Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

Abdunoor M Kabanywanyi,Aggrey Malila,Blaise Genton,Christian Lengeler,Nathan Mulure,Christopher Migoha,Raymond Schlienger

doi:10.1186/1475-2875-9-205

Abstract

ObjectivesTo identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania.MethodsPharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008).ResultsTraining was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence.DiscussionSafety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges.ConclusionExperience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing authorization holders.

Highlights

Spontaneous reporting of suspected adverse drug reactions (ADRs) utilizing post-marketing surveillance or pharmacovigilance techniques during drug therapy is less applicable in many sub-Saharan African countries [1].Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem [2]
Experience gained in this setting could help to improve spontaneous reporting of adverse events (AEs) and serious adverse events (SAEs) to health authorities or marketing authorization holders
The second training session was attended by 35 healthcare providers, of whom more than half had not attended the first training course because they had recently been relocated from facilities outside the ALIVE study area or returned from college

Summary

Introduction

Spontaneous reporting of suspected adverse drug reactions (ADRs) utilizing post-marketing surveillance or pharmacovigilance techniques during drug therapy is less applicable in many sub-Saharan African countries [1]. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem [2]. The knowledge of a drug’s adverse effects can be increased by various means, including spontaneous reporting, intensive monitoring and database studies [3]. Post-marketing surveillance which is often used synonymously for pharmacovigilance [4] and will be used throughout this article - is an important component of safety monitoring for drugs after they have been licensed for use. Post-marketing surveillance, especially in the context of observational studies, can be a valuable source of additional safety data within a large patient population in a real-world setting

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