Oral Antineoplastics Research Articles

Reducing 30% of waiting time in the administration of antineoplastic oral drugs in patients with urological cancer.

325 Background: In order to reduce waiting time in the administration of oral antineoplastics we participated in ASCO/ECO QTP. We propose the creation of an oncology nursing office, trained to evaluate and administer oral antineoplastic medication. Methods: The waiting times of patients diagnosed with urological cancer and receiving treatment with oral antineoplastic drugs are collected, between their arrival at the hospital and the drug’s dispensation. Waiting times are calculated using a prospective qualitative analysis and we represent the data using SPC graphs such as R-Charts, process maps, Pareto and cause-effect diagram, objectifying, the longest waiting time between the oncology consultation appointment and the entrance to consultation. An oncology nursing consultation, with protocols based on checklists (where the most frequent adverse effects are collected, blood pressure is measured and the corresponding analytical parameters are assessed) is created to facilitate the job and train nursing for the administration of drugs. Subsequently, the waiting times are analyzed again, after the implementation of the nursing consultation and a month after it. Results: Along a period of 6 months (time from when we started the ASCO/ECO QTP course, until we implemented the medical oncology consultation), we have reduced the median time between the patient's appointment to the drug dispensation, from 35 minutes to 5 minutes, approximately a reduction higher than the 80%. One month after the implementation of the nursing consultation, waiting times are analyzed again, and the improvement is maintained. Conclusions: The creation of a specific nursing consultation has made possible to reduce waiting times in the administration of oral antineoplastic drugs, reducing the waiting list and managing to quote 3 more patients each day in medical oncology consultation.

Clinical pharmacist prescription review and modification for oral antineoplastic medications at an academic medical center.

64 Background: Collaboration between oncology providers and pharmacy teams has improved the safety of oral antineoplastic (OA) prescribing, but opportunities remain for improvements in care delivery. To this end, starting in March 1, 2021, the Dana Farber Cancer Institute Specialty Pharmacy implemented a new workflow - clinical verification of new specialty prescriptions by dedicated OA clinical pharmacists (OAPs) prior to prescription processing. To reduce the impact of initial prescription errors on efficiency and safety, one component of clinical verification was to expand the purview of OAPs to make certain modifications to prescriptions that could be automatically processed without requiring prescriber re-signing. Automatically processed prescription modifications include corrections to quantity or days supply, indication of cycle length or days on/off therapy, and clarification of directions. Here we report on the impact of this portion of the clinical verification program. Methods: OAP prescription modification (OAP-PM) was introduced on November 1, 2022. To assess the impact on efficiency, we conducted a pre-post analysis of the proportion of prescription modifications taking > 60 minutes to complete for 6 months before and after OAP-PM introduction. Using prescription-level data, we analyzed co-variates including pre-/post-OAP-PM, patient age (continuous), site (academic vs. network), communication with someone other than the primary prescriber (y/n), and medication category (anti-neoplastic vs. supportive). We used control charts to explore the contribution of specific medications and sites that might share best practices or be the focus of subsequent, more focused improvement projects. Results: From May 1, 2022 to May 1, 2023, 458 prescription modifications were completed, 180 pre- and 278 post-OAP-PM. The proportion of prescriptions requiring > 60 minutes to complete decreased from 29.4% to 19.8% (p = 0.0184). In multivariable regression, the significant predictors of prescription taking > 60 minutes to complete were pre-OAP-PM (LR 4.9, p = 0.027); network (LR 20.8, p < 0.0001); and communication with someone other than the primary provider (LR 18.6, p < 0.0010). Control charts demonstrated all sites were within 3-sigma limits pre- and post-OAP-PM, but with wide limits at many sites. Individual medications could not be meaningfully analyzed due to the small sample sizes. Conclusions: OAP-PM successfully reduced the proportion of OA prescriptions taking more than an hour to modify. This may be a useful workflow change for other specialty pharmacies to adopt to improve the efficiency of OA care. Additional work is needed to understand whether site-, provider- or medication-specific changes can improve upon this model.

Evolution of cancer treatment costs in the last 36 months in a self-funded health care in Brazil.

e18838 Background: In Brazil, cancer, in addition to being one of the main causes of illness and death, represents one of the highest public and private healthcare expenses. Regardless of the population profile, the direct costs of cancer pose as a real threat to the health system's sustainability. The objective of this study is to analyze the evolution of the use and costs of chemotherapy, targeted therapy, hormone therapy and immunotherapy. Methods: Retrospective cohort consisted of all health plan beneficiaries diagnosed with cancer and who received pharmacological treatment in the last 36 months (September/2019 to August/2022). Based on Period 1 (P1, Sep/2019 to Aug/2020), we analyzed the evolution in the other periods (P2 and P3, Sep/2020 to Aug/2021 and Sep/2021 to Aug/2022, respectively) of the use of chemotherapy and the costs involved (per capita and per patient treated). We also analyzed the evolution of expenses with oral antineoplastic agents and their proportion in relation to other routes of administration. The most prescribed therapies were analyzed. Microsoft Excel and Qlik Sense were used for relative and absolute frequencies, means and standard deviation (95% confidence intervals, significance when p < 0.05). Results: During the study period, 982 beneficiaries (683, 601 and 572, respectively in P1, P2 and P3) underwent treatment with antineoplastic agents (mean age 68 years, 50.7% women). In P1, 1.6% of the total exposed received some type of chemotherapy. In the following intervals, the percentage increased to 1.7% and 2.1%, P2 and P3, respectively. Although the cost per patient treated increased by 4.7% in 36 months, the annual expense per patient, that is, the entire portfolio of the plan and not just those diagnosed with cancer, increased by 40.5%. Should be noted that the variation that occurred in P2 in relation to P1 was 7.8%, however, in P3 compared to P2, 30.3%. The proportion of patients receiving oral antineoplastics in relation to those treated remained stable (53.6%, 54.7% and 52.3%, P1, P2 and P3, respectively). Ten active principles with the highest financial consumption and corresponding to more than half of the total expenses: nivolumab, daratumumab, bevacizumab, trastuzumab, pembrolizumab, pertuzumab, enzalutamide, atezolizumab, paclitaxel and brentuximab vedotin. Conclusions: Molecular and immunological therapies have revolutionized cancer treatment and improved patient outcomes and survival, however, new treatment options represent an additional challenge. In this study, the cost of cancer treatment has increased 40.5%, especially in the last period, which coincides with the expansion of the list of mandatory coverages and due to the resumption of procedures after COVID-19. Minimizing the financial impact of the new technologies, through responsible management focused on the patient and based on the best scientific evidence, is fundamental for maintaining the sustainability.

HSD33 Medical Costs, Hospitalizations, and Length of Stay Associated with Discontinuations in Cycled Oral Antineoplastics Among Medicare-Eligible Oncology Patients

Investigate the utilization of cycled antineoplastic therapies (where dosages vary per monthly supply) for various cancers among Medicare-eligible patients, and medical costs and outcomes associated with discontinuation gaps in monthly adherence.

Adherencia y calidad de vida en los pacientes con leucemia linfocítica crónica tratados con antineoplásicos orales

ObjectiveTo evaluate adherence and quality of life to oral antineoplastic treatment in patients with chronic lymphocytic leukemia. To compare adherence and QoL according to treatment subgroups and treatment-line subgroups. MethodsWe conducted a descriptive prospective study from June to November 2021 in a tertiary care hospital. Patients treated at the Oncology Pharmacy with a diagnosis of chronic lymphocytic leukemia and treatment with oral antineoplastics for at least 6 months before inclusion in the study were included. Adherence was assessed using Morisky’s 8 item Medication Adherence Scale and leftover pills counts, considering adherents if their adherence rate was ≥ 90%. Quality of life was assessed with Euro-Qol EQ-5D-3L questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue scale and QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer. Two interviews were scheduled: at the time of inclusion and at 3 months. Variable collected: demographic data, clinical data (disease and treatment); and response (scores obtained from questionnaires and adherence rate). The data statistical analysis was carried out with SPSS® 25.0 software. ResultsTwenty three patients were included, all of them showed an adherence rate higher than 90%; 20 patients were considered high adherent, and 3 patients medium adherent to treatment according to Morisky’s 8 item Medication Adherence Scale. The results of the EQ-5D-3L questionnaire showed that the patients were all of them autonomous in their personal care and daily activities, 69.6% did not have any mobility problems and 78.3% did not have anxiety/depression; 56.5% had some type of pain. Eighteen patients had no fatigue, and 5 had mild/moderate fatigue according to Functional Assessment of Chronic Illness Therapy – Fatigue scale. The results of the EORTC QLQ-C30 questionnaire showed that patients had a high /healthy functional level, a good quality of life and a low level of symptoms. Analysis by treatment subgroups and by treatment-line subgroups did not show statistically significant differences in adherence or quality of life. ConclusionsPatients diagnosed with chronic lymphocytic leukemia and treated with oral antineoplastic therapies showed a high adherence rate and referred a good quality of life.

Oral Antineoplastics in Acute Myeloid Leukemia: A Comprehensive Review.

AML is a biologically and clinically heterogeneous disease that is associated with poor overall long-term survival. The expanding knowledge of genomic landscape in AML as well as advancements in molecular and chemical biology over the pathway in AML. After 40 years of stagnancy, the recent approval of numerous novel oral anti-leukemic agents for the treatment of AML has changed both the armamentarium of medications and treatment paradigms. These agents have unique clinical considerations in terms of administration, adverse effects, and monitoring parameters which may differ from clinician's historical expectations. Understanding the data, indication and clinical considerations for such novel oral anti-leukemic agents is paramount for clinicians caring patients with AML.

Creation of standard work for the management of outpatient oral antineoplastic therapy.

369 Background: Recently, there has been a dramatic increase in the use of oral antineoplastics for the treatment of various malignancies. The development of these agents has been so rapid that the infrastructure needed for their appropriate supervision has trailed their availability. Previously at Virginia Mason, there was no standard work established for the management of patients starting these agents and consequently there were defects noted, including delays in the medications’ delivery to the patient, lack of appropriate teaching regarding potential medication toxicities and even delayed provider follow-up. The goal of this project was to create standard work around the treatment initiation and follow-up of all patients starting outpatient oral antineoplastic therapy. Methods: A multi-disciplinary team of providers, nurses, and pharmacists held a flow mapping session to identify defects and waste points in the process between the prescription being written until the first provider follow-up visit after medication delivery. The team focused on decreasing the amount of time between prescription initiation and first clinic follow up, as well as increasing the percentage of RN teaching sessions performed and documented. This involved the creation of a dedicated inbox in the Electronic Medical Record (EMR) to which pharmacy and care manager nurses had exclusive access to facilitate rapid communication between team members. The work also resulted in the creation of an antineoplastics teaching template which was used to document teaching on potential treatment toxicities. Results: Standard work was created for the outpatient oral antineoplastic administration process and teaching documentation. Using the new tools, lead time was improved by 21.7% and teaching documentation was improved by 185% at the 30-day mark. These metrics were monitored over a 3 month period, and at the end of 90 days the lead time improvement was maintained at 21.2% and teaching documentation improvement at 110% (Table). Conclusions: The rapid development of oral antineoplastic medications has required Oncology practices to develop more robust workflow infrastructure to administer these medications properly and safely. We created standard work for the proper initiation and follow-up of oral antineoplastic therapy. In doing so we identified specific defects and instances of waste and were able to improve the workflow process to address these issues, resulting in measurable quality improvements and overall better patient care.[Table: see text]

P71 Inpatient and Outpatient Medical Costs, Hospitalizations, and Length of Stay Associated with Adherence to Non-cycled Oral Antineoplastics Among Oncology Patients

10.1016/j.jaip.2021.12.026Increasing utilization of non-cycled antineoplastic therapies for a variety of cancers has generated interest in applying a proportion of days covered (PDC) adherence metric, and examining costs and health outcomes associated with adherent PDC (≥80%).

Oral microbiome and systemic antineoplastics in cancer treatment: A systematic review.

Background Oral mucositis is one of the most common side effects in cancer patients receiving systemic antineoplastics. However, the underlying biological mechanisms leading to this condition are still unclear. For this reason, it has been hypothesised that systemic antineoplastics may cause an imbalance on the oral microbiota that subsequently triggers oral mucosa damage.Material and Methods A systematic review was performed following the PRISMA protocol and the PICO question established was: patients diagnosed with cancer, who are candidates for receiving systemic antineoplastics (P=Patients), that undergo oral microbiome determinations (I=Intervention), before and after systemic antineoplastics administration (C=Comparison), to analyse changes in the oral microbiome composition (O=Outcome). The bibliographic search was carried out in PubMed and other scientific repositories.Results Out of 166 obtained articles, only 5 met eligibility criteria. Acute myeloid leukaemia (AML) was the most frequent type of cancer (40 %) among the participants. Only one of the studies included a control group of healthy subjects. Heterogeneity in the protocols and approaches of the included studies hindered a detailed comparison of the outcomes. However, it was stated that a decrease in bacteria α diversity is often associated with oral mucositis. On the other hand, fungal diversity was not associated with oral mucositis although α diversity was lower at baseline on patients developing oral candidiasis.Conclusions There is insufficient scientific evidence of oral microbiological changes in patients undergoing systemic antineoplastics. Further investigations ought to be carried out to identify microorganisms that might play a key role in the pathogenesis of oral mucosa damage in patients undergoing systemic antineoplastics. Key words:Stomatitis, antineoplastic agents, neoplasms, microbiota, immunotherapy.

Oral Antineoplastics: Treatment Adherence and Medication Beliefs

Introduction: Adherence to oral antineoplastics (OA) is an important indicator of therapeutic response related to personal, social, and structural factors. Objective: To determine rates of adherence to OA, investigating possible risk factors for nonadherence and to assess patient beliefs about medication, identifying opportunities for pharmaceutical intervention. Method: An analytical study was conducted with cancer patients using OA in 2015. Adherence to Refills and Medication Scale (ARMS) and Beliefs about Medicines Questionnaire (BMQ) were applied to assess adherence and beliefs about medication and treatment. Mann-Whitney, Chi-square, and Fisher’s Exact tests were used for data analysis. Results: A total of 222 patients were interviewed, with a 92.8% adherence rate according to ARMS and 84.7% according to BMQ, in which the necessity-beliefs exceeded the concerns with the treatment and use of OA. Family income, treatment interruption, number and causes of interruptions, depression, and medication possession ratio were the risk factors identified. Comparison of BMQ domains showed that, in the adherent group, patient beliefs in the necessity of the medication exceeded their concerns about it. Conclusion: Understanding the patient’s beliefs is a decisive factor in comprehending the risks related to nonadherence as well as in defining strategies to deal with it.

Impact of an Oral Antineoplastic Renewal Clinic on Medication Possession Ratio and Cost-Savings.

The primary objective of this study was to evaluate the impact of a pharmacist-driven oral antineoplastic (OAN) renewal clinic on medication adherence and cost savings. This was a preimplementation and postimplementation retrospective cohort evaluation within a single US Department of Veterans Affairs health care system following implementation of a pharmacist-managed OAN refill clinic. The primary outcome was medication adherence defined as the median medication possession ratio (MPR) before and after implementation of the clinic. Secondary outcomes included the proportion of patients who were adherent from pre- to postimplementation and estimated cost-savings of this clinic. Patients were eligible for inclusion if they had received at least 2 prescriptions of the most commonly prescribed oral antineoplastic agents at the institution between September 1, 2013 and January 31, 2015. Of preimplementation patients, 96 of 99 (96.9%) were male and all patients (n = 35) in the postimplementation group were male. The mean age of the preimplementation group was 69.2 years while the postimplementation group was 68.4 years. Median MPR in the preimplementation group was 0.94, compared with 1.06 in the postimplementation group (P < .001). Thirty-six (36.7%) patients in the preimplementation group were considered nonadherent to their OAN regimen compared with zero patients in the postimplementation group. Estimated total cost savings was $36,335 in the postimplementation period. Implementation of a pharmacist-driven OAN renewal clinic was associated with a 12% increase in median MPR while saving an estimated $36,335 during the 5-month postimplementation period.

Sensitivity and specificity of drug interaction databases to detect interactions with recently approved oral antineoplastics.

Drug-drug interactions (DDIs) with oral antineoplastics (OAs) are of increasing concern given the rapid increase in OA approvals and use in cancer patients. A small pilot study of 20 DDIs with OAs showed significant variability in commonly used DDI screening databases in sensitivity of detecting potentially clinically relevant DDIs. This study builds upon that work by expanding the number of potential DDIs analyzed and including a specificity analysis. Newly approved OAs from 2016 to May 2019 (n = 22) were included in this analysis. Prescribing information for each drug was reviewed. A list of explicit and theoretical drug interactions was created for each OA by the two investigators. A board-certified oncology pharmacist adjudicated all DDI pairs for potential clinical significance. In total, 229 DDI pairs were used to analyze sensitivity of 5 DDI databases (Lexicomp®, Micromedex®, Medscape, Eporactes®, & Drugs.com). Additionally, 64 "dummy" or false DDI pairs were created to analyze specificity. Sensitivity and specific were analyzed using Cochran's Qtest, while accuracy was analyzed using chi-square test. There was significant variability among the databases with regards to sensitivity (p < 0.0001), specificity (p < 0.0001), and accuracy (p < 0.0001). In terms of accuracy (max score = 400), Lexicomp®(355), Epocrates® (344), and Drugs.com (352) scored higher than MicroMedex® (270) and Medscape (280). Considerable variability exists among DDI screening databases with regards to OAs and potential drug interactions. Clinicians should be vigilant in both screening for DDIs with OAs and describing DDIs encountered in clinical practice.

Kanser hastalarının oral antineoplastik ilaç kullanımına ilişkin bilgi ve uygulamaları

Aim: Study was conducted as descriptive to evaluate information and practice about oral antineoplastics drug used of cancer patients.Material and Methods: There research sample consists of 100 people who use oral antineoplastic drugs in Ankara Numune and Ankara Yıldırım Beyazıt Education and Research Hospital Oncology wards. Patient conversation form and evaluation of dring information form, which was developed by the investigator according to literature, was used as a data obtaining an instrument. In the evaluation of data percentage and chi-square tests was used. Results: Average age of the person that participates in surveying is 51.5±7,1. We observed that 48% of participants use capecitabine as oral antineoplastic, and 51% of participants have cure number between 0-3. 93% of participant sex pres that they informed about medicine by the doctor when prescribed, and 50% by the nurse at the outpatient clinic. It is observed71% of participant stake medicine not in time. As the reason for this case, forget fullness is on the top with a 51% rate. It is observed male more successful than female for taking medicine in time (p&amp;lt;0.05) and the rate of taking medicine in time is increasing with education level (p&amp;lt;0.05). Besides, we observed that the rate of taking medicine in time is lower for participants that informed verbally than informed verbal and written.Conclusion: This study suggests that individuals have a low educational level successful in drug-taking at the same hour and the long period of drug-taking decrease this success. Female take assistance drug use more than male and taking assistance increases while the educational level decrease in both genders.

Factors associated with adherence to follow-up calls in cancer patients receiving care at a community oncology practice.

BackgroundFollow-up calls in the oncology setting are frequently used to augment care and encourage oral antineoplastic adherence. However, limited data are available on patient populations that would benefit from this intervention versus populations that may require alternative interventions. The purpose of this study was to identify characteristics among patients on oral antineoplastic agents that influence their likelihood to respond to follow-up calls.MethodsPatients receiving care from one of the eight community oncology clinics within the same branch were analyzed. Patients were included if they were ≥18 years, received a new oral antineoplastic agent that was electronically prescribed between August 2018–October 2018, and picked up their first fill from their pharmacy of choice. Patients received up to six follow-up calls after picking up their first prescription. Calls were categorized as adherent (≥3 monthly interactions) or non-adherent (<3 monthly interactions). Logistic regression models were used to evaluate factors associated with follow-up call adherence. Factors included demographics, cancer stage, marital status, employment, pharmacy setting (internal pharmacy versus external pharmacy), and insurance used by the patient. Descriptive analysis was performed to analyze response rates, cancer diagnosis, and to determine the best time and day patients responded to follow-up calls.ResultsData from 125 patients were analyzed, of which 65 patients (52%) were adherent to follow-up calls and the mean response rate over six months was 45% (range: 35% -- 54%). High success rates for follow-up calls were seen between 12–3 pm and on Tuesdays and Thursdays. After adjusting for covariates, patients with stage III-IV were 89% less likely to respond to follow-up calls compared to those with stage 0-II (95% CI: 0.02–0.64; p = 0.01), patients with commercial insurance were 79% less likely to adhere to follow-up calls compared to those on government insurance (95% CI: 0.06-0.71; p = 0.01), and patients using an external pharmacy had a 2.8 times increase odds of being adherent (95% CI 0.98-8.34; p = 0.05). All other factors were not significant.ConclusionsFor patients taking oral antineoplastics, non-adherence to follow-up calls was observed in more than 45% of patients receiving care from a community oncology clinic. Findings demonstrated that those with advanced stages of cancer, on commercial insurance, and going to an internal pharmacy were at higher risk for not adhering to follow up calls. Therefore, alternative methods for managing adherence and side effects in these populations are warranted.

Deriving real-world oral antineoplastic treatment endpoints: A comparison of automated data extraction versus manual chart abstraction.

e18070 Background: Real world data (RWD) is increasingly being used to generate evidence that informs clinical care. Calculating outcomes measures using RWD, such as time-on-treatment (ToT), requires accurate medication start/end dates. Whereas intravenously administered medication dates are typically available, dates for oral antineoplastics (OANs) are challenging as they are filled by specialty pharmacies and documented separately. To determine the feasibility of automated ToT extraction, we used the Syapse Learning Health Network to compare the utility of automated chart extraction (ACE) and of manual chart abstraction (MCA) from the electronic health record (EHR) in providing high-quality OAN data. Methods: We selected cancer patients (pts) from two histologies for whom OANs were prescribed. For these pts, ACE was compared to MCA. ACE data were derived from EHR structured medication lists through existing interoperability pipelines. MCA was performed by 4 trained data abstractors who reviewed the corresponding progress notes per pt. Expected date of OAN start/end, and actual medication start/end, were recorded as available. Chi-square and descriptive statistics were used for analysis. Results: 61 cancer pts (31 lung, 30 breast; mean age 62y [27-90]; 20% male) who received OAN from 3 multi-hospital medical systems were evaluated. ACE detected a greater number of expected start/end dates as compared to MCA (Table, P &lt; 0.001). In contrast, for actual start/end dates, the converse was true; ACE was inferior to MCA (P &lt; 0.001). Noteworthy, only 26% of pts had actual start/end dates using manual chart abstraction only. There was no concordance between the actual ACE and MCA dates. We evaluated if ACE expected ToT dates could be used as a surrogate for actual MCA ToT dates. Of the 12 pts satisfying this criteria, mean discordance in ToT was 19 days (1-71 days). Conclusions: MCA only captured actual ToT in a small minority of pts. ACE expected dates were a poor surrogate for ToT and highly discordant to over 2 months. Neither MCA nor ACE from EHR data were adequate for the majority of pts. Alternative mechanisms such as integration with additional data sources like specialty pharmacy dispensing records are essential. [Table: see text]

Do oral antineoplastic treatment data differ between Concerto Health AI Definitive Oncology EMR and Symphony Claims Data?

e18180 Background: Electronic Medical Records (EMRs) are increasingly being used for health outcomes research because they contain a rich array of clinical data. Oral medications are captured via structured medication order fields or abstracted from the clinical notes; however, it’s unknown how these correspond with dispensations. The objective of this study was to better understand how oral antineoplastic orders captured from an EMR database compare to dispensations from pharmacy claims. Methods: The Concerto Health AI Definitive Oncology Dataset is a deeply curated cohort of patients (pts) derived from a wide range of oncology practices throughout the United States. Concerto Health AI has a co-exclusive partnership with ASCO CancerLinQ &amp; collects data from multiple other sources. These data were deterministically linked to US Symphony Health’s (SH) Integrated Dataverse, an anonymized, HIPAA-compliant data set. Only advanced (stage IIIb/IV) non-small cell lung cancer (aNSCLC) pts with curated data via manual review by nurse practitioners &amp; oral antineoplastics prescribed for lung cancer were included in this analysis. Among a subset of pts that had a dispensation within 90 days of their 1st EMR order, treatment duration was calculated as time from 1st to last order/claim (before a 30-day gap) plus 30 days supply, for EMR &amp; claims, respectively. Results: Of 19,175 aNSCLC pts from Concerto, 8,864 pts were linked to SH. Among linked pts, there were 2,057 pt-drug instances; 750 (36.5%) were in both Concerto and SH, 1,160 (56.4%) in Concerto but not SH, and 147 (7.1%) in SH but not Concerto. Median time from 1st order in Concerto to 1st dispensation in SH was 16 days (interquartile range (IQR): 6, 78), with 76% of pt-drug instances having a dispensation within 90 days of 1st Concerto order. Median treatment duration was 44 (IQR: 30, 125) and 93 (IQR: 41, 241) days based on Concerto and SH, respectively. Conclusions: Concerto EMR orders identified more pts treated with oral antineoplastics, though treatment durations were longer using SH claims. Limitations of this analysis include use of orders from EMR instead of abstracted start and end dates and use of open claims with limited specialty pharmacy data. Linked datasets may provide more robust capture of orals data and warrant further research.

Recycling Discarded Drugs: Improving Access to Oral Antineoplastic Drugs.

It is common for patients to have limited access to oral antineoplastics or to discontinue treatment because of cost. Such oral treatments are also discontinued because of toxicity, disease progression, or death, resulting in unused portions of these medications. Policies for the subsequent use or destruction of unused drugs exist, but none completely address the need for methods of recycling back to the patients in need. This article addresses this wastefulness and ways to minimize it so that more patients benefit.

To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs.

There has been controversy regarding whether bioavailability of certain oral oncology drugs should be maximized by taking these medications with food, irrespective of label instructions in the dosing and administration section. To provide insight into this controversy, we conducted an in-depth analysis for oral antineoplastic drugs approved by the Food and Drug Administration in 2000-2016 and identified important issues influencing food labeling decisions. Furthermore, a case study involving sonidegib, a drug approved for locally advanced basal cell carcinoma with a significant food effect on exposure, was used to demonstrate the consequences of failure to adhere to food label recommendations using drug-specific population pharmacokinetic and exposure-toxicity models. In 2000-2009, 80% (4 out of 5) of all approved oral antineoplastics with increased bioavailability in the fed state were labeled as "take on empty stomach." In contrast, we found that in 2010-2016 there is a greater diversity in food recommendations for drugs with increased bioavailability in the fed state. Currently, many oral oncology drugs are given with food to maximize their bioavailability; however, as seen from our case study of sonidegib, failure to fully adhere to label recommendations to either take with food or not could lead to adverse consequences in terms of safety and efficacy.

Drug Interaction Database Sensitivity With Oral Antineoplastics: An Exploratory Analysis.

Drug interactions are a concern in oncology with the shift toward oral antineoplastics (OAs). Using electronic databases to screen for drug interactions with OAs is a common practice. There is little literature to guide clinicians on the reliability of these systems with OAs. The primary objective of this study was to explore the sensitivity of commonly available drug interaction databases in detecting drug interactions with OAs. A list of 20 drug interactions with OAs was developed by two Board-certified oncology pharmacists. The list included multiple types of drug interactions. The sensitivity in detecting these interactions by MicroMedex, Facts & Comparisons, Lexi-Interact, and Epocrates were evaluated. These databases were chosen based on their local availability and widespread use in practice. Drugs.com was evaluated as a surrogate for a patient-accessible drug interaction database. The Cochran Q test was used to assess the sensitivity distribution across the five groups. Lexi-Interact and Drugs.com had a sensitivity of 95% for the 20 tested drug interaction pairs. Epocrates had a sensitivity of 90%, and both Micromedex and Facts & Comparisons had a sensitivity of 70%. There was a statistically significant difference ( P = .016) in the distribution across the databases in detecting clinically significant drug interactions. Commonly used databases for identifying drug interactions with oral antineoplastics vary significantly in their sensitivity. Clinicians should not rely on a single database and should consider using multiple resources as well as sound clinical judgment. Further work is needed in this area.

Review of Experience of a Statewide Poison Control Center With Pediatric Exposures to Oral Antineoplastic Drugs in the Nonmedical Setting

The use of oral antineoplastic agents in nonmedical settings continues to increase. There are limited data available on pediatric exposures to these agents. We sought to identify characteristics of such exposures. We performed a retrospective review of database of a statewide poison system from 2000 to 2009 for all cases of pediatric exposures to oral antineoplastic agents, which took place in a nonmedical setting. Data collected include gender, age, agent of exposure, dose, drug concentration, reason for exposure, symptoms, outcomes, interventions, and length of hospital stay. There were a total of 328 patients. The mean average age was 4.1 years. Eighty-nine percentage (n = 293) was unintentional. Exposures to 21 different antineoplastic agents were identified. Methotrexate (n = 91) and 6-mercaptopurine (n = 47) were the most common agents encountered. Two hundred ninety-nine (91%) cases had no symptoms reported. When reported, gastrointestinal symptoms (n = 17) and central nervous system sedation (n = 6) were most common. One case of pancytopenia was reported. No deaths were reported in this series. Sixty-seven percent (n = 220) were managed at home, whereas 19 (6%) were admitted to a health care facility. Cases were followed by the poison control center for 0.34 days (SD = 1.40). In this study, exposures to oral antineoplastics were primarily unintentional, asymptomatic, and managed at home. Study limitations include possible reporting bias, inability to objectively confirm exposures, and limited duration of monitoring by the poison control center. In this retrospective review, no significant morbidity or mortality was reported from pediatric exposures to oral antineoplastic drugs in the nonmedical setting.