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
Abdunoor M KabanywanyiBlaise Genton

Abstract

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. 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). 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 3...Continue Reading

References

Jun 18, 1998·Australian and New Zealand Journal of Ophthalmology·M Easterbrook
Oct 5, 2002·Journal of Clinical Pharmacology·Gilbert LefèvreDereck Amakye
Apr 20, 2005·Transactions of the Royal Society of Tropical Medicine and Hygiene·Catherine FaladePatricia Ibarra de Palacios
May 19, 2005·Current Medical Research and Opinion·Stephen Gough
Sep 16, 2005·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Andreas MårtenssonAnders Björkman
May 13, 2006·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Lorna Hazell, Saad A W Shakir
Oct 20, 2006·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Harald NoedlCharles Knirsch
Jan 26, 2007·The Lancet Infectious Diseases·Stephen A WardRose McGready
May 24, 2007·JAMA : the Journal of the American Medical Association·Grant DorseyPhilip J Rosenthal
Sep 8, 2007·BMJ : British Medical Journal·Munir PirmohamedPeter Winstanley
Sep 18, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ushma MehtaKaren I Barnes
Jun 5, 2008·European Journal of Clinical Pharmacology·L Härmark, A C van Grootheest
Jul 18, 2008·Tropical Medicine & International Health : TM & IH·Hasifa BukirwaSarah G Staedke
Sep 2, 2008·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Esperança SeveneXavier Carné
Sep 23, 2008·Molecular Diagnosis & Therapy·Rachel N BronzanS Patrick Kachur
Oct 21, 2009·Malaria Journal·Abdoulaye Djimdé, Gilbert Lefèvre
Dec 8, 2009·Tropical Medicine & International Health : TM & IH·Hailemariam LemmaGebre Ab Barnabas
Jan 23, 2010·Biologicals : Journal of the International Association of Biological Standardization·UNKNOWN WHO
Nov 4, 2011·The American Journal of Tropical Medicine and Hygiene·Michael MakangaPhilip J Rosenthal

❮ Previous
Next ❯

Citations

Mar 1, 2012·PLoS Medicine·Dejan ZurovacRobert W Snow
May 4, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Cristian Gonzalez-GonzalezAdolfo Figueiras
Mar 26, 2011·Annals of the New York Academy of Sciences·Gilbert LefèvreHeiner Grueninger
Oct 19, 2017·Journal of the American Medical Informatics Association : JAMIA·Oscar O AgoroHamish S F Fraser
May 24, 2019·Zoonoses and Public Health·Tomislav BedekovićIvana Lojkić

❮ Previous
Next ❯

Software Mentioned

INDEPTH Phase IV Safety and Effectiveness Studies Platform ( I...
ALIVE

Related Concepts

Related Feeds

Anthelmintics (ASM)

Anthelmintics or antihelminthics are a group of antiparasitic drugs that expel parasitic worms (helminths) and other internal parasites from the body by either stunning or killing them and without causing significant damage to the host. Discover the latest research on anthelmintics here.

Antimalarial Agents (ASM)

Antimalarial agents, also known as antimalarials, are designed to prevent or cure malaria. Discover the latest research on antimalarial agents here.

Anthelmintics

Anthelmintics or antihelminthics are a group of antiparasitic drugs that expel parasitic worms (helminths) and other internal parasites from the body by either stunning or killing them and without causing significant damage to the host. Discover the latest research on anthelmintics here.

Antifungals

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antifungals (ASM)

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antiparasitics

Antiparasitics are medications which are indicated for the treatment of parasitic diseases. Discover the latest research on antiparasitics here.

Antimalarial Agents

Antimalarial agents, also known as antimalarials, are designed to prevent or cure malaria. Discover the latest research on antimalarial agents here.