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    Apr 11, 2021
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    Setting up pharmacovigilance based on available endTB Project data for bedaquiline

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    Lachenal et al 2020 Setting up ...
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    Authors
    Lachenal, N
    Hewison, C
    Mitnick, C
    Lomtadze, N
    Coutisson, S
    Osso, E
    Ahmed, S
    Leblanc, G
    Islam, S
    Atshemyan, H
    Nair, P
    Kholikulov, B
    Aiylchiev, S
    Zarli, K
    Adnan, S
    Krisnanda, A
    Padayachee, S
    Stambekova, A
    Sahabutdinova, Y
    de Guadalupe, S
    Moreno, P
    Kumsa, A
    Reshid, A
    Makaka, J
    Abebe, S
    Melikyan, N
    Seung, KJ
    Khan, U
    Khan, P
    Huerga, H
    Rich, M
    Varaine, F
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    Issue Date
    2020-10-01
    Submitted date
    2020-12-03
    
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    Journal
    The International Journal of Tuberculosis and Lung Disease
    Abstract
    SETTING: Active pharmacovigilance (PV) is recommended for TB programmes, notably for multidrug-resistant TB (MDR-TB) patients treated with new drugs. Launched with the support of UNITAID in April 2015, endTB (Expand New Drug markets for TB) facilitated treatment with bedaquiline (BDQ) and/or delamanid of >2600 patients in 17 countries, and contributed to the creation of a central PV unit (PVU). OBJECTIVE: To explain the endTB PVU process by describing the serious adverse events (SAEs) experienced by patients who received BDQ-containing regimens. DESIGN: The overall PV strategy was in line with the ‘advanced´ WHO active TB drug safety monitoring and management (aDSM) system. All adverse events (AEs) of clinical significance were followed up; the PVU focused on signal detection from SAEs. RESULTS and CONCLUSION: Between 1 April 2015 and 31 March 2019, the PVU received and assessed 626 SAEs experienced by 417 BDQ patients. A board of MDR-TB/PV experts reviewed unexpected and possibly drug-related SAEs to detect safety signals. The experts communicated on clusters of risks factors, notably polypharmacy and off-label drug use, encouraging a patient-centred approach of care. Organising advanced PV in routine care is possible but demanding. It is reasonable to expect local/national programmes to focus on clinical management, and to limit reporting to aDSM systems to key data, such as the SAEs.
    Publisher
    International Union Against Tuberculosis and Lung Disease
    URI
    http://hdl.handle.net/10144/619801
    Language
    en
    Collections
    TB

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