Current management of adults receiving oral anti-cancer medications: A scoping review protocol

Introduction

The introduction of novel oral anti-cancer medications (OAM) is a paradigm shift in cancer care and these are being approved at a record-setting pace (Meier et al., 2018) with almost 20 new approvals in oncology in the three years preceding 2019 (U.S. Food & Drug Administration, 2018). Oral anticancer medications are a sub-set of systemic anti-cancer treatments (SACT) and have a narrow therapeutic window with a unique mechanism of action which includes pro-drugs and targeted therapies, and excludes endocrine therapy (National Cancer Institute, 2020). The National Cancer Control Programme (NCCP) (2018) defines OAMs as all medications with direct anti-tumour activity administered by mouth (enteral route) for the treatment of cancer. They are increasingly common; a review of the NCCP website shows more than 50 different OAMs are currently in use alongside a suite of guidelines for Health Care Professionals (HCP) to direct safe and standardised patient care.

OAMs have the same benefits and risks as SACT given parenterally in terms of positive disease outcomes, treatment-related toxicities or potential for serious medication errors leading to patient harm (NCCP, 2018). Consequently individuals receiving OAMs require frequent (at least monthly) holistic patient assessment, and serum and/or urine analysis. While these medications are convenient for individuals, it shifts the responsibility for medication management from the oncology healthcare professionals to the patient. Consequently there are concerns regarding adherence and management of toxicities or adverse effects (Greer et al., 2016; Hammond et al., 2012; NCCP, 2018; Paolella et al., 2018; Wood, 2012). Evidence suggests that current health care practices globally do not ensure safe administration or patient adherence (Griffiths & Pasco, 2014; LeFebvre & Felice, 2016; Le Saux et al., 2018; Redelico et al., 2018; Zerillo et al., 2015). A review of OAM practices in North America, Zerillo et al. (2015) identified unmet patient needs of 43–49% for patient education and 19–25% for adherence/toxicity monitoring. Individuals prescribed OAMs often experience a high burden of cancer related symptoms which corresponds to reduced adherence and quality of life (Jacobs et al., 2019).

Due to the potential toxicity of these medications and associated safety challenges, the care and monitoring of patients receiving OAMs remains largely within the acute hospital setting by specialist health care teams (Department of Health, 2017; Hammond et al., 2012; Kinnaer et al., 2019; NCCP, 2018). A medication safety review in Ireland noted a recurring theme of diversity and often lack of processes for the management of OAM (Heckmann et al., 2014). Furthermore, anecdotal evidence from the authors suggest that in the hospital environment individuals on OAMs receive disproportionately less input than those on parenteral treatment as the former are incorrectly perceived as being less acute and as the medication is administered at home there is less requirement to expediently progress their care at their hospital visit. To try to maximise the safety of OAMs and improve hospital efficiency, the National Cancer Strategy (Department of Health, 2017) recommended the development of a model of care for OAM. Subsequently a guidance document for this was published by the NCCP (2018). The NCCP (2018) made 16 recommendations for the care of individuals receiving OAMs in an attempt to maximise safe practice. The focus was on safe and efficient care of individuals rather than prescriptive directions for which location that care should be delivered or by which HCP. The authors of the NCCP (2018) report recognised that there was a requirement for change within the Irish health care service to fully realise the recommendations. There is scope for these to be built upon to standardise and improve safe practice for the care of individuals receiving OAMs.

There is universal consensus in international healthcare policy documents regarding the crucial and central role which primary care should play in health care delivery. Systems with strong primary care have better health outcomes at lower costs (House of the Oireachtas, 2017; Randall et al., 2017; Starfield, 1998; World Health Organisation, 2018). Within Ireland, a shift from hospital to community-based care is being strongly promoted with the aim of delivering care closer to the person’s home within an integrated care context. This is evident in the Sláintecare health reform programme (Government of Ireland, 2018) which endorses efforts to transform health care to maximise hospital efficiency and patient convenience. The nursing profession is recognised as critical to implementing this shift from hospital to community-based care. Specifically, nurse-led clinics for management of chronic diseases have emerged as an ideal means to achieve improved organisation in the health service (Government of Ireland, 2018; Randall et al., 2017).

Patient satisfaction levels are high with specialist or advanced practice in nursing clinics (Liljeroos & Stromberg, 2019; Linedale et al., 2020). In Ireland, Advanced Nurse Practitioners (ANP) have scope for physical examination and medicinal prescribing (Department of Health, 2019). They have the required expertise and skills to undertake caseload management of a cohort of patients requiring advanced level decision making, such as those receiving OAMs. Currently, however advanced nursing assessment in cancer care is largely performed within a hospital context. Of particular relevance is a recent systematic review which assessed the impact of community-based nurse-led clinics on patient outcomes, and none of the studies included in the final review were oncological (Randall et al., 2017) indicating that oncology nurse-led care in the community is in its’ infancy. This review concluded that community-based nurse-led clinics have largely shown positive impact on patient outcomes, patient satisfaction and access to care despite the evidence base for such a key universal policy aim being limited. Extrapolating this to more specific care of individuals receiving OAMs, community-based care or integrated care models for this cohort of patients do not appear to be well established in national or international healthcare landscapes.

The coronavirus 2019 (COVID-19) pandemic has brought into sharp focus the requirement to reduce unnecessary hospital visits (Cucinotta & Vanelli, 2020). This is especially pertinent to individuals receiving cancer treatment due to potential immunosuppression and concomitant risk of infection. Those patients being treated with OAM require on-going assessment and monitoring but this does not necessarily require them to repeatedly attend the hospital. Consequently, within the COVID-19 context this is an opportune time to transform the care of this cohort of patients. This would be in line with the transformative vision of a shift beyond the acute hospital, yet at the same time implement the NCCP recommendations (2018). The document by the NCCP (2018), the Sláintecare health reform programme (Government of Ireland, 2018), the context of the COVID-19 pandemic alongside other literature promoting robust OAM patient monitoring provides the opportunity for a nurse-led integrated model of care to be developed for this patient cohort.

To consider the management of this subset of cancer patients, it is necessary to initially identify the specific aspects that constitute their assessment and care. The NCCP (2018) outlined five stages for generic SACT care which include: decision to treat, prescribing, dispensing, medication administration and patient monitoring (Figure 1).

Figure 1. Generic systemic anti-cancer treatments (SACT) processes (NCCP, 2018).

For parental SACT these stages are all performed within the hospital setting but for OAM, dispensing is performed by the community pharmacy and medication administration is within the patients’ home. Similarly Zerillo et al. (2018) outlines the care delivery domains for oral chemotherapy care process in their systematic review on the safety and quality of OAM. The authors do not specifically identify decision to treat as a specific stage and they include patient education occurring prior to drug administration which is a logical inclusion. Furthermore, storage and disposal are added as a final aspect of care (Zerillo et al., 2018) (Figure 2).

Figure 2. Oral anti-cancer medications (OAM) Care (Zerillo et al., 2018).

For the purposes of this scoping review, the processes outlined by the NCCP (2018) and Zerillo et al. (2018) will be used as a framework to guide the analysis and categorisation of literature. There will be a particular emphasis on literature pertaining to prescribing, dispensing, patient education and patient monitoring as these are encompassed within the concept of patient management. Treatment decision is a baseline initial assessment based on the individuals’ suitability for treatment to commence and is not part of the daily ongoing management of care and consequently will be excluded from this review.

Aim

A preliminary search of relevant databases, CINAHL, Medline and Web of Science was conducted, and no published systematic reviews on the overall management or continued monitoring of individuals receiving OAM were identified. Therefore, the aim of this scoping review is to identify how patients receiving OAM are currently managed from an international perspective.

Objectives

The specific objectives of the review are to:

This organization of information is the initial stage in a multi-phased research study which aims to establish and analyse the safety and efficacy of an integrated care model for the management of patients receiving OAM by an ANP. The scope of the review will be deliberately broad so as not to exclude the identification of best practice from any one HCP group or any country/health service. In addition, the iterative nature of this work allows for a replicable process that can be adapted to ensure it is fit for the desired endpoint. Guidance produced by Peters et al. (2015) will be used to direct the various stages of this scoping review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist will be followed throughout (Tricco et al., 2018).

Discussion

The scoping review protocol is an essential component in the process of performing a scoping review of a chosen topic (Moloney et al., 2020) and provides an outlined method for exploring and mapping relevant literature (Lafferty et al., 2019). Individuals being treated with OAM require on-going assessment and monitoring (NCCP, 2018) yet with increasing numbers of patients on OAMs there is a requirement to improve hospital efficiency and reduce overcrowding in cancer units yet provide safe, appropriate and timely patient care. The knowledge obtained in this scoping review will be presented to an advisory panel and will help inform the subsequent steps in a multi-phased research study which aims to establish and analyse the safety and efficacy of an integrated care model for the management of patients receiving OAM in the community by an ANP.

Data availability