EMA

PGEU is a long-time member of the European Medicines Agency’s Healthcare Professionals’ Working Party (HCPWP), as well as having been Co-chair of the HCPWP’s Topic Group on Minimisation Measures (TG on RMM). Additionally, PGEU has had a nominated representative on the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) for three consecutive terms representing Healthcare Professionals.

EMA’s Healthcare Professionals’ Working Party (HCP/WP) Representation
The PGEU is a proud member of the EMA’s HCPWP, a network of European healthcare professionals associations’ stakeholder groups. The HCP/WP acts as platform for exchange of information and discussion of issues of common interest between HCPs and the EMA. Formed in 2013, it builds on the previous established relations between HCPs and the EMA. The WP provides recommendations to the EMA and its human scientific committees (such as PRAC) on issues related to medicines. The HCP/WP meets three times a year at the Agency’s Headquarters, along with the Patients and Consumers Working Party. Membership of the HCPWP provides an excellent opportunity for the needs, perspectives and experiences of community pharmacists to be reflected in the work of the EMA and related policy, communications and guidance.

 

Consultations
In the past three years, PGEU has responded to over 50 public and targeted consultations for the EMA as part of its role in the HCP/WP. The responses comprised general PGEU feedback, as well as individually and in smaller groups, as several PGEU member representatives are approved as technical experts for the EMA. The majority of consultations for which PGEU provided input were related to pharmacovigilance, medication safety and related issues.

 

Participation in EMA Workshops
In the past three years, PGEU has presented, participated in panel discussions or actively contributed to over 30 workshops and meetings hosted by the EMA on various topics, most notably on pharmacovigilance, medication safety and related topics. PGEU is often invited to present or contribute to EMA workshops as a result of PGEU’s active contribution to pharmacovigilance activities and being the representative organisation of the 400.000 community pharmacists in Europe. Examples include workshops on measuring the impact of pharmacovigilance activities, medication errors, medication or class-specific workshop consultations and the annual Pharmacovigilance Stakeholders Forum.

 

Public Hearings
One of the developments following the 2012 EU pharmacovigilance legislation was the introduction of ‘Public Hearings’ as part of PRAC’s work. Public hearings are organised in order to give EU citizens a voice in medication safety evaluations and enable them to express their views on issues related to the safety of specific medicines and the management of such risks.
The first public hearing has been held under the auspices of the September 2017 PRAC meeting and focused on sodium valproate (and related substances) in the context of the PRAC referral on this medication. As valproate is a commonly dispensed medication in community pharmacies, this referral and public hearing had particular relevance to community pharmacists across Europe and PGEU has been closely following the work concerning the valproate referral and public hearing.

 

EMA HCP/WP Topic Group on Risk Minimisation Measures
As part of PGEU’s role in the HCP/WP, between 2015-2017 PGEU was the co-chair of the HCP/WP’s Topic Group (TG) on Risk Minimisation Measures (RMMs). As a result of the work conducted in the RMM TG, several recommendations (see annex 5) were made to the EMA and PRAC for consideration to improve the implementation and adherence to RMMs. They include a recommendation to involve HCPs earlier on in the development process of additional risk minimisation measures and likewise to involve HCPs earlier on in the development of routine risk minimisation measures.

Additionally, the TG recommended that guides and checklists should cover all HCPs involved in medication use, including pharmacists and that information provided to patients could be better balanced / articulated (e.g. include side effect frequencies, information on risk of other medicines in same class / alternatives). The TG also recommended that consideration should be given to making information available on the outside of the package and in the SmPC, as a summary, prompt or removable card to facilitate dialogue with patients.

The TG made further recommendations that communications should be targeted to the various audiences with appropriate tools, using mixed media channels and the use of scientific publications, communications or events for disseminating information concerning RMMs.
The TG also proposed points for consideration by HCPs, including the possibility of incorporating RMMs into institutional protocols or guidelines and incorporating RMMs into HCP Continuous Education (CE) / Continuous Professional Development (CPD).

Furthermore, the TG recommended widening access to shared eHealth records (with indications / diagnoses / reported ADRs or side effects) and encouraging multi-professional collaboration and shared responsibilities. Finally, reflection on dissemination practices concerning RMMs for European level stakeholder / representative bodies could also be considered.

 

EMA Pharmacovigilance Risk Assessment Committee (PRAC)
Since PRAC’s formal inception in 2012, PGEU has played a pivotal role in PRAC by having a PGEU member representative nominated by the European Commission as the official representative for HCPs on the committee. A PGEU member representative held this position for the first mandate (Mr Filip Babylon, Belgium), PGEU continued to have a member representative nominated for the second mandate in 2016 in the person of Mr Raymond Anderson (UK), who has also been re-elected for the third mandate (2019-2021). PGEU’s presence on PRAC provides the opportunity to bring a practicing healthcare professional’s perspective to the work of PRAC more generally, but also the perspective, experiences and opinions of pharmacists to relevant discussions in the committee.
This is particularly important when the practical aspects of medicine prescribing, supply issues and their associated risks are being discussed by the committee. Input from a HCP/pharmacist can facilitate the PRAC in discussions when assessing changes to a medicines licence. It can also help in assessing the need to communicate directly with healthcare professionals, how this should be done and the value of doing so.