{"title":"4CPS-295 Immunotherapy for cancer therapeutic positioning reports: knowledge, expectations and experiences through a national survey","authors":"M. González, J. M. Pozo, E. G. Peña, A. C. Lleti","doi":"10.1136/EJHPHARM-2021-EAHPCONF.127","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.127","url":null,"abstract":"Background and importance In our country, considerable progress has been made in recent years since the establishment of the clinical therapeutic position reports (TPR) in 2013, but more research is needed about their impact on decision making. Aim and objectives To determine the value of immunotherapy for cancer therapeutic positioning reports (ITc-TPR) in clinical practice. Material and methods A nationwide survey was designed for hospital pharmacists and clinical oncologists of the ITc-TPR, published between May 2013 and March 2020. The main variables collected were: sociodemographics of the hospitals and health professionals, approval criteria and variables related to the acceptance of the ITc-TPR recommendations. Results During the study period, 46 ITc-TPR of 22 active substances were published. 27 health professionals answered the survey, 81.5% hospital pharmacists and 18.5% oncologists, ascribed to 24 hospitals in the national territory. 33.3% of the professionals had participated in the development of some TPR-ITc. In 45.8% of hospitals, incorporation of ITc was decided at the regional level, and in 66.7% of hospitals the drug and therapeutic indication with ITc-TPR published should be re-evaluated by the pharmacy and therapeutics hospital commission. In 50%, the authorised indications were the same as those of the ITc-TPR and 70.8% followed the recommendations of the ITc-TPR. 48.1% of the professionals who responded to the survey believed that ITc-TPR have eliminated barriers for access of patients to ITc, have decreased the variability of clinical care and promoted equity in the national territory. 66.7% believed the incorporation of the drug into clinical practice was faster if there was a published ITc-TPR. The main limitations for patients to access ITc were: not financed by the national health system (55.6%), high cost (37.1%) and the restrictions at the autonomic level (29.6%). The aspects of the ITc-TPR that should be improved were: pharmacoeconomic evaluation (66.7%), conclusions useful for clinical practice (70.4%), a single evaluation at the national level (70.4%) and decisions binding (80.5%). Conclusion and relevance ITc-TPR is a useful and well established tool at the national level for the positioning of a new drug. The results of the survey will allow the development of strategies to improve ITc-TPR. References and/or acknowledgements Acknowledgements: AEMPS, GEDEFO, participants, directors, teachers and tutors of Master Inmunoterapia del Cancer. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90098669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. P. Mondéjar, C. I. Navalón, I. Valverde, Amelia Soto, P. Fernández, M. Candel, M. Candela, A. Asencio, Mdc Caballero Requejo, L. R. Redondo, E. U. Sanz
{"title":"5PSQ-176 Discontinuation of etanercept due to adverse events in patients with rheumatic diseases","authors":"C. P. Mondéjar, C. I. Navalón, I. Valverde, Amelia Soto, P. Fernández, M. Candel, M. Candela, A. Asencio, Mdc Caballero Requejo, L. R. Redondo, E. U. Sanz","doi":"10.1136/EJHPHARM-2021-EAHPCONF.295","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.295","url":null,"abstract":"Background and importance Etanercept is a fusion protein composed of the p75 receptor of tumour necrosis factor (TNF) and the Fc portion of human immunoglobulin. It is indicated for the treatment of diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis as its mechanism of action is blocking TNF. Aim and objectives The aim of this study was to analyse the causes of treatment discontinuation due to adverse events. Material and methods A retrospective study was performed in which all patients diagnosed with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis treated with etanercept at some point (between 2007 and 2016) were included. Data for etanercept’s dispensations, causes of treatment discontinuation, sex and age of the patients were collected. We used Excel to analyse the data. Results 85 patients diagnosed with rheumatoid arthritis, 59 with ankylosing spondylitis and 44 with psoriatic arthritis treated with etanercept were included. 76.47%, 45% and 54.8% were women, with an average age of 58.2 (±13.6), 41.1 (±11.3), 55.3 (±13.1) in the rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis groups, respectively. 132 patients (70%) discontinued treatment with etanercept for different reasons. The main cause was adverse events, representing 28% of the total. Other causes were: secondary failure (27%), primary failure (22%), patient’s reasons (5%) and remission (4%). Among the adverse events, about 50% were dermatological: 27.8% related to the injection site, 22.2% skin reactions and 44.4% due to hypersensitivity. Other causes were infection (21.6%), diarrhoea (5.4%) and neutropenia (2.7%), among others. Conclusion and relevance Etanercept is the most commonly used anti-TNF biological drug to treat rheumatological diseases. Among the different reasons for treatment discontinuation with etanercept, adverse effects was the main cause (28%). Allergic reactions or skin reactions were the most common adverse events. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81210336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Wuyts, P. Landuyt, Pieter-Jan Cortoos, P. Cornu
{"title":"5PSQ-133 Evaluation of a quality monitoring programme for intravenous fluid management","authors":"S. Wuyts, P. Landuyt, Pieter-Jan Cortoos, P. Cornu","doi":"10.1136/EJHPHARM-2021-EAHPCONF.252","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.252","url":null,"abstract":"Background and importance Intravenous fluid stewardship can support caregivers to optimise the patient’s outcome, avoid fluid overload or electrolyte disorders, and control costs. Implementing a stewardship initiative requires monitoring to guarantee guideline adherence. Aim and objectives To evaluate the impact of an internal audit on intravenous fluid use and identify opportunities to improve quality monitoring. Material and methods To evaluate fluid guideline adherence in a Belgian university hospital, an internal audit was organised comprising five QIs, developed by the fluid stewardship programme. The QIs were calculated every 2 weeks over a 6 month period (August 2019 to January 2020), focusing on prescription and labelling, documentation of indication and monitoring of body weight and electrolytes. Every ward steward (22 physicians, 16 nurses) received the results of the first 3 months (T1) in an electronic report. The report’s impact on the QIs between T1 and the following 3 months (T2) was assessed using a χ2 test and interrupted time series (ITS) analysis. Afterwards, stewards were surveyed on how to further optimise fluid management monitoring. Results In total, 729 patients (T1: 361; T2: 368) receiving 758 intravenous fluid bags (T1: 381; T2: 377) were screened. QIs on prescription and labelling were close to the target value. The QI ‘documented indication’ was low (21%). ‘Availability of electrolyte values’ increased significantly between T1 and T2 (90.3% vs 96.2%, p Conclusion and relevance Awareness of electrolyte disorders increased among physicians, but the direct impact of our feedback remains unclear. Other QIs showed little room for improvement and need re-evaluation. Overall results suggested a persistent need for training on intravenous fluids, especially on surgery wards, and feedback should include tailored communication with staff. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90575022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mdp Briceño Casado, Gil-Sierra, B. D. L. C. Riaguas, M. Domínguez-Cantero
{"title":"4CPS-324 Effectiveness and safety of ixekizumab in moderate-to-severe plaque psoriasis","authors":"Mdp Briceño Casado, Gil-Sierra, B. D. L. C. Riaguas, M. Domínguez-Cantero","doi":"10.1136/EJHPHARM-2021-EAHPCONF.156","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.156","url":null,"abstract":"Background and importance Ixekizumab is a high affinity monoclonal antibody against interleukin 17A. It is used for the treatment of moderate-to-severe plaque psoriasis (MTSPP). Aim and objectives To assess the effectiveness and safety of ixekizumab in MTSPP in clinical practice. Material and methods A descriptive, retrospective, multicentre study was conducted. Patients with MTSPP receiving ixekizumab between 1 January 2017 and 30 September 2020 were included. Electronic clinical history and the prescription programme Farmatools were used to record data: sex, age, previous treatment, dosage and duration of therapy. Effectiveness was measured by the psoriasis area severity index (PASI): PASI-75 (≥75% reduction in baseline PASI), PASI-90 (≥90% reduction) and PASI-100 (total clearance of lesions) at weeks 12 and 36. Failure to achieve PASI-75 was considered no response. Safety was evaluated according to adverse events (AE) and discontinuations of treatment. Results 46 patients were included, 27 (59%) were men. Mean age was 49 (23–74) years. Previous treatments: methotrexate (n=33), cyclosporine (n=29) and biological therapy (n=35). Mean number of prior biological drugs was 3 (1–5), including anti-TNF (etanercept, n=23; adalimumab, n=22; infliximab, n=3), anti-IL-12-23 (ustekinumab, n=16) and anti-IL-17A (secukinumab, n=7). All patients received ixekizumab with an induction dose of 160 mg at week 0 and then 80 mg at weeks 2, 4, 6, 8, 10 and 12. Maintenance dose was 80 mg every 4 weeks in 34 (74%) patients and every 6 weeks in 12 (26%). Mean duration of ixekizumab therapy was 17 (3–44) months. Baseline PASI was >5 in all patients and >10 in 37 (80%) cases. Effectiveness was not evaluated in 5 (11%) patients at week 12 and in 8 (17%) patients at week 36 due to lack of information. At week 12: 1 (2%) patient presented PASI-75, 12 (26%) PASI-90, 23 (50%) PASI-100 and 5 (11%) no response. At week 36: 1 (2%) patient achieved PASI-75, 15 (33%) PASI-90, 16 (35%) PASI-100 and 6 (13%) no response. Regarding the safety profile, 3 (7%) patients presented AE: alopecia, eosinophilia and injection site reaction. No discontinuations of treatment were reported. Conclusion and relevance Ixekizumab was effective and provided total clearance of MTSPP lesions to half of the patients by week 12, with this considerable response in more than a third of patients at week 36. Ixekizumab was well tolerated, with a low frequency of AE. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87590554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Perić, V. Šuljagić, B. Milenković, S. V. Kovačević
{"title":"4CPS-243 Healthcare associated Clostridioides difficile infection in surgical and medical patients","authors":"A. Perić, V. Šuljagić, B. Milenković, S. V. Kovačević","doi":"10.1136/EJHPHARM-2021-EAHPCONF.75","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.75","url":null,"abstract":"Background and importance Clostridioides difficile (C difficile) infection (CDI) is one of the most common healthcare associated (HA) infections in contemporary medicine. The risk factors (RFs) for HA CDI in medical and surgical patients are poorly investigated in countries with a limited resource healthcare system. Aim and objectives To investigate differences in patient characteristics and RFs associated with HA CDI in surgical and medical patients. Material and methods A prospective cohort study was conducted including adult patients diagnosed with an initial episode of HA CDI from 2011 to 2017 in a 1200 bed teaching hospital. Patients hospitalised for any non-surgical illness, who developed initial HA CDI, were assigned to the medical group, whereas those who developed initial HA CDI after surgical procedures were in the surgical group. Data on the use of proton pump inhibitors (PPIs), chemotherapy and antibiotic usage were gathered by hospital pharmacists. Results From 553 patients diagnosed with HA CDI, 268 (48.5%) and 285 (51.5%) were surgical and medical patients, respectively. Medical patients were significantly older than surgical patients (68.59±15.46 vs 64.91±14.86 years, p=0.005), and were treated significantly more frequently with PPIs (38.9% vs 19%, p Conclusion and relevance Age ≥65 years, use of PPIs, chemotherapy and fluoroquinolones were positively associated with the medical group and were significant predictors of CDI, whereas admission to the ICU and the use of second and third generation cephalosporins were positively associated with being in the surgical group and were significant predictors of CDI. We conclude that medical patients were more endangered with HA CDI than surgical patients. References and/or acknowledgements Peric A, Dragojevic- Simic V, Milenkovic B, et al. Antibiotic consumption and healthcare-associated infections in a tertiary hospital in Belgrade, Serbia from 2011 to 2016. J Infect Dev Ctries 2018;12:855–863. Suljagic V, Miljkovic I, Starcevic S, et al. Risk factors for Clostridioides difficile infection in surgical patients hospitalised in a tertiary hospital in Belgrade, Serbia: case-control study. Antimicrob Resist Infect Control 2017;6:31. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88864291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Torrente-López, J. Hermosilla-Fernández, J. Hernández-Jiménez, J. Cabeza, A. Salmerón-García, N. Navas
{"title":"3PC-065 Impact of light stress on the isoform profile of nivolumab (Opdivo) in opened vials estimated by (RP)UHPLC-UV-(HESI/Orbitrap)-MS","authors":"A. Torrente-López, J. Hermosilla-Fernández, J. Hernández-Jiménez, J. Cabeza, A. Salmerón-García, N. Navas","doi":"10.1136/EJHPHARM-2021-EAHPCONF.40","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.40","url":null,"abstract":"Background and importance Nivolumab (Opdivo) is a human IgG4 monoclonal antibody from the group of immunomodulators which bind to the programmed death receptor 1 (PD-1). As a complex protein, physical aggregation and chemical degradation can occur throughout its life, and even modest environmental stresses can cause extensive damage.1 As indicated in its technical report,2 the unopened vials can be stored at a controlled room temperature up to 25°C with room light for up to 48 hours. Aim and objectives To assess the impact on the isoform profile of nivolumab 10 mg/mL (Opdivo) promoted by exposure to light in its own opened vial at a controlled temperature of 25°C to evaluate likely risks from unintentional mishandling in real hospital conditions. Material and methods Nivolumab (Opdivo, 10 mg/mL) was placed in an accelerated stress test chamber to simulate sunlight (Solarbox 3000e RH, Cofomegra, Milan, Italy) for 24 hours at 25°C. Irradiation was set at 250 W/m2, between 320 and 800 nm.3 A validated reverse phase ultra high resolution liquid chromatography coupled to high resolution mass spectrometry and exact mass ((RP)UHPLC-UV-(HESI/Orbitrap)-MS) method was used to analyse intact nivolumab. UV-chromatograms and total ion chromatograms (TICs) were recorded and the deconvoluted mass spectra gave the nivolumab mass isoform profile. Results UV chromatograms and TICs suggested no degradation products after light exposure. However, isoform profiles clearly showed changes in the light submitted nivolumab samples. An important increase in the number of isoforms even with changes in their masses, including the main isoform, was detected. Conclusion and relevance Exposure to light may cause modifications in the nivolumab isoform profile which suggests protein degradation. This work shows the importance of protecting opened vials of the medicine Opdivo from light (and by extension, bags for infusion) when they are at room temperature (up to 25°C). References and/or acknowledgements Nejadnik MR, et al. J Pharm Sci 2018;107:2013–19. Nivolumab Technical Report. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf Scientific discussion ICH Q1B photostability testing of new active substances and medicinal products. European Medicines Agency (EMEA) 1998 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-b-photostability-testing-new-active-substances-medicinal-products-step-5_en.pdf Funded by project FIS: PI-17/00547 (Instituto Carlos III, Spain), which means that it was also partially supported by European Regional Development Funds. AT-L is currently receiving an FPU predoctoral grant (reference FPU18/03131) from the Ministry of Universities, Spain. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85120396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Soler, M. A. Fullana, V. Collado, N. Ramos, A. Ruiz, F. P. Rossello, MM Crespi Magro, G. Ruiz, F. Alomar, M. Riera, V. Llodrá Ortolá
{"title":"4CPS-354 Efficacy and safety with erenumab and galcanezumab: our experience","authors":"A. Soler, M. A. Fullana, V. Collado, N. Ramos, A. Ruiz, F. P. Rossello, MM Crespi Magro, G. Ruiz, F. Alomar, M. Riera, V. Llodrá Ortolá","doi":"10.1136/EJHPHARM-2021-EAHPCONF.186","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.186","url":null,"abstract":"Background and importance Calcitonin gene related peptide (CGRP) receptor inhibitors are a new group of drugs that have been included for migraine pharmacotherapy and migraine prevention. Erenumab and galcanezumab have notable individual variance and we wanted to explore this effect and also their safety. Aim and objectives To assess the efficacy and safety of the CGRP receptor inhibitors erenumab and galcanezumab. Material and methods In this 6 month observational retrospective study (January to June 2020), based on patient interviews, we obtained demographic parameters, reduced monthly migraine days (RDMM), a response rate of 50% (TR50) and adverse effects during treatment. RDMM are calculated by subtracting the migraine days 4 weeks before starting the treatment from the monthly migraine days between weeks 9 and 12 of treatment. TR50 are patients who achieved at least a 50% reduction in monthly migraine days in comparison with their initial condition. Results 31 patients were registered with a mean age of 43.9 years (±12.1), 77.4% were women and 22.6% were men. 66.7% (n=22) of patients were treated with erenumab and 33.3% (n=9) with galcanezumab. The RDMM for erenumab was −10.5 days (−17.1; −3.9) and a TR50 of 81.8% (n=18). For galcanezumab, the RDMM was −5.5 days (−8.6; −0.8) and a TR50 of 33.3% (n=3). The most frequent adverse reactions to erenumab were constipation (31.8% (7)) and erythema at the injection site (9.1% (2)); for galcanezumab, it was erythema at the injection site (22.2% (2)). Conclusion and relevance Despite the disparity between the sample sizes of both drugs, in our study erenumab showed greater reduction in migraine days in comparison with patients treated with galcanezumab. Both drugs were safe in all patients, showing mild adverse reactions that did not require intervention. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74576149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D. Canales, J. Teller, F. Torre, I. G. Barrios, Jandira Ramos, Maeva Montero, Jm Ferrari Piquero
{"title":"5PSQ-142 Safety of azole antifungals in transplanted patients receiving tacrolimus","authors":"D. Canales, J. Teller, F. Torre, I. G. Barrios, Jandira Ramos, Maeva Montero, Jm Ferrari Piquero","doi":"10.1136/EJHPHARM-2021-EAHPCONF.261","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.261","url":null,"abstract":"Background and importance Potential interaction between tacrolimus and azole antifungals is often detected in transplanted patients with fungal colonisation or infection. Aim and objectives To compare the influence of voriconazole and isavuconazole on maintenance of plasma levels of tacrolimus and to analyse their safety. Material and methods A retrospective observational study was conducted according to cluster classification in all patients immunosuppressed with tacrolimus and receiving concomitant treatment with voriconazole or isavuconazole over a 2 year period in a class 5 hospital. The variables collected included age, plasma levels of tacrolimus for 10 days after the start of the combination, and toxicity associated with azole throughout treatment with it. The standard deviation of tacrolimus levels was calculated to determine which of the antifungals had generated more oscillation in plasma levels. For qualitative variables, absolute and relative frequencies were obtained, and for quantitative variables, the median (IQR) were used. For hypothesis contrast, Fisher’s exact test or the Mann–Whitney U test was performed according to the type of variable. Results 45 patients were included, 23 received voriconazole and 22 isavuconazole. Median age was 62 years (56–67) for those receiving voriconazole versus 63 years (54–68) for those receiving isavuconazole (p=0.91). 34.8% (n=8) of patients treated with voriconazole achieved concentrations of tacrolimus >20 ng/mL (toxic concentration) within 10 days from the start of the combination compared with 14.3% (n=3) of patients treated with isavuconazole (p=0.1685). The median standard deviation of plasma concentrations was 3.76 ng/mL (2.89–4.5) with voriconazole versus 3.17 ng/mL (1.4–5) with isavuconazole (p=0.272). The proportion of patients who temporarily discontinued tacrolimus treatment due to high level concentrations and associated toxicity was 18.2% (n=4) with isavuconazole versus 34.8% (n=8) with voriconazole (p=0.318). Regarding tolerance to treatment, 28.57% of patients treated with isavuconazole had side effects associated with azole, compared with 82.6% of those treated with voriconazole (p Conclusion and relevance Treatment with isavuconazole resulted in fewer tacrolimus poisonings, although the difference was not statistically significant. In addition, treatment with isavuconazole was found to be safer, had fewer side effects and did not require antifungal discontinuation. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72915304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"4CPS-302 Sorafenib in hepatocarcinoma: results in a real world setting","authors":"J. Parada, M. Gomariz, Á. P. Pérez, Cátia Jesus","doi":"10.1136/EJHPHARM-2021-EAHPCONF.134","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.134","url":null,"abstract":"Background and importance Hepatocarcinoma (HCC) is the leading cause of mortality in cirrhotic patients. Sorafenib has been shown to increase survival and is considered firstline therapy for patients with advanced unresectable HCC who are unsuitable for locoregional therapy and whose liver function is adequate to tolerate therapy (Child Pugh A/B). Aim and objectives The aim of this study was to evaluate the effectiveness and safety of sorafenib in adults with metastatic HCC in our clinical practice, based on overall survival (OS) and report of adverse events. Material and methods An observational, retrospective, descriptive study was conducted between January 2018 and October 2020. Age, sex, Barcelona Clinic Liver Cancer (BCLC) staging, adverse events (AEs), need for dose reduction or discontinuation, and time to progression or death were collected from our electronic records. None of the patients had received previous systemic therapy. The analysis was performed using R 4.0.3. Results 47 patients with metastatic HCC were treated with sorafenib. Patient characteristics are shown in table 1. Median overall survival (mOS) was 17.9 months (range 0.5–24.0; 95% CI 15.5 to not reached). The main AEs observed were: fatigue (42.5%), hand–foot skin reactions (42.5%), anorexia (40.4%), diarrhoea (38.3%), hypertension (14.9%), abdominal pain (14.9%), digestive bleeding (12.7%) and pruritus (10.6%). The most common reasons for treatment discontinuation were AEs (14 patients) and progression (22 patients). The rate of discontinuation due to AEs was 29.8%. 34 patients (72.3%) required dose reduction. Conclusion and relevance In our setting, mOS was superior to that reported in the pivotal clinical trial even though baseline characteristics were similar. Some of the AEs were more frequent, such as fatigue, hand–foot skin reactions, hypertension and anorexia, although the rate of discontinuation due to AEs was lower than reported in the SHARP trial. References and/or acknowledgements Llovet JM, Ricci S, Mazzaferro V, et al. SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378–90. doi: 10.1056/NEJMoa0708857. PMID: 18650514. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"63 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80651056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Sotelo, L. Valdivieso, I. M. Niño, J. Crespo, A. F. García, D. B. Hernández
{"title":"1ISG-023 Pharmacoeconomic analysis of reference bevacizumab: opportunity for improved efficiency","authors":"A. Sotelo, L. Valdivieso, I. M. Niño, J. Crespo, A. F. García, D. B. Hernández","doi":"10.1136/EJHPHARM-2021-EAHPCONF.4","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.4","url":null,"abstract":"Background and importance The recent approval of bevacizumab biosimilar (Beva-Bs) raises the possibility of a more efficient drug therapy. Reference bevacizumab (Beva-Ref) was the cancer drug with the greatest impact in our health area in 2019. Aim and objectives To evaluate the pharmacoeconomic impact of Beva-Ref in oncological therapy in 2019 and to analyse measures that promote its therapeutic optimisation, such as more efficient dosage regimens (DR) and implementation of Beva-Bs. Material and methods This was a descriptive retrospective study made in a level II hospital. Farhos-v5.3.3 was used as the pharmacotherapeutic management tool for cancer patients treated with Beva-Ref during 2019. Economic data were collected from the Gestion–Farmatools module. Pharmacoeconomic analysis was done by therapeutic cost of Beva–Ref use in 2019. Therefore, cost/indication consumption and therapeutic scheme were recorded. Therapeutic optimisation measures analyses were conducted according to efficient DR, in concordance with the product monograph. Possibility of using Beva–Bs: hypothetical savings were estimated on 2019’s annual consumption, assuming switching to Beva–Bs: (a) 100% of patients; (b) only new patients. Variables (Excel): indication, new patient/continuation in 2019, therapeutic scheme and treatment time. Results 58 patients were treated in 2019. Total cost was 710 842€ and according to indication: nine breast cancer 210 106€ (30%); 25 metastatic colorectal cancer (mCRC) 205 671€ (29%); and 11 ovarian cancer 165 346€ (23%). 41 patients (71%) started treatment with a total cost of 406 897€, mostly: 21 mCRC 169 274€ (42%); 4 breast cancer 74 139€ (18%); and 7 ovarian cancer 65 776€ (16%). Treatment continuations: 17 patients (29%) at a cost of 303 945€, mainly 5 breast cancer 135 967€ (45%), 4 ovarian cancer 99 570€ (33%) and 4 mCRC 36 396€ (12%). The most efficient DR in mCRC was prescribed 100%. In the remaining diagnoses, DR was achieved, except for ovarian/endometrial cancer, with agreement of 45% and 0%, respectively. With respect to the possibility of using Beva-Bs: a saving of 312 800€ was estimated if switching to Beva-BS in all patients, with savings in breast cancer 92 450€, mCRC 90 500€ and ovarian cancer 72 750€. Considering only new patients, savings would be 179 000€, mostly mCRC, breast and ovarian cancer (74 500€, 32 600€ and 28 900€, respectively). Conclusion and relevance The 2019 results showed efficient DR, and consequently the potential for cost containment, given the incorporation of Beva-Bs into our therapeutic arsenal, and would be key for universal access to the best therapeutic option. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74739848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}