2015
DOI: 10.1007/s40264-015-0331-7
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Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey

Abstract: 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 … Show more

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Cited by 27 publications
(18 citation statements)
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“…The PV challenges we encountered are not unique and have been reported in PV programmes for antimalarials [ 18 ]. Despite geographical and resource-limited setting, the programme achieved increased awareness and interest in PV, built capacity and yielded clinically practical information that has affected practice.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…The PV challenges we encountered are not unique and have been reported in PV programmes for antimalarials [ 18 ]. Despite geographical and resource-limited setting, the programme achieved increased awareness and interest in PV, built capacity and yielded clinically practical information that has affected practice.…”
Section: Discussionmentioning
confidence: 99%
“…The PV program used a prospective cohort design analogous to the Cohort Event Monitoring (CEM) design [ 18 ]. The specific objectives were: (a) to determine the incidence of non-serious adverse events (AEs) during 17 days of treatment with combination SSG-PM and of serious AEs during and after treatment for up to 6 months following the end of treatment (EOT); (b) to identify additional risks that had not been reported in pre-approval clinical studies by reporting and characterizing previously undetected adverse drug reactions (ADRs); (c) to determine whether the occurrence of ADRs was higher in specific groups of patients by correlating unexpected ADRs (i.e.…”
Section: Methodsmentioning
confidence: 99%
“…Cohort event monitoring is a prospective observational study design used by many researchers to monitor safety of medicines or vaccines in public health programmes [33][34][35][36]. Two cohorts were recruited for this study: Infants who received 1st dose of MMR vaccine at the age of 1 year, and infants who received the LJEV at the age of 9 months.…”
Section: Methodsmentioning
confidence: 99%
“…The most widespread challenge facing PV is a high level of under-reporting ( [15], [16], [17], [18], [12]), typically attributed to a lack of knowledge, time, and incentive ( [19], [16], [20]), which alludes to the lack of standardised reporting protocols and methodologies. PV also faces socio-cultural challenges, such as the existence of a culture of fear surrounding the reporting of ADRs due to a fear of undue disciplinary action being taken against HCPs ( [21], [22], [19]). The literature also highlights the urgent need for educational awareness about PV activities and the simplification of the ADR reporting process to improve public participation ( [23], [24], [25], [11]).…”
Section: Effects Of a Lack Of Standardisationmentioning
confidence: 99%