Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

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safety information from around the world regarding the harm caused by medicines.

      Since 1978, the programme has been managed by the UMC from Uppsala, Sweden, and today over 150 government drug safety organizations participate in the network, along with the WHO in Geneva, and the UMC.

      UMC is one of the five WHO collaborating centers in the network. Member countries submit domestic suspected serious and non-serious adverse reactions electronically to VigiBase at UMC. Suspected reactions are coded with either MedDRA^® or legacy WHO-ART (A UMC coding terminology that is now largely out of date and is no longer maintained). However, enhanced capabilities for VigiFlow, the interface for electronic reporting to VigiBase, were introduced in 2017 and require MedDRA-coded adverse reactions. Fortunately, a one-way “cross-walk” is available for conversion of WHO-ART terms to MedDRA. Consistent with legislation, the interface also accommodates direct reporting from healthcare professionals, public health programs, patients, and the pharmaceutical industry. As of 2018, VigiBase contained more than 15 million reports of suspected adverse reactions for marketed medicines, including vaccines. Importantly, UMC has developed vigiMatch, an automatic algorithm in VigiLyze that has been available since early 2017 for detection of suspected duplicates in VigiBase. vigiMatch uses a statistical model that scores pairs of reports, taking into account the amount of matching and mismatching information. This is a complex system and much more information is available from the UMC.

Key Functions of UMC

      Maintenance of an international safety database, VigiBase, and interaction with contributing member states.

      Identification and analysis of aggregate data looking for new safety signals from VigiBase, primarily via a data mining tool, VigiLyze.

      Information exchange between WHO and national pharmacovigilance centers, mainly through “VigiMed,” a restricted Internet forum set up in 1997 for rapid e-mail information exchange on pharmacovigilance matters. This is not generally available to the public or industry.

      Publication of periodic newsletters (e.g., “Uppsala Reports”), guidelines, and books on the topics of pharmacovigilance and risk management. Some are available in languages other than English. Some are available at no charge, others not so.

      Supply of tools for management of clinical information, including adverse drug reaction case reports. The main product is the WHO Drug Dictionary (UMC formerly provided and maintained the WHO Adverse Reaction Terminology (WHO-ART)). This terminology is no longer being maintained, but government agencies may obtain a legacy copy from UMC by special request).

      Training and consulting support to national centers and countries for establishing and helping pharmacovigilance systems mature.

      Computer software for case report management, designed to suit the needs of national centers and consistent with the enhanced VigiFlow electronic interface.

      Annual meetings for representatives of national centers, at which scientific and organizational matters are discussed.

      Methodological research for the development of pharmacovigilance as a science, particularly in resource-constrained settings, but also customized research to complement mature pharmacovigilance systems (at a fee).

      Publication of scientific articles in pharmacovigilance. Note that all scientific papers by UMC authors have been freely available online at no charge since 2015 (www.who-umc.org).

      The UMC has played a major role in the development and propagation of the concepts and techniques of pharmacovigilance, particularly in less developed countries. For many years, it was a lone international voice. It has now been joined by others to advance the field of pharmacovigilance. The key publications on its website are well worth reviewing.

       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:

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