Towards the safer use of injectable medicines following NPSA Alert 20

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Pharmacists and nurses met in London in March to discuss the safe use of injectables. Topics included products in intensive care, intravenous guide preparation, safe purchasing and risk reduction

Christine Clark
PhD

Contributing Editor
HPE

Patient safety improvement is the day job and not an optional extra, according to Linda Matthew (senior pharmacist, UK National Patient Safety Agency). Of the 5,000 reports the NPSA receives each month, 800 relate to injectable medicines. These account for 24% of all medication incidents reported. Moreover, the majority of incidents (58%) that lead to deaths or severe harm are related to injectable medicines. These are significant errors and should send signals, Ms Matthew said. It is estimated that only about 10% of incidents are reported – the tip of “the error iceberg”, she added.

In March 2007 the NPSA published an alert document, Alert 20, aimed at improving safety of injectable medicines (see Box 1 and Resources). Part of this was better knowledge of the risks involved at local level. “If you have done the job you should know a lot more about the system than you did before,” Ms Matthew said. The ultimate goal is widespread, sustainable and auditable improvement. Often changes are made that are effective in the short term but are not embedded in the system so cannot be sustained. She noted that longer-term success depends on culture change, which involves changing both procedures and mindsets.

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Chief pharmacists are expected to lead the implementation of this alert with support from the institution’s chief executive and other key individuals. Ms Matthew recommended using local incident data, serious untoward incident reports (SUIs) and results of local risk assessment of injectable medicines to build the case for action.

Changes must be audited to check whether they have had the intended impact. To help with this process, Alert 20 includes an audit tool. Ms Matthew recommended using one’s local newsletter to celebrate success when an organisation succeeds in implementing critical changes. Every healthcare trust should have a risk register in which every risk faced by the organisation is recorded. Residual risks – those that cannot be avoided – and recommendations for change that have not been achieved must be recorded on the register. “Nondelivery should be shared at the highest level,” Ms Matthew stressed. In this context she pointed out that the Corporate Manslaughter and Homicide Act 2007 would come into effect on 6 April 2008, suggesting that in future elements of this Act could apply if a patient died due to a medication incident where the risks were recognised but recommendations to mitigate the risk had not been implemented.

Chief pharmacists have an obligation to report progress with NPSA alerts through the Department of Health Safety Alert Broadcast System mechanism. The deadline for reporting progress with the injectable medicines alert was 31 March 2008.

Finally, Ms Matthew drew attention to the Design for safety guides published by the NPSA (see Resources). These have already examined ways in which good design of labels, packaging and storage could contribute to greater safety. “Alert 20 is only the start,” she said.

Safe purchasing
Pharmacists need to set standards for products and not just accept what the industry offers, according to Kevan Wind (medicines procurement specialist pharmacist, North West London Hospitals NHS Trust). One step that could contribute to safer purchasing would be using product specifications that include the type of data required with the product. He noted that hitherto there had been little guidance on the type of standards pharmacists wanted.

Development of the IV guide
Sue Keeling (co-ordinator, IV Guide Group, Imperial College Healthcare NHS Trust) told the audience that critical information on intravenous (IV) medicines was often lacking at the point of use: there was little in the British National Formulary or in manufacturers’ data and pharmacy policies were often outdated. The problems are compounded by inexperienced staff giving more complex drug regimens than in the past, she added. Information on issues such as pH, osmolarity, drug compatibility and the consequences of extravasation was usually unavailable to the end user. Highly alkaline (pH >9) or acidic (pH <5) drugs should be administered centrally. Common examples include vancomycin (pH 2-3), calcium gluconate (pH 6-8) and aciclovir (pH 10-12). Similarly, drugs with osmolarity above 500 mOsm/l and vesicants should be given centrally to avoid damage to peripheral vessels. In critical care, complex intravenous administration decisions are often made with inadequate data on compatibility, pH, osmolarity, minimum dilution and route, she noted.

IV therapy is common, so everyone thinks they are experts – but in reality infusion practice is often poor, and professionals believe this is normal. A comprehensive user guide is long overdue, Ms Keeling said. A group of pharmacists started work on a guide in 1992, building on a document produced at London’s Hammersmith Hospital. Initially, the guide was designed as a reference source to help pharmacists write their own local guides. It was paper-based, written in a consistent format, fully referenced and coordinated by the pharmacy department at London’s Charing Cross Hospital. During the 1990s the IV Guide Group expanded and in 2001 a website for the guide was set up.

However, Ms Keeling noted that there has been little funding for this project; its survival has depended largely on the goodwill and enthusiasm of individual pharmacists. Recently, the IV Guide Group embarked on a collaboration with the NHS UK Medicines Information service to develop the IV Guide into a robust NHS injectable medicines guide for the entire UK. At present the guide is available to UK hospitals for an annual fee and, if possible, a contribution to the preparation of some drug monographs (for how to contribute, see Resources). Ms Keeling said contributions to these monographs needed to be clear and simple, and not written in “SPC gobbledegook”. They should also be applicable to all products containing the specified drug.

Intensive-care risks
Staff in intensive-care areas often do not report errors in preparing injectable medicines because they are not aware they have made an error, according to Mark Borthwick (consultant pharmacist, Oxford Radcliffe Hospitals NHS Trust).

Several studies have shown that even people who routinely prepare injectable medicines commonly make mistakes. A retrospective study conducted in four UK hospitals had shown that the majority of acetylcysteine infusions prepared in the emergency department were more than 10% outside the intended concentration and nearly one-tenth of the sample was more than 50% outside the intended concentration. Each patient receives three infusion bags of acetylcysteine injection. In this study, one of the injections prepared contained no active drug at all – the acetylcysteine was just not added, Mr Borthwick noted. In another case in Canada, experienced clinical staff were invited to participate in a study involving preparation of opioid injections in an unhurried laboratory situation.

The results showed that 35% of preparations had concentration errors greater than 10% and 8% had twofold or larger errors in concentration. Such findings suggest preparation errors cannot simply be attributed to pressure of work, Mr Borthwick argued.

Some preparation errors might be avoided by using standardised products but pharmacists need to advise the industry on strengths and presentations required. On some occasions, new products have been launched that met the needs of a minority of customers only, and uptake was poor. The Concentration Standardisation Group (an ad-hoc group of critical care specialists including anaesthetists, pharmacists and nurses) has been formed to tackle the problem. A recent study by this group investigated how 20 commonly used intensive care medicines are used in practice (see Resources). A total of 154 intensive care units responded; results showed that the 20 agents were used in 372 different ways (excluding diluent variations). Different concentration and volume combinations were counted as separate options; for example, 40 mg of drug X in 40 ml was counted as different from 50 mg of drug X in 50 ml. Phosphate, noradrenaline and adrenaline injections topped the list, with 45, 39 and 38 variations respectively.

Similarly, wide variations were seen when the concentrations of the 20 agents were examined; phosphate and amiodarone were the most variable (25 and 20 different concentrations), followed by noradrenaline (18), adrenaline (19), morphine sulphate (19) and potassium chloride (18). Differences in how the drugs were used influenced the selection of concentrations. For example, syringe drivers are widely used in southern England and Scotland, but volumetric pumps are more commonly used in northwestern England. For noradrenaline administration, 77% of ICUs use syringe drivers exclusively and concentrations of 4 mg, 8 mg and 16 mg in 50 ml were by far the most widely used. In contrast, there was little evidence of common practice with amiodarone injection – a wide range of doses and volumes were prepared.

The study group concluded that there is enough common ground to allow standardisation of some products. Work is in progress to set up a representative stakeholder group to take this forward. A second survey will be done to clarify certain points.

Workshop participants tackled scenarios based on the most commonly reported high-risk products. Several problems were illustrated by one particular scenario, where an adult neurological intensive care unit requested a stock of 30% sodium chloride ampoules to prepare a 3% solution. This is used to treat raised intracranial pressure that has not responded to mannitol treatment and is always required quickly.

Given the known dangers of hypertonic solutions, possible risk reduction measures include using a 1.8% injection, a written preparation procedure, a kit for making up the 3% solution and storage separate from other sodium chloride preparations. Clare Crowley (medicines safety pharmacist, Oxford Radcliffe NHS Hospitals Trust) described how a 2.7% solution available as a “special” has been introduced in her hospital for this purpose. The situation is complicated by the fact that the national treatment guideline recommends a 3% solution. This should be referred back to the authors of the guidance, Dr Crowley suggested.

The meeting formed part of a series sponsored by Baxter Healthcare Ltd. â–

Resources
National Patient Safety Agency. Patient safety alert 20: promoting safer use of injectable medicines. London: NPSA; 2007.
W: www.npsa.nhs.uk

National Patient Safety Agency. Design for patient safety. London: NPSA; 2007.

W: www.npsa.nhs.uk/patientsafety/improvingpatientsafety/design

IV Group, Charing Cross Hospital. Development of an intravenous drug demonstration guide. Pharm J 2002;269:366.

Keeling P. Intravenous drug error and the introduction of an electronic IV guide. Care of the Critically Ill 2003;19:94-7.

Borthwick M, Woods J, Keeling S, Keeling P, Waldmann C. A survey to inform standardisation of intravenous medication concentrations in critical care. J Intensive Care Soc 2007;8:92-6.

W: www.ics.ac.uk

Pharmacists who wish to contribute to the IV Guide should contact:
Gill Bullock, Pharmacy Department, Charing Cross Hospital, London, UK

E: [email protected]