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Review

Preparing injectable medicines safely

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Advice on minimising the risks to patients when preparing injectable medicines

Abstract

Risks to patients are greater when injectable medicines are prepared in clinical areas (wards, theatres, clinics or even patients’ homes), rather than provided in ready-to-use form. This article describes the risks involved in preparing injectable medicines in such areas and outlines key principles to ensure they are prepared safely. It also suggests that high-risk injectable medicines be provided in ready-to-use form, either in house, by pharmacy or by pharmaceutical companies.

Citation: Beaney AM et al (2012) Preparing injectable medicines safely. Nursing Times [online]; 108: 3, 20-23.

Authors: Alison M Beaney is regional quality assurance specialist pharmacist for North East England; Anne Black is quality assurance pharmacist; both at Newcastle upon Tyne Hospitals Foundation Trust.

Introduction

Although various reports have recommended that all injectable medicines be prepared in pharmacy (Audit Commission, 2001; Breckenridge, 1976), nurses continue to perform this task in most cases (Beaney and Goode, 2003; NHS North West, 1997). Risks to patients are greater when injectable medicines are prepared in clinical areas, both in terms of medication errors (Cousins et al, 2005; Taxis and Barber, 2003) and from microbiological contamination, which can lead to infection (Pharmaceutical Journal, 1999).
Injectable medicines prepared in NHS pharmacies are made in specialist cleanrooms. They are prepared according to defined national standards and pharmacies are regularly audited to ensure standards are maintained (Beaney, 2006). By contrast, standards in clinical areas vary widely, both in terms of the environment in which injectables are prepared and in nurses’ level of training and the procedures available to them (Beaney and Goode, 2003). This justifies the premise that ideally all injectable medicines should be provided in a ready-to-use form, either by pharmacy or by pharmaceutical companies. Unfortunately, this is not yet possible for several reasons, including:

  • Capacity for preparation in pharmacy is limited;
  • Although the pharmaceutical industry has been encouraged to produce ready-to-use formulations, these are slow to come on stream and, on occasions where they have been made available, they have not been taken up due to cost implications for the NHS (Black et al, 2007);
  • Nurses worry that if injectables are provided in a ready-to-use format, they will become deskilled and may not be competent to prepare them if required to do so.

Local risk-reduction measures

A study on the ward-based preparation of parenteral medicines showed that the environment in clinical areas is of variable standard (Beaney and Goode, 2003). To assess the risk of contamination microbiologically in a clinical area, a trained pharmacy operator undertook a series of broth transfers using a non-touch technique. Seven of the 20 containers prepared on the ward showed contamination with staphylococcus, a skin micro-organism. This illustrates that the risk of microbiological contamination is much greater when manipulations are carried out in an uncontrolled environment such as a ward, as opposed to a pharmacy cleanroom that is supplied with filtered clean air and in which the operators are clothed to prevent contamination of the product.
The study recommended reducing risks to patients by:

  • Improving the environment - for example, cleaning, avoiding thoroughfares, washing hands and putting on gloves before preparation;
  • Improving non-touch manipulation techniques;
  • Minimising the time between preparation and administration of injectable medicines (so that any contamination has minimal time to grow) (Beaney and Goode, 2003).

These principles are still relevant and form the cornerstone of any procedure involving preparation of injectable medicines. Indeed the Department of Health’s (2008) Clean, Safe Care initiative was based on the same principles, although it applies more widely than simply the preparation of injectable medicines.
Nurses should review the arrangements for preparing injectable medicines in their own areas of practice, taking into consideration the following points:

  • Is there an organisational policy?
  • Is a local protocol in place?
  • Are guidelines prominently displayed?
  • Are they followed?

This is particularly challenging for nurses in community practice. Trusts should ensure that procedures are in place to guide preparation technique regardless of the working environment.

Risk assessment

To assess the extent of, and risks posed by, the preparation of injectable medicines, a large-scale study was carried out across all acute trusts in the north of England. This project showed that 1.2 million doses of high-risk preparations were prepared annually in clinical areas (Hardy and Mellor, 2007).
To make best use of the capacity within pharmacy to prepare injectable medicines, it is sensible to risk assess products needed in clinical areas so that those with higher risk can be transferred to pharmacy preparation, providing the shelf life of the prepared product allows this in practice. To help this targeted transfer to pharmacy, a risk assessment tool was developed (Beaney et al, 2005). Risks (including number of manipulations, calculations, patient factors, nature of the drug factors and so on) were given a weighting and injectables prepared in clinical areas were assessed against the criteria; the higher the score, the greater the risk to patients.
The study concluded that the risk assessment tool could be used to identify high-risk injectable products that should be targeted for pharmacy preparation. It also recommended that nurses preparing lower-risk items still dealt with in clinical areas be supported by pharmacy involvement in their training and given advice on non-touch techniques (Beaney et al, 2005).

Patient safety alert on injectable medicines

The National Patient Safety Agency (2007a) became aware of a high level of errors reported in relation to injectable medicines and produced a patient safety alert on the topic. Evidence from the National Reporting and Learning Service and research indicated some of the major problem areas (Taxis and Barber, 2003). As a result, the NPSA (2007a) required the NHS to carry out six actions (Box 1).

BOX 1. ACTIONS REQUIRED OF THE NHS

  • Action 1 Undertake a risk assessment of injectable medicine procedures and products in all clinical areas to identify high risks, and develop an action plan to minimise them
  • Action 2 Ensure there are up-to-date protocols and procedures for prescribing, preparing and administering injectable medicines in all clinical areas
  • Action 3 Ensure essential technical information on injectable medicines is available and accessible to healthcare staff in clinical areas at the point of use
  • Action 4 Implement a “purchasing for safety” policy to promote procurement of injectable medicines with inherent safety features
  • Action 5 Provide training for, and supervision of, all healthcare staff involved in prescribing, administering and monitoring injectable medicines
  • Action 6 Include an audit of medication practice with injectable medicines as part of healthcare organisations’ annual medicines management audit programme

Source: National Patient Safety Agency (2007a)

How to assess risk

The first action in the patient safety alert required risk assessment of practices and individual injectable products prepared in all clinical areas using a risk assessment tool (NPSA, 2007b), which was based on work by Beaney et al (2005).
This risk assessment was intended to be a joint initiative between pharmacy and nurses. For the assessment to be accurate, the way in which an injectable medicine is prepared and used needs to be considered; nurses are in an ideal position to provide this information. Using the NPSA’s (2007b) tool, products are assessed and ranked using a traffic-light system (red signifies high risk, amber represents medium risk, and green is low risk), according to the number of risk factors present. The aim is to reduce all red risks to at least amber by providing them as ready-to-use preparations or by giving guidance such as dose calculation tools or methods. This work is ongoing in hospitals across the country and nurses and pharmacy staff should continue to work together to reduce risks of injectable medicines to patients.
The recommendations on preparation risk assessment in the NPSA’s (2007a) alert must continue to be implemented as they have been carried forward in the DH’s (2011) Never Events policy. This penalises trusts for errors made with the preparation of high-risk injectable medicines that result in severe patient harm. The issue is relevant to all healthcare settings; it is in every trust’s interests to reduce risks with injectable medicines - that is, to convert red-risk preparations to amber, or ideally green, and to not make errors.

Protocols and procedures

The second action in the NPSA’s (2007a) safety alert required up-to-date protocols and procedures for prescribing, preparing and administering injectable medicines in all clinical areas. A supplementary document identified the 12 main risks involved with injectable medicines and gave safer practice standards (NPSA, 2007c). Many trusts have used this helpful document as the basis of their injectable medicines policy; nurses should be aware of the contents of such a policy at their place of work (usually available on the trust’s intranet). Similarly, the NPSA (2007d) also produced a template procedure for preparing and administering injectable medicines in clinical areas, which included detailed stepwise instructions for preparation using a non-touch technique.
There is often confusion around the terminology describing the techniques used when preparing and administering injectable medicines. While some favour the term “aseptic”, this is usually reserved for truly sterile procedures, so the term “non-touch technique” is often used for preparing injectables. Many trusts have now combined these terms and use “aseptic non-touch technique” or ANTT as described by Rowley (2001) and later updated (Rowley et al, 2010).
The philosophy behind ANTT is to identify and protect key parts and key sites regardless of the procedure being undertaken, while differentiating between surgical and standard procedures. ANTT has repeatedly been shown to significantly improve staff aseptic practice and behaviour when audited 6-12 months after implementation (Rowley, 2001). This “ANTT effect” has been recognised in the epic2 guidelines (Pratt et al, 2007), which recommend ANTT as a standard aseptic technique.
ANTT has been implemented within Newcastle upon Tyne Hospitals Foundation Trust.
It is extremely important to have any injectable preparation independently checked unless an individual trust has specifically excluded staff from this requirement. The checker must ensure that all calculations, preparation (including choice of diluents and confirmation of correctly measured volumes) and labelling have been carried out in line with the injectable medicines policy.

Essential technical information

Another requirement of the NPSA’s (2007a) patient safety alert was that nurses have access to essential technical information on all injectable medicines they have to prepare. Since the alert was issued many hospitals have subscribed to Medusa, the NHS injectable drug administration guide. This online guide provides monographs for a vast number of individual injectable medicines with clinical and technical information (including suitable diluents, compatibilities, sample calculations, and so on) and also gives a risk assessment. If nurses are asked to prepare injectable medicines but do not have access to this type of information, they should query this with their managers or pharmacy.
Numerous medication incidents are reported because of the absence of essential technical information. Pharmaceutical companies have provided more information over the years since the NPSA’s (2007a) alert was published, although it is still missing in some cases. New products can also present a risk to patients, so nurses should be vigilant in this area.

Purchasing for safety

Most trusts have now implemented a “purchasing for safety” policy where any new injectable product is risk assessed before purchase. It is important that this continues so that high-risk “red” preparations do not creep into common use in clinical areas. Ready-to-use products should be purchased wherever possible; nurses can help pharmacy identify potential products that would be more safely provided in a ready-to-use form. They can also lobby the pharmaceutical industry to produce more nurse-friendly (and ultimately patient-friendly) preparations.

Training for healthcare staff

Action 5 of the NPSA’s (2007a) alert requires trusts to provide training for, and supervision of, all healthcare staff who are involved in prescribing, administering and monitoring injectable medicines (Box 1). In many ways this action has been the most challenging for those charged with implementing this alert. In a large NHS organisation, the sheer number of people to whom this training must apply means that it must be delivered in a broad, general way.
At Newcastle upon Tyne Hospitals Foundation Trust non-medical training and competency has improved since this safety alert was implemented, with the introduction of preceptorship coordinators and clinical educator posts doing much to help this. A training pack and competency assessment for preparing, administering and monitoring peripheral IV medicines has been implemented alongside the development of electronic training packages. For large staff numbers, this represents a good balance between individualised training and the need for all staff involved with injectable medicines to receive the same key messages, regardless of their profession or designation.
Alongside this, much work has been done for junior doctors’ training with the Foundation Programme (Williamson, 2009). This includes a competency assessment of injectable medicine preparation technique by simulating the process using nutrient broth; if the broth grows after incubation, the trainee fails the test.

Conclusion

Although the deadline for implementing the NPSA’s (2007a) patient safety alert has passed, there is an ongoing requirement to audit medication practice with injectable medicines. Nurses should be aware of the risks with preparing injectable medicines and the ways in which these can be reduced. Working together with pharmacy and ensuring training initiatives are in place can support nurses and protect patients.

Key points

  • The majority of injectable medicines are prepared in clinical areas
  • The risk presented by preparation of these medicines varies
  • Risks to patients are greater when injectable medicines are prepared in clinical areas rather than in pharmacy
  • High-risk products should be prepared in pharmacy or be provided by pharmaceutical companies in ready-to-use form
  • Defined standards and competency-based training should cut risks for injectable medicines that are still prepared in clinical areas
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