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Eur Respir Rev. 2019 Oct 11;28(153). pii: 180115. doi: 10.1183/16000617.0115-2018. Print 2019 Sep 30.

Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences.

Author information

1
KNCV Tuberculosis Foundation, Den Haag, the Netherlands edine.tiemersma@kncvtbc.org.
2
KNCV Tuberculosis Foundation, Den Haag, the Netherlands.
3
Centre for Infectious Disease Epidemiology and Surveillance, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.
4
KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.
5
KNCV Tuberculosis Foundation, Jakarta, Indonesia.
6
National Tuberculosis Program, Ministry of Health, Jakarta, Indonesia.
7
Dept of Public Health, Ministry of Health and Sports, Yangon, Myanmar.
8
FHI360, Yangon, Myanmar.
9
National Tuberculosis Program, Ministry of Health, Hanoi, Vietnam.
10
National Centre of Drug Information and Adverse Drug Reactions & Hanoi University of Pharmacy, Hanoi, Vietnam.
11
KNCV Tuberculosis Foundation, Bishkek, Kyrgyzstan.
12
National Tuberculosis Program, Ministry of Health, Bishkek, Kyrgyzstan.
13
KNCV Tuberculosis Foundation, Dushanbe, Tajikistan.

Abstract

New drugs and shorter treatments for drug-resistant tuberculosis (DR-TB) have become available in recent years and active pharmacovigilance (PV) is recommended by the World Health Organization (WHO) at least during the early phases of implementation, with active drug safety monitoring and management (aDSM) proposed for this. We conducted a literature review of papers reporting on aDSM. Up to 18 April, 2019, results have only been published from one national aDSM programme. Because aDSM is being introduced in many low- and middle-income countries, we also report experiences in introducing it into DR-TB treatment programmes, targeting the reporting of a restricted set of adverse events (AEs) as per WHO-recommended aDSM principles for the period 2014-2017. Early beneficial effects of active PV for TB patients include increased awareness about the occurrence, detection and management of AEs during TB treatment, and the increase of spontaneous reporting in some countries. However, because PV capacity is low in most countries and collaboration between national TB programmes and national PV centres remains weak, parallel and coordinated co-development of the capacities of both TB programmes and PV centres is needed.

PMID:
31604816
DOI:
10.1183/16000617.0115-2018
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Conflict of interest statement

Conflict of interest: E. Tiemersma reports grants from USAID under the Challenge TB Project, during the conduct of the study. Conflict of interest: S. van den Hof has nothing to disclose. Conflict of interest: G. Dravniece has nothing to disclose. Conflict of interest: F. Wares reports grants from USAID under the Challenge TB Project, during the conduct of the study. Conflict of interest: Y. Molla reports grants from the USAID under the Challenge TB Project, during the conduct of the study. Conflict of interest: Y. Permata has nothing to disclose. Conflict of interest: E. Lukitosari has nothing to disclose. Conflict of interest: M. Quelapio has nothing to disclose. Conflict of interest: S.T. Aung has nothing to disclose. Conflict of interest: K.M. Aung has nothing to disclose. Conflict of interest: H.T. Thuy has nothing to disclose. Conflict of interest: V.D. Hoa has nothing to disclose. Conflict of interest: M. Sulaimanova has nothing to disclose. Conflict of interest: S. Sagyndykova has nothing to disclose. Conflict of interest: M. Makhmudova has nothing to disclose. Conflict of interest: A. Soliev has nothing to disclose. Conflict of interest: M. Kimerling has nothing to disclose.

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