Kabanywanyi A.M., Mulure N., Migoha C., Malila A., Lengeler C., Schlienger R., Genton B.
Ifakara Health Institute, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania; Novartis Pharma Inc, Nairobi, Kenya; Tanzanian Food and Drugs Authority, Dar es Salaam, Tanzania; Novartis Pharma AG, Basel, Switzerland; Swiss Tropical and Public Health Institute, Basel, Switzerland
Kabanywanyi, A.M., Ifakara Health Institute, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania; Mulure, N., Novartis Pharma Inc, Nairobi, Kenya; Migoha, C., Tanzanian Food and Drugs Authority, Dar es Salaam, Tanzania; Malila, A., Ifakara Health Institute, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania; Lengeler, C., Swiss Tropical and Public Health Institute, Basel, Switzerland; Schlienger, R., Novartis Pharma AG, Basel, Switzerland; Genton, B., Ifakara Health Institute, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania, Swiss Tropical and Public Health Institute, Basel, Switzerland
Objectives. To 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. Methods. Pharmacovigilance 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). Results. Training 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. Discussion. Safety 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. Conclusion. Experience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing authorization holders. © 2010 Kabanywanyi et al; licensee BioMed Central Ltd.
amodiaquine; amoxicillin; artemether plus benflumetol; fansidar; ivermectin; metakelfin; paracetamol; penicillin G; quinine; antimalarial agent; artemether plus benflumetol; artemisinin derivative; ethanolamine derivative; fluorene derivative; adolescent; adult; amnesia; article; child; clinical article; convulsion; dizziness; drug eruption; drug safety; drug surveillance program; drug withdrawal; dyspnea; dysuria; erythema; eyelid edema; fatigue; female; fever; headache; health care facility; health care personnel; health survey; human; infant; insomnia; joint stiffness; malaria; male; medical education; muscle twitch; observational study; paraplegia; preschool child; pruritus; refresher course; respiratory distress; rural area; school child; side effect; stiff neck; stillbirth; Tanzania; unspecified side effect; vomiting; drug combination; education; health auxiliary; longitudinal study; methodology; middle aged; patient compliance; patient satisfaction; prospective study; rural population; safety; telecommunication; Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Antimalarials; Artemisinins; Child; Child, Preschool; Community Health Aides; Drug Combinations; Ethanolamines; Female; Fluorenes; Humans; Infant; Longitudinal Studies; Malaria; Male; Middle Aged; Patient Compliance; Patient Satisfaction; Prospective Studies; Rural Population; Safety Management; Tanzania; Telecommunications