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Aseptic services: reducing risks in a changing climate

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Pharmacy aseptic services are set to lead one of the most important improvements in patient safety for years. Significant investment may be needed, but pharmacists should not refrain from seeking it

Peter Rhodes
BPharm MRPharmS

Principal Pharmacist for Technical Services
Southampton University Hospitals NHS Trust
Southampton

Chair
NHS Pharmaceutical Aseptic Services Group

UK

Pharmacy-based aseptic medicines preparation services are now a cornerstone of pharmaceutical care in all general hospitals across the UK, and in many hospitals across Europe. Estimates suggest more than five million ready-to-administer doses are supplied annually by these services in the UK, supporting the care of some of the most critically ill patients in the health system. Specialist pharmacists and technicians in these services are contributing unique clinical and technical expertise to this care.

UK pharmacy aseptic services now stand at the brink of leading one of the most significant improvements in patient safety seen for some years, with developments having application across Europe. Failing to grasp this opportunity will ring in the ears of hospital managers, governance leads and patients’ groups for years to come.

Recognising clinical risk
As far back as 1976 Breckenridge identified serious failings in healthcare, with patients receiving intravenous treatments being exposed to unacceptable risk through contamination and error.[1] Since then numerous reports, papers and studies have confirmed both this risk and the fact that patients are harmed as a result. Such cases include infection and crossinfection, particle contamination, errors in preparation, incorrect route or method of administration, drug confusion and incompatibility, and more.[2-10] In the UK, 24% of all reported medicines-related adverse events and 58% of those causing serious harm or death concern injectable therapy.[11]

These are risks which can be reasonably predicted – overworked nurses and doctors working in difficult conditions over long periods will make mistakes, particularly as therapies become more complex and patients’ conditions become more acute. The UK National Patient Safety Agency (NPSA) recognised this when in 2007 it issued Medication Safety Alert 20 to all UK hospitals.[12] The alert required a thorough review of practices relating to injectable therapy. One of the key requirements of this alert was assessing the risk posed by all injectable medicines given within the NHS, with highest-risk products requiring action to minimise this risk. The alert included a tool for assessing the risk,[13] and the joint NHS technical services groups issued a summary of the top 100 highest-risk products in common use in the NHS, based on use of this tool.[14]

Approaches to risk reduction
It is clear that pharmacy-based aseptic preparation services are ideally equipped to reduce or eliminate these risks (see Table 1), with UK government-backed reports advocating them.[1,15,16] However, although some evidence does exist to support this,[17,18] firm evidence is lacking; my own centre expects to report later in the year on the outcomes of a major expansion of such a service. Pharmacy responded early to ­Breckenridge in chemotherapy and nuclear-medicine services and in parenteral nutrition preparation, due to the high risks of staff exposure and product microbial contamination associated with these treatments. There is now no sanction for any manipulation of these treatments outside of controlled aseptic facilities. Expansion in favour of intravenous additive services will be a key part of the continued response to NPSA Alert 20. However, it is equally clear that capacity, organisational and financial constraints limit their scope for all injectables. A typical UK teaching hospital supplies some four million injection doses per year, with 40% requiring manipulation before administration.[19] The risk assessment approach should therefore be used to prioritise existing pharmacy resources and secure funding for further development.

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Pharmacy-based aseptic preparation
Models where 100% preparation by pharmacy is the norm do exist outside the UK. Although this is desirable from some viewpoints, it is unlikely to be achievable within current national resources.

Satellite aseptic services based near wards may be harder to staff due to contingency cover and skills needs, and may take additional infrastructure costs. However, such services support near-patient, short-lead-time care and allow specialist pharmacy staff to provide clinical pharmacy care as well as hold technical responsibilities. Economies of scale may be lost in favour of improved responsiveness and focus on one clinical specialism. This model particularly lends itself to cancer and nuclear-medicine services and the intensive/high-care environment.

Centralised aseptic services offer high-quality, high-capacity preparation for intravenous additives. These services may have a longer lead time but can smooth fluctuations in demand across the organisation and better focus effort and skills. Parenteral nutrition is also best provided centrally due to the high levels of skill and control measures required and the wide range of wards served.

Outsourced supply can augment in-house services, and is particularly valuable for high-usage standard-dose products, leaving capacity in-house for the more specialist, shorter-lead-time or short-expiry drugs.

In the UK these services are operated both within the NHS and by commercial providers; both operate to equally robust standards of good manufacturing practice, although NHS services have the advantages of not needing to charge

value-added tax to NHS customers, and of product availability from all NHS suppliers being pooled on one NHS web-mounted database. When considering outsourcing, a clear user-requirement specification should form the basis for tenders and contracts, and manufacturers’ facilities should be submitted to a quality-systems inspection by purchasers or their agents (such as regional quality assurance advisers).

On-site supply by external contractor is in place at some sites, with the service meeting full provision to the hospital and making further capacity available for commercial supply elsewhere. Financial and service-level agreements will play a significant part in these arrangements, and must ensure that robust and timely delivery of services to the host hospital is the highest priority.

Service development
As patient safety takes on a higher profile there is growing recognition that investment may be required to deliver it.

Aseptic services should seek funding for service development, but should expect to bid for this in an increasingly competitive environment. Business cases will need to show:

  • Robust financial modelling.
  • Clear evidence to support the development.
  • Strategic vision over the foreseeable future.
  • Thorough option appraisal, including the nonpharmacy development options.
  • Focus on the organisation’s objectives.
  • Engagement and support from stakeholders and management.

The early involvement of planning specialists within the organisation is important in following the often-complex business processes, and gaining support from likely users’ management will make the outcome of approval discussions more favourable.

Nonpharmacy models to reduce risk
While risk assessment will drive pharmacy-based preparation of high-risk injectables, there may be insufficient capacity or resources to transfer those assessed as at or below moderate risk. Additionally, not all high-risk drugs are suitable for pharmacy-based preparation. Aseptics specialist pharmacists have a key part to play in supporting wards to reduce this risk, using their unique combination of technical skills and clinical insight. Where pharmacists consider they lack this interface experience, it is vital that these skills are developed to improve service responsiveness and patient care. Potential ways to reduced risk with ward-based preparation are set out in Table 3; aseptic services pharmacists have a key role in leading with these examples.

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Conclusion
Pharmacy aseptic services have come of age: with our exemplary standards and clinical experience we are ideally placed to reduce the real risks faced by patients from their injections – treatment intended to improve their health may instead lead to harm. Significant investment in staff, facilities and training may be needed to develop services, but we should not hold back from seeking this in an informed way while government safety agencies and white papers[25] are seeking our leadership. â–

References
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2. Austin P. Review in preparation, 2008.
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5. Pharm J 2000;264:281.
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7. Pharm in Prac 1996;6:307-10.
8. Pharm J 2008;280:206.
9. Toft B. Independent review of the circumstances surrounding four serious adverse incidents that occurred in the Oncology Day Beds Unit, Bristol Royal Hospital for Children. Bristol: UBHT; 2007.
9. National Patient Safety Agency. Rapid response report 2. London: NPSA; 2008.
10. Department of Health. Building a safer NHS for patients. London: DH; 2004.
11. Cousins D. Presentation at Improving Aseptic Services, 6 May 2008.
12. NPSA. Patient safety alert 20. London: NPSA; 2007.
13. NPSA. Risk assessment tool for the preparation and administration of injectable medicines in clinical areas. London: NPSA; 2007
14. Rhodes P, et al. Example risk assessments of injectable medicines. 2007. Available at: www.CIVAS.co.uk
15. Audit Commission. A spoonful of sugar. London: HMSO; 2001.
16. Department of Health. National service framework for children, young people and maternity services. London: DH; 2004.
17. Hosp Pharm 2000;1(7):192.
18. Pharm J 2006;276:47-9.
19. Southampton University Hospitals NHS Trust. Pharmacy medicines supply data 2007-8 (unpublished).
20. Beaney A (ed). Quality assurance of aseptic preparation services. London: Pharmaceutical Press; 2006.
21. Farwell J. Aseptic dispensing for NHS patients. London: Department of Health; 1995.
22. Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme. PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments. Geneva: PIC/S; 2008. Available at: www.picscheme.org
23. Pharm J 2006;276:17-19.
24. Hosp Pharm 2003;10:127-30.
25. Department of Health. Pharmacy in England. London: DH; 2008.



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