Tuberculosis and pharmacovigilance
WHO/(from left to right) G. Steenbergen, P. Nunn, G. Hampton, P. Virot
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.
Handbook- PV for TB
Key messages
- 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.
Useful links
- Pharmacovigilance and WHO
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Minimum requirements for a functional pharmacovigilance system
pdf, 163kb - 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]