MONITORING MEDICINES

Optimizing drug safety monitoring to enhance patient safety and achieve better health outcomes

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 Obiettivo del progetto (Objective)

'Medicines are one of the most common health interventions. Expenditure on pharmaceuticals range from 10–20 % of all health expenditure in rich countries & from 20–60 % in poor countries. Knowledge of appropriate & safe medicines has grown. But the incidence of medicines adverse effects remains high. In a UK study 6.5% of hospitals admissions were related to an adverse drug reaction (ADR). And as many as 10% of hospital admissions may result in death or disease due to errors, half of which may be avoidable. There are gaps in what we know. But even where there is sufficient knowledge, brokering of that knowledge is insufficient. There is a clear & present need to build a network of stakeholders in patient safety, to strengthen information & share the evidence towards actionable learning. The EC Work Programme for 2007–2008 relating to health calls for projects that 'advance the applications of evidence based medicine in Europe'. This proposal will respond to that call by strengthening what we know about medicines, sharing that knowledge, & putting that knowledge to use, to reduce patient deaths & adverse effects due to medicines. Specifically, building patient safety networking to: 1. support & strengthen consumer reporting of ADRs & adverse events 2. expand the role of national pharmacovigilance centres to prevent medicine-related adverse events 3. promote better & broader use of existing pharmacovigilance data for patient safety 4. develop additional methods of pharmacovigilance to complement data from spontaneous reporting systems. Achieving these objectives will help build the scientific basis needed for making informed policy decisions on disease prevention & therapy, & management of resources for health. In particular achieving these objectives will help to identify best clinical practice, to understand decision-making in clinical settings in primary & specialized care & to foster application of evidence-based medicine & patient empowerment.'

Introduzione (Teaser)

Strengthening pharmacovigilance

Descrizione progetto (Article)

'Optimizing drug safety monitoring to enhance patient safety and achieve better health outcomes' (http://www.monitoringmedicines.org (MONITORING MEDICINES)) was designed to learn more about the underlying reasons for adverse reactions to medicines. The project also aimed to reduce patient deaths and negative health impacts from undetected medicine safety problems.

Spanning 4 years, the project included a consortium of 11 partners from Africa, Asia and Europe. During that time, the partners strived to coordinate and encourage greater involvement of all stakeholders. The result was innovative solutions that otherwise might not have been explored.

The project focused on four areas: supporting and empowering patients in reporting medicine-related problems; strengthening the role of pharmacovigilance centres; making better use of existing data; and improving pharmacovigilance systems by developing additional data collection methods.

Project members accomplished many of the original goals. The team produced a handbook, published by the World Health Organization (WHO), on how to establish systems for consumer reporting of ADRs. In addition, practical tools for web-based reporting were developed and implemented.

To improve current pharmacovigilance efforts, guiding principles for detecting, analysing and preventing medication errors were established. MONITORING MEDICINES then encouraged national pharmacovigilance centres to use the information collected to deepen their understanding of adverse incidents. One aspect of this work included developing methods for identifying sub-standard products.

Another goal was to help health care workers and the public retrieve information about ADRs related to HIV/AIDS treatment. By merging HIV ADR data from several sources into a common database, the team was able to develop tools for estimating ADR risks of individual patients. The project also developed methods for detecting problems with drugs for malaria and tuberculosis.

MONITORING MEDICINES has laid the foundation for more work in this area. Based on current findings, additional research and best practice technology can be implemented to enhance patient safety.