International Journal of Clinical Pharmacy最新文献

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

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.

Background

Medicine shortages are a challenge in upper, lower and middle-income countries, including South Africa. In recent years, community pharmacists, in Durban, South Africa, have experienced the COVID-19 pandemic, flooding, civil unrest and electricity disruptions. Little is known about the impact of these disruptions on medicine shortages in community pharmacies.

Aim

To explore community pharmacists' perceptions and their experiences with medicine shortages during the COVID-19 pandemic and other disruptive situations.

Method

Convenience and snowball sampling were used to recruit participants. Semi-structured interviews were conducted in person or via an online video conferencing platform, which were audio-recorded and transcribed verbatim. Using the Framework Method, the transcripts were analysed thematically on NVivo 14 software.

Results

Fifteen community pharmacists were interviewed. Five major themes emerged from thematic analysis: general perceptions of medicine shortages, the impact of disruptive situations, the consequences of medicine shortages, mitigation strategies; and further suggestions and resources. Disruptive situations were perceived to exacerbate shortages. Participants perceived a negative financial impact on patients and pharmacies, with out-of-pocket costs affecting the former and loss of income affecting the latter. The mitigation strategies used were contacting stakeholders, medicine substitution and stock management.

Conclusion

Community pharmacists felt that improved communication, collaboration, policies, notification systems and guidelines would mitigate shortages.

Background

While the effects of anticholinergic drug use have been increasingly highlighted, trends in anticholinergic use remain poorly understood.

Aim

To determine the changes in frequency and pattern of anticholinergic drug use within a low- and middle-income country.

Method

Comparisons were made between population-based datasets collected from Malaysian residents aged 55 years and older in 2013–15 and 2020–22. Anticholinergic exposure was determined using the anticholinergic cognitive burden (ACB) tool. Drugs with ACB were categorised according to the Anatomical Therapeutic Chemical (ATC) classification.

Results

A total number of 5707 medications were recorded from the 1616 participants included in the 2013–15 dataset. A total number of 6175 medications were recorded from 2733 participants in 2020–22. Two hundred and ninety-three (18.1%) and 280 (10.2%) participants consumed (ge 1) medication with ACB (ge 1) in 2013–15 and 2020–22 respectively. The use of nervous system drugs with ACB had increased (27 (0.47%) versus 39 (0.63%). The use of ACB drugs in the cardiovascular (224 (3.9%) versus 215 (3.4%)) and alimentary tract and metabolism (30 (0.52%) versus 4 (0.06%)) classes had reduced over time. Participants in 2020–22 were significantly less likely than those in 2013–15 to have total ACB = 1 − 2 (odds ratio [95% confidence interval] = 0.473[0.385–0.581]) and ACB (ge) 3 (0.251[0.137 − 0.460]) compared to ACB = 0 after adjustment for potential confounders (p < 0.001).

Conclusion

Although anticholinergic exposure has decreased over time, the use of medications with anticholinergic effects in the nervous system class has risen. This increase is attributable to antipsychotic use, which is of concern due to potential cardiovascular complications, and deserves further evaluation.

Background

Immunotherapy provides new hope to individuals with small cell lung cancer (SCLC). Predicting biomarkers for clinical effects is crucial for SCLC patients receiving programed death-ligand 1 (PD-L1) inhibitor treatment.

Aim

The aim of this study was to clarify the value of serum lipids as predictors of immune related adverse events (irAEs) and the anti-tumour effects in SCLC patients who received PD-L1 inhibitors as first-line treatment.

Method

This study included patients with SCLC who received at least one cycle of PD-L1inhibitors at Shanghai Pulmonary Hospital from August 2020 to December 2023. We collected the clinical data of the SCLC patients, including basic information and serum lipid levels, before immunotherapy.

Results

The irAEs rate was 16.1% of 124 enrolled patients. In multivariate analysis, the triglyceride (TG)/high-density lipoprotein cholesterol (HDL-C) ratio was an independent predictor of irAEs (p = 0.045). Tumour response analysis indicated that the objective response rate (ORR) was 43.4% and the disease control rate (DCR) was 79.5%. Seventy-seven patients experienced any progression-free survival (PFS) event. The median PFS was longer in the HDL-C-high group (10.03 months) than in the HDL-C-low group (6.67 months) (p = 0.043). In Cox regression analysis, the serum HDL-C level was an independent predictor of PFS (p = 0.002). For patients of the high TG/HDL-C ratio, the ORR significantly differed between patients who suffered from any irAEs and those who did not (p = 0.0139).

Conclusion

This study found that serum lipid levels might predict the responses to anti-PD-L1 as first-line treatment for SCLC.

Background

The relative occurrence of infection in patients treated with cytotoxic chemotherapeutic drugs and molecularly targeted drugs is unclear.

Aim

To compare the occurrence of respiratory and urinary tract infections in patients treated for lung cancer with docetaxel versus afatinib and to predict the occurrence of the respiratory and urinary tract infections.

Method

Data on patients who received docetaxel or afatinib were obtained from a health insurance claims database. After propensity score matching, the occurrence of respiratory and urinary tract infections in each group was compared. Factors associated with respiratory and urinary tract infections were evaluated using multivariable conditional logistic regression analysis.

Results

Each group included 855 patients. The occurrence of respiratory infections was significantly higher in the docetaxel group than in the afatinib group (22.6% [193/855] vs. 13.9% [119/855]; p < 0.01). The occurrence of urinary tract infections did not differ significantly by group. Docetaxel was independently associated with a significantly increased risk of respiratory infections (adjusted odds ratio: 1.68, 95% confidence interval: 1.23–2.29), but not urinary tract infections.

Conclusion

Patients with lung cancer treated with docetaxel should be closely monitored for the occurrence of respiratory infection in clinical settings.

Background: Independent prescribing (IP) has not been extensively investigated in community pharmacy (CP). Normalization process theory (NPT) constructs help explain how interventions are integrated into practice and include: 'coherence' (understanding), 'cognitive participation' (what promotes engagement), 'collective action' (integration with existing systems), and 'reflexive monitoring' (evaluation).

Aim: To use NPT to investigate the integration of pharmacist IP in CP.

Method: NHS Scotland Pharmacy First Plus (PFP) is a community pharmacy IP service. Questionnaire items were developed using the NPT derived Normalisation MeAsure Development (NoMAD) tool for an online survey of all PFP IP pharmacists. Demographic data were analysed descriptively and scale scores (calculated from item scores for the 4 NPT constructs) were used for inferential analysis.

Results: There was a 73% (88/120) response rate. Greater than 90% 'strongly agreed'/'agreed' to NoMAD items relating to most NPT constructs. However, responses to 'collective action' items were diverse with more participants answering 'neither agree nor disagree' or 'disagree'. A statistically significant difference in NPT construct scale scores with significant p-values (ranging from p < 0.001 to p = 0.033) was shown on all the NPT constructs for the variable 'On average, how often do you consult with patients under the PFP service?'.

Conclusion: This theory-based work offers perspectives on IP integration within CP. Despite its geographic focus this work offers insights relevant to wider contexts on IP integration. It shows 'collective action' focused 'organisation' and 'group process' challenges with a need for further work on staff training, resource availability and utilisation, working relationships, communication and management.