The WHO Programme for International Drug Monitoring
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
The aims of PV are to enhance patient care and patient safety in relation to the use of medicinal products; and to support public health programmes by providing reliable, balanced information to assess the risk-benefit profile of medicines.
In 1968, during the 16th World Assembly the 16.36 resolution called for “a systematic collection of information on serious adverse drug reactions during the development and particularly after medicines have been made available for public use”. This led to the formation of the WHO Programme for International Drug Monitoring (PIDM).
WHO promotes PV at country level. Initially the WHO PIDM members consisted of 10 countries. As of March 2022, 151 members have joined the WHO PIDM, and in addition 21 associate members are awaiting full membership.
WHO PIDM Members submit reports of adverse reactions associated with medicinal products, known as Individual Case Safety Reports (ICSRs) to the WHO global database, VigiBase. VigiBase is managed and maintained by the WHO Collaborating Centre for International Drug Monitoring, known as Uppsala Monitoring Centre. In October 2021, there were over 28 million reports of adverse reactions in VigiBase. Data in VigiBase are recorded in a structured and comprehensive way to allow the detection of potential medicinal safety hazards.
In April 2015, WHO launched VigiAccess. VigiAccess is a new web application that will allow anyone to access information and encourage the reporting of adverse effects from medicinal products.
The WHO Programme for International Drug Monitoring (WHO PIDM) is an international collaboration with the goal to ensure timely identification of medicines-related safety problems. With more than 170 full members and associate members in the programme in 2022, it covers about 99% of the world’s population.
The countries and regions that are members of the programme work nationally and collaborate globally to monitor and identify harm caused by medicines, to reduce the risks to patients, and to establish worldwide pharmacovigilance standards and systems.
Uppsala Monitoring Centre, in its capacity as the WHO Collaborating Centre for International Drug Monitoring, provides support to programme members to establish and develop national systems for monitoring the safety of medicines. Members have access to UMC’s research expertise and a range of resources, such as data management and analytical tools and services.
MCQ on Pharmacovigilance given at the end of Lecture (see above lecture)
Pharmacovigilance Lectures Playlist
Disclaimer: The presented matter is compilation of various online materials available on the topic with modification and simplification. The content is presented here for student’s easy accessibility as online study material and not for commercial purpose. Plagiarism is not removed.