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Background: The aim of the study was to measure the adherence to oral anticancer treatments in cancer patients using the Modified Morisky Scale (Modified Medication Adherence Scale 6) which has been shown to be valid and reliable in Turkish. Methods: This study was an observational, single-center study involving 300 cancer patients receiving various oral anticancer agents admitted to our outpatient clinic. Motivation and knowledge scores were calculated as per the Modified Medication Adherence Scale 6. Results: The motivation and knowledge levels of the population aged less than 65 years were found to be significantly higher than the geriatric population (≥65 years old) (P <.003 and P <.001, respectively). It was observed that the patients with higher education levels had significantly higher motivation and knowledge levels (P <.0001 for both). There was no correlation between the motivation and knowledge levels of the patients with gender, marital status, living status, and stage of the disease (P >.05). In addition, the duration of drug use >12 months and the cyclical use of drugs were also found to be significantly associated with increased motivation and knowledge levels. Conclusion: Identifying adherence and related factors, informing patients in detail about the efficacy and toxicity of treatments are the simplest and most basic methods. Particular attention should be paid to patients aged > 65 years, patients with a low level of education, and patients in the earlier stages of their treatments. [ABSTRACT FROM AUTHOR]

Rationale: In the Collaborative Network To Take Responsibility for Oral Anticancer Therapy (CONTACT) project, an evidence‐based and patient‐centred care(PCC) pathway was implemented in 12 oncology departments in Flanders. The care pathway was developed in cocreation by an interdisciplinary project team, and tailored to the local hospital context. Aims and Objectives: In this study, the impact of the care pathways on quality of PCC and other patient outcomes was investigated. Method: A pre−posttest study was performed in nine of the participating oncology departments. The primary outcome was quality of PCC. Furthermore, level of patient self‐management, medication adherence, satisfaction with information about the oral anticancer drug and quality of life were measured as secondary outcomes. Linear mixed models were used to investigate differences in outcomes between the pre‐ and posttest group. Results: Quality of PCC, as well as all secondary outcomes improved after implementation of the care pathway. However, the changes in pre‐ and posttest scores were not significant. The overall quality of PCC increased from 3.72 to 3.88, measured on a five‐point Likert scale (p = 0.124). Conclusion: This study showed small, however, no significant improvements in the quality of PCC and other patient outcomes. The lack of significant changes can be attributed to the complexity of the care pathway development, poor or unstable implementation of the care pathway and limited changes in follow‐up care. More insight in the actual implementation of the care pathway and potential contextual factors influencing its effect is needed to help understand the outcomes of this pre−posttest study. [ABSTRACT FROM AUTHOR]

Background: Minimizing medication waste through the redispensing of oral anticancer drugs (OADs) that were unused by patients provides economic and environmental benefits, but this is not yet universally implemented in clinical care. Objective(S): To identify barriers and facilitators to the implementation of redispensing unused OADs in clinical care. Methods: A multicentre intervention study following a hybrid effectiveness-implementation type I design was conducted, consisting of semi-structured interviews with key stakeholders involved in the redispensing program: pharmacy employees, prescribing clinicians in oncology and haematology, patients who participated in redispensing and patients who declined trial participation. Questions encompassed experiences and suggestions for future implementation. The Consolidated Framework for Implementation Research (CFIR) guided data collection and categorisation of identified barriers and facilitators through thematic analysis. Results: In total, 35 interviews were conducted, identifying 15 themes encompassing barriers and facilitators, reflecting all CFIR domains. Facilitators encompassed: 1) convenient process requiring an acceptable time-investment; 2) support from project leaders and implementation champions; 3) being well-motivated by personal values and societal impact; 4) feeling ensured of medication quality upon redispensing; 5) endorsement by healthcare providers for patient participation; 6) clear and personal patient communication; 7) good visibility of intervention successes; and 8) implementation well supported through a collaborative network. Barriers encompassed: 1) unclear target population; 2) redispensing legally prohibited; 3) absence of financial compensation for pharmacies; 4) complexity arising from two parallel work processes; 5) widespread communication on adjustments within local teams challenging; 6) patient's low receptiveness due to burden of oncology treatment; and 7) lack of familiarization among pharmacy technicians. Conclusions: Facilitators for implementation of redispensing unused drugs mainly related to people's values, motivation, and societal demand, whereas barriers mainly encompassed practical issues, including knowledge, time, financial resources, and legal conditions. Strategies emphasizing the benefits of redispensing and further streamlining process compatibility could support implementation.

Patients who take oral anticancer drugs (OACD) alternate between the hospital and the community setting. Little is known about how general practitioners (GPs) and community pharmacists (CPs) from primary care (PC) can be involved in providing seamless care. In an exploratory qualitative study, semi-structured interviews with healthcare professionals from primary and secondary care (SC) and (N = 26) were performed to investigate perceptions of seamless collaboration for patients on OACD. Seamless collaboration initiated by SC was restricted to informing GPs about treatment-initiation and delegating limited tasks to them in treatment monitoring. CPs are currently not informed by SC about the treatment. PC expressed willingness for seamless collaboration. However, collaboration is currently impeded due to an expressed lack of trust and desire for control by SC. Moreover, SC expressed unfamiliarity with the organization of PC. Findings suggest that healthcare professionals from SC and PC need to get to know each other and to discuss expectations in the seamless care for patients on OACD. A possible strategy is to elaborate a shared care model based on a partnership between PC and SC, in which the specific expertise of each partner contributes to patient-centered care and the qualitative and safe use of OACD. [ABSTRACT FROM AUTHOR]

• Little is known regarding the extent and severity of financial toxicity (FT) in patients with advanced prostate cancer. • Out-of-pocket costs are significantly higher for oral advanced prostate cancer treatments compared to ADT or chemotherapy. • Recent policy efforts such as the Oncology Care Model and the Inflation Reduction Act of 2022 may help limit FT for some patients. • Further study is needed to better understand how best to include FT discussions in shared decision-making processes. The treatment landscape of advanced prostate cancer (CaP) has evolved significantly over the past 20 years. As the number of oral anticancer treatment options continues to increase, so do the costs of these drugs. Furthermore, payment responsibility for these treatments is increasingly shifted from insurers to patients. In this narrative review, we sought to summarize existing assessments of financial toxicity (FT) associated with oral advanced CaP treatments, describe efforts targeted at limiting FT from these agents, and identify areas in need of further investigation. FT is understudied in advanced CaP. Oral treatment options are associated with significantly higher direct costs to patients compared to standard androgen deprivation therapy or chemotherapy. Financial assistance programs, Medicare low-income subsidies, and recent health policy changes help offset these costs for some patients. Physicians are reluctant to discuss treatment costs with patients and further work is needed to better understand best practices for inclusion of FT discussions in shared decision-making. Oral therapies for advanced CaP are associated with significantly higher patient out-of-pocket costs which may contribute to FT. Currently, little is known regarding the extent and severity of these costs on patients' lives. While recent policy changes have helped reduce these costs for some patients, more work is needed to better characterize FT in this population to inform interventions that improve access to care and lessen the harms associated with the cost of novel treatments. [ABSTRACT FROM AUTHOR]

Background: Long term treatment of pediatric patients with oral anticancer drugs (OADs) requires the parents/caregivers to prepare the drug at home. The handling procedures in the home setting are, however, not regulated by Swedish law and the parents are often left without guidance on how to handle OADs in a safe way. Aim: The aim of this study was to increase understanding of how OADs are handled by parents/caregivers in the home setting before and after an intervention. Methods: Parents of pediatric cancer patients were observed and videotaped during their handling of OADs in the home setting before and after the intervention. During the intervention, the parents were provided with written instructions, movie clips and practical training on handling the OADs. Four checklists were used to compare and score the four handling procedures (measuring an oral suspension, cutting tablets, dissolving tablets, and opening capsules) for each parent before and after the intervention. Results: The intervention significantly improved the OAD handling procedures among the studied parents. The median score for correct handling was 19% (IQR: 3.6 to 30%) before the intervention and 89.5% (IQR: 71.5 to 94.5%) after the intervention (p < 0.0001). Conclusions: An intervention comprising practical training and information presented in different forms improved the handling of OADs at home by parents. There is an urgent need to implement this method in all oncology centers in Sweden, educate HCPs to standardize the presentation of information. There is also a great need to provide parents with age-appropriate oral drug formulations from the local hospital pharmacies in Sweden. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to describe the experiences of parents handling oral anticancer drugs in a home setting. Methods: Parents of children with cancer were recruited from a paediatric oncology ward in Sweden to participate in an interview. The interviews were transcribed verbatim and subjected to qualitative content analysis. Results: We found the following categories and subcategories: parents' views on the provided information—lack of, too little or contradictory information, and parents' preferences for information delivery; safety over time; correct drug dose; and drug administration. As time passed, most parents adapted to their child's illness, felt safer and found it easier to take in and process any given information. Parents preferred information in different formats (written, movie clips and orally) and in their mother tongue. Many parents were aware of the importance of giving an accurate dose to their child and described the process of drug administration as overwhelming. Conclusion: Parents need to be provided with accurate, timely, nonconflicting and repeated information—in different forms and in their mother tongue—on how to handle oral anticancer drugs at home. [ABSTRACT FROM AUTHOR]

Orally administered, small-molecule anticancer drugs with tumor-specific cellular protein targets (OACD) have revolutionized oncological pharmacotherapy. Nevertheless, the differences in exposure to these drugs in the systemic circulation and extravascular fluid compartments have led to several cases of therapeutic failure, in addition to posing unknown risks of toxicity. The therapeutic drug monitoring (TDM) of OACDs in therapeutically relevant peripheral fluid compartments is therefore essential. In this work, the available knowledge regarding exposure to OACD concentrations in these fluid spaces is summarized. A review of the literature was conducted by searching Embase, PubMed, and Web of Science for clinical research articles and case reports published between 10 May 2001 and 31 August 2022. Results show that, to date, penetration into cerebrospinal fluid has been studied especially intensively, in addition to breast milk, leukocytes, peripheral blood mononuclear cells, peritoneal fluid, pleural fluid, saliva and semen. The typical clinical indications of peripheral fluid TDM of OACDs were (1) primary malignancy, (2) secondary malignancy, (3) mental disorder, and (4) the assessment of toxicity. Liquid chromatography–tandem mass spectrometry was most commonly applied for analysis. The TDM of OACDs in therapeutically relevant peripheral fluid spaces is often indispensable for efficient and safe treatments. [ABSTRACT FROM AUTHOR]

Objective: Instruments to measure quality of patient‐centred care (PCC) for the rapidly growing population of patients treated with oral anticancer drugs (OACD) are lacking. The aim of this study was to develop a valid and reliable instrument to assess PCC in the context of OACD. Methods: The CONTACT–Patient‐Centred Care Questionnaire (CONTACT‐PCCQ) was developed based on a validated set of key elements (KEs) for patient‐centred education and counselling in patients taking OACD, and face validity was evaluated by means of cognitive interviews. In 16 Belgian hospitals, adult patients treated with OACD were asked to complete the questionnaire. Construct validity was investigated through exploratory factor analyses (EFAs) and internal consistency of the subscales was examined using Cronbach's alpha. Results: The initial 86‐item instrument was completed by 464 patients. Each EFA confirmed the a priori PCC‐based structure of the subscales. However, EFA revealed more than one factor for two of the subscales. Therefore, multiple subsections within these subscales were created. Based on factor loadings and item content, six items were removed. This resulted in a final 80‐item instrument with seven subscales and five subsections. Cronbach's alpha for the subscales and subsections ranged between 0.732 and 0.918, which implies adequate internal consistency. Conclusion: A final instrument with 80 items divided into seven subscales, covering all six dimensions of PCC, was obtained. The CONTACT‐PCCQ has acceptable psychometric properties, supporting its use as a measure to assess care experiences of patients treated with OACD. [ABSTRACT FROM AUTHOR]

Information on interprofessional team composition and functioning in the care for patients on oral anticancer drugs (OACDs), and how healthcare professionals (HCPs) evaluate in-hospital care processes is scarce. We aimed to investigate interprofessional care processes for OACD-patients in a partially mixed-methods study. A combination of (a) the CareProces Self-Evaluation Tool (CPSET), completed by HCP-team members by health profession who were either currently involved in care processes (oncologists and nurses) or potentially involved in future care (pharmacists, psychologists, social workers), and by hospital managers (N = 87) and (b) semi-structured interviews in a subsample of oncologists, nursing staff, and pharmacists (N = 26) were used. Care process coordination was evaluated poorly, mainly by nurses, pharmacists, and psychologists. Nurses and pharmacists believed that they were not engaged in the organization of OACD care, lacked role clarity, and perceived no meaningful interprofessional practice. HCPs had different perceptions toward timing and planning of patient education and follow-up. Monitoring of care processes occurred only occasionally and was unstructured resulting in apoor complication-management and variance within care processes. Care processes for OACD-patients showed opportunities for optimization of interprofessional practice in timing, planning, and monitoring. Rethinking care processes through co-design is needed. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to explore the beliefs, perceptions and representations of patients in order to identify the determinants of oral anticancer drugs adherence and to take action in current practice to improve patient support in digestive oncology.Methods: We constructed a semi-directed interview guide which aimed to explore the patient's relationship with medication, their health history, their experiences at the time of the announcement of treatment, their confidence, their fears, their motivations to adhere to their treatment and the constraints linked to their treatment. The data were analysed and discussed using a thematic approach.Results: Seventeen patients agreed to participate in the study. The median age was 60 years. Ten patients had colorectal cancer, 3 patients had hepatocellular carcinoma, 3 patients had gastrointestinal stromal tumour and 1 patient had neuroendocrine pancreatic tumour. We identified five categories of factors influencing adherence: demographic and socioeconomic, disease-related, treatment-related, care system-related, and patient representation and pathways' factors. A majority of patients emphasised the importance of family support in the adherence process and the convenience of per os treatment compared to other intravenous treatments. However, several negative determinants emerged such as the toxicity of the treatment, fears of forgetting to take the medication, difficulties with the galenic formulation and negative beliefs of the family.Conclusion: This study demonstrates the need to address the different dimensions of the patient in order to understand his or her behaviour with regard to adherence and to identify the levers for improvement. [ABSTRACT FROM AUTHOR]

Orally administered, small-molecule anticancer drugs with tumor-specific cellular protein targets (OACD) have revolutionized oncological pharmacotherapy. Nevertheless, the differences in exposure to these drugs in the systemic circulation and extravascular fluid compartments have led to several cases of therapeutic failure, in addition to posing unknown risks of toxicity. The therapeutic drug monitoring (TDM) of OACDs in therapeutically relevant peripheral fluid compartments is therefore essential. In this work, the available knowledge regarding exposure to OACD concentrations in these fluid spaces is summarized. A review of the literature was conducted by searching Embase, PubMed, and Web of Science for clinical research articles and case reports published between 10 May 2001 and 31 August 2022. Results show that, to date, penetration into cerebrospinal fluid has been studied especially intensively, in addition to breast milk, leukocytes, peripheral blood mononuclear cells, peritoneal fluid, pleural fluid, saliva and semen. The typical clinical indications of peripheral fluid TDM of OACDs were (1) primary malignancy, (2) secondary malignancy, (3) mental disorder, and (4) the assessment of toxicity. Liquid chromatography–tandem mass spectrometry was most commonly applied for analysis. The TDM of OACDs in therapeutically relevant peripheral fluid spaces is often indispensable for efficient and safe treatments.

Oral care is recommended for the prevention of the onset of oral mucositis associated with anticancer drug administration. However, there are few reports examining the utility of oral care guidance by pharmacists. Therefore, in the present study, we investigated the efiects of oral care guidance by pharmacists on the onset of oral mucositis in patients taking oral anticancer drugs. Pharmacists in several pharmacies provided oral care guidance to patients who use the oral anticancer drug capecitabine or tegafur/gimeracil/oteracil potassium combination regimen. Following the provision of oral care guidance, the patients were classified into four groups according to their status of performance of oral care at home and the period from the initiation of anticancer drug administration to oral care guidance. A three-month follow-up survey regarding the onset of oral mucositis was subsequently conducted. Furthermore, risk Actors for the onset of oral mucositis were analyzed using logistic regression analysis. Sixteen males and 22 females (median age: 61 years) were included. For the early-intervention group, the incidence of oral mucositis tended to be higher in the non-oral-care group (30.0%) than that than in the oral-care group (9.1%), although the difference was not significant (p = 0.311). Conversely, for the non-early-intervention group, the incidence rate was similar in the oral-care and non-oral-care groups (12.5% vs. 11.1%), and no significant difference was observed (p =1.000). Moreover, the risk of the onset of oral mucositis was significantly associated with older age (odds ratio: 1.218; 95% confidence interval: 1.040-1.428). The results of this study suggest that the provision of oral care guidance at pharmacies during the early stage of anticancer therapy might facilitate the prevention of the onset of oral mucositis. However, the results also suggested that the effects of oral care guidance alone might be insufficient for patients with advanced oral mucosal disease. [ABSTRACT FROM AUTHOR]

Purpose: This review provides an overview of the current challenges in oral targeted antineoplastic drug (OAD) dosing and outlines the unexploited value of therapeutic drug monitoring (TDM). Factors influencing the pharmacokinetic exposure in OAD therapy are depicted together with an overview of different TDM approaches. Finally, current evidence for TDM for all approved OADs is reviewed. Methods: A comprehensive literature search (covering literature published until April 2020), including primary and secondary scientific literature on pharmacokinetics and dose individualisation strategies for OADs, together with US FDA Clinical Pharmacology and Biopharmaceutics Reviews and the Committee for Medicinal Products for Human Use European Public Assessment Reports was conducted. Results: OADs are highly potent drugs, which have substantially changed treatment options for cancer patients. Nevertheless, high pharmacokinetic variability and low treatment adherence are risk factors for treatment failure. TDM is a powerful tool to individualise drug dosing, ensure drug concentrations within the therapeutic window and increase treatment success rates. After reviewing the literature for 71 approved OADs, we show that exposure-response and/or exposure-toxicity relationships have been established for the majority. Moreover, TDM has been proven to be feasible for individualised dosing of abiraterone, everolimus, imatinib, pazopanib, sunitinib and tamoxifen in prospective studies. There is a lack of experience in how to best implement TDM as part of clinical routine in OAD cancer therapy. Conclusion: Sub-therapeutic concentrations and severe adverse events are current challenges in OAD treatment, which can both be addressed by the application of TDM-guided dosing, ensuring concentrations within the therapeutic window. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness, feasibility, meaningfulness and appropriateness of the development and implementation of a transmural care pathway in four hospitals in Flanders to improve self‐management support in healthcare professionals and self‐management in patients treated with oral anticancer drugs. Design: A multicentre, prospective, interventional before‐after study. Method: The development and implementation of the care pathway is based on the 7‐phase method by Vanhaecht et al. (2012). Before and after, the care process will be evaluated from the perspective of patients, healthcare professionals in the hospital and from primary care and the available evidence. In both study‐parts, a mixed methods approach will be used including observations, semi‐structured interviews, focus groups and validated questionnaires for outcome assessments. The primary outcome is self‐management in patients and self‐efficacy and perception towards self‐management in healthcare professionals. This study was funded in October 2015 and has been approved by the Ethics Committee in June 2016. Discussion: Due to the growing number of patients taking oral anticancer drugs, there is need for a rigorous study that aims to optimize self‐management in patients and self‐management support provided by an interdisciplinary team of healthcare professionals (including oncology nurses and clinical nurse specialists). The care pathway should therefore consist of effective self‐management supporting interventions and should clearly define the role of all stakeholders. Impact: This study attempts to obtain standardization, uniformity and continuity of self‐management support provided by healthcare professionals to patients on oral anticancer drugs with the aim to achieve an adequate level of self‐management. Trial registration: clinicaltrials.gov NCT02861209. [ABSTRACT FROM AUTHOR]

The process of education and counselling of patients treated with oral anticancer drugs, aimed to achieve adequate self-management, involves different stakeholders (i.e. physicians, oncology nurses, pharmacists) from primary and secondary care. However, currently no guiding principles exist on how to organize and perform education and counselling for these patients. Therefore, the purpose of this study was to develop and build consensus on key elements for the education and counselling in patients on oral anticancer drugs. A multi-method approach combining a literature search, semi-structured interviews with patients and healthcare professionals, and input from experts were used to develop an initial list of key elements. Subsequently, consensus was built in a two-round Delphi-study, involving patients and healthcare professionals from primary and secondary care. Key elements were retained if at least 80% of respondents in all groups considered the element as important or if in at least one group 90% consensus was reached. The initial list contained 110 key elements, divided in 7 themes: coordination of care, patient contacts: style and content, medication counselling at the start of the treatment and during follow-up, psychosocial support, and involvement of family and friends. After the first Delphi round, 80% consensus was reached for 23 elements; 6 new key elements were added. After the second round, 80% consensus was reached for 51 out of 116 elements; 31 elements were added following the 90%-rule, yielding a list of 82 elements. The final list of 82 key elements, obtained in this study, could be used to develop clinical pathways that guide adequate education and counselling of patients on oral anticancer drugs. Due to the open description, the implementation of these elements can be adapted to the specific context and composition of the oncology team. • Consensus among patients and healthcare professionals from primary and secondary care was obtained for 82 key elements. • The key elements are divided in themes based on the six dimensions of patient-centered care from the Institute of Medicine. • The implementation of each key element can be adapted to the specific context and composition of the oncology team. [ABSTRACT FROM AUTHOR]

Background Substantial quantities of unused medicines are returned by patients to the pharmacy each year. Redispensing these medicines would reduce medicinal waste and health care costs. However, it is not known if medicines are stored by patients as recommended in the product label. Inadequate storage may negatively affect the medicine and reduce clinical efficacy whilst increasing the risk for side effects. Objective To investigate the proportion of patients storing oral anticancer medicines according to the temperature instructions in the product label. Methods Consenting adult patients from six Dutch outpatient hospital pharmacies were included in this study if they used an oral anticancer medicine during February 2014 – January 2015. Home storage temperatures were assessed by inclusion of a temperature logger in the original cancer medicines packaging. The primary outcome was the proportion of patients storing oral anticancer medicines as specified in the Summary of Product Characteristics, either by recalculating the observed temperature fluctuations to a single mean kinetic temperature or by following the temperature instructions taking into account a consecutive 24-h tolerance period. Results Ninety (81.1%) of the 111 included patients (47.8% female, mean age 65.2 (SD: 11.1)) returned their temperature loggers to the pharmacy. None of the patients stored oral anticancer medicines at a mean kinetic temperature above 25℃, one patient stored a medicine requiring storage below 25℃ longer than 24 h above 25℃. None of the patients using medicines requiring storage below 30℃ kept their medicine above 30℃ for a consecutive period of 24 h or longer. Conclusion The majority of patients using oral anticancer medicines store their medicines according to the temperature requirements on the product label claim. Based on our results, most oral anticancer medicines will not be negatively affected by temperature conditions at patients' homes for a maximum of three months and are likely to be suitable for redispensing. [ABSTRACT FROM AUTHOR]

Background: Unused medications (UM) are an important issue, with the waste associated with UM a burden to the health-care system. The aims of this study were to clarify the amount and costs of UM in patients with advanced cancer at the time of their last admission to a palliative care unit and to explore the factors contributing to the cost of UM and how patients dealt with UM. Methods: A prospective observational study was conducted in single palliative care unit. Unused medications were classified into 6 categories and the number and cost of UM by category calculated per patient. Patients were classified into 2 cost groups (high and low) based on the total cost of UM, and the number and cost of UM by category were compared between these 2 groups. Results: Of 194 consecutive hospitalized patients, data were analyzed for 90. The mean number and cost of UM per patient was 440 and US$301, respectively. Opioids accounted for 47% of the cost of UM. Comparing costs by UM category, the proportion of opioids (51% vs 21%; P < .0001) and oral anticancer drugs (14% vs 3%; P = .02) was higher in the high- than in the low-cost group. Conclusion: Based on the results of the present study, the estimated annual waste cost of UM for patients with cancer who died in Japan was approximately US$110 million. Interventions to educate patients regarding UM and to eliminate barriers to opioid use may help reduce the cost of UM, particularly opioids and anticancer drugs. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the OCTO clinical study was to measure patients' adherence to capecitabine-based treatment.Methods: A cohort of ambulatory patients treated with capecitabine monotherapy for either locally advanced or metastatic, breast or colorectal cancer was monitored for 6 cycles. Adherence was assessed in all patients by self-completed questionnaires on disease, pill-count and pharmacological dosage of FBAL (metabolite of capecitabine); and in half of the cohort by electronic medication event monitoring systems (MEMS™) recording the opening times of the device.Results: Forty patients were enrolled between November 2008 and September 2011 and treated by capecitabine for an average of 4.75 cycles (range 1-6). Hand-foot syndrome (HFS) was the most frequently reported toxicity (35% patients), and to a lesser extent fatigue and/or asthenia (21%), nausea and/or vomiting (13%) and diarrhea (11%). In the MEMS™ cohort, 20 patients were included. Patients' adherence was excellent with very few missing occasions (23/2272 records). Close analysis of MEMS™ data revealed unexpected medication patterns, such as patients taking extra days of medication beyond planned cycle, patients taking extra doses per day and patients missing a day of dosing and "compensating" by taking extra the following day (N = 7, 18%). A trend was found between over-adherence and high-grade toxicity (grades 3 and/or 4): OR 4.74 [0.65-45.2], p = 0.13 and higher AUC (p = 0.16). There was a trend towards increased AUC of FBAL in over-adherent patients (p = 0.16).Conclusion: Adherence to oral anticancer chemotherapy was found excellent in this population suggesting over-adherence to capecitabine and potential safety implications for outpatients' drugs. [ABSTRACT FROM AUTHOR]

In this multicenter cross-sectional study, the quality of patient-centered education and counseling for patients treated with oral anticancer drugs was examined. The CONTACT-Patient-Centered Care Questionnaire was administered to 266 patients, recruited in 11 Flemish hospitals. The questionnaire consists of 80 items, each evaluating the degree of performance of a key element in patient-centered education and counseling. In total, 15 key elements were seriously underperformed (degree of performance < 50%). Elements regarding adherence monitoring, specific topics in patient education, and involvement of the community pharmacist and home care nurse received a very low score. Only six key elements were systematically performed (degree of performance ≥ 90%), among which the elements on communication style and involvement of the general practitioner. This study uncovered three major gaps in patient-centered education and counseling of patients on oral anticancer drugs: unmet patient information needs due to shortcomings in patient education, inadequate adherence monitoring, and lacking collaboration with community pharmacists and home care nurses. This study highlights the need for interdisciplinary and patient-centered education and counseling of patients using OACD, including all key stakeholders: physicians, nurses, hospital pharmacists, general practitioners, community pharmacist and home care nurses. • The CONTACT-PCCQ was used to investigate the quality of patient-centered care. • Patient-provider communication proved to be of high quality. • Several areas of low-quality care could be identified. • Rethinking and reorganizing care, considering patients' experiences, is needed. • Initiatives to improve patient-centered care can be guided by these findings. [ABSTRACT FROM AUTHOR]

To provide in-depth insight in stakeholders' experiences with the self-directed co-creation of a care pathway for patients treated with oral anticancer drugs, and to identify influencing factors for the success of the co-creation process that are persistent throughout the prior pilot phase and the scale-up phase. This qualitative process evaluation was performed in 11 Belgian oncology departments participating in a scale-up project. Semi-structured interviews with local coordinators (n = 13) and members of the project teams (n = 19), responsible for the co-creation of the care pathway, were conducted. Data were thematically analyzed. Despite the external support (including group-level coaching and the use of well-defined supportive tools) to promote self-directedness, the co-creation process was perceived burdensome. Three influencing factors were persistent throughout the pilot and scale-up phase: a) shared leadership among the coordinator, physician and hospital management, b) an intrinsically motivated team driven by additional extrinsic factors, and c) a balance between external support and self-directedness. This study shows that the self-directed co-creation of a care pathway is feasible on the condition that important prerequisites are met, including shared leadership and team motivation. More concrete tools, such as a model care pathway, seem needed to increase feasibility of the self-directed co-creation of the care pathway. Yet, these tools should allow tailoring to the specific hospital context. The findings of this study can be useful for further scale-up to other oncology centers, but can also be extrapolated to other healthcare settings. • The self-directed co-creation is perceived burdensome by most coordinators. • Shared leadership between project coordinators, physicians and hospital management is needed. • Intrinsic motivation by the project team should be sufficiently high. • An appropriate balance between self-directedness and external support is crucial. • More concrete or stand-alone tools can enable a self-directed co-creation. [ABSTRACT FROM AUTHOR]

Adherence has become an important issue in modern oncology treatment. Most studies have included heterogeneous target tumor types, regimens, and therapy settings. Our study focused on capecitabine during capecitabine plus oxaliplatin (XELOX) treatment as an adjuvant therapy for colorectal cancer. The main aims of this study were to evaluate real-life adherence to capecitabine and to investigate candidate factors that might decrease adherence. We studied 338 consecutive patients who received XELOX treatment between December 1, 2011, and April 30, 2015, at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. Our study assessed adherence to capecitabine through patient-reported treatment diaries and interviewed nonadherents to determine the reasons for not taking capecitabine at a pharmaceutical outpatient clinic. We calculated the adherence rate in a cycle as: number of times the patient took capecitabine/28. Relative dose intensities and factors associated with deteriorating adherence to capecitabine were retrospectively surveyed from electronic patient records. Uni- and multivariate logistic regression analyses were used to investigate factors associated with optimal adherence. The study covered 282 patients who received 2,055 cycles of XELOX. Median adherence rate was 94.0% in the first cycle, and median relative dose intensity of capecitabine was 77.8%. The most common reasons for nonadherence were nausea/vomiting and diarrhea. The presence of the following factors was not significantly associated with adherence: ECOG performance status ≥1 (p = 0.715), clinical stage (p = 0.408), primary tumor site (p = 0.576), age ≥70 years at study entry (p = 0.757), female gender (p = 0.504), and not living alone (p = 0.579). The adherence rate from this study was significantly higher than the adherence from metastatic settings. Adherence-enhancing interventions for capecitabine in XELOX treatment as adjuvant therapy comprised management of nausea/vomiting and diarrhea. [ABSTRACT FROM AUTHOR]

Background: Fear of cancer progression/recurrence (FOP/FCR) is considered one of the most prevalent sources of distress in cancer survivors and associated with lower quality of life and functional impairment. Detailed measures of FOP/FCR are needed because little is known about the knowledge of FOP/FCR, its associations with the patient-doctor relationship, and the rate of adequate therapy. Colorectal cancer (CRC) is one of the most prevalent cancer entities, and oral capecitabine is widely prescribed as treatment. Therefore, we initiated a pilot study to expand the literature on FOP/FCR in CRC outpatients receiving capecitabine and to generate hypotheses for future investigations. Methods: This study included 58 patients treated at a comprehensive cancer center. FOP/FCR was assessed with the Fear of Progression Questionnaire (FOP-Q-SF). Satisfaction with the relationships with doctors was assessed with the Patient-Doctor Relationship Questionnaire-9 (PRDQ-9). Levels of side effects were rated by the patients on a visual analog scale. Clinical data were extracted from the charts. Results: A total of 19 out of 58 patients (36%) suffered from FOP/FCR according to our assessment. Levels of FOP/FCR seemed to be mostly moderate to high. Only four out of the 19 distressed patients (21%) were treated accordingly. Typical side effects of oncological treatment were associated with higher FOP/FCR. Satisfaction with doctor-patient relationships was not associated with FOP/FCR. Regarding single items of FOP/FCR, three out of the five most prevalent fears were associated with close relatives. Discussion: FOP/FCR occurred frequently in more than one in three patients, but was mostly untreated in this sample of consecutive outpatients with CRC receiving oral capecitabine. In detail, most fears were related to family and friends. In addition to an unmet need of patients, our data indicate sources of distress not considered thus far. If replicated in larger studies, results may help to inform intervention development and improve patient care. [ABSTRACT FROM AUTHOR]

Patients with hematologic malignancies are increasing being prescribed oral anticancer medications (OAMs) and/or biologics. These newer targeted OAMs are associated with a host of practical and pharmacoeconomic implications for patients and healthcare providers. Issues such as safety, procurement challenges, and the need for proactive involvement of all stakeholders to optimize adherence for successful use of these agents are increasingly being recognized. The current reactive model is negatively impacting the patient experience through delays in care, financial toxicity, and decreased safety. It also impacts the healthcare providers in the form of lost revenue and staff burnout due to labor-intensive procurement and patient financial assistance burdens. In this review, we describe some of the issues identified and discuss potential strategies to improve patient access, minimize healthcare burden, and review current policy initiatives and patient advocacy efforts to reduce financial toxicity. [ABSTRACT FROM AUTHOR]

Many studies have demonstrated that non-adherence to oral anticancer drugs (OACDs) has challenged treatment efficacy. Otherwise, few validated tools exist to measure patients’ adherence to medication regimen in clinical practice. To synthesize previous studies on adherence by cancer patients taking OACDs, especially in targeted therapy, a systematic search of several electronic databases was conducted. We analyzed existing scales’ contents for various cancer patients and outcomes of studies assessing adherence. However, a well-validated scale designed particularly for OACD adherence is still lacking. Most adherence scales used in the studies reviewed contain items focused on measuring patients’ medication-taking behavior more than their barriers to medication compliance and beliefs. However, non-adherence to OACDs is a complex phenomenon, and drug-taking barriers and patient beliefs significantly affect patients’ non-adherence. To understand the key drivers and predisposing factors for non-adherence, we need to develop a well-validated, multidimensional scale. [ABSTRACT FROM PUBLISHER]

To investigate factors affecting the co-creation and implementation of care pathways for patients treated with oral anticancer drugs. An explorative qualitative process evaluation was performed at four Belgian hospitals, co-creating and implementing a care pathway for patients on oral anticancer drugs. Semistructured interviews and focus groups were performed by a) local coordinators leading an interprofessional project team during the co-creation and implementation stage, b) external implementation coaches, and c) teams of healthcare professionals with a role in the care pathway. In total, 47 stakeholders were interviewed. Interviews were audio-taped, transcribed verbatim, and analyzed thematically. We found four factors affecting co-creation and implementation of care pathways for patients on oral anticancer drugs. Developing an adequate supporting context using motivated interprofessional project teams of clinical and management staff led by competent coordinators is one important facilitator. Leadership of local coordinators and oncologists is crucial for progressing the co-creation. Other factors included the complexity of the oral anticancer drug intervention, the interprofessional character of the care pathway, and involving primary care. External coaching during co-creation proved an important facilitator. Prior investigation of willingness and motivation to change in clinical and management staff, competent coordinators, and leadership of oncologists are needed. In addition, external support determines the success of co-creating and implementing care pathways for patients on oral anticancer drugs. The complexity of co-creating and implementing a seamless care pathway for patients treated with oral anticancer drugs: a qualitative process-evaluation – highlights. • Oncology centers struggle to organize seamless care for patients on oral anticancer drugs (OACD) • Co-creating and implementing care pathways can be a strategy but is a challenging process • A supporting context and leadership in coordinators and oncologists facilitates co-creation • Aligning work processes in interprofessional teams and involving primary care was difficult • Tailoring care pathways and external coaching determine the success of co-creation [ABSTRACT FROM AUTHOR]

Background: Capecitabine plus oxaliplatin (XELOX) has been established as a first-line treatment for metastatic colorectal cancer. Adherence is particularly important with capecitabine to maintain appropriate curative effect. In this study, we monitored the adherence to capecitabine on XELOX treatment and investigated which factors might decrease compliance. Methods: The study included 242 consecutive patients who received XELOX treatment for metastatic colorectal cancer between October 2009 and March 2012. Adherence to capecitabine was checked by pharmacists with a patient-reported treatment diary at a pharmaceutical outpatient clinic. Adherence rate was defined as the number of times that a patient took capecitabine in a 14-day cycle/28 prescribed doses. We retrospectively surveyed median relative dose intensities of capecitabine and the factors deteriorating adherence across eight cycles from electronic patient records and examined differences in compliance rates according to age. Results: The study included 144 male and 98 female patients. The overadherence rate was 1.5% (n=23). The median adherence rate was 93.5% (n=242) in the first cycle of XELOX treatment, which gradually rose to 96.1% (n=148) in the eighth cycle. The median relative dose intensity of capecitabine was 79.2%. The main factors contributing to decreased adherence to capecitabine were diarrhea (22.5%, 352 instances) and nausea/vomiting (13.8%, 215 instances). The rate of missed dose was 12.1%. Analysis of adherence issues in relation to patient age showed a trend toward worse adherence to capecitabine therapy in the group of patients aged ⩾80 years (hazard ratio =3.83; 95% confidence interval 2.48-5.91, P<0.001 versus 70-80 years group and versus <70 years group, chi-square test). Conclusion: Patient-reported adherence to capecitabine on XELOX treatment in clinical practice is high but adversely affected by side effects. Patients aged 80 years or more exhibit a significant decrease in compliance compared with younger patients. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: The use of oral anticancer drugs has increased in modern oncology treatment. The move from intravenous treatments towards oral anticancer drugs has increased the patients’ own responsibility to take oral anticancer drugs as being prescribed. High rates of non-adherence to oral anticancer drugs have been reported. A systematic literature review was conducted to gain insight into determinants and associated factors of non-adherence and non-persistence in patients taking oral anticancer therapy. Review methods: PubMed, Cochrane, Web of Science and Cinahl were systematically searched for studies focusing on determinants and associated factors of medication non-adherence and non-persistence to oral anticancer drugs. The methodological quality of the included studies was assessed by two independent reviewers. No studies were excluded based on the quality assessment. Results: Twenty-five studies were included and systematically reviewed. The quality of the studies was moderate. Associated factors influencing medication non-adherence and non-persistence to oral anticancer drugs are multifactorial and interrelated. Older and younger age, and the influence of therapy related side effects were found to be predominant factors. Conclusion: Non-adherence and non-persistence to oral anticancer drug therapy are complex phenomena. More qualitative research is needed to facilitate the development of patient tailored complex interventions by exploring patients’ needs and underlying processes influencing medication non-adherence and non-persistence to oral anticancer drugs. [Copyright &y& Elsevier]

Oncology pharmacists face a constant challenge with patients who cannot swallow oral anticancer drugs, making extemporaneous oral liquid preparation a requirement. Improper extemporaneous preparation of these agents, especially with the traditional chemotherapy with a narrow therapeutic index, may increase the risk of over- or underdosing. In community pharmacies, multiple barriers exist that prevent these pharmacies from preparing extemporaneous oral anticancer drug formulations for a patient's use at home. In a home setting, patients or caregivers without proper counseling and education on how to safely handle chemotherapy are at increased risk for exposure to these drugs. Based on a review of the literature, compounding recipes are available for 46% of oral anticancer agents. A paucity of data exists on dose uniformity, bioequivalence, and stability of extemporaneous oral liquid formulations of anticancer drugs. Pharmacists must have an understanding of the basic scientific principles that are an essential foundation for the proper preparation of extemporaneous oral anticancer liquid formulations. The collaborative effort of a multidisciplinar team can also help identify different barriers in the community setting especially in areas where community pharmacies may lack resources for the extemporaneous compounding of oral chemotherapy, and to find ways to coordinate better pharmaceutical care. There are great opportunities for oncology pharmacists, as well as community pharmacists, as a resource for educating and monitoring patients receiving oral chemotherapy to ensure dosing accuracy, safe administration, and proper disposal of hazardous drugs. Development of national guidelines to promote standards of practice in the community and/or home setting is urgently needed to help improve the safety of dispensing and handling oral chemotherapeutic agents, including extemporaneously compounded oral liquid formulations of these drugs. [ABSTRACT FROM AUTHOR]

Background: Existing research has suggested that there can be potential drug-drug interaction (DDI) between antiepileptic drugs (AED) and anticancer drugs (ACD). However, information on the prevalence of patients on concurrent oral AED and oral ACD is limited. Methods: A retrospective study was conducted at the National Cancer Centre Singapore. Prevalence was calculated by identifying prescriptions with both oral AED and oral ACD from the outpatient prescription database over three years. Prevalence and physicians’ prescribing patterns were evaluated. Co-prescription was defined as medications that were prescribed by the same physician on the same day. Potentially interacting combinations were further detected using an existing database, OncoRx (www.onco-informatics.com). Results: 42,810 prescriptions that contained at least one oral ACD were identified from the database. The number and prevalence of prescriptions that had a combination of oral ACD and AED were 274 and 0.64%, respectively, with the majority (82.8%) of the AED-oral ACD pairs being co-prescribed. Per patient, the average number of exposure days to the AED-oral ACD pair was 19.5 days annually. Fifty-one (18.6%) prescriptions were identified as containing potentially interacting AED-oral ACD pairs. Discussion: There is a relatively low prevalence of AED-oral ACD combined exposure in the population we sampled; however, the combined exposure is long enough to produce clinically important DDI effects. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background. In view of the increased usage of oral anticancer drugs in the contemporary treatment of cancer, we aimed to examine cancer patients' perspectives of oral anticancer drugs, through a survey at an Asian cancer centre. This study also intended to describe patients' behavior regarding storage, handling, and administration of oral anticancer drugs. Methods. This cross sectional survey was conducted at a single site. The interviewer-administered survey was undertaken at the outpatient pharmacy of National Cancer Centre Singapore (NCCS), the largest ambulatory cancer center in Singapore, between January and March 2008. Eligible patients had received at least one cycle of oral anticancer agent treatment or had been taking oral anticancer agents continuously for 3 months. Results. A total of 126 patients were surveyed. Median age of surveyed patients was 58 years (range 31-85 years). The drugs involved were capecitabine (39.7% of patients), tamoxifen (23.1%), aromatase inhibitors (18.2%), gefitinib (9.1%), and imatinib (3.3%). Over 90% patients self-administered their oral anticancer drugs. The majority of the patients (94.2%) reported no difficulties in adherence to their oral anticancer treatment regimens. Forty per cent of patients reported habitually washing their hands after administering their anticancer drugs. None of the patients, except two patients receiving capecitabine, indicated that they habitually used gloves to handle their oral anticancer medications. Conclusion. The majority of patients receiving oral anticancer agents reported no difficulty in adhering to their oral anticancer treatment regimens as prescribed. However, this survey demonstrated the need to improve patients' understanding of the requirements for storage, handling and safe administration of oral anticancer drugs. [ABSTRACT FROM AUTHOR]

The present study assessed the safety of outpatient oral anticancer chemotherapeutic drugs by investigating the type and frequency of serious adverse effects (SAEs). Emergency hospitalization, unplanned consultations and telephone calls were investigated in 1,832 patients who received oral anticancer drug treatment at the National Cancer Center Hospital East between December 1, 2014 and November 30, 2015. Oral cytotoxic anticancer and molecular targeted drugs were administrated to 1,140 (62.2%) and 692 (37.8%) patients, respectively. A total of 52 (2.8%) SAEs were reported, with 32 (2.8%) occurring following cytotoxic anticancer drug administration and 20 (2.9%) occurring after molecular targeted drug treatment. The most common SAE was gastrointestinal toxicity. The median time to SAE occurrence was 32 days (range, 5-1,705 days). The rate of unplanned consultations and telephone calls were 5.5 and 37.9% among all patients, respectively, with skin reactions being the most common reason for unplanned consultations. SAEs often occurred early after treatment initiation. It was concluded that measures against gastrointestinal toxicity are particularly important were administering chemotherapeutic agents. [ABSTRACT FROM AUTHOR]

To analyse the importance and performance of key elements in patient-centered care coordination, education and counseling of patients treated with oral anticancer drugs. In four Belgian non-academic hospitals, the importance and performance of a set of 82 key elements was cross-sectionally evaluated by primary and secondary healthcare professionals and by patients. These key elements were divided in 6 themes: coordination of care, style and content of patient contacts, medication counseling at treatment initiation, follow-up of treatment, psychosocial support, and involvement of family and friends. Participants were asked to indicate for each key element if it was implemented in the current care process for patients on oral anticancer drugs ('yes', 'no', 'I don't know') and if they considered it important that the component was implemented or would be in the future ('yes' or 'no'). Three levels of performance were defined, based on the number of participants who had answered 'yes' or 'no': 'systematically performed' (≥90% of participants), 'not systematically performed' (≥75% and <90%) and 'not performed' (<75%). Importance-rates were based on the number of 'yes' or 'no'. In total, 85 participants evaluated the key elements. More than half of key elements, 13/82 (15.9%) and 35/82 (42.6%) respectively, were considered as 'not' or 'not systematically performed'. The majority of these elements concerned coordination of care, medication counseling at treatment initiation and follow-up of treatment. Especially key elements on involving primary care and on discussing adherence had low performance rates. Nearly all key elements were assigned an importance score of ≥90%. Performance of key elements of patient-centered care coordination, education and counseling of patients treated with oral anticancer drugs proved moderate. Our findings suggest that strategies are needed to prioritize and operationalize key elements to coordinate transmural care and to provide effective education and counseling. • An importance-performance (IPA) analysis was used to evaluate clinical practice. • 82 key elements (KE) for care coordination, education and counseling were evaluated. • 48/82 (58.5%) of KE were reported as not or not systematically performed. • All KE were perceived as important by almost all participants. • Strategies are needed to prioritize and operationalize KE in oncology centers. [ABSTRACT FROM AUTHOR]