Pharmacovigilance identifies and quantifies the risks of medicines use by analysing reports of adverse drug reactions and other adverse events, such as medication errors, and considers them within the context of their effectiveness. Although existing pharmacovigilance systems and activities are useful in identifying patient safety issues, there is considerable scope for optimizing and improving their use, particularly through wider inclusion of stakeholders in reporting of adverse drug reactions, promotion of harmonized reporting systems and broader application of data gathered on adverse drug reactions.
Monitoring Medicines is a large-scale collaborative project with the main aim to reduce patient deaths and negative health impacts arising from undetected medicines safety problems in the EU and globally.
This is being achieved through four specific objectives:
The project is coordinated by Uppsala Monitoring Centre (Sweden) with World Health Organization (Headquarters) as the main partner and with nine other beneficiaries world-wide.
Medicines are one of the most common health interventions globally. Knowledge of appropriate and safe medicines has increased, but the incidence of adverse effects of medicines remains high. There is a clear and present need to build a network of stakeholders in patient safety to strengthen information and share the evidence towards actionable learning.
This project aims to increase our knowledge about medicines, to share that knowledge and put it to active use to reduce the number of patient deaths and adverse effects occurring from medicines in a global perspective.
A practical handbook entitled ‘Safety monitoring of medicinal products – Reporting system for the general public’ has been developed and published by WHO. It provides practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines .
The Uppsala Monitoring Centre has developed a unique web-based reporting tool for patients. It will be offered to 4–5 national pharmacovigilance centres for piloting during 2012. Thereafter it will be available to any country wishing to use it. In countries adopting the new reporting tool, patients will be in a better position to express their experiences with medicine therapy directly to the health authorities.
A training course on Medication Errors (ME) was organized for representatives of 10 countries in 2011. The training was aimed at identifying preventable safety problems associated with medicines. A guideline on detecting, analyzing and preventing medication errors within pharmacovigilance is being developed. The document will be finalized during this year and will be available from WHO.
The research team at Uppsala Monitoring Centre has developed data mining methods that will increase the ability to identify early signs of dependence liability of medicines in VigiBase, the WHO database of adverse drug reactions and other similar databases.
Data mining methods that can identify clusters of reports of therapeutic inefficiency from geographical areas in limited time windows have also been developed by the team. These novel algorithms provide methods for the identification of suspected substandard medicinal products and antibiotic resistance from existing pharmacovigilance data.
A detailed manual giving a step by step approach to undertaking the pharmacovigilance of anti-tubercular medicines has been produced. It is intended to be a source of practical advice for pharmacovigilance centres and health professionals involved in the National TB Control programmes. Training courses on Cohort Event Monitoring and Targeted Spontaneous Reporting in public health programmes have been conducted. These methods are now being piloted in selected countries in Europe and Africa.
The Monitoring Medicines has resulted in the development of important guidelines, tools and information resources for the safety monitoring and safe use of medicines. These achievements will help build the scientific basis needed for making informed policy decisions on disease prevention and therapy, and for the effective use of resources for health. The results will promote best clinical practices, by supporting decision-making in clinical settings and will empower patients in pharmacovigilance.