It is estimated worldwide that half of all medicines are inappropriately prescribed or dispensed, and half of all patients use them incorrectly.
Errors related to the use of medicines, lack of documentation on how medicines are prescribed, used, and dispensed, as well as insufficient communication, have a significant impact on mortality and morbidity. The large amount of resources spent on the development and regulatory control of medicines only make sense if the medicine is used appropriately and everyone has access to the necessary information to ensure this.
In this regard, the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) of the EDQM was established, which oversees the work of three expert committees in three main areas:
- The classification of medicines as regards their supply;
- Setting quality and safety standards in pharmaceutical practices and pharmaceutical care;
- Preventing and managing risks posed by counterfeit medical products and related crimes.
On June 6-7, 2023, the 74th meeting of the Committee of Experts on the Classification of Medicines as Regards their supply (CD-P-PH/PHO) of the EDQM took place in Strasbourg, French Republic, in a hybrid format (combining in-person and online participation). Natalia VOLOVYK, Deputy Director for Quality of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, participated in the meeting via video conference. This was the first meeting of the CD-P-PH/PHO Experts Committee in which a representative from Ukraine took part.
The classification status of medicines authorised in Europe as prescription or non-prescription medicines remains a competency of the individual countries.
The Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PC/PHO) annually updates its recommendations to national competent authorities regarding the classification of medicines and conditions for their supply (prescription and non-prescription status), which are published in the Melclass database.
The medicines classified by CD-P-PC/PHO may or may not be licensed for use in the EU. The Melclass database also contains national information on the classification status and conditions for the supply of medicines in Member States of the Council of Europe, which are parties to the Convention on the Elaboration of a European Pharmacopoeia. National information on the classification and conditions for the supply of medicinal products is provided by delegates of CD-P-PH/PHO member countries and is regularly updated.
The Melclass database is hosted by the EDQM and is supervised by the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO).
The 74th meeting of the CD-P-PH/PHO Experts Committee focused on the discussion of survey results among Member States of the Council of Europe, which are parties to the Convention on the Elaboration of a European Pharmacopoeia, regarding the national classification of a range of pharmaceutical substances and the inclusion of corresponding recommendations in the Melclass database. In addition, progress and feedback on the draft Guidance on the Classification of Medicines were discussed.
During the discussion about the classification of medicines, a number of problematic issues have been identified. For instance, there is difficulty in classifying certain pharmaceutical substances that border between being a chemical active pharmaceutical ingredient and a dietary or food supplement. Additionally, it is not entirely clear how to correctly classify medicines that are generally prescription-only but require immediate use in life-threatening situations where there is no time to obtain a prescription from a doctor (e.g., the use of naloxone). Furthermore, the definition of life-threatening situations itself is unclear. Some countries have lists of medicinal products specifically designated for use in emergency situations. The question of the appropriateness of classifying herbal medicines was also raised.
For external users, the Expert Committee plans to develop training on the use of the Melclass database for the classification and supply of medicines.