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6. Intrathecal chemotherapy: keeping up the pressure for safe administration

A total of 23 incidents are known to have occurred around the world in which the drug vincristine has been injected intrathecally (spinally) during the treatment of a patient.

This drug is intended for intravenous (injected into a vein) use only. If injected intrathecally by mistake it causes paralysis usually followed by death. This type of medical error was identified in my report 'An organisation with a memory' and was targeted for elimination as part of a drive to improve patient safety in the NHS. Progress has been made in putting in place action to reduce the risk of this specific class of error, but more still needs to be done.

Key points

  • 23 people worldwide (usually children or young people) have been reported as paralysed or having died as a result of the maladministration of vincristine intrathecally (spinally). The most recent British case was in Nottingham in 2001, and worldwide was in Spain in 1996.
  • The true incidence of this medical error is unknown and the 23 cases only represent those which have been reported in medical journals or have become public in other ways.
  • Although rare, these incidents have catastrophic effects for the patient, their family and the clinical team concerned.
  • The circumstances of many incidents have been very similar and typically involve multiple failures of procedure, checking or decision-making. These failures then create the conditions for a serious error to occur.
  • So-called 'systems failure' as the cause of many unsafe situations is well recognised in other sectors (eg. the airline industry) but until recently was not well recognised in health care.
  • Elimination of intrathecal error is one of a number of targets set as part of a major NHS programme to improve patient safety by learning from medical errors and strengthening systems to reduce future risks of health care.
  • Action has been taken to achieve this target and more is planned. Local NHS organisations have been slow in complying with national guidance. They need to be rigorous in implementing safer administration of intrathecal chemotherapy.

Action specifically to prevent spinal injection errors needs to be seen within the broader context of the agenda to improve the safety and quality of care for NHS patients.

In 1997, the Government published its White Paper, 'The New NHS, Modern Dependable', which set out to define and provide the focus on quality. At a national level, the National Service Frameworks (NSFs) and the National Institute for Clinical Excellence (NICE) have helped to ensure that health care delivery is based on a clear set of standards.

At local level, all NHS organisations are required to fulfil a statutory duty of quality which was set out in the Health Act 1999. This duty of quality is delivered by the establishment in each local NHS organisation of a system of clinical governance. In this way quality assurance, patient safety and quality improvement became part of the routines of every clinical team and the central component of the culture of the hospital or primary care service. The development of clinical governance throughout the NHS is facilitated by a National Clinical Governance Support Team, part of the NHS Modernisation Agency.

This NHS framework of quality (national standards, local clinical governance) is completed by the process of inspection. Since 2000, this has been carried out by the Commission for Health Improvement (CHI). From 2004, subject to legislation, the inspection remit will broaden to include private health care and will be undertaken by a Commission for Health Care Audit and Inspection (CHAI).

Fatal event in Oviedo, Spain

Intrathecal vincristine errors have occurred in other countries:

Intrathecal vincristine was inadvertently injected into a 12 year old girl with acute leukaemia. Her condition progressively deteriorated with initial paralysis of both upper limbs and cranial nerves, proceeding to difficulty in swallowing and breathing, then paralysis of all four limbs, coma and death.

Source: Alcaraz A, Rey C, Concha A & Medina A. Intrathecal vincristine: fatal myeloencephalopathy despite cerebrospinal fluid perfusion. Clinical Toxicology 2002; 40(5):557-561.

The NHS Patient Safety Agenda

In June 2000, I produced a report that established the way forward to ensure that the NHS learns from what goes wrong. Not only did 'An organisation with a memory' draw attention to the scale of the problem of potentially avoidable events that result in unintended harm to patients, but it also set-out a number of proposals for developing a culture of openness, reporting and safety consciousness within NHS organisations.

Ensuring the safety of everyone who comes into contact with health services is one of the most important challenges facing health care today, not just here but worldwide. In the United States of America, for example, medical error in hospitals is now believed to be potentially the third commonest cause of death. Perhaps as much as a half of these adverse events are judged to be avoidable. I promoted a resolution (WHA55.18) through the World Health Assembly - adopted in May 2002 recognising the need to promote patient safety as a fundamental principle of all health systems.

These international developments are important for two reasons:

  • Firstly, they demonstrate that the problems we face in this country are not unique to the NHS. Similar problems, of equal magnitude, and probably of similar causes with similar solutions, are found in fee-for-service and insurance based systems, every bit as much as they are in the state funded NHS.
  • Secondly, these data demonstrate that there is a huge potential to reduce suffering and avoidable death if we pay greater attention to safety and quality, if we learn from and act on our mistakes, and if we learn from other industries - such as the airlines - where safety is 'mission critical'.

An increasing body of evidence is already pointing to the fact that in the majority of instances, it is not bad or poorly performing health care professionals who are directly responsible for adverse events. Rather, the fault lies in the systems in place to support the delivery of safe, high quality health care. Health care professionals clearly need to be trained to be competent in the care of patients. They also need to practise very conscientiously and be supported in doing so. However, if the risks to patients are to be lessened and if the quality of care given to patients is to improve, within health care organisations there need to be the skills to recognise, analyse and learn from errors.

In an organisation as complex as the NHS, things will sometimes go wrong and some patients will suffer unintended harm. 'An organisation with a memory' concluded that if the NHS was to successfully modernise its approach to learning from failure, four key areas must be addressed:

  • unified mechanisms for reporting and analysis when things go wrong;
  • a more open culture, in which errors or service failures can be reported and discussed;
  • mechanisms for ensuring that, where lessons are identified, the necessary changes are put into practice;
  • a much wider appreciation of the value of the system approach in preventing, analysing and learning from errors.

A National Patient Safety Agency (NPSA) has been established. It has already begun collecting and analysing key information from local organisations and from other sources - with the aim of providing relevant and timely feedback to organisations and clinicians to help them improve patient safety. The National Patient Safety Agency's national reporting and learning system for adverse events is undergoing testing and development prior to being implemented across the NHS from summer 2003.

By collecting and analysing data on adverse events, the Agency will be able to identify trends and patterns of avoidable adverse events, provide feedback to organisations to enable them to change their working practices, help develop models of good practice and systems solutions at national level, and also support ongoing education and learning to promote patient safety.

The information received from the National Patient Safety Agency's reporting system and from other information sources - such as litigation and research - will inform the development of safety solutions to reduce both the numbers of incidents that occur and the seriousness of the outcomes for patients.

Over time, the National Patient Safety Agency will begin to give us a real understanding of the scale of the problem - a baseline allowing us to understand the real extent and nature of adverse events, and a means to act on that knowledge.

Improving patient safety requires change in many different areas, not least in the culture of organisations. Evidence shows that if the culture is open and fair and people are encouraged to speak up about mistakes and near misses, patient safety is improved as people are able to learn about what has gone wrong and are able to put things right.

Safe administration of intrathecal chemotherapy - national guidance

'An organisation with a memory' proposed a number of specific targets for action (agreed within 'The NHS Plan'), including the target to:

  • Reduce to zero the number of deaths from maladministered spinal injections by the end of 2001.

Subsequent reports in April 2001 - by Professor Kent Woods on the prevention of intrathecal medication errors, and by Professor Brian Toft who led the external enquiry into the adverse event at Queen's Medical Centre Nottingham which caused the death of Wayne Jowett - highlighted the large number of separate factors which, in combination, can lead to this type of tragic medical error.

These broadly fell into the areas of training and education, ward procedures and protocols, and pharmacy procedures and protocols. However, in preventing unsafe practices that lead to serious error, including the maladministration of chemotherapy drugs, there is a need to address broader issues such as management accountability for the systems and culture within organisations.

Drawing on the learning from these reports, the Department of Health issued national guidance on the safe administration of intrathecal chemotherapy [HSC 2001/022] on 6 November 2001. This required all NHS Trusts where intrathecal chemotherapy is administered to take appropriate action to ensure the introduction of safe practice. The guidance issued by the Department of Health was developed by an expert panel which drew on the learning from the Toft and Woods reports. The recommendations by Brian Toft were incorporated into the guidance except where the Panel was satisfied that an alternative recommendation would further enhance safety. The Department of Health consulted on the draft guidance before it was issued.

Health Service Circular (HSC 2001/022) on the Safe Administration of Intrathecal Chemotherapy

The guidance requires NHS organisations to:

  • set up a register listing staff trained and authorised to handle intrathecal chemotherapy drugs
  • provide regular training for all professional staff on the register and introduce a formal induction programme for all new staff involved
  • provide a written protocol for all staff involved with chemotherapy, reflecting both national guidance and local information
  • ensure intrathecal chemotherapy is only prescribed by a consultant or specialist registrar
  • use an intrathecal chemotherapy chart
  • ensure intrathecal chemotherapy drugs are issued or received only by designated staff
  • ensure intrathecal drugs are kept in a lockable designated refrigerator when they cannot be administered immediately
  • ensure intravenous drugs are given before intrathecal drugs are issued, unless intrathecal chemotherapy is being given to a child under general anaesthesia
  • provide intrathecal chemotherapy only in designated, separate areas and within normal working hours
  • ensure relevant checks are made throughout the administration process
  • ensure all drugs with life threatening consequences are clearly labelled
  • standardise the dilution of intravenous chemotherapy drugs

(Health Service Circular (HSC 2001/022): Safe Administration of Intrathecal Chemotherapy)

 NHS organisations completed a self-assessment exercise in early 2003. This demonstrated that a number of NHS Trusts were not completely compliant with the national guidance and that further action was required to ensure that services are being delivered safely.

Follow-up independent peer review visits to all relevant NHS Trusts have now been completed. The aim of these visits was to validate NHS Trusts' original self-assessments, identify areas that fell below the accepted level and make recommendations to address these, so that NHS Trusts can be certain they are providing safe intrathecal chemotherapy services to patients.

The visits have covered a range of issues including: the clinical environment; formal and informal staff interviews; checks of medical notes and charts A report of the national position in May 2003 showed less than full compliance with the guidance and urgent action is being taken with the hospitals concerned.

I have been disturbed by the time taken to implement this clear national guidance. Following this exercise, we aim to engage with front line staff and managers to learn lessons and find how what more can be done to support the NHS in ensuring that this and future safety guidance can be quickly and successfully implemented.

A training pack and video will be available in 2003 to support local training programmes and locally tailored protocols and processes.

Further work to help prevent intrathecal chemotherapy errors

There are a number of further steps that are being taken to prevent these and other errors occurring across the NHS.

A design solution could make it physically impossible to accidentally inject vincristine and other drugs using the wrong route. Advocated by many people in the past, this seemingly obvious solution is not as straightforward as it might at first seem. Currently, standard medical connectors (Luer connectors) are used in a wide variety of systems including the administration of intravenous, spinal and other injections as well as delivering fluids and gases in other settings. Their wide use in health care allows cross connection between these different medical systems and this has been a contributing factor in intrathecal chemotherapy errors. We need to be certain that any potential new design solution is rigorously tested and, crucially, that by introducing new equipment to prevent one specific type of error, we do not, in turn, introduce new unforeseen risks to patients.

The Department of Health is working with manufacturers to identify a design solution. To identify options, an announcement was placed in the Official Journal of European Communities (OJEC) seeking devices for spinal procedures which must be fitted with connectors which are not compatible with standard medical connectors. The announcement (OJEC Reference (02/S 66-51750/EN) sought expressions of interest for devices including syringes, drawing up needles, spinal needles, microbiological filters and epidural catheters. This is the first step in a programme to identify and, if possible, introduce alternative equipment as a further measure to reduce risk of harm to patients through mis-connection errors.

Current connector systems are well established and in regular daily use across the NHS - consequently, identifying and introducing possible new equipment and changing practice will inevitably take time.

My report 'An organisation with a memory' also highlighted the risks of medication errors more generally, in addition to the very specific risk with intrathecal chemotherapy. A prescribed medicine is the most frequent treatment provided for patients in the NHS. General practitioners in England issue almost 600 million prescriptions every year, and there are an estimated 200 million prescriptions in hospitals. Standards of prescribing in this country are high and the vast majority of drug treatment is provided safely. However, mistakes do occur - they can arise in the prescribing, dispensing or administration of medicines, and the consequences can be serious.

The NHS is committed to making drug treatment as safe as possible. I have therefore asked the Chief Pharmaceutical Officer, to draw up a report providing guidance for health professionals and NHS organisations, drawing on experience and good practice within the NHS and worldwide.

Improving the labelling and packaging of drugs can be a further means to reducing the risks of these and other medication errors. We know that problems with labelling have also been associated with a high percentage of errors and that there is the potential for improving the layout of medicines labelling to aid clarity. This would assist health professionals and patients/carers to select the correct medicine and use it safely, thereby helping to minimise medication errors.

Following the publication of 'An organisation with a memory', The Medicines Control Agency (MCA, now called the Medicines and Healthcare products Regulatory Agency) reviewed the labelling of all vinca alkaloids and took steps to ensure that companies complied with labelling changes.

Since then, the Medicines Control Agency has been working with the National Patient Safety Agency, the pharmaceutical industry, health care professionals and lay interests to develop best practice guidance on medicines labelling and packaging to improve patient safety.

The Best Practice Guidance, published on 3 March 2003 and taking effect immediately, set out the factors to be considered when designing medicines labelling. These include layout, size of text and colours used. In addition, although 15 different pieces of information are legally required to appear on a label, users need rapid access to only five key pieces of critical information:

  • the name of the medicine
  • strength
  • route of administration
  • dose
  • any warnings.

The guidance advises that these should be brought together on the pack for ease of access.

Conclusion

Improving patient safety is now a major government priority. Indeed, ensuring the safety of patients is becoming one of the most important challenges facing health care today, not just here but worldwide.

It is an issue that, properly addressed, will reap tremendous benefits both in reduction in unintended harm to patients and a reduction in unnecessary financial costs associated with such harm. Improvements in patient safety will contribute significantly to improving the quality of care for NHS patients. Reduction in errors will also free up resources at present used to cope with the consequences of those errors.

Those specific errors involving chemotherapy drugs, thankfully, appear to be uncommon, both here and internationally. However, when they do happen, the consequences can be devastating for everyone involved: for patients and their loved ones, as well as for staff.

Moreover, this is an area where we already have much of the learning we need to ensure similar cases are not repeated in the future - we have been able to set clear guidance to the NHS to help achieve this goal.

However, we need to continue to work on a number of fronts. In particular, NHS organisations need to assure themselves that they are doing all they can to deliver safe care for those receiving spinal chemotherapy drugs.

The clear national guidance must be fully implemented, and the time being taken to achieve full compliance is a source of concern.

Action recommended

  • NHS organisations must ensure that they are complying in full with Health Service Circular 2001/022 on the Safe Administration of Intrathecal Chemotherapy.
  • NHS Trust Chief Executives need to ensure that intrathecal chemotherapy and other patient safety issues are recognised as clear clinical governance issues and are addressed in quarterly risk management reports.
  • NHS Chief Executives must provide leadership in promoting a safety culture within their organisations, where all staff are actively encouraged to report and learn from mistakes and near misses, to avoid errors being repeated.
  • NHS organisations need to ensure that they provide adequate and appropriate induction and formal training for all staff entering a department where intrathecal chemotherapy is administered.
  • Building on the work to develop a design solution to prevent cross-connection errors and on safer labelling and packaging of medicines, the Department of Health and the NHS must continue to work with the pharmaceutical and medical devices industries to jointly promote better and safer products.
  • The NHS should review the criteria it uses to inform its purchasing decisions - as purchasing based on consistent, well-founded criteria could, in turn, help focus manufacturers and suppliers on delivering improved patient safety.

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