European journal of hospital pharmacy : science and practice最新文献

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Comment on: Retrospective study of patient characteristics and treatment for mucormycosis in post-COVID-19 population. 评论COVID-19后人群中粘孢子菌病患者特征和治疗方法的回顾性研究。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-29 DOI: 10.1136/ejhpharm-2024-004273
Hinpetch Daungsupawong, Viroj Wiwanitkit
{"title":"Comment on: Retrospective study of patient characteristics and treatment for mucormycosis in post-COVID-19 population.","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1136/ejhpharm-2024-004273","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004273","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141476299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Potential medicine waste in the process of outpatients receiving cost-free medicines from medicine pick-up lockers in the North Denmark region. 北丹麦地区门诊病人从药品领取柜领取免费药品过程中可能出现的药品浪费。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-26 DOI: 10.1136/ejhpharm-2024-004224
Lisa Greve Routhe, Iben Bang Andersen, Mille Vraa Gamborg Eisenhardt, Maja Beck Mejlholm, Helena Birk Wisby, Anne Estrup Olesen
{"title":"Potential medicine waste in the process of outpatients receiving cost-free medicines from medicine pick-up lockers in the North Denmark region.","authors":"Lisa Greve Routhe, Iben Bang Andersen, Mille Vraa Gamborg Eisenhardt, Maja Beck Mejlholm, Helena Birk Wisby, Anne Estrup Olesen","doi":"10.1136/ejhpharm-2024-004224","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004224","url":null,"abstract":"<p><strong>Objectives: </strong>In the Danish healthcare system, restructuring is an ongoing process to accommodate the rising number of patients and to optimise resource allocation. To ease departmental burdens at hospitals in the North Denmark Region, outpatients are empowered to collect their cost-free medicines from medication pick-up lockers. The lockers function similarly to a package box, thereby enhancing patient freedom. Due to lack of evidence within the published literature regarding cost-free medicines and medicine waste, the aim of our study was to identify the common medications delivered to medicine pick-up lockers and secondly, to evaluate potential medicine waste.</p><p><strong>Methods: </strong>Data from ApoVision provided insights into medications delivered to medicine pick-up lockers from March to October 2023 in the North Denmark Region. To estimate unused medicines we obtained data on the number of medications returned from medicine pick-up lockers.</p><p><strong>Results: </strong>From 2020 to 2023, the number of patients receiving cost-free medicines at medication pick-up lockers increased. In total, approximately 30 000 packages of medicine were delivered to medicine pick-up lockers from March to October 2023 in the North Denmark Region; 1.7% were returned. Methotrexate, adalimumab, and omalizumab were among the most common deliveries and were also the three most returned from the medicine pick-up lockers.</p><p><strong>Conclusions: </strong>This study is an initial attempt to investigate potential medicine waste in cost-free medicines dispensed to outpatients via pick-up lockers. Antineoplastic and immunomodulating agents were the most common medicines delivered to medication pick-up lockers in the North Denmark Region from March to October 2023. In this period, approximately 2% of all delivered medicine packages were returned to the hospital pharmacy. Our analysis solely focuses on waste associated with medications left uncollected from medicine pick-up lockers. Addressing the impact of medicine waste in a hospital setting requires a comprehensive approach, thus future studies should also focus on other sites relevant for medication waste as, for example, the patient's household.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementing an innovative, patient-centered approach to day case arthroplasty: improving patient outcomes through remote preoperative pharmacist consultations. 在日间病例关节置换术中实施以患者为中心的创新方法:通过远程术前药剂师会诊改善患者预后。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003573
Kieran Fitzpatrick, Keith Addie, Martin Shaw, Roger Higginson, Lindsay Hudman, Jasmine Samuel, Ruth Forrest, Pamela MacTavish
{"title":"Implementing an innovative, patient-centered approach to day case arthroplasty: improving patient outcomes through remote preoperative pharmacist consultations.","authors":"Kieran Fitzpatrick, Keith Addie, Martin Shaw, Roger Higginson, Lindsay Hudman, Jasmine Samuel, Ruth Forrest, Pamela MacTavish","doi":"10.1136/ejhpharm-2022-003573","DOIUrl":"10.1136/ejhpharm-2022-003573","url":null,"abstract":"<p><strong>Objective: </strong>Elective surgery suffered significant loss of capacity during the COVID-19 pandemic. To address this, hip and knee arthroplasties are being conducted as day case procedures. Pre-admission pharmacist consultations were introduced (the intervention) for these patients. This consultation aimed to address perioperative medicines issues, promote patient empowerment, improve prescribing quality and contribute to reduction in length of stay (LoS).</p><p><strong>Methods: </strong>All patients listed for a total/unicompartmental knee replacement (TKR/UKR) or total hip replacement (THR) at an ambulatory care hospital were identified by a pharmacist prescriber 1-2 weeks before the operation. Pharmacist consultations were conducted remotely with discharge prescriptions written electronically and dispensed before admission. Prescribing data were collected for both pre-intervention (n=80) and post-intervention (n=129) groups along with all interventions undertaken during consultations. Staff opinion was sought via online questionnaire and patient opinion was gathered via post-discharge telephone calls.</p><p><strong>Results: </strong>A total of 115 interventions took place during 129 patient consultations and >75% of interventions were of a significance expected to improve patient care. Prescribing standards were improved in the intervention group compared with patients whose arthroplasty was before the introduction of this service. The pharmacy service would have produced a different prescription in 38.8% of the pre-intervention group. Staff and patient feedback was extremely positive and all patients with previous surgical experience in the health board reported an improved experience. There was a statistically significant reduction in post-discharge healthcare encounters (such as general practitioner (GP) visits) in the intervention group.</p><p><strong>Conclusion: </strong>This novel remote preoperative pharmacist consultation improved prescribing standards, enhanced the patient's surgical experience and reduced the burden on post-discharge healthcare systems.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"321-326"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10627822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Performance evaluation of the HPLC diode array and evaporative light scattering detection for the implementation of dose-banded gemcitabine infusion bags. 高效液相色谱二极管阵列和蒸发光散射检测法用于剂量分段吉西他滨输液袋的性能评估。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003540
Thomas Stalder, Claire Andre, Maurad Ben Mahi, Lydie Lethier, Samuel Limat, Christine Legat, Yves Guillaume
{"title":"Performance evaluation of the HPLC diode array and evaporative light scattering detection for the implementation of dose-banded gemcitabine infusion bags.","authors":"Thomas Stalder, Claire Andre, Maurad Ben Mahi, Lydie Lethier, Samuel Limat, Christine Legat, Yves Guillaume","doi":"10.1136/ejhpharm-2022-003540","DOIUrl":"10.1136/ejhpharm-2022-003540","url":null,"abstract":"<p><strong>Background: </strong>Dose banding (DB) was used to optimise the individualisation of patient treatments with gemcitabine (Gem) in order to improve workload planning at the pharmacy of the University Hospital Centre of Besançon (UHCB). A new simple and fast high-performance liquid chromatographic (HPLC) method was also developed for the quantification of Gem without dilution of the infusion bags.</p><p><strong>Methods: </strong>Individual doses of Gem preparations were retrospectively analysed over a 1-year period to determine the frequency of prepared doses. Using a maximum gap of 7.5% around the doses chosen, the selected Gem standard doses were 1400 mg, 1600 mg, 1800 mg and 2000 mg. Following the DB scheme, the frequency of prescription of standard and individualised Gem doses was analysed over a period of 10 months. The four selected Gem standard doses were aseptically prepared in polyolefin infusion bags. Each series of 20 bags was stocked under refrigerated storage conditions (4°C) for up to 84 days. The quantification of Gem without dilution of the infusion bags was obtained by the development of a HPLC method coupled to a diode array detector (DAD) or an evaporative light scattering detector (ELSD).</p><p><strong>Results: </strong>During the 10-month period following implementation of the DB, 75.6% of the 1266 prescribed doses were covered by the four standardised preparations. The number of different Gem doses was reduced from 183 to 55. Concerning the Gem quantification, both heteroscedasticity and non-linearity were observed with DAD. Using an ELSD, the trueness values were between 98.59% and 101.52% with excellent repeatability values between 0.66% and 1.42%.</p><p><strong>Conclusion: </strong>A new HPLC method has been developed for the quantification of Gem without dilution of the infusion bags prepared in advance as a result of a target DB scheme successfully implemented in our pharmacy department.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"369-375"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265545/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10637451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A pharmacist-led intervention to improve kidney transplant recipient outcomes and identify patients at risk of highly variable trough tacrolimus levels: a cohort study. 一项由药剂师主导的干预措施,旨在改善肾移植受者的预后,并识别存在他克莫司谷值高度变化风险的患者:一项队列研究。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003625
Roxane Lhermitte, Brendan Le Daré, Florian Laval, Florian Lemaitre, Barbara Troussier, Marie-Pascale Morin, Cécile Vigneau, Jonathan M Chemouny, Astrid Bacle
{"title":"A pharmacist-led intervention to improve kidney transplant recipient outcomes and identify patients at risk of highly variable trough tacrolimus levels: a cohort study.","authors":"Roxane Lhermitte, Brendan Le Daré, Florian Laval, Florian Lemaitre, Barbara Troussier, Marie-Pascale Morin, Cécile Vigneau, Jonathan M Chemouny, Astrid Bacle","doi":"10.1136/ejhpharm-2022-003625","DOIUrl":"10.1136/ejhpharm-2022-003625","url":null,"abstract":"<p><strong>Objectives: </strong>Given the positive impact of appropriate medication management on graft outcome and therefore of patient survival and graft function, the pharmacist's role in the kidney transplantation team has evolved over recent decades. The primary objective of this study was to determine whether pharmacist-led intervention after kidney transplantation is associated with a lower graft rejection rate and intra-patient variation in tacrolimus trough concentrations (C<sub>min</sub>). The study's secondary objective was to develop a questionnaire to identify patients at risk for highly variable C<sub>min</sub>.</p><p><strong>Methods: </strong>We retrospectively analysed kidney transplant recipients at Rennes University Hospital (France) between January 2013 and December 2020. Patients who received pharmacist-led education (intervention group, n=139) were compared with patients who did not (control group, n=131), according to graft survival at 1 year post-transplant, coefficient of variation (%CV) for the tacrolimus C<sub>min</sub>, age, sex, length of hospital stay post-transplantation, body mass index, and Charlson Comorbidity Index. In the intervention group, a questionnaire assessing patient knowledge was introduced to compare scores with the %CV.</p><p><strong>Results: </strong>In the intervention group, 1 year post-transplant graft survival was higher (95.7% vs 88.5%, p=0.0289) and patients had fewer variabilities in C<sub>min</sub>. The %CV was correlated with questionnaire scores (r=-0.9758, p<0.0001).</p><p><strong>Conclusions: </strong>Pharmacist-led interventions may have contributed to improved graft survival and patient management of immunosuppressants. Because %CV correlates with the patient questionnaire score, its introduction could be useful in identifying kidney transplant patients who would benefit most from a pharmacist-led patient education.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"314-320"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10637452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Antibiotic de-escalation in pneumonia with pharmacist education and ordering of methicillin-resistant Staphylococcus aureus nasal swabs. 通过药剂师教育和订购耐甲氧西林金黄色葡萄球菌鼻拭子,实现肺炎抗生素降级。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003504
Kevin Doan, Steven Smoke
{"title":"Antibiotic de-escalation in pneumonia with pharmacist education and ordering of methicillin-resistant <i>Staphylococcus aureus</i> nasal swabs.","authors":"Kevin Doan, Steven Smoke","doi":"10.1136/ejhpharm-2022-003504","DOIUrl":"10.1136/ejhpharm-2022-003504","url":null,"abstract":"<p><strong>Introduction: </strong>When methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) is the causative pathogen in pneumonia, in-hospital mortality rate is approximately 31.2%. However, the occurrence of MRSA pneumonia is uncommon, with a reported incidence of approximately 4.2%. Vancomycin is often empirically used for MRSA pneumonia coverage, but can lead to serious harm. The purpose of this study was to measure the impact of a pharmacy-driven MRSA nares testing protocol on vancomycin and linezolid prescribing patterns and clinical outcomes in patients diagnosed with pneumonia after removal of immediate educational intervention.</p><p><strong>Methods: </strong>This single-centre, quasi-experimental study evaluated the use of a MRSA nasal swab on patients diagnosed with community-acquired pneumonia, hospital-acquired pneumonia and ventilator-associated pneumonia. This study consisted of three phases, the preimplementation phase, the active/educational phase and the postimplementation phase. The primary outcome was intravenous anti-MRSA antibiotic duration of therapy. Secondary outcomes included the occurrence of acute kidney injury, duration of hospital stay, number of vancomycin levels obtained, the number of MRSA nares swabs ordered and time points in the MRSA nares collection process.</p><p><strong>Results: </strong>The preimplementation phase (n=39), the active phase (n=45) and the postimplementation phase (n=26) demonstrated similar baseline characteristics. The primary outcome for duration of anti-MRSA therapy 0-72 hours was 61.5% vs 77.8% vs 76.9% (p=0.19). Acute kidney injury was decreased throughout the study at 25.6%, 24.4% and 16.7% (p=0.32). The number of MRSA nares swabs ordered were 23.1%, 60% and 30.8% in each of the phases, respectively (p=0.49).</p><p><strong>Discussion: </strong>Our novel approach to measuring the impact of pharmacist education and ordering of MRSA nasal swabs has demonstrated benefits that were sustained for a short period after the intervention was removed. Additional study is required to determine the long-term impact.</p><p><strong>Conclusion: </strong>The implementation of a hospital-wide anti-MRSA protocol in patients with confirmed or suspected pneumonia indicated sustained changes for at least 3 months after direct intervention.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"327-331"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10666304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Public information on shortages in the EU/EEA: improvements made between 2018 and 2020. 欧盟/欧洲经济区关于短缺的公共信息:2018 年至 2020 年间的改进。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003554
Inga Abed, Juan Garcia Burgos, Yngvil Knudsen
{"title":"Public information on shortages in the EU/EEA: improvements made between 2018 and 2020.","authors":"Inga Abed, Juan Garcia Burgos, Yngvil Knudsen","doi":"10.1136/ejhpharm-2022-003554","DOIUrl":"10.1136/ejhpharm-2022-003554","url":null,"abstract":"<p><strong>Background: </strong>In July 2019, the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA) Task Force on Availability of Authorised Medicines for Human and Veterinary Use (TFAAM) published good practice guidance which provides key principles for European Union (EU) regulatory authorities for communication on shortages and availability issues. The use of a shortage catalogue was a key recommendation.</p><p><strong>Objectives: </strong>To assess how EU/European Economic Area (EEA) national competent authorities have implemented the recommendations of the good practice guidance.</p><p><strong>Methods: </strong>A survey was run in 2020 among EU/EEA national competent authorities to assess communication practices. The results were compared with those of a similar survey carried out 2 years earlier, before publication of the guidance. The survey covered human medicines only and was sent to 31 authorities: one per EU/EEA member state (and two to Germany's two medicines regulatory authorities).</p><p><strong>Results: </strong>In 2020, 81% of authorities (25/31) had a dedicated public shortage catalogue on their website. This was an increase from 74% (23/31) in 2018, when a similar survey was run. In future this is expected to increase to 87% with two more member states making plans to implement catalogues. Although many member states publish information on shortages there is still selection in terms of the details that are being published, and there is further scope to extend the information currently provided.</p><p><strong>Conclusion: </strong>Since publication of the EMA/HMA good practice guide in 2019, transparency has increased across the EU/EEA, and public catalogues of shortages are now a routine tool used by many medicines agencies.Further opportunities to improve transparency on supply issues lie ahead with the EMA network strategy to 2025, the revised EU pharmaceutical legislation and the new legal mandate reinforcing the role of the EMA.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"344-347"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11228212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10672690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hospital pharmacy workforce. 医院药剂师队伍。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2023-003919
Petr Horák, Despina Makridaki, Piera Polidori, András Süle, Louis Bertin, Stephanie Kohl
{"title":"Hospital pharmacy workforce.","authors":"Petr Horák, Despina Makridaki, Piera Polidori, András Süle, Louis Bertin, Stephanie Kohl","doi":"10.1136/ejhpharm-2023-003919","DOIUrl":"10.1136/ejhpharm-2023-003919","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"384-386"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10212064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimised quality control method for determination of the radiochemical purity of [99mTc]Tc-mebrofenin and [99mTc]Tc-etifenin in a clinical context. 在临床中测定[99m锝]锝-美布非宁和[99m锝]锝-依替非宁放射化学纯度的优化质量控制方法。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003512
Charlotte Pirot, Damien Peyronnet, Jonathan Vigne
{"title":"Optimised quality control method for determination of the radiochemical purity of [<sup>99m</sup>Tc]Tc-mebrofenin and [<sup>99m</sup>Tc]Tc-etifenin in a clinical context.","authors":"Charlotte Pirot, Damien Peyronnet, Jonathan Vigne","doi":"10.1136/ejhpharm-2022-003512","DOIUrl":"10.1136/ejhpharm-2022-003512","url":null,"abstract":"<p><strong>Objectives: </strong>In the context of a supply disruption of mebrofenin (Cholediam)-based kits for radiolabelling with technetium-99m [<sup>99m</sup>Tc], the medicine agencies allowed the importation of a back-up radiopharmaceutical diagnostic agent, etifenin (Techida), to ensure continuous management of patients with hepatobiliary disorders in nuclear medicine departments. There are still issues regarding the measurement of radiochemical purity (RCP) with these kits based on the European Pharmacopoeia and the Summary of Product Characteristics (SPC). This study aims to identify and to optimise, in a clinical context, the most suitable thin layer chromatography (TLC) method for the determination of the RCP in terms of speed of response and reliability for [<sup>99m</sup>Tc]Tc-mebrofenin and [<sup>99m</sup>Tc]Tc-etifenin.</p><p><strong>Methods: </strong>[<sup>99m</sup>Tc]Tc-etifenin (n=4) and [<sup>99m</sup>Tc]Tc-mebrofenin (n=5) were individually controlled using six different TLC methods and one high-performance liquid chromatography (HPLC) method for impurity identification ([<sup>99m</sup>Tc](TcO<sub>2</sub>)<sub>n</sub> and Na[<sup>99m</sup>Tc]TcO<sub>4</sub>), RCP (%) and duration of analysis (min). Two TLC methods were selected according to the recommendations of the Pharmacopoeia and SPC, two others were exactly the same but with a heating step, and the other two corresponded to a mix between the methods of the SPC and the Pharmacopoeia that were chosen to optimise RCP determination parameters.</p><p><strong>Results: </strong>Radio-HPLC analysis allowed effective separation of [<sup>99m</sup>Tc]Tc-etifenin and [<sup>99m</sup>Tc]Tc-mebrofenin with a retention time of 8.05±0.02 min and 8.94±0.07 min, respectively, from Na[<sup>99m</sup>Tc]TcO<sub>4</sub> (retention time 2.76±0.03 min). HPLC showed an absence of Na[<sup>99m</sup>Tc]TcO<sub>4</sub> for [<sup>99m</sup>Tc]Tc-mebrofenin and 0.2% for [<sup>99m</sup>Tc]Tc-etifenin. Among the TLC methods, we identified the most suitable method which ensures the most compliant RCP (98.3±0.9%) in a time of 31.5±1.1 min. Also, it allowed a time saving of 15 min compared with the methods proposed by the Pharmacopoeia and the SPCs.</p><p><strong>Conclusion: </strong>We propose a TLC method that accelerates quality control by an average of 15 min while guaranteeing a reliable RCP.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"376-380"},"PeriodicalIF":1.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265548/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10604986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Container closure integrity testing and process validation of closed system transfer devices for aseptic reconstitution of drug vials connected to fluid bags. 用于无菌重组连接到液体袋的小药瓶的封闭系统传输装置的容器封闭完整性测试和工艺验证。
IF 1.6 4区 医学
European journal of hospital pharmacy : science and practice Pub Date : 2024-06-21 DOI: 10.1136/ejhpharm-2022-003604
Roland B van den Berg, Kübra Akgöl, Eleonora L Swart, Bastiaan Nuijen, Mirjam Crul
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