Reporting Adverse Drug Reactions: A guide for healthcare professionals
May 2006
The European Medicines Agency and EudraVigilance
The European Medicines Agency (EMEA) was set up in 1995 to ensure the safe and effective use of Centrally Authorised medicines, that is, those medicines which are authorised throughout the European Union. EudraVigilance, the data processing network and management system is one method used by the EMEA to coordinate monitoring of these medicines (see reference 44). It was launched in December 2001 to facilitate the collection of information about ADRs. Requirements are set out in Council Regulation (EEC) 2309/93 and Commission Directive 2000/38/EC.
The MHRA, as the UK’s Competent Authority, must send details of all serious UK ADR reports it receives from any health professional or pharmaceutical company to the EudraVigilance database within 15 days of receiving the report (see reference 29). Reports are also received from the pharmaceutical industry. The mechanisms for electronic reporting are still being developed and there are yet questions to be resolved regarding access to the database and ensuring patient confidentiality. Currently the European Commission, EMEA and EU Competent Authorities have full access to the EudraVigilance database and pharmaceutical companies have limited access. Individual doctors, pharmacists and patients do not have access, although this may change as the system is developed.
Further information about EudraVigilance can be found on its website at http://eudravigilance.emea.eu.int
World Health Organisation Programme (WHO) for International Drug Monitoring
The World Health Organisation (WHO) Programme for International Drug Monitoring is operated by the Uppsala Monitoring Centre, in Sweden. The programme allows collaboration in monitoring drug safety between participating countries (see reference 45). The monitoring centre was established in 1968, and consists of a network of National Centres for pharmacovigilance.
Box 3, below, summarises the functions of this WHO monitoring programme. At present there are 79 member countries in the programme, and a further 18 associate members. The designated National Centre in each member country submits individual case reports of suspected ADRs to be stored in a common database. The MHRA is the UK’s designated National Centre. The WHO database currently holds around 3.4 million ADR case records and thus can be a rich data source for pharmacovigilance. Access to these data is, however, limited primarily to National Centres.
Further information about the WHO programme can be found on its website at www.who-umc.org.
Box 3: Functions of the WHO Programme for International Drug Monitoring
- Identification and analysis of new adverse reaction signals from the case report information submitted to the National Centres, and from them to the WHO database.
- Provision of the WHO database as a reference source for signal strengthening and ad hoc investigations.
- Information exchange between WHO and National Centres.
- Publication of WHO Pharmaceuticals Newsletter and Uppsala Reports.
- Provision of training and consultancy support to National Centres and countries establishing pharmacovigilance systems.
- Computer software for case report management designed to suit the needs of National Centres (Vigibase Online).