Pharmaceutical Group of the European Union

Members Area


Pharmacists, along with other health professionals play a key role in collecting and interpreting Adverse Drug Reactions and medication errors, and therefore very much welcomed recognition of this role, and the possibility of specific obligations being given a legal basis in the new Pharmacovigilance Directive.

More than 75%12of medicines are prescribed in the primary care setting and therefore dispensed by the community pharmacists. Hence, effective reporting of ADRs by the community pharmacists is an essential aspect of the pharmacovigilance system in particular when the aim is to be proactive in anticipating and minimising medicines safety issues. Important is the fact that pharmacists come into contact with patient groups that are not routinely involved in clinical trials, for ethical and/or practical reasons (e.g.: pregnant women, children, elderly people and people using many drugs simultaneously). Moreover, pharmacists’ contributions to pharmavogilance systems are not limited to reporting episodic adverse drug reactions but include as well the collection of data that complement longitudinal pharmacoepidemiological studies.

In the number of countries the pharmacists already play a significant role in the reporting of suspected ADRs, while in the others the contribution is still relatively low. In the Netherlands pharmacists are responsible for 40%1 of reports sent to the National Medicines Agency, Lareb. There reports from pharmacists have their own specific characteristics and therefore complement reports received from physicians. Dutch community pharmacists report more on eye and skin diseases because these disorders are more likely to be observed and they also have a special role to play in the reporting of ADRs of the non-prescription medicines. The reporting in the Netherlands is assisted by the fact that pharmacists are able to access medication record of the patient and derive crucial information about patient’s medication history.

No modern pharmacy in Europe could function without a computer and Internet connection; hardware for labelling and ordering medicines, and an e-system to record data regarding reimbursed prescription. Therefore, the establishment of national web portals for electronic reporting will greatly facilitate the process and help reduce uncertainties surrounding the current reporting process.

Seminar on Pharmacovigilance:

PGEU organised in 2010 a seminar on "Adverse Drug Reactions: Moving forward together on Patient Safety" at the European Parliament. The seminar aimed at exploring the practical implications of the new Pharmacovigilance legislation to enable patients and healtporfessionals to act more effectively on adverse drug reactions.

See event page here.

Pharmacovigilance Risk Assessment Committee (PRAC)The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines. The members and alternates of the PRAC are nominated by European Union Member States, in consultation with the Agency's Management Board. To represent healthcare professionals and patient organisations, the European Commission appoints two members and two alternates following consultation with the European Parliament.

Filip Babylon, PGEU President 2010, is the first healthcare professional representative in the PRAC appointed by the European Commission in March 2013. The PRAC's recommendations are considered by the Committee for Medicinal Products for Human Use (CHMP) when it adopts opinions for centrally authorised medicines and referral procedures and by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) when it provides a recommendation on the use of a medicine in Member States.