Aseptic preparation

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Most aseptic preparation work undertaken in the hospital setting is described by the following categories: · IV additions · TPN · cytotoxic infusions/syringes · radiopharmaceuticals.


Aseptic preparation

 

Scope

 

Most aseptic preparation work undertaken in the hospital setting is described by the following categories:

 

·      IV additions

 

·      TPN

 

·      cytotoxic infusions/syringes

 

·      radiopharmaceuticals.

 

Stability issues frequently preclude the provision of ‘ready-to-use’ parenteral medicines by the pharmaceutical industry. Many drugs, including antibiotics, opioid analgesics and cytotoxics, are degraded by hydrolysis. In order to assign a reasonable shelf-life to these medicines, parenteral formulations are presented as vials containing lyophilised powders, which require reconstitu-tion (in some cases dilution) before administration to the patient. Aseptic manipulation is also necessary for clinical reasons, in which doses or formula-tions need to be tailored for individual patients, requiring the preparation of ‘bespoke’ infusions.

 

The same principles of aseptic preparation apply to all four categories (above), although there are subtle differences in the processes and equipment used for each product type. Many hospitals group the first three activities under the heading CIVAS, although others consider TPN and cytotoxic work to be separate.

 

Aseptic preparation work is a high-risk activity; the risk of calculation or compounding errors and the risk of microbiological contamination must be controlled to ensure the safety and efficacy of aseptic preparations. The UK CIVAS group conducted a national study on failure rates in media-fill simulations of aseptic processes and found this to be approximately 1 in 500. However, these risks need to be placed in the context of the alter-native to hospital pharmacy-based aseptic services. Although evidence is limited, intuitively it is clear that the risk of calculation and compounding errors and the incidence of microbiological contamination will be consid-erably higher if aseptic manipulations are carried out by untrained nurs-ing and medical staff in clinical areas. Certainly the Audit Commission supported the use of CIVAS in its A Spoonful of Sugar: ‘making up aseptic preparations in hospital wards should be stopped’. With the ongoing problem of hospital-acquired infections associated with clinical areas, this would seem sensible advice. The need to move from ward preparation to pharmacy provision was also included in the 2008 pharmacy White Paper.

 

Since the unfortunate deaths of children from contaminated parenteral nutrition solutions, the regulation of aseptic preparation has been strictly enforced by the UK Health Departments.

 

Hospitals preparing aseptic products under a specials manufacturing licence are subject to rigorous inspection by the MHRA. Unlicensed units (those working under Medicines Act section 10 exemption) must follow the guidance set out in Aseptic Dispensing for NHS Patients. The authority for enforcing compliance with this document has been delegated to regional QA pharmacists by the Department of Health. The document also restricts the shelf-life assigned to products produced in unlicensed facilities to a maxi-mum of 7 days, irrespective of whether stability data would support a longer shelf-life.

 

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