(2009; 32 pages)
There is no complete understanding of the safety of new medicines at the point of registration. Data on the safety of new medicines are mainly derived from preauthorization clinical trials in controlled settings. Clinical trials for the evaluation of safety and efficacy are conducted in a limited number of patients with strict inclusion criteria, often excluding special patient groups such as those with comorbid conditions, children, the elderly, and pregnant women. Patients often have no long-term exposure to the product during clinical trials, and the new drug may not have been tested in some racial groups who may end up using the medicines. These limitations of preauthorization clinical trials enforce the importance of monitoring the safety of all medicines. Besides the discovery of new medicine-induced disorders, including rare and serious adverse drug reactions (ADRs) that were not known during clinical trials, monitoring the safety of health products postauthorization can provide useful information for the characterization and quantification of prevalence and risk factors of known ADRs and can warn of cases of counterfeit products. The need for more scrutiny of the safety of health products is well recognized in developed countries. Increasingly, in developing countries, the importance of pharmacovigilance is also being recognized. One of the key factors for this recognition is the increased availability of new essential medicines used in mass treatment health programs like antiretroviral therapy (ART), tuberculosis (TB), malaria, and vaccination programs. The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems. Pharmacovigilance or postmarketing surveillance is crucial to quantify previously recognized ADRs, identify unrecognized adverse drug events, and evaluate the effectiveness of medicines in real-world situations as well as to decrease mortality and morbidity associated with adverse events. In many countries, national drug authorities are responsible of ensuring the quality, safety, and efficacy of medicines in the public and private sectors. Rwanda currently does not have a drug regulatory authority. However, the recently established Pharmacy Task Force (PTF) is currently addressing some of the regulatory activities of drug regulatory authorities. The PTF is responsible for the protection of the population by supervising the effectiveness and the quality of pharmaceutical products and ensuring they are available at national level and appropriately used. The PTF has made some efforts to initiate pharmacovigilance activities. In addition, the public health programs in Rwanda have recently indicated interest in monitoring the safety of medicines used in their programs. The Treatment and Research AIDS Center and the National Integrated Program to Fight Malaria (PNILP) are concerned about the need to establish an ADR reporting system given the lack of long-term experience in the use of the current treatment.