Appropriate Pharmacovigilance Needed For The Developing World

Editor's Choice
Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist;  Public Health
Article Date: 08 Sep 2007 - 0:00 PDT

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If the finest medicines are to have the best impact on the developing world there needs to be a proper monitoring program to protect people, according to an editorial in the British Medical Journal this week.

Approximately 90% of the global disease burden is borne by the developing world, say the authors. As pressure is being put to bear on the drug companies to get rid of legal and financial obstacles, the developing world has started to receive more effective medicines. However, this beneficial flow is not being accompanied by the development of adequate drug safety monitoring.

In the 1960s thousands of babies were born with disabilities following the thalidomide tragedy. Thalidomide was a medication taken by pregnant women for morning sickness. Pharmacovigilance (drug safety monitoring) was developed in the industrial world in response to this disaster.

These days, all adverse effects (undesirable effects, side effects) on any medicine are systematically collected and investigated. The aim is to identify any latent problems. Virtually all developed countries have rigorous pharmacovigilance systems. A mere 25% or so of the nations in the developing world have such systems.

You cannot simply take pharmacovigilance data from one country and automatically apply it to another. The severity of adverse reactions can be different from country-to-country, say the authors. There may be genetic differences in the population of another country, as well as different types of environments.

The authors say the information in these countries should be better pooled. If collaboration between the academic community, the drug industry and individual governments were such that their information could go into one single database, it would benefit public health greatly. They give as an example, the collaboration between drug access campaigns, regional surveillance systems and public health in East Africa - The East African Network for Monitoring Anti-malarial Treatment. Such partnerships could be set up, write the authors.

More has to be done than just getting a drug license. The pharmaceutical industry should become more involved and effective public-private partnerships need to be set up. The development of programs which showed the effectiveness of a drug in the real world would provide valuable information, say the writers. Rather than being the exception, the examples of successful programs taking place in Africa should become the standard, they urge.

The long term aim should be for every country to eventually have its own pharmacovigilance system. Unfortunately, these systems are costly and some countries simply do not have the resources to set them up. A country with limited resources does not have the money to fund a new vaccine program as well as a pharmacovigilance system - when pushed to choose one, it will opt for the vaccine program.

The World Health Organization needs to develop a novel funding model to aid pharmacovigilance in the developing world. Exchange programs could be set up to help develop local know-how.

Editorial: Pharmacovigilance in developing countries
BMJ Volume 335 p 462
Munir Pirmohamed, Kwame N Atuah, Alex N O Dodoo, Peter Winstanley
Click here to read the first 150 words of the full text

Written by: Christian Nordqvist
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