BMJ：全球数据库对发展中国家药物安全至关重要

生物谷

What role should the drug industry have in promoting pharmacovigilance? The current model for drug development in resource poor settings depends on public-private partnerships, such as the Medicines for Malaria Venture. These partnerships should be encouraged to continue beyond the point of obtaining a drug licence to developing a proactive phase IV programme. Such a programme could be designed to show the effectiveness of the drug in a real world situation, and through this obtain safety data in much larger cohorts of patients. A few examples of this approach already exist in Africa,10 but these need to become the norm rather than the exception.

In the long term, every country should develop its own national pharmacovigilance system, which contributes to a global database such as that held by the Uppsala Monitoring Centre. This will need an extensive infrastructure, however, which would be costly. In a climate where health resources are limited, funding a pharmacovigilance system will come second to other competing priorities such as implementing a new vaccine programme. The funding model for pharmacovigilance activities in the United States recently advocated by the Institute of Medicine11 is unlikely to work in developing countries if it increases drug costs, as this defeats the aim of increasing access to medicines. No easy answers are available, but WHO needs to lead a dialogue between the major stakeholders with the aim of developing a novel funding model that supports pharmacovigilance activities in developing countries. The lack of local expertise in pharmacovigilance could be tackled through developing exchange programmes with the major drug regulatory agencies and sharing of best practices.

Munir Pirmohamed, professor of clinical pharmacology1, Kwame N Atuah, postdoctoral research fellow1, Alex N O Dodoo, senior pharmacovigilance scientist2, Peter Winstanley, professor of clinical pharmacology3

1 Department of Pharmacology, University of Liverpool, Liverpool L69 3GE, 2 Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana Medical School, Korle-Bu Teaching Hospital, Accra, Ghana, 3 Department of Pharmacology, University of Liverpool, Liverpool L69 3GE

munirp@liv.ac.uk

Competing interests: MP is a member of the UK Commission on Human Medicines. PW is the chairman of the CDA Product Development Team (MMV, GSK, and WHO-TDR). ANOD has received research funding from WHO-TDR.

Provenance and peer review: Non-commissioned; externally peer reviewed.

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