{"title":"Cleaning validation for blister packaging machines in hospital-supplying pharmacies.","authors":"Dominic Fenske, Lilly Zerrenner, Stephanie Zergiebel","doi":"10.1136/ejhpharm-2024-004232","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004232","url":null,"abstract":"<p><strong>Objective: </strong>To ensure quality-assured care for patients, validation of a cleaning process for blister machines is essential. Due to the high operating costs of maintaining high-performance liquid chromatography (HPLC) which is mainly used for this type of analysis, a new, quick and cost-effective analysis method using UV-Vis spectroscopy has been developed.</p><p><strong>Method: </strong>Marker substances (metamizole (dipyrone) and paracetamol tablets) were packed in blisters. Afterwards test tablets were packaged before and after cleaning the blister machine and examined for contamination using UV-Vis spectroscopy.</p><p><strong>Results: </strong>UV-Vis spectroscopy has been shown to be superior to HPLC analysis for cleaning validation of blister machines, as it is much faster and cheaper, requires less equipment and personnel effort, while maintaining the same reliability and sensitivity.</p><p><strong>Conclusion: </strong>Unit-dose blistering is becoming increasingly popular in the daily routine of hospital pharmacies worldwide due to a variety of advantages. Therefore, cleaning validation of blistering machines has become a mandatory duty of care. The UV-Vis spectroscopic method presented here is the first innovative method suitable for the cleaning validation of blister machines to date.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751431","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}
Lorene Lipszyc, Louise Triquet, Baptiste Giguet, Olivier Lambotte, Samy Babai
{"title":"Budd-Chiari syndrome after BNT162b2 mRNA vaccination: two case reports.","authors":"Lorene Lipszyc, Louise Triquet, Baptiste Giguet, Olivier Lambotte, Samy Babai","doi":"10.1136/ejhpharm-2023-003997","DOIUrl":"https://doi.org/10.1136/ejhpharm-2023-003997","url":null,"abstract":"<p><p>Budd-Chiari syndrome (BCS) is a rare disease characterised by an obstruction in the hepatic venous outflow. We describe two cases of patients hospitalised a few days after tozinameran vaccination. Liver tests and medical imaging were carried out, and BCS was diagnosed. After treatment including anticoagulant therapy, the first patient improved clinically, unlike the second patient with persistent hepatic thrombosis. According to the WHO-UMC causality assessment system, the vaccine's share was assessed as 'probable' for the first patient as BCS occurred during anticoagulant therapy, and 'possible' for the second patient as no other aetiology was found. Further epidemiological studies are needed to confirm or refute the causal relationship between BCS and tozinameran vaccination.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747778","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}
Patricia M L A van den Bemt, Margriet Y Blijham, Laura Ten Broek, Jacqueline G Hugtenburg, Bart P H Pouls, Job F M van Boven, Charlotte L Bekker, Bart van den Bemt, Liset van Dijk
{"title":"Patient reported medication-related problems, adherence and waste of oral anticancer medication over time.","authors":"Patricia M L A van den Bemt, Margriet Y Blijham, Laura Ten Broek, Jacqueline G Hugtenburg, Bart P H Pouls, Job F M van Boven, Charlotte L Bekker, Bart van den Bemt, Liset van Dijk","doi":"10.1136/ejhpharm-2024-004205","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004205","url":null,"abstract":"<p><strong>Objectives: </strong>Patients on oral anticancer therapy regularly experience medication-related problems (MRPs), potentially leading to non-adherence and medication waste. Most studies reporting these experiences have cross-sectional designs. The aim of our study was to explore patient reported MRPs, adherence and waste of oral anticancer medication over time.</p><p><strong>Methods: </strong>A prospective longitudinal quantitative interview study with 4 months follow-up was performed among patients on oral anticancer medication (mainly tyrosine kinase inhibitors, (anti)hormonal therapy, pyrimidine antagonists) using a semi-structured questionnaire. Patients from two Dutch university medical centres were included from March to December 2022 after informed consent was given. Four interviews were performed with 1 month in between. All interviews were audiotaped, after which the data were entered into an electronic case report form. The primary outcome was the mean number of MRPs per patient per interview round. Secondary outcomes were the proportion of patients with at least one MRP, types of MRPs, perceived non-adherence, medication waste (both in general and specifically for anticancer medication), costs of anticancer medication waste, and factors associated with medication waste as mentioned by the patient. Descriptive statistics were used to analyse the data.</p><p><strong>Results: </strong>Forty patients were included with a mean (SD) age of 64 (9) years; 43% were male. The mean number of MRPs per patient was 2.1 in the first interview and 1.2, 1.0 and 0.9 in the second, third and fourth interviews, respectively. Adverse drug reactions were the most frequently reported type of MRPs (30 (75%) patients in the first interview and 19 (65%) in the last interview). Unintentional non-adherence was regularly reported, especially in the first interview. Medication changes were frequent and associated medication waste was mentioned in all interviews.</p><p><strong>Conclusions: </strong>Many patients using oral anticancer treatment report MRPs and this number remains substantial over time.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633075","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}
Alena Pilková, Jan Hartinger, Ondřej Slanař, Martin Matoulek
{"title":"Pharmacotherapy of carbamazepine-treated patient after bariatric surgery: a complex interplay between altered absorption and drug-drug interactions.","authors":"Alena Pilková, Jan Hartinger, Ondřej Slanař, Martin Matoulek","doi":"10.1136/ejhpharm-2024-004236","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004236","url":null,"abstract":"<p><p>Changes in absorption and bioavailability of drugs have been described after bariatric surgery, especially shortly after the procedure. When a significant drug-drug interaction also occurs, it is difficult to predict the final combined effect of the surgery and the interaction. In this article, we present a case report of a patient with chronic psychiatric poly-medication including carbamazepine, a strong cytochrome P450 3A4 (CYP3A4) inducer. Significant changes in serum drug concentrations were observed during the 6 months after the surgery, including increased levels of quetiapine and trazodone, that cannot be attributed to the post-surgical alteration of absorption from the gastrointestinal tract. The influence of fluctuating carbamazepine levels on concomitant medication seemed to outweigh the effect of reduced absorption after surgery. This report highlights the need for careful pre-surgical evaluation of the patient's pharmacotherapy and pre- and post-operative therapeutic drug monitoring to prevent destabilisation of chronic conditions.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633076","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}
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":"https://doi.org/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":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-15","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":"How can oral second-line anti-tuberculosis medications be administered to an extremely preterm neonate?","authors":"Tien Thuy Ngo, Charis Lau","doi":"10.1136/ejhpharm-2024-004109","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004109","url":null,"abstract":"<p><p>Congenital pre-extensively drug-resistant tuberculosis is rare, and administration of second-line anti-tuberculosis medications to neonates is challenging due to the small doses required and limited availability of suitable formulations. Paediatric formulations have increasingly become available but may not be readily accessible in all countries. For the extremely preterm and low birth weight neonate, doses equivalent to a fraction of a tablet or capsule are required, with frequent dose adjustment for increasing age and weight during the course of treatment. The pharmaceutical formulation must be suitable for administration via enteral feeding tube and must be free of unsafe excipients. We report on the challenges, considerations and outcome of an extremely premature neonate with congenital pre-extensively drug-resistant tuberculosis who was successfully treated with second-line anti-tuberculosis medications. Child-friendly formulations were procured where available, and extemporaneous compounding of clofazimine, moxifloxacin and prothionamide oral suspensions was undertaken to enable administration of these medications.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603534","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}
Thais Lizondo López, Aina Font I Barceló, Carlos García Gutiérrez, Miquel Blasco, Ignacio Grafia, Carla Bastida, Pedro Castro-Rebollo, Dolors Soy-Muner
{"title":"Clopidogrel-induced thrombotic microangiopathy: a case report.","authors":"Thais Lizondo López, Aina Font I Barceló, Carlos García Gutiérrez, Miquel Blasco, Ignacio Grafia, Carla Bastida, Pedro Castro-Rebollo, Dolors Soy-Muner","doi":"10.1136/ejhpharm-2024-004209","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004209","url":null,"abstract":"<p><p>Thrombotic microangiopathy is a serious condition that can be precipitated by exposure to certain medications. Although rare, it is life threatening and requires a high index of clinical suspicion, appropriate laboratory testing and immediate cessation of the offending agent. We present a case of a 75-year-old man with a history of ischaemic heart disease treated with clopidogrel and aspirin. One month after initiating the treatment he developed microangiopathic haemolytic anaemia and thrombocytopenia. Extensive clinical and laboratory investigations suggested thrombotic microangiopathy secondary to clopidogrel. The drug was immediately discontinued and treatment with intravenous corticosteroids was started. Within a week the patient's laboratory parameters normalised, indicating successful recovery. This case highlights the role of early detection and immediate discontinuation of suspected medication in the effective management of clopidogrel-induced thrombotic microangiopathy. Healthcare professionals should consider drug-induced thrombotic microangiopathy as a possible diagnosis in patients receiving clopidogrel who present with thrombocytopenia and microangiopathic haemolytic anaemia.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534065","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}
Daniel Gómez Costas, Almudena Ribed, Alvaro Gimenez-Manzorro, Ignacio Garutti, Francisco Javier Sanz, Irene Taladriz-Sender, Sergio Herrero, Yeray Rioja, Anais Carrillo, Ana Herranz, María Sanjurjo-Saez
{"title":"Cost-effectiveness of preoperative pharmaceutical care consultations: a 5-year analysis.","authors":"Daniel Gómez Costas, Almudena Ribed, Alvaro Gimenez-Manzorro, Ignacio Garutti, Francisco Javier Sanz, Irene Taladriz-Sender, Sergio Herrero, Yeray Rioja, Anais Carrillo, Ana Herranz, María Sanjurjo-Saez","doi":"10.1136/ejhpharm-2024-004222","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004222","url":null,"abstract":"<p><strong>Objectives: </strong>Preoperative medication errors can be prevented by screening patients through a preoperative pharmaceutical care consultation. The aim of this study was to analyse the cost-effectiveness of implementing such a consultation and to determine which patients would benefit most.</p><p><strong>Methods: </strong>A retrospective study was conducted that included all patients who underwent a preoperative pharmacy consultation between 2016 and 2020. During this consultation, two part-time pharmacists reviewed patients' appropriate preoperative chronic medication management. All prevented errors were collected and classified by therapeutic group and type of error. A team of pharmacists and anaesthetists assigned to each prevented medication error a probability of causing an adverse event 'p', following the methodology of Nesbit <i>et al</i> by establishing five different 'p' values: 0, 0.01, 0.1, 0.4, and 0.6. 'p' = 1 was not considered. The cost of an adverse event was determined to be between €4124 and €6946 according to current literature, and a sensitivity analysis was performed by increasing the interval by 20% above and below. The cost of employing two part-time specialist pharmacists was estimated to be €59 142. Savings per medication error prevented were calculated as (€4124 OR €6946) × 'p'. Total savings were the sum of all costs associated with prevented medication errors. Patients on chronic medications who were in therapeutic groups with a 0.6 probability of an adverse event or who were in therapeutic groups responsible for 50% of the prevented adverse events were considered prioritisable.</p><p><strong>Results: </strong>3105 patients attended the consultation and 1179 medication errors were prevented, corresponding to 300 adverse events. 42.2% of the errors had a 'p' of 0.4. The costs avoided by this consultation ranged from €1 237 200 to €2 083 800, while the cost of its implementation was €295 710. The cost-effectiveness ratio was between €4.2 and €7.0 saved per euro invested. In the sensitivity analysis, the ratios ranged from €3.3 to €8.5 per euro invested. Fifteen different therapeutic groups accounted for 90% of the medication errors prevented. The therapeutic groups 'Agents acting on the renin-angiotensin system', 'Antidiabetics, non-insulin (excluding SGLT2)' and 'Antithrombotics: low molecular weight heparins' were responsible for 56% of the prevented adverse events. The therapeutic groups 'Antidiabetics: rapid-acting insulin' and 'Antithrombotic agents: vitamin K antagonists, low-molecular-weight heparins, or direct oral anticoagulants' had a 'p' of 0.6. Therefore, patients in six therapeutic groups should be prioritised for preoperative pharmacy counselling.</p><p><strong>Conclusions: </strong>The implementation of preoperative pharmaceutical care consultations in Spain has proven to be cost-effective. Incorporating the probability of a medication error causing an adverse event allowed the prioritisati","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534066","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}
Daniele Mengato, Anna Zanin, Simona Russello, Fernando Baratiri, Barbara Roverato, Nicola Realdon, Franca Benini, Francesca Venturini
{"title":"Taking care of caregivers: enhancing proper medication management for palliative care children with polypharmacy.","authors":"Daniele Mengato, Anna Zanin, Simona Russello, Fernando Baratiri, Barbara Roverato, Nicola Realdon, Franca Benini, Francesca Venturini","doi":"10.1136/ejhpharm-2024-004282","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004282","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141497531","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}
Zahra Irshad, Abi Jenkins, Hoong Sern Lim, Ian D Maidment
{"title":"Antifungal prophylaxis against invasive <i>Candida</i> and <i>Aspergillus</i> infection in adult heart transplant recipients: protocol for a systematic review and meta-analysis.","authors":"Zahra Irshad, Abi Jenkins, Hoong Sern Lim, Ian D Maidment","doi":"10.1136/ejhpharm-2024-004266","DOIUrl":"https://doi.org/10.1136/ejhpharm-2024-004266","url":null,"abstract":"<p><strong>Introduction: </strong>Invasive fungal infections (IFI) can contribute to increased mortality and morbidity rates after heart transplant in adults. The most common causes are <i>Aspergillus</i> and <i>Candida</i> species. There is uncertainty on how effective antifungal prophylaxis is against <i>Candida</i> spp infections and limited guidance on the prevention of <i>Aspergillus</i> spp infections. This systematic review and meta-analysis will assess the literature to see if antifungal prophylaxis reduces the incidence of IFI after heart transplant in adults.</p><p><strong>Methods and analysis: </strong>This systematic review protocol follows the Preferred Reporting Items for Systematic reviews and Meta Analysis guidelines. A systematic search of the Cochrane Library, Web of Science, Scopus, Embase, MEDLINE, and Proquest databases will be undertaken. Reference lists of retrieved publications and conference abstracts will also be searched. Title, abstract and full-text screening will be undertaken by two reviewers. Discrepancies will be resolved by a third reviewer. Studies with paediatric patients, multi-organ transplants, or patients with a second heart transplant will be excluded, along with those who do not have clear definitions and diagnostic criteria for IFI. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool and the Risk of Bias in Non-randomised Studies of Interventions tool. A meta-analysis will be carried out, but if studies are not deemed to be sufficiently similar, only a narrative synthesis will be undertaken.</p><p><strong>Ethics and dissemination: </strong>Ethical approval is not required for this systematic review as primary data will not be collected. The results of the review will be disseminated through publication in an academic journal and scientific conferences.</p><p><strong>Prospero registration number: </strong>CRD42024516588.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141497530","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}