Dear All,
Based on monitoring activities conducted by national competent authorities, it has emerged that in hospital pharmacy settings a longer in-use storage time is sometimes assigned to reconstituted anticancer medicines (to be administered parenterally), which is not consistent with the in-use storage time reported in the terms of the marketing authorisation and in the summary of product characteristics (SmPC), and may not be based on well-documented stability studies. If not supported by stability data, such practice may pose serious risks to patient safety and, as a consequence, it should be discouraged.
Also, the use of open single-dose/single-use vials of anticancer medicines has been detected. Such action directly puts the patient's health at risk and is not officially reflected in the terms of the marketing authorisation of the medicinal product or in the SmPC.
General practice in hospital pharmacies should be that medicinal products are reconstituted on the basis of the SmPC and, when there is a deviation from it, the basis for such action should be documented, i.e. there should be both the manufacturer's data and the hospital pharmacy's own quality guidelines for cases where specific rules are laid down. As a general rule, such cases must be treated as an exception and separately by hospital pharmacies.
This survey aims to explore whether the above practices are common in Europe, what sources are used to extend the in-use storage time of reconstituted medicines (if applicable) and the rationale behind these practices. The objective is to map the actual situation and identify the potential need for a guidance document to support the appropriate use of reconstituted medicines.
Your answers will be kept confidential. All answers will be reported only in aggregate form, and no individual person or organization will be identified.
The deadline to complete the survey is 08/11/2024
If you have any questions or comments about this survey, please contact the EDQM Secretariat at PC@edqm.eu
Thank you for your help.
Yours sincerely,
The EDQM Secretariat on behalf of the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC)
