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

Malaria Journal

Research

Abdunoor M Kabanywanyi¹  Aggrey Malila¹  Blaise Genton²  Raymond Schlienger³  Nathan Mulure⁴  Christian Lengeler⁵  Christopher Migoha⁶ 

[1] Ifakara Health Institute, P.O. Box 78373, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania;Ifakara Health Institute, P.O. Box 78373, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania;Swiss Tropical and Public Health Institute, Basel, Switzerland;Novartis Pharma AG, Basel, Switzerlandx;Novartis Pharma Inc, Nairobi, Kenya;Swiss Tropical and Public Health Institute, Basel, Switzerland;Tanzanian Food and Drugs Authority, Dar es Salaam, Tanzania;

关键词: Malaria;    Health Facility;    Short Message Service;    Artemether;    Lumefantrine;   

DOI  :  10.1186/1475-2875-9-205

 received in 2010-05-10, accepted in 2010-07-14,  发布年份 2010

来源: Springer

【 摘 要 】

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 (A rtemether-L umefantrine I n V ulnerable patients: E xploring 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.

【 授权许可】

CC BY   
© Kabanywanyi et al; licensee BioMed Central Ltd. 2010