Pub Date : 2024-03-19DOI: 10.1136/ejhpharm-2024-004133
Gunar Stemer, Steven David Williams
EJHP is the European platform to publish your manuscript addressing all practical and innovative aspects of hospital pharmacy practice research. Just looking at the current issue of the journal a lot of interesting stuff is being published, covering clinical pharmacy research, addressing medicines safety aspects and answering production-related research questions. One could say, all aspects of the broad discipline of hospital pharmacy are covered and represented in the sense of a carefully balanced potpourri. There’s something in here for everybody! Look carefully though. Is anything missing? Are there black spots not covered in the journal, not addressed by authors? We hypothesise: Yes, there are. Presumably, several areas of hospital pharmacy are under represented, but we would like … Correspondence to Dr Gunar Stemer, Pharmacy Department, University Hospital Vienna, Vienna, Vienna 1090, Austria; gunar.stemer{at}akhwien.at
{"title":"The threatened medicines information pharmacist!","authors":"Gunar Stemer, Steven David Williams","doi":"10.1136/ejhpharm-2024-004133","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004133","url":null,"abstract":"EJHP is the European platform to publish your manuscript addressing all practical and innovative aspects of hospital pharmacy practice research. Just looking at the current issue of the journal a lot of interesting stuff is being published, covering clinical pharmacy research, addressing medicines safety aspects and answering production-related research questions. One could say, all aspects of the broad discipline of hospital pharmacy are covered and represented in the sense of a carefully balanced potpourri. There’s something in here for everybody! Look carefully though. Is anything missing? Are there black spots not covered in the journal, not addressed by authors? We hypothesise: Yes, there are. Presumably, several areas of hospital pharmacy are under represented, but we would like … Correspondence to Dr Gunar Stemer, Pharmacy Department, University Hospital Vienna, Vienna, Vienna 1090, Austria; gunar.stemer{at}akhwien.at","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140172405","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 : 2024-03-19DOI: 10.1136/ejhpharm-2023-003727
Joshua Dray, Annaelle Soubieux, Catherine Chenailler, Remi Varin, Franck Dujardin, Jonathan Curado, Eric Barat
Objectives This review of the literature aimed to evaluate the economic impact of a clinical pharmacist in the orthopaedic sector. Methods The review followed the PRISMA recommendations. A bibliographic search was conducted on 23 June 2023 using PubMed, Cochrane Library and Web of Science. All articles in French or English with economic data on clinical pharmacy activities in orthopaedics were included. Articles not mentioning the term ‘orthopaedics’ and those published prior to 1990 were excluded. Data from the studies were compiled in an Excel table. A bias analysis using the ROBINS-I Cochrane tool was performed. The methodology of the studies was compared and weighted using the CHEERS and STROBE checklists. Results Among 529 articles initially identified, 10 were included in the review. The cost–benefit ratio of a clinical pharmacist in orthopaedics ranged from 0.47:1 to 28:1. The maximum savings reached US$73 410 /year in the American study and €1 42 356 /year in the French study. For three studies, the cost of a clinical pharmacist was not evaluated. Eight studies showed a positive economic impact. The Dutch study showed a balance and the Danish study showed a negative economic impact of €3442/month. Conclusions This literature review has shown an economic benefit of a clinical pharmacist in the orthopaedic sector despite several biases and methodological limitations. The two studies that did not confirm this benefit only evaluated a limited number of expected benefits. Nevertheless, the economic impact of the clinical pharmacist in the orthopaedic sector seems positive and undervalued.
{"title":"Economic impact of a clinical pharmacist in the orthopaedic sector: a review of the literature","authors":"Joshua Dray, Annaelle Soubieux, Catherine Chenailler, Remi Varin, Franck Dujardin, Jonathan Curado, Eric Barat","doi":"10.1136/ejhpharm-2023-003727","DOIUrl":"https://doi.org/10.1136/ejhpharm-2023-003727","url":null,"abstract":"Objectives This review of the literature aimed to evaluate the economic impact of a clinical pharmacist in the orthopaedic sector. Methods The review followed the PRISMA recommendations. A bibliographic search was conducted on 23 June 2023 using PubMed, Cochrane Library and Web of Science. All articles in French or English with economic data on clinical pharmacy activities in orthopaedics were included. Articles not mentioning the term ‘orthopaedics’ and those published prior to 1990 were excluded. Data from the studies were compiled in an Excel table. A bias analysis using the ROBINS-I Cochrane tool was performed. The methodology of the studies was compared and weighted using the CHEERS and STROBE checklists. Results Among 529 articles initially identified, 10 were included in the review. The cost–benefit ratio of a clinical pharmacist in orthopaedics ranged from 0.47:1 to 28:1. The maximum savings reached US$73 410 /year in the American study and €1 42 356 /year in the French study. For three studies, the cost of a clinical pharmacist was not evaluated. Eight studies showed a positive economic impact. The Dutch study showed a balance and the Danish study showed a negative economic impact of €3442/month. Conclusions This literature review has shown an economic benefit of a clinical pharmacist in the orthopaedic sector despite several biases and methodological limitations. The two studies that did not confirm this benefit only evaluated a limited number of expected benefits. Nevertheless, the economic impact of the clinical pharmacist in the orthopaedic sector seems positive and undervalued.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140172453","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 : 2024-03-04DOI: 10.1136/ejhpharm-2024-004137
Peter Chengming Zhang, Cheyenne Matinnia, Zubin Austin
Hospital pharmacists are essential to patient care and the integrity of the healthcare system. By applying their expertise as medication experts, they act to improve patient outcomes and reduce the cost of medication therapy. These outcomes have been demonstrated by numerous studies. In one meta-analysis, it was observed that the addition of a hospital pharmacist on interdisciplinary rounds in the intensive care unit (ICU) reduced adverse drug events, patient mortality, and length of stay.1 Another study found that the introduction of a clinical pharmacist to the ICU team led to cost savings of $1977 (€1822) on medication over the 24-week study.2 Despite their positive impact on patients and the healthcare system, hospital pharmacists are underrepresented in the media and with the public. These gaps in representation contribute to a lack of visibility within and outside of the hospital setting. Visibility is important as it is linked to professional advocacy. The lack of visibility may result in underrepresentation of hospital pharmacists in leadership or governance activities. One study evaluating healthcare professional representation on hospital boards in New York City found that while physicians and nurses were represented, not a single pharmacist was found on hospital boards in the city.3 Encouragingly, one pharmacist was found to sit on the governing body of a federally qualified health centre.3 One way to increase visibility is by increasing public knowledge of the … Correspondence to Dr Peter Chengming Zhang, University of Toronto Leslie Dan Faculty of Pharmacy, Toronto, ON, Canada; petercm.zhang{at}mail.utoronto.ca
{"title":"To maximise impact, hospital pharmacists need to increase visibility","authors":"Peter Chengming Zhang, Cheyenne Matinnia, Zubin Austin","doi":"10.1136/ejhpharm-2024-004137","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004137","url":null,"abstract":"Hospital pharmacists are essential to patient care and the integrity of the healthcare system. By applying their expertise as medication experts, they act to improve patient outcomes and reduce the cost of medication therapy. These outcomes have been demonstrated by numerous studies. In one meta-analysis, it was observed that the addition of a hospital pharmacist on interdisciplinary rounds in the intensive care unit (ICU) reduced adverse drug events, patient mortality, and length of stay.1 Another study found that the introduction of a clinical pharmacist to the ICU team led to cost savings of $1977 (€1822) on medication over the 24-week study.2 Despite their positive impact on patients and the healthcare system, hospital pharmacists are underrepresented in the media and with the public. These gaps in representation contribute to a lack of visibility within and outside of the hospital setting. Visibility is important as it is linked to professional advocacy. The lack of visibility may result in underrepresentation of hospital pharmacists in leadership or governance activities. One study evaluating healthcare professional representation on hospital boards in New York City found that while physicians and nurses were represented, not a single pharmacist was found on hospital boards in the city.3 Encouragingly, one pharmacist was found to sit on the governing body of a federally qualified health centre.3 One way to increase visibility is by increasing public knowledge of the … Correspondence to Dr Peter Chengming Zhang, University of Toronto Leslie Dan Faculty of Pharmacy, Toronto, ON, Canada; petercm.zhang{at}mail.utoronto.ca","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"123 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140034589","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 : 2024-02-21DOI: 10.1136/ejhpharm-2023-004028
Lex L Haegens, Victor J B Huiskes, Charlotte L Bekker, Bart J F van den Bemt
Objectives Biological disease-modifying antirheumatic drugs (bDMARDs) require specific storage temperatures, but are frequently stored outside the recommended range of 2–8°C. As incorrect storage may affect therapy effectiveness and consequently lead to higher disease activity, compliance with recommended storage temperatures should be improved. eHealth interventions can provide insight into storage temperatures and alerts in case of deviations from recommended temperatures. Therefore, this study aims to assess the effect of a smart temperature logger on correctly storing bDMARDs at home by patients with rheumatic diseases. Methods A pre-post study was performed in a hospital in the Netherlands. The baseline period consisted of 12 weeks of storage temperature measurement with a passive temperature logger, and the intervention period consisted of 12 weeks of storage temperature measurement with a smart temperature logger. This smart logger included a smartphone application which provided insight into storage temperatures and real-time alerts when exceeding recommended temperatures. The main outcome measure was the difference in the number of patients who stored their bDMARDs correctly between baseline and intervention. Secondary outcomes were the difference in the proportion of measurement time within 2–8°C between baseline and intervention, the distribution of measurement time among temperature categories, and the patient’s acceptance measured using a questionnaire based on the Technology Acceptance Model. Results In total, 48 participants (median age 55 years (IQR 47–64), 53% male) were analysed. The proportion of participants correctly storing bDMARDs increased from 18.8% (n=9) during baseline to 39.6% (n=19) during intervention (p=0.004). The median proportion of measurement time between 2–8°C improved by 6% (IQR 0–34%) (p<0.0001). Technology acceptance was scored as moderate. Conclusions Temperature monitoring and real-time feedback with a smart temperature logger shows potential to improve at-home storage of bDMARDs, provided that continuous connection is realised to ensure real-time alerts and data collection. Data are available upon reasonable request.
{"title":"Effect of a smart temperature logger on correctly storing biological disease-modifying antirheumatic drugs at home: a pre-post study","authors":"Lex L Haegens, Victor J B Huiskes, Charlotte L Bekker, Bart J F van den Bemt","doi":"10.1136/ejhpharm-2023-004028","DOIUrl":"https://doi.org/10.1136/ejhpharm-2023-004028","url":null,"abstract":"Objectives Biological disease-modifying antirheumatic drugs (bDMARDs) require specific storage temperatures, but are frequently stored outside the recommended range of 2–8°C. As incorrect storage may affect therapy effectiveness and consequently lead to higher disease activity, compliance with recommended storage temperatures should be improved. eHealth interventions can provide insight into storage temperatures and alerts in case of deviations from recommended temperatures. Therefore, this study aims to assess the effect of a smart temperature logger on correctly storing bDMARDs at home by patients with rheumatic diseases. Methods A pre-post study was performed in a hospital in the Netherlands. The baseline period consisted of 12 weeks of storage temperature measurement with a passive temperature logger, and the intervention period consisted of 12 weeks of storage temperature measurement with a smart temperature logger. This smart logger included a smartphone application which provided insight into storage temperatures and real-time alerts when exceeding recommended temperatures. The main outcome measure was the difference in the number of patients who stored their bDMARDs correctly between baseline and intervention. Secondary outcomes were the difference in the proportion of measurement time within 2–8°C between baseline and intervention, the distribution of measurement time among temperature categories, and the patient’s acceptance measured using a questionnaire based on the Technology Acceptance Model. Results In total, 48 participants (median age 55 years (IQR 47–64), 53% male) were analysed. The proportion of participants correctly storing bDMARDs increased from 18.8% (n=9) during baseline to 39.6% (n=19) during intervention (p=0.004). The median proportion of measurement time between 2–8°C improved by 6% (IQR 0–34%) (p<0.0001). Technology acceptance was scored as moderate. Conclusions Temperature monitoring and real-time feedback with a smart temperature logger shows potential to improve at-home storage of bDMARDs, provided that continuous connection is realised to ensure real-time alerts and data collection. Data are available upon reasonable request.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139919810","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}
Aims and objective The aim of the European Association of Hospital Pharmacists (EAHP)’s 2023 shortages survey was to collect data on causes and mitigation strategies of shortages of medicines and medical devices and their impact on patient care. The survey targeted hospital pharmacists (HPs), physicians (PHYs), nurses (NRS) and other healthcare professionals (OHCPs). A separate set of questions addressed patients (PTNs). Methods A 49-question survey was carried out by a team at EAHP, collecting information from European HPs, PTNs, NRS, PHYs and OTHCs on shortages of medicines and medical devices in their respective countries. The survey ran from 27 February to 19 May 2023. The results were analysed by EAHP. Results There were 1497 HP responses to the 2023 survey. While 95% (n=1429) of HPs and 86% (n=127) of OHCPs consider medicine shortages an ongoing problem, 84% (n=48) of PHYs and 68% (n=15) of NRS also agreed. Shortages of active pharmaceutical ingredients (77%, n=1148), manufacturing (67%, n=1007) and supply chain problems (50%, n=752) are major causes of shortages according to HPs as well as NRS and OHCPs; PHYs (49%, n=18) consider pricing to be the driver. More than 60% (n=765) of HPs, 55% (n=11) of NRS, 57% (n=30) of PHYs and 46% (n=56) of OHCPs experienced shortages of medical devices in 2022. Antimicrobials were most affected, according to all respondent groups, followed by analgesics, anaesthetics, cardiovascular and paediatric medicines. HPs (59%, n=269), NRS (57%, n=4), OHCPs (56%, n=37) and PHYs (54%, n=14) consider delays in care as the main consequence of medication shortages. Conclusions Shortages of medicines and medical devices affect healthcare services and patient care. Increased transparency and access to information regarding ongoing and emerging shortages as well as better preparedness of healthcare professionals is crucial to their effective management. Data are available upon reasonable request.
{"title":"Results of EAHP’s 2023 shortages survey","authors":"Nenad Miljković, Piera Polidori, Daniele Leonardi Vinci, Darija Kuruc Poje, Despina Makridaki, Stephanie Kohl, András Süle","doi":"10.1136/ejhpharm-2024-004090","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004090","url":null,"abstract":"Aims and objective The aim of the European Association of Hospital Pharmacists (EAHP)’s 2023 shortages survey was to collect data on causes and mitigation strategies of shortages of medicines and medical devices and their impact on patient care. The survey targeted hospital pharmacists (HPs), physicians (PHYs), nurses (NRS) and other healthcare professionals (OHCPs). A separate set of questions addressed patients (PTNs). Methods A 49-question survey was carried out by a team at EAHP, collecting information from European HPs, PTNs, NRS, PHYs and OTHCs on shortages of medicines and medical devices in their respective countries. The survey ran from 27 February to 19 May 2023. The results were analysed by EAHP. Results There were 1497 HP responses to the 2023 survey. While 95% (n=1429) of HPs and 86% (n=127) of OHCPs consider medicine shortages an ongoing problem, 84% (n=48) of PHYs and 68% (n=15) of NRS also agreed. Shortages of active pharmaceutical ingredients (77%, n=1148), manufacturing (67%, n=1007) and supply chain problems (50%, n=752) are major causes of shortages according to HPs as well as NRS and OHCPs; PHYs (49%, n=18) consider pricing to be the driver. More than 60% (n=765) of HPs, 55% (n=11) of NRS, 57% (n=30) of PHYs and 46% (n=56) of OHCPs experienced shortages of medical devices in 2022. Antimicrobials were most affected, according to all respondent groups, followed by analgesics, anaesthetics, cardiovascular and paediatric medicines. HPs (59%, n=269), NRS (57%, n=4), OHCPs (56%, n=37) and PHYs (54%, n=14) consider delays in care as the main consequence of medication shortages. Conclusions Shortages of medicines and medical devices affect healthcare services and patient care. Increased transparency and access to information regarding ongoing and emerging shortages as well as better preparedness of healthcare professionals is crucial to their effective management. Data are available upon reasonable request.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"42 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139661254","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 : 2024-02-01DOI: 10.1136/ejhpharm-2023-004032
Nikolaus Riesenhuber, Maxine Krauss, Korinna Moßburger, Christina Gradwohl, Gunar Stemer
Medicine shortages, especially those involving antibiotics, pose a global public health dilemma that can lead to adverse health outcomes. The aim of this study was to assess the supply situation of various antimicrobials in liquid dosage forms, which represent the mainstay of therapy for paediatric infections. The availability was examined over a period of 27 weeks in Austria. During the time period investigated, 34 products (81.0%) were not available for over 50% of the time; eight of those (19.0%) experienced complete unavailability. Only four products (9.5%) demonstrated continuous availability. Regarding penicillin antibiotics, amoxicillin was not available for 77.8% of the time (21 weeks) and amoxicillin/clavulanic acid for 59.3% (16 weeks). Regular monitoring of availability status can help mitigate this issue; however, cross-national strategies are urgently needed to guarantee a constant supply in the future. Data are available upon reasonable request.
{"title":"Liquid antimicrobials: a national analysis of critical shortages","authors":"Nikolaus Riesenhuber, Maxine Krauss, Korinna Moßburger, Christina Gradwohl, Gunar Stemer","doi":"10.1136/ejhpharm-2023-004032","DOIUrl":"https://doi.org/10.1136/ejhpharm-2023-004032","url":null,"abstract":"Medicine shortages, especially those involving antibiotics, pose a global public health dilemma that can lead to adverse health outcomes. The aim of this study was to assess the supply situation of various antimicrobials in liquid dosage forms, which represent the mainstay of therapy for paediatric infections. The availability was examined over a period of 27 weeks in Austria. During the time period investigated, 34 products (81.0%) were not available for over 50% of the time; eight of those (19.0%) experienced complete unavailability. Only four products (9.5%) demonstrated continuous availability. Regarding penicillin antibiotics, amoxicillin was not available for 77.8% of the time (21 weeks) and amoxicillin/clavulanic acid for 59.3% (16 weeks). Regular monitoring of availability status can help mitigate this issue; however, cross-national strategies are urgently needed to guarantee a constant supply in the future. Data are available upon reasonable request.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139661452","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 : 2023-12-09DOI: 10.1136/ejhpharm-2023-003937
Inés Jiménez-Lozano, Carmen Luna-Paredes, Emilio Monte-Boquet, Aurora Fernández-Polo, Carme Cañete-Ramírez, María Roch-Santed, Silvia Gartner, Antonio Álvarez-Fernández
Background Inhaled antibiotics have achieved or stabilised the clinical condition of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection. We aimed to determine the effectiveness of aztreonam lysine inhaled solution (AZLI) in patients with CF and chronic P. aeruginosa infection. Methods A retrospective observational study was conducted on patients with CF and chronic P. aeruginosa infection who received AZLI between July 2012 and September 2018 inclusive in three Spanish hospitals in a routine clinical practice setting. The primary endpoint was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV1) compared with the previous 12 months, at the start of AZLI treatment and 12 months after starting the drug. Other variables analysed were exacerbations, hospitalisations, type and route of antibiotics prescribed, weight and body mass index (BMI) and adverse drug reactions. Results In a cohort of 52 patients, AZLI treatment led to stabilisation of FEV1, changing from a mean (SD) value of 55.60 (21.3)% at the start of treatment to 56.8 (20.4)% after 12 months of treatment (p=0.5296) in patients who had not previously received the drug. In addition, it significantly reduced exacerbations from a median (P25; P75) of 2.0 (1.0; 3.0) in the 12 months prior to AZLI to 1.0 (1.0; 2.0) in the 12 months after treatment initiation (p=0.0350). AZLI also reduced the need for other antibiotics and prevented a decrease in BMI, with an adequate safety profile. Conclusions AZLI achieved stabilisation of lung function measured by FEV1 in patients with CF and chronic P. aeruginosa infection, along with an adequate safety profile. Data are available upon reasonable request. no applicable.
{"title":"Inhaled aztreonam lysine in the management of Pseudomonas aeruginosa in patients with cystic fibrosis: real-life effectiveness","authors":"Inés Jiménez-Lozano, Carmen Luna-Paredes, Emilio Monte-Boquet, Aurora Fernández-Polo, Carme Cañete-Ramírez, María Roch-Santed, Silvia Gartner, Antonio Álvarez-Fernández","doi":"10.1136/ejhpharm-2023-003937","DOIUrl":"https://doi.org/10.1136/ejhpharm-2023-003937","url":null,"abstract":"Background Inhaled antibiotics have achieved or stabilised the clinical condition of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection. We aimed to determine the effectiveness of aztreonam lysine inhaled solution (AZLI) in patients with CF and chronic P. aeruginosa infection. Methods A retrospective observational study was conducted on patients with CF and chronic P. aeruginosa infection who received AZLI between July 2012 and September 2018 inclusive in three Spanish hospitals in a routine clinical practice setting. The primary endpoint was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV1) compared with the previous 12 months, at the start of AZLI treatment and 12 months after starting the drug. Other variables analysed were exacerbations, hospitalisations, type and route of antibiotics prescribed, weight and body mass index (BMI) and adverse drug reactions. Results In a cohort of 52 patients, AZLI treatment led to stabilisation of FEV1, changing from a mean (SD) value of 55.60 (21.3)% at the start of treatment to 56.8 (20.4)% after 12 months of treatment (p=0.5296) in patients who had not previously received the drug. In addition, it significantly reduced exacerbations from a median (P25; P75) of 2.0 (1.0; 3.0) in the 12 months prior to AZLI to 1.0 (1.0; 2.0) in the 12 months after treatment initiation (p=0.0350). AZLI also reduced the need for other antibiotics and prevented a decrease in BMI, with an adequate safety profile. Conclusions AZLI achieved stabilisation of lung function measured by FEV1 in patients with CF and chronic P. aeruginosa infection, along with an adequate safety profile. Data are available upon reasonable request. no applicable.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"67 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138562094","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 : 2023-12-06DOI: 10.1136/ejhpharm-2023-003784
Fekade Bruck Sime, Steven Wallis, Conor Jamieson, Tim Hills, Mark Gilchrist, Mark Santillo, R Andrew Seaton, Felicity Drummond, Jason Roberts
Objectives To investigate the stability of aciclovir solutions in elastomeric devices used for outpatient parenteral antimicrobial therapy (OPAT). Methods Triplicates of two elastomeric devices, Accufuser and Easypump II, were filled with a solution of 200 mg, 2400 mg, and 4500 mg aciclovir in 240 mL 0.9% w/v saline. Devices were stored at room temperature for 14 days, followed by 24 hours storage at 32°C. Assessment using a stability indicating assay, pH and subvisible particle analysis was undertaken at 11 time points throughout the study. Results Aciclovir solution at 200 mg and 2400 mg in 240 mL was stable for 14 days at room temperature (<20°C) and 24 hours of 32°C ‘in-use’ temperature exposure, remaining above the 95% limit for NHS stability protocols. The high dose was also stable for 14 days at room temperature, but when stored at 32°C there was precipitation of aciclovir within 4 hours in both devices. The precipitate was confirmed as aciclovir and precipitation was not a sign of chemical degradation. Conclusions Aciclovir concentrations above 2400 mg/240 mL are liable to precipitation and cannot be recommended for OPAT services because of heightened risks of nephrotoxicity. Aciclovir solution can be given as a continuous 24-hour infusion for OPAT services at a concentration range of 200–2400 mg in 240 mL in Accufuser and Easypump II elastomeric devices following 14 days storage at room temperature, protected from light. All data relevant to the study are included in the article or uploaded as supplementary information.
{"title":"Evaluation of the stability of aciclovir in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy","authors":"Fekade Bruck Sime, Steven Wallis, Conor Jamieson, Tim Hills, Mark Gilchrist, Mark Santillo, R Andrew Seaton, Felicity Drummond, Jason Roberts","doi":"10.1136/ejhpharm-2023-003784","DOIUrl":"https://doi.org/10.1136/ejhpharm-2023-003784","url":null,"abstract":"Objectives To investigate the stability of aciclovir solutions in elastomeric devices used for outpatient parenteral antimicrobial therapy (OPAT). Methods Triplicates of two elastomeric devices, Accufuser and Easypump II, were filled with a solution of 200 mg, 2400 mg, and 4500 mg aciclovir in 240 mL 0.9% w/v saline. Devices were stored at room temperature for 14 days, followed by 24 hours storage at 32°C. Assessment using a stability indicating assay, pH and subvisible particle analysis was undertaken at 11 time points throughout the study. Results Aciclovir solution at 200 mg and 2400 mg in 240 mL was stable for 14 days at room temperature (<20°C) and 24 hours of 32°C ‘in-use’ temperature exposure, remaining above the 95% limit for NHS stability protocols. The high dose was also stable for 14 days at room temperature, but when stored at 32°C there was precipitation of aciclovir within 4 hours in both devices. The precipitate was confirmed as aciclovir and precipitation was not a sign of chemical degradation. Conclusions Aciclovir concentrations above 2400 mg/240 mL are liable to precipitation and cannot be recommended for OPAT services because of heightened risks of nephrotoxicity. Aciclovir solution can be given as a continuous 24-hour infusion for OPAT services at a concentration range of 200–2400 mg in 240 mL in Accufuser and Easypump II elastomeric devices following 14 days storage at room temperature, protected from light. All data relevant to the study are included in the article or uploaded as supplementary information.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"221 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138546851","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 : 2022-05-25DOI: 10.1101/2022.05.22.22275426
K. J. Frost, R. Hamilton, S. Hughes, C. Jamieson, P. Rafferty, O. Troise, A. Jenkins
Background Updated European Committee on Antimicrobial Susceptibility Testing (EUCAST) amikacin breakpoints for Enterobacterales and Pseudomonas aeruginosa included revised dosing recommendations of 25–30 mg/kg to achieve key pharmacokinetic/pharmacodynamic parameters, higher than recommended in the British National Formulary. The objectives of this review were to identify clinical evidence for high-dose amikacin regimens and to determine drug exposures that are related to adverse events and toxicity. Methods The literature search was conducted in October 2021 and updated in May 2022 using electronic databases for any study reporting adult participants treated with amikacin at doses ≥20 mg/kg/day. Reference lists of included papers were also screened for potential papers. Data were extracted for pharmacokinetic parameters and clinical outcomes, presented in a summary table and consolidated narratively. Meta-analysis was not possible. Each study was assessed for bias before, during and after the intervention using the ROBINS-I tool. Results Nine studies (total 501 participants in 10 reports) were identified and included, eight of which were observational studies. Assessment of bias showed substantial flaws. Dosing regimens ranged from 25 to 30 mg/kg/day. Six studies adjusted the dose in obesity when participants had a body mass index of ≥30 kg/m2. Target peak serum concentrations ranged from 60 mg/L to 80 mg/L and 59.6–81.8% of patients achieved these targets, but there was no information on clinical outcomes. Two studies reported the impact of high-dose amikacin on renal function. No studies reporting auditory or vestibular toxicity were identified. Conclusion All included papers were limited by a significant risk of bias, while methodological and reporting heterogeneity made drawing conclusions challenging. Lack of information on the impact on renal function or ototoxicity means high-dose regimens should be used cautiously in older people. There is a need for a consensus guideline for high-dose amikacin to be written. Trial registration number PROSPERO (CRD42021250022).
{"title":"Systematic review of high-dose amikacin regimens for the treatment of Gram-negative infections based on EUCAST dosing recommendations","authors":"K. J. Frost, R. Hamilton, S. Hughes, C. Jamieson, P. Rafferty, O. Troise, A. Jenkins","doi":"10.1101/2022.05.22.22275426","DOIUrl":"https://doi.org/10.1101/2022.05.22.22275426","url":null,"abstract":"Background Updated European Committee on Antimicrobial Susceptibility Testing (EUCAST) amikacin breakpoints for Enterobacterales and Pseudomonas aeruginosa included revised dosing recommendations of 25–30 mg/kg to achieve key pharmacokinetic/pharmacodynamic parameters, higher than recommended in the British National Formulary. The objectives of this review were to identify clinical evidence for high-dose amikacin regimens and to determine drug exposures that are related to adverse events and toxicity. Methods The literature search was conducted in October 2021 and updated in May 2022 using electronic databases for any study reporting adult participants treated with amikacin at doses ≥20 mg/kg/day. Reference lists of included papers were also screened for potential papers. Data were extracted for pharmacokinetic parameters and clinical outcomes, presented in a summary table and consolidated narratively. Meta-analysis was not possible. Each study was assessed for bias before, during and after the intervention using the ROBINS-I tool. Results Nine studies (total 501 participants in 10 reports) were identified and included, eight of which were observational studies. Assessment of bias showed substantial flaws. Dosing regimens ranged from 25 to 30 mg/kg/day. Six studies adjusted the dose in obesity when participants had a body mass index of ≥30 kg/m2. Target peak serum concentrations ranged from 60 mg/L to 80 mg/L and 59.6–81.8% of patients achieved these targets, but there was no information on clinical outcomes. Two studies reported the impact of high-dose amikacin on renal function. No studies reporting auditory or vestibular toxicity were identified. Conclusion All included papers were limited by a significant risk of bias, while methodological and reporting heterogeneity made drawing conclusions challenging. Lack of information on the impact on renal function or ototoxicity means high-dose regimens should be used cautiously in older people. There is a need for a consensus guideline for high-dose amikacin to be written. Trial registration number PROSPERO (CRD42021250022).","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74038416","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 : 2022-01-01DOI: 10.1136/ejhpharm-2022-eahp.49
R. Trittler, B. Altmann, M. Garcia-Käufer, R. Gminski, M. Hug
Background and importance The importance of mRNA-based vaccines increased rapidly due to the COVID-19 pandemic. However, little is known on the challenges linked to handling shortages and extended stability of these new types of substance. Since vaccine remnants have to be discarded according to the Summary of Product Characteristics, we hypothesise that sterile filtration after pooling is suitable to save vaccine material for clinical application. Aim and objectives The aim of this pilot study was to compare quality parameters of remnants derived from ready-to-use mRNA vaccine solutions before and after sterile filtration. Therefore, we pooled mRNA vaccine solution remnants from Corminaty vials (BioNTech/Pfizer) and compared particle size, distribution and quantity of the lipoplexes. In addition, quantity and/or quality of the mRNA was determined. Material and methods Measurements of invisible particulates in the range 1-50 mm were performed by light obscuration according to the European Pharmacopoeia (10th edn). The size of lipoplexes was measured with nanoparticle tracking analysis (NTA) to determine hydrodynamic diameter and particle concentration. Dynamic light scattering was employed complementarily to the NTA technique to focus on particle size from 0.3 nm to 10 mm. The concentration, purity and integrity of the mRNA was analysed by ultraviolet (UV) spectrophotometry and capillary electrophoresis after mRNA purification. Results After pooling the remnants of the vials we found a substantial increase of particulates >1 mm when compared to fresh vaccine samples. This effect was likely due to contamination of the examined probes with particles from ambient air. As expected, all these particulates were eliminated by sterile filtration. Size distribution and concentration of the lipoplexes were comparable between unfiltered and filtered samples. With respect to the mRNA, we identified the fragment of interest in all examined samples. Sterile filtration did not change the concentration, purity and integrity of the mRNA. Conclusion and relevance Our results indicate that sterile filtration of mRNA-based vaccines eliminates particle contamination from the vaccine solution while the concentration of lipoplex nanoparticles was not altered. Moreover, neither the quantity nor quality of the mRNA was affected by the filtration process. The results of our pilot study provide the first data on the stability of mRNA vaccines and help to fill knowledge gap when dealing with these substances in hospital pharmacy.
{"title":"Quantitative and Qualitative Evaluation of Mrna Vaccines after Sterile Filtration","authors":"R. Trittler, B. Altmann, M. Garcia-Käufer, R. Gminski, M. Hug","doi":"10.1136/ejhpharm-2022-eahp.49","DOIUrl":"https://doi.org/10.1136/ejhpharm-2022-eahp.49","url":null,"abstract":"Background and importance The importance of mRNA-based vaccines increased rapidly due to the COVID-19 pandemic. However, little is known on the challenges linked to handling shortages and extended stability of these new types of substance. Since vaccine remnants have to be discarded according to the Summary of Product Characteristics, we hypothesise that sterile filtration after pooling is suitable to save vaccine material for clinical application. Aim and objectives The aim of this pilot study was to compare quality parameters of remnants derived from ready-to-use mRNA vaccine solutions before and after sterile filtration. Therefore, we pooled mRNA vaccine solution remnants from Corminaty vials (BioNTech/Pfizer) and compared particle size, distribution and quantity of the lipoplexes. In addition, quantity and/or quality of the mRNA was determined. Material and methods Measurements of invisible particulates in the range 1-50 mm were performed by light obscuration according to the European Pharmacopoeia (10th edn). The size of lipoplexes was measured with nanoparticle tracking analysis (NTA) to determine hydrodynamic diameter and particle concentration. Dynamic light scattering was employed complementarily to the NTA technique to focus on particle size from 0.3 nm to 10 mm. The concentration, purity and integrity of the mRNA was analysed by ultraviolet (UV) spectrophotometry and capillary electrophoresis after mRNA purification. Results After pooling the remnants of the vials we found a substantial increase of particulates >1 mm when compared to fresh vaccine samples. This effect was likely due to contamination of the examined probes with particles from ambient air. As expected, all these particulates were eliminated by sterile filtration. Size distribution and concentration of the lipoplexes were comparable between unfiltered and filtered samples. With respect to the mRNA, we identified the fragment of interest in all examined samples. Sterile filtration did not change the concentration, purity and integrity of the mRNA. Conclusion and relevance Our results indicate that sterile filtration of mRNA-based vaccines eliminates particle contamination from the vaccine solution while the concentration of lipoplex nanoparticles was not altered. Moreover, neither the quantity nor quality of the mRNA was affected by the filtration process. The results of our pilot study provide the first data on the stability of mRNA vaccines and help to fill knowledge gap when dealing with these substances in hospital pharmacy.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"53 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75173176","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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