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