International Journal of Clinical Pharmacy最新文献

Background: Although selpercatinib has shown clinical benefits for rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), its cost-effectiveness requires further evaluation.

Aim: This study aimed to evaluate the cost-effectiveness of selpercatinib versus chemotherapy and pembrolizumab in the first-line treatment of RET fusion-positive NSCLC from the perspective of the United States (US) payer.

Method: A partitioned survival model was developed based on data from the LIBRETTO-431 trial. Cost and utility values for the health state were obtained from database data or published literature. The measured outcomes included quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratio (ICER). One-way sensitivity analysis and probabilistic sensitivity analyses (PSA) were conducted to assess the uncertainty of the model.

Results: Selpercatinib increased QALYs in patients with RET fusion-positive NSCLC by 0.90 compared to chemotherapy plus pembrolizumab, with an additional cost of $542,517.45, resulting in an ICER of $603,286.49/QALY, which exceeded the willingness-to-pay (WTP) threshold ($150,000) in the US. One-way sensitivity analysis suggested that the utility of progressed disease, the utility of progression-free survival, the price of selpercatinib, the discount, the price of pemetrexed, and the price of pembrolizumab had the greatest influence on the cost- effectiveness analysis process. In the PSA, 99.9% of the scatter points were distributed above the US WTP threshold of $150,000.

Conclusion: From the perspective of the US payer, selpercatinib is not cost-effective compared to chemotherapy and pembrolizumab for first-line treatment in patients with RET fusion-positive NSCLC.

Background: Polypharmacy is associated with the prescription of inappropriate medications and avoidable medication-related harm. A novel pharmacist-led intervention aims to identify and resolve inappropriate medication prescriptions in older adults with polypharmacy.

Aim: To conduct a preliminary feasibility assessment of the intervention in primary care, testing whether specific components of the intervention procedures and processes can be executed as intended.

Method: The mixed-methods study was approved by the New Zealand Health and Disability Ethics Committees and public health agency. Patients from a New Zealand general practice clinic were recruited over 4 weeks to receive the intervention. The preliminary feasibility assessment included measures of intervention delivery, patient-reported outcome measures, and perspectives from ten patients and six clinicians. Data were analysed quantitatively and qualitatively to determine if a full-scale intervention trial is warranted. The study's progression criteria were based on established research and guided the decision-making process.

Results: The intervention met the study's progression criteria, including patient recruitment, retention, and adherence to the intervention procedures. However, several modifications were identified, including: (1) enhancing patient recruitment, (2) conducting a preliminary meeting between the patient and pharmacist, (3) supporting pharmacists in maintaining a patient-centred approach, (4) reviewing the choice of patient-reported outcome measure, (5) extending the 8-week follow-up period, (6) allocating more time for pharmacists to conduct the intervention.

Conclusion: The study found the intervention feasible; however, additional development is required before progressing to a full-scale trial. This intervention has the potential to effectively reduce medication-related harm and improve outcomes for older adults with polypharmacy.

Trial registration number: ACTRN12621000268842 Date registered: 11/03/2021.

Background: Chronic non-cancer pain may affect up to 51% of the general population. Pharmacist interventions have shown promise in enhancing patient safety and outcomes. However, our understanding of the scope of pharmacists' interventions remains incomplete.

Aim: Our goal was to characterise pharmacists' interventions for the management of chronic non-cancer pain.

Method: Medline, Embase, PsycINFO via Ovid, CINAHL via EBSCO databases and the Cochrane Library were systematically searched. Abstracts and full texts were independently screened by two reviewers. Data were extracted by one reviewer, and validated by the second. Outcomes of studies were charted using the dimensions of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).

Results: Forty-eight reports were included. Interventions ensuring appropriate drug prescription occurred in 37 (79%) studies. Patient education and healthcare professional education were reported in 28 (60%) and 5 (11%) studies, respectively. Therapy monitoring occurred in 17 (36%) studies. Interventions regularly involved interprofessional collaboration. A median of 75% of reported outcome domains improved due to pharmacist interventions, especially patient disposition (adherence), medication safety and satisfaction with therapy.

Conclusion: Pharmacists' interventions enhanced the management of chronic non-cancer pain. Underreported outcome domains and interventions, such as medication management, merit further investigation.

This commentary narrates on the building of an effective and innovative medicines optimisation model. It discusses the essential features, emphasizes the need, and considers the strong health and pharmacy system as a prerequisite before such a model could be built. The paper argues that it is important to strengthen the health system before the elements of pharmaceutical care and medicine optimisation can take shape. It discusses the discourse and interplay between medicine use and medicine access research. The other important elements to include are the "selection of medicines by health technology assessment", "economic evaluation of pharmacy services", "pharmacists' remuneration by the government", "Health system strengthening status", "quality use of generic medicines programmes", "rationale prescribing", "access to medicines and medicines pricing", "medicines advertising" and the "state of pharmacy practice and the development of the pharmacist's role". A set of different high-, middle- and low-income countries are used to provide examples of the status of the health system and the subsequent development of pharmacy practice and medicines optimisation. The countries include the UK, Australia, New Zealand, Pakistan, Türkiye, Malaysia, India, and Pakistan.

Background: Codeine was rescheduled in Australia to prescription only in February 2018. Initial studies reported an increase in population level paracetamol and ibuprofen sales following codeine upscheduling. However, to date no study has been able to investigate changes in non-opioid analgesic use at the individual patient level to determine if sales data reflect actual consumption patterns.

Aim: To address this gap, we aimed to determine the impact of codeine rescheduling on non-opioid analgesic use in people who regularly used over-the-counter codeine, primarily for pain, prior to the rescheduling change.

Method: We conducted a prospective cohort study with 260 participants who reported regular over-the-counter codeine consumption at cohort entry. Surveys were completed at baseline (November 2017, 3 months before rescheduling) and at 1 month (February 2018), 4 months (June 2018), and 12 months (February 2019), following rescheduling. The primary outcomes were mean daily doses of non-opioid analgesics, captured through a 7 day medication diary.

Results: The mean daily paracetamol dose decreased from 1754.4 mg (95% CI 1300.5-2208.3) at baseline to 1023.8 mg (95% CI 808.5-1239.1) at the final time-point (+ 12 months) (p = .009). The mean daily ibuprofen dose decreased from 305.1mg (95% CI 217.9-392.4) at baseline to 161.2 mg (95% CI 98.5-224.0) 12 months after rescheduling (p = .03). No significant change in doses of other medications remained was found.

Conclusion: In people who regularly consumed over-the-counter codeine, doses of non-opioid analgesics either reduced or remained stable following codeine rescheduling, suggesting concerns of medication substitution or overuse following the change were not realised.

Background: Continuity of medicines management can be compromised when older people are transferred between hospital and residential aged care facilities.

Aim: This study explored medicines management practices at facilities during patients' transfer of care from hospital, and staff experiences with medicines information handover from hospitals.

Method: An electronic cross-sectional questionnaire sent to all residential aged care facilities within a metropolitan region in Australia, in February 2022. The questionnaire comprised 23 questions covering facilities' profiles, medicines management practices, and medicines management at transfer of care from 2 public hospitals.

Results: Of 53 listed facilities, 31 [58.5%] responded. Facilities varied in size ranging between < 50 and up to 200 beds. Twenty-seven [87.1%] facilities offered more than one level of care. Of those 27 facilities, 26 [96.3%] offered dementia care, and 23 [85.2%] offered palliative care. Six (19.4%) solely used hardcopy medication charts. Handover from hospitals to manage patients' medicines at transfer was inconsistent with only 15 [48.4%] reporting consistently receiving appropriate documentation.

Conclusion: Residential aged care facilities varied in size and level of care. Diverse processes exist for medicines management. There is inconsistency in information received when residents transfer from hospital to facilities, potentially compromising patient safety.

Background: Although several pharmacoeconomic studies have assessed the cost-effectiveness of maintenance immunosuppressive regimens for heart transplant recipients, economic comparisons between various combination drug therapies remain sparse.

Aim: This study used an economic evaluation based on network meta-analysis to assess the cost-effectiveness of four immunosuppressive regimens for adult heart transplant recipients in China.

Method: We conducted a systematic search for clinical trials in PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP database. A validated Markov model was adapted to reflect the Chinese medical landscape. Four maintenance immunosuppression regimens were considered: tacrolimus/mycophenolate mofetil (TAC/MMF), cyclosporine/mycophenolate mofetil (CSA/MMF), everolimus/cyclosporine (EVL/CSA), and sirolimus/tacrolimus (SRL/TAC). The probabilities of health events were derived from a comprehensive literature review. Direct medical costs, adjusted for 2022 values, were from public documents and websites, while utilities for quality-adjusted life-years (QALYs) were taken from previous studies. Primary outcomes were mean lifetime cost, QALYs, and cost-effectiveness, with a willingness-to-pay (WTP) threshold set at three times China's GDP per capita in 2022. Sensitivity analyses were conducted to test the robustness of the results.

Results: The base case analysis identified TAC/MMF as the most cost-effective regimen, producing a mean of 6.31 QALYs per patient at a cost of Chinese Yuan (CNY) 534,182.89. Sensitivity analyses consistently reinforced TAC/MMF as the most cost-effective and robust choice.

Conclusion: TAC/MMF is the most cost-effective maintenance immunosuppressive regimen for heart transplant recipients within the Chinese health system. The study findings are reinforced by sensitivity analyses, affirming their robustness amid various uncertainties.

Background: People who are d/Deaf face challenges when communicating with pharmacists, especially during medication counseling.

Aim: This study aimed to explore and understand the perceptions and experiences of d/Deaf people regarding medication counseling by hospital pharmacists.

Method: Five sets of semi-structured in-depth interviews (44 total) and one focus group were conducted among d/Deaf people, hospital pharmacists, and Thai sign language (TSL) interpreters. Data from d/Deaf people's perspectives were triangulated with data from pharmacists and TSL interpreters.

Results: Five themes emerged from the interview: (1) d/Deaf people believe that deafness is stigmatized, (2) d/Deaf people's needs during medication counseling, (3) skills for d/Deaf people to communicate with pharmacists, (4) values identified in d/Deaf people, 5) emotions related to medication counseling with pharmacists. Effort, trust, confidentiality, and privacy were values associated with counseling. d/Deaf people preferred communicating with pharmacists in TSL to communicating with pharmacists via TSL interpreters because of trust and confidentiality. They also preferred pharmacists with d/Deaf knowledge and skills. Moreover, d/Deaf people believed that deafness was stigmatized, so signing in nonprivate areas was embarrassing. When TSL was not used in communication, language, lipreading, and technology skills became important. With these non-TSL communications, d/Deaf people may not have understood the conversation. However, they may not have asked pharmacists because they felt Krengjai (the hesitancy to bother).

Conclusion: Thai d/Deaf people have negative experiences during medication counseling. Skills and emotions can act as barriers to communication with pharmacists. TSL should be used to improve d/Deaf people's experiences during medication counseling.

Background

Tislelizumab combined with chemotherapy has shown significant clinical benefits in improving overall survival compared to chemotherapy alone for patients with extensive-stage small-cell lung cancer (ES-SCLC).

Aim

This study aimed to evaluate the cost-effectiveness of tislelizumab plus chemotherapy versus standard chemotherapy as a first-line treatment for ES-SCLC from the US payer perspective and the perspective of the Chinese healthcare system.

Method

We conducted an economic evaluation using a Markov state-transition model, reflecting the US payer perspective and the perspective of the Chinese healthcare system. Baseline patient characteristics and essential clinical data were obtained from the RATIONALE-312 trial. The costs and utilities were derived from open-access databases and published literature. The primary outcomes measured included quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB). Uncertainties in the model were addressed by probabilistic sensitivity analysis (PSA) and one-way sensitivity analysis (OWSA).

Results

In the base-case analysis, the addition of tislelizumab to chemotherapy provided an incremental gain of 0.16 QALYs at an additional cost of $7430.73, resulting in an ICER of $46,132.33 per QALY. Although above the willingness-to-pay (WTP) threshold of China of $38,042.49 per QALY, the cost-effectiveness was marginal, with an INHB of − 0.03 QALYs and an INMB of $− 1303.06. In the US, despite a slightly higher effectiveness gain of 0.28 QALYs, the increased cost of $45,157.35 resulted in an unfavorable ICER of $163,885.06 per QALY, exceeding the US WTP threshold of $150,000.00. PSA showed probabilities of cost-effectiveness of tislelizumab plus chemotherapy at 17.18% in China and 40.41% in the US.

Conclusion

Tislelizumab combined with chemotherapy was not a cost-effective first-line treatment option for ES-SCLC in China or the US; however, the margin of cost-effectiveness was narrow.

Background

Cefoperazone/sulbactam is commonly prescribed for the treatment of infected patients with cirrhosis.

Aim

To investigate the effect of cefoperazone/sulbactam on coagulation in cirrhotic patients and assess the effectiveness of vitamin K1 supplementation in preventing cefoperazone/sulbactam-induced coagulation disorders.

Method

This retrospective cohort study compared coagulation function in 217 cirrhotic patients who received cefoperazone/sulbactam with and without vitamin K1 supplementation (vitamin K1 group, n = 108; non-vitamin K1 group, n = 109). Propensity score matching (PSM) was used to to reduce confounders’ influence, the SHapley additive exPlanations (SHAP) model to explore the importance of each variable in coagulation disorders.

Results

In the non-vitamin K1 group, the post-treatment prothrombin time (PT) was 16.5 ± 6.5 s and the activated partial thromboplastin time (aPTT) was 34.8 ± 9.4 s. These were significantly higher than pre-treatment values (PT: 14.6 ± 2.4 s, p = 0.005; aPTT: 30.4 ± 5.9 s, p < 0.001). In the vitamin K1 group, no differences were observed in PT, thrombin time, or platelet count, except for a slightly elevated post-treatment aPTT (37.0 ± 10.4 s) compared to that of pre-treatment (34.4 ± 7.2 s, p = 0.033). The vitamin K1 group exhibited a lower risk of PT prolongation (OR: 0.211, 95% CI: 0.047–0.678) and coagulation disorders (OR: 0.257, 95% CI: 0.126–0.499) compared to that of the non-vitamin K1 group. Propensity score matching analysis confirmed a reduced risk in the vitamin K1 group for prolonged PT (OR: 0.128, 95% CI: 0.007–0.754) and coagulation disorders (OR: 0.222, 95% CI: 0.076–0.575). Additionally, the vitamin K1 group exhibited lower incidences of PT prolongation, aPTT prolongation, bleeding, and coagulation dysfunction compared to the non-vitamin K1 group.

Conclusion

Cefoperazone/sulbactam use may be linked to a higher risk of PT prolongation and coagulation disorders in cirrhotic patients. Prophylactic use of vitamin K1 can effectively reduce the risk.