International Journal of Clinical Pharmacy最新文献

Background: Deucravacitinib, a selective inhibitor of TYK2 kinase, has been recently approved for the treatment of moderate to severe plaque psoriasis. Although the safety of deucravacitinib has been observed in clinical trials, its safety in the real world remains to be fully understood.

Aim: The purpose of this study was to analyze post-marketing adverse events (AEs) associated with deucravacitinib using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to better understand its safety in real-world conditions.

Method: This study performed a retrospective analysis of AEs associated with deucravacitinib from the FAERS database, spanning from the third quarter of 2022 to the second quarter of 2024. AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, Version 27.0). Disproportionality analysis was conducted using several statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network. Additionally, time-to-onset analyses and sensitivity analyses were performed to provide a comprehensive assessment.

Results: AE reports from 1573 individuals were analyzed, revealing a total of 2895 AEs. Most of these events occurred within the first month of treatment. The primary AEs were associated with skin and subcutaneous tissue disorders, as well as infections and infestations. The study confirmed several known common AEs, including acne (n = 172, ROR 75, PRR 70.61, EBGM 69.14, IC 6.11), folliculitis (n = 51, ROR 62.45, PRR 61.37, EBGM 60.25, IC 5.91), and herpes zoster (n = 18, ROR 6.46, PRR 6.43, EBGM 6.42, IC 2.68), and identified some unexpected AEs such as urticaria (n = 36, ROR, PRR 5.27, EBGM 5.27, IC 2.4), skin burning sensation (n = 42, ROR 21.84, PRR 21.54, EBGM 21.41, IC 4.42), and myalgia (n = 26, ROR 3.93, PRR 3.9, EBGM 3.9, IC 1.96).

Conclusion: Our study confirms the known AEs associated with deucravacitinib and identifies several potential AEs. These findings provide preliminary safety data for the practical use of deucravacitinib.

Background: Artificial intelligence (AI) applications in medicines, pharmacotherapy, and pharmaceutical services are expanding, yet the lack of standardized reporting guidelines for scientific studies hinders transparency, comparability, and reproducibility in evidence-based healthcare decision-making.

Aim: To develop and validate comprehensive reporting guidelines for AI studies in these fields through expert consensus.

Method: Following the Guidance for Developers of Health Research Reporting Guidelines (Moher in PLoS Med, https://doi.org/10.1371/journal.pmed.1000217 , 2010), this study was conducted between May and October 2024 in two phases. Phase 1 involved drafting the initial guidelines through literature reviews and structured expert discussions by an internal committee. Phase 2 employed the Delphi method for validation and refinement. Twenty-six experts from nine countries, representing clinical pharmacy, pharmaceutical services, computer science, and AI, participated in the first round, with 21 completing the second round. Items were included if they received a median ≥ 7 on a 9-point evaluation scale, with ≥ 75% agreement defining publication consensus.

Results: The final MedinAI guidelines comprise 14 items and 78 sub-items across four domains: core aspects, ethical considerations in medication and pharmacotherapy, medicines as products, and services related to medicines and pharmacotherapy. All items achieved consensus (median = 8, with 95.2% agreement on publication readiness). MedinAI's items adapt to different AI development stages, and its structure operates in parallel with EQUATOR Network reporting guidelines for most study designs (CONSORT, STROBE, PRISMA, SPIRIT, etc.), ensuring versatility.

Conclusion: MedinAI provides validated reporting guidelines for AI studies in medicines, pharmacotherapy and pharmaceutical services, promoting transparency, comparability, reproducibility, responsible and ethical AI development for these fields.

Background: Methotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment. However, patients using MTX often experience drug-related problems (DRPs), negatively affecting adherence and persistence.

Aim: To identify the number and type of DRPs experienced by RA patients during the first 3 months of MTX treatment.

Method: A longitudinal observational study was conducted in the Sint Maartenskliniek, The Netherlands, between March and August 2023. Adult RA patients were interviewed at 2, 6 and 12 weeks after MTX initiation using the United Kingdom's New Medicines Service interview guide. DRPs were categorized using a classification system for patient-reported DRPs, and analyzed descriptively.

Results: All fifty participants (median age 62 years (IQR 51-68), 66% female) reported a DRP, with a median of 6 (IQR 3-8) DRPs per patient and a total of 301 DRPs. The top 5 most frequently reported DRPs were concerns about (long-term) side-effects, nausea, fatigue, remembering intake and information needs regarding dose instructions. Of the DRPs reported at weeks 2 and 6, 33% were unresolved at week 12.

Conclusion: Patients with RA experience numerous DRPs in the first 3 months of MTX use. Resolving DRPs soon after occurrence may reduce the burden of drug treatment and improve adherence and/or persistence.

Background: Pharmacist prescribing legislation aims to enhance healthcare quality and accessibility. However, in many countries, like the Netherlands, it has not yet been legally established.

Aim: To investigate pharmacists' perspectives on potential pharmacist prescribing in the Netherlands.

Method: An online survey using a questionnaire that was distributed via e-mail and electronic newsletters to most practicing pharmacists in the Netherlands during October and November 2023. The questionnaire was based on previous literature, further developed during an international conference with pharmacists and piloted with Dutch pharmacists. Agreement with statements about potential prescribing models, settings, preconditions, and perceived benefits and risks was measured using a 4-point Likert scale. Data were analysed descriptively.

Results: In total, 625 participants from community pharmacy (n = 432; 69.1%), hospital pharmacy (n = 149; 23.8%), or other/combined settings (n = 44; 7.0%) completed the questionnaire. Most pharmacists (somewhat) agreed with the introduction of an independent prescribing model with limitations (n = 538; 86.1%) or a model dependent on collaborative agreements with physicians (n = 471; 75.4%). A minority (n = 245; 39.2%) supported independent prescribing with diagnostic authority. The precondition that participants most frequently (somewhat) agreed with was access to health records (n = 607; 97.1%). The most (somewhat) agreed-upon benefits were enhanced professional position of pharmacists (n = 574; 91.8%) and reduced workload for other prescribers (n = 573; 91.7%). Increased workload for pharmacists (n = 495; 79.2%) was the most (somewhat) agreed-upon identified risk.

Conclusion: Pharmacists in the Netherlands are generally supportive of an independent but limited or collaborative pharmacist prescribing model. These findings support further investigations into the potential introduction of pharmacist prescribing legislation.

Background: Pembrolizumab monotherapy significantly extends progression-free and overall survival compared to platinum-based chemotherapy for advanced non-small cell lung cancer (NSCLC), but also has a significant impact on medical costs.

Aim: To clarify the health economic evidence for selecting the first-line treatment for patients with stage IV advanced NSCLC with a programmed cell death ligand 1 tumor proportion score of 50% or greater in Japan, we assessed the cost-effectiveness of pembrolizumab monotherapy compared with that of platinum-based chemotherapy.

Method: Using a Markov model, the study simulated three health states for patients, based on clinical data and utility values from KEYNOTE-024. Transition probabilities were estimated exponentially. Direct medical costs were calculated according to the 2022 National Health Insurance Medical Fee Points and Drug Price Standards. The outcomes measured included life years, quality-adjusted life years, and incremental cost-effectiveness ratio, with sensitivity analysis performed to evaluate the effect of uncertainties.

Results: Pembrolizumab led to an additional 1.58 life years and 1.23 quality-adjusted life years at an additional cost of 7,009,888 Japanese yen (48,448 U.S. dollars [USD]), resulting in incremental cost-effectiveness ratio of 4,436,638 Japanese yen (30,663 USD) per life year and 5,699,096 Japanese yen (39,388 USD) per quality-adjusted life year. Pembrolizumab was deemed cost-effective under a threshold of 7.5 million Japanese yen (51,835 USD) per quality-adjusted life year.

Conclusion: Pembrolizumab monotherapy is a cost-effective option for the first-line treatment of advanced NSCLC with high programmed cell death ligand 1 expression in Japan, providing valuable health economic evidence for treatment selection.

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: Paxlovid® (nirmatrelvir and ritonavir) is the only licensed oral antiviral for COVID-19. Ritonavir is a potent inhibitor of cytochrome P450 enzymes causing numerous drug-drug interactions (DDIs).

Aim: To describe the frequency, type, and severity of detected drug related problems (DRPs) associated with Paxlovid®.

Method: This study involved a retrospective quantitative analysis including all patients prescribed Paxlovid® at a public hospital in Vienna, Austria. Data were collected from the patients' records by a clinical pharmacist. A customised, piloted data collection form was used. A sample of data was checked for consistency by an independent clinical pharmacist. Any DDI and severity classification was recorded using an established interaction checker tool. Dosage adjustments due to renal impairment were recorded.

Results: One hundred twenty-two of 140 patients (87.1%) required interventions to prevent DRPs. Pharmacists' intervention at dispensing was needed in 63.6% (n = 89) of cases. In 3 (2.1%) patients, Paxlovid® was prescribed despite being contraindicated due to severe renal impairment. The most common were DDIs (n = 80; 57.1%). Renal impairment and DDIs were noted in 24.3% (n = 34) of cases. A total of 313 DDIs were recorded in 114 (81.4%) patients, with severe interactions in 24 (17%) patients.

Conclusion: Pharmacists' involvement in prescribing highly interacting drugs such as Paxlovid® is essential to enhance patient safety.

Background: The analgesic efficacy of esketamine combined with butorphanol in thoracoscopic surgery remains unclear.

Aim: This study explored the effects of perioperative esketamine combined with butorphanol versus butorphanol alone on acute and chronic postoperative pain in patients who underwent video-assisted lobectomy.

Method: A total of 181 patients were enrolled, with 90 in the esketamine-butorphanol group (Group BK) receiving intraoperative esketamine infusion and postoperative patient-controlled intravenous analgesia (PCIA) (esketamine 1.5 mg/kg, butorphanol 0.15 mg/kg, azasetron 20 mg). The remaining 91 patients in the butorphanol group (Group B) received normal saline and PCIA with butorphanol (0.15 mg/kg) and azasetron (20 mg). Primary endpoints included Visual Analog Scale (VAS) scores in the first week and chronic pain incidence at three months. Secondary endpoints included intraoperative vital signs, morphine consumption, postoperative adverse events, and 15-item Quality of Recovery-15 (QoR-15) scores.

Results: Group BK demonstrated significantly lower VAS scores within 48 h at rest and within 24 h during coughing postoperatively (P < 0.001). However, no significant differences were observed in VAS scores [(Group B, 5 (0-12)) vs. (Group BK, 5 (0-9)), P = 0.517] or chronic pain incidence [(Group B, 34.1%) vs. (Group BK, 23.3%), P = 0.111] between the two groups at the three-month follow-up. Patients in Group BK exhibited improved postoperative stability of vital signs and higher QoR-15 scores.

Conclusion: Perioperative administration of esketamine significantly mitigates acute postoperative pain and enhances recovery quality in patients undergoing video-assisted lung resection.

Trial registration: This trial protocol is registered with ClinicalTrials.gov (NCT06398834, date: 2024-05-01).

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.