International Journal of Clinical Pharmacy最新文献

The national centralized drug procurement (NCDP) policy, known as the "4 + 7" policy in China, has transformed pharmaceutical procurement and access by leveraging healthcare institutions' collective buying power to reduce drug prices substantially. This policy has profoundly impacted drug pricing mechanisms, healthcare expenditures, market dynamics, and the quality of available drugs. This commentary evaluates the efficacy, challenges, and broader implications of the NCDP, summarizes the current state of post-marketing monitoring of selected generic drugs for centralized procurement, and presents relevant considerations.

Background: Pharmacist-led management of urinary tract infections has been introduced as a service in the United Kingdom, Canada, United States of America, New Zealand, and Australia. The management of acute uncomplicated urinary tract infections by community pharmacists has gained increasing attention as a potential avenue to alleviate the burden on primary healthcare services.

Aim: The objectives of the review were to: (1) identify protocols for community pharmacist management of acute uncomplicated urinary tract infections in women aged 16-65 years; (2) outline their key components; and (3) appraise the quality of protocols.

Method: A grey literature search was undertaken for protocols intended for use by community pharmacists for the management of acute uncomplicated urinary tract infections in women aged 16-65 years, met the definition of a clinical management protocol and written in English. Their quality was appraised using the Appraisal Guidelines for Research and Evaluation version II instrument.

Results: Forty of the 274 records screened were included. Content analysis identified ten key components: common signs/symptoms, differential diagnosis, red flags/referral, choice of empirical antibiotic therapy, nonprescription medications, nonpharmacological/self-care advice, patient eligibility criteria, patient follow-up, dipstick testing recommendations, and recommendations on antimicrobial resistance. The lowest scoring domains in the quality assessment were 'Editorial Independence' and 'Rigour of Development'. Only four protocols were deemed high-quality.

Conclusion: The review demonstrates that clinical management protocols for pharmacist-led management of urinary tract infections consist of similar recommendations, despite variation in international practice. However, the findings highlight a deficiency in the quality of most clinical management protocols governing pharmacist-led urinary tract infection management.

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: Mobile health clinics have been used to provide healthcare to underserved communities, especially during the COVID-19 pandemic. Student-led clinics, operated by undergraduate health students, offer valuable training while serving these populations.

Aim: This cross-sectional study investigated the demographic characteristics and services provided by a mobile health clinic run by undergraduate pharmacy students, assessing its potential to reach underserved communities.

Method: The mobile health clinic operated from October 2023 to April 2024, staffed by 36 fourth-year pharmacy students. Services included cardiovascular disease risk screening and lifestyle advice. Demographic and service data were collected using an electronic primary care system and analysed with descriptive statistics.

Results: The clinic served 716 users, with a demographic breakdown of 53.2% female and 46.8% male, predominantly aged 31-60 years. Users were ethnically diverse. Services provided included blood pressure (91.3%), BMI (91.3%), and diabetes risk assessments (54.9%). Many users reported low risk for smoking and alcohol consumption, but varied levels of physical activity. Referrals were made for cardiovascular disease risk and lifestyle support.

Conclusion: The mobile health clinic effectively reached a diverse, underserved population, providing essential health services and facilitating student training. Further research is needed to evaluate the long-term impact and cost-effectiveness of such clinics, and the follow-up care for referred patients.

Background: With hospital electronic prescribing and medicines administration (HEPMA) systems now in widespread use across hospital inpatient clinical services, work is underway to measure the benefits of HEPMA on healthcare systems and patient care. HEPMA functionality enables users to prescribe medicines by 'bundle' or 'protocol'. Although it is assumed that this is a significant system benefit, there are few qualitative studies supporting this conclusion.

Aim: To explore the impact of an electronic anticipatory care medicines protocol on junior doctor perceptions of their confidence and competence to prescribe opioids and midazolam for patients at the end of life.

Method: Between May and August 2022, one-to-one semi-structured interviews were conducted at a 570-bed District General Hospital with junior doctors who had experience of prescribing on both HEPMA and paper-based systems. Audio recordings of the interviews were transcribed verbatim and underwent thematic analysis.

Results: Ten junior doctors participated (median age 23 years). Analysis generated five main themes that described perceptions and attitudes towards confidence and competence. These were prescribing safety benefits; information technology infrastructure, interoperability and system design concerns; clinical knowledge and training needs; cultural and social factors and risks of automation in prescribing.

Conclusion: This study suggests that junior doctors experienced an overall increase in their confidence and perceived competence to prescribe anticipatory medicines post-implementation of a HEPMA protocol. Further studies are required to detail the impact of HEPMA/CPOE protocols on clinical practice.

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: Endothelin receptor antagonists are commonly used in clinical practice, with concerns about their hepatotoxicity.

Aim: This study aimed to conduct a comprehensive pharmacovigilance study based on FDA adverse event reporting system data to evaluate the possible association between endothelin receptor antagonists and drug-induced liver injury.

Method: Adverse event reports from FDA adverse event reporting system between January 2004 and December 2022 were analyzed. Disproportionality algorithms, including reporting odds ratio and information component, were used to evaluate the association between endothelin receptor antagonists and liver injury. Sex- and age-stratified analyses of drug-induced liver injury events were also conducted in relation to endothelin receptor antagonists.

Results: Significant associations between bosentan, macitentan, and liver injury were identified. Bosentan showed a strong link with liver injury, with reporting odds ratios for cholestatic injury at 7.59 (95% confidence interval: 6.90-8.35), hepatocellular injury at 5.63 (5.29-6.00), and serious drug-related hepatic disorders events at 1.33 (1.24-1.43). Drug-induced liver injury signals associated with bosentan were detected in all age groups. Macitentan was associated with liver injury, with reporting odds ratios for hepatic failure at 1.64 (1.39-1.94), cholestatic injury at 1.62 (1.43-1.83), and serious drug-related hepatic disorders events at 1.40 (1.29-1.51). No drug-induced liver injury signal was detected for ambrisentan, and no significant sex differences were observed in drug-induced liver injury events.

Conclusion: Both bosentan and macitentan are associated with liver injury. Routine monitoring of serum aminotransferase levels is recommended, especially in patients at higher risk of liver injury. Further research into drug-drug interactions involving endothelin receptor antagonists is warranted.

Background: While there is an accumulation of evidence that pharmacist prescribing is safe and effective, there is a lack of research on processes of implementation into practice, particularly for patients with complex clinical conditions such as chronic kidney disease (CKD).

Aim: The aim was to explore the facilitators and barriers to the implementation of pharmacist prescribing for patients with CKD in the United Kingdom (UK).

Method: Semi-structured interviews were conducted with UK Renal Pharmacy Group members who were independent prescribers. The Consolidated Framework for Implementation Research (CFIR) underpinned the interview schedule. Interviews were recorded, transcribed, and independently coded by two researchers. A thematic approach was used for analysis, with data generation continuing until saturation of themes. Ethical approval was granted.

Results: Data saturation was achieved following 14 interviews. Most interviewees were female (n = 11), all had secondary care as their main practice setting, and were highly experienced prescribers with 8 having 11 or more years of prescribing practice. Interviewees were positive regarding the development of their prescribing practice. Facilitators and barriers emerged across all 5 of the CFIR domains. Key facilitators were aspects of inner setting (e.g., organisational support and communication) while key barriers were also related to inner setting, specifically the need for adequate structural and financial resources.

Conclusion: This theory-based study has illuminated the facilitators and barriers for the implementation of pharmacist prescribing in CKD. There is a need to consider the resources required for implementation of prescribing practice at an early stage of planning and development.

Background: Despite the publication of a European wide competency framework for hospital pharmacy by the European Association of Hospital Pharmacist (EAHP) in 2017, not all countries have adopted and implemented such a framework.

Aim: This study aimed to develop and validate a bespoke national hospital pharmacy competency framework for Austria that supports the hospital pharmacy workforce development.

Method: A multi-method study was carried out in three phases. (I) A systematic literature review across 48 websites of healthcare-related associations and six scientific databases was conducted, identifying competency frameworks, guidelines and related documents. (II) Extracted behaviour competencies were reviewed for contextual national appropriateness by three researchers prior to mapping against the "Patient Care and Clinical Pharmacy Skills" domain of European Common Training Framework (CTF). (III) Validation of the resultant draft clinical skills competency framework took place by an expert panel (n = 4; Austrian Association of Hospital Pharmacists (AAHP) board members) discussion. Reporting of findings is aligned with the recommendations for reporting Competency Framework Development in health professions (CONFERD-HP guidelines) and the PRISMA 2020 checklist.

Results: The systematic review (SR) resulted in 28 frameworks, guidelines and related documents and the identification of 379 behaviour competencies, with nineteen mapped to the "Patient Care and Clinical Pharmacy Skills" domain of the CTF (after removal of duplicates). Expert panel discussion resulted in suggested changes to ensure contextual national appropriateness.

Conclusion: This study resulted in the development and validation of the first clinical national pharmacy competency framework for Austria. Future studies should focus on political and practical structures necessary for its successful implementation.

Background: The use of digital health technologies (DHTs), systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses, is rapidly increasing. Assessing literacy in this area may be challenging given the absence of comprehensive instruments, especially those dedicated to health care professionals. The digital health technology literacy assessment questionnaire (DHTL-AQ) is a 34-item instrument that assesses an individual's ability to use DHTs, services, and data.

Aim: To translate and culturally adapt the DHTL-AQ and to evaluate the psychometric properties of the Serbian version.

Method: The DHTL-AQ English version was translated into Serbian, back-translated, and adapted via expert consensus discussion. Pilot testing was conducted among a population of community pharmacists. To gather evidence of initial validity, the culturally adapted version was tested in the same population as the pilot. Reliability was examined using Cronbach's alpha (Cα), and a test-retest methodology for temporary stability. Validity was explored through factor analysis.

Results: A pilot study (n = 22) included linguistic and cultural adjustments, confirming the item comprehensibility. The final Serbian DHTL-AQ consists of 5 questions and 25 items. The psychometric analysis (n = 162) indicated, satisfactory internal consistency (Cα = 0.822) and temporal stability (ICC = 0.981). Factor analysis identified 3 factors that explained 52% of the total variance, reducing the number of factors to 3 compared with 4 into the original questionnaire.

Conclusion: The culturally adapted DHTL-AQ Serbian version demonstrated strong psychometric properties. Practical application can support the development and implementation of customized education and training programs and new DHT-related services that pharmacists can offer patients.