Pharmacovigilance: update on activities by the European Medicines Agency

Fergus Sweeney (EMA) & June Raine (PRAC Chair)
Fergus Sweeney (EMA) & June Raine (PRAC Chair)

The European Medicines Agency is today holding its Tenth stakeholder forum on the pharmacovigilance legislation of the European Union. This forum brings together regulators with patients, consumers, healthcare professionals and industry, to take stock of what the EMA has achieved and what needs to be the focus over the coming years.

The programme is being broadcast live with presentations thereafter available on the EMA website.

Key presentations include:

  • a 3-year update on pharmacovigilance activities by Dr Helen Lee from the European Commission
  • a report on SCOPE (The Strengthening Collaboration for Operating Pharmacovigilance in Europe) by Dr June Raine, head of the EMA’s PRAC (Pharmacovigilance Risk Assessment Committee)
  • the Impact of pharmacovigilance by Almath Spooner from the Health Products Regulatory Authority, Ireland
  • the PROTECT health project involving active information-sharing by patients
  • the WEB-RADR project on harnessing mobile apps and geo-tagging from Philip Tregunno from the UK MHRA – using social media as a signal detection and strengthening tool
  • actions from the EMA Risk Minimisation Measures Topic Group from Jamie Wilkinson, PGEU (Pharmaceutical Group of the European Union)

The EACPT – the European Assocation for Clinical Pharmacology and Therapeutics – has 34 member countries in the EU region and beyond, and around 800 individual members. Considering some of the recent pharmacovigilance activities important for an organisation such as the EACPT, these include:

  • the 2013 black triangle scheme which concerns an evolving list of medicines under additional monitoring, building on UK experience of this approach to pharmacovigilance. Many EACPT members are directly or indirectly involved in reporting and monitoring issues related to safety of medicines
  • The EMA-ADR database of ~6 million reports – a growing resource for recording and assessing risk from medicines
  • Robust systems regarding the supply chain are vital to ensure safe medicines including from internet pharmacies. Falsified/contaminated/counterfeit medicines must be excluded both in established and newer members of the EU. This will be one of the– key themes at the next EACPT Congress in Prague in June in 2017.

Important drivers for change over the next five years include

  • transparency and impact of EMA pharmacovigilance activities
  • enabling partnerships, including through active EMA working parties involving healthcare professionals, patients and consumers
  • Digital Media to complement current safety systems for evaluating medicines

Enhanced systems are needed for evaluating Real World health data across the EU region, for example analogous to the US Sentinel model – an HMO partnership with FDA and Harvard, and large Clinical Practice databases in the UK.

These Real World health data resources are needed to support evaluating signals from social media to complement existing systems for identifying and preventing adverse drug reactions, as well as to support development of medicines for patients with rare diseases.

Effective expanding use of social media will to enhance communications on PV from the EMA to its partner organisations: and through them tp health professionals, patients and other stakeholders. Systematic heterogenous use of social media provides great opportunities to enhance efficiency of effective delivery and monitoring adoption of safety messages – some of which were aired at the EMA earlier this week – presentations from the day will be on the EMA website.

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