Abstract BackgroundEverolimus in combination with exemestane is indicated for the treatment of hormone receptor-positive, HER 2-neg endocrine resistant advanced breast cancer in postmenopausal women. This study investigated treatment adherence, tolerability, satisfaction and efficacy. MethodsA prospective, non-interventional, non-controlled, multicentric observational study assessed adherence by means of a validated questionnaire (‘Morisky Medication Adherence Scale’) and ‘Medication Event Monitoring System’ (MEMS®) data. The level of adherence was calculated per patient as percentage of days on which the medicine was taken as prescribed during the total treatment period, referred to as ‘unadjusted adherence rate’ (UAR). Second, MEMS® data were adjusted for treatment interruptions according to the CRF and questionnaire data, approved by the treating physician (‘adjusted adherence rate’ (AAR)). Successful adherence was defined as ≥ 95% – ≤ 105%. Validated questionnaires (‘Patient Satisfaction with Cancer Treatment Education’, ‘Cancer Treatment Satisfaction Questionnaire’ (CTSQ) and ‘Functional Assessment of Cancer Therapy – General’ (FACT-G) were used to report patients experience and satisfaction with the treatment and perceived care, questioned at initial visit and after approximately 1, 3, 6 and 12 months. The efficacy was primary analyzed through progression free survival (PFS). ResultsBetween Dec 2015 and Nov 2017, a total of 58 women (median age 65 yrs) from 7 oncology centers were included after a mean of 34m ± 36.9 (SD) of being diagnosed with stage IV disease; most (62.1%) had ≥3 organs involved and 84.5% had ≥2 prior metastatic treatment lines. The mean follow-up duration was 185.5 ± 100.0 days. The mean UAR for exemestane, everolimus and the combination were 92.9 %, 84.8 % and 81.7 % respectively. For everolimus and the combination therapy these rates differ significantly from the mean AAR, with p < 0.05 (see table 1). For the AAR of the combination therapy, 13.8 % of the patients showed optimal adherence (100 %). Six patients (10.3%) interrupted their treatment with exemestane with a mean time of treatment pause of 34.3 ± 19.1 days. The treatment with everolimus was interrupted by 36 (62.1%), with a mean interruption time of 24.3 ± 16.5 days, which corresponds with a mean of 19.6 % ± 17.6% of the total follow-up duration. Some patients interrupted their treatment multiple times. The most common side effect was mucositis (n=26 at 1 month, of whom 8 patients grade 3 and 15 patients grade 2)). Six (10.4 %) of the 58 patients stopped treatment with everolimus and exemestane due to side effects. The median PFS was 170 days. With regard to quality of life, patients scored lowest on emotional and functional well-being. However, there were no significant differences measured for the mean FACT-G score between Day0, M1 and M3 (P = 0.273). Also, patients scored overall low on the ‘CTSQ’. Conclusion Despite close monitoring and preventive measures to overcome side effects, adherence to everolimus and exemestane was rather low. Many patients needed to interrupt the treatment due to side effects; treatment is perceived as intensive. Nevertheless, median PFS is 170 days, even when used late in the therapeutic journey of breast cancer patients. Table 1. UAR and AAR for Exemestane, Everolimus and the combinationExemestaneEverolimusCombination therapyUAR (%)mean ± SD92.97 ± 13.1784.86 ± 19.4081.74 ± 20.98AAR (%)mean ± SD93.07 ± 13.1491.81 ± 15.0487.55 ± 18.17Significance differenceP-value0.277< 0.001< 0.001 Citation Format: Veerle Foulon, Carrie Visser, Sandra De Coster, Lise-Marie Kinnaer, Ellen Reynders, Anne Deblander, Patrick Berteloot, Kevin Punie, Hans Wildiers, Véronique Cocquyt, Hannelore Denys, Ahmad Awada, Eric Strobbe, Andrea Gombos, Isabelle Spoormans, Ximena Elzo-Kraemer, Christof Vulsteke, Marleen Borms, Philip Debruyne, Wim Wynendaele, Patrick Neven. Adherence to and patient satisfaction with the combination therapy of exemestane and everolimus in postmenopausal women with HR+ HER2- advanced breast cancer: Results from the IPSOC-mamma study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-06.

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

BACKGROUND:Medicine information is an integral part of patient care and a patient right. In particular, patients with a mental health diagnosis have a need for information on medicines.OBJECTIVE:This study aims to describe the current practice on information provision on antidepressants to inpatients in psychiatric hospitals.METHODS:A qualitative study was conducted consisting of semi-structured interviews with health care professionals (n=46) and patients (n=17) in 11 Flemish psychiatric hospitals. Two topic guides were designed for conducting the interviews with these respective stakeholders. The issues addressed in the topic guides related to: organization of information provision in the hospital, information on demand of the patient, information provision by health care professionals, information for relatives, evaluation of provided information, interdisciplinary contacts on information provision and satisfaction on current practice of information provision. The interviews were analysed according to the five stages of the framework analysis.RESULTS:Psychiatrists and nurses are the key players to provide information on antidepressants. Their approach depends on patient characteristics and mental state. Information is provided mainly orally. Health care professionals consider non-verbal cues of patients to verify if information has been understood. Health care professionals reported lack of time and lack of interdisciplinary contacts as negative aspects. Patients indicated that health care professionals take too little initiative to provide medicine information.CONCLUSIONS:Patients are informed about their antidepressants through various pathways. Although the awareness is present of the importance of the individual approach and efforts are done to tailor information to the individual patient, improvement is still possible. Tailoring communication; assessing patient needs and preferences; matching of health care professional style and patient needs; and achieving concordance, is a complex and challenging task for health care professionals in mental health care.

Study objective The aim of this study is to gain knowledge on the opinion of psychiatric patients about the provision of drug information so that the psychiatric hospital pharmacist can consider opportunities to be directly involved in patient care.Methods Qualitative interviews were performed in a convenience sample of psychiatric patients. The interviews were audio taped, transcribed verbatim and coded. The questions concerned the content and the format of information, the information provider and the possible role of the hospital pharmacist.Results The sample consisted of 16 patients. Nearly all topics covered by the summary of product characteristics, especially side effects, were considered. Patients were open to a wide variety of drug information formats. They spontaneously named the psychiatrist, general practitioner and nursing staff as the most appropriate people to provide drug information. The hospital pharmacist was not spontaneously mentioned.Conclusion Psychiatric patients did not identify the hospital pharmacist as being a partner in their treatment. This provides a challenge for the development of clinical psychiatric pharmacy.

4622 Background: Patient adherence to oral therapy is a critical issue in cancer treatment. The aim of this study is to investigate the prevalence and severity of non-adherence to OAD in mRCC and to identify factors predictive of non-adherence. Methods: Prospective observational multicenter trial performed at 11 Belgian academic and non-academic centers. All pts with mRCC starting OADs (sunitinib, pazopanib, everolimus or sorafenib) are eligible for the study. Pts are contacted by phone at baseline and at 1, 3, 6 and 12 months. At each contact, pts are asked to complete questionnaires investigating 1) medication adherence (MMAS), 2) patient satisfaction with treatment (CTSQ) and with treatment education (PS-CaTE), 3) the extent of information desire (EID), 4) quality of life (FACT-G and FKSI) and 5) the role of the pharmacist (SWiP). Adherence is measured using an electronic medication event monitoring system (MEMS, Aardex). Results: Between 02/2011 and 11/2011, 49 pts (m: 33, f: 16) with a median age of 63 years (range 25 - 87) have participated in the IPSOC study. Twenty-nine pts (64%) were treated with an OAD in first-line, 15 pts (33%) in second-line. With a median follow-up of 131 days (range 2 - 313) 45 pts (92%) claimed to be fully adherent to their treatment (based on MMAS and CTSQ data). Four patients indicated to have missed at least one dose, of whom two indicated they occasionally forgot their medication and two others interrupted treatment because of side effects. Based on MEMS data, mean adherence, defined as the percentage of days with at least the prescribed number of dosage taken, was 98.91%. Conclusions: The IPSOC study, the first to examine adherence to OAD among mRCC pts, shows that mRCC pts are almost fully adherent to treatment recommendations. This seems to be in contrast to adherence data for other, long-lasting, anti-cancer treatments. Further investigations will focus on the question whether extensive counseling and participation in side-effect programs contribute to the high percentage of adherence in this study.

OBJECTIVE:This study aims to use a pharmacoepidemiological approach to study the drug use of patients during the year prior to diabetes diagnosis (i.e. pre-diabetic patients) and control patients. Drug use might reveal cardiovascular, metabolic and/or endocrinological changes and help to identify indicators for active monitoring of Type 2 diabetes mellitus.METHODS:A retrospective case-control study compared drug use of patients with a future diagnosis of diabetes (experimental patients) with patients without a diabetes diagnosis (control patients) based on community pharmacy records. An experimental patient had used oral hypoglycaemic drugs during 2005 or 2006. Experimental and control patients were matched in terms of age, gender and quarter of index date. Drugs were selected based on possible co-morbidities of diabetes. Drug use was expressed as a binary variable, indicating whether or not a patient took specific drugs. Drug use was compared between experimental patients during the year prior to diagnosis and control patients using the chi-squared test.RESULTS:Our dataset covered 5,064 patients (1,688 experimental and 3,376 control patients). A higher probability of taking cardiovascular drugs was observed for specific subgroups of patients with pre-diabetes as compared to control patients: this trend was observed for men as well as for women, for various cardiovascular drug classes, and for different age groups (p<0.05), although it was not always statistically significant for the 29-38 age group. For each selected age and gender group, patients with pre-diabetes had a higher probability of taking a combination of a lipid-modifying agent and an antihypertensive drug than control patients (p<0.005).CONCLUSIONS:Using community pharmacy data, this study demonstrated that age and a characteristic drug use pattern could contribute to detecting pre-diabetes. There is a potential role for community pharmacists to follow up drug indicators of patients with a view to refer high-risk people for screening by a physician.

OBJECTIVES:The literature indicates that cardiovascular drug use is higher during the years prior to diagnosis of type 2 diabetes mellitus. As there are pharmaco-epidemiological and economic consequences of enhanced medication use prior to diagnosis of diabetes, there is a need for a comparative analysis of the drug-use pattern by patients with a subsequent diagnosis of diabetes and control patients. This pilot study aimed to investigate cardiovascular drug use in patients with a subsequent diagnosis of diabetes using data extracted from 200 community pharmacies in the Belgian township of Hasselt.METHODS:Based on community pharmacy data, a retrospective case-control study compared the drug use of patients with a subsequent diagnosis of type 2 diabetes (cases) with patients without a subsequent diagnosis (controls). Cases were identified if patients started taking metformin (and possibly other drugs used in diabetes) during the 2004-2006 study period. Drug use was expressed as a binary variable, reflecting whether or not a patient took drugs belonging to a specific cardiovascular subclass.KEY FINDINGS:Our dataset consisted of 158 cases with a subsequent diagnosis of type 2 diabetes and 632 control patients. Patients with a subsequent diagnosis of type 2 diabetes had a higher propensity to take cardiovascular drugs prior to diagnosis than control patients. This trend was observed across all cardiovascular drug classes, except for calcium-channel blockers, and was statistically significant for beta-blocking agents and agents acting on the renin-angiotensin system.CONCLUSIONS:A positive association was observed between cardiovascular drug use and subsequent diagnosis of type 2 diabetes. This study emphasizes the potential role for community pharmacy in early identification of diabetes using more targeted screening based on cardiovascular drug use as derived from pharmacy databases.

This study compared market prices (i.e. third-party reimbursement and patient co-payment) of prefabricated neck, wrist and knee braces in Belgium, France, the Netherlands, Ontario (Canada) and the UK. Data were collected through contacts with health authorities, health insurance funds, manufacturers and distributors. Market prices varied substantially between countries, indicating that manufacturers adapt their price setting strategy to the policy environment and the structure of the brace market of a country. Belgian prices tended to exceed prices in other countries for the selected neck, wrist and knee braces. There seems to be scope for reducing Belgian prices of selected braces.

Abstract Objectives: The Belgian third-party payer wishes to set reimbursement tariffs at a level that reflects the costs of orthotic braces. This article aims to calculate production and distribution costs of a prefabricated hard neck and knee brace and to explore whether Belgian tariffs and actual retail prices correspond with estimated costs of these two braces. Methods: The cost model considered manufacturing costs, general overheads, research and development costs, warehousing costs, profit and distribution margins. Data were gathered from manufacturers, a production site visit, desk research, a decomposition of finished products and stakeholder interviews. The price year was 2007. Results: The cost model estimated a retail price of €55–€150 for the neck brace, depending on assumptions. The estimated retail price for the neck brace was lower than the reimbursement tariff of €194 and the actual retail price of €241. The estimated retail price of €331–€694 for the knee brace was lower than the actual retail price of €948. Conclusions: Actual retail prices and reimbursement tariffs for a neck brace and a knee brace exceeded prices based on estimated costs. Therefore, there appears to be scope for reducing tariffs.

OBJECTIVES:This article aims to review regulation governing outpatient orthotic braces (neck, wrist and knee braces) in France, the Netherlands and Sweden with a view to reforming the Belgian market. METHODS:Information about the regulatory framework was derived from an analysis of legal texts and a survey completed by national experts. RESULTS:Strategies to keep down prices include public procurement in Sweden, maximum prices in France, and exclusion of expensive braces from reimbursement in the Netherlands. Reimbursement is linked to a medical indication or a chronic condition in France, the Netherlands and Sweden. To gain reimbursement, the cost-effectiveness of orthotic braces needs to be demonstrated in France and the Netherlands. Orthotic braces tend to be initially prescribed by a specialist physician and distributed by orthotists, medical equipment shops and/or community pharmacies. CONCLUSIONS:Extensive government intervention exists in the outpatient orthotic brace market in the countries studied. Our recommendations to reform the Belgian market for prefabricated orthotic braces are to separate reimbursement for service provision from reimbursement for braces; to set prices by means of a tendering process or an international price comparison; and to make reimbursement conditional on effectiveness and cost-effectiveness of braces.