International Journal of Pharmacy Practice最新文献

Objectives: The primary objective of the study focused on the analysis of the terminology used to describe race and/or ethnicity in package inserts for the 100 top-selling medicines in 2021 and to the evaluation of this data based on overall terminology use frequency, terminology use frequency by medication class, and frequency of terminology appearance under specific insert headings.

Methods: Data collection involved reviewing package inserts for 100 top-selling medicines approved in the USA starting with the top 10 medicines followed by the remaining 90 medicines on the list. For the initial 10 medicines, a sample package insert was obtained from the DailyMed website, a resource supported by the US National Library of Medicine and analyzed for the explicit use of race or ethnicity terminology. Identified terms were coded and a list of relevant terms was compiled. A sample package insert for each of the other 90 medicines was analyzed using the list of relevant terminology. A final list to represent the use and quantification of race and ethnicity terminology was compiled.

Key findings: This qualitative study revealed that some of the terminology in US medicine information labeling is not consistent with the current wording recommended in FDA guidance for race and ethnicity data collection during clinical trials and other studies. Another finding of this analysis is variation in the frequency of use of race and ethnicity terminology relative to the medicine category and sections of the package insert.

Conclusions: Healthcare providers must be cautious when evaluating package inserts, especially race/ethnicity-related terminology that may not reflect current medicine development requirements or when changes occur to tools previously influenced by information used in clinical trials.

Objectives: To evaluate the pain-relief efficacy for non-bacterial sore throat by comparing ibuprofen alone with ibuprofen combined with lozenges containing amylmetacresol 0.6 mg (AMC) and 2,4-dichlorobenzyl alcohol 1.2 mg (DCBA).

Methods: In this randomized, open-label trial, sore throat patients meeting inclusion criteria were recruited from drugstores. Patients received either ibuprofen alone or ibuprofen with AMC/DCBA lozenges. Pain scores were recorded at 0, 30, 60, 120, and 360 minutes, and on days 3 and 5. Efficacy was measured by total pain relief score (TOTPAR) and pain relief difference over 360 minutes and on day 3. Safety and patient satisfaction were assessed on day 3.

Key findings: TOTPAR and pain relief differences were not significant at all measured times, with P = 0.77 and 0.68, respectively. Over 95% of patients in both treatments reported no pain on day 3. The pain reduction time for ibuprofen with AMC/DCBA lozenge was 0-30 minutes, while for ibuprofen alone, it was 0-60 minutes, showing a significant difference in comparison to 0-15 minutes (P < 0.05). No significant differences were found in safety and patient satisfaction.

Conclusions: Combining AMC/DCBA lozenges with ibuprofen in community pharmacies enhances sore throat management by providing faster relief without affecting overall efficacy. This study highlights the potential of lozenges to complement standard care, improve satisfaction, and reduce antibiotic reliance.

Objective: To assess the rationale for using lemborexant 10 mg as a starting dose or for those with partial response to 5 mg for the management of insomnia.

Methods: A review of MEDLINE, regulatory reports, and Canadian Agency for Drugs and Technologies in Health data was conducted.

Key findings: Lemborexant 10 mg as an initial dose offers minimal improvement in sleep metrics over 5 mg but increases somnolence risk. No evidence supports dose escalation for partial responders to 5 mg.

Conclusion: Lemborexant 10 mg is generally not advisable as an initial or escalated dose due to higher harm risk and unlikely clinical benefit.

Objectives: This study aimed to identify the impact of the coronavirus disease 2019 (COVID-19) pandemic on changes in the trend and quality of adverse drug reaction (ADR) reports in the Japanese Adverse Drug Events Report (JADER) database using the vigiGrade completeness score as an indicator.

Methods: A JADER dataset consisting of ADR reports from April 2004 to March 2025 was used. VigiGrade completeness scores were determined for ADR reports, and the quality of the reports was assessed as 'well documented' or not, depending on the score obtained.

Key findings: Of 969 520 ADR reports, 393 168 submitted between the fourth quarter of 2018 and the fourth quarter of 2024 were included. The number of ADR reports declined in the first quarter of 2020 but peaked in the second quarter of 2021. The proportion of 'well-documented' reports remained between ~20% and 30% during most quarters, but increased to ~40% in the first and second quarters of 2021, during which COVID-19 vaccine-related reports accounted for 29.0% and 39.2% of all reports, respectively. This surge in vaccine-related submissions coincided with a temporary improvement in documentation quality.

Conclusions: The COVID-19 pandemic and the increase in ADR reports related to COVID-19 vaccines have affected the trends and quality of reporting in the JADER database. Notably, a substantial increase in vaccine-related ADRs during mass immunization corresponded with a temporary rise in reporting quality. These findings highlight the importance of maintaining robust pharmacovigilance systems that can adapt to large-scale public health interventions and sustain data quality during future emergencies.

Objective: To create a short-term medical service trip (MST) focused, standardized, evidence-based, cost-effective, locally appropriate formulary.

Methods: Documents from the World Health Organization (WHO), related entities, and primary literature were reviewed to determine best practices. Specific diagnosis and treatment formularies (DTFs) for MST use in the WHO Regions of Africa and the Americas were created.

Key findings: The DTF guiding principles were being WHO-region specific, addressing primary health needs, including essential medications based on disease prevalence, local availability and affordability, and optimizing patient labeling.

Conclusions: A thoughtfully crafted DTF for MSTs is one way to advance equitable and safe health care.

Objectives: The Treatment Satisfaction with Medicine Questionnaire (SATMED-Q) is a valuable instrument for pharmacy practice research, but psychometric properties have not been investigated widely. Therefore, the aim of this study was to evaluate the psychometric properties of the Indonesian version of the SATMED-Q.

Methods: This was a cross-sectional study of patients with type 2 diabetes recruited from five community health centers in Indonesia. Participants completed the SATMED-Q, the Medication Adherence Report Scale (MARS-5), the 5 Level EuroQol 5 Dimensions (EQ-5D-5L) and the EuroQol Visual Analog Scale (EQ-VAS) instruments. Reliability and validity were tested.

Key findings: Overall, 486 patients (mean age 59 years old, 73.3% female) participated. Both internal reliability (Cronbach's alpha 0.97) and test-retest reliability (intraclass correlation coefficient ranging from 0.615 to 1 across the domains) were high. Exploratory factor analysis supported the original six domain structure, with factor loadings exceeding 0.5. Confirmatory factor analysis showed a well-fitted model (comparative fit index = 0.968, Tucker-Lewis index = 0.958, standardized root mean square residual = 0.051, χ2/df = 3.652) and a moderate root mean square error of approximation value of 0.074. Convergent validity was demonstrated by a significant positive correlation between SATMED-Q and MARS-5 (r = 0.276) and EQ-VAS (r = 0.330).

Conclusions: The Indonesian SATMED-Q was found to be a valid and reliable instrument for assessing medication satisfaction as an important outcome to develop and evaluate pharmacy practice interventions.

To optimize student engagement and maximize student outcomes pharmacy curricula design should be informed by educational evidence and learning theories. This article explores the reasons why student engagement might be suboptimal and how educational evidence and learning theories can be used to design a new pharmacy curriculum to optimize student engagement and maximize student outcomes. This article introduces Thomas et al.'s [3] six-step approach to curriculum development and provides arguments and evidence for using educational theories and best practices in the curricula design process. A case study shows how University of Bradford School of Pharmacy developed a highly integrated programme with identifiable themes that developed through a spiral curriculum with a clearly defined core curriculum, but with space for significant student choice to enhance learner motivation. To optimize engagement and encourage students to take deeper approaches to learning the curriculum is predominantly delivered by Team-Based Learning, an active and collaborative learning strategy that is informed by social constructivist learning theories.

Objectives: The environmental impact of asthma is multifactorial and personalized strategies to optimize treatment and achieve improved asthma control are required to reduce asthma related carbon emissions. Digital interventions, such as electronic monitoring devices (EMDs) could be one potential solution to support inhaler optimization. This article explores the clinical and sustainability benefits of EMDs and the impact they could have on decarbonizing the asthma pathway.

Methods: An electronic database search was carried out on PubMed, Ovid Embase, Ovid Medline, and the Cochrane library, in November 2024 and updated in April 2025. A structured search was used including free text and MeSH terms using the key terms 'asthma', 'adherence', and terms related to 'digital inhaler', 'digital sensor', 'electronic monitoring device', and 'environmental sustainability'. Fully published randomized controlled trials, systematic reviews or meta-analyses, and cohort studies were retrieved. Search results were limited to adolescent and adult asthma patients. Articles not published in English language were excluded.

Key findings: The review identifies that EMDs, particularly when combined with education and feedback, have the potential to reduce the carbon impact of asthma through improved adherence to preventer inhalers, reduced reliever overuse, and improved asthma control. However, the current evidence is limited and larger comparative studies demonstrating their impact on clinical outcomes and health economic and environmental factors are required.

Conclusions: Digital inhaler monitors could potentially support treatment optimization and decarbonization of the asthma pathway. Further research is required to truly understand their potential and support their adoption into clinical practice in the UK.