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It is important for healthcare professionals not only to understand the risks of intravenous neoplastic drugs, but also to have essential safety equipment available to prevent exposure
Elaine Lennan RN BN MSc DClinP
Chemotherapy Forum Lead, UKONS;
Consultant Chemotherapy Nurse,
University Hospital Southampton;
Academic Practitioner,
University of Southampton, UK
Email: [email protected]
In the European Union (EU), nearly two million people are diagnosed with cancer each year and there are over one million deaths from the disease. The global burden is 12.6 million. It is estimated that there are nearly three million people alive in the EU who have received a diagnosis of cancer in the past five years.(1) Macmillan Cancer Care predicts that this figure will reach four million in the UK alone by 2030. Added to this is the change in population demographics; we are simply getting older. It is predicted that the numbers of people aged over 65 years and 80 years will rise by 20% and 50%, respectively, by 2015. Given this shift, we are likely to see more cancer diagnoses, and therefore more treatments.(1)
The increasing number of people living with cancer is, in some way, a result of improved treatments and coordinated management of side-effects. Better surgical techniques and innovative radiation therapies are now commonplace in many countries. But it is the explosion in the number of chemotherapy options that has caused the greatest challenges in clinical practice. The combination of patients living longer, additional lines of treatment where previously there were none, and the addition of targeted therapies for those eligible have increased the throughput of chemotherapy clinics worldwide.
In addition to the increase in drug treatment options, there has been a rapid expansion in the number and range of settings in which chemotherapy can be provided. Today, a high proportion of chemotherapy treatment can be delivered in the ambulatory setting and away from the hospital. While these advances are to be welcomed, concerns have been raised about the safety and quality of chemotherapy services.(2)
Patient outcome
This safety concern was highlighted in a National Confidential Enquiry into Patient Outcome and Death (NCEPOD) from the Department of Health.(3) The audit investigated 546 patients who died within 30 days of receiving chemotherapy and reported that there was room for improvement in 49% of cases, and, in 27% of cases, chemotherapy was judged to have caused or hastened death. In the UK, this audit was considered significant in driving better governance structures for chemotherapy services.
Chemotherapy services vary across Europe, with different health care systems and different professional boundaries, and attempts to address shortfalls in the quality or governance of a service should be mindful of this. Clinicians will be experiencing the challenge of trying to keep on top of horizon scanning for new drugs, given the steep rise in chemotherapy use over the past ten years. This makes capacity planning almost impossible, resulting in piecemeal solutions.
Oral chemotherapy has added additional challenges to chemotherapy services but this article focuses on intravenous safety and practices.
Improving chemotherapy services
The first thing to do in any service improvement or examination is to outline the chemotherapy pathway; this must be agreed by all involved – nurses, doctors, pharmacists and managers. This is helpful in understanding each individual’s role and scope and will highlight bottlenecks and ‘hot spots’ on which to concentrate for maximum effect.
In the UK there has been significant investment in medical oncologist training since the production of the Cancer Plan in 2000.(4) This investment has not been quite so forthcoming for oncology pharmacists and chemotherapy nurses. There has, however, been a redesign of the chemotherapy pathway to allow senior nurses and pharmacists to develop roles in assessing and prescribing chemotherapy(5); this requires prescriptive authority and is not something that can be introduced overnight.(6) It will not suit all European practices, and readers should look to their registration boards for guidance.
Waiting times for the delivery of chemotherapy, that is, verification and checking of a prescription by a pharmacist and waiting for a treatment chair or a nurse to administer the treatment, remains a key metric for good patient experience and is a good benchmark for a quality service. No matter what the current delays or frustrations within the chemotherapy pathway, safety must always be the prime concern. Irrespective of pressures of the unit, safety checks must be in place and must be followed at all times.
Reducing the risks of exposure
According to Connor et al,(7) there is no other occupation population that handles as many known human carcinogens, and therefore there is a significant risk from short- and long-term exposure. The risks from cytotoxics are genotoxic, mutagenic, teratogenic and carcinogenic and clinicians need to be aware of these. Occupational exposure is problematic and studies have demonstrated cytotoxic drugs in the urine of healthcare professionals.(8)
Personal protective equipment
Primarily, it is nurses and pharmacists who are at risk from exposure to antineoplastic agents, although in some countries doctors are still involved in their administration. All healthcare professionals involved in preparation or administration must protect themselves from exposure to cytotoxic drugs by observing, at all times, the need for personal protective equipment (PPE). While standards exist for pharmacy preparation units, including the use of protective cabinets and protective clothing, the recommendations for nurses administering the drugs are less straightforward. They range from wearing just gloves, wearing gloves and gown, to donning full PPE, including overshoes, face masks and goggles. Readers should be directed to their local hospital policies and national societies for advice.
What is clear is that nurses should not, in any circumstance, be preparing the drugs in the clinical areas.
Safe disposal
Cytotoxic safety is paramount not only to protect the individuals working with the drugs but also their colleagues and the environment. Any clinical waste should be disposed of in a container that is fit for purpose to hold cytotoxics. All units should have a spill kit available at all times, which contains step-by-step instructions on how to contain the hazard. If a spill should occur, dealing with the incident should be an immediate concern.
Reducing medication errors
Medication errors are a significant burden to health economies, accounting for approximately 4.8% of all health expenditure. The consequences of antineoplastic drug errors can be devastating because these drugs have a very low safety threshold. A review of medication safety in an ambulatory chemotherapy unit of over 10,000 medication orders found a medication error rate of 3%. Of these errors, 82% occurring in adults had the potential for harm and were potential adverse drug events (ADEs), compared with 60% of orders occurring in paediatric patients. Of these, approximately one third were potentially serious. Pharmacists and nurses intercepted 45% of potential ADEs during the checking process before they reached the patient. Given that there is such a low margin of error, these figures are alarming.(9)
The nurse, then, is the last line of defence before a potential medication error can occur. Creating a safe culture of reporting near-misses and actual events is the first step in improving medication administration safety.
The five ‘Rs’
It is important in administration to always using the fundamentals of the five Rs: right patient, right drug, right dose, right time, right route. This simple mnemonic used every time can be highly effective. Other solutions to improved safety include the exclusive use of electronic prescribing systems, awareness of look-alike/sound-alike drugs and electronic wristbands.(10)
Closed and needle-free systems
Once all safety checks regarding administration are performed, potential hazards for the nurse during administration still remain. Administration sets should be of a closed nature and needle-free where possible. General characteristics of a closed system include:
- Protects integrity of the IV fluid container whether on a syringe for transfer or on the end of an IV set
- Creates a needle-free closed system
- Allows safe transport of prepared syringes
- Upon disconnection, the system seals and closes, reducing or eliminating the risk of drips and spills.
All connections should be luer- or screw-locked to achieve a tight, leak-free connection and these connections should remain closed at disposal of equipment.
Infusion systems
Extravasation is a devastating consequence of maladministration of a vesicant drug. Some organisations have chosen to place vascular access devices (VADs) for all vesicant administration, but this is for individual units to determine based against the risk of the VAD insertion. Whether given peripherally or centrally, the responsibility remains with the administering nurse.(11) In addition to vesicant administration, another hazard is rate of administration. Technology in the form of sophisticated infusion pumps (smart pumps) is now commonplace and many of these devices include titration options and sensitive pressure sensors for early detection of any resistance in the vein. Many hospitals have adopted smart pumps to improve medication safety. Some pumps allow clinicians to program dose limits and rate limits that are either ‘soft’ (can be over-ridden) or ‘hard’ (that is, the pump must be reprogrammed with settings that are within facility limits before the infusion can begin). Some smart pumps can log all alerts and provide immediate standardised reports that can be used for continuous quality improvement.
Alarms in the pumps are sensitive and the nurse can spend a significant amount of time attending to them, so it is important that alarm fatigue does not manifest. Safety infusion systems certainly help in the busy chemotherapy units but ultimately it remains a nursing responsibility to monitor the individual until completion of the treatment. A machine and all its safety features are only as good as the programmer.(12)
Conclusions
The steep rise in chemotherapy options has resulted in extremely busy chemotherapy units, and while this is welcome news for patients, it is important for healthcare professionals to ensure services are safe. The antineoplastic chemotherapy agents used for treating cancer patients are hazardous drugs. The known risks of occupational exposure to these drugs are well documented, and can include acute, long-term, and reproductive complications. It is important for nurses and other healthcare professionals to not only understand these risks but to also have essential safety equipment available to prevent exposure and provide a safe environment during preparation and administration of cytotoxics. Human error cannot be eliminated completely, but implementing clear systems and processes ensures the service can be as safe as possible. ‘First do no harm’ principles clearly apply to both patients and health professionals.
Key points
- In the European Union, nearly two million people are diagnosed with cancer each year and there are over one million deaths from the disease.
- In addition to the increase in drug treatment options, there has been a rapid expansion in the number and range of settings in which chemotherapy can be provided.
- The National Confidential Enquiry into Patient Outcome and Death from the Department of Health was considered significant in driving better governance structures for chemotherapy services in the UK.
- All healthcare professionals involved in preparation or administration of cytotoxics must protect themselves from exposure and have essential safety equipment available.
- Human error cannot be eliminated completely, but implementing clear systems and processes ensures that the chemotherapy service can be as safe as possible.
References
- Cancer Research UK. CancerStats. Cancer in the European Union. November 2004. http://publications.cancerresearchuk.org/cancerstats/statsworldwide/cancereu2005.html (accessed 29 January 2013).
- National Chemotherapy Advisory Group. Chemotherapy services in England: ensuring quality and safety. 2009;Department of Health, London. www.dh.gov.uk/en/Publicationsandstatistics/Publications/DH_104500 (accessed 29 January 2013).
- National Confidential Enquiry into Patient Outcome and Death For better, for worse? A review of the care of patients who died within 30 days of receiving systemic anti-cancer therapy. www.ncepod.org.uk/2008sact.htm (accessed 29 January 2013).
- Department of Health. The NHS cancer plan: a plan for investment, a plan for reform. www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4009609 (accessed 29 January 2013).
- Lennan E et al. Best practice in nurse-led chemotherapy review: a position statement from the United Kingdom Oncology Nursing Society; 2012. Ecancermedicalscience 2012;6:263.
- National Prescribing Centre. A single competency framework for all prescribers;2012. www.npc.nhs.uk/improving_safety/improving_quality/ (accessed 29 January 2013).
- Connor TH et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med 2010;52:1019–27.
- Connor T, McDiarmid M. Preventing occupational exposures to antineoplastic drugs in health care settings. CA-Cancer J Clin 2006;56;354–65.
- Gandhi TK et al. Medication safety in the ambulatory chemotherapy setting. Cancer Dec 2005;104(11):2477–83.
- Kloth D. Guide to prevention of chemotherapy medication errors, 2nd Ed;2010:MacMahon Publishing Group.
- Wengström Y, Margulies A, European Oncology Nursing Society Task Force. European Oncology Nursing Society extravasation guidelines. Eur J Oncol Nurs 2008;12(4):357–61.
- Kirkbride G, Vermace B. Smart pumps: implications for nurse leaders. Nurs Adm Q 2011;35(2):110–18.
