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Learning and practicing pharmacovigilance in the Mediterranean countries of the EU

Final Report Summary - MED EPHV (Learning and practicing pharmacovigilance in the Mediterranean countries of the EU)

Pharmacovigilance consists in identifying collecting and analysing the adverse reactions to medicines following their market authorisation; it is an essential practice to safeguard public health and is intended to minimise risks. The recognition and notification of Adverse drug reactions (ADRs) is a complex task requiring knowledge and expertise from health professionals.

The complexity of ADRs recognition and notification is at the origin of the current poor delivery of notifications, in terms of both quality and quantity, to the central medicines authorities (national and European Agency).

In addition, the limited pharmacovigilance support provided, in terms of knowledge dissemination and technical systems, to health practitioners and patients contributes significantly to the scarce production of ADRs recognitions and notifications in the periphery of the health systems and of the market authorisation holders networks. All parties recognise it but in particular the EU pharmaceutical regulators underline that pharmacovigilance is an essential tool in order to ensure public health in the Union.

The MED EPHV project was intended to research and develop an innovative approach to the EU pharmacovigilance practice by designing and implementing a pharmacovigilance cooperative e-learning system specifically addressing the needs and profile of health practitioners and patients of southern Europe (Mediterranean countries). The system will permit to learn and practice adverse drug reactions notification at the peripheral edge of the pharmacovigilance systems.

These objectives that have been set by the MED EPHV consortium were to be achieved through:
- Development of pharmacovigilance e-learning courses and tutoring schemes in line with the latest EU legislation and adapted to the specific national implementation schemes and directed to health professionals of France Italy and Spain.
- Test and validation of the e-learning modules by a representative sample of health practitioners and by selected pharmaceutical industry representatives.
- Study and design of a cooperative environment as the central component of an application grid accessible to LHAs, MAHs and health professionals, to be implemented upon satisfactorily completion of the project.

Upon completion of the project the participating small to medium-sized enterprises (SMEs) intend to commercially exploit the e-learning modules in their respective countries and to establish cooperation agreements in other Mediterranean countries, which have similar business interest and needs.

The MED EPHV approach is based on the modelling of the pharmacovigilance practice, allowing to deliver a suite of software solutions and network based integration services capable to support an efficient ADRs recognition and notification. The grid-based services will include an e-learning system focused on pharmacovigilance science and regulation which will be developed, tested and validated during the project with the active support of three levels of end-users (the SMEs, the health practitioners and the pharmaceutical industry). A knowledge-based notification module compliant with ADRs standardisation (ICH M2). An integration and cooperation environment providing on-line, internet-based portal type of services.

Recognising that at present, in the target EU Mediterranean countries a comprehensive pharmacovigilance e-learning service that addresses the new EU legislation, does not exist, the MED EPHV consortium believes that the potential impact of the project in France, Italy and Spain will certainly be highly positive for public health and represents an unmatched business opportunity for the SMEs. The MED EPHV project development phase has produced as pilot applications a number of models for knowledge representation and for cognition implemented as on-line, Internet based software products.

The expected end-users of these services, which will be offered in the respective markets by the participating SMEs, are of three distinct levels:
a) the health practitioners, LHAs and MAHs staff;
b) the pharmaceutical industries;
c) the SMEs that will exploit the e-learning services.

The consortium partners and the sponsoring institutions believe that the suite of pharmacovigilance services to be provided by MED EPHV could be of great importance for orphan drugs and biomedicines, which represent an increasing market. It is quite clear that the MED EPHV project addresses one very important public health issue of the EU, especially where the performance of the pharmacovigilance is far from being optimal. An efficient EU pharmacovigilance system could also indirectly provide strong support to the solution of other recent issues such as the monitoring of bio terrorism and the increasing appearance of adverse reactions in young people to tattoo colours and body piercing practices.

Concerning the consortium management activities, the project coordinator has implemented the intranet-based MED EPHV communication and cooperation platform, not only for the purpose of sharing project related documents and deliverables between partners, but also for loading and testing the on-line ADR notification software and e-learning modules. A project master document has been approved and adopted by all partners together with common cost control procedures and tools. A project risk analysis has been conducted and a project risk management plan put in place to promptly address unexpected threats, and allowing the undertaking of any needed remedial actions. Five project steering committee meetings have been held as planned.

Concerning the RTD and innovation activities, the SME partners with the support of RTD performers have conducted a detailed analysis of the pharmacovigilance business process, identifying the current pharmaceutical legislation of the EU as implemented in France, Italy and Spain.

Overall the main achievements of these project activities are:
a) the comparative analysis of the implementation of this business process in the EU and in particular in the three Mediterranean countries;
b) the identification of the requirements for an improved pharmacovigilance business process.

The design work performed prior to the implementation of the e-learning pilot applications has covered the following main lines:
- Definition of cognitive models for the design of advanced e-learning schemes. These models have been based on a detailed map of the medical, pharmacological and genetic issues at the origin of the adverse drug reactions and on the different types of actors that operate at the peripheral edge of the pharmacovigilance systems.
- Definition of the knowledge base representations and the inference mechanisms needed to support the identification of ADRs, focusing on the established standard model for ADRs notification (ICHM2) as implemented in Italy, France and Spain. The selection of representative case histories to be included in the ADRs recognition module.

The implementation phase, based on the MED EPHV system design, has been satisfactorily accomplished and the French, Italian and Spanish pilot systems tested and validated by a representative samples of selected end-users. The implementation phase of the e-learning pilot system included setting up of the on-line ADR recognition and notification pilot following the rules prescribed by the ICHs standard, integrated with all the available notes / improvements from the quoted sources. The integration has also covered all those taxonomies which were considered to be more beneficial for didactic purpose. The DRUPAL open-source platform satisfactorily used for the MED EPHV Intranet, has been chosen also for developing the ADRs software.

Setting up of the online e-learning modules using the MOODLE open-source platform. The modules that have been implemented cover a complete in-depth pharmacovigilance training program in the three languages. The system permits to automatically extract and package the modules to fit the specific learning needs of the target categories of end-users. The modules include learning tests based on questionnaires and automatic rating system of the answers. Design of a state-of-the-art grid middleware to be shared among the SME partners during the commercial exploitation phase. The resources that MED EPHV integrates are a learning management system (LMS) and a grid middleware. These two elements are based on web and grid services respectively.

Promotion of the MED EPHV project and dissemination of the achieved results in the three countries and at EU level have played an important role since the start of the project. Partners of the Consortium have been active in presenting the MED EPHV project with articles and at conferences in their respective countries, following a pre-established plan jointly developed by the SME and RTD partners. The MED EPHV website (see http://www.medephv.net online) is the mirror of the project and point of access to the online services.

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