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CHAPTER

11

The Uppsala Monitoring Centre

The Uppsala Monitoring Centre (UMC) is a not-for-profit foundation that operates the WHO Programme for International Drug Monitoring and maintains both a drug dictionary, WHODrug Global, and a post-marketing safety database, VigiBase. A third UMC database contains WHO-ART, an adverse reaction terminology that is being sunset. The UMC also provides many research publications and services related to pharmacovigilance.

WHO Programme for International Drug Monitoring

Ten founding government safety organizations created the WHO Programme for International Drug Monitoring in 1968 following the thalidomide birth defect tragedy. To prevent recurrence of another such tragedy, the concept was to systematically collect spontaneously reported drug 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 Suspected reactions are coded with either MedDRA^® or legacy WHO-ART (A UMC coding terminology that is now largely out of date and is no longer maintained).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.