Giulia Cancellieri, Alessio Provenzani, Carlo Polidori, Piera Polidori
{"title":"Risk assessment of clinical trial protocols: a tool for hospital pharmacists to reduce human error in experimental drug management.","authors":"Giulia Cancellieri, Alessio Provenzani, Carlo Polidori, Piera Polidori","doi":"10.1136/ejhpharm-2024-004154","DOIUrl":"10.1136/ejhpharm-2024-004154","url":null,"abstract":"<p><strong>Background and objectives: </strong>Hospital pharmacists collaborate in clinical trials by managing the reception, conservation, distribution, return and destruction of the investigational medical products (IMP). However, errors can happen during the simultaneous management of multiple trials because each clinical trial stipulates its own method for managing the drug under study. In order to promote optimal management by hospital pharmacists, we developed a method for calculating a risk of error index for each experimental protocol, and wrote standard procedures for managing trials assigned low, moderate and high risk levels, to provide hospital pharmacists with a systematic tool for reducing human error in the management of IMPs for multiple clinical trials.</p><p><strong>Methods: </strong>Calculation of this risk of error index (ρ) entails four factors: the pharmacological risk of error (φ) inherent in the pharmacological characteristics and route of administration of the IMP (carcinogenic, mutagenic, cytotoxic nature of the drug, parental or non-parenteral administration), the technological risk of error (α) involved should drug compounding be required, the risk of error related to the number of patients enrolled (n<sub>p</sub>) and the risk of error intrinsic to the protocol (π) when it involves placebos, randomisation or other factors. We developed the formula [Formula: see text] to define trials as low (ρ<50), moderate (51<ρ<150) and high risk (ρ>151) for hospital pharmacist error.</p><p><strong>Results: </strong>Calculations of this formula for 60 active trials indicated that seven (11.7%) of the protocols were low risk of hospital pharmacist error, 43 (71.7%) were moderate risk and 10 (16.6%) were high risk. For each of these categories (low, moderate and high risk) we have outlined standard procedures in order to minimise the occurrence of any errors.</p><p><strong>Conclusions: </strong>Following validation of our formula and standard procedures by the ISMETT Research Institute, we are promoting the use of the tool in other clinical centres as we believe it can help hospital pharmacists minimise the risk of error in managing experimental drugs for clinical trials.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"121-125"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619623","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}
{"title":"Correspondence on: 'Patient reported medication-related problems, adherence and waste of oral anticancer medication over time' by van den Bemt <i>et al</i>.","authors":"Jinming Cao, Zhicong Chen, Feng Xu","doi":"10.1136/ejhpharm-2024-004424","DOIUrl":"10.1136/ejhpharm-2024-004424","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"195-196"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853481","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}
{"title":"Importance of randomisation-a call to researchers.","authors":"Philip Wiffen","doi":"10.1136/ejhpharm-2025-004501","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004501","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":"32 2","pages":"99"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472279","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}
S M D K Ganga Senarathna, Tobias Strunk, Michael Petrovski, Sarah Woodland, Jorge Martinez, Victor T G Chuang, Kevin T Batty
{"title":"Physical compatibility of lipid emulsions and intravenous medications used in neonatal intensive care settings.","authors":"S M D K Ganga Senarathna, Tobias Strunk, Michael Petrovski, Sarah Woodland, Jorge Martinez, Victor T G Chuang, Kevin T Batty","doi":"10.1136/ejhpharm-2023-003870","DOIUrl":"10.1136/ejhpharm-2023-003870","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this study was to investigate the physical compatibility of intravenous lipid emulsions with parenteral medications used in neonatal intensive care.</p><p><strong>Methods: </strong>Lipid emulsion and drug solutions were combined 1:1 in glass vials, inspected for physical incompatibility at 0, 1 and 2 hours, and assessed on the basis of lipid droplet size at 0 and 2 hours after mixing. Intravenous fluid controls (Water for Injection, sodium chloride 0.9% w/v, glucose 5% w/v), positive controls (gentamicin, albumin), negative controls (metronidazole, paracetamol, vancomycin) and 21 previously untested drug combinations were evaluated.</p><p><strong>Results: </strong>No phase separation, change in colour, gas production or other visible anomaly was observed. The between-run mean droplet diameter (MDD) for SMOFlipid20% alone (0.301±0.008 µm) was comparable to the lipid emulsion/intravenous fluid and lipid emulsion/drug solution combinations. In addition to gentamicin and albumin, caffeine citrate (20 mg/mL) was shown to be incompatible with the lipid emulsion. All other lipid:drug combinations were compatible, based on the MDD data.</p><p><strong>Conclusion: </strong>Intravenous lipid emulsions were found to be compatible with 20 parenteral medications, including antimicrobial agents, inotropes, anti-inflammatory drugs and caffeine base, in simulated Y-site conditions. The lipid emulsion was incompatible with caffeine citrate injection.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"149-153"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50157461","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}
Gerda Ratzinger-Stoeger, Maria Anzengruber, Katharina Skoll, Diana-Alexandra Ertl, Gabriele Hartmann, Franz Gabor
{"title":"Formulation and characterisation of metyrapone suppositories for the first effective long-term use in an infant with McCune-Albright syndrome-related Cushing syndrome.","authors":"Gerda Ratzinger-Stoeger, Maria Anzengruber, Katharina Skoll, Diana-Alexandra Ertl, Gabriele Hartmann, Franz Gabor","doi":"10.1136/ejhpharm-2023-003853","DOIUrl":"10.1136/ejhpharm-2023-003853","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this project was to develop a rectal formulation of metyrapone suitable for application in an infant hospitalised with McCune-Albright syndrome (MAS)-related Cushing syndrome and to provide a detailed description of the formulation protocol including quality control parameters.</p><p><strong>Methods: </strong>Suppositories with a drug load of up to 100 mg metyrapone were prepared. Mass variation, content uniformity and drug release were analysed according to the guidelines set out by the European Pharmacopoeia. Monitoring of the drug content for 6 weeks allowed for estimation of the storage stability at 2-8°C.</p><p><strong>Results: </strong>A protocol for the reproducible preparation of suppositories with intended metyrapone content of 30-100 mg was established. The suppositories were well tolerated by the patient and the clinical outcome is promising. The suppository preparations complied with the regulations from the European Pharmacopoeia. Further, a stability of the rectal formulation of at least 1 month was confirmed, facilitating medication supply for home care.</p><p><strong>Conclusions: </strong>An adequate and easy to follow protocol for preparation of high-quality metyrapone suppositories, with sufficient stability for practical use and fulfilling major pharmaceutical quality parameters, was established. The protocol can be easily replicated by skilled personnel in a community pharmacy facilitating treatment of the infant in home care.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"161-165"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138482247","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}
{"title":"HMGCR-associated myopathy in polymorbid patients with polypharmacy should not be attributed solely to statins.","authors":"Josef Finsterer","doi":"10.1136/ejhpharm-2024-004253","DOIUrl":"10.1136/ejhpharm-2024-004253","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"194-195"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310420","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}
Beatriz Montero-Llorente, Covadonga Pérez Menéndez-Conde, Eduardo González Ferrer, Genoveva Teresa López Castellanos, Luis Miguel Bedoya Del Olmo, Teresa Bermejo Vicedo
{"title":"Impact of pharmaceutical care on hospital readmissions for heart failure: a randomised trial.","authors":"Beatriz Montero-Llorente, Covadonga Pérez Menéndez-Conde, Eduardo González Ferrer, Genoveva Teresa López Castellanos, Luis Miguel Bedoya Del Olmo, Teresa Bermejo Vicedo","doi":"10.1136/ejhpharm-2024-004218","DOIUrl":"10.1136/ejhpharm-2024-004218","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the impact of pharmaceutical care on the number of readmissions and visits to the emergency department due to heart failure 30 days after hospital discharge, based on a programme of continuous pharmaceutical care throughout the care process, and to assess the differences between the control and intervention groups at 90 days after discharge (number of readmissions and visits to the emergency department, time from discharge to new readmission or visit to the emergency department).</p><p><strong>Methods: </strong>A single-centre experimental longitudinal prospective open and parallel-group study with balanced randomisation (1:1) was carried out in a tertiary hospital in Spain. Patients with a diagnosis of primary or decompensated heart failure admitted to the Cardiology Service or the Heart Failure and Vascular Risk Unit were recruited between March 2019 and November 2021 and randomly assigned, using a randomised block model, to the control (standard care) or intervention (continuing care model) groups. Epidemiological, clinical and pharmacology data were recorded. As a measure of association, we used the mean difference and the Student's t-test. A p value of <0.05 was considered significant.</p><p><strong>Results: </strong>296 patients were included (150 randomised to the control group, 146 to the intervention group). The results showed no significant differences between the control and intervention groups in the number of readmissions and visits to the emergency department during the 30 days after discharge (p=0.092), but a statistically significant difference was seen at 90 days (p=0.043). The number of days until the first visit to the emergency department or readmission was higher in the intervention group (p=0.021).</p><p><strong>Conclusions: </strong>Continuous care and follow-up by the pharmacist 30 days after discharge has a neutral impact on hospital readmissions and visits to the emergency department of patients with heart failure, but it is positive in the 90 days following discharge.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"126-131"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738897","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}
Pierre Nizet, Charlotte Grivel, Mathilde Petit, Pierre Chapron, Yvan Derouin, Erwan Corbineau, Romain Dumont, Jean-François Huon
{"title":"Evaluation of the impact of pharmacist-led educational intervention on knowledge and skills of cancer patients with totally implantable venous access port: a single-centre, non-randomised controlled study.","authors":"Pierre Nizet, Charlotte Grivel, Mathilde Petit, Pierre Chapron, Yvan Derouin, Erwan Corbineau, Romain Dumont, Jean-François Huon","doi":"10.1136/ejhpharm-2023-003896","DOIUrl":"10.1136/ejhpharm-2023-003896","url":null,"abstract":"<p><strong>Background: </strong>Totally implantable venous access port (TIVAP) is a type of implantable medical device that enables repetitive access to the intravenous system through use of a Huber needle. This device facilitates the administration of aggressive or long-term treatments while ensuring the comfort and safety of the patient. To ensure proper use of the medical device and lower the risk of complications, it is essential that patients acquire the necessary knowledge and skills regarding TIVAP.</p><p><strong>Objective: </strong>The main objective of the study was to assess the impact of a pharmaceutical interview on patients' knowledge and skills for patients with TIVAP.</p><p><strong>Methods: </strong>To achieve this goal, a pharmaceutical interview guide and an 18-item questionnaire were developed, based on a three-part competency framework (knowledge, know-how and attitudes) previously constructed by a multidisciplinary team. The intervention consisted of a pharmacist-led interview with every patient on the day of the TIVAP insertion. Patients in the control group received usual care. Patients included were interviewed by telephone 14 days after implantation. χ<sup>2</sup> tests were conducted to compare the scores obtained by each group.</p><p><strong>Results: </strong>The average score obtained by the control group (n=30) was 8.97, while the intervention group (n=59) achieved an average score of 12.66 (p<0.001). The intervention group demonstrated increases in correct responses for all items, with eight questions displaying significantly higher scores. Six of these pertained to theoretical knowledge, one to know-how and one to attitudes.</p><p><strong>Conclusion: </strong>The interviews had a clear impact on the knowledge and skills of TIVAP patients.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"172-177"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828922","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}
{"title":"Clinical experience with immunotherapy in patients with diffuse intrinsic pontine glioma.","authors":"Mónica Gasanz Garicochea, Isabel Martínez-Romera, Marta Pilar Osuna-Marco, Blanca López-Ibor Aliño","doi":"10.1136/ejhpharm-2022-003511","DOIUrl":"10.1136/ejhpharm-2022-003511","url":null,"abstract":"<p><p>The objective of the article is to report the case of three patients with diffuse intrinsic pontine glioma (DIPG) treated with immunotherapy. In particular we report the data related to the treatments' efficacy and tolerance.To achieve this, we review the medical records in the Paediatric Oncology and Haematology Unit of HM Hospitales/Centro Integral Oncológico Clara Campal (CIOCC). We focused on patients diagnosed with DIPG who were administered oncolytic viruses followed by immune checkpoint inhibitors (ICI) (pembrolizumab, anti PD-1) plus a concomitant antiangiogenic agent (bevacizumab).The results we obtained showed the three paediatric DIPG patients studied presented good tolerance, with disease stabilisation for approximately 5 months after immunotherapy. However, subsequent clinical worsening required clinicians to change the patients' treatment.In conclusion, immunotherapy combined with other conventional antineoplastic treatments (chemotherapy, radiotherapy) is postulated as a very promising future therapeutic option. However, further research is warranted in the paediatric population to demonstrate safety and effectiveness.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"190-192"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71520944","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}
Jamie Talbot, Rebecca Stuckey, Natasha Wood, Alexander Gordon, Ginette Crossingham, Stuart Weatherby
{"title":"Switching anti-CGRP monoclonal antibodies in chronic migraine: real-world observations of erenumab, fremanezumab and galcanezumab.","authors":"Jamie Talbot, Rebecca Stuckey, Natasha Wood, Alexander Gordon, Ginette Crossingham, Stuart Weatherby","doi":"10.1136/ejhpharm-2023-003779","DOIUrl":"10.1136/ejhpharm-2023-003779","url":null,"abstract":"<p><strong>Objectives: </strong>The anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAb) are effective in migraine; however, few studies have examined the benefit of switching from one anti-CGRP-mAb to another. In order to better inform clinical practice in this situation, we present our real-world findings of switching anti-CGRP-mAb in chronic migraine.</p><p><strong>Methods: </strong>Individuals with chronic migraine that switched anti-CGRP-mAb treatment (erenumab, fremanezumab or galcanezumab) due to ineffectiveness or adverse effects were retrospectively identified. Headache diary data before and up to 6 months after anti-CGRP-mAb switch were analysed. Main outcome measures were monthly red days (days with headaches limiting activity or requiring triptans), headache days (days with any kind of headache), triptan use, other analgesic use and headache disability (Headache Impact Test-6 (HIT-6) score) at 3 months.</p><p><strong>Results: </strong>The analysis included 66 instances of switching among 54 individuals. There were non-significant reductions of -1.2 (-2.7, 0.3) red days from baseline at 3 months, with 10 individuals (15%) showing ≥50% improvement and 22 (33%) experiencing a ≥30% improvement. Improvements in headache days, triptan days, other painkiller use and HIT-6 score were non-significant. When individuals that switched due to side effects were excluded from the analysis, significant reductions in headache (Friedman p=0.044) and a trend for improvement in red days (Friedman p=0.083) were observed. With regard to side effects, on 12 occasions these improved or resolved on switching to a different anti-CGRP-mAb, while new symptoms were reported on eight occasions following a switch.</p><p><strong>Conclusion: </strong>We recorded modest improvements in headache outcomes, although significant results were only observed in those that switched anti-CGRP-mAb due to ineffectiveness. Switching may therefore be a viable option for these individuals.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":"178-185"},"PeriodicalIF":1.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139106072","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}