International Journal of Clinical Pharmacy最新文献

Background: Remimazolam tosilate is a new type of benzodiazepine currently used for gastrointestinal endoscopy and can be combined with alfentanil.

Aim: This trial compared the effectiveness and safety of remimazolam with alfentanil to propofol with alfentanil in patients undergoing gastrointestinal endoscopy.

Method: One hundred and sixty-six patients were randomly divided into propofol-alfentanil anaesthesia (Group P) and remimazolam-alfentanil anaesthesia (Group R). The primary outcomes were perioperative haemodynamic variables, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) and oxygen saturation (SpO₂) preoperatively (T0); after anaesthesia induction (T1); when the gastroscope passed through the oropharynx (T2); 3 min (T3), 5 min (T4) and 7 min (T5) after T2; at the end of surgery (T6); and when patients successfully awakened (T7). The secondary outcomes included induction and awakening time, patient satisfaction, operator satisfaction, and adverse event occurrences.

Results: Compared with those in Group P, the SBP in Group R was significantly higher at T1, T2, T3, and T6 (P < 0.05); the DBP and MAP were significantly higher at T1, T2, T3, T5, and T6 (P < 0.05); the HR was significantly faster at T1 to T6 (P < 0.05); the SpO₂ was significantly higher at T1 to T4 (P < 0.05); the incidences of hypoxemia, hypotension, and drug injection pain were significantly lower in Group R (P < 0.05); the incidence of hiccups was higher (P < 0.05); the awakening time was shorter in Group R (P < 0.05); and the operator satisfaction score was high (P < 0.05).

Conclusion: Compared to propofol with alfentanil, remimazolam with alfentanil can be used safely and effectively for sedation in patients undergoing gastrointestinal endoscopy, with less impact on the patient's circulatory and respiratory systems and a lower incidence of adverse events.

Trial registration: This trial protocol was registered in the Chinese Clinical Trial Registry (ChiCR2300077252, date: 2023-11-02).

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: Provision of take-home naloxone (THN) and overdose education reduces opioid-related mortality. In Australia, from July 2022, all Australian community pharmacies were eligible to supply naloxone for free through the national THN Program.

Aim: This study aimed to identify naloxone stocking rates and correlates of stocking naloxone across Australian pharmacies.

Method: Data were collected from a representative sample of Australian pharmacists in Victoria, New South Wales, Queensland and Western Australia via an online survey. Data collected included pharmacy and pharmacist characteristics and services offered within the pharmacy, including needle and syringe programs, opioid agonist treatment (OAT) and stocking naloxone. Binary probit regression analysis was used to identify correlates of stocking naloxone after controlling for key covariates.

Results: Data from 530 pharmacists were analysed. In total, 321 pharmacies (60.6%) reported stocking naloxone. Chain pharmacies and pharmacies that provided OAT had a greater probability of stocking naloxone (B = 0.307, 95%CI: [0.057, 0.556], and B = 0.543, 95%CI: [0.308, 0.777] respectively). Most (61.7%) pharmacists felt comfortable discussing overdose prevention with patients who use prescription opioids, and this comfort was associated with a higher probability of stocking naloxone (B = 0.392, 95%CI: 0.128, 0.655). Comfort discussing overdose prevention with people who use illicit opioids was lower (49.4%) and was not associated with stocking naloxone.

Conclusion: There is scope to increase stocking of naloxone and comfort with overdose prevention, particularly through addressing comfort working with higher risk groups such as people who use illicit opioids.

Background: Proton pump inhibitors (PPIs) are commonly prescribed for treating upper gastrointestinal hemorrhage, eradicating Helicobacter pylori, and stress ulcer prophylaxis, among other digestive system diseases. Recent case reports provided limited evidence of a correlation between PPIs and drug reactions with eosinophilia and systemic symptoms (DRESS). However, there is currently no established association between PPIs and DRESS.

Aim: This research aimed to identify the associations between PPIs and DRESS using the US Food and Drug Administration Adverse Events Reporting System (FAERS) database.

Method: A retrospective investigation of DRESS associated with six PPIs used FAERS data from Q1 2004 to Q3 2023. Data mining algorithms were used to identify adverse events in the FAERS database that met the following criteria: (1) proportional reporting ratio (PRR) ≥ 2; (2) reporting odds ratio (ROR) > 1; (3) 95% confidence interval (CI) of ROR > 1; (4) Chi-square (χ²) ≥ 4 and case count ≥ 3.

Results: There were 495 reports of PPI-related DRESS, including pantoprazole (174, 35.2%), omeprazole (103, 20.8%), lansoprazole (103, 20.8%), esomeprazole (101, 20.4%), rabeprazole (8, 1.6%), and dexlansoprazole (6, 1.2%). The results indicated a significant association of three PPIs (pantoprazole, omeprazole, and lansoprazole) with DRESS. The sensitivity analysis demonstrated that only pantoprazole remained significantly associated with DRESS after 10 concomitant drugs had been removed (ROR: 3.00, PRR: 2.99, and information component [IC]: 1.57).

Conclusion: This study identified the signals suggesting a potential association between DRESS and six PPIs. However, more investigation of epidemiological data is required to validate of these conclusions.

Background: Despite developing a polypharmacy core outcome set (COS) in primary care, it is not clear how these outcomes should be measured.

Aim: To select outcome measurement instruments (OMIs) for a COS targeting appropriate polypharmacy in older patients in primary care.

Method: Following the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, OMIs were identified from a Cochrane review focusing on appropriate polypharmacy. The quality of OMIs was assessed using a published checklist. Subsequently, two rounds of Delphi questionnaires were conducted via the SoGoSurvey^® platform, engaging stakeholders (researchers, clinicians and journal editors specialising in geriatric primary care) to achieve consensus on OMIs using a scale encompassing "agree", "disagree", or "unsure". Consensus was achieved if 70% or more participants chose "agree" and 15% or fewer chose "disagree."

Results: The quality of 20 OMIs identified from the Cochrane review was evaluated. Seven OMIs were selected based on meeting the COSMIN guideline's minimum requirements. Out of 188 potential participants, 57 (30.3%) consented to participate. Rounds 1 and 2 of Delphi exercises were completed by 50 respondents, achieving agreement on three OMIs: 'number of serious adverse drug reactions (ADRs)' (98%), 'number of deaths' (76%), and 'number of patients who fell' (70%) for measuring 'serious ADRs,' 'mortality,' and 'falls,' respectively. No agreement was reached for 'medication appropriateness,' 'medication side-effects,' 'quality of life,' and 'medication regimen complexity.'

Conclusion: OMIs were selected for a limited number of outcomes in the polypharmacy COS. Future research should identify suitable OMIs for the remaining four outcomes.

Background: Tirzepatide was approved to treat type 2 diabetes and obesity, but its efficacy and safety in patients without diabetes has not been investigated.

Aim: This meta-analysis aimed to evaluate the efficacy and safety of tirzepatide compared to placebo in overweight or obese patients without diabetes.

Method: PubMed, Embase and Cochrane were searched on January 18, 2024. Randomized controlled trials (RCTs) that used tirzepatide in overweight or obese adults without diabetes were included. Efficacy outcomes included the proportion of participants achieving weight loss targets, changes in body weight (%), body mass index (BMI), waist circumference (WC), and blood pressure (BP). Safety outcomes were commonly reported adverse events. Standardized mean differences (SMD) or odds ratios (OR) with 95% confidence intervals (CIs) were used for continuous and dichotomous outcomes, respectively.

Results: Three RCTs with 3901 participants were included. Tirzepatide was associated with increased proportion of participants achieving weight loss targets, reduced body weight (SMD - 1.61, 95% CI - 2.20 to - 1.02), BMI (SMD - 2.13, 95% CI - 3.08 to - 1.18), WC (SMD - 0.91, 95% CI - 1.14 to - 0.69), and BP versus placebo. However, the risk of adverse events such as nausea (OR 4.26, 95% CI 2.60 to 3.81), vomiting (OR 8.35, 95% CI 5.19 to 13.45), and diarrhea (OR 3.57, 95% CI 2.80 to 4.57) was significantly higher for tirzepatide versus placebo.

Conclusion: Tirzepatide significantly reduced weight and improved metabolic markers among overweight or obese without diabetes. However, increased adverse events highlights the need for benefits versus risks assessment before initiation and continuous monitoring.

Medicine shortages are an increasing issue, with broad public health implications for patients, health professionals and institutions. Despite national notification mechanisms involving sponsors and national regulators (e.g. Australian Therapeutic Goods Administration), shortages continue to be a significant workload in hospitals, particularly for pharmacy staff. In this article, we describe the implications of medicine shortages and a team approach to their management in an Australian public hospital. The medicine shortages team comprises senior pharmacists, a pharmacy technician, and a purchasing officer, in consultation with medical staff. A 10 week audit recorded 34 medicine shortages and/or discontinuations, comprising 49 usually stocked products. Shortages were more quickly identified by the purchasing officer using established relationships with suppliers, rather than relying on sponsor or government communication. Having a team systematically dealing with these shortages enables expertise in supply chains, finances, therapeutics, and medicine safety to be shared, to identify optimal interventions to mitigate patient risk.

Background: Anticholinergic medications are now widely acknowledged for their unfavorable risk-to-benefit profile owing to their adverse effects. Health-related quality of life (HRQoL) is commonly regarded as a crucial person-centered outcome.

Aim: This study aimed to investigate the association between anticholinergic burden and HRQoL in hospitalized and ambulatory patients seen in Ethiopia.

Method: This cross-sectional study utilized a questionnaire and medical records to collect data from a convenience sample of adult patients attending both inpatient wards and ambulatory clinic of University of Gondar Comprehensive Specialized Hospital between April and September 2022. Anticholinergic burden was measured by anticholinergic cognitive burdens scale (ACBS), while HRQoL was measured using EQ5D-index (Euroqol-5 dimensions-5-Levels index) and EQ5D-VAS (visual analogue scale). Linear regression was used to assess the influence of high anticholinergic burden (ACBS score ≥ 3) on EQ5D-index and EQ5D-VAS, with adjustments made for sociodemographic and clinical confounders.

Results: A total of 828 patients participated in this study (median (IQR) age was 45.0 (30, 60) and 55.9% were female). On multiple linear regression analysis, high anticholinergic burden was associated with a statistically significant decline in HRQoL, as evidenced by reductions in both EQ5D index (- 0.174 (- 0.250, - 0.098)) and EQ5D-VAS scores (- 9.4 (- 13.3, - 5.2)).

Conclusion: A significant association between high anticholinergic burden and diminished HRQoL was found among a relatively younger cohort in a resource-limited setting, even after adjustment for important confounding variables. Clinicians should be cognizant of the cumulative impact of anticholinergic burden on HRQoL outcomes and strive to minimize anticholinergic burden.

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: Monoclonal antibodies targeting calcitonin gene-related peptide (anti-CGRP mAbs) have shown clinical effectiveness and safety in randomized clinical studies. However, long-term studies in clinical practice remain limited.

Aim: To assess the long-term effectiveness, clinical predictors and safety of three anti-CGRP mAbs (erenumab, galcanezumab, fremanezumab) in resistant migraine patients.

Method: A single-center retrospective study was conducted from December 2019 to June 2023 involving 120 resistant migraine patients who received at least a month of anti-CGRP mAbs treatment. Patients completed a headache diary that included monthly acute medication intake (MAM), monthly migraine days (MMD), adverse events as well as completed Patient-Reported Outcome questionnaires (MIDAS [Migraine Disability Assessment] and Headache Impact Test 6 [HIT-6]). The number of patients achieving a ≥ 50% reduction in monthly migraine days was determined and classified as ≥ 50% responders, and baseline parameters and logistic regression between responders and non-responders were analyzed to identify potential predictors of response. Adverse events were registered in every follow-up.

Results: Treatment with anti-CGRP mAbs led to reductions in MIDAS, HIT-6, MMD and MAM from baseline to 6-24 months. At 6-12 months, responders (61% and 57%, respectively) exhibited lower baseline MMD and MAM. Medication overuse  was associated with non-responders from 6 to 24 months and it was identified as a negative predictor of treatment effectiveness (OR 0.23, 95% CI 0.07-0.74; p = 0.014).

Conclusion: Anti-CGRP mAbs prove effectiveness and safety over a 24-month period in a RM population. Patients with no medication overuse and lower basal MMDs and MAM may respond better to anti-CGRP mAbs.