Drug Safety 2007; 30 (10): 919-990 0114-5916/07/0010-0919/$44.95/0
ABSTRACTS
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Poster Presentations P.159 Development of a Simplified Procedure for Assessing the Effectiveness of a Spontaneous Reporting ADR System in Resource Limited Settings J. Nee-Whang,1 T. Ofori,1 A.N.O. Dodoo,1 E. Inkoom,2 A. De Sousa,2 M. Young,2 A. Appiah-Danquah1 1 University of Ghana Medical School, Accra, Ghana; 2 UNICEF - Ghana, Accra, Ghana Introduction: The biggest drawback to spontaneous reporting ADR systems is underreporting with the best reporting countries receiving a mere 5% or so of possible reports. Ghana is implementing Intermittent Preventative Treatment of malaria in Infants (IPTi) with administration of sulfadoxine-pyrimethamine (SP) to over 40,000 infants in the pilot region. This is part of a Bill and Melinda Gates Foundation sponsored UNICEF IPTi implementation programme taking place in five other African countries. The pharmacovigilance programme for this project involves the strengthening of existing spontaneous reporting systems as well as active follow up of a cohort of infants. A novel method for assessing the effectiveness of spontaneous reporting was developed and this may find utility in resource-limited settings. Objective: To develop a simplified and customisable algorithm-based procedure for assessing the effectiveness of spontaneous reporting in a resource limited setting. Methodology: An algorithm which takes into account the key steps in spontaneous reporting was developed and supplemented with questionnaires and interviews to obtain data to permit the modelling of a putative successful ADR reporting structure. Overall, 54 sub-districts were assessed for the presence and availability of Adverse Event (AE) forms, knowledge of healthcare workers about the existing spontaneous reporting system and the proportion of healthcare workers who had actually filled and submitted Adverse Drug Reaction (ADR) / AE forms. Results: Thirty health facilities (55.6%) of the 54 had ADR forms. Of the 319 out of 800 health workers interviewed, 189 (59.2%) had knowledge on the spontaneous reporting system and 172 (53.9%) had seen an AE form before. However, only 40 (12.5%) had ever filled an ADR/AE form. Using this and other criteria, a model and algorithm was developed to identify and make useful interventions to correct lapses in the spontaneous reporting system of the region. Assuming each step contributed equally to spontaneous reporting, the current system in the region would be said to be only 2.23% effective; a figure not dissimilar from the frequently quoted maximum of 4% or 5%. This model did not take into account qualitative and motivational issues all of which affect reporting. Individual systems may therefore adapt it to fit their situation. Conclusion: A simplified algorithm for assessing the effectiveness of spontaneous reporting systems has been developed and tested.
