Quality assurance standards and their use in the preparation of parenteral systemic anticancer therapy products in healthcare establishments: a scoping review.

Autor:	Murphy KD; School of Pharmacy, University College Cork, Cork, Ireland kevin.murphy@ucc.ie., O' Mahony C; School of Pharmacy, University College Cork, Cork, Ireland., McCarthy M; School of Nursing and Midwifery, University College Cork, Cork, Ireland., Saab MM; School of Nursing and Midwifery, University College Cork, Cork, Ireland., Barbosa TM; School of Pharmacy, University College Cork, Cork, Ireland., Fleming A; School of Pharmacy, University College Cork, Cork, Ireland.; Department of Pharmacy, Mercy University Hospital, Cork, Ireland., Cotter P; School of Nursing and Midwifery, University College Cork, Cork, Ireland., Noonan B; School of Nursing and Midwifery, University College Cork, Cork, Ireland., Breen E; National Cancer Control Programme, Health Service Executive, Dublin, Ireland., Carroll G; National Cancer Control Programme, Health Service Executive, Dublin, Ireland., De Frein A; National Cancer Control Programme, Health Service Executive, Dublin, Ireland., Heckmann P; National Cancer Control Programme, Health Service Executive, Dublin, Ireland., Triggs M; National Cancer Control Programme, Health Service Executive, Dublin, Ireland., Sahm L; School of Pharmacy, University College Cork, Cork, Ireland.; Department of Pharmacy, Mercy University Hospital, Cork, Ireland.
Jazyk:	angličtina
Zdroj:	European journal of hospital pharmacy : science and practice [Eur J Hosp Pharm] 2024 Feb 22; Vol. 31 (2), pp. 88-93. Date of Electronic Publication: 2024 Feb 22.
DOI:	10.1136/ejhpharm-2023-003922
Abstrakt:	Objectives: The use of parenteral systemic anticancer therapy (SACT) has led to improved cancer survival. A quality assurance (QA) system of the aseptic compounding process is necessary to ensure safe and consistent production of parenteral SACT. This scoping review identifies international evidence and practice relating to QA standards in the preparation of parenteral SACT in healthcare establishments. Methods: Standards relating to aseptic compounding in hospital pharmacies and literature exploring the aseptic compounding of parenteral SACT were included. Literature relating to the non-aseptic compounding of medicines and records specific to sterile manufacturing in industrial settings were excluded. A search of several electronic databases, trial registries, the grey literature and websites of key European hospital pharmacy groups and accreditation bodies was conducted on 16 March 2022. A narrative discussion was performed by country, and content analysis of articles was conducted. Results: Thirty-seven records were included. Standards reviewed covered the work environment, the preparation process and the safety of the workers who are potentially exposed to hazardous chemicals. It was a common practice to include frequent audits to ensure adherence to standards. Some standards also recommended external inspections to allow for further learnings. Periodic reviews are encouraged to ensure standards maintain relevance. National standards of the countries reviewed were based on international standards, with minor adaptations for local conditions. Conclusions: The main limitation of this review is that it is limited to countries with a high human development index. The review shows that the use of an internationally recognised standard as a basis for national standards is best practice, and will allow for relevance into the future. Competing Interests: Competing interests: PH, EB, ADF, GC and MT work for the National Cancer Control Programme. (© European Association of Hospital Pharmacists 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
Databáze:	MEDLINE
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