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PARENTERAL PRODUCTS: IN-USE SHELF LIFE AFTER PREPARATION ON THE WARD

European Statement

Clinical Pharmacy Services

Author(s)

VC Lamprecht, J Pont, SD Brugger, M Dunic, T Stutz, AR Burch

Why was it done?

The preparation of parenteral medication on wards pose a hygienic challenge. It is however imperative that parenteral solutions remain aseptic, as they evade the primary barrier of the human immune defense.
The bioburden of non-preserved parenteral medications after manipulation depends on the setting. Therefore, manufacturers cannot provide guidelines on microbial stability after manipulation and hence limit the retention period to immediate use.
National recommendations concerning this issue range from cautious to restrictive, but often allow exceptions e.g. for emergency medication. These recommendations, are difficult to implement universally due to the non-transferable framework conditions from one hospital to another.

What was done?

A practical framework for the determination of retention time of manipulated parenteral medication was developed, as economic and ecological perspectives stand in contrast to the hygienic ideal.

How was it done?

International recommendations were sighted. Recommendations of the German Commission for Hospital Hygiene and Infection Prevention (KRINKO), as well as the American Society of Anesthesiologists (ASA) and The Society for Healthcare Epidemiology of America (SHEA) were used as references, as well stated sources.

What has been achieved?

Key points were identified to create a directory that enables clinical professionals to use standardized cornerstones while adapting to their individual clinical setting.
The following are indicators for the retention period in which the parenteral medication may be used: (1) primary packaging; (2) type of manipulation; (3) physicochemical properties and (4) storage temperature.

What next?

A collaboration with the Department of Infectious Diseases and Hospital Epidemiology of the University Hospital of Zurich was established to record the hospital specific conditions and to subsequently adapt the clinical practice as well as evaluate cost-effectiveness and patient safety.
Further collaborations with Swiss hospitals are being sought.

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