Inter‐regional workshop on pharmacovigilance for new drugs and novel regimens for the treatment of drug‐resistant tuberculosis

Overview

Pharmacovigilance (PV), defined by WHO as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug‐related problem" is a core component of the pharmaceutical management system, and represents an arm of patient care.

In many countries, the notification of adverse drug reactions (ADRs) to any medicines, including anti‐ TB drugs, is normally in the form of spontaneous reporting. While this is considered the most common form of PV that all countries should have, it is not an active measure to look for and report all adverse events and safety concerns when the risk of harm related to medicines is high, especially when treatment regimens are complicated or limited experience exists with the use of certain medicines in particular patient subgroups. Such is the case today for patients with multidrug‐ resistant TB (MDR‐TB), especially when patients receive treatment with regimens based on new (e.g. bedaquiline or delamanid) and repurposed (e.g. linezolid, clofazimine) drugs. Under such circumstances, active PV techniques, such as Cohort Event Monitoring (CEM), can monitor patient safety in a more rigorous and systematic manner, as recommended in the WHO interim policies for the use of bedaquiline and delamanid. Some countries are currently introducing CEM within the monitoring framework of TB patients, such as in Belarus where CEM has been used since 2013 to monitor the HIV‐infected TB (TB/HIV) patients on anti‐TB and antiretroviral medication. A number of partners are supporting these efforts in several countries, including KNCV‐Tuberculosis Foundation, Médecins Sans Frontières (MSF), Partners In Health (PIH), the UNION, and US CDC. In addition, the USAID‐funded project Systems for Improved Access to Pharmaceuticals and Services (SIAPS) of Management Sciences for Health (MSH) is promoting PV and safe drug use in a number of countries and settings.