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CHAPTER

12

Council for International Organizations of Medical Sciences

This chapter summarizes the functions of the Council for International Organizations of Medical Sciences (CIOMS) and the reports issued by working groups created by CIOMS. These reports have been crucial for the International Council on Harmonization (ICH) and the development of safety regulations in North America, Europe, Japan, and elsewhere. They are worth reviewing. Keep in mind that not all proposals from the CIOMS reports were adopted, and those that were adopted were not necessarily adopted directly and without change by ICH and national regulatory authorities.

Introduction

From the CIOMS website: “CIOMS is an international, non-governmental, non-profit organization established jointly by World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949.” The membership of CIOMS includes 60 international member organizations, representing many of the biomedical disciplines, national academies of sciences, and medical research councils. The main objectives of CIOMS are as follows:

To facilitate and promote international activities in biomedical sciences, especially when the participation of several international associations and national institutions is deemed necessary;

To maintain collaborative relations with the United Nations and its specialized agencies, in particular with WHO and UNESCO;

To serve the scientific interests of the international biomedical community in general.

CIOMS has several long-term programs, including one on drug development and use. Starting in the early 1980s, working groups composed of experts from industry and governments have been examining key issues in drug safety. They have issued many reports, several of which have served as seminal documents for procedures and regulations that ICH, the US. Food and Drug Administration (FDA), the European Union, Japan, and other drug safety authorities have issued. The key documents are summarized in the following sections.

CIOMS I (1990): International Reporting of Adverse Drug Reactions

The goal of this working group was “to develop an internationally acceptable reporting method whereby manufacturers could report post-marketing adverse drug reactions rapidly, efficiently, and effectively to regulators”. It noted the fact that post-marketing surveillance is necessary because pre-marketing studies in animals and humans have “inherent limitations”. It noted the need for standardization internationally.

The report established several conventions that have largely been adopted, including the following:

The concept and format of a report (“a CIOMS I report”) from the manufacturer receiving the event to the regulators.

“Reactions” are different from “events”. “Reactions” are reports of clinical occurrences that have been judged by a physician or healthcare worker as having a “reasonable possibility” that the report has been caused by a drug. “Events” have not had a causality evaluation made, and thus may or may not be related to or associated with the drug.

Causality is discussed. No particular method of assessing causality is recommended. The report recommends that manufacturers not separate out those spontaneous reports that they receive into those that seem to be drug-related and those not seemingly drug-related. The physician, by voluntarily making the report to the manufacturer, indicates that there is some level of causality possible in the report. This is a “suspected reaction”. This has become a fundamental concept in most spontaneous reporting systems around the world, wherein all spontaneous reports from physicians (now extended to all healthcare providers, and in most countries, such as the United States and Canada, to consumers) are to be considered possibly related to the drug; that is, they are “reactions”, not “events”.