Keywords
Citation
(2011), "Europe - Medicinal products prepared in pharmacies: Committee of Ministers of the Council of Europe adopts resolution", International Journal of Health Care Quality Assurance, Vol. 24 No. 5. https://doi.org/10.1108/ijhcqa.2011.06224eaa.008
Publisher
:Emerald Group Publishing Limited
Copyright © 2011, Emerald Group Publishing Limited
Europe - Medicinal products prepared in pharmacies: Committee of Ministers of the Council of Europe adopts resolution
Article Type: News and views From: International Journal of Health Care Quality Assurance, Volume 24, Issue 5
Keywords: Quality assistance requirements, Pharmaceutical healthcare, Patient safety
The Committee of Ministers of the Council of Europe has adopted a resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients.
Patients have special needs as regards the medication they need caused by age, medical condition, individual disposition and environmental factors. Medicinal products made available by the pharmaceutical industry cannot always cover these needs: therefore, medicinal products prepared in pharmacies are important elements of pharmaceutical care in Europe.
The preparation of medicinal products in pharmacies is not harmonised throughout Europe.
Patients rightfully expect medicinal products that are of appropriate quality, safety and therapeutic value irrespective of whether they are prepared in a licensed pharmacy by virtue of the pharmacist’s professional qualification or placed on the market by the pharmaceutical industry.
This resolution is a major breakthrough to protect patient safety and to prevent quality and safety gaps between medicinal products prepared in pharmacies and at industrial scale through outlining assurance principles for structures and processes.
As an innovative approach to assist in the selection of the quality system required for the preparation, the resolution proposes a model for assessing the risk carried by the preparation.
Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients recommends the adaptation of regulations in line with principles inter alia for the:
- •
added value of pharmacy-preparations and responsibilities of health-care professionals;
- •
preparation process;
- •
product dossier;
- •
labelling;
- •
reconstitution of medicinal products in health-care establishments; and
- •
authorisation for pharmacies or licences for companies making preparations for pharmacies.
The European Directorate for the Quality of Medicines and HealthCare (EDQM) and its bodies promotes human and animal health through the setting of standards and norms for the quality of medicinal products and their safe and effective use in society.
For more information: www.coe.int