Evaluating the patient‐perceived impact of a neratinib special access program in an Australian community pharmacy

In Australia, breast cancer is the most commonly diagnosed cancer in women, and improved survival rates have placed an increased burden on the healthcare system. To better utilise community pharmacists in anticancer therapy, a medicine management service for neratinib was initiated in an Australian community pharmacy for patients with breast cancer.


INTRODUCTION
In Australia, breast cancer is the most commonly diagnosed cancer in women and the second most common cause of cancer-related death. 1,2 In 2018, 18 742 new cases were reported, and in 2020, 3110 women and 34 men died from the disease. 2 Despite increasing incidence, the number of deaths from breast cancer is decreasing due to advances in diagnosis and treatment, which have improved the 5-year relative survival rate to 92%. 1,2 This positive improvement in patient outcomes has also resulted in an increased burden on the Australian healthcare system. 3 Globally, the roles of pharmacists are evolving to meet the increasing healthcare needs of their populations. Pharmacists with specialised training have become valuable members of oncology health teams, providing clinical services in both the hospital and community settings. [4][5][6] Cancer medicines carry a high risk of toxicity and associated adverse drug reactions, making it imperative for patients to understand their medicine regimen and the supportive care measures for anticipated toxicities. An extensive body of literature supports the benefits of clinical pharmacy services provided to outpatients with cancer, such as medicine reviews, drug-specific patient education, treatment monitoring, telephone followups or home visits, and counselling on supportive selfcare measures to prevent and manage treatment-related side effects. [5][6][7][8] Research has indicated that these pharmacist-led oncology services can lead to reduced drug-related issues, improved symptoms, and medication adherence, as well as improved patient understanding and satisfaction with pharmacists' contributions. [5][6][7][8] Despite support for the implementation of oncology pharmacy interventions, a major gap remains in the availability of medicine management services for cancer patients in Australian community pharmacies.
To better utilise community pharmacists in anticancer therapy, a medicine management service was initiated in an Australian community pharmacy for patients with breast cancer. In 2019, neratinib (Nerlynx) was approved for use in Australia for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. 9 Neratinib is an irreversible tyrosine kinase inhibitor which blocks signal transduction through the epidermal growth factor receptors HER1, HER2, and HER4, thereby reducing the growth and spread of cancer cells and preventing early-stage cancer from progressing to metastatic cancer. 9 Although not subsidised by the Australian Government, eligible patients may access neratinib through a special access program provided by the pharmaceutical company Specialised Therapeutics Australia. 10 Medicines access programs are available in various formats and arrangements with pharmacies, providing a mechanism for patients with a clinical need to access medicines that may otherwise be inaccessible for financial reasons. 11 In this case, patients were enrolled in the program under the care of specialised medical oncologists. To facilitate the introductory phase, Specialised Therapeutics Australia arranged for and remunerated a community pharmacy, located in Canberra, to deliver a non-traditional service that included extended treatment support. The existing team of pharmacists received specialised training on neratinib, and to ensure a consistent service that could reach patients in rural and remote areas, the pharmacy utilised telecommunications and information technologies to provide the oncology medicine management service to all enrolled patients located across Australia. This service included the dispensing and supply of neratinib, telephone counselling on neratinib and side-effect management strategies, and regular telephone follow-up sessions (weekly for the first five weeks of treatment and monthly calls thereafter) for ongoing monitoring of medicine use and adverse effects. Patients could also phone a dedicated Nerlynx pharmacist support line or contact the pharmacist team with any questions via message or email.
Assessing the value of the neratinib service provided to patients in an Australian community pharmacy setting is essential for quality care. Australian pharmacists' roles are evolving, and breast cancer diagnosis and survival rate are rising, necessitating a framework for community pharmacists to respond to increasing demands. 3,12 Patient satisfaction surveys in oncology care settings can provide valuable insight into patient behaviour, as well as guidance for service benchmarks. 13 Research has shown that patient satisfaction is related to quality of service and survival outcomes. [14][15][16][17] Satisfied patients are more likely to follow treatment plans, seek medical advice, and continue relationships with healthcare providers, all of which influences disease outcomes. [13][14][15]17 Gaining insights into patients' perceptions and experiences is essential for ensuring ongoing improvements to meet their health needs.
Currently, limited information is known about how patients perceive the impact of oncology medicine management services delivered by community pharmacists in Australia. Therefore, this pilot study aimed to explore the experience and satisfaction of Australian breast cancer patients who received a pharmacist medicine management service for their neratinib treatment through a community pharmacy.

METHOD
This was an observational study where an electronic survey was conducted from February-September 2019.  13,15 As part of the survey development process, questions were adapted to assess service delivery by community pharmacists in the Australian healthcare context. The survey questions were reviewed by three Australian registered pharmacists with current community pharmacy experience, and feedback was incorporated to refine the questions.
The 21-item survey included six Likert-scaled questions (1 = very satisfied to 5 = very dissatisfied) assessing satisfaction with the time, respectfulness, knowledge of neratinib, side-effect management, and follow-up support provided by the pharmacist. A Likert-scale was used in four questions assessing the benefits of the pharmacist interaction at both the initial and follow-up sessions (1 = yes, absolutely to 5 = definitely not). A further three yes/no/unsure questions assessed whether participants' interactions with the pharmacist increased their understanding of neratinib therapy, whether they learnt something new by talking to the pharmacist, and whether they would recommend such a pharmacy service to other patients on anticancer medicinewith additional openended questions allowing for elaboration by participants. Basic demographic information was collected, and two final open-ended questions allowed participants to provide additional comments about the elements of the service they valued most and provide suggestions for service improvements. A copy of the survey is included in Appendix 1. electronic survey. The survey was administered using Qualtrics (Qualtrics, Provo, Utah, USA) software. The inclusion criteria were an age of 18 years old or over, enrolment in the neratinib program during recruitment period, and fluency in English. To ensure collected data reflected both participants' initial and follow-up sessions with the community pharmacists, eligible participants were recruited one month after receiving their first medicine management service. The community pharmacy was provided with paper copies of participant information forms and recruitment flyers. These documents were included in the postal package which the pharmacists used to deliver dispensed neratinib medicine to patients across Australia. Patients who wished to participate in the study accessed the electronic survey online via the provided weblink. Participants completed a consent form before they were permitted to proceed through the online survey questions. It was made clear that answers collected would remain anonymous and participation, or lack thereof, would not affect the care received. Participants who completed all survey questions were compensated with a $20 electronic gift card.

Data Analysis
This study used a mixed-methods approach incorporating both quantitative and qualitative analysis. Quantitative data were compiled and entered into a Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA) spreadsheet. Descriptive statistics were used to summarise quantitative variables for each survey item. Qualitative analysis was used to evaluate responses from open-text questions. Two researchers (JZ and LC) independently conducted thematic analysis using the six steps proposed by Braun and Clarke. 18 This involved (1) familiarisation with data, (2) generation of initial codes, (3) search for themes, (4) review of themes, (5) naming of themes, and (6) producing the report. 18 Themes were identified using an inductive approach, and discrepancies were discussed by the research team members and resolved through negotiated consensus.
Overall, the study results indicated a very high level of satisfaction with various aspects of the pharmacy service provided (Table 1). Of the 33 participants, a high proportion were either 'very satisfied' or 'satisfied' with the time the pharmacists spent talking with them (n = 31, 94%), as well as the respectfulness shown by the pharmacists (n = 31, 94%). In addition, 91% of participants (n = 30) were either 'very satisfied' or 'satisfied' with the pharmacists' ability to answer questions and the information provided by the pharmacists about neratinib therapy and its side-effect management. The majority of participants (n = 28, 90%) were 'very satisfied' or 'satisfied' with the pharmacists' weekly followup calls. Table 2 shows the patient-perceived impact of their pharmacist interactions. The first session with the pharmacist was perceived by 88% of participants (n = 28) to be 'absolutely' worthwhile, and 68% of participants (n = 19) viewed the weekly follow-up sessions with the pharmacist as 'absolutely' worthwhile. A majority reported that it was important for patients starting neratinib therapy to consult with a pharmacist, with 85% indicating it was 'absolutely' important (n = 28) and 12% viewing it as 'somewhat' important (n = 4). Almost all participants (97%, n = 32) reported that they now 'absolutely' understood how to correctly take their neratinib medication.
Seventy-nine percent of participants (n = 26) believed that the pharmacist interaction increased their understanding of the neratinib therapy regimen, while 18% (n = 6) believed that this interaction did not increase their understanding. Common reasons provided by participants as to why the pharmacist increased their understanding included the following: pharmacists clarified and filled in medicine information gaps, provided information about side effects and how they might be managed, evaluated and provided advice regarding interactions with other medicines, and were very accessible and available to answer patient questions. Where participants reported that the pharmacists did not increase their understanding of neratinib therapy, the main reasons were that they had conducted their own prior research or they had already been provided with comprehensive information by their oncologist. A sample of participants' comments on how the pharmacists affected their understanding of neratinib is presented in Table 3.
As a result of speaking with the service pharmacist, 26 out of 33 participants (79%) learnt something new, whereas four participants (12%) did not learn anything from the interaction, and three (9%) were unsure whether they learnt anything. The most commonly acquired knowledge was about side effects and their management, interactions of the neratinib medine with other medicines and managing those interactions, and insights into experiences of other patients when on the medicine therapy regime.
The survey responses demonstrate that the service was valued by the majority of the participants; 29 of 33 participants (88%) would recommend a similar pharmacy service to other patients on similar medicines. The aspects of the service most valued by participants were the accessibility of the pharmacists and timeliness of advice, the ongoing support and monitoring provided by the service, the specialised knowledge of the pharmacists involved in the service, and the simplicity and user-friendliness of the service. Table 4 details examples of comments by participants as to their favourite aspect of the service. When prompted for suggestions for service improvement, most participants had no suggestions as they were satisfied. However, some participants suggested increasing the duration of their interaction with the pharmacist, holding more frequent follow-up sessions, providing more information regarding their medicine, and establishing consistency in terms of interacting with the same individual pharmacist rather than a different member of the pharmacist team. It was also suggested that the service be expanded, so that all cancer patients could access a similar service.
Where participants were asked to provide additional comments, the majority of the comments were positive, supporting participant satisfaction with the service. One participant noted that, although the information provided by the pharmacist was the same as that given by their oncologist, the consistency was reassuring. These comments demonstrated that participants valued the additional support provided by the pharmacy service.

DISCUSSION
The overall positive results of the program suggest that an oncology medicine management service provided by community pharmacists in Australia can positively impact the experience and satisfaction of patients receiving neratinib treatment for breast cancer. Participants reported that their interactions with the pharmacists increased their understanding of the therapy regimen and they valued their pharmacists' input to help with managing side effects and drug interactions. There was a high level of satisfaction with the service and participants recognised the importance of their time spent with the pharmacist. Participants supported the continued provision and expansion of the service, especially for oncology patients commencing new therapy.  Weekly follow-up phone calls with pharmacist (n = 31) 58% (18) 32% (10) 6% (2) 3% (1) 0 Participants from this study were spread across Australia, with most residing in different states and territories to the community pharmacy providing the service. They received a telehealth service where consultations were conducted primarily via telephone, and their neratinib medicine was delivered to their home through post. Despite the remote nature of the service, this study's results were consistent with international studies that explored patient satisfaction with face-toface pharmacy services in oncology settings. 13,15,19 Participants in the study had no concerns with the use of telephone as the service delivery medium; they responded very positively to the service. Prior research reviewing clinical pharmacy telemedicine interventions showed an overall positive impact on outcomes related to disease management, patient adherence with medicine, and self-management of chronic diseases. 20 The positive results from this study further support the utilisation of telehealth interventions to extend the reach of pharmacy services, particularly when frequent follow-ups are required for patient monitoring.
A range of benefits have been observed from the delivery of this oncology medicine management service. The accessibility of the pharmacist and timeliness of their advice were commonly reported by participants as benefits of the service. Participants felt reassured with the ongoing support and follow-up sessions and appreciated the specialised knowledge of the pharmacist regarding their neratinib therapy. Participants reported that their interactions with the pharmacists helped bridge information gaps between themselves and their oncologists and facilitated the development of their own  understanding of neratinib therapy. They valued learning more about how to take their medicine, potential side effects and their management, and the advice they received about interactions with other medicines. Though it is widely known that meeting the information needs of cancer patients has beneficial effects, unmet information needs are still being reported and continue to be a challenge in current care. 14,21,22 The positive patient feedback received in this study suggests a potential strategy in bridging these information gaps for patients surrounding oncology medicines. When prompted, some participants made various suggestions for service improvements. These reflected the varying needs of individual patients and highlighted the importance of tailoring information provision to each specific patient. Though most participants expressed a high level of satisfaction and recommended that no changes be made to the provided service, a few participants had specific suggestions to help meet their personal preferences and health needs. These included longer duration of consultation with the pharmacist, more frequent follow-up contact from the pharmacist, more indepth information about specific aspects of their medicine, and a preference to interact with the same pharmacist at every encounter rather than a different member of the pharmacist team. To achieve optimal oncology medicine education, it is important to consider the individual needs of patients and how this may change over the course of their treatment. 14,22 Since the delivery of this service, various standards and guidelines have been updated and published to guide medicine management in cancer services. [23][24][25] To meet patients' increasing needs, future emerging pharmacy services may build on our current model to include additional services, such as medication reconciliation, clinical verification, and collaboration with hospital pharmacists for both inpatient and outpatient support care. With health professionals already under pressure from the increasing burden of breast cancer and improved prognoses of those affected, 1 it is vital to ensure that future delivery models be sustainable and effective to support patients.
The limitations of this study include the small sample size and potential recall bias due to the delay between the initial interaction with the pharmacist and the time of survey completion. It is also unclear if non-response bias impacted the results presented. It is important to note that this was a pilot study based on a single