A meeting organised by B Braun Medical reviewed the impact of National Patient Safety Agency IV alert and considered ways in which products and practices could be improved to reduce risks further
The National Patient Safety Agency (NPSA) plans to introduce neuraxial (intrathecal and epidural) products with safe connectors as soon as possible through a purchasing for safety initiative. A functional specification will be given and, if trusts cannot obtain safe products, then the unsafe products will be placed on the trust risk register, according to David Cousins (head of safe medication practice and medical specialties, NPSA).
The death of theatre nurse Mayra Cabrera in 2004 following accidental intravenous administration of an epidural injection focused attention on this area. In March 2007 the NPSA issued a safety alert concerned with epidural injections and infusions. The implementation date was December 2007. However, by September 2008 three trusts were still assessing the
significance of the alert and 50 had action on going.
Meanwhile, reports of incidents with epidural injections have continued and a number of medicines, including adrenaline, potassium chloride and oxytocin, have all been given accidentally via the epidural route, said Professor Cousins. Incidents in which epidural injections have been given intravenously have also been reported. Fortunately, most have been near misses, but they still provide evidence of a “slapdash” approach, he said.
A recent audit conducted by the Royal College of Anaesthetists concluded that wrong-route errors might be more common than reports have previously suggested. It recommended that technical, noninterchangeability solutions should be pursued with vigour. Moreover, these should take into account the distal
connections in the administration route, including the â€œspikeâ€ between infusion bag and giving set. The report noted that protocols which use physical separation, special labelling of bags, and colour-coding of lines may have some impact upon the frequency of such errors, but are not fool-proof.
The majority of oncologists and haematologists in the UK believe that dose-banding would provide benefits and the doses would not vary greatly from individualised doses, according to Graham Sewell (professor of clinical pharmacy, Kingston University and Assistant Director of Pharmacy, Plymouth Hospitals NHS Trust).
Dose banding involves rounding up or down the calculated dose to one of a limited range of predetermined doses. Batches of standardised doses can be prepared in advance and so prospective product testing is possible. In addition, delays between prescribing and administration are minimised and aseptic processing time is freed for preparation of difficult
In dose-banding schemes, doses can be made using several syringes. For example, in Professor Sewell’s hospital methotrexate is available in syringes containing doses of 10 mg, 15 mg, 20 mg, 30 mg and 60 mg. This allows doses of 40-85 mg in 5 mg increments – to be given. Nurses prefer to use several small syringes because drug solution occasionally squirts back past the plunger in large syringes, explained Professor
Sewell. A crossover study comparing the pharmacokinetic
effects of 5-fluorouracil given by standardised (banded) and individualised doses showed that there was no difference between the two methods in terms of area under the concentration-time curve.
An audit of injectable products carried out at Leeds Teaching Hospital Trust identified 82 instances of highrisk practices, and the most common were the use of unlabelled syringes, multidosing, unlicensed use and inadequate technical information, Liz Kay (clinical director medicines management and pharmacy services, Leeds Teaching Hospitals) told delegates. The same audit showed that no cytotoxic injections or total parenteral nutrition (TPN) additives were made outside
the pharmacy, she continued.
The team in Leeds decided that a multidisciplinary solution was required. In addition to auditing high-risk activities, a team comprising a senior nurse and a clinical pharmacist jointly risk-assessed all intravenous medicines stocked in clinical areas over a six-week period. The results of the audit were used to develop a risk reduction strategy at trust level and to produce
individual directorate feedback. A live database, held on the Trusts intranet, was used to capture all the results of the audit and the planned actions. A total of 5,099 injectable products were assessed using the NPSA methodology and 322 (6%) were found to fall into the red (high-risk) category.
Although clinical practices had turned out to be better than predicted, the process of converting the mass of data into action plans was still a challenge, Professor Kay admitted. The first step was to feed back data to clinical directors emphasising the high-risk items. Organisational commitment is essential at this stage to ensure that financial constraints do not become a barrier to action, she added. Technical information about injectable medicines was upgraded by linking web-based monographs to the national database (Medusa). Other measures included discontinuation of the use of open bowls for injection preparation, risk assessment and registration of multidosing practices through the Drug and Therapeutic Committee and the introduction of standardised prescribing systems.
Insulin, amiodarone and phenytoin were the most common high-risk products. A standardised, pre-prepared insulin (Actrapid 50 units in 50 ml) was introduced, and a standardised concentration of amiodarone and preprinted prescription was agreed. Improved clinical guidelines for prescribing and preparation of phenytoin were also introduced. Professor Kay confirmed that she was willing to provide copies of the Leeds standardised prescribing documents to colleagues to minimise duplication of effort.
She concluded with a recommendation for standardisation
wherever possible, and a plea to the pharmaceutical industry to produce more ready-to-use injectable products.
All intravenous injections are risky for paediatric patients because children are intrinsically more vulnerable than adults, explained Karen Selwood (advanced nurse practitioner, Alder Hey Children’s NHS Foundation Trust). The problem is compounded by the fact that the patients range from neonates to 19-year-olds, she added.
When injectable medicines were audited, unlabelled syringes were found everywhere except in operating theatres. Other high-risk practices were admixtures of two or more products usually involving propofol or lignocaine and multidosing from
Risk assessment of injectable medicines yielded a list of 51 red, 128 amber (moderate risk) and 104 green (low risk) items. The top 20 red items include clonazepam, sodium nitroprusside, alteplase, epoprostanol and hydralazine. However, some of these are infrequently used and this increases the risk of incorrect preparation or use. Injectable paracetamol presented a particular problem because the smallest available ampoule contains 50 ml, making it easy to give an accidental 10-fold overdose when dealing with neonates. Neonatal doses are now prepared by the pharmacy centralised intravenous additive service (CIVA S), said Ms Selwood.
Other risk reduction approaches were less straightforward.
There were limited opportunities for dose banding so far this has only been done with cefotaxime. Purchasing of ready-to-use products is not practical because most of the products required are unlicensed. As a result, most risk reduction measures
involve preparation in the CIVA S, but only eight products can easily be made there because of considerations such as stability and frequency of use. Out of-hours preparation of intravenous doses remains a problem, Ms Selwood acknowledged.
Education of staff about injectable medicines is critical. Ward nurses and pharmacists receive annual updates, but other staff can miss out. Steps have now been taken to correct this. For example, operating department practitioners (ODPs) and radiology staff are now to receive IV training tailored to their needs. It had been suggested that perfusionists, who operate heartlung machines, did not need training because they add
medicines to machines rather than directly to patients. This argument was discounted because the machines are connected to patients, said Ms Selwood. Doctors are also required to undertake calculation tests and an e-learning package is available for annual updates.
The annual health check of healthcare organisations relies on self-declarations of compliance, but the Healthcare Commission asks them to provide evidence of their own assurance, rather than simply asking for box ticking, Gillian Arr-Jones (head of pharmacy, Healthcare Commission) told the audience. A sample of declarations is followed up and if organisations are unable to produce evidence to substantiate their declarations then the record is modified.
The Healthcare Commission assesses trusts performances
against the standards laid down in Standards for Better Health. The first of the core standards is concerned with safety, and it includes the provision that, alerts which require action are acted upon within the required timescale. In order to check on this item, the Healthcare Commission picks two alerts and follows
up their implementation as a kind of litmus test. Last year, one of the alerts selected was the NPSA injectable medicines alert (NPSA/2007/20). The findings were published in the Healthcare Commission report published in October 2008 (see Resources).
Rationalisation and consolidation of supply and demand is critical, and pharmacy should take the lead here, but in order to achieve this the NHS will have to decide what it really wants and needs, Tim Root (specialist pharmacist, clinical governance and technical services East and South East England Specialist
Pharmacy Services) told delegates.
Mass-market medicines are generally of good quality, safety and efficacy, feed a large market and are expensive to develop, but are not always entirely fit for purpose. On the other hand, ready-to-use products are essentially niche-market items. As such they face uncertain and unconsolidated demand and uncertain returns so they are not commercially attractive. This situation favours reliance on unlicensed medicines, said Mr Root.
If more ready-to-use products are to become massmarket items, the NHS will first have to think hard about rationalisation and standardisation of products, he said. In addition, the regulatory process needs to be simplified and redesigned to ensure that compliance with regulations not only ensures quality, safety and efficacy, but also fitness for purpose. In the ideal supplier market there would be a smaller product range; fewer, larger NHS units would make niche products whilst non-NHS manufacturers would make high-volume products. Amongst the challenges to be tackled he highlighted effective use of resources: Do not waste time on dilutions of dermatological products and then complain that there is no time to prepare intravenous doses, he cautioned.
Other important measures include ensuring that there is evidence of effectiveness for products that are requested and educating finance officers so that they also understand the issues. Finally, he recommended cautious and constructive dialogue with the pharmaceutical industry.
Closing the meeting, Laurence Goldberg (HPE consultant editor) reminded the audience that in 1976 – 31 years before the issue of the NPSA injectable medicines alert the Breckenridge report had recommended the preparation of intravenous doses in
pharmacies, but uptake of the idea had been patchy. Implementation of the measures described in NPSA 20 should ensure that we are not obliged to revisit the same issues in 30 years time.
The annual health check 2007/08: a national overview
of the performance of NHS trusts in England. London: Healthcare Commission; 2008 October 16. Available from: www.healthcarecommission.org.uk