Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.

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IntroductionCohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s, and has since been adapted by WHO for monitoring the safety of medicines used in Public Health Programmes. CEM aims to capture all adverse events that occur in a defined group of patients after starting treatment with a specific medicine during the course of routine clinical practice.ObjectiveThe aims of this study were to describe the experiences of National Pharmacovigilance Centres (NCs) that have used CEM to monitor artemisinin-based combination therapy (ACT) for uncomplicated malaria in the African setting, to raise awareness of some of the challenges encountered during implementation and to highlight aspects of the method that require further consideration.MethodA questionnaire-based survey was conducted to capture the experiences of NCs that have implemented CEM for active post-marketing surveillance of antimalarial medicines in sub-Saharan Africa. Six NCs were identified as having implemented CEM programmes and were invited to participate in the survey; five NCs indicated willingness to participate and were sent the questionnaire to complete.ResultsFour NCs responded to the survey—Ghana, Kenya, Nigeria and Zimbabwe—providing information on the implementation of a total of six CEM programmes. Their experiences indicate that CEM has helped to build pharmacovigilance capacity within the participating NCs and at the monitoring sites, and that healthcare providers (HCPs) are generally willing to participate in implementing the CEM method. All of the programmes took longer than expected to complete: contributing factors included a prolonged enrolment period and unexpectedly slow data entry. All of the programmes exceeded their budget by 11.1–63.2 %. Data management was identified as a challenge for all participating NCs.ConclusionsThe reported experiences of four NCs that have undertaken CEM studies on ACTs indicate that CEM has helped to build pharmacovigilance capacity within NCs and monitoring sites and that HCPs are willing to participate in CEM programmes; however, the method was found to be labour intensive and data management was identified as a challenge. Reducing the workload associated with CEM, particularly in relation to data management, and integrating the method into the routine work of HCPs and NCs should be considered for future implementation.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-015-0331-7) contains supplementary material, which is available to authorized users.

Dear Healthcare Professional (DHP) letter is a risk minimization tool used to inform health workers about new and emerging safety information during the marketing period of medicinal products. DHP letters in some cases may not be effective because targeted audience may not be aware of these letters or even understand them. The objectives of this study were to assess the effectiveness and relevance of DHP letters as effective risk minimization tool and to seek opinion of health workers about the most effective way of communicating safety information. A descriptive correlational study of 913 health workers selected by convenient sampling through face-to-face interviews from Apr. to June, 2014 was conducted, with a response rate of 83.15%. The data was analyzed using descriptive analysis and Pearson-chi square test (χ 2 ) with STATA version 13. A p-value of < 0.05 was considered significant during the analysis. Of the 913 respondents only 350 (38.34%) were aware of at least one of the letters distributed in 2013 and 314 (89.71%) out of these admitted that these letters have influenced their way of prescribing, dispensing and administering the medicines involved. One hundred and ninety-two (54.82%) of the respondents rated the level of understanding of the language used as good and there was no significant difference in the health workers rating of the language used in the letters (p=0.40). Health workers suggested electronic methods such as short messaging service to their mobile phones 56.81% (438), e-mail 91 (85.85%) and posting the letters on the Food and Drugs Authority's website 26.85% (207). The results suggest that DHP letters issued by the Food and Drugs Authority (FDA) are effective in changing behavior of those who receive them but they are received late or not at all. The FDA should therefore explore other means of communicating safety information such as electronic means as suggested by the health workers.

Background With over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana’s Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system’s performance in meeting its objectives. Methods A case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC’s Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system’s attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews. Results In all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated “fear of being victimized” as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics. Conclusion The AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.