European Pharmacists release Best Practice Paper on Pharmacovigilance and Risk Minimisation

On the 26th September, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) held its first ever Public Hearing. Such Public Hearings are intended to give EU citizens a voice in medication safety evaluations and their introduction is as a direct result of the 2012 revisions to EU pharmacovigilance legislation, which this year, celebrates its fifth anniversary.

On the same date, the Pharmaceutical Group of the European Union (PGEU) published a Best Practice Paper on Pharmacovigilance and Risk Minimisation in order to highlight the role community pharmacists play in ensuring the safe,
rational and effective use of medicines across Europe.

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 paper provides an overview of the activities and services community pharmacists provide to ensure the highest level of patient safety, as well as several key recommendations:

  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.