Pharmacovigilance in developing countries

Efforts are increasing to ensure that resource poor countries, which bear almost 90% of the global disease burden, have access to effective medicines.1 As a result, drug companies are facing increased pressure from governments, the World Health Organization, and patient lobby groups to remove legal and financial barriers to access.2 However, although these campaigns are necessary and clearly laudable, they are not accompanied by the development or upscaling of processes for monitoring drug safety. Although many drugs have been extensively used and studied in developed countries (thus informing global practice), their safety profile cannot necessarily be generalised to developing countries, where the incidence, pattern, and severity of adverse reactions may differ markedly because of local environmental and genetic influences.3
After the thalidomide disaster in the 1960s, most Western countries developed national pharmacovigilance systems.4 These systems use spontaneous reporting or other pharmacoepidemiological methods to systematically collect and analyse adverse events associated . . . [Full text of this article]
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

Ethnicity and adverse drug reactions

Personalised drug treatment is getting closer but will not replace good clinical judgment

Whether ethnicity is an important contributor to the variable outcome of drug treatment is still a matter of debate. Research evidence on such associations is limited in quantity and variable in quality. Too often patients' ethnicity is classified by using poorly defined criteria or an inadequate scientific basis.1 Indeed, both skin colour and self identification of ethnic origin seem to be poorly correlated with molecular genetics, and most genetic variability is found within, rather than among, continental populations.2 In addition, ethnic differences in drug response might originate from cultural or environmental factors.
In a meta-analysis on p 1177 McDowell and colleagues systematically reviewed the literature and summarised consistent findings about ethnicity and adverse drug reactions to cardiovascular drugs.3 They found, among other interesting results, a threefold higher risk of angioedema in black compared to non-black patients when taking angiotensin converting enzyme inhibitors as well as a doubled risk of . . . [Full text of this article]

Mucocutaneous Lesions of Behçet's Disease

1Department of Dermatology, Akdeniz University School of Medicine, Antalya, Turkey; 2Department of Dermatology, University Medical Center Benjamin Franklin, The Free University of Berlin, Berlin, Germany; 3Section of Rheumatology, University of Pennsylvania, Philadelphia, USA.Behçet's disease is particularly prevalent in ”Silk Route” populations, but it has a global distribution. The diagnosis of the disease is based on clinical criteria as there is as yet no pathognomonic test, and mucocutaneous lesions, which figure prominently in the presentation and diagnosis, may be considered the diagnostic hallmarks. Among the internationally accepted criteria, painful oral and genital ulcers, cutaneous vasculitic lesions and reactivity of the skin to needle prick or injection (the pathergy reaction) are considered hallmarks of Behçet's disease, and often precede other manifestations. Their recognition may permit earlier diagnosis and treatment, with salutary results. This paper describes the various lesions that constitute the syndrome and focuses on those that may be considered characteristicDr. Erkan Alpsoy, Department of Dermatology, Akdeniz University School of Medicine, 07070 Antalya, Turkey. Tel: 90-242-2274343, Fax: 90-242-2274490, E-mail: ealpsoy@akdeniz.edu.tr