International Journal of Clinical Pharmacy最新文献

Background: The application of digital technologies has shown benefits in enhancing pharmacovigilance activities but consumers views on the use of these tools for this purpose are not well described.

Aim: To explore consumers' views on using digital tools to report adverse drug reactions (ADRs) and identify key features that consumers want in digital tools for ADR reporting.

Method: An online survey was conducted among adults who had taken medicine in the previous six-months in Australia. The development of questions was guided by the Combined Technology Acceptance Model and Theory of Planned Behaviour (C-TAM-TPB) framework. Responses to closed-ended questions were analysed using descriptive statistics and chi-square/Fisher's exact test, while free-text responses were analysed using qualitative content analysis.

Results: A total of 494 responses were included in the analysis. Eighty-seven percent of respondents preferred using digital tools for reporting ADRs. Consumers indicated a free-text space for describing ADRs (90%) as important or very important features of digital tools for ADR reporting, followed by acknowledgement of their report submission (87%) and receiving summary of previously reported ADRs (87%). Women (p < 0.001), advanced smartphone users (p < 0.001), and previous digital healthcare tool users (p = 0.017) showed higher intention to use digital tools. Consumers emphasized the importance of ease-of-use, accessibility, receiving medicine safety information, feedback, and advice for reporting ADRs via digital tools.

Conclusion: Consumers prefer using digital tools for reporting ADRs and place high value on features such as a free-text space for describing ADRs, acknowledgement of report submissions, and access to summaries of previously submitted reports.

Background: Since May 2007, topical levofloxacin 0.5% ophthalmic solution for prophylaxis of postoperative endophthalmitis (POE) in cataract surgery has been reimbursable in Taiwan.

Aim: We used the National Health Insurance Research Database to estimate the practice of levofloxacin in cataract surgery from 2001 to 2019 and compared the POE rates before and after the introduction of levofloxacin using interrupted time series (ITS) analysis.

Method: We did propensity score-based stabilized weights (PSSW) for each quarterly cohort and used the Joinpoint Regression Program to determine the significant change time point.

Results: 1,456,380 patients and 2,208,126 eyes were eligible. The Joinpoint Regression Program revealed a significant change in the second quarter of 2010. Levofloxacin use started from 0% in the second quarter of 2007, and increased to 6.3% and 30.2% in the second quarter of 2010 and the last quarter of 2019. The POE rate (per 1000 eyes) was 3.7 in the first quarter of 2001, reduced to 1.9, 1.7, and 1.4 in the first, second quarters of 2010, and the last quarter of 2019, respectively. ITS reveals a significant but smaller time trend of - 0.0088‰ during 2010Q2-2019 (post-interruption). The r-square between the levofloxacin use and the POE rate was 0.305. The results of ITS and r-square after PSSW are similar to those without PSSW.

Conclusion: Although the POE reduction rate in cataract surgery aligns with the increased use of levofloxacin, the small r-square and low usage implied topical levofloxacin use is not the sole determinant of POE reduction.

Background: Since 2006, French hospital pharmacists have been able to document their interventions in the National Observatory Act-IP© and, since 2016, to assess the potential clinical, economic and organizational impacts of pharmacist interventions (PIs) via the CLEO© tool.

Aim: To describe pharmacist interventions in French hospitals from 2017 to 2021 and to evaluate their potential impacts using the CLEO© tool.

Method: The study was conducted to examine PIs documented in the Act-IP© Observatory. For each intervention, the pharmacist used the CLEO© tool to evaluate the clinical impact, using a six-point scale ranging from negative to avoiding a fatality; the economic impact, i.e., whether there was a decrease or an increase in direct costs; and whether there was a positive or negative organizational impact from the health care providers' perspective.

Results: 121,792 PIs were assessed using the CLEO© tool for at least one outcome. Interventions with a potentially significant clinical impact accounted for 84.3% interventions and were classified as follows: minor, 28.3%; moderate, 40.3%; major, 15.0%; and avoiding a fatality, 0.7%, impacts. These interventions mainly involved antineoplastics, antithrombotic agents and some antibacterial agents. Most of the pharmacist interventions led to decreases in direct costs (50.4%) and positive organizational impacts (61.0%), especially for proton pomp inhibitors.

Conclusion: Many PIs have positive clinical, economic and organizational impacts, which highlights the added value of pharmacists in patient safety and positive impacts on health care teams. The pertinence of PIs can now be assessed by the CLEO© tool with a broader focus than prescribers' acceptance.

Background: Inappropriate polypharmacy arises through many factors including deficiencies in prescribing processes. Most research has focused on solutions at the clinician/patient levels with less at the organisational level.

Aim: To explore key stakeholder identified barriers and facilitators to implementation of an organisational level polypharmacy management framework.

Method: Qualitative data were collected within the Ministry of Health in Oman. Key stakeholders were purposively sampled encompassing senior representatives of pharmacy, medicine, and nursing directors; healthcare policymakers; patient safety leaders; and academic leaders. A semi-structured interview schedule was developed informed by a recent scoping review and underpinned by the Consolidated Framework for Implementation Research (CFIR). Interviews, which continued until data saturation, were audio-recorded, transcribed and analysed using the Framework Approach.

Results: Thirteen key stakeholders were interviewed, with representation of each target group. Facilitators largely mapped to the CFIR domain of inner setting (i.e., aspects of stakeholder awareness, the electronic health system and national leadership), intervention characteristic (evidence gaps), characteristics of individuals (stakeholders and champions) and process (change strategy). Barriers also largely mapped to the inner setting (policy absence, communication and health professional practice) and outer setting (resource needs).

Conclusion: This study has illuminated the facilitators and barriers to the implementation of an organisational level polypharmacy management framework. Further work is required to translate these themes into an actionable plan to implement the framework. Particular attention is required for aspects of the CFIR domain of inner setting (i.e., the internal context within which implementation occurs) as most barriers mapped to this domain.

Background: Patients transitioning from hospital to home while starting long-term cardiovascular medicines are likely to experience drug-related problems (DRPs). The New Medicine Service (NMS) may support readmission to primary care.

Aim: To evaluate NMS in a real world setting, for patients transitioning from hospital to primary care with newly prescribed cardiovascular medicines on identifying DRPs, patient satisfaction with medication information and patient self-efficacy. Secondary objectives were identifying risk factors for DRPs and assessing first-fill discontinuation.

Method: A cohort study in an outpatient pharmacy and 14 community pharmacies in Almere, the Netherlands, involved patients ≥ 18 years receiving new cardiovascular prescriptions. Usual pharmacy care was complemented with a telephone counselling two weeks post-dispensing to identify and address DRPs. Patient satisfaction and self-efficacy were assessed during a follow-up call. First-fill discontinuation was measured using dispensing data, and logistic regression identified risk factors for DRPs.

Results: Of 1647 eligible patients, 743 received NMS; 72.5% experienced ≥ 1 DRP. NMS improved patients' satisfaction with information and self-efficacy (p < 0.001). Outpatient visits (adj. OR 0.64), cardiovascular medicine use (adj. OR 0.65), and use of chronic medicines (adj. OR 1.71) influenced DRPs. First-fill discontinuation remained unchanged post-NMS, but patients with DRPs discontinued more often (14.8% vs. 8.6%, p = 0.030).

Conclusion: Implementing the NMS in a real-world transitional care setting allowed pharmacists to identify DRPs and provide counselling tailored to patient needs. Patients reported higher satisfaction with information and increased self-efficacy. Priority should be given to at-risk patients for DRPs, and deploy other pharmacy staff to perform the NMS.

Background: The recent surge in the capabilities of artificial intelligence systems, particularly large language models, is also impacting the medical and pharmaceutical field in a major way. Beyond specialized uses in diagnostics and data discovery, these tools have now become accessible to the general public.

Aim: The study aimed to critically analyse the current performance of large language models in answering patient's self-care questions regarding medications and supplements.

Method: Answers from six major language models were analysed for correctness, language-independence, context-sensitivity, and reproducibility using a newly developed reference set of questions and a scoring matrix.

Results: The investigated large language models are capable of answering a clear majority of self-care questions accurately, providing relevant health information. However, substantial variability in the responses, including potentially unsafe advice, was observed, influenced by language, question structure, user context and time. GPT 4.0 scored highest on average, while GPT 3.5, Gemini, and Gemini Advanced had varied scores. Responses were context and language sensitive. In terms of consistency over time, Perplexity had the worst performance.

Conclusion: Given the high-quality output of large language models, their potential in self-care applications is undeniable. The newly created benchmark can facilitate further validation and guide the establishment of strict safeguards to combat the sizable risk of misinformation in order to reach a more favourable risk/benefit ratio when this cutting-edge technology is used by patients.

Background: Medication errors frequently happen during patients' transitions between different healthcare settings. Medication reconciliation, provided by various healthcare specialists, could help reduce these errors. However, clinical pharmacists do not lead this service nationally in most countries.

Aim: This paper describes the development, implementation, and national evaluation of medication reconciliation in Slovenia as part of seamless care.

Setting: All hospitals and community pharmacies in Slovenia.

Development: The initial step involved the successful development of legislation in Slovenia. This process, termed 'seamless care,' was defined as a pharmaceutical service and five different steps of this process were developed: medication reconciliation upon admission (including the best possible medication history), during discharge, personal medication cards, and medication dispensing. A standard operational procedure was established in 2023 to guide these practices.

Implementation: A critical milestone in the implementation process was establishing a successful reimbursement scheme in 2023. Hospitals and community pharmacies implemented this service following successful reimbursement. Pharmacy managers and heads of hospital pharmacy departments were responsible for overseeing its implementation in hospitals and community pharmacies. The Health Insurance Institute of Slovenia is measuring the implementation.

Evaluation: Trials were conducted in various Slovenian hospitals to evaluate this service's effectiveness, appropriateness, and adoption before its full implementation (reduced medication-related problems were observed). The Health Insurance Institute of Slovenia is currently evaluating the sustainability of the service and providing feedback to the providers.

Conclusion: Slovenia is the first country in this part of Europe to fully reimburse and implement medication reconciliation as a pharmaceutical service. This practice holds promise for exporting to other countries.

Background: Posaconazole is widely recommended for preventing and treating invasive fungal infections (IFIs) in immunocompromised patients, especially those with prolonged neutropenia. However, the concentration of the oral suspension formulation can be affected by factors such as co-administration with acid-suppressing medications, influencing its efficacy and safety.

Aim: This study examined the impact of proton pump inhibitors (PPIs) and other factors on posaconazole concentrations and the concentration-to-dose ratio (C/D) while also evaluating adverse drug reactions in patients with hematologic malignancies.

Method: We conducted a retrospective analysis of patients who received posaconazole for IFI prophylaxis or treatment, assessing demographic and clinical data, adverse reactions, treatment outcomes, and drug concentration assays. The study focused on the effects of PPIs on Cmin and C/D.

Results: Data from 283 posaconazole Cmin measurements in 86 patients were analyzed. The incidence of probable or proven IFIs was 6.4% (5/78). PPI use reduced posaconazole Cmin levels but did not significantly impact prophylactic efficacy. Esomeprazole and rabeprazole were explicitly associated with decreased Cmin. Hepatotoxicity was linked to the co-administration of hepatotoxic drugs, indicating that posaconazole was not the sole contributor.

Conclusion: Co-administration of esomeprazole or rabeprazole lowers posaconazole plasma concentrations without compromising prophylactic efficacy against IFIs. Nonetheless, caution is advised when combining these drugs in high-risk immunocompromised patients.

Background: Inclisiran, the newest lipid-lowering drug, has not shown significant safety problems in major clinical studies. However, its recent market introduction and limited clinical use have produced few reports of adverse reactions, leaving a comprehensive understanding of its long-term safety yet to be established.

Aim: The aim of the study was to conduct a signal detection analysis of adverse events (AEs) associated with inclisiran using FDA Adverse Event Reporting System (FAERS) datasets.

Method: Data on AEs associated with inclisiran were collected from the FAERS database from 2021 to 2023. Signal detection was conducted using the reporting odds ratio (ROR) and the information component (IC). The analysis was standardized using the Medical Dictionary for Regulatory Activities (MedDRA) and focused on System Organ Classes (SOCs) and Preferred Terms.

Results: Of 17,307,196 AE reports, 2976 were relevant to inclisiran. The male-to-female ratio of these events was 0.74:1, predominantly in patients aged 45 to 74 years. A total of 102 AE signals associated with inclisiran were identified in 15 SOCs. Among these, 86 involved muscle injuries, liver injuries, diabetes, neurocognitive dysfunction, and other events not listed on the drug label.

Conclusion: The findings confirm all AEs documented on the drug label and in current clinical trials while also revealing new AEs such as muscle pain, elevated liver enzymes, increased blood glucose levels, and neurocognitive dysfunction. This study contributes to real-world research data, providing valuable references for rational drug use.

Background: QTc interval prolongation can result in potentially lethal arrhythmias. One risk factor is QTc-prolonging drugs, including some antifungals often used in hemato-oncology patients. Screening tools for patients at risk have not yet been investigated in this patient population.

Aim: Our aim was to evaluate the sensitivity and specificity of five QTc risk scores in hemato-oncology patients receiving systemic antifungal therapy.

Method: Data were retrieved from an internal study database including adult hemato-oncology patients prescribed systemic antifungal therapy. Data on QTc-prolonging medication, risk factors for QTc prolongation, and electrocardiograms (ECG) were collected retrospectively for a period of 12 months. The QTc risk scores according to Tisdale, Vandael, Berger, Bindraban, and Aboujaoude as well as their sensitivity and specificity were calculated.

Results: During the evaluated period, 77 patients were prescribed systemic antifungals resulting in 187 therapy episodes. Regarding therapy episodes, median age was 56 years (IQR 44-68), 41% (77) were female, and a median of 3 QTc-prolonging drugs were prescribed (range 0-6). ECGs were available for 45 (24%) of the therapy episodes 3-11 days after initiation of the antifungal therapy, 22 of which showed QTc prolongation. Regarding these 45 therapy episodes, sensitivity and specificity of the risk scores were calculated as follows: Tisdale 86%/22%, Vandael 91%/35%, Berger 32%/83%, Bindraban 50%/78%, Aboujaoude 14%/87%.

Conclusion: The QTc risk scores according to Tisdale and Vandael showed sufficient sensitivity for risk stratification in the studied patient population. In contrast, risk scores according to Berger, Bindraban, and Aboujaoude cannot be considered suitable due to poor sensitivity.