CIOMS Working Groups and their Contribution to Pharmacovigilance

CIOMS Working Groups and their Contribution to Pharmacovigilance

INTRODUCTION

The term ‘CIOMS’ is in daily use in international pharmacovigilance departments. For example, CIOMS forms are used for expedited case reporting, CIOMS line listings are used for presenting groups of cases, and CIOMS frequency definitions are used in product information labelling. The aim of this chapter is to describe who or what CIOMS is and to examine the contributions that the individual working groups have made to present-day pharmacovigilance practice.

The Council for International Organisations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organisation which was established in 1949 under the auspices of the World Health Organisation (WHO) and the United Nations Educational, Scientific and Cultural Organisation (UNESCO). It is responsible for the collection and dissemination of informed opinion on new devel-opments in biology and medicine, and exploring their social, moral, administrative and legal impli-cations. In 1977 it was recommended that CIOMS should facilitate discussions between national regu-latory authorities and pharmaceutical companies on policy matters by providing an independent forum. It also convenes groups of experts to make recommen-dations on specific topics when appropriate.

In 1986, CIOMS set up the first pharmacovigilance working group to discuss international reporting of adverse drug reactions (ADRs). By the end of 2005, six further working groups had completed recommen-dations and suggested guidelines for harmonisation of various aspects of pharmacovigilance (Table 23.1).

CIOMS drug safety working groups are composed of pharmacovigilance specialists from regulatory agencies and pharmaceutical manufacturers princi-pally from North America and Europe. Historically, members were selected for their personal expertise and contributions rather than to represent specific organisations. Observers from organisations such as the WHO and the International Federation of Phar-maceutical Manufacturers Association (IFPMA) are also invited. The size of the groups has usually been restricted to 20–30 members to ensure opti-mum discussion and completion of tasks. Consid-erable overlap of membership between consecutive working groups has enhanced productivity. Consulta-tion with various specialists has also occurred when appropriate.

Each working group is co-chaired by a member from a regulatory agency and a pharmaceutical manu-facturer. Win Castle deserves particular mention for co-chairing all the working groups until her retire-ment in 2000. Her enthusiasm, determination and hard work often provided the impetus necessary for the successful completion of each initiative.

As the CIOMS working groups have no legal juris-diction, reliance is placed on other bodies to incor-porate the CIOMS recommendations and guidelines into a regulatory or legislative framework. For exam-ple, the International Conference on Harmonisation (ICH) has progressed the CIOMS initiatives on expe-dited and electronic reporting as well as having used the CIOMS II recommendations as the basis for the requirements for periodic safety update reports (Table 23.2). The ICH process is based on five steps:

• Step 1 – Technical discussion by the Expert Working Group who produce a preliminary draft document;

• Step 2 – The consensus text is released for a 6-month period of consultation;

• Step 3 – Formal consultation outside ICH;

• Step 4 – Sign off of finalised text;

• Step 5 – Implementation.

Therefore, Step 4 is the stage at which the document is finalised and released with the intention that the countries represented by the ICH (Europe, the United States and Japan) will incorporate the requirements into their local legislation and regulations.

The acceptance, adaptation and utilisation of CIOMS principles by other bodies will be discussed later in this chapter.