Project 0708

[Pavan Outlaw]

TheStrengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action brought together national medicines regulators from the European Economic Area to develop guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice.

The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action was a public initiative co-ordinated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). The SCOPE Joint Action was created to support pharmacovigilance operations in the European network, minimise duplication of work, and make the best use of work sharing and resources. A key aim of the project was to help lower-resourced national competent authorities (NCAs) develop skills and capacity in pharmacovigilance, and thereby help safeguard public health in both national territories and the European Union (EU) as a whole.

Second, in July 2012, the new pharmacovigilance legislation specified in Regulation (EU) No 1235/2010 and Directive 2010/84/EU came into force across the EU, introducing new standards and requirements for all Member States to meet, including supporting the work of the Pharmacovigilance Risk Assessment Committee (PRAC). PRAC members are appointed by the EU Member States, and the committee includes independent experts appointed by the European Commission (EC), as well as representatives of healthcare professionals (HCPs) and patients [3].

The Joint Action aimed to provide NCAs with the knowledge, tools and confidence in their capability to identify and promote strengths and expertise while developing weaker pharmacovigilance areas in order to broaden capacity and breadth of work and meet their statutory obligations. The SCOPE outputs aim to provide practical advice and tools, supporting Good Vigilance Practice (GVP) guidelines and other existing systems.

The SCOPE consortium consisted of 28 medicines regulators from the EU and European Economic Area (EEA), and was supported by several other organisations with specific interest and expertise in pharmacovigilance topics (Table 1). The outputs from the SCOPE Joint Action were developed through a number of work packages (WPs) (Fig. 1):

Coordination (WP1) had overall responsibility for the coordination and project management of SCOPE, including financial management, reporting to the EC, and ensuring that the Joint Action was accomplished on time and with high-quality deliverables.

ADR collection (WP4) focused on national schemes for the spontaneous reporting of ADRs by HCPs and patients, and aimed to provide NCAs with a better understanding of available systems and practices for collecting ADRs.

Signal management (WP5) sought to further improve understanding of signal management within the EU NCA network, develop best practice in signal management, and provide training to national medicines regulators.

Risk communication (WP6) focused on risk communication practices in the EU network, and aimed to understand communication channels, tools used, and effectiveness of different strategies and methods.

Quality management systems (WP7) aimed to develop tools to support quality standards in pharmacovigilance systems, and to increase existing knowledge on quality management systems through provision of a training programme.

Lifecycle Pharmacovigilance (WP8) explored existing standards for pharmacovigilance assessments and examined the availability and use of alternative data sources (outside of spontaneous reports) for pharmacovigilance assessments in different European NCAs.

The WPs were led by NCAs from seven Member States, and representatives from these organisations comprised the WP Leaders Group (Table 1), which was responsible for the delivery and management of SCOPE. The project was also supported by a General Advisory Board. The Board was formed of representatives from organisations independent of those delivering and managing the joint action, and provided strategic advice and enabled the delivery of high standard outputs and results (Table 1).

This paper focuses on the work completed by the SCOPE consortium, and provides an overview of all outputs released to the pharmacovigilance network. The deliverables presented in this publication relate to the research conducted by the SCOPE Joint Action between 2013 and 2017. For a full description of the studies, please refer to the cited original survey reports published on the project website, or to scientific publications. The SCOPE outputs have been published on the project website ( ), which will continue to be live until the end of 2019. These outputs will also be transferred to the CHAFEA and included in the project database. SCOPE learning materials were also transferred to the EU Network Training Centre (EU NTC), a joint training initiative endorsed by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA).

The results from all survey reports were used to inform SCOPE recommendations, training materials, guidance documents and other tools delivered over three years, as well as to design training sessions and workshops.

An ADR is defined as a noxious and unintended response to a medicine, and the legislation requires that Member States take all measures to ensure that the ADR reporting legislative requirements are fully met [4]. Information about national pharmacovigilance systems, information technology (IT) system capabilities, implementation of patient reporting schemes, reporting forms in use, and electronic reporting developments was collected from national medicines regulators via web-based survey tools. In total, six questionnaires were developed and covered topics including national reporting systems, medication errors, patient reporting, awareness levels, reporting forms and IT systems and special report forms [5,6,7].

Overall, differences in national pharmacovigilance systems among NCAs were observed, including various systems for processing ADR reports; legal specifications in addition to the EU legal requirements; resources and budgets; and various IT systems. Therefore, recommendations from this work stream focused on different aspects of pharmacovigilance business activities using good practice examples from NCAs [5,6,7].

The EU legislation introduced an EU-wide process for signal management, with specific responsibilities and interactions among all stakeholders involved [4]. A web-based survey was developed by WP5 to gather information on all aspects of signal management among the different Member States in the EU. The survey contained questions about general organisation, approaches to signal detection, signal validation and prioritisation, signal confirmation and assessment, and reports of special interest. The results outlined the existing heterogeneity in the process of signal management within the EU network. This heterogeneity appears to be beneficial for the whole system, especially with regard to the signal detection process. Several challenges were identified, such as the terminology and definitions used in the signal management process at Member State level, which lead to complexities in the interpretation and implementation of the existing legislation, the need for resources and good training, awareness of the available data sources and access to data, and the need for tools to support the signal management process [8].

Three web-based questionnaires aimed at identifying quality management systems were developed, including processes and preferences. The first questionnaire asked Member States a series of questions on their national quality systems; the second questionnaire investigated how Member States approach resource management; and the third questionnaire focused on interactions between pharmacovigilance assessors and inspectors. Analysis of responses provided insight into the quality management practices of EU NCAs, including challenges that national medicines regulators are facing and good practices developed to operate their pharmacovigilance quality systems [12,13,14]. Survey results illustrated the diverse approaches used nationally, and informed development of a quality management toolkit that comprised of guidance documents, e-learning modules and other supporting tools (Table 2).

European NCAs differ in terms of structure, organisation and resources available. The SCOPE recommendations and outputs aim to complement the existing GVP guidance to enhance pharmacovigilance practice in the EU. The SCOPE project delivered sustainable outcomes for NCAs that last beyond the end of the project through the creation of training materials and living documents, which can be reviewed and adapted periodically. The SCOPE WPs focused on different aspects of pharmacovigilance practice and produced various deliverables depending on the network needs identified via SCOPE surveys. Thus, WPs delivered different numbers and types of outputs (Table 2).

A comprehensive overview of national ADR reporting schemes, presenting a variety of current methods and practices identified in WP4 surveys, were delivered in the form of three reports. These reports present an overview of national schemes and how ADR processes have been implemented across Europe.

Recommendations from this work, along with good practice examples identified in the WP4 surveys and via follow-up communication, informed the development of guidance documents, e-learning modules and other learning materials (Table 2). These tools are intended to support NCAs, including their regional centres and national pharmacovigilance centres where applicable, to strengthen their existing strategies and practice in order to increase the number and quality of suspected ADR reports.

The 2012 pharmacovigilance legislation required all Member States to provide a web-based form for reporting suspected ADRs for patients and HCPs [4]. In 2014, the WP4 surveys found that ADRs can be spontaneously reported by patients to NCAs via the following channels: mail (24 NCAs), fax (20 NCAs), e-mail (21 NCAs), web-based forms (20 NCAs) and telephone calls (19 NCAs). One NCA also had mobile reporting availability. Of the Member States, 21 had a web form for receiving reports from HCPs. The same NCAs who did not have a web form for patients, also did not offer this way of reporting to HCPs. However, there were two exceptions; one NCA had a web form for HCPs, but not for patients, and another had a web-based application only for patients [5].

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