title: Spontaneous adverse drug reaction reporting in rural districts of Mozambique.
abstract: BACKGROUND
  The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and their performance under any circumstance is difficult to predict given the known shortage of human, financial and technical resources. Nevertheless, the importance of such systems in all countries is not in doubt, and research to identify problems, with the aim of offering pragmatic solutions, is urgently needed.
  
  
  OBJECTIVE
  To examine the impact of training and monitoring of healthcare workers, making supervisory visits and the availability of telecommunication and transport facilities on the implementation of a pharmacovigilance system in Mozambique.
  
  
  METHODS
  This was a descriptive study enumerating the lessons learnt and challenges faced in implementing a spontaneous reporting system in two rural districts of Mozambique - Namaacha and Matutuíne - where remote location, poor telecommunication services and a low level of education of health professionals are ongoing challenges. A 'yellow card' system for spontaneous reporting of adverse drug reactions (ADRs) was instituted following training of health workers in the selected districts. Thirty-five health professionals (3 medical doctors, 2 technicians, 24 nurses, 4 basic healthcare agents and 2 pharmacy agents) in these districts were trained to diagnose, treat and report ADRs to all medicines using a standardized yellow card system. There were routine site visits to identify and clarify any problems in filling in and sending the forms. One focal person was identified in each district to facilitate communication between the health professionals and the National Pharmacovigilance Unit (NPU). The report form was assessed for quality and causality. The availability of telecommunications and transport was assessed.
  
  
  RESULTS
  Fourteen months after the first training, 67 ADR reports involving 74 adverse events were received by the NPU involving 25 separate drugs, 16 of which were causally (certainly, probably or possibly) linked to the reaction. Most reported ADRs were dermatological reactions (83.1%). Antimalarial drugs (chloroquine, amodiaquine, quinine, artesunate and sulfadoxine/pyrimethamine) were mentioned in 33 (50.8%) of the reports. There were 14 reactions classified as serious and no fatal reactions were reported. There were differences in telecommunications and transport facilities between the districts that might have contributed to the different number of reports.
  
  
  CONCLUSIONS
  Health professionals of all levels of education (including basic training) from rural areas could contribute to ADR spontaneous reporting systems. Training, quality-assurance visits and the ongoing presence of focal persons can promote reporting and improve the quality of reports submitted.
authors.affiliation: Eduardo Mondlane University Medical School, CIMed, Maputo, Mozambique. esevene68@gmail.com
authors.forename: Esperança
authors.initials: E
authors.lastname: Sevene
authors.forename: Alda
authors.initials: A
authors.lastname: Mariano
authors.forename: Ushma
authors.initials: U
authors.lastname: Mehta
authors.forename: Maria
authors.initials: M
authors.lastname: Machai
authors.forename: Alexander
authors.initials: A
authors.lastname: Dodoo
authors.forename: David
authors.initials: D
authors.lastname: Vilardell
authors.forename: Sam
authors.initials: S
authors.lastname: Patel
authors.forename: Karen
authors.initials: K
authors.lastname: Barnes
authors.forename: Xavier
authors.initials: X
authors.lastname: Carné