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New medicines in resource limited settings: what pharmacovigilance can deliver
- Shanthi N. Pal, Mary Couper, Lembit Rägo (1 July 2009)
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Shanthi N. Pal, Technical Officer, Quality and Safety of Medicines World Health Organization, 1211 Geneva 27, Switzerland, Mary Couper, Lembit Rägo
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The recent Drugs for Neglected Diseases Initiative meeting in Nairobi for the development of new drugs for neglected tropical diseases is a laudable and a much needed initiative. That these efforts can facilitate access to new and affordable medicines in the least privileged countries is very well demonstrated by the improved access to artemisinin combination therapy (ACTs) in sub-Saharan Africa. But equally, these efforts will introduce new medicines in resource limited settings (RLS) with little or no capacity to fully assess these new molecules, in the context of these settings, prior to their market approval. Launching medicines in RLS is a great responsibility due to the limited national regulatory capacity and the lack of a good health-care infrastructure where, de facto, all medicines are available over-the-counter (OTC) from the very first day of approval except when delivered exclusively by special programmes. A good pharmacoviglance programme can identify, in a short period of time, safety issues with these medicines with important consequences for the patient, the product and the treatment programme. In response to the urgent need for additional safety information on ACTs in countries that are planning a major scale up of these medicines, WHO has been working to introduce the principles of Cohort Event Monitoring (CEM), a prospective, observational method of recording adverse events in patients treated with one or more medicines. Two ACT-CEM projects are currently under way, in Nigeria and in Tanzania. These CEM projects will, when completed, provide information on, and a measure of any risk associated with ACTs in the treated population. Similar methods are being discussed for the monitoring of adverse events in leishmaniasis and in the Chagas disease treatment programmes. The WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre has developed a data management tool with a built-in adverse-events terminology, CEMFlow, for managing the data from the CEM projects. It is hoped that these efforts will usher in an important method that strengthens public health programmes with better knowledge of risks from medicines, to protect patients. In settings with little or no resource to assess the safety or efficacy of medicines, this approach can improve product information, its rational use and quality of care, albeit in a post- introduction, post-marketing context. Because, while access to medicines is a human right, protecting patients from preventable harms from medicines is a professional and a moral obligation (Couper et al, BMJ, 2006). Competing interests: None declared |
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