Introducing the United Kingdom Oncology Nursing Society's (UKONS) Position Statement on Oral Chemotherapy'

BACKGROUND TO THE SUPPLEMENT

The past decade has seen dramatic changes in the way that many cancers are now treated. There has been a huge increase in the number of oral anticancer drugs licensed for the treatment of solid and haematological tumours with nearly 24 million doses of oral chemotherapy drugs being prescribed in England alone between 2006 and 2007 (National Patient Safety Agency (NPSA) 2008). Their enthusiastic uptake has been driven by the significant advantages they offer in terms of lowered toxicity profiles, convenience and cost-effectiveness, particularly as patients do not require admission to an inpatient ward or day unit unless receiving intravenous therapies in combination with their oral drugs. This helps to reduce demand on chemotherapy units, pharmacy reconstitution services and treatment facilities which are already overstretched; and patients reportedly prefer oral chemotherapy regimens because of their undoubted convenience (Twelves et al. 2006).

However, while chemotherapy services recognise standards advocating the administration of intravenous cancer treatments by appropriately trained nursing staff a recent survey of UK pharmacists suggests that procedures for the administration of oral chemotherapy are less than rigorous (Williamson 2008). This has worrying consequences, and in January 2008, the NPSA issued a rapid response report on the potential for fatal outcomes if incorrect doses of oral chemotherapy drugs are administered (NPSA 2008). This was issued in response to three deaths and 400 patient safety reports involving oral chemotherapy agents administered between November 2003 and July 2007. Half of these reports concerned the wrong dosage, frequency or duration of treatment, but it is likely that patient self-administration errors are significantly under-reported within the literature (Oakley et al. 2008).

Findings from a national UK study on patients who died within 30 days of receiving either oral or intravenous chemotherapy agents judged that only 35% of those dying had received ‘good’ care in relation to their chemotherapy regimens (National Confidential Enquiry into Patient Outcome and Death (NCEPOD 2008), and there is clearly a need to improve procedures for the management of patients receiving oral chemotherapy. Without a structured approach to the delivery of oral chemotherapy treatments, it is impossible to know whether patients are regularly and adequately assessed or reviewed by appropriately qualified healthcare professionals. This may leave patients and carers feeling overwhelmed by the responsibility of managing their own treatment (Twelves et al. 2006; Oakley et al. 2008), and patient errors may consequently include incorrect dosing or the late reporting of treatment-related toxicities. In 2004 The British Oncology Pharmacy Association (BOPA) published a position statement intended to improve the preparation and dispensing of oral chemotherapy drugs (BOPA 2004), and the United Kingdom's National Chemotherapy Advisory Group (NCAG 2009) and the NPSA (2008) have stated that the governance frameworks and care processes applied to intravenous chemotherapy should apply equally to oral chemotherapy regimens.

THE UNITED KINGDOM ONCOLOGY NURSING SOCIETY POSITION STATEMENT

The United Kingdom Oncology Nursing Society (UKONS) is the most recent group to add their voice to this debate (Oakley et al. 2010a). The role of the position statement is to outline the knowledge and skills required to ensure the safe, competent delivery of orally administered chemotherapy drugs and the appropriate monitoring of patients receiving these treatments. UKONS advocates that the principles applied to the safe administration of oral chemotherapy should be the same as those for the intravenous treatment of cancer. Healthcare organisations in the UK are required to produce guidelines and protocols for the management of oral chemotherapy covering such factors as the prescription and supply of treatment, procedures for ensuring that patients are adequately prepared and supported to manage oral therapies, and verifying the patient's identity before treatment is dispensed (DOH 2004). Providers should also ensure that those caring for such patients also have appropriate knowledge and skills to ensure their safe administration (DOH 2004). UKONS recommend that nurses administering oral chemotherapy should have undertaken bachelors level study in oncology nursing including one or more modules in chemotherapy administration, and their competence to administer these should be assessed annually (DOH 2004).

Nurses are well placed to check patient suitability for oral chemotherapy by noting for example, whether cognitive state, social isolation or the presence of severe dysphagia prevent their administration by this route (NCEPOD 2008). Education is also important, and the position statement focuses on the importance of enabling patients and carers to safely manage oral chemotherapy to ensure patient concordance and treatment response. Cancer nurses and/or pharmacists with specialist anti-cancer medication knowledge can ensure that patients receive comprehensive education appropriate to their needs (BOPA 2004, Health and Safety Executive 2003), so UKONS recommends that patient preparation takes place within dedicated specialist clinics, and cancer services should therefore urgently assess the potential role of nurse/pharmacist led clinics in the management of patients prescribed oral chemotherapy (Molassiotis et al. 2009; NCAG 2009).

Unique to oral chemotherapy is the need to educate patients with regard to all aspects of self-administration including the regimen, treatment plan, monitoring arrangements, toxicity management and what to do in the event of a missed dose or vomiting (Department of Health (DOH) 2004; NCAG 2009). They should also be taught how to take the tablets safely and principles of safe handling, storage and disposal (BOPA 2004; Health and Safety Executive 2003). Pretreatment consultation should be structured and supported by nursing protocols, checklists, written information and tools such as the Multinational Association for Supportive Care in Cancer (MASCC) oral agent teaching tool (MOATT) (MASCC 2010) or patient scheduling diaries. The consultation should be tailored to individual patient needs, knowledge, perception and psychological status to promote patient self-management, and understanding should be checked before the patient is given their oral medication (MASCC 2010). It is further recommended that patient or carer responses to possible serious side effects such as neutropenic sepsis are rehearsed, and that key points are reviewed at the end of the consultation to ensure optimal management of complications.

UKONS advocate that chemotherapy nurses are actively involved in the patient consent process, and nurses in the UK may legally take written consent from patients prescribed oral therapies if supported by local Trust policy (Treleaven et al. 2006). UKONS also recommends nurse prescribing of oral chemotherapy which enables patients to get the required medication on time and may allow patients to be managed nearer their home (DOH 2007). It facilitates a holistic approach to patient care, and enables sharing of the prescribing workload in busy chemotherapy clinics (NCEPOD 2008; Courtenay & Gordon 2009). Community services also have the potential to support patients receiving oral chemotherapy and identify toxicities and complications early, allowing prompt remedial action to prevent serious complications and possible hospitalisation (NCEPOD 2008; Molassiotis et al. 2009; NCAG 2009). All providers should ensure availability of a 24-hour telephone advice service for patients prescribed oral therapies with appropriately trained nursing, medical or pharmacy staff handling enquiries (DOH 2004).

When treatment is initiated by specialists but patient follow-up or monitoring is shared, protocols and guidelines should be developed with primary care providers so that communication with all healthcare providers, including primary and community healthcare practitioners is maximised (O’Neill & Twelves 2002). All stakeholders should be given precise, regular information on a patient's treatment, potential side effects and drug interactions, where to get advice, where patients should report, and how they should be managed in the event of treatment complications (DOH 2004; NCEPOD 2008). Twenty-four-hour telephone advice lines should be supported by dedicated acute oncology staff to help manage patients who develop complications following chemotherapy, including neutropenic sepsis (NCAG 2008), and UKONS recommend that nurses be involved in the proactive monitoring of patients to identify problems before they become serious (Molassiotis et al. 2009; NCAG 2009).

A PRACTICAL GUIDE

Given the above, we are delighted to introduce this much needed supplement which looks at the practical aspects of oral chemotherapy administration and provides an overview of the UKONS position statement, the full version of which can be found at http://www.ecancermedicalscience.com. In the first article, Irshad and Maisey (2010) introduce the concept of oral chemotherapy, which is commonly understood to mean the oral administration of drugs which have direct anti-tumour activity (BOPA 2004). The definition includes traditional cytotoxic drugs such as capecitabine, cyclophosphamide, busulphan, hydroxycarbamide, idarubicin, chlorambucil, vinorelbine, tegafur, etoposide, topotecan, methotrexate and melphalan; as well as the targeted therapies imatinib, lapatinib, erlotinib, gefitinib, sunitinib, sorafenib and everolimus. It does not include hormonal or anti-hormonal agents such as tamoxifen or anastrozole, but it does include thalidomide and lenalidomide. The article provides valuable insight into the benefits of oral therapies and necessary considerations when identifying suitable patients for treatment. It is also the first of two articles in this supplement to draw upon newly published guidance from the UK Colorectal Practical Guidance Group on the use of capecitabine in colorectal cancer (Cassidy et al. 2009).

The second and third articles focus on patient management from a nursing perspective. In the first, Harrold (2010) reviews the evidence for nursing management of adverse effects from therapy. She also refers to the UK Colorectal Practical Guidance Group guidelines on the use of capecitabine in colorectal cancer in order to identify appropriate dosing regimens and the rationale for dose modifications. In the following papers, Oakley et al. (2010b) outline the patient experience of oral chemotherapy and the development of an oral chemotherapy patient diary to assist them in managing their own treatments, and Vidall (2010) outlines the development of community oral chemotherapy nursing support roles. In the final paper, So (2010) outlines the cost effectiveness of delivering oral therapies in the home from the perspective of the hospital pharmacy service in line with the requirements of the UK Chemotherapy Services in the Community (DOH 2010) report, which urges the commissioners of healthcare services to consider how chemotherapy services may be better provided to patients in their own homes.

The supplement provides opportunity to highlight two important pieces of guidance recently published by UKONS and the UK Colorectal Practical Guidance Group, and show-case a number of highly innovative approaches to improving the care of patients treated with oral chemotherapy. It shows that far from being a simplification of existing treatment regimens, oral chemotherapy poses new challenges and exciting opportunities for the multi-professional care team designated with their delivery.