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

Objectives: Several studies have investigated the effectiveness of high-dose ambroxol in treating patients with Gaucher disease type 3. Since there are no registered high-dose ambroxol preparations available, information on the development of this preparation can be important to improve access. The pharmacy and clinical pharmacology department of Amsterdam University Medical Center has developed a simple 75 mg ambroxol hydrochloride (HCl) capsule formulation for this purpose. The aim of this study was to investigate the stability of 75 mg ambroxol capsules.

Methods: Three batches (n=1000) of 75 mg ambroxol HCl capsules were produced and stored in climate chambers for 6 months under accelerated (40±2°C and 75% relative humidity (RH)±5% RH) and long-term (25±2°C and 60% RH±5% RH) conditions. At 0, 3 and 6 months, appearance, identity, related substances, assay, uniformity of dosage units (content uniformity (CU)), dissolution and microbiology were evaluated. The specifications and acceptance criteria were derived from the European Pharmacopoeia and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.

Results: All parameters met the predefined specifications from t=0 to t=6 months for both the accelerated and long-term stability studies. There were no visible changes in appearance of the capsule content, no degradation products above 0.05%, and no decrease in ambroxol content. Furthermore, the capsules met the criteria for CU with an acceptance value ≤15.0. The dissolution was rapid, with ≥80% of ambroxol released from the capsules within 30 min, and no microbiological growth was observed.

Conclusions: The 75 mg ambroxol HCl capsules are stable for at least 6 months at room temperature. This paper provides guidance to pharmacies for compounding of high-dose ambroxol HCl capsules to ensure the availability of ambroxol for patients in need.

Objectives: The preparation of cytotoxic drugs requires high quality levels to limit biocontamination and chemocontamination risks. While standardised measures exist for biocontamination, this is not the case for chemocontamination. Despite precautions, chemocontamination can occur at many stages. This study aims to evaluate the efficacy of decontamination solutions following intentional contamination on stainless steel surfaces inside a biosafety cabinet using antineoplastic drugs.

Methods: Three sessions were conducted to assess the effectiveness of four decontamination solutions (Surfa'Safe, Septalkan, ethanol 70% and Versol water) on areas contaminated with antineoplastic drugs. Ten areas were tested: one negative and one positive control area and eight contaminated areas followed by decontamination: four 'wet' (decontaminated immediately) and four 'dry' areas (decontaminated after 1 hour). The effectiveness of decontamination (Eff_q) and the impact of drying time were analysed using Kruskal-Wallis and Wilcoxon tests.

Results: Negative controls showed very low levels of contamination. Septalkan and Surfa'Safe, both quaternary ammonium-based solutions, were the most effective for decontamination (Eff_q >95%), with greater effectiveness in the 'wet' protocol than in the 'dry' protocol (Surfa'Safe: 95.3% vs 97.3%; Septalkan: 95.3% vs 98%). Despite a lower value, decontamination was not statistically significant between the two methods of decontamination (immediate and after drying; p=0.125).

Conclusions: Quaternary ammonium-based solutions appear to be the best options for limiting chemocontamination. Despite the similar effectiveness of Septalkan and Surfa'Safe, the latter seems to be a more efficient option for routine use of an appropriate cleaning solution.

Objectives: The increasing number of patients challenges healthcare and drives demand for home-based treatments. In the North Denmark Region, outpatients can acquire their hospital medication as 'cost-free medicine' through home delivery or medication pickup lockers. With a focus on home-based treatments and limited household medicine tracking, investigating medicine waste is crucial for resource optimisation. This study aimed to investigate the prevalence of excess medication among outpatients in the North Denmark Region, whether there was an association between excess cost-free medicine and type of delivery method, and reasons for the excess.

Methods: This study included outpatients from the Department of Neurology or Department of Gastroenterology at Aalborg University Hospital receiving cost-free medication from March to October 2023. Eligible outpatients received a questionnaire via Digital Post. As medicine waste is difficult to measure directly, excess medication was used as a surrogate measure. Patient data were acquired through Apovision and stored in REDCap. Pearson's χ² test was performed to examine the difference in excess medicine between medication pickup locker and home delivery.

Results: 52.8% (233/441) of outpatients reported excess cost-free medication at home. Medication pickup lockers, where 58.9% (132/224) reported an excess, were associated with larger medicine stocks at home compared with home delivery where 46.5% (101/217) reported excess (p=0.009). For 45.5% (106/233) of medicine pickup locker users and 24% (56/233) of home delivery users, the excess was planned with the hospital department. If the excess was not planned with the department, most users reported receiving too much medicine (23/76) or 'Other' (42/76).

Conclusions: Over half of the outpatients reported excess cost-free medication, with the largest excess linked to medication pickup lockers. Patients managing their own pickup tend to accumulate more. To minimise accumulation of medicine for personal use, it may be worth investigating whether deliveries through medication pickup lockers should be scheduled at fixed intervals.

Objectives: Natalizumab is a disease-modifying drug approved for the treatment of relapsing-remitting multiple sclerosis. It is available as vials for intravenous administration and in 2021 was approved as syringes for the subcutaneous route; both have to be administered in a daycare unit in the hospital. Some studies have addressed the cost-effectiveness of changing the route of administration from intravenous to subcutaneous, but the Patient Reported Outcomes Measures (PROMs) and Patient Reported Experience Measures (PREMs) regarding this change have not yet been studied. The objective of this work is to assess switching from the intravenous route to the subcutaneous route in our centre through the evaluation of PROMs and PREMs.

Methods: An implementation study was conducted to evaluate the PROMs and PREMs of patients after changing the route of administration of natalizumab from intravenous to subcutaneous. An ad hoc questionnaire was developed, in consensus with the neurology team, which was performed by telephone to patients who agreed to participate in the study. The questionnaire was divided into three fields: pain during administration for both routes, patient satisfaction and adverse events of subcutaneous administration.

Results: Forty-seven patients participated in the study. They reported greater pain with subcutaneous administration, but no patient defined it as unbearable. The subcutaneous route was preferred by 97.9% of patients, who stated that this route of administration was less time consuming than the intravenous route. Regarding adverse events, 94.5% patients reported none, and itching was the most common local adverse event reported (29.8%).

Conclusions: This is a novel experience in our setting of collaboration between pharmacy and neurology services to implement PROMs and PREMs in the evaluation of a health intervention. Patients expressed satisfaction with changing the route of administration of natalizumab. This study has enabled us to detect interventions to use to achieve a better patient experience.

Objectives: The aim of this study was to estimate the main hospital organisational impacts of in vivo gene therapy medicine (GTM) deployment, experienced during clinical trials, with a focus on hospital pharmacy.

Methods: Interviews were performed with 11 healthcare professionals involved in three clinical trials, as was an active field observation.

Results: Interviews showed high impact for the management of hospital beds and human resources. Moderate impact concerned facilities/equipment, coordination between stakeholders and training/software. The total cumulative working time of the pharmacy staff, estimated at 11.12 and 11.67 hours in the two centres for a single GTM, has been identified as the main limiting factor for the pharmacy.

Conclusions: This study showed that major organisational impacts of in vivo GTMs in injection centres concern hospital bed and pharmaceutical staff management, rather than technical and operational aspects. Overall, no more than 150 GTMs could be prepared each year by one pharmacist and one technician.