Pub Date : 2021-03-01DOI: 10.1136/EJHPHARM-2021-EAHPCONF.170
JL Ortiz Latorre, N. Casanova, C. Lopez, E. Yáñez, I. Moya-Carmona
Background and importance Tocilizumab is an anti-human IL-6 receptor monoclonal antibody used in the treatment of cytokine release syndrome in patients with pneumonia associated with coronavirus disease. Despite the data from the COVACTA study, tocilizumab continues to be the gold standard for patients in our centre. Aim and objectives To describe the use of tocilizumab in the first peak versus the second peak of the SARS-CoV-2 pandemic, and to describe the results of the use of tocilizumab in both situations. Material and methods All patients treated with tocilizumab were included in the study periods: first peak (March to June 2020) and second peak (August to the present 2020). Demographic and clinical variables were collected. Data were obtained from the electronic medical records and prescription applications. Results 65 patients were included, 36 patients (55.38%) in the first peak versus 29 patients (44.62%) in the second peak. Conclusion and relevance In the first peak, tocilizumab was prescribed to more serious patients: those admitted to the ICU, with a higher FINE score and needing aggressive support therapy. In addition, it was prescribed in patients with a higher D-dimer. Doses and number of administrations were higher in the first peak. New scientific evidence led to the use of different concomitant treatments in the second peak: corticosteroids (second peak dexamethasone versus first peak methylprednisolone) and antiviral therapy (only remdesivir in the second peak). In the second peak, hospital and ICU stays were shorter, probably because tocilizumab was used in less serious patients. Despite this, no differences in mortality were observed. A study limitation was sample size. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-338 Use and efficacy of tocilizumab in patients with severe COVID-19 pneumonia","authors":"JL Ortiz Latorre, N. Casanova, C. Lopez, E. Yáñez, I. Moya-Carmona","doi":"10.1136/EJHPHARM-2021-EAHPCONF.170","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.170","url":null,"abstract":"Background and importance Tocilizumab is an anti-human IL-6 receptor monoclonal antibody used in the treatment of cytokine release syndrome in patients with pneumonia associated with coronavirus disease. Despite the data from the COVACTA study, tocilizumab continues to be the gold standard for patients in our centre. Aim and objectives To describe the use of tocilizumab in the first peak versus the second peak of the SARS-CoV-2 pandemic, and to describe the results of the use of tocilizumab in both situations. Material and methods All patients treated with tocilizumab were included in the study periods: first peak (March to June 2020) and second peak (August to the present 2020). Demographic and clinical variables were collected. Data were obtained from the electronic medical records and prescription applications. Results 65 patients were included, 36 patients (55.38%) in the first peak versus 29 patients (44.62%) in the second peak. Conclusion and relevance In the first peak, tocilizumab was prescribed to more serious patients: those admitted to the ICU, with a higher FINE score and needing aggressive support therapy. In addition, it was prescribed in patients with a higher D-dimer. Doses and number of administrations were higher in the first peak. New scientific evidence led to the use of different concomitant treatments in the second peak: corticosteroids (second peak dexamethasone versus first peak methylprednisolone) and antiviral therapy (only remdesivir in the second peak). In the second peak, hospital and ICU stays were shorter, probably because tocilizumab was used in less serious patients. Despite this, no differences in mortality were observed. A study limitation was sample size. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83575239","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.144
J. D. Menendez, A. R. Amallo, C. Gallego, M Vara Urruchua, U Blazquez Urtizberea, S. V. Hidalgo, E Oñate Muzas, E. T. Orbegozo, A. Arredondo
Background and importance The role of the pharmacist in the validation and dispensing of medications is already known. But the increasingly frequent use of high cost drugs makes that role essential for the sustainability of health systems. Aim and objectives To describe and analyse the pharmaceutical interventions carried out in a non-oncohaematological daily hospital (NOHDH) and to evaluate the economic impact of these interventions. Material and methods From April 2019 to March 2020, pharmacist interventions in the validation and dispensing of electronic prescriptions of intravenous treatments in the NOHDH were recorded. It should be noted that preparation of infusions is not centralised in the pharmacy but is carried out in the daily hospital units. Infusions prepared in the pharmacy, acute treatments and intravenous iron were excluded. To calculate the economic impact, only the dose administered and the average cost of drugs during the year of the study were considered. Results 30 interventions were carried out in 434 patients (6.9% patients) and 2240 dispensations (1.3% dispensations). 29 were accepted (97%). They were classified according to the type of intervention: 15 presentation changes (14 to a biosimilar), 10 dose adjustments (5 to commercial presentations), 4 request errors (1 of dose and 3 of administration date) and 1 change of medication. Intervention according to services: 10 rheumatology (9.6% of patients and 2.2% of dispensations), 5 nephrology (26.3% and 11.4%), 4 digestive (2% and 0.4%), 4 neurology (11.1% and 1.3%), 3 nursing unit (0.7% and 0.13%), 1 haematology (7.7% and 1.9%), 1 allergy (4.3% and 0, 61%), 1 paediatrics (10% and 2%) and other (9.1% and 3.6%). Intervention according to drug: 10 rituximab (23.3% and 11.5%), 7 infliximab (3.6% and 0.74%), 5 immunoglobulins (9.8% and 1.1%), 4 tocilizumab (16.7% and 3.3%), 3 vedolizumab (5.6% and 1.1%) and 1 reslizumab (4.3% and 0.7%). The total estimated savings from performing the interventions was 12 186.9€ (406.2€/intervention). Conclusion and relevance Approximately half of the interventions carried out consisted of exchange to the biosimilar drug, after consensus. Although the number of interventions was low, their economic impact is important. Despite not being able to prepare these medications centrally and individually, the validation of the prescription and monitoring of the dispensations by the pharmacist is essential. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-312 Pharmaceutical interventions in a non-oncohaematological daily hospital","authors":"J. D. Menendez, A. R. Amallo, C. Gallego, M Vara Urruchua, U Blazquez Urtizberea, S. V. Hidalgo, E Oñate Muzas, E. T. Orbegozo, A. Arredondo","doi":"10.1136/EJHPHARM-2021-EAHPCONF.144","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.144","url":null,"abstract":"Background and importance The role of the pharmacist in the validation and dispensing of medications is already known. But the increasingly frequent use of high cost drugs makes that role essential for the sustainability of health systems. Aim and objectives To describe and analyse the pharmaceutical interventions carried out in a non-oncohaematological daily hospital (NOHDH) and to evaluate the economic impact of these interventions. Material and methods From April 2019 to March 2020, pharmacist interventions in the validation and dispensing of electronic prescriptions of intravenous treatments in the NOHDH were recorded. It should be noted that preparation of infusions is not centralised in the pharmacy but is carried out in the daily hospital units. Infusions prepared in the pharmacy, acute treatments and intravenous iron were excluded. To calculate the economic impact, only the dose administered and the average cost of drugs during the year of the study were considered. Results 30 interventions were carried out in 434 patients (6.9% patients) and 2240 dispensations (1.3% dispensations). 29 were accepted (97%). They were classified according to the type of intervention: 15 presentation changes (14 to a biosimilar), 10 dose adjustments (5 to commercial presentations), 4 request errors (1 of dose and 3 of administration date) and 1 change of medication. Intervention according to services: 10 rheumatology (9.6% of patients and 2.2% of dispensations), 5 nephrology (26.3% and 11.4%), 4 digestive (2% and 0.4%), 4 neurology (11.1% and 1.3%), 3 nursing unit (0.7% and 0.13%), 1 haematology (7.7% and 1.9%), 1 allergy (4.3% and 0, 61%), 1 paediatrics (10% and 2%) and other (9.1% and 3.6%). Intervention according to drug: 10 rituximab (23.3% and 11.5%), 7 infliximab (3.6% and 0.74%), 5 immunoglobulins (9.8% and 1.1%), 4 tocilizumab (16.7% and 3.3%), 3 vedolizumab (5.6% and 1.1%) and 1 reslizumab (4.3% and 0.7%). The total estimated savings from performing the interventions was 12 186.9€ (406.2€/intervention). Conclusion and relevance Approximately half of the interventions carried out consisted of exchange to the biosimilar drug, after consensus. Although the number of interventions was low, their economic impact is important. Despite not being able to prepare these medications centrally and individually, the validation of the prescription and monitoring of the dispensations by the pharmacist is essential. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85686880","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.294
S. Traina, M. Scaldaferri, E. Caiazza, F. Cattel
Background and importance The lymphoproliferative autoimmune syndrome caused by cytotoxic T lymphocyte antigen 4 (CTLA-4) insufficiency is characterised by immune dysregulation, haploinsufficiency and multiorgan disorders. This condition is classified as a rare disease and no drugs are yet registered for treatment. Abatacept, an antirheumatic agent that prevents T lymphocyte activation, was proposed. Aim and objectives To report the clinical record of a 15-year-old female patient with autoimmune disorders. Material and methods In 2015, the patient showed Gilbert pityriasis rosea with significant and diffused lymphoadenopathy, and levothyroxine was prescribed for her hypothyroidism. In July 2018, the patient had chronic urticaria and angio-oedema with a low antihistamine response. In April 2019, she showed persistent fever, asthenia and splenomegaly, associated with multiple lymphoadenopathies, compatible with a lymphoproliferative autoimmune syndrome.1 Functional tests evidenced a significant reduction in CTLA-4 expression on T reg lymphocytes. In November 2019, omalizumab was started instead of levocetirizine with benefit. In February 2020, clinicians from the paediatric infections unit proposed to the internal pharmaceutical committee the use of intravenous abatacept as off-label chronic treatment to manage autoimmune disorders related to CTLA-4 mutations. As the patient was suffering from a rare disease, the pharmacists suggested compassionate use of the drug, as for the DM 07/09/2017, also due to the elevated cost of the therapy chosen. Results The use of abatacept has shown a positive outcome to date (after seven doses), with regression in all lymphoadenopathy sites observed. Moreover, because the patient is successfully responding to intravenous administration in hospital, the ethical committee also approved the switch to the subcutaneous form which can be administered at home. Conclusion and relevance Abatacept use in CTLA-4 mutations on T reg may represent a valid chance of positive disease regression. However, eight months of observation of a single patient is not sufficient and more studies and applications are required. Moreover, a literature research and evaluation led the pharmacist to suggest compassionate use to guarantee the patient’s therapy and to optimise drug governance, not affecting hospital costs. References and/or acknowledgements Schwab, et al. J Allergy Clin Immunol 2018;142:1932–46. Conflict of interest No conflict of interest
{"title":"5PSQ-175 Cytotoxic T lymphocyte antigen 4 mutations on T reg and abatacept: a paediatric case report","authors":"S. Traina, M. Scaldaferri, E. Caiazza, F. Cattel","doi":"10.1136/EJHPHARM-2021-EAHPCONF.294","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.294","url":null,"abstract":"Background and importance The lymphoproliferative autoimmune syndrome caused by cytotoxic T lymphocyte antigen 4 (CTLA-4) insufficiency is characterised by immune dysregulation, haploinsufficiency and multiorgan disorders. This condition is classified as a rare disease and no drugs are yet registered for treatment. Abatacept, an antirheumatic agent that prevents T lymphocyte activation, was proposed. Aim and objectives To report the clinical record of a 15-year-old female patient with autoimmune disorders. Material and methods In 2015, the patient showed Gilbert pityriasis rosea with significant and diffused lymphoadenopathy, and levothyroxine was prescribed for her hypothyroidism. In July 2018, the patient had chronic urticaria and angio-oedema with a low antihistamine response. In April 2019, she showed persistent fever, asthenia and splenomegaly, associated with multiple lymphoadenopathies, compatible with a lymphoproliferative autoimmune syndrome.1 Functional tests evidenced a significant reduction in CTLA-4 expression on T reg lymphocytes. In November 2019, omalizumab was started instead of levocetirizine with benefit. In February 2020, clinicians from the paediatric infections unit proposed to the internal pharmaceutical committee the use of intravenous abatacept as off-label chronic treatment to manage autoimmune disorders related to CTLA-4 mutations. As the patient was suffering from a rare disease, the pharmacists suggested compassionate use of the drug, as for the DM 07/09/2017, also due to the elevated cost of the therapy chosen. Results The use of abatacept has shown a positive outcome to date (after seven doses), with regression in all lymphoadenopathy sites observed. Moreover, because the patient is successfully responding to intravenous administration in hospital, the ethical committee also approved the switch to the subcutaneous form which can be administered at home. Conclusion and relevance Abatacept use in CTLA-4 mutations on T reg may represent a valid chance of positive disease regression. However, eight months of observation of a single patient is not sufficient and more studies and applications are required. Moreover, a literature research and evaluation led the pharmacist to suggest compassionate use to guarantee the patient’s therapy and to optimise drug governance, not affecting hospital costs. References and/or acknowledgements Schwab, et al. J Allergy Clin Immunol 2018;142:1932–46. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"71 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74950322","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.59
R. R. Mauriz, L. Trias, P. Gallo, AA Villagrasa Vilella, N. Almendros-Abad, A. Sosa-Pons, N. R. Solá
Background and importance Human serum albumin (HSA) is widely used in clinical practice, although many indications are still being debated. Aim and objectives To analyse the clinical indications for HSA and the level of evidence for them. Material and methods This was an observational, retrospective, multidisciplinary study. Inclusion criteria were: patients >18 years admitted, patients treated in a specialised outpatient clinic or emergency department, in a secondary hospital, who had received at least one dose of HSA during 2019. Variables studied were: demographics, admission diagnosis, number of HSA prescriptions, duration of treatment, previous serum albumin, previous infection, HSA indication and level of evidence of the indications. The classification was based on the scale established by the American Society of Apheresis, which categorises four groups according to the degree of evidence: High priority (grade I): paracentesis induced circulatory dysfunction (PICD) after large volume paracentesis (>5 L); hepatorenal syndrome, renal failure after spontaneous bacterial peritonitis (SBP) and plasmapheresis. Reasonable evidence, but with available alternatives (grade II): resuscitation in critically ill patients with septic shock when crystalloids are insufficient. Weak evidence (grade III): hypervolaemic hyponatraemia in decompensated cirrhosis, awaiting liver transplantation, non–SBP bacterial infections in cirrhotic patients, prevention of PICD Treatment not recommended (grade IV): other indications. Results The study included 142 patients, 41% women, mean age 66±11 years. The main admission diagnoses were: decompensated cirrhosis (32%), septic shock (31%), haemorrhagic shock (5%) and respiratory infection (4%). They received a total of 223 batches of HSA. The median duration of prescription was 3 days (IQR 2–4). The mean basal plasma albumin was 2.5±0.5 mg/dL. 48% had a previous active infection. The major indications of HSA were: anasarca and hypoalbuminaemia (32%), prevention of PICD >5 L (17%), resuscitation in shock septic (13%) and protein malnutrition (9%). 26% of the indications had grade I evidence, 13% grade II, 9% grade III and 53% grade IV. Conclusion and relevance There is an important use for HSA in hospitals with a low level of evidence. It is necessary to train prescribing doctors to optimise the use of HSA in hospital. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性人血清白蛋白(HSA)广泛应用于临床实践，尽管许多适应症仍存在争议。目的和目的分析HSA的临床适应症及其证据水平。材料与方法这是一项观察性、回顾性、多学科研究。纳入标准为:住院患者>18岁，在二级医院的专科门诊或急诊科治疗的患者，在2019年期间至少接受过一剂HSA。研究的变量包括:人口统计学、入院诊断、HSA处方数量、治疗持续时间、既往血清白蛋白、既往感染、HSA指征和指征证据水平。分类依据美国穿刺学会(American Society of Apheresis)制定的分级标准，根据证据程度分为四组:高优先级(I级):大容量穿刺(> 5l)后穿刺诱发循环功能障碍(PICD);肝肾综合征，自发性细菌性腹膜炎(SBP)和血浆置换后的肾功能衰竭。合理的证据，但有可用的替代方案(II级):当晶体不足时，对感染性休克的危重患者进行复苏。弱证据(III级):失代偿肝硬化患者高血容量性低钠血症，等待肝移植，肝硬化患者非收缩压细菌感染，预防PICD治疗(IV级):其他适应症。结果纳入142例患者，女性41%，平均年龄66±11岁。主要入院诊断为失代偿性肝硬化(32%)、感染性休克(31%)、出血性休克(5%)和呼吸道感染(4%)。他们共收到223批HSA。处方持续时间中位数为3天(IQR 2-4)。平均基础血浆白蛋白为2.5±0.5 mg/dL。48%以前有活动性感染。HSA的主要适应症为:无血和低白蛋白血症(32%)，预防PICD > 5l(17%)，休克败血症复苏(13%)和蛋白质营养不良(9%)。ⅰ级循证率为26%，ⅱ级循证率为13%，ⅲ级循证率为9%，ⅳ级循证率为53%。结论及相关性HSA在低循证率的医院有重要应用。有必要对处方医生进行培训，以优化医院对HSA的使用。参考文献和/或致谢利益冲突无利益冲突
{"title":"4CPS-227 Human serum albumin: analysis of use","authors":"R. R. Mauriz, L. Trias, P. Gallo, AA Villagrasa Vilella, N. Almendros-Abad, A. Sosa-Pons, N. R. Solá","doi":"10.1136/EJHPHARM-2021-EAHPCONF.59","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.59","url":null,"abstract":"Background and importance Human serum albumin (HSA) is widely used in clinical practice, although many indications are still being debated. Aim and objectives To analyse the clinical indications for HSA and the level of evidence for them. Material and methods This was an observational, retrospective, multidisciplinary study. Inclusion criteria were: patients >18 years admitted, patients treated in a specialised outpatient clinic or emergency department, in a secondary hospital, who had received at least one dose of HSA during 2019. Variables studied were: demographics, admission diagnosis, number of HSA prescriptions, duration of treatment, previous serum albumin, previous infection, HSA indication and level of evidence of the indications. The classification was based on the scale established by the American Society of Apheresis, which categorises four groups according to the degree of evidence: High priority (grade I): paracentesis induced circulatory dysfunction (PICD) after large volume paracentesis (>5 L); hepatorenal syndrome, renal failure after spontaneous bacterial peritonitis (SBP) and plasmapheresis. Reasonable evidence, but with available alternatives (grade II): resuscitation in critically ill patients with septic shock when crystalloids are insufficient. Weak evidence (grade III): hypervolaemic hyponatraemia in decompensated cirrhosis, awaiting liver transplantation, non–SBP bacterial infections in cirrhotic patients, prevention of PICD Treatment not recommended (grade IV): other indications. Results The study included 142 patients, 41% women, mean age 66±11 years. The main admission diagnoses were: decompensated cirrhosis (32%), septic shock (31%), haemorrhagic shock (5%) and respiratory infection (4%). They received a total of 223 batches of HSA. The median duration of prescription was 3 days (IQR 2–4). The mean basal plasma albumin was 2.5±0.5 mg/dL. 48% had a previous active infection. The major indications of HSA were: anasarca and hypoalbuminaemia (32%), prevention of PICD >5 L (17%), resuscitation in shock septic (13%) and protein malnutrition (9%). 26% of the indications had grade I evidence, 13% grade II, 9% grade III and 53% grade IV. Conclusion and relevance There is an important use for HSA in hospitals with a low level of evidence. It is necessary to train prescribing doctors to optimise the use of HSA in hospital. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82742399","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.226
R. Sevilla, M. Salvador, I. Baena, García Cerezuela, C. L. Llano, A. Álvarez, SM Sanz Rodríaguez, Jiménez López, T. M. Gomez, MP Ussetti Gil, A. S. Guerrero
Background and importance Lung transplant (LT) recipients require intensive and continuous care due to the complexity and relevance of pharmacological treatments in the clinical course after transplantation. Acute rejection, infections and side effects of immunosuppressants are common, especially during the first year after transplantation. Patients must acquire knowledge and skills that allow them to actively participate in the control of their ‘new disease’. Aim and objectives To analyse the degree of LT recipient knowledge about their treatment in the immediate post-transplant period and to identify weaknesses and characteristics of the patients. Material and methods A prospective observational study was conducted from June to December 2019, corresponding to the pilot phase of an e-learning programme in LT recipients (e-duca). We designed a 25 multiple answer question test which was completed by the patients before post-transplant discharge. Variables studied were: age, gender, LT indication, educational level, number of drugs prescribed at discharge, test score (TS) and answers correctly with more or less frequency. We considered a high degree of knowledge as a TS ≥20, moderate 13–20 and deficient Results 16 patients were included with a mean age of 61.4 years (48–68) and 81.3% (13) were men. The LT indication was COPD in 56.3% (9), idiopathic pulmonary fibrosis in 37.5% (6) and bronchiectasis in 6.2% (1). Educational levels were university (3), secondary (4) and basic (9). The average number of drugs prescribed at discharge was 14.31 (9–20). Mean TS was 14.56 (6–22), equivalent to 58.2% of correct answers. 31.3% (5) of patients demonstrated a poor degree of knowledge, 62.5% (10) moderate and 6.2% (1) high. The most frequently correct answers were related to how to take tacrolimus and mycophenolate (87.5%) and the function and duration of immunosuppressive treatment (93.8%). On the other hand, the least frequently correct answers were related to the role of adjuvant therapy: only to prevent infections (93.8%), to identify prednisone as immunosuppressant (56.3%) and acting correctly when vomiting after taking immunosuppressants (56.3%). Conclusion and relevance This type of test allows us to know the patients’ skills about their treatment and to identify which points need to be reinforced by the pharmacist as part of the healthcare team that attends to the patient. It also allows early detection of possible medication errors. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-394 Evaluation of the degree of therapeutic knowledge in lung transplant recipients","authors":"R. Sevilla, M. Salvador, I. Baena, García Cerezuela, C. L. Llano, A. Álvarez, SM Sanz Rodríaguez, Jiménez López, T. M. Gomez, MP Ussetti Gil, A. S. Guerrero","doi":"10.1136/EJHPHARM-2021-EAHPCONF.226","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.226","url":null,"abstract":"Background and importance Lung transplant (LT) recipients require intensive and continuous care due to the complexity and relevance of pharmacological treatments in the clinical course after transplantation. Acute rejection, infections and side effects of immunosuppressants are common, especially during the first year after transplantation. Patients must acquire knowledge and skills that allow them to actively participate in the control of their ‘new disease’. Aim and objectives To analyse the degree of LT recipient knowledge about their treatment in the immediate post-transplant period and to identify weaknesses and characteristics of the patients. Material and methods A prospective observational study was conducted from June to December 2019, corresponding to the pilot phase of an e-learning programme in LT recipients (e-duca). We designed a 25 multiple answer question test which was completed by the patients before post-transplant discharge. Variables studied were: age, gender, LT indication, educational level, number of drugs prescribed at discharge, test score (TS) and answers correctly with more or less frequency. We considered a high degree of knowledge as a TS ≥20, moderate 13–20 and deficient Results 16 patients were included with a mean age of 61.4 years (48–68) and 81.3% (13) were men. The LT indication was COPD in 56.3% (9), idiopathic pulmonary fibrosis in 37.5% (6) and bronchiectasis in 6.2% (1). Educational levels were university (3), secondary (4) and basic (9). The average number of drugs prescribed at discharge was 14.31 (9–20). Mean TS was 14.56 (6–22), equivalent to 58.2% of correct answers. 31.3% (5) of patients demonstrated a poor degree of knowledge, 62.5% (10) moderate and 6.2% (1) high. The most frequently correct answers were related to how to take tacrolimus and mycophenolate (87.5%) and the function and duration of immunosuppressive treatment (93.8%). On the other hand, the least frequently correct answers were related to the role of adjuvant therapy: only to prevent infections (93.8%), to identify prednisone as immunosuppressant (56.3%) and acting correctly when vomiting after taking immunosuppressants (56.3%). Conclusion and relevance This type of test allows us to know the patients’ skills about their treatment and to identify which points need to be reinforced by the pharmacist as part of the healthcare team that attends to the patient. It also allows early detection of possible medication errors. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"111 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85816744","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.120
J. Tabe
Background and importance Oral anticancer agents (OAA) are frequently used in oncology practice. Drug interactions involving OAA are of great concern as they can cause an altered safety or efficacy profile for cancer treatments. Aim and objectives To estimate the prevalence of potential drug interactions in cancer patients to justify the implementation of preventive actions to optimise the effectiveness and efficiency of cancer management, in a context where the relevance of care is a public health issue. Material and methods Data on drugs used for comorbidities, OAA, over-the-counter (OTC) drugs and herbal supplements were collected through a structured interview with the patient, a review of medical records and a call to the dispensing pharmacist. Potential drug interactions involving OAA were detected during the primary prescribing process using the databases Lexicomp and Micromedex. Results 51 patients were included in the study. The median age of patients was 70 years. We identified 26 potentially clinically significant interactions (PCSI) in 24 patients (47%). Of the PCSI detected, 17.4% were assessed by both sources as major interactions and 8.7% as moderate interactions. The OAA that interacted the most were anagrelide (19.2%), capecitabine (15.4%) and lenalidomide (11.5%). PCSI involving OAA appeared in the following therapeutic classes: PPI 26.9%, herbal therapy 11.5% and antiplatelet–anticoagulants 11.5%. We observed that 30.8% of PCSI resulted in an altered efficacy profile of the OAA. Conclusion and relevance Analysis of PCSI in cancer patients allows the description of the use of OAA and thus how to optimise monitoring of the correct use of these drugs. The clinical pharmacist can improve drug safety by notifying hospital and frontline healthcare staff of PCSI to reduce drug therapy problems and optimise drug therapy for these patients. References and/or acknowledgements Ranchon F, Bouret C, Charpiat B, et al. Securisation de l’emploi des chimiotherapies anticancereuses administrables par voie orale. Le Pharmacien Hospitalier 2009;44:36–44. Banna GL, Collova E, Gebbia V, et al. Anticancer oral therapy: Emerging related issues. Cancer Treatment Reviews 2010;36:595–605. Conflict of interest No conflict of interest
{"title":"4CPS-288 Clinical pharmacist’s impact in improving the safety of therapies for patients using oral anticancer agents: a prospective single centre study","authors":"J. Tabe","doi":"10.1136/EJHPHARM-2021-EAHPCONF.120","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.120","url":null,"abstract":"Background and importance Oral anticancer agents (OAA) are frequently used in oncology practice. Drug interactions involving OAA are of great concern as they can cause an altered safety or efficacy profile for cancer treatments. Aim and objectives To estimate the prevalence of potential drug interactions in cancer patients to justify the implementation of preventive actions to optimise the effectiveness and efficiency of cancer management, in a context where the relevance of care is a public health issue. Material and methods Data on drugs used for comorbidities, OAA, over-the-counter (OTC) drugs and herbal supplements were collected through a structured interview with the patient, a review of medical records and a call to the dispensing pharmacist. Potential drug interactions involving OAA were detected during the primary prescribing process using the databases Lexicomp and Micromedex. Results 51 patients were included in the study. The median age of patients was 70 years. We identified 26 potentially clinically significant interactions (PCSI) in 24 patients (47%). Of the PCSI detected, 17.4% were assessed by both sources as major interactions and 8.7% as moderate interactions. The OAA that interacted the most were anagrelide (19.2%), capecitabine (15.4%) and lenalidomide (11.5%). PCSI involving OAA appeared in the following therapeutic classes: PPI 26.9%, herbal therapy 11.5% and antiplatelet–anticoagulants 11.5%. We observed that 30.8% of PCSI resulted in an altered efficacy profile of the OAA. Conclusion and relevance Analysis of PCSI in cancer patients allows the description of the use of OAA and thus how to optimise monitoring of the correct use of these drugs. The clinical pharmacist can improve drug safety by notifying hospital and frontline healthcare staff of PCSI to reduce drug therapy problems and optimise drug therapy for these patients. References and/or acknowledgements Ranchon F, Bouret C, Charpiat B, et al. Securisation de l’emploi des chimiotherapies anticancereuses administrables par voie orale. Le Pharmacien Hospitalier 2009;44:36–44. Banna GL, Collova E, Gebbia V, et al. Anticancer oral therapy: Emerging related issues. Cancer Treatment Reviews 2010;36:595–605. 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":"76292661","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.94
A. Mcdonnell, D. Murphy, S. Shane, P. Moloney, J. Brown
Background and importance Intravenous immunoglobulin (IVIg) is a blood derived medicinal product prescribed for a range of medical conditions. Clinical evidence strongly supports the use of IVIg as firstline therapy in three neurological disorders; chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain–Barre syndrome (GBS) and multifocal motor neuropathy. There are an increasing number of other neurological conditions where IVIg is used despite limited evidence based data. Careful consideration of the efficacy of IVIg in each indication is required as it is a limited resource associated with high costs and potential supply shortages. Aim and objectives To review the clinical indications for IVIg use in neurology patients at the Mater Misericordiae University Hospital (MMUH) and to compare prescribing practices to international evidence based guidelines. Material and methods All neurology patients treated with IVIg between 2016 and 2018 were retrospectively reviewed using patient medical notes and pharmacy functionalities at the MMUH. Data collected included indication, dose prescribed, total number of IVIg courses, use of alternative therapies before IVIg and documentation of clinical benefit. Results were compared with international evidence based guidelines and verified by a neurology consultant. Results 67 patients were included in the study. IVIg was prescribed for 15 indications. The most common were GBS, myasthenia gravis and CIDP. 31 patients received IVIg for licensed indications, whereas 36 patients received IVIg for unlicensed indications. The level of evidence from international evidence based guidelines supported the use of IVIg for most indications. Conclusion and relevance This study demonstrated that IVIg was prescribed for a variety of neurological conditions at the MMUH, the majority of which were unlicensed. IVIg use was supported for most indications compared with international evidence based guidelines. However, IVIg was prescribed for several indications despite limited evidence of efficacy. This study highlights the need for evidence based clinical practice guidelines for IVIg use at the MMUH and Ireland. References and/or acknowledgements Perez EE, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol 2017. Updated Commissioning Criteria for the use of therapeutic immunoglobulin in immunology, haematology, neurology and infectious diseases in England January 2019. Department of Health 2019. National Blood Authority of Australia. Criteria for the clinical use of intravenous immunoglobulins in Australia. October 2019. Conflict of interest No conflict of interest
{"title":"4CPS-262 Clinical efficacy of intravenous immunoglobulin in neurology: a retrospective cohort study at the Mater Misericordiae University Hospital","authors":"A. Mcdonnell, D. Murphy, S. Shane, P. Moloney, J. Brown","doi":"10.1136/EJHPHARM-2021-EAHPCONF.94","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.94","url":null,"abstract":"Background and importance Intravenous immunoglobulin (IVIg) is a blood derived medicinal product prescribed for a range of medical conditions. Clinical evidence strongly supports the use of IVIg as firstline therapy in three neurological disorders; chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain–Barre syndrome (GBS) and multifocal motor neuropathy. There are an increasing number of other neurological conditions where IVIg is used despite limited evidence based data. Careful consideration of the efficacy of IVIg in each indication is required as it is a limited resource associated with high costs and potential supply shortages. Aim and objectives To review the clinical indications for IVIg use in neurology patients at the Mater Misericordiae University Hospital (MMUH) and to compare prescribing practices to international evidence based guidelines. Material and methods All neurology patients treated with IVIg between 2016 and 2018 were retrospectively reviewed using patient medical notes and pharmacy functionalities at the MMUH. Data collected included indication, dose prescribed, total number of IVIg courses, use of alternative therapies before IVIg and documentation of clinical benefit. Results were compared with international evidence based guidelines and verified by a neurology consultant. Results 67 patients were included in the study. IVIg was prescribed for 15 indications. The most common were GBS, myasthenia gravis and CIDP. 31 patients received IVIg for licensed indications, whereas 36 patients received IVIg for unlicensed indications. The level of evidence from international evidence based guidelines supported the use of IVIg for most indications. Conclusion and relevance This study demonstrated that IVIg was prescribed for a variety of neurological conditions at the MMUH, the majority of which were unlicensed. IVIg use was supported for most indications compared with international evidence based guidelines. However, IVIg was prescribed for several indications despite limited evidence of efficacy. This study highlights the need for evidence based clinical practice guidelines for IVIg use at the MMUH and Ireland. References and/or acknowledgements Perez EE, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol 2017. Updated Commissioning Criteria for the use of therapeutic immunoglobulin in immunology, haematology, neurology and infectious diseases in England January 2019. Department of Health 2019. National Blood Authority of Australia. Criteria for the clinical use of intravenous immunoglobulins in Australia. October 2019. Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"25 9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91067181","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.276
B. Parola, S. Alemanno, M. Capilli, I. Colasanto, D. Fiorentino, M. Marcato, L. Pestrin, S. Strobino, A. Varese, E. Viglione, G. Brunitto
Background and importance The introduction of biological drugs changed the pharmaceutical market, improving patients‘ prognoses and quality of life. Intravenous MabThera, authorised in January 1998, is the originator of the monoclonal antibody rituximab. In Italy, the regulatory agency approved the first rituximab biosimilar, Truxima, in July 2014, and the second, Rixathon, in December 2017. Aim and objectives The objective was to analyse and compare MabThera and its biosimilars in our region in the period 2017–2019 in terms of regional consumption, costs and adverse drug reactions (ADRs). Material and methods Regional consumption and costs data for rituximab between January and September 2017, 2018 and 2019 were collected and analysed, using Microsoft. ADR reports were extracted from the Adverse Drug Reactions National Report (ADRsNR) and stratified by gravity, gender of the patient and diagnosis. Results In 2017, the number of intravenous MabThera dispensed packs was 10 017, with a progressive reduction over the years (552 in 2019). Truxima decreased from 2274 delivered packs in 2018 to 117 in 2019; Rixathon increased from 3491 in 2018 to 9259 in 2019. Intravenous distributed pack numbers of MabThera decreased from 2017 to 2019 and was about −94.49%. Regarding costs, MabThera expenditure in 2017 was about 9 902 232.64€, in 2018 it was 3 590 428.00€ and in 2019 it was 613 502.88€. Truxima costs were 2 027 695.38€ in 2018 and 91 438.67€ in 2019. Rixathon expenditure was 2 066 974.79€ in 2018 and 5 473 728.71€ in 2019. A reduction of 93.80% was registered for MabThera expenditure from 2017 to 2019. From January 2002 to March 2020, ADRsNR rituximab ADRs were 2865: 10.23% MabThera, 19.02% Truxima and 10.66% Rixathon. 50.3% of patients were men and 49.7% women. ADR gravity was 2.2% deaths, 39.1% serious and 57.8% not serious. Diagnoses principally concerned itch 7.9%, dyspnoea 7%, neutropenia 7.3% and pyrexia 7%. Conclusion and relevance ADRsNR biosimilar data are still limited: greater collaboration between health professionals is needed to structure a system of more robust and adequate pharmacovigilance, to overcome the information gap relating to the security of the originator and biosimilar. Nonetheless, biosimilar drugs are a valid therapeutic alternative for patients, and a good way to reduce expenditure and to optimise available resources, ensuring good pharmaceutical governance. Biosimilar switch involves a multidisciplinary team composed by prescribers and pharmacists. Pharmacovigilance is important to discover and characterise ADRs in the post-marketing phase. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"5PSQ-157 Expenditure and consumption descriptive analysis: rituximab originator versus biosimilar in an Italian district","authors":"B. Parola, S. Alemanno, M. Capilli, I. Colasanto, D. Fiorentino, M. Marcato, L. Pestrin, S. Strobino, A. Varese, E. Viglione, G. Brunitto","doi":"10.1136/EJHPHARM-2021-EAHPCONF.276","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.276","url":null,"abstract":"Background and importance The introduction of biological drugs changed the pharmaceutical market, improving patients‘ prognoses and quality of life. Intravenous MabThera, authorised in January 1998, is the originator of the monoclonal antibody rituximab. In Italy, the regulatory agency approved the first rituximab biosimilar, Truxima, in July 2014, and the second, Rixathon, in December 2017. Aim and objectives The objective was to analyse and compare MabThera and its biosimilars in our region in the period 2017–2019 in terms of regional consumption, costs and adverse drug reactions (ADRs). Material and methods Regional consumption and costs data for rituximab between January and September 2017, 2018 and 2019 were collected and analysed, using Microsoft. ADR reports were extracted from the Adverse Drug Reactions National Report (ADRsNR) and stratified by gravity, gender of the patient and diagnosis. Results In 2017, the number of intravenous MabThera dispensed packs was 10 017, with a progressive reduction over the years (552 in 2019). Truxima decreased from 2274 delivered packs in 2018 to 117 in 2019; Rixathon increased from 3491 in 2018 to 9259 in 2019. Intravenous distributed pack numbers of MabThera decreased from 2017 to 2019 and was about −94.49%. Regarding costs, MabThera expenditure in 2017 was about 9 902 232.64€, in 2018 it was 3 590 428.00€ and in 2019 it was 613 502.88€. Truxima costs were 2 027 695.38€ in 2018 and 91 438.67€ in 2019. Rixathon expenditure was 2 066 974.79€ in 2018 and 5 473 728.71€ in 2019. A reduction of 93.80% was registered for MabThera expenditure from 2017 to 2019. From January 2002 to March 2020, ADRsNR rituximab ADRs were 2865: 10.23% MabThera, 19.02% Truxima and 10.66% Rixathon. 50.3% of patients were men and 49.7% women. ADR gravity was 2.2% deaths, 39.1% serious and 57.8% not serious. Diagnoses principally concerned itch 7.9%, dyspnoea 7%, neutropenia 7.3% and pyrexia 7%. Conclusion and relevance ADRsNR biosimilar data are still limited: greater collaboration between health professionals is needed to structure a system of more robust and adequate pharmacovigilance, to overcome the information gap relating to the security of the originator and biosimilar. Nonetheless, biosimilar drugs are a valid therapeutic alternative for patients, and a good way to reduce expenditure and to optimise available resources, ensuring good pharmaceutical governance. Biosimilar switch involves a multidisciplinary team composed by prescribers and pharmacists. Pharmacovigilance is important to discover and characterise ADRs in the post-marketing phase. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78185486","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.105
J. Barceló-Vidal, X. Fernández-Sala, A. Rodríguez-Alarcón, I. Tusquets, D. Conde-Estévez
Background and importance Cancer patients receive multiple medications, exposing them to an increased risk of drug–drug interactions (DDI). Moreover, DDIs represent an escalating concern for older adults. Screening for DDI is not generally performed with endovenous chemotherapy. Aim and objectives The aim of this study was to evaluate the influence of DDI in the elderly treated with endovenous chemotherapy (EVC). Material and methods A retrospective study was performed in a tertiary hospital. Patients who initiated EVC during 2019 were included. All DDI were screened and categorised. Data collected were: demographic, cancer by site, chemotherapy treatment and concomitant drugs. DDI in patients aged ≥70 and Results 679 patients were included. 65 (9.6%) presented 127 DDI (median 1.95 interactions/patient). Differences between groups are shown in table 1. The most implicated chemotherapy drug was paclitxel (104, 81.9%), interacting mainly with antihypertensive agents, enhancing a blood pressure lowing effect. For all category D DDI, six resulted in an increase in chemotherapy concentrations, potentially increasing toxicity, with two decreasing chemotherapy concentrations and one causing higher anticoagulant drug concentrations. Conclusion and relevance Older patients presented a higher number of DDI although they seemed to be less severe DDI than in younger patients. Future studies need to identify the relevant DDI with clinical implications to optimise medication safety in older adults. References and/or acknowledgements Conflict of interest No conflict of interest
{"title":"4CPS-273 Does age really matter on the prevalence of drug–drug interactions with endovenous chemotherapy?","authors":"J. Barceló-Vidal, X. Fernández-Sala, A. Rodríguez-Alarcón, I. Tusquets, D. Conde-Estévez","doi":"10.1136/EJHPHARM-2021-EAHPCONF.105","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.105","url":null,"abstract":"Background and importance Cancer patients receive multiple medications, exposing them to an increased risk of drug–drug interactions (DDI). Moreover, DDIs represent an escalating concern for older adults. Screening for DDI is not generally performed with endovenous chemotherapy. Aim and objectives The aim of this study was to evaluate the influence of DDI in the elderly treated with endovenous chemotherapy (EVC). Material and methods A retrospective study was performed in a tertiary hospital. Patients who initiated EVC during 2019 were included. All DDI were screened and categorised. Data collected were: demographic, cancer by site, chemotherapy treatment and concomitant drugs. DDI in patients aged ≥70 and Results 679 patients were included. 65 (9.6%) presented 127 DDI (median 1.95 interactions/patient). Differences between groups are shown in table 1. The most implicated chemotherapy drug was paclitxel (104, 81.9%), interacting mainly with antihypertensive agents, enhancing a blood pressure lowing effect. For all category D DDI, six resulted in an increase in chemotherapy concentrations, potentially increasing toxicity, with two decreasing chemotherapy concentrations and one causing higher anticoagulant drug concentrations. Conclusion and relevance Older patients presented a higher number of DDI although they seemed to be less severe DDI than in younger patients. Future studies need to identify the relevant DDI with clinical implications to optimise medication safety in older adults. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84480106","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.240
B. Serrano, A. S. Martínez, A. Walsh, I Pérez Alpuente, V Lerma Gaude, M. Andújar, R. Frances
Background and importance Fidaxomicin is a macrolide antibiotic used to treat intestinal Clostridium difficile (CD) infection in the absence of metronidazole or vancomycin treatments. Pharmacovigilance collects information, and analyses and notifies cases of suspected adverse drug reactions (ADRs) to prevent them occurring in the future. Aim and objectives To describe a case of metabolic acidosis in a patient treated with fidaxomicin and establish its possible association. Material and methods We describe the case of an 82-year-old man diagnosed with multiple myeloma and treated with two full cycles of bortezomib–dexamethasone. He was referred to the emergency department after presenting with melenic diarrhoea for 1 week. As a result, he was hospitalised and diagnosed with upper gastrointestinal bleeding, acute prerenal renal failure, mild thrombopenia, hypokalaemia and hyponatraemia. After fluid and electrolyte stabilisation, it was decided to start fidaxomicin 200 mg/12 hours due to fever, confusional syndrome, persistence of diarrhoea and positive CD toxin test. The following constants were measured to confirm metabolic acidosis: gas level of bicarbonate (HCO3−), partial pressure of carbon dioxide (pCO2), hydrogen ion potential (pH) and anion GAP. The degree of drug adverse reaction causality was evaluated using the Naranjo algorithm. Results Two blood gas tests on consecutive days confirmed very low HCO3− (9 mmol/L) and pCO2 (16 mm Hg) with normal pH (7.4), after which the patient was diagnosed with compensated metabolic acidosis with normal GAP anion. Finally, it was decided to suspend fidaxomicin and in the following days the patient experienced a progressive clinical improvement. Naranjo’s algorithm established the causality relationship as ‘probable’ (score of 6). The regional pharmacovigilance centre (RPC) was notified. Conclusion and relevance The European Medicines Agency’s technical sheet for fidaxomicin does not describe metabolic acidosis as an ADR. However, UpToDate Clinical Library reports References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性:非达霉素是一种大环内酯类抗生素，在没有甲硝唑或万古霉素治疗的情况下用于治疗肠道艰难梭菌(CD)感染。药物警戒收集信息，分析和通报疑似药物不良反应(adr)的病例，以防止它们在未来发生。目的和目的描述一例接受非达霉素治疗的患者发生代谢性酸中毒，并确定其可能的相关性。材料和方法我们描述了一例82岁的男性诊断为多发性骨髓瘤，并接受了两个完整周期的硼替佐米-地塞米松治疗。他在出现黑质腹泻1周后被转到急诊科。结果，他住院并被诊断为上消化道出血、急性肾前性肾衰竭、轻度血小板减少症、低钾血症和低钠血症。在体液和电解质稳定后，由于发热、混乱综合征、持续腹泻和CD毒素试验阳性，决定开始使用非达霉素200mg /12小时。测量以下常数以确定代谢性酸中毒:碳酸氢盐气体水平(HCO3−)，二氧化碳分压(pCO2)，氢离子电位(pH)和阴离子GAP。采用Naranjo算法评价药物不良反应的因果关系程度。结果连续2天血气检查，HCO3−(9 mmol/L)、pCO2 (16 mm Hg)极低，pH值(7.4)正常，诊断代偿性代谢性酸中毒，GAP阴离子正常。最后，决定停用非达霉素，在接下来的几天里，患者经历了渐进式的临床改善。Naranjo的算法将因果关系确定为“可能”(得分为6)。区域药物警戒中心(RPC)得到通知。结论和相关性欧洲药品管理局的非达霉素技术说明书没有将代谢性酸中毒描述为不良反应。然而，最新临床文库报告参考文献和/或致谢利益冲突无利益冲突
{"title":"5PSQ-121 Fidaxomicin related metabolic acidosis: a case report","authors":"B. Serrano, A. S. Martínez, A. Walsh, I Pérez Alpuente, V Lerma Gaude, M. Andújar, R. Frances","doi":"10.1136/EJHPHARM-2021-EAHPCONF.240","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.240","url":null,"abstract":"Background and importance Fidaxomicin is a macrolide antibiotic used to treat intestinal Clostridium difficile (CD) infection in the absence of metronidazole or vancomycin treatments. Pharmacovigilance collects information, and analyses and notifies cases of suspected adverse drug reactions (ADRs) to prevent them occurring in the future. Aim and objectives To describe a case of metabolic acidosis in a patient treated with fidaxomicin and establish its possible association. Material and methods We describe the case of an 82-year-old man diagnosed with multiple myeloma and treated with two full cycles of bortezomib–dexamethasone. He was referred to the emergency department after presenting with melenic diarrhoea for 1 week. As a result, he was hospitalised and diagnosed with upper gastrointestinal bleeding, acute prerenal renal failure, mild thrombopenia, hypokalaemia and hyponatraemia. After fluid and electrolyte stabilisation, it was decided to start fidaxomicin 200 mg/12 hours due to fever, confusional syndrome, persistence of diarrhoea and positive CD toxin test. The following constants were measured to confirm metabolic acidosis: gas level of bicarbonate (HCO3−), partial pressure of carbon dioxide (pCO2), hydrogen ion potential (pH) and anion GAP. The degree of drug adverse reaction causality was evaluated using the Naranjo algorithm. Results Two blood gas tests on consecutive days confirmed very low HCO3− (9 mmol/L) and pCO2 (16 mm Hg) with normal pH (7.4), after which the patient was diagnosed with compensated metabolic acidosis with normal GAP anion. Finally, it was decided to suspend fidaxomicin and in the following days the patient experienced a progressive clinical improvement. Naranjo’s algorithm established the causality relationship as ‘probable’ (score of 6). The regional pharmacovigilance centre (RPC) was notified. Conclusion and relevance The European Medicines Agency’s technical sheet for fidaxomicin does not describe metabolic acidosis as an ADR. However, UpToDate Clinical Library reports References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85313804","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：