Management Of Oral Chemotherapy Research Articles

Impact of the oral chemotherapy pharmacist on direct cost avoidance and cost savings of oral oncolytics at an integrated health system.

e18839 Background: The impact of oncology pharmacists on patient care have been well-documented including enhanced medication safety and efficacy, increased medication adherence, improved provider and clinic burden, and increased patient and provider satisfaction. There is a scarcity of articles relating to pharmacists’ drug cost savings or cost avoidance of oncologic drugs in an oral chemotherapy management clinic within an integrated healthcare system. Cost savings and cost avoidance studies are needed to reinforce this practice and gain support and funding from hospital administration. Methods: This retrospective, observational study analyzed interventions made by oncology pharmacists in the Pharmacist-Managed Oral Chemotherapy Clinic at Kaiser Permanente San Diego and determine the direct drug cost savings and cost avoidance effects over one year. Cost savings and cost avoidance were calculated by comparing the costs of drug utilization if no interventions were implemented versus costs of drug saved from accepted interventions for dose reduction, dose delay, temporary dose hold, therapy discontinuation, therapy conversion, formulary alternative conversion, and brand to generic conversion. Secondary outcomes included the highest and average cost avoidance per intervention, intervention type, medication, medication class, and cancer type. Additionally, interventions that did not lead to direct drug cost savings such as adverse drug reaction management, drug interaction identification, and supportive care recommendation were also recorded. The secondary endpoint was oncologist satisfaction via a six-question satisfaction survey. All documented oncology pharmacist interventions that were made in the Oral Chemotherapy Clinic from January 1 to December 31, 2021 were reviewed for study inclusion. From a report generated monthly from the electronic health record (EHR), retrospective chart review was conducted to verify whether each cost-savings intervention was truly recommended by an oncology pharmacist and if the intervention was accepted by the treating oncologist. The Average Wholesale Price (AWP) of drugs listed on Lexicomp as of November 1, 2021 was used to calculate the drug cost savings and cost avoidance. During this period, there were no changes to practice and no increased efforts to identify interventions. Results: As of September 2021, 156 interventions were identified, with a total cost savings and cost avoidance of $2,245,856. Once all data have been collected for the remainder of 2021, descriptive statistics will be used to analyze and stratify the data as appropriate. Conclusions: Pharmacist interventions in the Oral Chemotherapy Clinic led to significant overall cost savings to the health care system. It is reasonable to expect that higher cost savings will be achieved as more oral chemotherapy agents are managed by pharmacists.

Role of the Advanced Practitioner in the Management of Oral Chemotherapy for Adults With AML.

Recent advances have resulted in an expansion of treatment options for AML, especially targeted therapies and low-intensity regimens. At JADPRO Live Virtual 2021, presenters reviewed novel and targeted oral chemotherapy for adults with AML and discussed multidisciplinary collaboration for patients with complex AML chemotherapy regimens.

Impact of a pharmacist-led telehealth oral chemotherapy clinic

Oral oncolytics come with significant concerns of noncompliance due to complex regimens, adverse effects, and high overall costs. The Geisinger Oral Chemotherapy Clinic is a fully telephone-based medication therapy disease management (MTDM) program designed to integrate pharmacists as advanced practitioners in hematology/oncology clinics for comanagement of oral chemotherapy. To date, Geisinger has 11 oncology clinics and 3 full-time pharmacists designated to the management of oral chemotherapy. Pharmacists receive referrals for comanagement of patients starting oral oncolytics. Under a collaborative practice agreement, they can order laboratory tests as well as supportive care medications and refills. Pharmacists review planned therapies, perform medication reconciliations, and provide medication counseling. Once treatment has been initiated, pharmacists contact patients for laboratory and toxicity assessments. The clinic incorporates the use of customized smart data elements within the electronic medical record to collect data regarding pharmacist interventions and time allocations in the clinic. As of March 31, 2021, the clinic was actively following approximately 1,100 patients, resulting in an average of 80 to 90 encounters per day for new referrals, chemotherapy education, and laboratory and toxicity assessments. Approximately 2,113 patients were followed from December 1, 2019, to March 31, 2021, with 46,929 interventions documented. By obtaining provider buy-in for pharmacy services, acquiring enough personnel resources to meet the needs of the growing patient population and respective therapies, and proper utilization of technology, the program has thrived, allowing for increased provider and patient satisfaction. Future goals include expanding collection of pharmacist intervention metrics and analysis of patient perceptions of services provided by the clinic.

Implementation and outcomes of a pharmacist-led oral chemotherapy clinic at VA Maine Healthcare System.

Patients undergoing intravenous chemotherapy tend to receive more structured follow-up and closer monitoring than those taking oral chemotherapy. The management of oral chemotherapy at our facility was historically segmented and weighed heavily on veteran self-advocacy. It was hypothesized that routine check-ins with a clinical pharmacy specialist with a scope of practice would allow for a more proactive, supportive approach to care. The primary purpose of this quality improvement project is to ascertain the impacts of a pharmacist-led oral chemotherapy clinic at the VA Maine Healthcare System. Methods: Starting January 7, 2019, all patients filling an oral medication(s) for cancer treatment were considered for enrollment into the pharmacist-run clinic at the time of medication approval. The pharmacist contacted each patient by phone at patient-specific intervals determined by drug-specific lab monitoring requirements, side effect prevalence, refill due date, and overall patient preference. The total number of interventions was tallied by intervention category. Medication adherence was assessed as a secondary outcome by comparing medication possession ratios preclinic and postclinic implementation. From January 7, 2019, to January 5, 2020, there were a total of 698 interventions made by the clinical pharmacist. These impacts are a composite of pharmacologic (n = 141), nonpharmacologic (n = 115), and surveillance (n = 442) interventions. Medication possession increased from 92% to 96% (p < 0.05). A pharmacist-led oral chemotherapy clinic allows for a variety of clinically significant interventions and improved monitoring of patients on oral anticancer medication(s). Providing proactive follow-up with a scoped pharmacist improved medication compliance and improved the quality of care for our veterans.

The association of self-efficacy and health literacy to chemotherapy self-management behaviors and health service utilization.

Increasing demands on Canada's healthcare system require patients to take on more active roles in their health. Effective self-management has been linked to improved health outcomes; and there is evidence that effective behaviors, and subsequent healthcare utilization, are linked to self-efficacy and health literacy; however, this link has had minimal testing in the cancer context. Our aim is to examine the association between self-efficacy, health literacy, chemotherapy self-management behaviors, and health service utilization. A cross-sectional survey that included validated measures of self-efficacy, health literacy, chemotherapy self-management, and health service utilization was completed by participants (N = 213). Multivariable modeling using hierarchical linear regression was used to examine the association between variables. Self-efficacy contributed significantly to explaining variation in chemotherapy self-management score. Health literacy was not significantly associated with any of the dependent variables. Participants with higher self-efficacy had higher chemotherapy self-management scores compared to participants with low self-efficacy. Contrary to evidence in the chronic disease self-management literature, this study demonstrated that health literacy was not associated with chemotherapy self-management behavior nor was it associated with self-efficacy. Building patient self-efficacy in the context of chemotherapy self-management could be particularly helpful both in the cancer center and in the domain of oral chemotherapy management at home where patients are required to take on significant responsibility for self-management.

Impact of Oral Chemotherapy Management Program on Capecitabine Toxicity Management

Increasing use of oral chemotherapy has created unique challenges related to patient safety and compliance. To address this issue, the Henry Ford Cancer Institute at Henry Ford Health System developed and implemented a system-wide, multidisciplinary program named the Oral Chemotherapy Management Program (OCMP). The purpose of this study was to evaluate the impact of OCMP on patient outcomes in those receiving capecitabine. This was a retrospective, quasi-experimental study that compared outcomes in patients receiving capecitabine before and after OCMP implementation. The co-primary outcomes were incidence(s) of grade 1-4 and grade 3-4 adverse effects (AEs) associated with capecitabine. Secondary outcomes were emergency department (ED) visits, hospitalizations because of toxicity, and adherence rate. OCMP patients had significantly lower overall incidence of AE of any grade (58.9% v 70.3%; 95% CI, 0.39 to 0.94; P = .03). OCMP implementation significantly lowered incidence of any grade and grade 3-4 nausea, vomiting, and/or diarrhea, and grade 3-4 hand-foot syndrome. It resulted in the decreased number of ED visits (8.9% v 18.9%; P = .005) and hospitalizations (6.3% v 17.1%; P = .002), as well as improved medication adherence rates (0.94 v 0.97; P = .03). Most patients who developed capecitabine-related AE required intervention by OCMP. Implementation of OCMP reduced the incidence of high-grade AE, decreased the number of ED visits and hospitalizations because of AE, and improved the medication adherence rate.

Enabling sustained communication with patients for safe and effective management of oral chemotherapy: A longitudinal ethnography.

To examine how patients received, understood, and acted on healthcare professional communication about their oral chemotherapeutic regimen throughout their treatment. A longitudinal ethnographic study. Over 60hr of observational data were recorded, in the form of field notes and audio-recordings from interactions among nine oncology doctors, six oncology nurses, eight patients, and 11 family members over a period of 6months in outpatient departments in one hospital in Northern Ireland. Sixteen semi-structured interviews with patients and three focus groups with healthcare professionals were also carried out. This study took place from October 2013-June 2016. Data were thematically analysed. Three themes where identified from the data. These were initiating concordance through first communication about oral chemotherapy; which focused on initial communication during oncology consultations about oral chemotherapy, sustained communication of managing chemotherapy side effects; which was about how communication processes supported timely and effective side effect management and un-sustained communication of oral chemotherapy medication-taking practice; when patients and healthcare professionals failed to communicate effectively about chemotherapy medication-taking. The two most important factors in ensuring the optimal management of oral chemotherapeutic medicines are early recognition and appropriate response to side effects and the maintenance of safe and effective medication administration. This study found that oncology doctors and nurses engaged in sustained communication about the side effects of chemotherapy but did not focus their communication on safe administration after the first consultation. Based on this evidence, we recommend that healthcare professionals who provide oral chemotherapy for home administration should review their processes and procedures. Healthcare professionals need to ensure that they embed frequent communication for the duration of treatment between themselves and patients, including open discussion and advice, about side effects and medication administration.

Assessment of scheduled pharmacy follow-up for patients receiving oral chemotherapy.

151 Background: Management of oral chemotherapy presents many challenges to oncology practitioners. The purpose of this study is to describe how incorporation of pharmacy scheduled calls to oncology patients receiving oral chemotherapy can identify patients who are experiencing moderate-to-severe symptom burden and/or medication non-adherence and require a therapeutic intervention. Methods: We utilized multiple resources from a statewide quality collaborative aimed at the management of patients receiving oral chemotherapy including patient education, a patient reported outcome (PRO) assessment, and templated documentation. As part of our planned workflow enhancements, our pharmacist provided patient education before chemotherapy started and regularly called patients within 2 weeks of starting their oral therapy. The pharmacist asked the patient about symptoms and adherence using the PRO assessment. A chart audit was performed to summarize the patient reports and recorded interventions. Results: 203 patients taking oral chemotherapy were called by the pharmacist in an 18-month time period between 10/1/16 - 3/28/18. In this study, we will summarize patient demographic information including age, gender, diagnosis, oral chemotherapy medication; PRO assessment results including symptom burden based on the Edmonton Symptom Assessment Scale (ESAS), most bothersome symptom, confidence to self-manage, medication adherence, and reasons for non-adherence, and pharmacist interventions and consequential treatment modifications. Conclusions: Patients taking oral chemotherapy for the treatment of cancer are at risk of side effects from their treatment and suboptimal therapeutic benefits in the setting of non-adherence. Our analysis will summarize the degree of symptom burden patients experience in the first couple weeks of treatment and areas were a pharmacist may optimize their medication regimen prior to their scheduled follow-up with their oncologist. We plan to use this data to improve patient self-management support.

Developing a standardized process for oral chemotherapy management for neuro-oncology.

258 Background: Oral chemotherapies (OC) have transformed cancer care for millions of patients. While this has improved the patient experience, it presents significant challenges to safety of prescription, administration and side effect monitoring. While there are guidelines for documentation, there is not a best practices system for managing OC. This project identified areas of latent errors and implemented a standardized process for OC management. Methods: After review of the literature, we developed a process map for OC prescriptions at our institution. We then compared processes at three other neuro oncology clinics. We completed a hazard analysis and implemented several changes (see table). We identified binary measures in the medical record for every OC prescription that related to the process changes. Chart review of the 6 months prior to process change was used to create a baseline process mean for each variable. These same variables were monitored every 2 weeks after process change implementation using run charts. Successful process shift was defined as 7 consecutive 2-week averages that were continually on one side of the baseline process mean. Results: 5 months after process change was implemented, we had successfully reduced refills for OC and increased documentation of dose and dose calculation. There is a trend towards improvement in independently verified dose calculation and dedicated chemotherapy teaching visits, however these have not yet reached criteria for process change. Conclusions: This project used published studies, multi-institutional process mapping and hazard analysis to develop and implement a standardize process for OC. This process can be implemented for OC management in other oncology practices. [Table: see text]

Implementation of oral chemotherapy management program in the large integrated health care system and its impact on patient safety.

279 Background: Oral chemotherapy is a progressively growing portion of antineoplastic agents. Although convenient for the patient, it creates a unique challenges for the drug complacency and safety. To address these issues variety of programs and solutions were proposed, ranging from the smart pill bottles and mobile phone applications to telemedicine monitoring programs. This presentation describes development and implementation of the integrated monitoring program within a large health care system and assess impact of this program on patients safety and compliance. Methods: This is a retrospective, quasi-experimental study that compared outcomes of the patients treated with capecitabine, before and after implementation of OCMP (Oral Chemotherapy Management Program) in the Henry Ford Health System. The primary outcome was incidence of all grade and specifically grade 3-4 toxicities commonly associated with capecitabine. Secondary outcomes included emergency department (ED) visits and hospitalizations due to toxicity, adherence rates, and number of clinical interventions. Results: The incidence of adverse effects of Any Grade was significantly lower in the post-OCMP group compared to pre-OCMP group (70.3% vs 58.9%; 95% CI, 0.39-0.94; P = 0.03). All grade and grade 3-4 nausea, vomiting and diarrhea along with grade 3-4 hand-foot syndrome were significantly lower in the post-OCMP group, as well as decreased ED visits (18.9% vs. 8.6%; P = 0.005) and hospitalizations due to toxicities (17.1% vs. 6.3%; P = 0.002). The study also found higher adherence rates in the post-OCMP group. In the post-OCMP period, more than 50% of the patients required clinical interventions by OCMP nurse, mostly for side effect management. Conclusions: Administration of capecitabine on OCMP reduced rate of higher grade adverse events, most likely due to early intervention. OCMP implementation was associated with decreased rate of ED visits and hospitalizations due to the side effects. Patients who were managed by OCMP had higher adherence rates to the prescribed oral chemotherapy.

Optimization of oral chemotherapy in outpatient clinics in Spain: results from a survey of the Spanish Society of Medical Oncology (SEOM).

To determine the current management of oral and intravenous chemotherapy (OC and IVC) in outpatient clinics of Oncology Departments in Spain to detect opportunities for improvement. The Spanish Society of Medical Oncology designed a questionnaire specifically for Heads of Oncology Department: 142 were invited and 52 responded. In most centers, the waiting time (69.7%) and time at the outpatient clinic (84.8%) was shorter for patients receiving OC compared to those receiving IVC. The time spent at the outpatient clinic by the patients having OC was approximately 30min (88.5%). In addition, the time expended by the oncologist with each patient was shorter when they were treated with OC in 21.2% of cases. Patients' waiting times and individual dedication of oncologists might be reduced by administering OC, and general management might be improved. This should be considered when planning therapies if OC is an option.

Improved Adherence Rates and Clinical Outcomes of an Integrated, Closed-Loop, Pharmacist-Led Oral Chemotherapy Management Program.

To address the growing use of oral anticancer therapy, an integrated, closed-loop, pharmacist-led oral chemotherapy management program was created within an academic medical center. An integrated, closed-loop, pharmacy-led oral chemotherapy management program was established. From September 2014 until June 2015, demographic information, rates of adherence, patient understanding of treatment, pharmacist interventions, patient and provider satisfaction, and molecular response rates in patients with chronic myeloid leukemia (CML) were collected. After full implementation, 107 patients were enrolled in our oral chemotherapy management program from September 2014 until June 2015. All patients were educated before starting oral chemotherapy, and using pre- and postassessment tests, comprehension of oral chemotherapy treatment increased from 43% to 95%. Patient-reported adherence was 86% and 94.7% for the GI/breast and malignant hematology patient populations, respectively, and these were validated with medication possession ratio, revealing adherence rates of 85% and 93.9% for the GI/breast and malignant hematology patient populations, respectively. A total of 350 encounters with a clinical pharmacist and 318 adverse effects were reported, which led to 235 interventions. This program led to a higher major molecular response rate (83%) in our CML population compared with published clinical trials (average major molecular response rates, 40% and 60% with 1- and 2-year follow-up, respectively). An innovative model was developed and resulted in improved patient knowledge regarding oral chemotherapy, improved adherence rates that exceeded nationally established thresholds, and superior major molecular response outcomes for patients with CML compared with published literature. As a result, this model has produced the gold standard in managing patients receiving oral chemotherapy.

Impact on treatment adherence, side effects control, patients QoL, and rehospitalization rate through new management of oral chemotherapy.

e18533Background: In our oncology department, serving an under-privileged suburban area north-east of Paris, the patient’s population treated with oral chemotherapy increased steadily during the la...

Practice model: Establishing and running an oral chemotherapy management clinic

Oral anticancer agents, while potentially more convenient and better tolerated than traditional intravenous therapy, come with significant concerns of noncompliance, adverse effects, and high cost. This presents an opportunity for health-care practitioners to develop a method to educate and support patients who are placed on these agents. To provide a detailed example of a currently established oral chemotherapy clinic and provide direction toward setting up a new clinic at other institutions. A description of the establishment of the clinic, how it is run and examples of interventions are provided. Establishment of an oral chemotherapy clinic run by supportive oncology practitioners is feasible and may provide added value to existing oncology care. It can also provide an opportunity to further involve health-care trainees in patient care.

Utilizing patient reported outcomes for patients recieving oral chemotherapy.

190 Background: Management of oral chemotherapy presents many challenges to oncology practitioners. The purpose of this study is to describe how incorporation of patient reported outcomes (PRO) for patients receiving oral chemotherapy can identify those patients who are experiencing moderate to severe symptom burden and nonadherence. Methods: As part of a statewide quality collaborative, we wished to improve our monitoring of patients receiving oral chemotherapy. The quality collaborative created a PRO assessment that includes a revised Edmonton Symptom Assessment Scale (ESAS), a single-item adherence question, reasons for nonadherence, the patient’s most bothersome symptom and questions related to patient confidence. Our medical assistants provide the assessment to the patient before each appointment. Results: Patients completing the PRO during the first 3 months (7/7/16 – 9/27/16) were evaluated. We had 32 assessments completed by 23 patients. The oral chemotherapy prescribed were capecitabine (48%), erlotinib (13%), temozolomide (13%), and not recorded (26%). Of the 29 completed ESAS assessments, 72% included at least 1 moderate side effect, and 48% included at least 1 severe side effect. 29% of patients reported low-moderate confidence to self-manage their symptoms. Less than excellent adherence (&lt;80% adherence) was reported in 30% of patients with the most commonly reported reason being related to side effects or concerns about side effects. Conclusions: Use of PROs in our oral chemotherapy population identified a large proportion of patients experiencing moderate to severe side effects. Further assessment of how this compares to what patients report to their oncologist during their visits will be reviewed. In addition, we found that approximately 30% of our patients are nonadherent to their oral chemotherapy. This is consistent with recent publications. We plan to continue assessing patient outcomes and utilizing the data we collect to improve patient self-management support.

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology

To update the American Society of Clinical Oncology (ASCO)/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards.

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

Building a new process: Nursing verification of pediatric oral chemotherapy.

199 Background: While team-based safety checks ensure safe prescribing of parenteral chemotherapy, oral chemotherapy is usually prescribed by a single clinician. With the growing use of oral chemotherapy, processes are needed to protect these vulnerable patients from prescription errors. Methods: A team of nurses, clinicians, pharmacists and administrators developed a new process and checklist for nursing verification of oral chemotherapy prescriptions at Dana-Farber’s pediatric neuro-oncology program. Prescriptions are verified against the treatment plan by two pediatric oncology nurses. The verification checklist includes drug, dose with any modifications, height and weight, laboratory values and patient instructions. When available, the prescription bottle is also verified. Data was collected over a three-month pilot period. Results: From 6/18/15-9/16/15, 56 prescription verifications occurred. Verification rate of on-site retail pharmacy filled prescriptions was 47% (32/68 prescriptions). Median time for verification was 20 minutes (IQR 15, 40) per nurse. Nurses identified problems outside of prescription verification, including missing prior authorizations and unclear treatment plans. Medication bottles were not routinely available for verification. One identified near miss would have resulted in an 80% under-dose of everolimus. Conclusions: Prescription verification by nursing in a pediatric oncology clinic was feasible. While it was successful in identification of one medication error before it reached the patient, only 47% of prescriptions were verified. Since prescription bottles are usually obtained after a visit, verification of the actual bottles will require new workflows, such as additional clinic visits or uploading a picture via the patient portal. Involving the nurse in the review of oral chemotherapy not only identified a prescription error, but also highlighted issues within other aspects of patients’ care, including inconsistent documentation of the treatment plan. The inclusion of nursing in the review and management of oral chemotherapy has the potential to improve safety and outcomes for these patients.

Development of a mobile application (app) for improving symptoms and adherence to oral chemotherapy in patients with cancer.

189 Background: An advantage of oral chemotherapy is ease of administration, yet patients and family caregivers receive less support for adherence and monitoring of side effects. Effective interventions should support adherence to oral chemotherapy. We conducted qualitative interviews with patients, clinicians, and relevant stakeholders to inform the development of a proposed mobile app intervention to improve adherence and symptoms to oral chemotherapy. Methods: We conducted qualitative interviews and focus groups with multiple stakeholder groups (18 oncology physicians, 8 healthcare representatives, 8 cancer practice administrators, 18 patients and family members). Eligible patients had a diagnosis of cancer, a prescription for oral chemotherapy, cancer care at the MGH Cancer Center, and access to a smart phone. Stakeholders and clinicians evaluated the study approach, patient engagement, and intervention implementation. Patients reviewed wireframes of the mobile app to evaluate the components, usability, feasibility, and acceptability. Results: The app features include a treatment plan, medication reminders, symptom reporting, and cancer-specific resources. The themes from the qualitative interviews suggest that this mobile app would be helpful in improving adherence to oral chemotherapy and symptom management. Patients reported the wireframes to be acceptable and potentially user-friendly. Clinicians found that ongoing symptom reports would be helpful for proactively managing patients’ symptoms. Stakeholders recognized the importance of an app with functional tools to aid adherence and symptom management. All parties agreed that app features should remain simple, avoid undue burden, and thus enhance usability. Conclusions: Our findings suggest that a mobile app could be helpful for adherence and improving symptoms to oral chemotherapy in patients with cancer. Patients and clinicians rated the wireframe content favorably and commended the different features. We refined and finalized the mobile app based on feedback from the qualitative interviews. These findings support our plan to test the efficacy of this intervention in a randomized controlled trial. Clinical trial information: NCT02157519.

Establishing an international baseline for medication safety in oncology: Findings from the 2012 ISMP International Medication Safety Self Assessment® for Oncology.

In 2012, the Institute for Safe Medication Practices (ISMP) and the Institute for Safe Medication Practices Canada (ISMP Canada) collaborated with an international panel of oncology practitioners to develop the ISMP International Medication Safety Self Assessment® for Oncology. This self-assessment was designed to assist oncology practitioners in hospitals, ambulatory care centers, and office practice settings throughout the world to evaluate safe practices related to medication use in the oncology setting and to identify opportunities for improvement. The self-assessment consists of 175 items organized into 10 key elements subdivided into 18 core characteristics of safe medication use. Assessment results were submitted via a secure online portal. The online program allows participants to print and graph their results and to compare their findings with those of similar organizations both nationally and internationally. Complimentary access to the self-assessment was made available for a seven-month "snapshot" period in 2012. A total of 352 organizations from 13 countries submitted assessment results. Key opportunities for improvement were identified in five areas: implementation of the World Health Organization recommendations for management of vinCRIStine and other vinca alkaloids, safe management of oral chemotherapy, labeling of distal ends of intravenous tubing, implementation of technology-based safeguards, and patient education. This international snapshot provides important data about the level of implementation of system-based safeguards in oncology practice, key improvement opportunities, and represents a baseline for future improvement efforts. A collaborative approach to identifying vulnerabilities and developing solutions for safe medication use in oncology will enhance the care of patients with cancer internationally.