Pub Date : 2021-04-23DOI: 10.1136/ejhpharm-2021-002831
Stephanie Kohl
[ ]EAHP calls on the European Commission to make the mapping of the GMDN to the EMDN fully available before May 2021 since it is of relevance for the work of hospital pharmacists Hospital pharmacists should be involved in the selection, procurement and evaluation of medical devices in the hospital sector with other healthcare professionals, including the management of clinical trials with medical devices and the evaluation of software classified as a medical device [ ]EAHP would like to emphasise again the need for close collaboration between authorities and healthcare professionals Centring around the theme ‘Hospital Pharmacy 5 0 - the future of patient care’ the scientific programme developed by EAHP’s Scientific Committee did not only provide participants with a look forward but also looked back at the impact that the COVID-19 pandemic has had and still has on the profession Besides being reflected among the different poster submissions the topic also was the focus of two sessions looking at multi-disciplinary care for COVID-19 patients and the repurposing of treatment options
{"title":"EAHP opinion focusing on the application of the medical device regulations","authors":"Stephanie Kohl","doi":"10.1136/ejhpharm-2021-002831","DOIUrl":"https://doi.org/10.1136/ejhpharm-2021-002831","url":null,"abstract":"[ ]EAHP calls on the European Commission to make the mapping of the GMDN to the EMDN fully available before May 2021 since it is of relevance for the work of hospital pharmacists Hospital pharmacists should be involved in the selection, procurement and evaluation of medical devices in the hospital sector with other healthcare professionals, including the management of clinical trials with medical devices and the evaluation of software classified as a medical device [ ]EAHP would like to emphasise again the need for close collaboration between authorities and healthcare professionals Centring around the theme ‘Hospital Pharmacy 5 0 - the future of patient care’ the scientific programme developed by EAHP’s Scientific Committee did not only provide participants with a look forward but also looked back at the impact that the COVID-19 pandemic has had and still has on the profession Besides being reflected among the different poster submissions the topic also was the focus of two sessions looking at multi-disciplinary care for COVID-19 patients and the repurposing of treatment options","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"145 1","pages":"176 - 178"},"PeriodicalIF":0.0,"publicationDate":"2021-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89371160","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}
Pub Date : 2021-04-21DOI: 10.1136/ejhpharm-2021-002830
Stephanie Kohl
Updates from the European Medicines Agency The European Medicines Agency (EMA) published a direct to healthcare professional communication for Vaxzevria (previously COVID-19 Vaccine AstraZeneca), a plain-language description of medical terms related to medicines use and communications advising against the use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials and on the precautionary marketing suspension of the thalassaemia medicine Zynteglo Following recent media reports and publications on the use of ivermectin, EMA reviewed the latest published evidence from laboratory studies, observational studies, clinical trials and meta-analyses Precautionary marketing suspension of thalassaemia medicine Zynteglo The company that markets the gene therapy medicine Zynteglo for treating the rare blood condition beta thalassaemia has suspended sales pending investigation of a safety concern MDR infographic – identifying medical device software Medical devices are an essential part of the delivery of high-quality healthcare and their procurement and management in the European hospital setting is often under the authority of hospital pharmacist
{"title":"The European coalition for vaccination calls on healthcare professionals to get vaccinated against COVID-19","authors":"Stephanie Kohl","doi":"10.1136/ejhpharm-2021-002830","DOIUrl":"https://doi.org/10.1136/ejhpharm-2021-002830","url":null,"abstract":"Updates from the European Medicines Agency The European Medicines Agency (EMA) published a direct to healthcare professional communication for Vaxzevria (previously COVID-19 Vaccine AstraZeneca), a plain-language description of medical terms related to medicines use and communications advising against the use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials and on the precautionary marketing suspension of the thalassaemia medicine Zynteglo Following recent media reports and publications on the use of ivermectin, EMA reviewed the latest published evidence from laboratory studies, observational studies, clinical trials and meta-analyses Precautionary marketing suspension of thalassaemia medicine Zynteglo The company that markets the gene therapy medicine Zynteglo for treating the rare blood condition beta thalassaemia has suspended sales pending investigation of a safety concern MDR infographic – identifying medical device software Medical devices are an essential part of the delivery of high-quality healthcare and their procurement and management in the European hospital setting is often under the authority of hospital pharmacist","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"2 1","pages":"179 - 180"},"PeriodicalIF":0.0,"publicationDate":"2021-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72753815","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.214
C. Reimer, N. Gillard, A. Sennesael, E. Deflandre, P. Anrys, S. Demaret
Background and importance Transition of care (TOC) is a high risk period for medication errors. Discrepancies and incomplete medication information are common on hospital admission and discharge, potentially leading to drug related problems and adverse drug events at TOC. Aim and objectives The objectives of this study were to identify discrepancies on admission and at discharge and to detect the completeness of medication information in the discharge documents; and to assess the potential clinical impact of discrepancies. Material and methods A 4 week prospective interventional study was carried out in a 29 bed orthopaedic surgery ward of a regional hospital. On admission, the pharmacist compared his best possible medication history to previous medication histories and to prescriptions to identify discrepancies. They were classified by type, ATC classes and level of risk for the patient. Risk was evaluated by one physician and one clinical pharmacist assessing potential clinical impact and likelihood of occurrence. At discharge, completeness of medication related information in discharge letters and prescriptions was analysed. Discrepancies between inpatient treatment and discharge prescriptions were reported and their clinical impact was evaluated. Results 94 patients were included. On admission, 331 discrepancies with the previously recorded medication history were observed in 81 patients (92%). Regarding prescriptions, there were 97 unintentional discrepancies that impacted 41 patients (43.6%). Among these, 38 discrepancies (39.2%) were classified as high or extreme risk and involved psycholeptics, antidiabetic drugs and antithrombotic agents. Omission was the most common discrepancy. At discharge, 36 patients (40.4%) had at least a high or extreme risk discrepancy. Patients had a risk of treatment duplication. Antithrombotic agents were a major class in which patients were at extreme risk. Only 60% of drugs prescribed were found in the discharge letters. Conclusion and relevance Discrepancies and incomplete medication information are real issues at TOC. To improve patient care, the hospital pharmacist is a suitable and valuable healthcare professional. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-382 Impact of a clinical pharmacist at transition of care: a prospective study in an orthopaedic ward of a regional hospital","authors":"C. Reimer, N. Gillard, A. Sennesael, E. Deflandre, P. Anrys, S. Demaret","doi":"10.1136/EJHPHARM-2021-EAHPCONF.214","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.214","url":null,"abstract":"Background and importance Transition of care (TOC) is a high risk period for medication errors. Discrepancies and incomplete medication information are common on hospital admission and discharge, potentially leading to drug related problems and adverse drug events at TOC. Aim and objectives The objectives of this study were to identify discrepancies on admission and at discharge and to detect the completeness of medication information in the discharge documents; and to assess the potential clinical impact of discrepancies. Material and methods A 4 week prospective interventional study was carried out in a 29 bed orthopaedic surgery ward of a regional hospital. On admission, the pharmacist compared his best possible medication history to previous medication histories and to prescriptions to identify discrepancies. They were classified by type, ATC classes and level of risk for the patient. Risk was evaluated by one physician and one clinical pharmacist assessing potential clinical impact and likelihood of occurrence. At discharge, completeness of medication related information in discharge letters and prescriptions was analysed. Discrepancies between inpatient treatment and discharge prescriptions were reported and their clinical impact was evaluated. Results 94 patients were included. On admission, 331 discrepancies with the previously recorded medication history were observed in 81 patients (92%). Regarding prescriptions, there were 97 unintentional discrepancies that impacted 41 patients (43.6%). Among these, 38 discrepancies (39.2%) were classified as high or extreme risk and involved psycholeptics, antidiabetic drugs and antithrombotic agents. Omission was the most common discrepancy. At discharge, 36 patients (40.4%) had at least a high or extreme risk discrepancy. Patients had a risk of treatment duplication. Antithrombotic agents were a major class in which patients were at extreme risk. Only 60% of drugs prescribed were found in the discharge letters. Conclusion and relevance Discrepancies and incomplete medication information are real issues at TOC. To improve patient care, the hospital pharmacist is a suitable and valuable healthcare professional. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74162436","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.112
H. R. Ramallo, N. Gutiérrez, C. A. Vayo, M. Moreno
Background and importance Monitoring of methotrexate serum levels in osteosarcoma paediatric patients includes estimation of serum levels of methotrexate 24 hours after initiation of the infusion ([MTX24h]), which allows folinic acid rescue to be started at adjusted doses. When pharmacokinetic estimation is not possible, the standard rescue (15 mg/m2/6 hours) is recommended and subsequently adjusted according to the real [MTX24h]. Aim and objectives To evaluate the correlation and concordance of the estimated and real [MTX24h], and the benefits of the estimation in comparison with the dosage by protocol. Material and methods A retrospective study of paediatric patients treated with 12 g/m2 methotrexate monitored by the pharmacy department from January 2014 to June 2020 was conducted. Estimated [MTX24h] was determined with a Bayesian model with PKS software. Variables collected were age, sex, number of cycles received, estimated and real [MTX24h] and folinic rescue dose. Pearson and intraclass correlation coefficients between real and estimated [MTX24h] were calculated. The agreement between the dosage of folinic acid by protocol and by estimating [MTX24h] was assessed with the Cohen kappa coefficient. Results 23 patients, 56.5% (13) men, median age 14 (4–17) years, received 152 cycles of methotrexate. The median number of cycles per patients was 8 (2–8). Median estimated [MTX24h] was 7 (2–80) and real [MTX24h] was 8 (1–85). The Pearson’s correlation coefficient and intraclass correlation coefficient for real and estimated [MTX24h] were r=0.949 and CCI=0.974, respectively, indicating a high linear correlation and concordance between the two. In 71.8% (94) of the cycles, the estimated folinic rescue matched with the dose which the patient should receive according to real [MTX24h]. Assuming the dosing of folinic acid at 24 hours by protocol (15 mg/m2/6 hours) in all cases, only 35.1% (46) of patients would have received the correct dose. The Cohen kappa between the two methods was 0.189, indicating only slight agreement between both methods in favour of estimating [MTX24h]. Conclusion and relevance Estimated and real [MTX24h] showed high correlation and concordance, and in most cases the folinic acid rescue dose was correctly administered based on the estimated [MTX24h]. These results seem to indicate that the estimation of [MTX24h] and posterior estimation of folinic acid rescue are superior to systematic administration of 15 mg/m2/6 hours. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-280 Benefits of pharmacokinetic estimation of methotrexate levels in paediatric osteosarcoma patients","authors":"H. R. Ramallo, N. Gutiérrez, C. A. Vayo, M. Moreno","doi":"10.1136/EJHPHARM-2021-EAHPCONF.112","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.112","url":null,"abstract":"Background and importance Monitoring of methotrexate serum levels in osteosarcoma paediatric patients includes estimation of serum levels of methotrexate 24 hours after initiation of the infusion ([MTX24h]), which allows folinic acid rescue to be started at adjusted doses. When pharmacokinetic estimation is not possible, the standard rescue (15 mg/m2/6 hours) is recommended and subsequently adjusted according to the real [MTX24h]. Aim and objectives To evaluate the correlation and concordance of the estimated and real [MTX24h], and the benefits of the estimation in comparison with the dosage by protocol. Material and methods A retrospective study of paediatric patients treated with 12 g/m2 methotrexate monitored by the pharmacy department from January 2014 to June 2020 was conducted. Estimated [MTX24h] was determined with a Bayesian model with PKS software. Variables collected were age, sex, number of cycles received, estimated and real [MTX24h] and folinic rescue dose. Pearson and intraclass correlation coefficients between real and estimated [MTX24h] were calculated. The agreement between the dosage of folinic acid by protocol and by estimating [MTX24h] was assessed with the Cohen kappa coefficient. Results 23 patients, 56.5% (13) men, median age 14 (4–17) years, received 152 cycles of methotrexate. The median number of cycles per patients was 8 (2–8). Median estimated [MTX24h] was 7 (2–80) and real [MTX24h] was 8 (1–85). The Pearson’s correlation coefficient and intraclass correlation coefficient for real and estimated [MTX24h] were r=0.949 and CCI=0.974, respectively, indicating a high linear correlation and concordance between the two. In 71.8% (94) of the cycles, the estimated folinic rescue matched with the dose which the patient should receive according to real [MTX24h]. Assuming the dosing of folinic acid at 24 hours by protocol (15 mg/m2/6 hours) in all cases, only 35.1% (46) of patients would have received the correct dose. The Cohen kappa between the two methods was 0.189, indicating only slight agreement between both methods in favour of estimating [MTX24h]. Conclusion and relevance Estimated and real [MTX24h] showed high correlation and concordance, and in most cases the folinic acid rescue dose was correctly administered based on the estimated [MTX24h]. These results seem to indicate that the estimation of [MTX24h] and posterior estimation of folinic acid rescue are superior to systematic administration of 15 mg/m2/6 hours. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76584585","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.310
D. Murphy, K. Holacka, J. Brown
Background and importance A new general drug chart was introduced in May 2019. The chart was developed in response to medication incidents and in line with national medication record templates. The new drug chart has a new configuration and format for prescribing. Changes include dedicated sections for anticoagulants and antimicrobials and a venous thromboembolism and bleeding risk assessment (VTE-RA) tool, which was previously available on the hospital intranet. Aim and objectives To assess the implementation of this change in prescribing practice. Material and methods A data collection form was designed using the hospital’s ‘prescribing and drug administration standards’. This document describes how prescribers and nursing staff are to use the drug chart. Guidelines include where to prescribe specific medication, use of abbreviations and general best practice guidelines. Data were collected by nurse and pharmacist volunteers in September 2019. A target sample size of approximately 275 patients was chosen as this equates to half of the inpatients. A convenience sample was collected. Data collectors were assigned to collect data on specific wards until the target sample number was reached. Anonymised data were analysed by pharmacy staff using Microsoft Excel. Descriptive statistics were calculated. Results 273 drug charts were reviewed. An average of 16 medicines were prescribed per patient (range 1–41). 75% (n=204) of patients were prescribed an anticoagulant, however, only 3% (n=8) of patients had the VTE–RA tool completed by the medical team. The majority of anticoagulant (99.5%) and antimicrobial (95%) prescriptions were written in the correct section. The surgical antimicrobial prophylaxis (SAP) section was used in 42% (n=11) of applicable cases. For patients prescribed an antimicrobial requiring therapeutic drug monitoring (TDM), the correct section was always used. Completion of target and attained levels was documented for 38% and 35% of patients on TDM antimicrobials, respectively. Documentation of ‘proposed duration’ and ‘clinical indication’ for antimicrobials was 25% and 50%, respectively. Conclusion and relevance The new general drug chart is being used in line with hospital standards in most instances. Topics that could be targeted for improvement include the use of the SAP section, documentation of target/attained levels of TDM antimicrobials and specifying ‘proposed duration’ and ‘clinical indication’ for antimicrobials. Research on the appropriate completion of the VTE-RA tool is currently underway. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"5PSQ-191 New general drug chart, post-implementation clinical audit","authors":"D. Murphy, K. Holacka, J. Brown","doi":"10.1136/EJHPHARM-2021-EAHPCONF.310","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.310","url":null,"abstract":"Background and importance A new general drug chart was introduced in May 2019. The chart was developed in response to medication incidents and in line with national medication record templates. The new drug chart has a new configuration and format for prescribing. Changes include dedicated sections for anticoagulants and antimicrobials and a venous thromboembolism and bleeding risk assessment (VTE-RA) tool, which was previously available on the hospital intranet. Aim and objectives To assess the implementation of this change in prescribing practice. Material and methods A data collection form was designed using the hospital’s ‘prescribing and drug administration standards’. This document describes how prescribers and nursing staff are to use the drug chart. Guidelines include where to prescribe specific medication, use of abbreviations and general best practice guidelines. Data were collected by nurse and pharmacist volunteers in September 2019. A target sample size of approximately 275 patients was chosen as this equates to half of the inpatients. A convenience sample was collected. Data collectors were assigned to collect data on specific wards until the target sample number was reached. Anonymised data were analysed by pharmacy staff using Microsoft Excel. Descriptive statistics were calculated. Results 273 drug charts were reviewed. An average of 16 medicines were prescribed per patient (range 1–41). 75% (n=204) of patients were prescribed an anticoagulant, however, only 3% (n=8) of patients had the VTE–RA tool completed by the medical team. The majority of anticoagulant (99.5%) and antimicrobial (95%) prescriptions were written in the correct section. The surgical antimicrobial prophylaxis (SAP) section was used in 42% (n=11) of applicable cases. For patients prescribed an antimicrobial requiring therapeutic drug monitoring (TDM), the correct section was always used. Completion of target and attained levels was documented for 38% and 35% of patients on TDM antimicrobials, respectively. Documentation of ‘proposed duration’ and ‘clinical indication’ for antimicrobials was 25% and 50%, respectively. Conclusion and relevance The new general drug chart is being used in line with hospital standards in most instances. Topics that could be targeted for improvement include the use of the SAP section, documentation of target/attained levels of TDM antimicrobials and specifying ‘proposed duration’ and ‘clinical indication’ for antimicrobials. Research on the appropriate completion of the VTE-RA tool is currently underway. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84218810","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.271
Marianna Veraldi, S. Esposito, Cristina Zito, C. Monopoli, Naturale, A. Francesco
Background and importance Non-small cell lung carcinoma (NSCLC) accounts for 85–90% of all forms of lung cancer. In recent years, the development of immune checkpoint inhibitors has completely changed the therapeutic landscape of NSCLC and changed treatment standards. Immuno-oncology is a promising therapeutic option based on the use of synthetic antibodies, such as nivolumab and pembrolizumab which can both improve the survival of patients. All this represents a valid new approach, but the high cost requires a specific evaluation of health outcomes. Aim and objectives The main aim of this retrospective observational study was to analyse the characteristics of NSCLC patients, treatment outcomes and costs of treatment of advanced stage NSCLC with nivolumab and pembrolizumab in an Italian teaching hospital in a cohort of 102 selected patients. Material and methods A retrospective observational analysis was conducted in patients treated with immune checkpoint inhibitors from September 2016 to September 2020 at the university hospital ‘Mater Domini’ in Catanzaro, Italy. Data sources were medical records, internal prescription cards and reports of adverse reactions. Results 102 patients (89.2% men) were diagnosed with advanced NSCLC, 69.6% characterised by a non-squamous histology and 30.4% squamous. Firstline treatment with pembrolizumab was administered to 53 patients for an average of 11.5 months, 9 of whom were receiving innovative treatment with pembrolizumab+pemetrexed as firstline treatment with an average annual patient cost of 4915.78€, while 49 patients were treated with nivolumab for an average of 16.5 months with an average annual patient cost of 11 306.08€. The data showed a survival rate of 64.8% after 12 months, 57.9% after 24 months and 48.1% after 36 months. Most patients received immunotherapy as firstline and the others as subsequent treatment. Conclusion and relevance Currently, there are numerous clinical studies for NSCLC but no study has compared immunotherapy treatments. From this study, based on real world data, it emerged that the impact on budget was greater for nivolumab which had a higher survival value than pembrolizumab. This analysis was a first step in assessing the impact of introducing a significant new class of treatments, immunotherapy, comparing two drugs that have totally changed the prognosis of NSCLC patients. References and/or acknowledgements NCCN guidelines insights: NSCLC, V.5.2018. Conflict of interest No conflict of interest
{"title":"5PSQ-152 Real world efficacy and cost data on patients with metastatic non-small cell lung cancer treated with checkpoint inhibitors in an Italian university hospital in September 2016–2020","authors":"Marianna Veraldi, S. Esposito, Cristina Zito, C. Monopoli, Naturale, A. Francesco","doi":"10.1136/EJHPHARM-2021-EAHPCONF.271","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.271","url":null,"abstract":"Background and importance Non-small cell lung carcinoma (NSCLC) accounts for 85–90% of all forms of lung cancer. In recent years, the development of immune checkpoint inhibitors has completely changed the therapeutic landscape of NSCLC and changed treatment standards. Immuno-oncology is a promising therapeutic option based on the use of synthetic antibodies, such as nivolumab and pembrolizumab which can both improve the survival of patients. All this represents a valid new approach, but the high cost requires a specific evaluation of health outcomes. Aim and objectives The main aim of this retrospective observational study was to analyse the characteristics of NSCLC patients, treatment outcomes and costs of treatment of advanced stage NSCLC with nivolumab and pembrolizumab in an Italian teaching hospital in a cohort of 102 selected patients. Material and methods A retrospective observational analysis was conducted in patients treated with immune checkpoint inhibitors from September 2016 to September 2020 at the university hospital ‘Mater Domini’ in Catanzaro, Italy. Data sources were medical records, internal prescription cards and reports of adverse reactions. Results 102 patients (89.2% men) were diagnosed with advanced NSCLC, 69.6% characterised by a non-squamous histology and 30.4% squamous. Firstline treatment with pembrolizumab was administered to 53 patients for an average of 11.5 months, 9 of whom were receiving innovative treatment with pembrolizumab+pemetrexed as firstline treatment with an average annual patient cost of 4915.78€, while 49 patients were treated with nivolumab for an average of 16.5 months with an average annual patient cost of 11 306.08€. The data showed a survival rate of 64.8% after 12 months, 57.9% after 24 months and 48.1% after 36 months. Most patients received immunotherapy as firstline and the others as subsequent treatment. Conclusion and relevance Currently, there are numerous clinical studies for NSCLC but no study has compared immunotherapy treatments. From this study, based on real world data, it emerged that the impact on budget was greater for nivolumab which had a higher survival value than pembrolizumab. This analysis was a first step in assessing the impact of introducing a significant new class of treatments, immunotherapy, comparing two drugs that have totally changed the prognosis of NSCLC patients. References and/or acknowledgements NCCN guidelines insights: NSCLC, V.5.2018. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84898898","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.99
J. D. Valencia, A. Pintado-Álvarez, R. T. Bermejo, I. Castillo
Background and importance Carboplatin is one of the antineoplastics in which the dose must be adjusted according to the glomerular filtration rate (GFR) and the area under the curve (AUC). The Cockroft–Gault equation is the most widely used for the calculation of GFR and the Calvert formula is the most commonly used for carboplatin dosing. The Cockroft–Gault equation has two variables (weight and serum creatinine) that depend on the body composition of the patient, and therefore overweight and cachectic people are at risk of undergoing inappropriate carboplatin dosing. Aim and objectives To analyse carboplatin dosage in cancer patients to determine whether they are over or underdosed in comparison with the theoretical dose during the first cycle, and to determine the relationship between the dosage received in this cycle and dose reduction in subsequent cycles, as a result of side effects. Material and methods This was a retrospective analysis of prescriptions of chemotherapy with carboplatin conducted in 2019. The variables collected were: anthropometric data (age and sex), number of cycles, chemotherapy scheme, diagnosis, analytical data and dose of carboplatin prescribed based on the AUC of the scheme. They were used as tools to support pharmaceutical validation: creatinine clearance (CrCl) according to the Cockroft–Gault equation and Calvert formula. The mean per cent error (MPE) was used to determine the relationship between the dose received and the theoretical dose calculation during the first cycle. The Shapiro–Wilks test was used to see if the cohort was parametric and the Mann–Whitney U test to assess the possible relationship between the patient’s dosage during the first cycle and dose reduction in subsequent cycles. Results 50 patients were selected, 84% were men and mean age was 66.72±6.66 years. After assessment, 25 patients (50%) received higher doses than the theoretical dose calculation. The mean MPE value (with standard error) for this group was 15.88 ±2.7%. In total, six patients in this group underwent dose reduction due to toxicity related to overdose. No link was found with dose reduction in subsequent cycles for this cohort of patients after performing statistic analyses. Conclusion and relevance Not using adjusted body weight in obese patient or capping the level of serum creatinine in cachectic patients (0.7–0.8 mg/dL) may lead to incorrect doses of carboplatin and subsequent toxicity (neutropenia and thrombocytopenia). References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-267 Retrospective analysis of carboplatin dosing prescribed in a chemotherapy regimen and its relationship with toxicity","authors":"J. D. Valencia, A. Pintado-Álvarez, R. T. Bermejo, I. Castillo","doi":"10.1136/EJHPHARM-2021-EAHPCONF.99","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.99","url":null,"abstract":"Background and importance Carboplatin is one of the antineoplastics in which the dose must be adjusted according to the glomerular filtration rate (GFR) and the area under the curve (AUC). The Cockroft–Gault equation is the most widely used for the calculation of GFR and the Calvert formula is the most commonly used for carboplatin dosing. The Cockroft–Gault equation has two variables (weight and serum creatinine) that depend on the body composition of the patient, and therefore overweight and cachectic people are at risk of undergoing inappropriate carboplatin dosing. Aim and objectives To analyse carboplatin dosage in cancer patients to determine whether they are over or underdosed in comparison with the theoretical dose during the first cycle, and to determine the relationship between the dosage received in this cycle and dose reduction in subsequent cycles, as a result of side effects. Material and methods This was a retrospective analysis of prescriptions of chemotherapy with carboplatin conducted in 2019. The variables collected were: anthropometric data (age and sex), number of cycles, chemotherapy scheme, diagnosis, analytical data and dose of carboplatin prescribed based on the AUC of the scheme. They were used as tools to support pharmaceutical validation: creatinine clearance (CrCl) according to the Cockroft–Gault equation and Calvert formula. The mean per cent error (MPE) was used to determine the relationship between the dose received and the theoretical dose calculation during the first cycle. The Shapiro–Wilks test was used to see if the cohort was parametric and the Mann–Whitney U test to assess the possible relationship between the patient’s dosage during the first cycle and dose reduction in subsequent cycles. Results 50 patients were selected, 84% were men and mean age was 66.72±6.66 years. After assessment, 25 patients (50%) received higher doses than the theoretical dose calculation. The mean MPE value (with standard error) for this group was 15.88 ±2.7%. In total, six patients in this group underwent dose reduction due to toxicity related to overdose. No link was found with dose reduction in subsequent cycles for this cohort of patients after performing statistic analyses. Conclusion and relevance Not using adjusted body weight in obese patient or capping the level of serum creatinine in cachectic patients (0.7–0.8 mg/dL) may lead to incorrect doses of carboplatin and subsequent toxicity (neutropenia and thrombocytopenia). References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"46 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80370310","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.168
C. Quintens, J. Coster, L. Linden, B. Morlion, E. Nijns, B. V. D. Bosch, W. Peetermans, I. Spriet
Background and importance Pain therapy in inpatients is regularly suboptimal and might be improved by clinical pharmacy services with the aim of optimising pain control and reducing iatrogenic harm related to adverse drug events and overuse. In our hospital, we have implemented a software supported check of medication appropriateness (CMA), which is a centralised pharmacist led service consisting of a clinical rule based screening for potentially inappropriate prescriptions (PIPs) and a subsequent medication review by pharmacists. Aim and objectives We aimed to investigate the impact of the CMA on pain related prescribing. Material and methods A quasi-experimental study was performed in a 1995 bed tertiary hospital, using an interrupted time series design. Pre-implementation, patients were exposed to standard of care. Afterwards, a pain focused CMA comprising 12 clinical rules pertaining to analgesic prescribing were implemented in the post-implementation period. A regression model was used to assess the impact of the intervention on the number of pain related residual PIPs. For the pre-implementation period, data collection was performed retrospectively (January 2016 to December 2018). Post-implementation (January 2019 to July 2020), an initial PIP was identified prospectively in the CMA. The total number of recommendations and acceptance rate were recorded for the post-implementation period. Results At baseline, the median proportion of residual PIPs was 69.0% (range 50.0–83.3%) with a median number of 13.1 (range 9.5–15.8) residual PIPs per day. After the CMA intervention, the median proportion and median number decreased to 11.8% (range 0–50%) and 2.2 (range 0–9.5), respectively. Clinical rules showed an immediate relative reduction of 66% (p Conclusion and relevance We proved that the CMA approach improved analgesic prescribing, as the number of pain related residual PIPs was reduced in a highly significant and sustained manner. The downward trend in the post-implementation period might indicate a learning effect on physicians, resulting in a higher acceptance rate of recommendations over time. More pharmacist involvement and the use of clinical rules during hospital stay should be further promoted to optimise appropriate prescribing of analgesics. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-336 Impact of check of medication appropriateness (CMA) in optimising analgesic prescribing","authors":"C. Quintens, J. Coster, L. Linden, B. Morlion, E. Nijns, B. V. D. Bosch, W. Peetermans, I. Spriet","doi":"10.1136/EJHPHARM-2021-EAHPCONF.168","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.168","url":null,"abstract":"Background and importance Pain therapy in inpatients is regularly suboptimal and might be improved by clinical pharmacy services with the aim of optimising pain control and reducing iatrogenic harm related to adverse drug events and overuse. In our hospital, we have implemented a software supported check of medication appropriateness (CMA), which is a centralised pharmacist led service consisting of a clinical rule based screening for potentially inappropriate prescriptions (PIPs) and a subsequent medication review by pharmacists. Aim and objectives We aimed to investigate the impact of the CMA on pain related prescribing. Material and methods A quasi-experimental study was performed in a 1995 bed tertiary hospital, using an interrupted time series design. Pre-implementation, patients were exposed to standard of care. Afterwards, a pain focused CMA comprising 12 clinical rules pertaining to analgesic prescribing were implemented in the post-implementation period. A regression model was used to assess the impact of the intervention on the number of pain related residual PIPs. For the pre-implementation period, data collection was performed retrospectively (January 2016 to December 2018). Post-implementation (January 2019 to July 2020), an initial PIP was identified prospectively in the CMA. The total number of recommendations and acceptance rate were recorded for the post-implementation period. Results At baseline, the median proportion of residual PIPs was 69.0% (range 50.0–83.3%) with a median number of 13.1 (range 9.5–15.8) residual PIPs per day. After the CMA intervention, the median proportion and median number decreased to 11.8% (range 0–50%) and 2.2 (range 0–9.5), respectively. Clinical rules showed an immediate relative reduction of 66% (p Conclusion and relevance We proved that the CMA approach improved analgesic prescribing, as the number of pain related residual PIPs was reduced in a highly significant and sustained manner. The downward trend in the post-implementation period might indicate a learning effect on physicians, resulting in a higher acceptance rate of recommendations over time. More pharmacist involvement and the use of clinical rules during hospital stay should be further promoted to optimise appropriate prescribing of analgesics. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77027141","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}
Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.15
Mdp Briceño Casado, S. Fénix-Caballero, V. Gimeno-Ballester, M. Domínguez-Cantero, B De La Calle Riaguas, E. A. Rey
Background and importance Multiple therapeutic alternatives are used in untreated metastatic squamous non-small cell lung cancer (umSNSCLC). Paclitaxel–carboplatin–pembrolizumab combination (PC-pembrolizumab) has recently been authorised for this indication. Aim and objectives To assess the comparative efficacy among different therapeutic alternatives used in mSNSCLC through a network meta-analysis (NMA). Material and methods A search was conducted on 19 February 2020 with the following inclusion criteria: phase II/III randomised clinical trials (RCT), including drugs used in umSNSCLC, and overall survival (OS) as the efficacy endpoint. Exclusion criteria: mSNSCLC population with EGFR or ALK mutations and RCTs without a comparator common to the evaluated alternatives. Pooled hazard ratios (HR) were calculated by Bayesian methods, through the combination of direct and indirect evidence by the NMA. Fixed and random effects were evaluated. Deviance information criteria (DIC) statistics were used to compare the models. The agreement of direct and indirect estimations was assessed by node splitting models to evaluate the consistency of NMA. Delta value, maximum acceptable difference as clinical criterion of non-inferiority, was set at 0.70 (and its inverse, 1.43), used to calculate the sample size in the PC-pembrolizumab trial. Results Nine RCTs were selected. PC was the common comparator. The DIC value for the fixed effects model was more favourable. No statistically significant differences between direct and indirect evidence were found, and therefore NMA was consistent. The PC-pembrolizumab combination was considered as the reference (treatment with the greatest magnitude of effect). HR for OS were: 1.4 (95% CI 0.89 to 2.3) versus carboplatin–gemcitabine; 1.6 (1.2 to 2.1) versus PC; 1.5 (1.1 to 2.1) versus nab–PC-atezolizumab; 1.8 (1.3 to 2.5) versus PC-figitumumab; 1.4 (0.96 to 2.0) versus PC-motesanib; 1.3 (0.66 to 2.5) versus PC-necitumumab; 2.1 (0.86 to 5.0) versus PC-olaratumab; 2.9 (1.7 to 4.8) versus PC-sorafenib and 1.2 (0.82 to 1.7) versus pembrolizumab monotherapy. Carboplatin–gemcitabine, PC-motesanib, PC-necitumumab, PC-olaratumab and pembrolizumab did not present statistically significant differences compared with PC-pembrolizumab. Statistically significant benefit was observed for PC-pembrolizumab over PC, nab–PC-atezolizumab, PC-figitumumab and PC-sorafenib. According to the delta values, there could be clinically relevant differences among them. Conclusion and relevance NMA showed no significant differences in OS between PC-pembrolizumab and carboplatin–gemcitabine, PC-motesanib, PC-necitumumab, PC-olaratumab and pembrolizumab in umSNSCLC, but there could be clinically relevant differences. PC, nab–PC-atezolizumab, PC-figitumumab and PC-sorafenib were inferior to PC-pembrolizumab, with possible clinically relevant differences. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性在未经治疗的转移性鳞状非小细胞肺癌(umSNSCLC)中使用多种治疗方案。紫杉醇-卡铂-派姆单抗组合(PC-pembrolizumab)最近被批准用于这一适应症。目的和目的通过网络荟萃分析(NMA)评估不同治疗方案在mSNSCLC中的比较疗效。材料和方法于2020年2月19日进行了一项检索，纳入标准如下:II/III期随机临床试验(RCT)，包括用于umSNSCLC的药物，总生存期(OS)作为疗效终点。排除标准:伴有EGFR或ALK突变的mSNSCLC人群和没有与评估备选方案共同比较物的随机对照试验。通过NMA的直接和间接证据相结合，采用贝叶斯方法计算合并风险比(HR)。评估固定效应和随机效应。采用偏差信息标准(DIC)统计对模型进行比较。通过节点分裂模型对直接估计和间接估计的一致性进行评估，以评价NMA的一致性。作为非劣效性临床标准的最大可接受差异的Delta值设置为0.70(其倒数为1.43)，用于计算PC-pembrolizumab试验中的样本量。结果共选择9个rct。PC是常用的比较物。固定效应模型的DIC值更有利。在直接和间接证据之间没有发现统计学上的显著差异，因此NMA是一致的。将PC-pembrolizumab联合作为参考(效果最大的治疗)。与卡铂-吉西他滨相比，OS的HR为1.4 (95% CI 0.89至2.3);1.6 (1.2 - 2.1) vs PC;1.5 (1.1 - 2.1) vs nab-PC-atezolizumab;1.8 (1.3 - 2.5) vs PC-figitumumab;1.4 (0.96 - 2.0) vs PC-motesanib;1.3 (0.66 - 2.5) vs PC-necitumumab;2.1 (0.86 - 5.0) vs PC-olaratumab;与pc -索拉非尼相比，2.9(1.7至4.8)，与派姆单抗单药相比，1.2(0.82至1.7)。卡铂-吉西他滨、PC-motesanib、PC-necitumumab、PC-olaratumab和派姆单抗与pc -派姆单抗相比，差异无统计学意义。统计学上，PC-pembrolizumab优于PC、nab-PC-atezolizumab、PC-figitumumab和PC-sorafenib。根据delta值，两者之间可能存在临床相关的差异。结论及相关性NMA显示PC-pembrolizumab与卡铂-吉西他滨、PC-motesanib、PC-necitumumab、PC-olaratumab和pembrolizumab在umSNSCLC中的OS无显著差异，但可能存在临床相关差异。PC、nab-PC-atezolizumab、PC-figitumumab和PC-sorafenib均劣于PC-pembrolizumab，可能存在临床相关差异。参考文献和/或致谢利益冲突无利益冲突
{"title":"2SPD-032 Network meta-analysis of therapeutic alternatives in untreated metastatic squamous non-small cell lung cancer","authors":"Mdp Briceño Casado, S. Fénix-Caballero, V. Gimeno-Ballester, M. Domínguez-Cantero, B De La Calle Riaguas, E. A. Rey","doi":"10.1136/EJHPHARM-2021-EAHPCONF.15","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.15","url":null,"abstract":"Background and importance Multiple therapeutic alternatives are used in untreated metastatic squamous non-small cell lung cancer (umSNSCLC). Paclitaxel–carboplatin–pembrolizumab combination (PC-pembrolizumab) has recently been authorised for this indication. Aim and objectives To assess the comparative efficacy among different therapeutic alternatives used in mSNSCLC through a network meta-analysis (NMA). Material and methods A search was conducted on 19 February 2020 with the following inclusion criteria: phase II/III randomised clinical trials (RCT), including drugs used in umSNSCLC, and overall survival (OS) as the efficacy endpoint. Exclusion criteria: mSNSCLC population with EGFR or ALK mutations and RCTs without a comparator common to the evaluated alternatives. Pooled hazard ratios (HR) were calculated by Bayesian methods, through the combination of direct and indirect evidence by the NMA. Fixed and random effects were evaluated. Deviance information criteria (DIC) statistics were used to compare the models. The agreement of direct and indirect estimations was assessed by node splitting models to evaluate the consistency of NMA. Delta value, maximum acceptable difference as clinical criterion of non-inferiority, was set at 0.70 (and its inverse, 1.43), used to calculate the sample size in the PC-pembrolizumab trial. Results Nine RCTs were selected. PC was the common comparator. The DIC value for the fixed effects model was more favourable. No statistically significant differences between direct and indirect evidence were found, and therefore NMA was consistent. The PC-pembrolizumab combination was considered as the reference (treatment with the greatest magnitude of effect). HR for OS were: 1.4 (95% CI 0.89 to 2.3) versus carboplatin–gemcitabine; 1.6 (1.2 to 2.1) versus PC; 1.5 (1.1 to 2.1) versus nab–PC-atezolizumab; 1.8 (1.3 to 2.5) versus PC-figitumumab; 1.4 (0.96 to 2.0) versus PC-motesanib; 1.3 (0.66 to 2.5) versus PC-necitumumab; 2.1 (0.86 to 5.0) versus PC-olaratumab; 2.9 (1.7 to 4.8) versus PC-sorafenib and 1.2 (0.82 to 1.7) versus pembrolizumab monotherapy. Carboplatin–gemcitabine, PC-motesanib, PC-necitumumab, PC-olaratumab and pembrolizumab did not present statistically significant differences compared with PC-pembrolizumab. Statistically significant benefit was observed for PC-pembrolizumab over PC, nab–PC-atezolizumab, PC-figitumumab and PC-sorafenib. According to the delta values, there could be clinically relevant differences among them. Conclusion and relevance NMA showed no significant differences in OS between PC-pembrolizumab and carboplatin–gemcitabine, PC-motesanib, PC-necitumumab, PC-olaratumab and pembrolizumab in umSNSCLC, but there could be clinically relevant differences. PC, nab–PC-atezolizumab, PC-figitumumab and PC-sorafenib were inferior to PC-pembrolizumab, with possible clinically relevant differences. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88022309","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}
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