Uppsala Monitoring Centre

The Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. The UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance programs in regard to the benefits, harm, effectiveness and risks of drugs.[1]

Background

Since 1978, responsibility for managing the WHO Programme for International Drug Monitoring has been carried by the UMC. In the early years the staff consisted of just three pharmacists based at the Swedish Medical Products Agency (Läkemedelsverket); currently over 80 staff work in central Uppsala. The founding chairman and acting Director was Professor Åke Liljestrand. From 1990 to 2009 the Director was Professor Ralph Edwards.[2] Since September 2009 Dr. Marie Lindquist is the Director. The Chief Medical Officer is Dr. Pia Caduff and the Head of Research is Dr. Niklas Norén.

The work of the UMC is:

The main focus and source of data in pharmacovigilance are reports of ICSRs (individual case safety reports) from healthcare providers and patients in member countries of the WHO Programme. A WHO global individual case safety report database (VigiBase) is maintained and developed on behalf of the WHO by the UMC.[3] The UMC develops and provides several tools and classifications for use by organisations involved in drug safety, including the WHO Drug Dictionary, WHOART (adverse reaction terminology)[4] – with a bridge to the MedDRA terminology, tools for searching in the database, and a program for case report management, VigiFlow.[5]

The UMC's research covers mainly three areas: data-driven discovery (especially statistical techniques), dis-proportionality analyses, interaction detection, patterns and duplicate case detection), safety surveillance and signaling (among which drug dependence and pediatric use) and benefit—risk analysis.[6]

The centre has been active in presenting research in the medical literature which has included some seminal works in the field.[6] The Uppsala centre has also published books in the field of drugs safety including a regular newsletter.[5] In 2010 the 2nd edition of a crisis management guide was published, entitled 'Expecting the Worst'.[7]

The UMC's role in drug safety has not been without controversy for both medicines agencies and pharmaceutical companies, despite an open approach willing to engage with many parties in the pharmaceutical world. They are closely involved in outreach to developing countries and other areas where pharmacovigilance is not yet handled.[6]

WHO Programme key dates

See also

References

  1. Drug Benefits and Risks – International Textbook of Clinical Pharmacology (2nd edition). Van Boxtel C, Santoso B and Edwards IR, eds. IOS Press, Amsterdam, 2008.
  2. Spross Å. Uppsala leder forskning om biverkningar. Uppsala Nya Tidning, 28 December 2008.
  3. Lindquist M. Vigibase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal, 2008, 42:409–419.
  4. US National Library of Medicine, 2010 entry for UMC, retrieved 28 January 2014
  5. 1 2 Textbook of Pharmacovigilance (Chapter 11). Ed: SK Gupta. Jaypee Brothers Medical Publishers, New Delhi, 2011.
  6. 1 2 3 Telerx website; description and critique of the Uppsala Monitoring Centre, retrieved 28 January 2014.
  7. Clark D. Review: Expecting the Worst – a publication from the Uppsala Monitoring Centre. Drug Safety 2010; 33(12):1135–36.

External links

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