Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2016

News 15/01/2016

Measuring the impact of pharmacovigilance activities - PRAC adopts new strategy

The Pharmacovigilance Risk Assessment Committee (PRAC), at its January meeting, adopted a 'Strategy on measuring the impact of pharmacovigilance activities'. The new strategy details how to gather data and knowledge on the concrete effect of measures and processes meant to ensure the safe use of medicines for patients in the European Union (EU).

A number of activities are carried out in Europe to ensure medicines are used as safely as possible. These include proactive planning of risk-minimisation measures before a medicine is authorised, the collection and management of suspected adverse reaction (ADR) reports, the detection and management of potential new safety signals for medicines, as well as the planning of post-authorisation studies to generate data on the use of medicines in the real world. As new information emerges from these activities, regulators may take further actions to minimise risks. They can, for example, inform and advise patients and doctors on the best use of this medicine or restrict the use of a medicine in case the medicine's benefits no longer outweigh its risks in a certain population.

Measuring the impact of such activities is crucial in order to know whether the measures taken to minimise the risks of a medicine have been effective. Measuring the impact of pharmacovigilance activities also allows regulators to determine which activities are most successful and so helps to promote best practice and improve pharmacovigilance.

The new strategy adopted by the PRAC builds on existing activities in the Member States and the Agency and relies on a collaborative approach with stakeholders. The strategy will focus on four areas: measuring the effectiveness of risk-minimisation measures on specific products; measuring the effect of specific pharmacovigilance processes (e.g. spontaneous reporting of suspected adverse reactions, signal management); investigating how to ensure engagement of key stakeholders (e.g. patients, healthcare professionals); and further improving methodologies to determine the effect of pharmacovigilance activities on public health.

The strategy includes an overview of activities and deliverables for implementation, with a high-level overview of the strategy's objectives for the next three years as well as a detailed work plan for 2016.

Ongoing referrals

During its January meeting, the PRAC discussed two ongoing referrals. More information on all ongoing referrals is included in the table below. The PRAC did not initiate or conclude a safety referral this month.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting, held from 8-11 February.


PDF icon Agenda - PRAC draft agenda of meeting 11-14 January 2016

Ongoing referrals

Article-20 procedure: TysabriUnder evaluationPRAC adopted a list of outstanding issues and updated the referral timetable.
Article-31 procedure: Fusafungine containing medicinal products for oromucosal and nasal useUnder evaluationPRAC agreed a final list of experts and an updated list of questions for the Scientific Advisory Group (SAG).
Article-31 referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary diseaseUnder evaluationPRAC continued its assessment.
Article-20 procedure: SGLT2 inhibitorsUnder evaluationPRAC continued its assessment.

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