The CIOMS III Criteria for Labeling Changes: A Survey at Schering-Plough
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THE CIOMS I11 CRITERIA FOR LABELING CHANGES: A SURVEY AT SCHERING-PLOUGH BARTON L. COBERT, MD, FACP, FACG Senior Director, Medical and Safety Services, Schering-Plough Research Institute, Kenilworth, New Jersey
The Council for International Organizations of Medical Sciences (CIOMS) III working group has published a report attempting to harmonize and set criteria for drug labeling, The group identified and ranked 39 criteria to determine the thresholdfor adding adverse events to the labeling of marketed drugs. A survey was taken in several departments of the Schering Corporation to determine whether these criteria would be ranked in a similar manner. The results showed that there was a high degree of correlation in the rankings (0.79) with the greatest correlation being seen in the drug safety groups both in the United States-based home ofice (0.88) and in the non-United States subsidiaries (0.74). It is concluded that there is a large degree of agreement between the criteria for addition of adverse events to product labeling proposed by the CIOMS group and at least one major pharmaceutical company. Key Words: CIOMS; Adverse events; Labeling; Core safety information
INTRODUCTION IN MOST COUNTRIES WHERE pharmaceutical products are marketed, there are regulations concerning the content of the product labeling. In the United States (1) and elsewhere, these requirements are extensive. Until recently there has been little or no guidance on which adverse eventdadverse drug reactions (AEs/ADRs) a label should contain and when a label should be changed to add postmarketing adverse events/reactions to it (2,341. In 1995 the Council for International Organizations of Medical Sciences published the “Report of CIOMS Working Group 111” (5) which attempted to harmonize and set criteria for the Core Safety Information (CSI)
and Core Data Sheets (CDS) that companies prepare for drugs. The group: “identified 39 relevant factors or criteria that may be useful in determining the threshold for adding an adverse event to the CSI and ranked them in order of importance” (5). These criteria are listed in Table 1 in column 1 along with the rankings in order of importance that the CIOMS members voted (column 2). In an attempt to gain better insight into the general level of acceptance of these concepts, a survey of employees at a large American pharmaceutical company was performed. This survey asked participants from various divisions within the company to rank the criteria in priority order.
MATERIALS AND METHODS Reprint address: Barton L. Coben. MD. FACP, FACG, Senior Director, Medical and Safety Services, ScheringPlough Research Institute, 2000 Galloping Hill Road, Mail Stop K6-1-1310, Kenilworth, NJ 07033.
The 39 CIOMS criteria were randomly scrambled and distributed to 144 professional employees of the Schering Plough Corporation in the United States and abroad
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TABLE 1
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