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

Objectives: In the context of a supply disruption of mebrofenin (Cholediam)-based kits for radiolabelling with technetium-99m [^99mTc], the medicine agencies allowed the importation of a back-up radiopharmaceutical diagnostic agent, etifenin (Techida), to ensure continuous management of patients with hepatobiliary disorders in nuclear medicine departments. There are still issues regarding the measurement of radiochemical purity (RCP) with these kits based on the European Pharmacopoeia and the Summary of Product Characteristics (SPC). This study aims to identify and to optimise, in a clinical context, the most suitable thin layer chromatography (TLC) method for the determination of the RCP in terms of speed of response and reliability for [^99mTc]Tc-mebrofenin and [^99mTc]Tc-etifenin.

Methods: [^99mTc]Tc-etifenin (n=4) and [^99mTc]Tc-mebrofenin (n=5) were individually controlled using six different TLC methods and one high-performance liquid chromatography (HPLC) method for impurity identification ([^99mTc](TcO₂)_n and Na[^99mTc]TcO₄), RCP (%) and duration of analysis (min). Two TLC methods were selected according to the recommendations of the Pharmacopoeia and SPC, two others were exactly the same but with a heating step, and the other two corresponded to a mix between the methods of the SPC and the Pharmacopoeia that were chosen to optimise RCP determination parameters.

Results: Radio-HPLC analysis allowed effective separation of [^99mTc]Tc-etifenin and [^99mTc]Tc-mebrofenin with a retention time of 8.05±0.02 min and 8.94±0.07 min, respectively, from Na[^99mTc]TcO₄ (retention time 2.76±0.03 min). HPLC showed an absence of Na[^99mTc]TcO₄ for [^99mTc]Tc-mebrofenin and 0.2% for [^99mTc]Tc-etifenin. Among the TLC methods, we identified the most suitable method which ensures the most compliant RCP (98.3±0.9%) in a time of 31.5±1.1 min. Also, it allowed a time saving of 15 min compared with the methods proposed by the Pharmacopoeia and the SPCs.

Conclusion: We propose a TLC method that accelerates quality control by an average of 15 min while guaranteeing a reliable RCP.

Objectives: The closure integrity and process validation of closed system transfer devices (CSTDs) should be confirmed before implementation in clinical settings. We aimed to investigate the closure integrity and validate the aseptic procedure of two types of CSTDs by using a combination of the dye ingress test and a media fill test.

Methods: The dye ingress test with methylene blue was used for both CSTDs with 10 samples of drug vials of three brands. A media fill test was performed with both CSTDs (300 samples per CSTD, 150 carried out in a safety cabinet and 150 under non-classified environmental conditions).

Results: In all samples of both CSTDs, methylene blue was absent after visual inspection and spectrophotometric analysis. The nutrient media of one sample with CSTD A and none of the CSTD B samples were contaminated when reconstituted in a GMP grade A environment. Under non-classified environmental conditions, one sample of CSTD A and two samples of CSTD B were contaminated.

Conclusions: Both CSTDs connected to the drug vials met the terms of closure integrity by using the dye ingress test. The aseptic procedure of CSTD B was validated with the media fill test when reconstituted in a GMP grade A environment, but failed for CSTD A. Both CSTDs failed the media fill test when reconstituted under non-classified environmental conditions.

Objectives: To describe the frequency of the different types of medication-related incidents that caused patient harm, or adverse consequences, in a major teaching hospital and investigate whether the likelihood of these incidents occurring would have been reduced by electronic prescribing and medicines administration (EPMA).

Methods: A retrospective review of harmful incidents (n=387) was completed for medication-related reports at the hospital between 1 September 2020 and 31 August 2021. Frequencies of different types of incidents were collated. The potential for EPMA to have prevented these incidents was assessed by reviewing DATIX reports and additional information, including results of any investigations.

Results: The largest proportion of harmful medication incidents were administration related (n=215, 55.6%), followed by incidents classified as 'other' and 'prescribing'. Most incidents were classified as low harm (n=321, 83.0%). EPMA could have reduced the likelihood of all incidents which caused harm by 18.6% (n=72) without configuration, and a further 7.5% (n=29) with configuration where configuration refers to adapting the software's functionality without supplier input or development. For 18.4% of the low-harm incidents (n=59) and 20.3% (n=13) of the moderate-harm incidents, EPMA could reduce the likelihood of the incident occurring without configuration. Medication errors most likely to be reduced by EPMA were due to illegibility, multiple drug charts or missing drug charts.

Conclusion: This study found that administration incidents were the most common type of medication-related incidents. Most of the incidents (n=243, 62.8%) could not be mitigated by EPMA in any circumstance, even with connectivity between technologies. EPMA has the potential to prevent certain types of harmful medication-related incidents, and further improvements could be achieved with configuration and development.

Objectives: Optimal perioperative success in cardiac surgery requires precise management of drug treatment. This study aimed to determine the prevalence, types and associated factors of drug-related problems (DRPs) during the entire hospital stay.

Methods: A prospective observational study was conducted at the department of cardiovascular surgery in a university hospital between November 2019 and March 2020. Patients with planned elective cardiac surgery, aged ≥18 years, were included. A clinical pharmacist collaboratively reviewed medications on a daily basis and identified DRPs.

Results: A total of 100 patients (60 male) were included; median (range) age was 62 (19-86) years, and median (IQR) length of stay in hospital was 15 (9) days. A total of 275 DRPs were identified (median (IQR) 3 (2-4)). The number of patients who had at least one DRP was 47 preoperatively, 55 in the postoperative intensive care unit, 100 in the postoperative ward, and 16 at discharge. In order to reduce bias because of the small sample size, Firth's logistic regression analysis was conducted. Statistically significant variables according to univariate analysis were included into a logistic regression model. Therefore the length of hospital stay (OR 1.14, 95% CI 1.03 to 1.26, p=0.008), living arrangements (living alone) (OR 4.24, 95% CI 1.41 to 12.73, p=0.009), number of medications at admission (OR 1.32, 95% CI 1.09 to 1.59, p=0.002), and having coronary artery bypass graft surgery (OR 2.87, 95% CI 1.07 to 7.70, p=0.03) were associated with an increased risk for DRPs in the final model.

Conclusion: Hospital stay carries an increased risk for DRPs, especially at the postoperative stage. Modifiable risk factors for DRPs can be managed by required interventions performed by a multidisciplinary healthcare team.

Objectives: Phenobarbital is a barbiturate, used to treat focal and generalised epilepsy. Since the end of marketing of the oral solution KANEURON in 2017, phenobarbital tablets remain the only available dosage form. Development of an oral phenobarbital solution for paediatric use is therefore essential to fulfil clinical needs. A new formulation of phenobarbital with hydroxypropyl-β-cyclodextrins (HPBCD) was developed, and the physicochemical stability of the solution was evaluated.

Methods: Different excipients have been selected to formulate a solution of phenobarbital. Samples were dosed by High Performance Liquid Chromatography (HPLC) at 216 nm with a LiChroCART C18 endcapped column and mobile phase composed of phosphate buffer pH 3 and methanol (50:50 v/v). Linearity, accuracy, sensibility and specificity of the method were tested, and a forced degradation study was carried out. During stability study, content of phenobarbital, pH, osmolality of the phenobarbital solution and degradation products were followed up for 6 months in line with GERPAC guidelines.

Results: The stability indicating the character of the assay method has been validated. The physicochemical stability study shows that the phenobarbital solution formulated is stable for 6 months, in line with International Conference of Harmonisation (ICH) recommendations Q1A and Q3B (R2) regarding the content of phenobarbital and levels of degradation products (no degradation products >0.01%). Phenobarbital concentration was 101.59±2.6% of initial concentration in refrigerated samples and 101.14±0.5% at 20±5°C. No phenobarbital degradation products (>0.01%) were observed throughout the 6 months. No significant variation of pH or osmolality was observed.

Conclusions: HPBCD solubilise phenobarbital and create a homogeneous solution. These stability data set the shelf life of this new phenobarbital solution at up to 6 months. A microbiological stability study will be carried out to ensure the possibility of using this solution in children.

Background: Patients are commonly reported as being allergic to beta-lactam (BL) antibiotics. However, many patients with this reported allergy are able to receive BL treatments because they do not have true allergies. In many cases these are simply intolerances due to side effects reported as an allergy. Delabelling these patients leads to better clinical outcomes, optimal antibiotic usage, decreased bacterial resistance and reduced healthcare costs. Therefore, the aims of this study were to identify incorrectly labelled BL allergies in hospitalised patients and to assess antibiotic use in delabelled patients in order to establish a quality indicator to optimise antimicrobial treatments.

Methods: A prospective study was conducted in which hospitalised patients treated with antimicrobial drugs and labelled as 'BL-allergic' were identified by clinical pharmacists. An allergist assessed whether patients were suitable candidates for a skin test or oral challenge. The Allergy Service removed 'BL-allergic' labels if negative results were obtained. Delabelled patients were followed up by clinical pharmacists to study the use of BL antibiotics as a result of the delabelling programme.

Results: A total of 176 suspected allergic patients were identified and 91 (51.7%) were tested either by a skin test or oral challenge based on the patient indicators. Seven (16.4%) patients tested were allergic to BL antibiotics, 76 (83.5%) were totally delabelled and eight (0.1%) were partially delabelled. Thirty-two (38.1%) delabelled patients required antibiotic treatment in another inpatient or outpatient setting, of whom 27 (84.3%) patients with a new infectious episode received BL treatments while five (15.7%) continued to receive antimicrobial treatments without BL.

Conclusion: After the implementation of a protocol to detect incorrect BL allergy labels, 83.5% of the patients in this cohort were completely delabelled. This shows that there is a clear opportunity to optimise the use of antibiotics by delabelling 'BL-allergic' patients.

Objectives: The emergence of artificial intelligence (AI) is catching the interest of hospital pharmacists. A massive collection of health data is now available to train AI models and hold the promise of disrupting codes and practices. The objective of this systematic review was to examine the state of the art of machine learning or deep learning models that detect inappropriate hospital medication orders.

Methods: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. MEDLINE and Embase databases were searched from inception to May 2023. Studies were included if they reported and described an AI model intended for use by clinical pharmacists in hospitals. Risk of bias was assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST).

Results: 13 articles were selected after review: 12 studies were judged to have high risk of bias; 11 studies were published between 2020 and 2023; 8 were conducted in North America and Asia; 6 analysed orders and detected inappropriate prescriptions according to patient profiles and medication orders; and 7 detected specific inappropriate prescriptions, such as detecting antibiotic resistance, dosage abnormality in prescriptions, high alert drugs errors from prescriptions or predicting the risk of adverse drug events. Various AI models were used, mainly supervised learning techniques. The training datasets used were very heterogeneous; the length of study varied from 2 weeks to 7 years and the number of prescription orders analysed went from 31 to 5 804 192.

Conclusions: This systematic review points out that, to date, few original research studies report AI tools based on machine or deep learning in the field of hospital clinical pharmacy. However, these original articles, while preliminary, highlighted the potential value of integrating AI into clinical hospital pharmacy practice.

Background: In recent years, an increasing number of patient-reported outcome assessment tools (PROs) have been developed specifically to ascertain patients' perceptions of different drug treatments. Among them, the injection process has been analysed, especially in patients chronically treated with chronic biological therapies. One of the main advantages of most current biological therapies is the possibility to self-administer medication at home through the use of a variety of devices, including prefilled syringes (PFS) and prefilled pens (PFP).

Objectives: The aim of this study was to conduct qualitative research to assess the degree of preference between the different pharmaceutical forms PFS and PFP.

Methods: We performed a cross-sectional observational study in patients on biological drug therapy through the compilation of a web-based questionnaire at the time of routine delivery of biological therapy. Questions regarding primary diagnosis, adherence to therapy, the preferred pharmaceutical form and the main reason for preference among five possibilities already reported in the scientific literature were included.

Results: During the study period, data were collected from 111 patients and 68 (58%) indicated PFP as their preference. From the analysis of reasons that led a patient to choose one device over another, PFSs are chosen mainly out of habit (n=13 (28.3%) PFS vs n=2 (3.1%) PFP) while PFPs are chosen to avoid needle vision (n=15 (23.1%) PFP vs n=1 (2.2%) PFS). Both differences were found to be statistically significant (p<0.001).

Conclusion: As biological subcutaneous drugs are increasingly prescribed for a wide variety of long-term therapies, further research focused on identifying patient factors which may enhance adherence to treatment will become even more valuable.