WHY CLOSED SYSTEMS?
potential health risks for chemotherapy nurses
WHY CLOSED SYSTEMS?
There is an increasing awareness amongst healthcare professionals about the potential health risks from an exposure to cytotoxic drugs. As well as clinical evidence and studies highlighting a range of issues, there is a recent survey of chemotherapy nurses, which revealed nearly 50% said they had experienced adverse effects on their health.
SACT and closed systems
Cytotoxic Systemic Anti-Cancer Therapy (SACT), or cytotoxic chemotherapy, is a group of medicines containing chemicals that are directly toxic to cells. In preventing the replication or growth of cells they are active against cancer.
By their very nature, the cytotoxic drugs also pose a threat to the clinicians and support staff who deliver the chemotherapy to patients. Many SACT agents are known to be carcinogenic, teratogenic and mutagenic by virtue of their mechanism of action within cells. There are now many clinical papers and reports outlining the risks to the health of staff and anecdotal accounts of possible exposure to chemotherapy ranging from itchy skin and hair loss to miscarriage and infertility. The risk of exposure comes from of the inhalation of contaminated air, or by skin contact with contaminated surfaces, material and medical equipment (Sessink, 2016)
As nurses very familiar with the oncology environment and the potential risks to our colleagues from exposure to cytotoxic drugs, we are adamant that CSDTDs must be made mandatory to protect healthcare workers. Through our work at Birmingham City University in researching the issue, the training we do in hospitals and the reaction to the clinical papers we’ve written, we know there’s a lot of work to do to make sure all healthcare workers are aware of the risks and are properly supported in keeping themselves as safe as possible.
We believe this can only truly be achieved when all cytotoxic drugs are administered through CSDTDs and that’s the aim of the SACT Safety campaign.
Why not join us? Register your contact details here and we’ll keep you informed of all the latest news.
Growing evidence
There is a growing body of evidence detailing the potential risks to healthcare workers of exposure to cytotoxic chemotherapy during administration. There is specific guidance from the Health and Safety Executive (HSE, 2014) about the Safe Handling of cytotoxic drugs in the workplace.
But anecdotal accounts and the experience of healthcare practitioners shows that current practices may not be keeping clinicians safe enough and the only way to achieve effective protection is by the mandatory use of closed system drug transfer devices.
Below is a list of clinical evidence as well as useful links to official guidance and legislation.
- Simons A and Toland S (2016) Closed systems for drug delivery; a necessity, not an option. British Journal of Nursing (IV therapy supplement) vol 24 no 14
- Simons A and Toland S (2017) Perceived effects from handling systemic anti-cancer therapy agents. British Journal of Nursing (Oncology supplement) vol 26 no 16
- BD Supplement in British Journal of Nursing: Be compliant, protect each other and stay safe: avoiding accidental exposure to cytotoxic drugs. British Journal of Nursing. 24(16):S1-56
- Control of substances hazardous to health (COSHH) (2002) available online at: http://www.legislation.gov.uk/uksi/2002/2677/regulation/11/made
- National Institute for Occupational Safety and Health. (2004) NIOSH Alert: Preventing occupational exposure to antineoplastic and other hazardous drugs in healthcare settings. DHHS publication no 2004-165 Cincinnati OH:US Department of Health and Human Services. Centers for Disease Control and Prevention
- Management of health and safety at work regulation (1999) available online at http://www.legislation.gov.uk/uksi/1999/3242/pdfs/uksi_19993242_en.pdf
- Health and Safety at Work Act (1974, 2002) Available online at http://www.legislation.gov.uk/ukpga/1974/37/contents
- Health and Safety Executive (HSE, 2014) Safe Handling of cytotoxic drugs in the workplace. Available online http://www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm
- European Policy Recommendations. (2016) Preventing occupational exposure to cytotoxic and other hazardous drugs. Available online http://www.europeanbiosafetynetwork.eu/wp-content/uploads/2016/05/Exposure-to-Cytotoxic-Drugs_Recommendation_DINA4_10-03-16.pdf
- American Society of Health-System Pharmacists (ASHP, 2006) AHSP Guidelines on Handling Hazardous drugs. Am J Health-Syst Pharm. 63:1172-93
- International Agency for Research on Cancer (IARC)(2016) IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. Lyon, France: World Health Organisation, International Agency for Research on Cancer, iarc.fr
- ISOPP (2007) Standards of Practice. Safe Handling of Cytotoxics. Journal of Oncology Pharmacy Practice 13(1) 1-81
- Beaney AM (2016) Quality Assurance of Aseptic Preparation Services: Standards, 5th Edition, Royal Pharmaceutical Society
- Instituto Nacional de Seguridad e Higiene en el Trabajo (INSHT, 2016) Dangerous drugs: preventative measures for preparation and administration, [in Spanish] Ministerio de employeo y segridad social. http://tinyurl.com/mjh6f5r
- MA, Oliver. M, Roth. T, Rogers. B and Escalante. C (2010) Chromosome 5 and 7 Abnormalities in Oncology Personnel Handling Anticancer Drugs, American College of Occupational and Environmental Medicine, 52 (10) p1028-1034
- Occupational Safety and Health Administration (OSHA, 2016) Controlling Occupational Exposure to Hazardous drugs, https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html#mgmt
- Pan American Health Organisation (2013) Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource settings Washington D.C PAHO
- Wiley, K (2017) What Are ONS’s Recommendations for Safe Handling of Hazardous Drugs? ONS Voice https://voice.ons.org/news-and-views/safe-handling-of-hazardous-cancer-drugs accessed on 28/6/17.
- Bartel, S et al Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs American Journal of Health-System Pharmacy 2018 Volume 75. Bartel-Multicenter-evaluation-of-a-new-closed-system
Our survey results
A survey to measure whether nurses experience any harm when administering chemotherapy drugs to patients reveals that 46% had experienced one or more adverse effects on their health.
The anonymous survey carried out by Alison Simons and Samantha Toland at Birmingham City University was completed by 200 nurses across 55 different healthcare organisations from all over the UK.
The most common complaints were headache, dizziness or nausea, or combination of two or more symptoms. One in every 10 respondents said they had suffered miscarriage or fertility problems, which they attributed to the drugs they had worked with and a further 9% said they’d experienced hair loss.
Concluding their research published in the Oncology Supplement of the British Journal of Nursing, Alison and Sam said: “There is an increase in the use of new therapies such as targeted therapies, immunotherapies and monoclonal antibodies (MABs) where the hazard of exposure of these agents to healthcare workers has not yet been identified.
“Therefore closed systems should be used to prevent exposure until there is documented evidence that these agents do not pose a health risk to people who work with them.”
Simons A and Toland S (2017) Perceived effects from handling systemic anti-cancer therapy agents. British Journal of Nursing (Oncology supplement) vol 26 no 16.
A Nurse’s Story
Alison Jones
Alison is an Acute Oncology Nurse Practitioner at Birmingham City University. She first came into contact with systemic anti cancer therapy (SACT) as an oncology nurse at the Queen Elizabeth Hospital in Birmingham in the 1990s.
Exposed to chemotherapy on a daily basis, Alison had a miscarriage and then experienced fertility problems, which resulted in IVF treatment. Two of her colleagues, who developed cancer, associated their health issues with the chemotherapy treatment they had administered.
Whilst standards of training and protection are much better for nurses today, Alison believes that any possible contact with chemotherapy needs to be eliminated to ensure carers are safe.
“There is no doubt that nurses are better protected now than when I started but there is still a way to go.
“When I first started as a chemotherapy nurse in 1993 we didn’t even have spillage kits. You spiked a bag and you taped it. There was no real knowledge of the risks and that the chemo could do us any harm. I made chemo up. If it had crystallised you would re-make it up. No-one showed me how to do it we just got on and drew it up in the clinical room, there was no face masks back then and definitely no isolator.
“You could definitely smell the chemo when you breathed it in. You’d open certain drugs, which smelled strongly of metal and some were definitely worse than others. When we made the drugs up we were often in a small, pokey room with no ventilation and you would cough with the fumes. There were times when I felt sick and once I spilled a bit of chemo on my leg and it left a burn. Rashes and dry skin were commonplace in the department and we liked to blame the gloves but it could have been the chemo.
“One of the scariest things looking back was when we spiked the bags and the chemo was being administered there was sometimes a pool of liquid on the floor. We assumed it was from the water jugs and we cleaned it up as if it was water, without gloves, but it was most likely chemo. There was no designated wash up area for the chemo equipment, we just washed everything up together. Because nothing was monitored or measured officially we will never know if the health problems we experienced were as a result of the exposure we had to the chemo but a tutor I had on an oncology course had made up hundreds and hundreds of drugs, without gloves or face mask and she got cancer. She was convinced it was the exposure to the chemo.
“Now there is much more awareness of the dangers when handing the drugs but there are still gaps that need plugging. Everyone should be choosing closed system drug transfer devices to offer the maximum protection but that will take time. In the meantime there is plenty that can be done. Better training that is consistent across the country is vital and agency staff need to be properly and consistently briefed to know what’s on a ward and what to look out for.
“The chemo passport* is an excellent initiative in to ensure SACT training is consistent across London and this needs to take place nationally.”
Do you have a story to tell?
If you have been affected by any of the issues outlined in Alison’s story, or you’ve experienced adverse effects on our health whilst administering chemotherapy and you would like to share your experiences or be part of the SACT Safety campaign, do please contact us on hello@sactsafety.com
What is SACT?
Cytotoxic Systemic Anti-Cancer Therapy (SACT), or cytotoxic chemotherapy, is a group of medicines containing chemicals that are directly toxic to cells. In preventing the replication or growth of cells they are active against cancer.
By their very nature, the cytotoxic drugs also pose a threat to the clinicians and support staff who deliver the chemotherapy to patients. Many SACT agents are known to be carcinogenic, teratogenic and mutagenic by virtue of their mechanism of action within cells. There are now many clinical papers and reports outlining the risks to the health of staff and anecdotal accounts of possible exposure to chemotherapy ranging from itchy skin and hair loss to miscarriage and infertility. The risk of exposure comes from of the inhalation of contaminated air, or by skin contact with contaminated surfaces, material and medical equipment (Sessink, 2016)
*The Systemic Anti-Cancer Therapy (SACT) competency passport has been developed by cancer nurses across London and the UK Oncology Nursing Society (UKONS), with support from Capital Nurse. It will ensure that training for nurses giving patients cancer therapies, such as chemotherapy, is consistent, up-to-date and standardised in NHS trusts and private hospitals across London. Previously nurses who administer SACT have needed to undertake re-training in any new place of work. This has led to inconsistencies in the quality of training and duplication.
FAQs
Many SACT drugs are identified as hazardous according to national/international available guidance such as HSE (2014), NIOSH (2004), European guidelines (2016) as there is evidence to suggest they can cause both short and long term effects in healthcare workers who handle them frequently. Short term effects include: nausea, dizziness, headaches, hair loss, abdominal pain, rashes, irritation of the eyes and throat. Longer term effects reported have included: altered blood counts, suboptimal fertility/foetal loss/foetal abnormalities and malignancy as many SACT drugs have carcinogenic properties. These side effects are a direct result of the drugs’ mechanisms of action which usually include some interaction with healthy DNA leading to cell mutation and abnormalities.
Most available guidance suggests a hierarchy of controls:
•First, use totally enclosed systems where reasonably practicable
•Second, control exposure at source, e.g. using adequate extraction systems and organisational measures
•Third, issue PPE where adequate control cannot be achieved by other measures alone (HSE 2014)
In the UK, these guidelines are often not followed completely and many hospital trusts depend upon the use of PPE as the primary control measure. Ideally a combination of both closed systems and PPE would ensure an optimal level of control of exposure. Risk assessments should always be carried out in areas where hazardous drugs are handled and this should also give you documented evidence of the risks and how they are currently controlled – and what steps should be taken to ensure the risk level is controlled as much as is reasonably practicable.
You will usually need to complete a business case for closed systems as they will always mean an initial outlay of cost – but very often this will off-set another cost, such as cost of flush bags, or if moving to a different pump so that a closed system can be used, there are often long term savings in relation to infusion lines that can be achieved. You will need to contact your procurement department, but also involve other colleagues in health and safety, infection control and your senior management teams.
There are case studies on this website for you to reference in helping you develop your own solution. Here is a link to a template to help you make your business case.
There is a wealth of evidence to suggest that many SACT drugs are classed as hazardous and therefore pose a risk to all healthcare workers that are involved in any part of the process – from transport, manufacture, manipulation, administration through to patient waste and disposal. We have many references and links on this website to support this – showing your manager the evidence available is the best way to persuade them – and to remind them that all available precautions should be taken to minimise the risk of exposure. Just because they have never experienced adverse effects does not mean that they don’t exist – just as patients all react very differently to SACT, healthcare workers may also have differing susceptibilities to the adverse effects that may occur as a result of handling these drugs.
As we currently do not have any long term data regarding the risks of exposure to these drugs, the best course of action would be to control the risk of exposure as much as possible – in the same way in which we should for all hazardous drugs. Some MABs have individual risks and so each drug should be individually risk assessed (usually by pharmacy) – however, the precautions should really remain standard when handling any drugs where there is any form of exposure risk. Ultimately, many drugs may pose a risk even when they may not be classed as hazardous – think about the risks of exposure to antibiotic drugs, particularly in the current climate of growing antibiotic resistance.
The recommend hierarchy of control measures that must be applied in the following order of priority:
- Use totally enclosed systems where reasonably practicable.
- Control exposure at its source, for example by using adequate extraction systems and appropriate organisational measures.
- Issue personal protective equipment (PPE) where adequate control cannot be achieved by previous measures alone.
These three sets of control measures must be used together, not in isolation, as one set of measures will not be sufficient on its own, but they must be applied in the order indicated.
Inhalation – for example, in case of spillage or splashing during drug reconstitution, drug administration and waste disposal.
Absorption – for example, in case of spillage, splashing or needlestick injury during drug reconstitution, drug administration, waste disposal and changing of bed linen.
Ingestion – for example, in case of suboptimal hand hygiene; eating, drinking or smoking in contaminated areas; and not maintaining the cleanliness of sluices.
