs from clinical trials Four of the companies used other personnel: are assessed by means of group compari- two used pharmacists, one with spot checks by a supervisor and the other sometimes used sons, 3. Two companies assessed only serious an outside consultant. One of the remainder used scientists who were not Pharmacists or AEs, physicians
Data Loading...
