Introduction
In March 2006, the Commission launched a public consultation on the Community system of pharmacovigilance. The objective of the consultation is to collect the views of stakeholders on the community system, including comments on the current functioning of the system and how it might be further strengthened.
At the same time, the Commission published a report entitled “An Assessment of the Community System of Pharmacovigilance”, with the aim of informing the consultation and stimulating the debate on the Community System of Pharmacovigilance. This study, funded by the Commission, was conducted by the Fraunhofer Institute Systems and Innovation Research, in collaboration with the Coordination Centre for Clinical Studies at the University Hospital of Tuebingen. The study was based on collection of data through questionnaires and interviews of staff working in pharmacovigilance in Member State regulatory authorities and in the European Medicines Agency(EMEA).
How has the report been received?
Both Health Action International (Europe) (HAI-E) and Pharmaceutical Group of the European Union (PGEU) - in conjunction with EuroPharm Forum and International Pharmaceutical Federation (FIP) - have drafted responses to the Commission’s consultation.
Response of Health Action International (Europe)
HAI-E argues that the present European system of pharmacovigilance is deeply flawed and probably not capable of ever developing from including the role of prescribing behaviour in contributing to it.
HAI-E believes that far less emphasis should be placed on generating larger volumes of spontaneous reports, with much greater emphasis on scrutiny and follow-up of the most significant adverse drug reactions (ADR) reports received, certainly including reports from patients.
HAI-E calls for a far greater regulatory emphasis on critical audit of Marketing Authorisation Holders’ (MAHs) pharmacovigilance systems, as well as formal and binding requirements on MAHs to conduct meaningful post-marketing investigations of possible problems.
For transparency and independence reasons, HAI-E recommends the appointment of ‘Compliance Officers’ for pharmacovigilance.
HAI-E calls for more transparency and accountability of pharmacovigilance and drug regulatory systems, so that data relating to drug benefit and risks are accessible and available.
HAI-E calls for more social and cultural iatrogenesis (the harm caused by treatment and medical intervention).
For more details, see HAI-E’s Response to the European Commission Public Consultation
Response of PGEU, EuroPharm Forum and International Pharmaceutical Federation
Unlike HAI-E, this response does not comment on the parts of the report dealing with weaknesses in pharmacovigilance systems in some Member States arising from wide variations in levels of staffing and technical resources or difficulties in accessing external expertise. Instead, the response discusses topics of specific relevance and importance to community pharmacists and their relationship with patients and other users of pharmacy services.
Overall, the response notes the important role of community pharmacies within the Community Pharmacovigilance System. The expertise of pharmacists and the existing network of pharmacies throughout national territories have long been available and should therefore be fully utilised.
More specifically, PGEU/EuroPharm Forum/FIP’s response examines safety issues of the recent changes to the legal framework of pharmacovigilance provisions. It calls for
the development of the Eudravigilance database to be priority.
better monitoring of the effectiveness of companies pharmacovigilance and risk management systems.
clear, pharmacovigilance to be pursued “throughout the lifecycle of a medicinal product .... to further strengthen public health protection.”
information about the risk of adverse reactions to non-perscription medicines to be provided on the package and the public to be made aware of the possibility for reporting any adverse drug reaction to their doctor or pharmacist.
PGEU/EuroPharm Forum/FIP’s response looks at "How community pharmacists can help through formal involvement in pharmacovigilance systems". The response notes the following - -spontaneous reporting of suspected adverse reactions to medicines by pharmacists will remain an important element of effective pharmacovigilance.
the role of community pharmacists in tackling underreporting of adverse reactions can be utilised by developing friendly reporting systems that can be easily used in daily practice by health professionals.
network of pharmacies could also be more involved in the collection of data needed to complement the “routine data”, especially on data combining medicines exposure and outcomes, including adverse drug reactions.
EMEA should take the lead in raising the awareness of the public of pharmacovigilance as a public health issue. All patient information leaflets issued with medicines should encourage users to discuss any perceived undesirable side effect with their doctor or pharmacist.
community pharmacists to be included formally in the system for reporting suspected adverse reactions to medicines in all Member States, not just physicians.
PGEU/EuroPharm Forum/FIP’s response also looks at "Improving communication with health professionals and patients and the public" and recommends the following -
relevant pharmacovigilant information is in the hands of health professionals before it is the subject of reports in the public media so as to avoid raising unneccessary public alarm.
communication between health professionals (especially doctors and pharmacists) be targeted for enhancing the pharmacovigilance system.
having well trained and qualified professionals within the National Pharmacovigilance Authorities who could easily guide and exchange information with the practicing professionals dealing with spontaneous reporting and collection of other additional data.
For more details, see the Submission of PGEU, EuroPharm Forum and International Pharmaceutical Federation.
