“Active drug safety monitoring [is] very important, not only for new and repurposed [drugs] but for all anti-TB drugs. If well implemented, it will be a pathway to improved treatment outcomes”
-Nana Kiria, Deputy Director of the National Center of Tuberculosis and Lung Diseases, Georgia
The new TB medicines—bedaquiline and delamanid— for the treatment of multidrug-resistant tuberculosis (MDR-TB) have undergone phase II and IIb clinical trials. However, the limited scale of the studies mean that less common and rare adverse drug reactions (ADRs) are unlikely to have been detected. Typically, the full safety profile of an approved product is established during years of use as more people of different ages, genders, and ethnicities are exposed to the medicines. There is increased potential for ADRs in a more complex patient population than was available during clinical trials. This is further complicated by concomitant diseases such as HIV and AIDS infections, diabetes, liver or renal dysfunction, or malignancies.
Generic model of aDSM within drug-safety structures at the national level
aDSM should be adapted to the local situation to avoid the creation of parallel systems of reporting
© World Health Organization 2015
WHO recommends that active pharmacovigilance and management of adverse drug reactions as one of the conditions under which the new TB medicines are used. Active pharmacovigilance involves proactive measures taken to detect safety concerns by the active monitoring before, during and after treatment.
Active TB drug-safety monitoring and management (aDSM) is used to monitor and manage ADRs in patients who receive new TB medicines and to assess causality. It applies the principles of active pharmacovigilance to the specific needs and context of national TB programs.
For more comprehensive technical assistance in developing a pharmacovigilance system or assessing an existing system for gaps and subsequent strengthening of the pharmacovigilance system, please contact us at newTBdruginfo@msh.org
For questions and information about PViMS, please contact the PViMS team at firstname.lastname@example.org.