Public Release:  Developing world could suffer if drug safety is not properly assessed

Pharmacovigilance in developing countries

BMJ-British Medical Journal

Millions of people could be put at risk because progress in getting the best medicines to the developing world is not being matched by an appropriate monitoring programme say the writers of an editorial in today's BMJ.

The developing world bears almost 90% of the planet's disease burden. More is being done to make sure the developing world has access to effective medicines. Drug companies are coming under greater pressure to remove the legal and financial barriers to access say the writers. While they acknowledge this is good they say progress is not being matched by the development of proper drug safety monitoring.

Drug safety monitoring, known as pharmacovigilance, was developed in the West after the thalidomide disaster in the 1960s. Around 10,000 babies were born with disabilities as a result of their mothers taking thalidomide as a remedy for morning sickness.

Now, data on any adverse effects associated with the use of a particular medicine are systematically collected and analysed identifying any potential problems. 96% of developed countries have pharmacovigilance systems in place compared to just over a quarter of countries in the developing world.

The writers argue that data compiled from countries in the West cannot simply be used to measure the effects of drugs new to the developing world. They say the incidence pattern and the severity of adverse reactions could differ greatly because of different genetic influences and the local environment.

The writers say there are a number of things that could and should be done.

In the short term they say information in these countries should be better pooled. So, for example, there should be more collaboration between the academic community, the pharmaceutical industry and individual governments in order to create a single database. They cite a successful collaboration between public health, drug access campaigns and a regional surveillance system called the East African Network for Monitoring Antimalarial Treatment and say more of these partnerships could be established.

They suggest the pharmaceutical industry needs to become more involved; effective public-private partnerships need to be established so there is collaboration beyond the obtainment of a drug license. Programmes should be developed which show the effectiveness of a drug in the real world. There are examples of this in Africa say the writers but they need to become the norm, not the exception.

In the long term every country should develop its own pharmacovigilance system, however the writers acknowledge this will be costly. At the moment countries in the developing world just don't have the resources, infrastructure and expertise. At the moment if it comes down to a choice between implementing a new vaccine programme and funding a pharmacovigilance system then the former will win.

So, they say, the WHO needs to take the lead in developing a novel funding model to support pharmacovigilance in the developing world. This could include, for example, developing exchange programmes to increase local expertise.

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