Oral Anticancer Medications Research Articles

Hospital pharmacists' perceived competence in providing care to oncology patients - (HoPP-CoP2).

Previous research has shown community pharmacists do not have high perceived competence or confidence providing care to patients on oral anti-cancer medications. There is a paucity of evidence when it comes to hospital pharmacists providing care to oncology patients admitted to the hospital for a reason other than cancer. To assess the perceived competence of hospital pharmacists not working in oncology in managing patients taking anticancer drugs. Additionally, identify factors impacting, potential interventions increasing, and any factors that improve perceived competence. An anonymous cross-sectional survey distributed to hospital pharmacists throughout Canada. Mean perceived competence results ranged from 2.52 to 3.97 out of 7.00 with respondents reporting most perceived competence managing electrolyte disturbances and least competence managing drug-disease interactions and intervening on hepatic dysfunction. Low confidence in knowledge received from previous oncology training was reported with a mean of 2.82 on the 7-point Likert Scale. Continuing education sessions were perceived as the intervention which would most improve perceived competence with a mean value of 5.92 to 5.94 on a 7-point Likert Scale. The number of CE hours completed in the last five years was the only factor shown to have a statistically significant correlation with perceived competence. Hospital pharmacists do not perceive themselves as competent in providing care to oncology patients. The implementation of a continuing education program related to oncology may improve perceived and actual competence.

Impact of Patient Personality on Adherence to Oral Anticancer Medications: An Opportunity?

Adherence to prescribed oral anticancer therapy is an important determinant of patient outcomes, including progression-free and overall survival. While many factors (eg, medication side effects and out-of-pocket costs, problems with insurance authorization, and timely medication refills) can affect adherence, one that is relatively unexplored is the impact of a patient's attitude and personality. Patient personality influences medication adherence and persistence in nonmalignant chronic conditions such as cardiovascular disease and diabetes. In breast cancer and chronic myeloid leukemia, studies suggest that personality also affects adherence to oral chemotherapy which can be targeted to improve adherence. In this viewpoint, we highlight the opportunity of incorporating patient personality as interventions to oral cancer therapy adherence and discuss current barriers to implementation.

Perspectives on Drug Product Design Among Patients with Lung Cancer in the United Kingdom.

The use of oral anticancer medications has become more prevalent in cancer therapy. This is particularly the case in the management of advanced non-small cell lung cancer (NSCLC). However, when the treatment delivery interaction between the patient and the healthcare provider is removed, the risk of non-adherence increases. Insights into patient preferences can allow drug product formulation scientists to design more patient-centric medications that may promote an increase in adherence which, in turn, may lead to more beneficial health outcomes. We conducted an advisory board with patients with NSCLC in the United Kingdom to elicit and understand preferences for drug product attributes related to appearance, instructions, and modality. The advisory board was preceded by a quantitative preference survey that included three object-case best-worst scaling exercises and was followed by administering the same survey to a broader group of patients to confirm the results. Patients strongly prefer once-daily dosing over more frequent dosing, regardless of the number of pills because taking tablets or capsules multiple times each day can disrupt daily activities. In addition, patients place high importance on surface smoothness because a rough surface implies decreased swallowability. Finally, food restrictions involving directions regarding taking medication with or without food represent difficulties for patients with cancer. Results of the follow-up survey confirmed these results. Drug developers should attempt to limit the dosing of these medications to once-daily regimens, avoid surface roughness, and develop formulations that can be taken without regard to the timing of meals to the greatest extent possible.

Dedicated OAM Oncology Navigation program to improve access to medication education, ePRO enrollment, and physician treatment plan completion adherence.

234 Background: Effective coordination of oncology care is essential for optimizing patient outcomes and ensuring adherence to treatment plans. When an Oncology Navigation program is implemented specifically related to patients on Oral Anticancer Medications (OAMs), it directly improves patient access to medication education and treatment adherence through enrollment in ePRO (electronic patient reported outcomes) tracking systems. Currently, there is limited evidence published related to the quantitative impact of dedicated OAM Navigation programs on patient treatment review and coordination visits, and provider completion adherence to treatment plans. Methods: This quality improvement initiative aimed to evaluate the impact of implementing an OAM Navigation program. Data were collected over a 90-day pilot period from a single geographic region within a community oncology practice. The patients’ medical records were reviewed to assess completion of treatment review and coordination visits by an APP or Physician, ePRO enrollment, and provider adherence to completion of treatment plans. Results: Analysis of the data revealed a significant increase in completed treatment review and coordination visits following the implementation of the OAM Navigation program, with a 28% increase observed compared to pre-implementation levels. Enrollment to ePRO system increased from 46 patients’ pre-pilot to 272 patients within the pilot period, a 491% increase in enrollment. Additionally, provider adherence to completion of treatment plans showed a marked improvement, increasing by 50% post-implementation. These findings suggest that the OAM Navigation program effectively facilitated enhanced quality and safety of care provided. Conclusions: Dedicated OAM Navigation programs play a crucial role in improving patient outcomes and optimizing oncology care delivery. Our findings demonstrate the significant positive impact of an OAM Navigation program on increasing patient education, ePRO enrollment, and improving provider adherence to completion of treatment plans. Incorporating OAM Navigation programs into ambulatory oncology practices can lead to more efficient and effective care coordination, ultimately enhancing the quality and safety of care. As we continue to expand and refine this program, we look forward to sharing our research findings and insights with the broader oncology healthcare community.

Oral self-management of palbociclib using mobile technology: Findings from a nurse-led randomized controlled trial

ObjectivesTest the feasibility and effectiveness of a text message reminder intervention for the self-management of oral anticancer medication in patients with metastatic breast cancer. MethodsForty-three females initiating treatment with palbociclib participated in a two-armed prospective randomized clinical trial. Participants were randomized into the control (N ​= ​21) and intervention groups (N ​= ​22) from January 2020 to January 2023. Survey responses were collected at three-time points; 1) at consent, 2)end of treatment cycles, and 3) at a follow-up clinic visit. Surveys included a demographic questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, post-study assessment, and the R-15 Participant Satisfaction Questionnaire. Nurse providers completed the Adaptation of Stamps Nurse Workload questionnaire. ResultsThe COVID-19 pandemic and regulatory decisions supporting other CDK4/6 medications negatively influence recruitment; thus, a small sample for each arm only detected large differences between the two arms regarding effectiveness. Feasibility analysis was not conducted due to insufficient data, but the participants frequently used their smartphones for text messaging. Although the survey data were limited, participants provided anecdotal information supporting the use of text messaging as a positive method to remind them to take their medication, have their labs drawn, and attend MD visits. Participants would have liked text messages at the exact time they took their medications as a simple reminder. ConclusionsGiven the importance of cancer treatments and the difficulties patients experience during these treatments, text messages using smartphones can actively improve patients' engagement and their ability to manage their treatment regimens.

Abstract B117: HT Helper Study: A phone application + patient navigation to improve medication adherence among Latina breast cancer patients experiencing social determinants of health

Abstract Background: Hormone therapy (HT) is highly effective for nearly all breast cancer patients with hormone receptor-positive tumors, which are about 80% of all breast cancer diagnoses. Long-term use of HT reduces cancer recurrence rates and cuts the risk of mortality nearly in half during the second decade after diagnosis. Despite proven benefits, 33% of women who are prescribed HT do not take it as prescribed by their doctor (<80% take their daily dosage). Latina patients are disproportionately affected by Social Determinants of Health (SDoH) that keep them from adhering to HT and are at higher risk of breast cancer recurrence and mortality. Objective: The goal of this 4-year randomized controlled study is to assess the effectiveness of the existing bilingual, culturally tailored, interactive HT Helper App, in combination with patient navigation (PN), on improving adherence to HT among Latina breast cancer patients experiencing SDoH barriers, i.e., income, health insurance, education, health literacy, and language, that impacts their medication adherence. This theory-based intervention will increase patient education, enhance self-efficacy, facilitate communication with the medical team and coordination of resources to address SDoH barriers and help patients develop self-care skills for optimal adherence to HT, ensuring patients the most equitable treatment outcomes possible, including improvement in quality of life, survival, and life expectancy. Study Design. The proposed study involves a parallel 3-group randomized controlled trial with 5-time assessments (baseline, 3, 6, 12, and 18 months) and will enroll 159 breast cancer patients who are prescribed HT and are attending the breast clinic at the Mays Cancer Center at UT Health San Antonio. Intervention components are based on Social Cognitive Theory and elements of Motivational Interviewing. Methods: We will compare the effectiveness of 3 groups on HT adherence: 1) the HT Helper App + PN group vs. the PN alone group vs. the usual care group, and will assess the effect of each study condition on patient self-efficacy to identify side effects, use self-care to manage side effects, and communicate with the medical team. We hypothesize that the HT Helper App + PN and the PN alone groups will have greater rates of HT adherence and higher patient self-efficacy than the usual care group, with the HT Helper App + PN achieving better results than both PN alone and the usual care groups. Conclusion: This proposed multi-level intervention involving a unique combination of mHealth technology + PN has the potential to improve adherence to HT by addressing SDoH and promote equitable breast cancer outcomes, including reduced recurrence and improved quality of life, overall survival and life expectancy among underserved Latina patients. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using oral anticancer medications. Citation Format: Patricia Chalela, Vivian Cortez, Sandra Sivak, Armida Flores, Martha De La Mora, Zully Garcia, Byeongyeob Choi, Edgar Muñoz, Qurathul Ahmed, Audrey Cordova, Maria I Sung-Cuadrado, Asra Aslam, Cliff Despres, Alyssa Gonzales, Virginia G Kaklamani, Kate I. Lathrop, Marcela Mazo Canola, Devasena Inupakutika, David Akopian, Amelie G. Ramirez. HT Helper Study: A phone application + patient navigation to improve medication adherence among Latina breast cancer patients experiencing social determinants of health [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B117.

376P Evaluating adherence to oral anticancer medications in metastatic and non-metastatic breast cancer patients

376P Evaluating adherence to oral anticancer medications in metastatic and non-metastatic breast cancer patients

Patient reported medication-related problems, adherence and waste of oral anticancer medication over time

ObjectivesPatients on oral anticancer therapy regularly experience medication-related problems (MRPs), potentially leading to non-adherence and medication waste. Most studies reporting these experiences have cross-sectional designs. The aim of our study...

Effectiveness of mHealth apps on adherence and symptoms to oral anticancer medications: a systematic review and meta-analysis.

Despite the rapid expansion of mHealth apps, their adoption has not always been based on evidence of effectiveness on patient outcomes. This systematic review aimed to determine the effect of mHealth apps on adherence and symptom to oral anticancer medications (OAMs) and identify the app design that led to such effects. Pubmed, Cochrane Central, PsycINFO, EMBASE, and WoS were searched from inception to April 2023. Randomised controlled trials (RCTs) that evaluated effects of mHealth apps on primary outcomes OAM adherence and symptom burden were included. Two reviewers independently assessed risk-of-bias using Cochrane Risk-of-Bias version 2 and extracted the data. Quality of evidence was assessed using GRADE. The protocol was registered in PROSPERO (CRD42023406024). Four RCTs involving 806 patients with cancer met the eligibility criteria. mHealth apps features included a combinations of symptom reporting, medication reminder, automated alert to care team, OAM and side effect information, one study implemented structured follow-up by a nurse. The intervention group showed no significant difference in OAM adherence (relative ratio 1.20; 95% CI 1.00 to 1.43), but significantly improved symptoms to OAMs with a lower standardised mean symptom burden score of 0.49 (SMD - 0.49; 95% CI - 0.93 to - 0.06), and a 25% lower risk of grade 3 or 4 toxicity (risk ratio 0.75; 95% CI 0.58 to 0.95) compared to usual care. These findings suggest a potential role for mHealth app in managing OAM side effect. Further research should explore the role of AI-guided algorithmic pathways on the interactive features of mHealth apps.

Financial impact of integrated specialty pharmacy efforts to avoid oral anticancer medication waste.

The growing number of oral anticancer medications represents a significant portion of pharmacy spending and can be costly for patients. Patients taking oral anticancer medications may experience frequent treatment changes following necessary safety and effectiveness monitoring, often resulting in medication waste. Strategies to avoid medication waste could alleviate the financial burden of these costly therapies on the payer and the patient. To evaluate the impact on waste and cost avoidance of reviewing the amount of medication patients have on hand and the presence of upcoming follow-up (ie, provider visit, laboratory testing, or imaging) before requesting a prescription refill renewal for patients taking oral anticancer medications through an integrated health system specialty pharmacy. We performed a retrospective review of patients filling oral anticancer medications prescribed by a Vanderbilt University Medical Center provider and dispensed by Vanderbilt Specialty Pharmacy between January 1, 2020, and December 31, 2020. Specialty pharmacists received a system-generated refill renewal request for oral anticancer medications when the final prescription refill was dispensed, prompting the pharmacist to review the patient's medical record for continued therapy appropriateness and to request a new prescription. If the patient had a sufficient supply on hand to last until an upcoming follow-up (ie, provider visit, imaging, or laboratory assessment), the pharmacist postponed the renewal until after the scheduled follow-up. Patients were included in the analysis if the refill renewal request was postponed after review of the amount of medication on hand and the presence of an upcoming follow-up. Medication outcomes (ie, continued, dose changed, held, medication changed to a different oral anticancer medication, or discontinued) resulting from the follow-up were collected. Cost avoidance in US dollars was assigned based on the outcome of follow-up by calculating the price per unit times the number of units that would have been unused or in excess of what was needed if the medication had been dispensed before the scheduled follow-up. The average wholesale price minus 20% (AWP-20%) and wholesale acquisition cost (WAC) were used to report a range of costs avoided over 12 months. The total cost avoidance over 12 months associated with postponing refill renewal requests in a large academic health system with an integrated specialty pharmacy ranged from $549,187.03 using WAC pricing to $751,994.99 using AWP-20% pricing, with a median cost avoidance per fill of $366.04 (WAC) to $1,931.18 (AWP-20%). Refill renewal requests were postponed in 159 instances for 135 unique patients. After follow-up, medications were continued unchanged in only 2% of postponed renewals, 56% of follow-ups resulted in medication discontinuations, 32% in dose changes, 5% in medication changes, and 5% in medication holds. Integrated health system specialty pharmacist postponement of refill requests after review of the amount of medication on hand and upcoming follow-up proved effective in avoiding waste and unnecessary medication costs in patients treated with oral anticancer medications at a large academic health system.

A qualitative exploration of community pharmacists’ experiences of dispensing oral anti-cancer medications

Abstract Introduction Oral anti-cancer medications (OAMs) have revolutionised cancer care. OAMs have a convenient route of administration, which avoid infection and extravasation risks, and injection site reactions associated with intravenous access. In Ireland, OAMs are dispensed from community pharmacies by community pharmacists who often have a lack of specialist training, insufficient access to patient notes, and prescriptions inadequate to clinically verify a patient’s treatment. No research has been conducted in Ireland on this topic since 2012.[1] The huge growth in OAMs since then means that the community pharmacy environment for dispensing OAMs have likely changed significantly. Aim To explore community pharmacists’ experiences of dispensing OAMs in Ireland and identify areas of improvement within the current system. Methods Semi-structured interviews were conducted with sixteen community pharmacists registered with the Pharmaceutical Society of Ireland who had dispensed OAMs in a community pharmacy setting. Participants were recruited through convenience (n=3), purposive (n=7), and snowball (n=6) sampling. Interview guides were developed from published literature. Interviews were conducted face-to-face or through Microsoft Teams and were recorded. Recordings were transcribed verbatim. The transcripts were analysed using an inductive thematic analysis approach using NVivo 12. Results The majority of participants were female (11/16), aged <40 years (11/16), and worked in a small pharmacy chain (2-9 pharmacies; 11/16). Only a quarter of participants had training in specific training about OAMs (4/16). There were three themes identified: ‘Patient Benefit’, ‘Communication’, and ‘Infrastructure’. Participants acknowledged that community pharmacists have strong relationships with their patients that facilitate an environment that aided counselling and eliciting patient queries. At the same time, it was noted that it is more difficult to monitor adherence of anti-cancer medications taken at home. Communication with hospitals was identified as a barrier. Discharge information is often inadequate to verify prescriptions due to insufficient details on the prescription or poor legibility. This is compounded by the difficulty in contacting OAM prescribers. On a systems’ level, community pharmacists feel that there is little support or training given to allow them to dispense OAMs. Participants found that only with time and experience in dispensing OAMs did they gain expertise and confidence. Conclusion Community pharmacists have an important role in the management of patients treating their cancer with OAMs; however, many feel that there are difficulties communicating with other healthcare professionals about potential OAM issues and that the infrastructure and resources are not in place to maximise the benefit to patients. Provision of OAM-specific training, provision of adequate discharge information, and ability to directly communicate with prescribers and/or oncology pharmacists would increase the competence and confidence of community pharmacists to dispense OAMs safely. This would reduce the risk of dispensing errors, missed supportive medications, and unrecognised adverse drug reactions.

A community-based advanced nurse practitioner-led integrated oncology care model for adults receiving oral anticancer medication: a pilot study

Oral anti-cancer medications (OAMs) are being used increasingly within cancer care. OAMs offer the potential to improve patient convenience and increase hospital capacity. The clinical assessment for each cycle of OAMs requires specialist patient review often performed in hospital-based oncology units. Consequently, any potential improvement in patient expediency or increased hospital capacity that OAMs can offer is not realised. This study aimed to develop and pilot the specialist assessment of patients receiving OAMs by an Advanced Nurse Practitioner (ANP) in a community-based location.The primary aim of this pilot study was to assess the feasibility of a community-based ANP-led integrated oncology care model for adults receiving OAMs in Ireland who met the pre-specified eligibility criteria. The objectives were to determine the feasibility of a definitive trial of this intervention by measuring patient safety, acceptability to patients and staff and cost of the new model of care.This single-centre pilot study provided patient care (n = 37) to those receiving OAM therapies within a community setting for a 4-month period. Consent rate was high with no attrition other than for clinical reasons. There were 151 contacts with the sample during that time.Results demonstrated that the ANP-led intervention and new model for OAM care was safe, highly acceptable to patients and staff and that related healthcare costs could be captured. Based on the success of this pilot study, the authors conclude that a community-based ANP-led integrated oncology care model for adults receiving OAMs is feasible, and a definitive trial is warranted.Trial registration ISRCTN, ISRCTN10401455. Registered 30 November 2020.

Association between adherence with oral anticancer medications and short-term health care resource utilization: A 2010-2018 claims-based analysis.

There is limited evidence on the effect of adherence to oral anticancer medications on health care resource utilization (HRU) among patients with cancer. To determine the association between adherence to oral anticancer medication and subsequent HRU. A retrospective cohort study was conducted using Optum Clinformatics® Data Mart commercial claims database. Patients who initiated an oral anticancer medication between 2010 and 2017 were included. Proportion of days covered was used to calculate medication adherence in the first 6 months after oral anticancer medication initiation. All-cause HRU in the following 6 months was assessed. Multivariable negative binomial regressions were used to determine the association between oral anticancer medication adherence and HRU, after controlling for confounders. Of 37,938 patients, 51.9% were adherent to oral anticancer medications. Adherence with oral anticancer medication was significantly associated with more frequent physician office and outpatient visits for several cancer types with the strongest association among those with liver cancer (adjusted incidence rate ratio [aIRR] = 1.34; 95% CI = 1.18-1.52 and aIRR = 1.32; 95% CI = 1.13-1.55, respectively). Oral anticancer medication adherence was associated with more emergency department visits only among patients with lung cancer (aIRR = 1.22; 95% CI = 1.01-1.48). Oral anticancer medication adherence was significantly associated with a higher rate of inpatient hospitalizations and longer stays among patients with liver cancer (aIRRs were 1.45 [95% CI = 1.02-2.05] and 2.15 [95% CI = 1.21-3.81], respectively), whereas hospitalizations were fewer and length of stay was shorter among patients with colorectal cancer who were adherent with oral anticancer medication (aIRRs were 0.77 [95% CI = 0.68-0.86] and 0.77 [95% CI = -0.66 to 0.90], respectively). Other measures did not reveal statistically significant differences in HRU among adherent and nonadherent patients for the cancer types included in the study. HRU following the initial phase of oral anticancer medication therapy was generally similar among adherent and nonadherent patients. We observed a slightly higher rate of office and outpatient visits among adherent patients, which may reflect ongoing monitoring among patients continuing oral anticancer medication. Further studies are needed to determine how oral anticancer medication adherence may affect HRU over a longer time period.

Pharmacy Assistance Programs for Oral Anticancer Drugs: A Narrative Review.

Oral anticancer medications (OAMs) are high priced with a significant cost-sharing burden to patients, which can lead to catastrophic financial, psychosocial, and clinical repercussions. Cost-conscious prescribing and inclusion of low-cost alternatives can help mitigate this burden, but cost transparency at the point of prescribing remains a major barrier to doing so. Pharmacy assistance programs, including co-payment cards and patient assistance programs administered by manufacturers and foundation-based grants, remain an essential resource for patients facing prohibitive co-payments for OAMs. However, access to these programs is fraught with complexities, including lack of trained financial navigators, limited transparency on eligibility criteria, onerous documentation burdens, and limits in available funding. Despite these drawbacks and the potential for such programs to incentivize manufacturers to keep list prices high, assistance programs have been demonstrated to improve financial well-being for patients with cancer. The increasing development of integrated specialty pharmacies with dedicated, trained pharmacy staff can help improve and standardize access to such programs, but these services are disproportionately available to patients seen at tertiary care centers. Multistakeholder interventions are needed to mitigate the burden of cost sharing for OAMs, including increased clinician knowledge of financial resources and novel assistance mechanisms, investment of institutions in trained financial navigation services and centralized platforms to identify assistance programs, and policies to cap out-of-pocket spending and improve transparency of rates charged by pharmacy benefit managers to a health plan.

Access to Financial Assistance Programs and Their Impact on Overall Spending on Oral Anticancer Medications at an Integrated Specialty Pharmacy.

Financial assistance (FA) programs are increasingly used to help patients afford oral anticancer medications (OAMs), but access to such programs and their impact on out-of-pocket (OOP) spending has not been well explored. This study aimed to (1) characterize the impact of receipt of FA on both OOP spending and likelihood of catastrophic spending on OAMs and (2) evaluate racial/ethnic disparities in access to FA programs. Patients with a cancer diagnosis prescribed an OAM anytime between January 1, 2021, and December 31, 2021 were included in this retrospective, single-center study at an integrated specialty pharmacy affiliated with a tertiary academic cancer center. Fixed-effect regression models were used to characterize the impact of receipt of FA on overall spending and likelihood of catastrophic spending on OAMs, as well as explore the association of race/ethnicity with receipt of FA. Across 1,186 patients prescribed an OAM, 37% received FA. Receipt of FA was associated with lower annual spending on OAMs (β = -$1,236 US dollars [USD; 95% CI, -$1,841 to -$658], P < .001) but not reduced risk of catastrophic spending (odds ratio [OR], 0.442 [95% CI, 0.755 to 3.199], P = .23). Non-White patients (OR, 0.60 [95% CI, 0.43 to 0.85], P = .004) and patients who spoke English as a second language (OR, 0.46 [95% CI, 0.23 to 0.90], P = .02) were less likely to receive FA compared with White and English-speaking patients, respectively. FA programs can mitigate high OOP spending but not for patients who spend at catastrophic levels. There are racial/ethnic and language disparities in access to such programs. Future studies should evaluate access to FA programs across diverse delivery settings.

Exploring adherence in patients with advanced breast cancer: focus on CDK4/6 inhibitors.

Treatment adherence is crucial for optimal outcomes in advanced breast cancer, but can be challenging due to various factors, i.e. patients' attitudes and behavior upon diagnosis, and complex therapies with high adverse effect rates. Our aim was to explore the adherence to oral anticancer medications (OAM) in women with advanced breast cancer, focusing on cyclin-dependent kinase 4 and 6 inhibitors (CDKI), and identify factors associated with the adherence. We conducted a cross-sectional study at the University Hospital Centre Zagreb, Croatia, involving women with stage IV advanced breast cancer receiving OAM. Data collection included a questionnaire assessing socio-demographic and clinical information, Beck Depression Inventory-II for depressive symptoms, Medication Adherence Report Scale (MARS-5) for adherence to OAM, and Beliefs about Medicines Questionnaire. Plasma concentrations of CDKI were confirmed by LC-MS/MS in three randomly selected participants. A total of 89 women were included. The most prescribed OAMs were anti-estrogen (71.3 %) and CDKI (60.9 %). MARS-5 scores (mean: 24.1 ± 1.6) correlated with CDKI plasma concentrations. Forgetfulness was the primary reason for non-adherence (25.9 %). Women receiving CDKI (p = 0.018), without depressive symptomatology (p = 0.043), and with more positive beliefs about medicines were more adherent (p < 0.05). This study enhances understanding of medication adherence in advanced breast cancer and identifies influential factors.

Financial Toxicity and Quality of Life in Patients Taking Oral Therapy for Hematologic Malignancies

Background There has been an increase in the use of oral agents for the treatment of hematologic malignancies. Though clinically efficacious and convenient, oral therapies often have higher out-of-pocket cost than intravenous medications due to differences in insurance coverage. High financial burden and sequelae thereof, known as financial toxicity (FT), can negatively impact patient mood, adherence, quality of life (QoL), and outcomes. We present cross-sectional data from a longitudinal survey to evaluate the economic, psychosocial, and QoL impact of oral anti-cancer medications (OAMs) in the treatment of hematologic malignancies. Methods We used database query to identify patients at a midwestern, tertiary care, academic medical center who were 18 years or older and were prescribed Enasidenib, Ivosidenib, Venetoclax, Gilteritinib, Midostaurin, Ibrutinib, Acalabrutinib, Imatinib, Nilotinib, Ponatinib, Bosutinib, Duvelisib, or Idelalisib within the past 3 months. Chart review confirmed medication initiation within the past 3 months for a diagnosis of MDS, AML, CML, ALL, CLL, HL, or NHL. Patients were recruited by phone and consented by email. Consenting patients were sent an 85-item online survey assessing sociodemographic information, treatment-related information, and validated surveys, including the Functional Assessment of Cancer Therapy (FACT-G7) and Comprehensive Score for Financial Toxicity (COST) questionnaires. Participants received a follow-up survey 3 months after completing the initial survey. Statistical analysis was performed with GraphPad Prism 9 by Spearman's rank correlation, Mann-Whitney U test, or Kruskal-Wallis H test as appropriate. Results Between November 2021 and April 2023, 528 patients were identified, of whom 152 were eligible for participation and 28 consented and completed the initial survey (18.4%). Demographics are reported in Table 1. The group was predominantly male (64.3%), white (92.9%), married (78.6%), college-educated (64.3%), and financially stable (50% with annual income over $100,000). In the six months prior to diagnosis, 57.1% of participants were working full time and 35.7% were retired. At the time of survey completion, 25% were working full time, 50% were retired, and 14.3% were disabled or unable to work due to health. All participants were insured (60.7% Medicare, 35.7% private insurance). All participants on Medicare had Part A and B coverage, and 82.4% had Part D coverage. All but 1 participant had prescription drug coverage. AML (32.1%), CLL (25%), and CML (17.9%) were the most common diagnoses. Venetoclax (46.6%) was the most common OAM. Results are summarized in Table 2. Those with a history of depression or anxiety had no difference in financial stress, experiencing cancer as a financial hardship, QoL satisfaction, or bother from side effects (SE) as those without such history. Income was inversely associated with identifying cancer as a financial hardship (rs -0.485; 95% CI, -0.732 to -0.125) and with pain (rs -0.389; 95% CI, -0.678 to -0.007). Income had no correlation with QoL satisfaction or bother from SE. Insurance coverage had no association with financial stress, seeing cancer as a financial hardship, QoL satisfaction, or bother from SE. Those disabled or unable to work felt more financial stress than those who were retired (P=0.018). They also saw cancer as more of a financial hardship than those who either worked full time or were retired (P=0.005). Those who had a family member stop working or reduce work hours had lower income (P=0.009), greater financial stress (P=0.015), worse QoL satisfaction (P=0.013), and increased bother from SE (P=0.017) than those who did not. Financial stress was negatively associated with QoL satisfaction (rs -0.552; 95% CI, -0.775 to -0.206) and positively associated with bother from SE (rs 0.469; 95% CI, 0.105 to 0.772). Experiencing cancer as a financial hardship was negatively associated with QoL satisfaction (rs -0.517; 95% CI, -0.755 to -0.159). Conclusions In this well-resourced cohort taking OAMs to treat hematologic malignancies, there were multiple indicators of FT. Patient or family loss of employment was notably associated with financial stress and hardship. Financial stress and hardship were associated with worse satisfaction with QoL and worse experience of SE. Further study should define change in these features over time and interventions to mitigate distress.

Factors associated with lenvatinib adherence in thyroid cancer and hepatocellular carcinoma.

Lenvatinib is an oral anticancer medication used to treat radioiodine-refractory thyroid cancer and unresectable hepatocellular carcinoma. The purpose of this study is to evaluate lenvatinib adherence by patients and to identify factors associated with decreased lenvatinib adherence. Among 153 patients who started treatment with lenvatinib for unresectable thyroid cancer or unresectable hepatocellular carcinoma between May 1, 2015 and August 31 2021 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 102 were eligible for this study (55 thyroid cancer, 47 hepatocellular carcinoma). The lenvatinib adherence rate in a treatment cycle was defined as the number of times a patient took lenvatinib in a 28-day cycle divided by the prescribed 28 doses. The rate was determined by pill counting and self-reporting at the pharmaceutical outpatient clinic. Reasons for non-adherence were established by interview and analyzed. The median adherence rate of lenvatinib in the first cycle was 90.1% (n = 55) in thyroid cancer and 94.9% (n = 47) in hepatocellular carcinoma. In thyroid cancer, there were 255 incidents of lenvatinib non-adherence. Non-adherence was mainly associated with bleeding events (18.6%), followed by hand-foot skin reactions (10.6%). In hepatocellular carcinoma, there were 97 incidents of non-adherence. Hypertension accounted for 20.6%, followed by hoarseness (18.6%) and diarrhea (17.5%). The adherence rate for lenvatinib in Japanese patients with thyroid and hepatocellular carcinoma in real-world clinical practice was more than 90% in this study. Hypertension was a major reason for non-adherence, followed by hand-foot skin reactions and diarrhea.

Improved oral anticancer medication (OAM) adherence/toxicity assessment documentation.

409 Background: Based on national OAM guidelines and to improve patient safety, most OAM programs monitor toxicity/adherence within 10-14 days following OAM initiation. At our institution, only 50% of toxicity/adherence documentation tasks were completed by day 10 of cycle 1 after initiating OAM. We aimed to increase toxicity/adherence documentation tasks to at least 75% by day 10 of cycle 1 following a newly prescribed OAM in collaboration with Hematology/Oncology Pharmacy Association/American Society of Clinical Oncology 2022 quality training program (QTP). Methods: We engaged a multidisciplinary team to gather/interpret data, create process map, and identify barriers. Outcome measure was documentation of toxicity/adherence by day 10 of cycle 1. Included all cancer patients initiating OAM treatment plan. Excluded those on intravenous/oral regimens and gynecology/oncology patients. Process measure was percentage of 9 crucial tasks identified as necessary to appropriately document toxicity/adherence. Balance measures included provider visits, emergency department visits, telephone/electronic medical record OAM-related messages, and nursing satisfaction. A cause-and-effect diagram, pareto chart and prioritization matrix were used to narrow focus of improvement changes. Two plan-do-study-act (PDSA) cycles were conducted from January 2023-June 2023. All data were analyzed using Statistical Process Control Charts with 3-sigma control limits. Results: Original high-impact, easy-to-implement intervention (re-training staff) delayed due to institutional-directed intervention (education documentation retraining due to The Joint Commission survey). Education documentation retraining did not significantly improve toxicity/adherence task completion rate (50% to 53%) by improved provider and emergency department visits (16.7% and 12.5% to 0%) (see Table 1). Nursing turnover, lack of formal OAM process training and institutional buy-in for OAM program/training likely contributed to results. Re-training supported with institutional buy-in completed. PDSA cycle 2 data collection is ongoing; preliminary results show no change in task completion rate. Conclusions: Education documentation and retraining alone is insufficient to improve OAM toxicity/adherence documentation rates. Other interventions are needed to attain our goal.[Table: see text]

Impact of medically integrated pharmacies on oral anticancer medication prescription abandonment.

66 Background: Due to the high cost of oral anticancer medications, financial toxicity may limit patient access to treatment. Abandonment occurs when a patient does not fill a prescription. Higher out of pocket costs have been associated with higher rates of prescription abandonment of treatment across cancers with national abandonment rates typically reported as 18%. An integrated patient assistance process within the care team as occurs in a medically integrated pharmacy is postulated to lower abandonment rates. We measured prescription abandonment rates in the Texas Oncology (TXO) medically integrated pharmacy (MIP). Methods: We reviewed prescription data from the electronic health record (EHR) and our pharmacy dispensing system, for all new oral anticancer medications prescribed from January 2022 to December 2022. Prescriptions that were sent electronically from the EHR but did not have a corresponding dispense in the pharmacy dispensing software were classified as having a barrier to fill. Among the prescriptions that had a barrier to fill, we randomly selected cases for further detailed review to identify cause of barrier. By reviewing the EHR, we also examined whether patients filled any alternate oral or injectable anticancer agent within 60 days due to a formulary block, patient choice or physician choice. Abandonment was defined when patients did not receive their treatment or appropriate alternative treatment within 60 days of the written prescription date. Results: 17,442 prescriptions for oral anticancer medications were prescribed by Texas Oncology physicians. Of those 8460 were filled by the TXO MIP without extensive barriers. 8982 of prescriptions were not filled at our TXO MIP and of those 2895 (32%) prescriptions were further reviewed to determine cause of barrier to fill. 1435 (49.5%) prescriptions had a pharmacy benefit manager (PBM) design that routed the prescription to an external pharmacy and out of the continuity of care of the MIP. 827 (29%) of patients experienced financial toxicity and received free drug assistance with the help of the MIP patient assistance team. 72 (1.3 %) of patients were started on an appropriate alternative therapy with input from the medically integrated care team. 15 patients did not start their oral anticancer treatment which resulted in an abandonment rate of less than 1%. Conclusions: National abandonment is reported as high as 18% largely due to high out of pocket costs. The Texas Oncology MIP has a dedicated patient assistance team. Within the MIP, although 29% of patients had a financial barrier to fill, the prescription abandonment rate was &lt;1%. Oral anticancer medications filled in the MIP led to decreased prescription abandonment due to the integrated patient assistance, pharmacy, and clinical teams. A medically integrated pharmacy should be the preferred approach for specialty cancer medications.