Oral Anticancer Drugs Research Articles

Environmental Outcomes of Reducing Medication Waste by Redispensing Unused Oral Anticancer Drugs

Medications are associated with substantial environmental outcomes, yet frequently end up being unused by patients. Waste-minimizing interventions, such as redispensing of quality-approved oral anticancer drugs remaining unused by patients at home, could reduce the environmental footprint of cancer treatment. To assess the environmental outcomes of redispensing quality-assured oral anticancer drugs and to explore how redispensing could be environmentally optimized. In this quality improvement study, a cradle-to-grave life cycle assessment was performed in the outpatient pharmacy of 4 Dutch hospitals, based on a prospective multicenter trial comprising 1071 patients with a clinical diagnosis of cancer and an active prescription for an oral anticancer drug stored at room temperature from February 1, 2021, to February 1, 2023, with a follow-up of 12 months per patient. Participants received prescribed oral anticancer drugs with additional quality-assurance materials (ie, seal bags and time-temperature indicators), so the pharmacy could redispense quality-assured drugs based on authenticity, appearance, remaining shelf life, and/or adequate storage. The estimated environmental outcomes avoided due to waste reduction (ie, production and transport and incineration of redispensed oral anticancer drugs) corrected for outcomes of process burdens (ie, quality assurance materials), quantified in 3 outcome measures: human health damage (disability-adjusted life-years), ecosystems damage (species × year), and climate change (kg of carbon dioxide equivalent [CO2-eq]) per patient per year. A volunteer sample of 1071 patients (median age, 70 years [IQR, 62-75 years]; 622 men [58.1%]) participated in the intervention. Redispensing oral anticancer drugs was initially associated with an environmental burden, mainly because of the high impact of time-temperature indicators. However, when quality-assurance materials were selectively used for temperature-sensitive oral anticancer drugs (ie, maximum storage temperature of 25 °C), redispensing was environmentally beneficial to human health and ecosystems, providing estimated climate benefits of 1.9 kg (95% CI, 1.4-2.6 kg) of CO2-eq per patient per year. In this quality improvement study, redispensing unused oral anticancer drugs was found to be a suitable strategy to reduce waste and improve environmental sustainability of cancer treatment after process optimization. Redispensing unused oral anticancer drugs could contribute to sustainability of cancer treatment through reduced costs and environmental outcomes.

Niosome as a drug delivery carrier for Sorafenib: Preparation, investigation of physicochemical properties, and in vitro effects on HepG2 cell line

Purpose: Sorafenib is known as one of the oral anti-cancer drugs used in liver cancer. However, its lipophilic nature can lead to side effects, variable pharmacokinetics, and poor absorption. The use of novel drug delivery systems, such as niosomes, may help address these issues and improve the effectiveness of sorafenib. Methods: Different niosomal formulations of sorafenib were prepared. The morphology, size analysis, and physical stability were investigated. The encapsulation efficiency percent of the selected formulations was measured using the dialysis method, and the release of sorafenib was checked for four hours using the Franz diffusion cell. The cytotoxicity and in vitro effect on the HepG2 cell line was investigated using the MTT assay and flow cytometry. Results: The mean volume diameter of Span 60/ Tween 60/ cholesterol (45/45/10 mole%) niosomal formulation was 6 µm with minimal size changes and good stability over six months of storage. The encapsulation efficiency percent of this formulation was 66.40±1.11, and 61.43±1.42 percent of the drug was released within four h. In vitro release followed Higuchi kinetics. Cytotoxicity tests showed an IC50 of 7.5 µg/mL for the niosomal formulation, compared to 15.96 µg/mL for the sorafenib solution. Conclusion: Niosomes containing Span 60/ Tween 60/ cholesterol (45/45/10 mole%) are promising for loading and sustained release of sorafenib. The use of niosome as a carrier can enhance the effectiveness of sorafenib on the HepG2 cell line. This niosomal formulation of sorafenib shows potential for future studies.

Pharmacist-Led Video Consultation to Identify and Mitigate Drug Interactions Among Patients Initiating Oral Anticancer Drugs.

The past decade has seen an increase in oral anticancer drug (OACD) approvals. Polypharmacy and drug-drug interactions (DDIs) likely contribute to OACD toxicity. We assessed a one-time pharmacist-led video consultation to identify DDIs. We conducted a single-arm telehealth intervention of a one-time 30-minute pharmacist-led video consultation among patients initiating OACDs. The visit focused on identifying polypharmacy and DDIs. Feasibility was defined as ≥50% completion of all study interventions. We determined the prevalence, characteristics, and severity of OACD-related potential DDIs. We also assessed the prevalence of medication list inaccuracies, polypharmacy, patient satisfaction, and patient perception of intervention acceptability, appropriateness, and feasibility. Of 58 eligible patients, 43 (74%) completed the intervention and 33 (57%) completed all evaluations. Median medication per patient was nine (range 4-21), and 98% of patients had at least five prescriptions. The median number of medication list errors was two (range 0-16), with at least one error for 76% and >1 for 52%. Pharmacists identified OACD-related interactions in 18 cases (42%), including change in drug metabolism (eight), elimination (one), and absorption (three). Interactions were classified as Lexicomp categories C (13), D (five), or X (one) requiring close monitoring or a change in treatment. All patients expressed high satisfaction with the intervention and agreed or completely agreed that it was acceptable, appropriate, and feasible. Polypharmacy, medication list errors, and DDIs are prevalent among patients initiating OACDs. A one-time remote pharmacist-led video consultation can address OACD-related DDIs, which may decrease medication complexity and improve adherence.

Efficacy on symptoms and mortality day vs. night administration of EGFR-TKIs for advanced non-small cell lung cancer.

This study has a purpose to investigate the side effects of three EGFR-TKIs targeted therapeutic agents (gefitinib, erlotinib, and afatinib) and all-cause mortality in patients with metastatic lung cancer. We performed a prospective cohort study. We selected all patients with newly diagnosed metastatic lung cancer between January and November 2019. Main exposure was daytime versus nighttime use of targeted EGFR TKIs. The study outcome was a symptom change using the mobile application, and all-cause mortality between January 2019 and March 2023. Among the 87 study participants, 35 (40%) took their medication at night. Among the 87 study participants, 35 (40%) took their medication at night. At 6weeks of treatment, acne (1.36; 95% confidence interval [CI] 1.09, 1.64; p for interaction = 0.04) and dry skin (1.35; 95% CI 1.09, 1.61, p for interaction = 0.01) in the day group showed a much increase from baseline compared to the night group. In contrast, the night group reported greater reductions in lung cancer-related symptoms from baseline compared to the day. During follow-up (median 43months), the night group had a lower risk of all-cause death than the day group, especially in younger patients (adjusted hazard ratio = 0.34; 95% CI 0.13, 0.87). The group taking EGFR-TKIs at night experienced fewer side effects and had longer overall survival compared to the day group. Clinicians should consider recommending that lung cancer patients take their once-daily oral anticancer drugs in the evening rather than the morning to improve treatment outcomes.

Barriers and facilitators to implement the redispensing of unused oral anticancer drugs in clinical care: A hybrid-effectiveness type I study

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

Impact of pharmacist managed oral epidermal growth factor receptor inhibitors.

Pharmacists are an integral part of medication management, with the positive impact of their clinical services in patient outcomes previously studied and reported in literature. The roles and responsibilities of pharmacists continue to expand, including optimizing patient medication and health outcomes related to complex oral anticancer drugs. To evaluate the impact of a pharmacist-managed oral chemotherapy clinic in patients with non-small cell lung cancer (NSCLC) taking oral epidermal growth factor receptor inhibitor (EGFRi) regimens within an integrated healthcare delivery system. This was an observational cohort study using data from Kaiser Permanente Northern and Southern California regions on adult patients who received oncology pharmacist-managed care compared to patients with usual care. Patients were newly initiated with EGFRi therapy to treat NSCLC between 2017 and 2019. The follow-up period was defined as the time from index date (first sold date of EGFRi) to December 2020 or end of membership or death, whichever occurred first. Primary outcome measures included adherence to EGFRi, frequency of imaging during drug exposure, and presence of imaging prior to treatment change. Outcomes were analyzed with Chi-square test for categorical variables, and Student's t-test or Wilcoxon rank-sum test for continuous variables. There were 613 patients in the pharmacist-managed group and 714 patients in the usual care group. Overall, the mean age was 68.2 ± 11.3 years, and 65.1% were female. In the pharmacist-managed group, there was a significantly higher mean proportion of days covered (PDC) during the first three months of therapy (0.86 ± 0.24 vs 0.82 ± 0.36, p = 0.01) and a higher percentage of patients who were adherent to EGFRi therapy (with PDC ≥0.80) during the drug exposure period (95.8% vs 92.4%, p = 0.01). The rate of computed tomography (CT) and magnetic resonance imaging (MRI) during drug exposure was higher in the pharmacist-managed group compared to the usual care group (31.8% vs 20.7%, p < 0.01) with a higher number of mean scans completed per patient (1.15 ± 2.42 vs 0.62 ± 1.63, p < 0.01) and per patient-year (2.60 ± 7.27 vs 1.58 ± 5.95, p < 0.01). Overall, 66.2% of patients had a treatment change, with a higher percentage of patients in the pharmacist-managed group who completed a CT or MRI scan prior to treatment change (36.3% vs 26.3%, p < 0.01). Additionally, the median time between the scan and treatment change was shorter for patients with pharmacist-managed care (1.8 vs 4 months, p = 0.04). Clinical pharmacy services contributed to improved adherence, higher rates of imaging, and shorter time between imaging and treatment changes in NSCLC patients who were taking EGFRi regimens.

Parents' experiences on handling paediatric anticancer drugs at home after an educational intervention.

The shift of treatment of paediatric cancer patients to include more care at home puts a lot of pressure on health care professionals (HCPs) to prepare and train parents on safe and correct drug handling at home. Parents must take in and understand the information presented to them while coping with their own fear related to their child's cancer diagnosis. In Sweden, parents are expected to handle and manipulate oral anticancer drugs (OADs) in the home setting. There is however a lack of a standardized method to inform and educate parents on how to handle OADs in a correct way at home. To describe parents' experiences of handling OADs at home after participating in an educational intervention. Educational intervention in the present study aimed to improve parents' knowledge in key concepts that is, handling OADs at home by using information presented in different forms. Fifteen parents to 12 children with cancer were recruited from a paediatric oncology ward in Sweden to participate in an interview. The interviews were transcribed verbatim and subjected to qualitative content analysis. Parents' experiences are presented in categories: Relieved stress, Awareness of own exposure, Facilitated my everyday life, Parents need continued support individually. The educational intervention resulted in both positive and negative feelings, increased awareness of drug exposure and correct drug handling at home. Practical training and information presented in different ways facilitated the process of drug handling. To handle the drug correctly at home parents requested to be trained and informed in the beginning of their child's oral drug treatment. In addition, parents requested to be individually approached by HCP to get answers to questions and concerns. This educational intervention study shows promising results for the method used by HCPs to inform and educate parents on complicated topics such as handling OADs at home.

PARP inhibitors in ovarian cancer therapy

Ovarian cancer is responsible for the highest number of deaths of all female genital cancers. It is ranked as the sixth in the incidence and fourth in the mortality rate of malignant tumours in women in Poland. The disease is initially asymptomatic, which is why it is usually detected at advanced stages. More than 70% of ovarian cancer cases are detected at the stage III or IV according to the FIGO classification. The treatment of ovarian cancer is mainly based on surgery combined with systemic treatment (chemotherapy based on platinum derivatives and taxanes). Although most patients achieve a good response to first-line chemotherapy, there is usually a recurrence and drug resistance at a later stage, and the prognosis for recurrence is poor. PARP (Poly ADP-ribose polymerase) inhibitors are a new class of oral anticancer drugs that target DNA repair pathways and have shown promising efficacy in ovarian cancer patients in recent clinical trials. Olaparib, rucaparib and niraparib are innovative drugs currently changing clinical practice in ovarian cancer patients.

A genetically engineered epothilone analog as a novel oral microtubule inhibitor: A clinical study of utidelone capsule for advanced breast cancer.

e13115 Background: Utidelone, a genetically engineered epothilone analog, is a potential best-in-class novel microtubule stabilizing agent. Utidelone injection was approved for advanced breast cancer in China in 2021. Utidelone is not susceptible to P-glycoprotein, leading to better oral bioavailability and successful development of an oral formulation-Utidelone Capsule (UTD2). As of now, there has been no oral microtubule stabilizing agent approved in China and the United States. UTD2 may benefit patients in various aspects including effectiveness, safety, better compliance, reduced medical cost, and facilitation of combination therapy, especially with other oral anti-cancer drugs. This is the first clinical study in China to investigate the efficacy and safety of UTD2 monotherapy for treatment of advanced breast cancer. Methods: This is an ongoing open-label, multi-center study (NCT05700084) consisting of three parts: dose escalation, bioavailability and food effect, and in combination with capecitabine for treatment of metastatic breast cancer. Here we report the preliminary results from single center for part I with determination of DLT and MTD as the primary objective, and efficacy, PK profile and safety in patients with pretreated metastatic breast cancer as the secondary objectives. Eligible patients are aged 18-70 years with confirmed advanced breast cancer refractory to prior standard therapies, and have an ECOG PS of 0-1, life expectancy ≥12weeks. Patients are treated with UTD2 monotherapy, at starting dose of 50 mg/m2/d-5day for two patients, with planned escalation (3+3) to 75 mg/m2/d-5day and 75 mg/m2/d-7day, then to 85 mg/m2/d-7day or down to 70 mg/m2/d-7day in a 21-day cycle. Results: As of 25th January 2024, 5 advanced breast cancer patients were enrolled, who had received prior treatment in advanced settings. Dose escalation is ongoing, and 75mg/m2/d-7day cohort is under evaluation. Four patients were evaluated for efficacy with an outcome of 2 PR (each for 50 and 75mg/m2/d-5day dose) and 2 SD (75mg/m2/d-5day dose) with treatment durations of 2 to 8 cycles. Most treatment-emergent adverse events (TEAEs) were Grade 1/2, manageable, and included peripheral sensory neuropathy (PN), dizziness and loss of appetite. There were two patients encountered Grade 3 TEAEs including one with PN and one with diarrhea/insomnia, that recovered through dose reduction or supportive treatment. No grade 4/5 adverse events and no treatment discontinuations due to AE were reported. There have been no DLTs and the MTD is not yet reached. Conclusions: These preliminary results suggested promising efficacy with a manageable safety profile of UTD2 in pretreated metastatic breast cancer patients. This study is still actively enrolling; further data will be provided at the time of presentation. Clinical trial information: NCT05700084 .

The impact of a patient-centred care pathway for patients treated with oral anticancer drugs: A multicentre pre-posttest study in Flanders.

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

Attributes for a discrete-choice experiment on preferences of patients for oncology pharmacy consultations.

To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. They are conditioned by the needs, expectations, and involvement of the patients in their care. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is a method recommended by the ISPOR for such a task. The "selection and validation of attributes and their values" step is fundamental in this process. In this context, the aim of this study was to present our research approach to identify and validate the attributes that characterize an OPC and their values. Due to the lack of relevant published data in the literature, the focus-group method was used in accordance with good research practices for the application of conjoint-analysis of the ISPOR. The two-round Delphi method was used to validate the attributes and their values identified by the focus-group method. The focus-group method enabled identification of nine attributes. Thirty-seven healthcare professionals at a national level, including 30 pharmacists andseven physicians, were selected to take part in the Delphi procedure. Seven attributes (frequency, planification, operation mode, duration, content, written support, and report) and their values were thus validated. Based on these results, the next step will be to elicit patient preferences for OPCs and to then shed light on the issues of pharmaceutical support for patients by comparing their preferences with those of informal caregivers and, in particular, those of the healthcare professionals involved in their care.

Evaluation of the Simple Suspension Method for Oral Anticancer Drugs.

The simple suspension method (SSM) involves administering tablets or capsules using a tube after disintegration and suspension in hot water without crushing or opening the capsule. Particularly, for anticancer drugs, it is an excellent method of administration that reduces the risk of exposure during dispensing. In contrast, information on SSM for individual drugs is insufficient. Anticancer drugs present a therapeutic challenge because their information is limited. We investigated whether SSM is possible with 36 anticancer drugs. Furthermore, we examined the pH of the suspension of these drugs, for which no information on SSM is available. We found that suspension was possible for 24 of the 36 drugs. Furthermore, the pH of the suspension was measured, which provided important information when considering dissolution solutions other than hot water. Little changes in the pH were observed before or after passing through the tube. The results of this study may improve medication adherence in patients with cancer experiencing dysphagia.

Prior Authorization and Association With Delayed or Discontinued Prescription Fills.

Prior authorization requirements are increasing but little is known about their effects on access to care. We examined the association of a new prior authorization policy with delayed or discontinued prescription fills for oral anticancer drugs among Medicare Part D beneficiaries. Using Medicare part D claims data from 2010 to 2020, we studied beneficiaries regularly filling one of 11 oral anticancer drugs, defined as three 30-day fills in 120 days preceding the plan's prior authorization policy change on that drug and continuously enrolled in the same plan for 120 days before and after the policy change at the start of a new year. The control group consisted of beneficiaries meeting the same utilization criteria, but who were enrolled in plans at the same time that did not implement a prior authorization policy change. The outcomes of interest were discontinuation of the drug within 120 days (analyzed with regression analyses) and time (in days) to next fill after a prior authorization policy change (analyzed using a quasi-experimental difference-in-differences event study). The introduction of a new prior authorization on an established drug increased the odds of discontinuation within 120 days (adjusted odds ratio, 7.1 [95% CI, 6.0 to 8.5]; P < .001) and increased time to next fill by 9.7 days (95% CI, 8.2 to 11.2; P < .001), relative to patients whose plans did not have a prior authorization policy change. Introduction of a new prior authorization policy on an established drug regimen is associated with increased probability of discontinued and delayed care. For some conditions, this may represent a clinically consequential barrier to access. Waiving prior authorization for patients already established on a drug may improve adherence.

Impact of bariatric surgery on oral anticancer drugs: an analysis of real-world data

PurposeThe number of patients with bariatric surgery who receive oral anticancer drugs is rising. Bariatric surgery may affect the absorption of oral anticancer drugs. Strikingly, no specific drug dosing recommendations are available. We aim to provide practical recommendations on the application of oral anticancer drugs in patients who underwent bariatric surgery.MethodsPatients with any kind of bariatric surgery were extracted retrospectively in a comprehensive cancer center. In addition, a flowchart was proposed to assess the risk of inadequate exposure to oral anticancer drugs in patients who underwent bariatric surgery. Subsequently, the flowchart was evaluated retrospectively using routine Therapeutic drug monitoring (TDM) samples.ResultsIn our analysis, 571 cancer patients (0.4% of 140.000 treated or referred patients) had previous bariatric surgery. Of these patients, 78 unique patients received 152 oral anticancer drugs equaling an overall number of 30 unique drugs. The 30 different prescribed oral anticancer drugs were categorized as low risk (13%), medium risk (67%), and high risk (20%) of underdosing. TDM plasma samples of 25 patients (82 samples) were available, of which 21 samples post-bariatric surgery (25%) were below the target value.ConclusionsThe proposed flowchart can support optimizing the treatment with orally administered anticancer drugs in patients who underwent bariatric surgery. We recommend performing TDM in drugs that belong to BCS classes II, III, or IV. If more risk factors are present in BCS classes II or IV, a priori switches to other drugs may be advised. In specific cases, higher dosages can be provided from the start (e.g., tamoxifen).

Digging in real-word electronic database for assessing CDK 4/6 inhibitors adherence in breast cancer patients from Romania.

Introduction: It is imperative for patients to respect the prescribed treatments to achieve the anticipated clinical outcomes, including the outpatients receiving oral anti-cancer drugs such as selective cyclin-dependent kinase 4/6 inhibitors (CDK 4/6i). With the introduction of three CDK 4/6i drugs in the Romanian pharmaceutical market in 2018, our study aimed to evaluate medication adherence and the influencing factors among patients undergoing treatment with palbociclib, ribociclib, or abemaciclib for advanced or metastatic breast cancer. Methods: Medication adherence was assessed using the Proportion of Days Covered (PDC) method, and Spearman correlation analysis was conducted to explore the relationships between adherence, age, gender, and follow-up duration. Results: The study enrolled 330 breast cancer patients, with an average follow-up period of 14.6 ± 12.5 months for palbociclib, 10.6 ± 7.1 months for ribociclib, and 8.6 ± 6.4 months for abemaciclib-treated patients. A small proportion of patients demonstrated non-adherence: 12.8% for palbociclib, 14.6% for ribociclib, and 14.7% for abemaciclib. Among patients receiving palbociclib, there was no significant correlation between adherence, age (rho = 0.07, p = 0.35), or gender (rho = -0.144, p = 0.054). However, a significant correlation was found with the duration of follow-up (rho = -0.304, p < 0.0001). Similar results were observed for patients receiving ribociclib or abemaciclib. Most patients received combination therapy with letrozole (46%) and exemestane (13%) for palbociclib, letrozole (48%) and fulvestrant (19%) for ribociclib, and fulvestrant (39%) and letrozole (27%) for abemaciclib, Discussion: High adherence rates were observed among patients treated with CDK 4/6i drugs, with no significant differences noted among the three drugs in this class. However, the collected patient data was limited, lacking information on adverse reactions that could potentially lead to treatment discontinuation, as determined by the oncologist's decision not to prescribe. Consequently, a comprehensive understanding of all factors contributing to the low adherence levels is hindered.

Novel Chitosan-Coated Liposomes Coloaded with Exemestane and Genistein for an Effective Breast Cancer Therapy.

For achieving high effectiveness in the management of breast cancer, coadministration of drugs has attracted a lot of interest as a mode of therapy when compared to a single chemotherapeutic agent that often results in reduced therapeutic end results. Owing to their proven effectiveness, good patient compliance, and lower costs, oral anticancer drugs have received much attention. In the present work, we formulated the chitosan-coated nanoliposomes loaded with two lipophilic agents, namely, exemestane (EXE) and genistein (GEN). The formulation was prepared using the ethanol injection method, which is considered a simple method for getting the nanoliposomes. The formulation was optimized using Box-Behnken design (BBD) and was extensively characterized for particle size, ζ-potential, Fourier transform infrared (FTIR), differential scanning calorimetry (DSC), and X-ray diffraction (XRD) analysis. The sizes of conventional and coated liposomes were found to be 104.6 ± 3.8 and 120.3 ± 6.4 nm with a low polydispersity index of 0.399 and 0.381, respectively. The ζ-potential of the liposomes was observed to be -16.56 mV, which changed to a positive value of +22.4 mV, clearly indicating the complete coating of the nanoliposomes by the chitosan. The average encapsulation efficiency was found to be between 70 and 80% for all prepared formulations. The compatibility of the drug with excipients and complete dispersion of the drug inside the system were verified by FTIR, XRD, and DSC studies. Furthermore, the in vitro release studies concluded the sustained release pattern following the Korsmeyer-Peppas model as the best-fitting model with Fickian diffusion. Ex vivo studies showed better permeation of the chitosan-coated liposomes, which was further confirmed by confocal studies. The prepared chitosan-coated liposomes showed superior antioxidant activity (94.56%) and enhanced % cytotoxicity (IC50 7.253 ± 0.34 μM) compared to the uncoated liposomes. 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay displayed better cytotoxicity of the chitosan-coated nanoliposomes compared to the plain drug, showing the better penetration and enhanced bioavailability of drugs inside the cells. The formulation was found to be safe for administration, which was confirmed using the toxicity studies performed on an animal model. The above data suggested that poorly soluble lipophilic drugs could be successfully delivered via chitosan-coated liposomes for their effective delivery in breast cancer.

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.

Key aspects of medication adherence to oral anticancer drugs: A literature review

At least 25% of the anticancer drugs are intended for oral use, while the creation and rapid introduction of oral drugs into clinical practice is constantly growing. Between 2006 and 2021, 80 oral forms of anticancer drugs were approved. It has been shown that patients prefer oral therapy to intravenous therapy if such a replacement is possible with equal efficacy and toxicity of the drugs. This once again emphasizes that the issue of adherence to treatment with oral forms is open and relevant for study. Currently, adherence, as the main factor in achieving the best clinical outcome, has been studied from different perspectives. However, there are no structured data globally, and, accordingly, evidence-based and specific recommendations in the absence of adherence. The review includes data from studies performed over the past 10 years, studying the adherence of patients to treatment with oral anticancer drugs. The data sources for the review were the Medline, Embase, and Scopus databases. Literature analysis showed that the most important aspects in the field of adherence to treatment with oral anticancer drugs include the level of patient adherence to treatment, factors affecting non-compliance, correlation of treatment adherence and clinical outcomes in malignant neoplasms. At the same time, the article considers the impact of non-compliance on the health care system as a whole. The most reliable and up-to-date data in the study area were examined to subsequently identify measures aimed at achieving the best practice in the organization of healthcare for patients with malignant neoplasms. The research results demonstrate the variability and heterogeneity of data, the lack of unified methodological approaches. In turn, this prevents the formation of objective and reliable conclusions about adherence. To make rational strategic decisions on monitoring adherence to treatment, it is necessary to initiate large-scale studies, adopt uniform standard procedures and recommendations for assessing adherence.

The Complexity of Co-designing and Implementing a Transmural Care Pathway for Patients treated with Oral Anticancer Drugs: a Qualitative Study

Background: Due to the emergence of oral anticancer drugs (OACD), changes in traditional roles and responsibilities of healthcare professionals (HCPs) in oncology and re-organization of current care processes are needed. Moreover, considering the ambulatory character of OACD, involvement of primary care HCPs seems crucial. Ten Belgian hospitals participated in the Collaborative Network to take Responsibility for Oral Anticancer Therapy (CONTACT)-project, aiming to co-design and implement a transmural care pathway for patients on OACD. This study aimed to get insight in the co-design process in these hospitals and its results. &#x0D; Methods: In each hospital, a project team, including a project coordinator, was set up. Project teams started the co-design process from the results of an assessment of the current care process, performed from the perspective of patients and HCPs, by using questionnaires. Throughout the co-design process, project team meetings and in-between meetings in smaller groups, were held and reported by the local coordinator. &#x0D; For this study, a qualitative content analysis was conducted using reports and care pathway documents provided by the local project coordinators. Additionally, semi-structured interviews with the coordinators were conducted to get a deeper understanding of the co-design process. &#x0D; Results: Although hospitals were encouraged to involve representatives of primary care in the co-design process, only few hospitals invited them to participate. Even in those hospitals where they were invited, their participation strongly decreased during the process. &#x0D; In the current practice assessment, the involvement of primary care HCPs was evaluated poorly by both patients and HCPs. In most hospitals, community pharmacists and home care nurses were not informed about the start of treatment. None of the primary care HCPs, including the general practitioner (GP), did receive necessary information about the OACD or contact details of the hospital team. Also, the therapy plan of the patient was not shared with the primary care HCPs. &#x0D; The care pathways that were developed during the co-design process almost all mentioned that an information leaflet about the OACD and a therapy plan of the patient should be added to the report for the GP at the start of treatment. In the care pathway of half of the hospitals, it was mentioned that the same information should also be provided to the community pharmacist and home care nurse. Based on the reports, the hospital teams did not seem to take any further initiatives to elaborate transmural care. In the interviews, coordinators indicated that more extensive transmural collaboration is rather a long-term perspective; hospital teams seem to think they first need to focus on in-hospital reorganization.&#x0D; Discussion: Informing primary care HCPs, especially the GP, about treatment-initiation seemed a feasible intervention and was considered a quick win. This rather small initiative can have a large impact on care quality as it enables primary care HCPs to take up their role in the care for patients on OACD. As building transmural collaboration does only seem feasible after a thorough in-hospital reorganization, a phased approach, in which collaboration with primary care is further elaborated in a second phase, seems appropriate.

Le pharmacien clinicien, un maillon indispensable dans la nouvelle gradation de prise en charge des patients ambulatoires

Pharmaceutical presence in oncology allows the clinical pharmacist to integrate tripartite consultations for primary prescription of oral anticancer drugs. The aim of the study is to describe the deployment of the clinical pharmacy activity in 2 oncology departments since its implementation in 2019, to assess the financial gain of the pharmaceutical interventions through the new gradation of outpatient management published on September 10, 2020, and finally to assess their satisfaction following the deployment of this pathway. A retrospective study was conducted to collect pricing data for oral therapy interviews in patients between January 2019 and December 2022. To complement this, a satisfaction survey was conducted by the oral therapy pharmaceutical team between 01/01/2022 and 12/31/2022 among patients undergoing treatment. 579 patients received a targeted pharmaceutical interview as part of the oral therapy patient pathway. The average invoiced amount of a pharmaceutical consultation carried out as part of a tripartite first prescription was 355.44 euros. The 579 patients who benefited from a targeted pharmaceutical interview generated a revenue of 87,545 euros for the hospital. In terms of evaluating patient satisfaction, 163 usable responses were received out of 267 patients questioned, representing a response rate of 61%, with an overall score of 9.1/10. Pending the introduction of a specific remuneration for clinical pharmacy activities, the valuation of tripartite consultations is a lever for financing clinical pharmacy activities in hospitals.