E-DRUG: Access to VigiBase: response from WHO - UMC to ISDB
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Dear Colleagues,
We would like to respond to the 15 February e-drug post from ISDB on Access to Vigibase.
We are grateful for the keen interest in the developments related to signal-related work at WHO and UMC, and with these comments on the new policy for SIGNAL, and would welcome any further input from International Society of Drug Bulletins, at any time, or perhaps arising from your upcoming General Assembly.
Points of clarification
In respect of MAHs (identified as uniquely responsible for a medicine which is the subject of a SIGNAL article) reading and commenting on an article: that pharmaceutical company is sent the final version of the signal three weeks before publishing and is offered the opportunity to provide a comment. Any such comment received by UMC will, unless otherwise advised, be included in an unedited form in WHO Pharmaceuticals Newsletter - alongside the original unchanged signal article.
In relation to 'public access' for searches in the WHO Global Individual Case Safety Reports (ICSR) database VigiBase: these are performed by UMC staff on request for commercial customers (the fee charged helps pay staff time the UMC), but are free-of-charge for staff at all National Pharmacovigilance Centres in countries in the WHO Programme for International Drug Monitoring, which also have access to all reports in VigiBase via an online search tool, free of charge. The 'Caveat document' remains a key feature in the use of VigiBase.
The future
Concerning the ISDB's request that VigiBase be made publicly accessible by the end of 2012. The intention of WHO is that the more than 7 million reports in VigiBase, from patients, doctors and regional and national pharmacovigilance centres around the world, be made accessible in a responsible, stepwise fashion in order to assist early detection of problems with medicines. Publishing SIGNAL in WHO Pharmaceuticals Newsletter is the first step.
The recommendations from the Advisory Committee for Safety of Medicinal Products (ACSoMP) in April 2011 underline that the process of opening access "would need to be done in a responsible, stepwise fashion. Some extensions will be made to the current data retrieval interface being used by national centres, a new search tool. Those who are not members of the national centres will be able to log on but with a different level of access, for example, to some summary tables. The UMC is preparing to make these summaries available and the necessary search tool."
The full ACSoMP statement is available on page 2 of their report available via: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/recommendations.pdf
We understand the frustrations of those keen to make use of VigiBase data in their scientific research. However, taking this gradual approach, involving partners at participating national centres and enhancing tools for accessing the data remain our priorities.
With kind regards,
Dr Shanthi Pal
Pharmacovigilance Programme Manager
Quality Assurance and Safety: Medicines
Department of Essential Medicines and Health Products
World Health Organization
Geneva, Switzerland
and
Dr Marie Lindquist
Director
Uppsala Monitoring Centre
Sweden
"Pal, Shanthi Narayan" <pals@who.int>