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

Objective: Esketamine (Vesierra) is a molecule, used alone or in combination, to induce and maintain general anaesthesia and to relieve pain in emergency medicine. The aim of this study is to evaluate the long-term physicochemical stability of a 1 mg/mL solution of esketamine diluted in 0.9% sodium chloride (NaCl) and stored in polypropylene syringes at 5±3°C during 65 days (64+1 day at 22±3°C) and 72 hours at 22±3°C (room temperature), in order to centralise preparation under aseptic conditions in hospital pharmacy.

Methods: Ten syringes were prepared under aseptic conditions. Five syringes were stored at 22±3°C for 3 days, and the five others were stored at 5±3°C for 64 days (+ 1 day at room temperature). The stability was periodically investigated. Particle appearance or colour changes were checked by visual inspection. A research of crystals was performed under the microscope. pH was followed to assess its stability. The turbidity of the solutions was estimated by a measure of optical densities at 350, 410 and 550 nm. The molecule concentrations were measured by ultra-high performance liquid chromatography (UHPLC) coupled with a photodiode array detection (PDA), using a newly developed method.

Results: Based on microscopic examination, no crystals were observed, during the observation period. pH and absorbances at 350, 410 and 550 nm were also stable. Macroscopically, there was no change in colour and appearance of opacity, turbidity or precipitation. Statistical analysis indicates that 1 mg/mL esketamine solutions were chemically stable under these conditions, given that less than 5% of the solutions have lost more than 10% of their initial content during the study based on the prediction interval.

Conclusions: One mg/mL solutions of esketamine hydrochloride are physically and chemically stable after production, for at least 72 hours at 22±3°C and 64 days at 5±3°C (+ 1 day at room temperature).

Objective: 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.

Method: 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.

Results: 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.

Conclusion: 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.

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.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: Many patients using oral anticancer treatment report MRPs and this number remains substantial over time.

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.

Background and objectives: 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.

Methods: 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_p) 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.

Results: 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.

Conclusions: 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.

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.

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.