Tuberculosis and pharmacovigilance
WHO defines pharmacovigilance (PV) as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem". The involvement of WHO in pharmacovigilance is intended to enhance patient care and safety in relation to the use of medicines, especially with regard to the prevention of unintended harm from the use of drugs.
- TB patients frequently suffer from adverse drug reactions. These unwanted effects influence patient adherence to prescribed medicine. In some cases TB drug side effects are life threatening. They often necessitate the suspension of treatment or the use of ancillary medication.
- Pharmacovigilance remains very relevant today for the TB practitioner. The scaling up of treatment among populations with varied demographic profile, nutritional status and background co-morbidity (eg, HIV-TB) may influence the form and frequency of adverse drug reactions. In the coming years more patients with drug-resistant TB are expected to be put on treatment, using regimens with multiple drugs lasting many months. Additionally, the prospect of having new TB drugs in the near future means that the clinicians need to be more vigilant for unforeseen side effects to these agents.
- While full capacity for cohort event monitoring (CEM) is being built, patients in need of new TB drugs can be enrolled on treatment as soon as the NTP has ready:
– A broad agreement with the national pharmacovigilance unit to jointly develop and implement a CEM project
– Pharmacovigilance data collection forms and instructions for completion
– Staff properly trained on how to complete data collection forms
Inter-regional workshop on pharmacovigilance for new drugs and novel regimens for the treatment of drug-resistant tuberculosis
Hanoi, Viet Nam 12 – 14 November 2014
The “Inter-regional workshop on pharmacovigilance for new drugs and novel regimens for the treatment of drug-resistant tuberculosis” was organised jointly by WHO Headquarters (the Global TB Programme (GTB) and Essential Medicines and Pharmaceutical Policies (EMP)), the WHO Regional Office for the Western Pacific (WPRO), and the WHO Representative Office in Viet Nam with the support of USAID and UNITAID. The meeting objectives fit within the framework of assistance being provided to national TB programmes (NTPs) and national regulatory authorities to strengthen their pharmacovigilance systems in accordance with WHO policies and ensure that patient safety is effectively monitored during treatment of MDR-TB with new drugs and novel regimens.
Frequently asked questions about the use of cohort event monitoring (CEM) for active pharmacovigilance in TB treatment
- Pharmacovigilance and WHO
Minimum requirements for a functional pharmacovigilance system
- The Uppsala Monitoring Centre
- The importance of pharmacovigilance [pdf 280kb]
- Safety of medicines - A guide to detecting and reporting adverse drug reactions (WHO/EDM/QSM/2002.2) [pdf 285kb]
- Supporting pharmacovigilance in developing countries: The systems perspective [pdf 1Mb]