Abstract
Background: In Belarus, care for multidrug-resistant tuberculosis (strains resistant to at least isoniazid and rifampicin, MDR-TB) patients has been effectively implemented since 2008. Outcomes however remain unsatisfactory: among patients starting treatment in 2011, 10% interrupted medication, in 24% treatment failed and 11% died. Adverse drug reactions (ADR) are likely to contribute to these negative outcomes. Introduction of new or repurposed drugs in MDR-TB regimens could provoke previously unrecognised ADRs.
Methods: We describe how active pharmacovigilance (cohort event monitoring) was used to improve the detection of drug-related harms in MDR-TB patients treated with Linezolid.
Results: Standard questionnaires were developed by the TB programme and the pharmacovigilance centre of the Ministry of Health to capture data on the safety and effectiveness of Linezolid-containing regimens in accordance with the recommendations of the World Health Organization (WHO). Health care staff collected clinical, laboratory and microbiology data at the start, during and after end of treatment. Between 6 June 2014 and 31 January 2015, 58 MDR-TB patients had Linezolid added for up to 8 months to regimens containing 5-7 other second-line TB medicines. Forty-six (79%) had deranged laboratory test results or other ADRs attributable to anti-TB treatment (various organ systems involved, including blood, metabolic, renal, hepato-biliary and neurological), and 3 (5%) developed serious ADRs requiring withdrawal or reduction of dose.
Conclusion: active pharmacovigilance adds value to other monitoring activities geared to improve outcomes in TB patients on new medicines and regimens.
- Copyright ©ERS 2015
