The overall aim of ‘Monitoring Medicines’ will enable us to learn more about why adverse drug events occur so that we can act to reduce patient deaths and negative health impacts arising from undetected medicines safety problems globally. This will be achieved by advancing application, co-ordination and optimal use of pharmacovigilance evidence, and strengthening the links between the various individuals, national pharmacovigilance centres and experts involved. Importantly, the project will also strive to advance consumer involvement in reporting of ADRs, and to mobilize and sustain political commitment to working on drug safety issues.

The four specific objectives will contribute to meeting the overall project objective. Activities to achieve these specific objectives will be undertaken via 13 work packages, with project management and co-ordination will be covered by an additional work package (WP14).

• Co-ordination objective 1

Strengthen consumer reporting of ADRs through review of existing consumer reporting methods, identification of optimal methods for consumer reporting, and training in best practice in consumer reporting of medication-related problems.

Work Package 1: Organize review of consumer reporting of ADRs
A review of consumer reporting of ADRs in about 10 countries will be organized. The results of the review will be used to identify optimal methods for consumer reporting.

Work Package 2: Organize preparation of a guideline on consumer reporting of ADRs

Work Package 3: Organize collection of consumer reports on ADRs
UMC will be supported to adapt its data management tool (VigiFlow) to receive, store and manage consumer reports.

Work Package 4: Organize consumer organization training in consumer ADR reporting
WHO will organize two workshops to train consumer organizations in using the guideline to promote collection and forwarding of consumer ADR reports to the WHO (UMC) database.

• Co-ordination objective 2

Encourage national pharmacovigilance centres to expand their activities to learn more from existing data through: collection of information on adverse events relating to drug prescribing, dispensing and administration, analysis of these data, and dissemination of findings internationally.

Work Package 5: Training in root cause analysis (RCA) of subsets of national pharmacovigilance data
Ten national pharmacovigilance centres will be trained to identify drugs that are frequently associated with safety risks, and in RCA of identified reports, with a view to actionable learning, i.e. changing behaviour, on the part of health care providers.

Work Package 6: Development of a guideline on national analysis of medication errors and their prevention
The Moroccan centre will collate the results of data analysis from the 10 national pharmacovigilance centres and produce a guideline describing how to undertake step-by-step analysis of data contained in national pharmacovigilance databases.

• Co-ordination objective 3

To promote better and broader use of existing global pharmacovigilance data through advanced data mining, to identify medicines with dependence liability and medicines of substandard quality.

Work Package 7: Oversee a pilot project aimed at identifying drug dependence indicators, for medicines in the WHO global individual case safety report (ICSR) database.
The research team at the Uppsala Monitoring Centre will identify indicators of dependence liability, using the ICSR data in the WHO ADR database. The work will take into account previous UMC research where a number of candidate terms were reviewed for their ability to predict dependence.

Work Package 8: Oversee a pilot project aimed at development of tools to identify reports indicating substandard medicines
The research team at UMC will identify ICSRs of therapeutic inefficacy, as an indicator of substandard medicines. Possible explanations, other than substandard medicines, will be reviewed. Those reports for which therapeutic inefficacy is suggestive of substandard medicines will be further analysed, and resulting patterns reviewed and classified.

• Co-ordination objective 4

To develop, in collaboration with target countries, robust and appropriate pharmacovigilance systems, incorporating both active and focussed spontaneous surveillance methods, to address national drug safety priorities.

Work Package 9: Define broad methodological principles for active and focussed spontaneous reporting systems
A draft guideline on the broad principles of active surveillance and focussed spontaneous reporting systems will be developed, for countries seeking to enhance their spontaneous reporting systems.

Work Package 10: Workshops for pilot countries on using active and focussed spontaneous surveillance for disease-specific pharmacovigilance
WHO will organize three regional workshops for 9 countries to introduce the guideline developed in WP9, and to pilot its adaptation and implementation for meeting disease-specific pharmacovigilance objectives.

Work Package 11: Review pilot of active surveillance and focussed spontaneous surveillance, and oversee finalization of guideline on these methods
Pharmacovigilance centres will collect reports of adverse events in patients treated with medicines for HIV/AIDS or malaria, using active and focussed spontaneous surveillance methods on which they received training under WP10. Based on the collated information, the guideline developed under WP9 will be finalized, published and disseminated to countries participating in the WHO Programme for International Drug Monitoring.

Work Package 12: Development of software for collecting active and stimulated passive surveillance data
UMC will be supported to develop software to create a WHO database for receiving reports collected through active and focussed spontaneous reporting methods.

Work Package 13: Organize a pilot pharmacovigilance database, using HIV ADR data, by merging HIV ADR from several sources into a common database
A user-friendly web-based query tool will be developed to enable health care workers to search and retrieve information contained in the database. A distant web-based learning tool to train and assist health care workers in evaluating the ADR information retrieved (and which will include testing of acquired skills) and a risk score calculation tool, to allow evaluation of ADR development based on clinical data, will also be developed.

Work Package 14: General project management, communication and co-ordination
This package is to manage and co-ordinate project activities; provide overall project direction; to effectively manage project finances and reporting to the EC; to ensure adequate communication; and to communicate project results and outputs to all relevant stakeholders.


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