Salvatore Messana is an Italian community pharmacist who sits as the healthcare professional representative on the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. In this article, Mr Messana explains the role of the Committee, and why he believes community pharmacists are best placed to contribute to keeping medicines effective and safe in the EU.
Community pharmacists, through their accessibility and frequent patient interactions, are uniquely positioned to enhance pharmacovigilance efforts, ensuring safer medication use and contributing to overall public health. Community pharmacists play a crucial role in the detection, assessment, understanding, and prevention of adverse effects and other medicine related problems.
The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency’s (EMA) Committee responsible for assessing and monitoring the safety of human medicines across the EU.
The PRAC is responsible for assessing all aspects of risk management of human medicines, including:
The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the EMA Committee for Medicinal Products for Human Use (CHMP) for centrally authorised medicines and referral procedures, to the Member States and to the European Commission.
The PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe.
The European Medicines Agency YouTube Channel hosts a video that provides an overview of the day-to-day activities of the EMA’s safety committee, searchable under the title ‘How does EMA ensure the safety of medicines in the EU’.
The members of the PRAC are the pharmacovigilance experts appointed by each Member State, scientific experts and representatives of healthcare professionals.
Salvatore Messana is a community pharmacist from Caltanissetta (Italy) who has been appointed since 2022 as the healthcare professional representative, for a three-year term, to the PRAC. In this interview, Mr Salvatore speaks about his experience at PRAC and about the role of pharmacists in pharmacovigilance.
It has been a fascinating experience to be the voice of community pharmacists in the PRAC, and to share our perspective in international discussions. The PRAC is the EMA Committee responsible for assessing and monitoring the safety of human medicines. Of course, no medicine is exempt from risk, and this is why the Committee meets once a month, to discuss and assess all aspects of risk management of human medicines. Our work focuses on the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account; but is also includes the design and evaluation of post-authorisation safety studies; or even pharmacovigilance audit.
It surely is interesting, and highly motivational to contribute to increasing the safe use of medicines in the EU. It is true that even though the Committee meets once a month, the week of the meeting is always very packed and intense! We take the time to prepare and read all the materials and study all the dossiers, as PRAC assesses all types of medicines, covering a vast spectrum of therapeutic indications. As a community pharmacist, my role is to provide insights and concrete examples of how risk minimisation measures, for example, can be applied in practice and have a maximum effect on primary care. Community pharmacists have direct contact with patients every day, and this is an invaluable experience to bring to a forum where mostly regulators are present. As a representative of European healthcare professionals, it is my duty to showcase how measures, when they are designed at central level, can have an impact on the practice level, impacting pharmacy practice on a day-to-day basis.
It is true that in the majority of cases pharmacists are the healthcare professional more readily available and accessible to patients. This means that pharmacists play a key role in notifying medicines adverse reactions that can occur, contributing to strengthening the pharmacovigilance system and increasing the safety profile of medicines. However, we still see room for improvement in what notification of adverse events concerns. This is an opportunity that should be better grasped by healthcare professionals, and in particular community pharmacists. The notification of adverse events is essential to maintain medicines information that is up-to-date, accurate, and is a responsibility of all citizens who take medicines. However, we still see a small percentage of adverse events being reported by community pharmacists. This is a lost opportunity to increase community pharmacists’ involvement in pharmacovigilance activities and improve the safety of the medicines on the market. Pharmacists and doctors should report more, and they should be enabled to do it in a quick and digital way. They should also provide support and guidance to patients who want to report the adverse events they experienced directly to their local national medicines’ agency.
When the safety profile of medicines changes due to a referral, a change in the safety signal or any other procedure, sometimes there are actions that need to be taken to minimise risks related to a medicine. These can be, for example, changes in the advice of healthcare professionals to patients, new information on the paper product information leaflet that accompanies every medicine in the EU, or changes in the prescription/dispensing pattern of a medicine. It is therefore fundamental to have the perspective of a community pharmacist, when PRAC recommends new measures to minimise the risk of a medicine. Community pharmacists know from their experience whether a risk minimisation measure would work, is effective, or the impact it can have on their daily practice. Furthermore, having direct liaison and a good collaboration with our colleagues from hospital pharmacy is critical to ascertaining that the measures are effective, proportionate and will not burden the healthcare professionals. My role in PRAC is often supported by my daily practice experience, being in contact with patients, and providing real-life experiences and events.
“I believe that community pharmacists, who are passionate about providing care to their patients, are the best equipped healthcare professionals to continuously contribute to keeping medicines effective and safe in the EU.”
The future of pharmacovigilance is, in my opinion, a bright one. As the number of innovative medicines that every year enter the market, based on new technologies and to respond to unmet needs, is increasing, so the vigilance system needs to adapt and to be nimble in collecting safety signals and addressing these appropriately. The number of medicines that are available to the public is increasing, and we see through recent cases that not only innovative medicines require special attention, but often medicines that have been in the market for a long time too. For example, the recent referral of pseudoephedrine-containing medicines, or valproate medicines, that had their safety profile changed, and therefore a set of measures had to be implemented to minimise the risk involved in taking these medicines. These were medicines that were available in community pharmacies in the EU, to which the role of community pharmacists is highly relevant. Following the recommendations from the EMA, increasing the number of adverse events reported by pharmacists, and contributing to monitoring and reporting activities, are areas in which pharmacists can be further involved in. I believe that community pharmacists, who are passionate about providing care to their patients, are the best equipped healthcare professionals to continuously contribute to keeping medicines effective and safe in the EU.
Highlighted Articles
