Pharmaceutical Group of the European Union

Members Area

PGEU Best Practice Paper on Pharmacovigilance and Risk Minimisation


This best practice paper outlines the evolution of pharmacovigilance in Europe, particularly in the context of the fifth anniversary of the 2012 EU pharmacovigilance legislation and recent developments in the field. Additionally, this paper describes the varied role of community pharmacists in ensuring the safe, effective and rational use of medicines in practice. Furthermore, this paper highlights PGEU’s work on pharmacovigilance and risk minimisation measures and provides an overview of best practices from PGEU member organisations.

As the experts in medicines, the most accessible group of healthcare professionals in Europe and often the last professional a patient sees before taking a medication, community pharmacists are profoundly implicated in aspects related to pharmacovigilance, medication use and patient safety.

The broad and diverse areas explored in this paper include prevention and reporting of adverse drug reactions, implementation and adherence to risk minimisation measures in practice, minimisation of medication errors and prevention of drug interactions. Additionally, the paper outlines the use of Good Pharmacy Practices and protocols, the safe use of medicines during pregnancy and breastfeeding and safe use in high risk or particularly vulnerable patient groups. The paper also highlights how community pharmacists improve adherence and promote the most effective use of medications and the use of innovative technologies to enhance patient safety and high quality of care.

As a consequence, the PGEU makes several recommendations in order to maximise the potential contribution community pharmacists can make to pharmacovigilance and risk minimisation activities. They are as follows:

  1. Patient-facing pharmacy services that support the safe, effective and rational use of medicines are beneficial in minimising risk (e.g. medication review and new medicine services) and should be expanded and supported by policy makers and health systems payers to complement services provided by pharmacists related to pharmacovigilance and medication safety;
  2. Where feasible, pharmacists should have access to shared electronic health records to ensure continuity of care and reduce the risks of adverse drug reactions, medication errors, interactions and other harmful events;
  3. Indications should be communicated to pharmacists (e.g. on the prescription) to ensure the most effective and appropriate therapy is provided, as well as to ensure the correct reporting of suspected adverse events from the use of medicines off-label;
  4. Further interdisciplinary collaboration is welcomed between pharmacists and other healthcare professionals to maximise the benefits for patient safety (e.g. more effective problem solving and prevention of adverse events in partnership, continuity of care, reduced costs and administrative burden);
  5. Continued collaboration between national pharmacy associations and national medicines agencies and the PGEU and the European Medicines Agency is welcomed to further strengthen the role and contribution pharmacists can make to patient and medication safety;
  6. Relevant authorities and organisations are incorporating good pharmacovigilance practices, risk minimisation measures and medication safety activities into Good Pharmacy Practices, standard operating procedures, institutional protocols, continuous education, continuous professional development and pharmacy education and training. Such incorporation should be encouraged and supported.