TY - JOUR
T1 - Pharmacovigilance methods in public health programmes: the example of miltefosine and visceral leishmaniasis
AU - Kshirsagar, N
AU - Ferner, Robin
AU - Figueroa, BAA
AU - Ghalib, H
AU - Lazdin, J
PY - 2011/2/1
Y1 - 2011/2/1
N2 - 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.
AB - 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.
U2 - 10.1016/j.trstmh.2010.11.004
DO - 10.1016/j.trstmh.2010.11.004
M3 - Article
C2 - 21185045
SN - 0035-9203
VL - 105
SP - 61
EP - 67
JO - Transactions of the Royal Society of Tropical Medicine and Hygiene
JF - Transactions of the Royal Society of Tropical Medicine and Hygiene
IS - 2
ER -
