Pharmacovigilance newsletter 16

Importance of Active surveillance and Cohort Event monitoring on ARV medicines in Ethiopia The cornerstone of any pharmacovigilance system is Spontaneous reporting system which is a passive surveillance system that uses voluntary reporting of an adverse drug reaction by a health professional or a patient with the main objective being able to provide signals with marketed drugs. This passive surveillance system has got various limitations in identifying and assessing drug related injuries. Some of this are; lack of denominator making it impossible to calculate rates and also assess risk factors, Only suspected reactions are reported and death is usually not reported, there is a huge Under-reporting [A meta-analysis showed that the median under-reporting rate for all adverse drug reactions ADRs was 95% (i.e. 5 % of all ADRs are reported) and 80% for serious ADRs (20% reported)] . For this purpose various countries are employing other additional active surveillance methods that could compliment the drug safety information obtained from the passive surveillance system to obtain a high quality data and result into proper decision making. One of these efficient methods is Cohort Event Monitoring (CEM) which is a time-limited, targeted programme and a prospective, observational, study of adverse events associated with one or more monitored medicines. It is advantageous over others in that early detection of signals of unsuspected ADRs is possible, denominator information allows incidence rates of ADRs to be calculated, risks and risk factors could be assessed; comparisons between drug, Pregnancy outcomes and deaths are obtained. Ethiopia is one of the countries with a high prevalence of HIV/AIDS in subSaharan Africa. This safety of the ARV medicines follow up has been carried out in the country by the National pharmacovigilance centre at FMHACA using a passive surveillance spontaneous reporting system . According to a summary of this spontaneous reports from 2001-2003E.C, (205, 77%) of the adverse drug events were caused by drugs of antiretroviral therapy followed by Antitubercular drugs (37,14%).The most observed reactions as reported by the health providers were; Lipodystrophy (65, 32%), Various skin reactions (41, 20%), Anemia (31, 15%), Peripheral Neuropathy (27, 13%) .Also current reports showed similar patterns for the years 2005-2007 E.C with specific drug reactions of Tenofovir (renal tubulopathy) and ZDV based fixed dose combination . The primary data obtained through this system needs to be strengthened by an active follow up in the form of Cohort Event monitoring (CEM) and the obtained data translated for the better and safer use of the ART drugs by the public. Hence for this purpose the Ethiopian Food, Medicine and Health care Administration and Control Authority (FMHACA) has planned to carry out Cohort Event monitoring (CEM) on antiretroviral drugs in collaboration with Stakeholders and partners and has undergone various preparatory steps for the successful implementation of the active safety surveillance on ARV medicines. September 2016 Volume 6 Issue 3 Pharmacovigilance newsletter This newsletter is prepared and shared quarterly by EFMHACA with the objective of providing Medicine safety information and sharing the activities of the pharmacovigilance center at EFMHACA to healthcare providers working at both the public and private sectors Inside this issue Activities at the pharmacovigilance center Face to face trainings ———————Page 2 Activities at the pharmacovigilance center Training of implementers of CEM pretesting tools __________Page 3 Summary of ADE reports from each region in 2008 ———————Page 3 Drug safety updateInternational __________Page 4 Drug safety update -local __________Page 4 Inside Story In service training on pharmacovigilance was given to 154 participants of 5 health centers i.e ; Wereda 3 Health center (HC) , Kolfe HC, kotebe HC, yeka HC, wereda 7 health center) in Addis Ababa from August 11-25/2016. Participants were trained on medicine related adverse drug events, adverse drug reaction, medication error, product quality defects, limitation of premarketing safety evaluations, the importance of pharmacovigilance, important terminologies in adverse drug event monitoring/ADE , Mandates , responsibilities, principles and tools of the national pharmacovigilance system, procedures of ADE processing, the contents of the national ADE reporting form, the role of Drug and therapeutic committee on assessing and managing drug safety, Prevention of an ADE, the types of adverse events to be reported, when to report an ADE, the three types of reporting mechanisms ( the yellow form hard copy which is available at each health facility to be filled and sent to the post office to reach EFMHACA, the different telephones including the toll free line 8482, the internet based online reporting system), when to report, to whom to report and what happens after an ADE is reported to the pharmacovigilance center at EFMHACA. The national ADE reporting form, different editions of the quarterly prepared pharmacovigilance newsletters and an allergy card to be given to patients who have experienced an allergy were distributed during the discussions to be used after the training. The medical directors of the facilities welcomed the EFMHACA pharmacovigilance team and USAID/ SIAPS for the effort shown to create awareness of drug safety monitoring to healthcare providers by the regulatory authority and informed the importance of the training to the participants before the trainings begun .They also reminded them to implement the knowledge provided during the training by reporting an encountered ADE and also to share the knowledge obtained at the events to their colleagues who were not able to attend the programme. At the end of each session, all the health facilities selected ADE focal persons for the sustainability of the monitoring programme and also to serve as a liaison for collaboration between EFMHACA and the facilities. ( Some Pictures attached below) Page 2 Pharmacovigilance newsletter Activities at the