title: Pharmacovigilance methods in public health programmes: the example of miltefosine and visceral leishmaniasis.
abstract: Pharmacovigilance is concerned with the assessment of benefit and harm. Disease burden, status of healthcare delivery through government centres and practitioners, existing pharmacovigilance programmes, relevant pre-marketing studies and the likely effectiveness and risks of drugs must be considered for planning pharmacovigilance activity. The risk of a drug may be known, unknown, potential or specific to the context of the programme. The potential benefits of a public health programme aimed at reducing or eliminating a specific condition will depend on the health burden due to that condition, which is a function of the seriousness of the condition and its frequency, as well as the likely efficacy of the programme in reaching its goals. The present article has outlined an approach to pharmacovigilance for such a donor-funded programme, using pharmacovigilance in leishmaniasis as an example.
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College and King Edward Memorial Hospital, Parel, Mumbai, India. kshirsagarna@yahoo.in
authors.forename: Nilima
authors.initials: N
authors.lastname: Kshirsagar
authors.forename: Robin
authors.initials: R
authors.lastname: Ferner
authors.forename: Byron Alfredo Arana
authors.initials: BA
authors.lastname: Figueroa
authors.forename: Hashim
authors.initials: H
authors.lastname: Ghalib
authors.forename: Janis
authors.initials: J
authors.lastname: Lazdin
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000981:Antiprotozoal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002986:Clinical Trials as Topic / Q000379:methods; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D017891:Pharmacoepidemiology; D010767:Phosphorylcholine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011634:Public Health; D012307:Risk Factors; D035862:Vulnerable Populations
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine