Uppsala Monitoring Centre
Encyclopedia
The Uppsala Monitoring Centre (the 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 regards to the benefits, harm, effectiveness and risks of drugs.
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 60 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. Since September 2009 Marie Lindquist is the Director.
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. The UMC develops and provides several tools and classifications for use by organisations involved in drug safety, including the WHO Drug Dictionary, WHO-ART (adverse reaction terminology) - with a bridge to the MedDRA terminology, tools for searching in the database, and a program for case report management, VigiFlow
The Uppsala centre has also published books in the field of drugs safety including a regular newsletter. In 2010 the 2nd edition of a crisis management guide was published, entitled 'Expecting the Worst'.
Uppsala
- Economy :Today Uppsala is well established in medical research and recognized for its leading position in biotechnology.*Abbott Medical Optics *GE Healthcare*Pfizer *Phadia, an offshoot of Pharmacia*Fresenius*Q-Med...
, Sweden
Sweden
Sweden , officially the Kingdom of Sweden , is a Nordic country on the Scandinavian Peninsula in Northern Europe. Sweden borders with Norway and Finland and is connected to Denmark by a bridge-tunnel across the Öresund....
, is the field name for the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
Collaborating Centre for International Drug Monitoring. The UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
programs in regards to the benefits, harm, effectiveness and risks of drugs.
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 60 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. Since September 2009 Marie Lindquist is the Director.
The work of the UMC is:
- To co-ordinate the WHO Programme for International Drug Monitoring and its more than 100 member countries
- To collect, assess and communicate information from member countries about the benefits, harms and risks of drugs and other substances used in medicine to improve patient therapy and public health worldwide
- To collaborate with member countries in the development and practice of the science of pharmacovigilance.
The main focus and source of data in pharmacovigilance
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
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. The UMC develops and provides several tools and classifications for use by organisations involved in drug safety, including the WHO Drug Dictionary, WHO-ART (adverse reaction terminology) - with a bridge to the MedDRA terminology, tools for searching in the database, and a program for case report management, VigiFlow
The Uppsala centre has also published books in the field of drugs safety including a regular newsletter. In 2010 the 2nd edition of a crisis management guide was published, entitled 'Expecting the Worst'.
WHO Programme key dates
- 1968 WHO Programme established. International ADR terminology and drug dictionary
- 1969 Definition of ADR
- 1978 Operations transferred to the UMC; setting-up of relational ADR database. Regular WHO Programme member meetings
- 1981 Computerised version of WHO Drug DictionaryWHO Drug DictionaryThe WHO Drug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre....
available to all - 1982 ATC classification coding of all medicinal products
- 1985 International expert review panel created
- 1991 On-line WHO database search programme available to national centres
- 1991 Definitions of adverse event, side effect and causality assessment terms
- 1993 Windows-based client server program for online database searches
- 1993 Regular training and educational activities
- 1994 Methodology for use of denominator data for calculation of ADR reporting rates
- 1997 Knowledge-detection tool for automated signal detection (BCPNNBcpnnA Bayesian Confidence Neural Network is an artificial neural network inspired by Bayes' theorem: node activations represent probability in the presence of input features or categories, synaptic weights are based on estimated correlations and the spread of activation corresponds to calculating...
) - 1997 Promotion of communication as a necessary discipline in pharmacovigilance : the 'Erice Declaration'
- 1998 Internet discussion group for national centres
- 2001 Start of Vigibase Online project (now VigiFlow)
- 2002 New database system (Vigibase)
- 2004 Pattern recognition using the BCPNNBcpnnA Bayesian Confidence Neural Network is an artificial neural network inspired by Bayes' theorem: node activations represent probability in the presence of input features or categories, synaptic weights are based on estimated correlations and the spread of activation corresponds to calculating...
on health databases to find safety information. - 2005 Launch of expanded WHO Drug Dictionary with additional data fields; agreement with IMS Health to increase information in the dictionary
- 2010 Over 5 million adverse reaction reports in the WHO database
- 2010 100th country joins the WHO Programme for International Drug Monitoring
See also
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Council for International Organizations of Medical SciencesCouncil for International Organizations of Medical SciencesThe Council for International Organizations of Medical Sciences is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949....
(CIOMS) - The International Society of PharmacovigilanceThe International Society of PharmacovigilanceThe International Society of Pharmacovigilance , previously the European Society of Pharmacovigilance , is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
(EEA) - Yellow Card SchemeYellow Card SchemeThe Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
(UK) - Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- MedDRAMedDRAMedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data...
- WHOARTWHOARTThe WHO Adverse Reactions Terminology is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre , the World Health Organization Collaborating Centre for International Drug Monitoring.-Structure:* 32...
External links
- http://www.who-umc.org/DynPage.aspx, Uppsala Monitoring Centre home
- http://www.who-umc.org/DynPage.aspx?id=13136&mn=1512#11, Uppsala Reports is the UMC's regular news bulletin for everyone concerned with the issues of pharmacovigilance.