PMID- 31604816 OWN - NLM STAT- MEDLINE DCOM- 20200420 LR - 20221115 IS - 1600-0617 (Electronic) IS - 0905-9180 (Print) IS - 0905-9180 (Linking) VI - 28 IP - 153 DP - 2019 Sep 30 TI - Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences. LID - 10.1183/16000617.0115-2018 [doi] LID - 180115 AB - 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. CI - Copyright (c)ERS 2019. FAU - Tiemersma, Edine AU - Tiemersma E AUID- ORCID: 0000-0002-2071-3038 AD - KNCV Tuberculosis Foundation, Den Haag, the Netherlands edine.tiemersma@kncvtbc.org. FAU - van den Hof, Susan AU - van den Hof S AD - KNCV Tuberculosis Foundation, Den Haag, the Netherlands. AD - Centre for Infectious Disease Epidemiology and Surveillance, National Institute for Public Health and the Environment, Bilthoven, the Netherlands. FAU - Dravniece, Gunta AU - Dravniece G AD - KNCV Tuberculosis Foundation, Den Haag, the Netherlands. FAU - Wares, Fraser AU - Wares F AD - KNCV Tuberculosis Foundation, Den Haag, the Netherlands. FAU - Molla, Yohannes AU - Molla Y AD - KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia. FAU - Permata, Yusie AU - Permata Y AD - KNCV Tuberculosis Foundation, Jakarta, Indonesia. FAU - Lukitosari, Endang AU - Lukitosari E AD - National Tuberculosis Program, Ministry of Health, Jakarta, Indonesia. FAU - Quelapio, Mamel AU - Quelapio M AUID- ORCID: 0000-0001-5423-9269 AD - KNCV Tuberculosis Foundation, Den Haag, the Netherlands. FAU - Aung, Si Thu AU - Aung ST AD - Dept of Public Health, Ministry of Health and Sports, Yangon, Myanmar. FAU - Aung, Khay Mar AU - Aung KM AD - FHI360, Yangon, Myanmar. FAU - Thuy, Hoang Thanh AU - Thuy HT AD - National Tuberculosis Program, Ministry of Health, Hanoi, Vietnam. FAU - Hoa, Vu Dinh AU - Hoa VD AUID- ORCID: 0000-0002-7976-6716 AD - National Centre of Drug Information and Adverse Drug Reactions & Hanoi University of Pharmacy, Hanoi, Vietnam. FAU - Sulaimanova, Merkinai AU - Sulaimanova M AD - KNCV Tuberculosis Foundation, Bishkek, Kyrgyzstan. FAU - Sagyndikova, Saadat AU - Sagyndikova S AD - National Tuberculosis Program, Ministry of Health, Bishkek, Kyrgyzstan. FAU - Makhmudova, Mavluda AU - Makhmudova M AD - KNCV Tuberculosis Foundation, Dushanbe, Tajikistan. FAU - Soliev, Alijon AU - Soliev A AD - KNCV Tuberculosis Foundation, Dushanbe, Tajikistan. FAU - Kimerling, Michael AU - Kimerling M AUID- ORCID: 0000-0001-7796-9598 AD - KNCV Tuberculosis Foundation, Den Haag, the Netherlands. LA - eng PT - Journal Article PT - Review DEP - 20191011 PL - England TA - Eur Respir Rev JT - European respiratory review : an official journal of the European Respiratory Society JID - 9111391 RN - 0 (Antitubercular Agents) SB - IM MH - *Adverse Drug Reaction Reporting Systems MH - Antitubercular Agents/adverse effects/*therapeutic use MH - *Drug Resistance, Multiple, Bacterial MH - Humans MH - Patient Safety MH - *Pharmacovigilance MH - Risk Assessment MH - Risk Factors MH - Time Factors MH - Treatment Outcome MH - Tuberculosis, Multidrug-Resistant/*drug therapy/epidemiology/microbiology PMC - PMC9488907 COIS- 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. EDAT- 2019/10/13 06:00 MHDA- 2020/04/21 06:00 PMCR- 2019/10/11 CRDT- 2019/10/13 06:00 PHST- 2018/12/17 00:00 [received] PHST- 2019/09/09 00:00 [accepted] PHST- 2019/10/13 06:00 [entrez] PHST- 2019/10/13 06:00 [pubmed] PHST- 2020/04/21 06:00 [medline] PHST- 2019/10/11 00:00 [pmc-release] AID - 28/153/180115 [pii] AID - ERR-0115-2018 [pii] AID - 10.1183/16000617.0115-2018 [doi] PST - epublish SO - Eur Respir Rev. 2019 Oct 11;28(153):180115. doi: 10.1183/16000617.0115-2018. Print 2019 Sep 30.