Quality & use of medicines
Pharmaceuticals and pharmaceutical care
The EDQM’s work on the optimal use of medicines is an integral part of a larger effort to protect and improve public health. By ensuring not only the quality and safety of medicines and healthcare but also how they are used by patients, the EDQM helps enhance the effectiveness of treatments, reduce health risks and improve patient quality of life. These co-ordinated activities contribute to better access to quality medicines and healthcare for all.
These efforts are overseen by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), with the support of its three subordinate bodies: the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC), the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO) and the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED). Together, they address key areas in the safe and effective use of medicines, safeguarding public health for all.
Activities
Guidance documents and recommendations
Two new guidelines on the safe use of herbal food supplements were finalised in 2024 – one targeted at healthcare professionals and the other designed for consumers. These documents aim to enhance safety and awareness when using herbal products. The approved final guidelines will be published in 2025.
Another guidance document on best practices for medicine traceability in hospitals was also finalised. It provides recommendations for authorities and stakeholders which aim to ensure that the right medication is administered to the right patient, via the right route, in the right amount and at the right time. Once adopted, this document will be published in 2025, followed by work with interested parties on its implementation.
A new project was launched in 2024 to develop a guidance document on providing advice to patients undergoing treatment for cancer. This initiative aims to empower healthcare providers with tools to support cancer patients during their treatment journey. A kick-off meeting with experts from member states and stakeholders was held at the end of 2024, marking the start of the drafting process of this important deliverable.
A draft recommendation on best practices for the remote and online provision of medicines was finalised and submitted to the CD-P-PH’s three subordinate committees. It will be submitted to the CD-P-PH for adoption in 2025.
The CD-P-PH/PHO issued 102 recommendations on the classification of medicines regarding their supply conditions (prescription or non-prescription status). The committee also launched a stakeholder consultation for a guidance document on the classification of medicines, explaining the recommended rationale for the assessment. The guidance may also be used by national competent authorities in determining whether a medicinal product can be given to patients without a prescription.
Communication with partners and stakeholders
The EDQM maintains relations with its international partner organisations to harmonise efforts aimed at promoting patient-centred care and the appropriate use of medications in Europe. This includes the European Medicines Agency and the Heads of Medicines Agencies, with its CMDh Non-Prescription Medicinal Products Task Force, as well as the World Health Organization and European professional bodies active in the public health and pharmacy sectors, such as the International Pharmaceutical Federation (FIP), the European Society of Clinical Pharmacy (ESCP), the European Society of Oncology Pharmacy (ESOP), the European Hospital and Healthcare Federation (HOPE), the Pharmaceutical Group of the European Union (PGEU) and the European Association of Hospital Pharmacists (EAHP).
Publications
The EDQM finalised and published Guidelines on medication review in October 2024. It is available for download (in English and French) on FreePub, the EDQM’s free publications platform. These guidelines provide practical recommendations to optimise patient care through structured reviews of their medications. To ensure wide dissemination and uptake of the guidelines, a promotion plan for 2025 has been established, including a comprehensive communication strategy and a webinar targeting healthcare professionals. Dates and registration details will be published on the EDQM website.
“Guidance to disseminate the deliverables related to pharmaceuticals and pharmaceutical care” was prepared by the CD-P-PH/PC to provide a general framework and guiding principles for the dissemination of deliverables of the CD-P-PH and its subordinate bodies in accordance with their terms of reference.
Melclass database
The Melclass database (melclass.edqm.eu) was regularly updated in 2024 with recommendations on the classification of medicines issued by the CD-P-PH/PHO to national health authorities, as well as with classification data from these authorities, in order to maintain the database as a unique source of information for stakeholders involved in the classification of medicines as regards their supply.
