Therapeutic Advances in Drug Safety最新文献

Background: Inappropriate medication prescribing in older patients increases the risk of poorer health outcomes and increased costs. The IMMENSE trial, integrated a clinical pharmacist into the health care team, to improve medication therapy among older patients, and to investigate the impact on acute revisits to hospital.

Objectives: This study investigated the prevalence of potentially inappropriate medications (PIMs) and prescribing omissions (PPOs) at hospital admission and discharge. It also explored the impact of the pharmacist intervention on PIMs and PPOs, and other factors associated with PIMs and PPOs at discharge.

Design: The STOPP/START criteria version 2 were retrospectively applied at admission and discharge. PIM and PPO changes were compared, and Poisson regression was used to assess factors influencing prevalence at discharge.

Results: At hospital admission, PIM prevalence was 58.6% among intervention patients and 64.8% among control patients. PPO prevalence was 55.3% and 55.5%, respectively. A larger proportion of PIMs identified at admission were resolved by discharge in the intervention group (42.9%) compared to the control group (27.4%). No difference was seen for PPOs. Poisson regression identified a significantly higher risk for PIMs at discharge in the control group compared to the intervention group (IRR 1.255; 95% CI 1.063-1.480, p = 0.007), but no effect for PPOs. Patients living in a nursing home, a home care facility, or an institution showed a higher risk of PPOs at discharge compared to patients living at home (IRR 1.378; 95% CI 1.156-1.644, p < 0.001).

Conclusion: The IMMENSE intervention significantly reduced the risk of PIMs at discharge, with no effect on PPOs. Living in nursing homes, home care facilities, or institutions prior to hospitalization increased the risk of PPOs at discharge. Pharmacists may contribute to improved medication appropriateness in older hospitalized patients.

Background: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem. Since its inception in the 1960s, PV has undergone continuous evolution, progressing from a basic level mainly focused on the collection and analysis of cases in its earliest years to a complex system regulated by rigorous standards and laws with modern PV. In recent years, PV has faced the challenge of adapting to rapid scientific advancements, the complexity of the pharma industry, and the digital revolution. To better understand the current state and future developments of PV within pharma companies, the PV working group "Ernesto Montagna" of the Italian Society of Pharmaceutical Medicine (SIMeF ETS) conducted a national survey in Italy.

Objectives: The main objective of this survey was to explore the current state and future developments of PV within Pharmaceutical Companies in Italy.

Design: This study was designed as a national survey targeting members of the Italian Society of Pharmaceutical Medicine (SIMeF ETS).

Methods: The survey utilized computer-assisted web interview (CAWI) technology to collect data from SIMeF members across affiliate and corporate companies, aiming to explore expectations for PV. A simplified version of the questionnaire was also sent to members of the Clinical Research and Medical Affairs (RICMA) and Real-World Evidence working groups of SIMeF to gather input from RICMA professionals regarding the role of PV in pharma companies.

Results: The survey revealed that PV in pharma companies is undergoing a transformation, with the potential for greater strategic alignment with business objectives and stakeholder focus. However, there is still room for improvement, particularly in terms of perception within other company departments. It is evident that PV's evolution has only just begun.

Conclusion: A critical factor in the evolution of PV is the adoption of a holistic and comprehensive approach to activities and processes. Scientific associations such as SIMeF can play a valuable role in cultivating new skills and capabilities among PV professionals, assisting, and supporting this change.

Background: Outpatient hysteroscopic surgery requires patients to be anaesthetised and recover quickly, and the drugs used must be safe and effective. Remifentanil is typically co-administered with propofol as total intravenous anaesthesia (TIVA) for hysteroscopy because of its favourable pharmacokinetic and pharmacodynamic properties. However, the optimal dose of remifentanil when co-administered with propofol without neuromuscular blocking agents (NMBAs) has not been established.

Objectives: In this sequential dose-finding study, the 90% effective dose (ED90) of remifentanil effect-site concentration (Ce) combined with propofol without NMBAs during outpatient hysteroscopy was calculated to minimise the side effects of using higher doses.

Design: This sequential dose-finding study was conducted in August 2022.

Methods: Forty patients who underwent outpatient hysteroscopy under TIVA were included in the study. With a biased coin up-and-down design, the initial remifentanil Ce was established at 2 ng/mL, and the subsequent remifentanil dosage was determined based on the reaction of the previous patient. The primary outcome was a remifentanil Ce that resulted in successful TIVA by maintaining a Narcotrend index < 60, surgical pleth index (SPI) < 50, and without patient movement throughout hysteroscopy. Secondary outcomes included rates of hypotension-related symptoms and interventions, drug consumption, post-anaesthesia care unit (PACU)-estimated visual analogue scale (VAS) and Ramsay sedation scores, modified Aldrete scores, and other adverse effects of anaesthesia. The ED90 and 95% confidence intervals (CI) were estimated using isotonic regression methods and bootstrapping.

Results: For TIVA without NMBAs during outpatient hysteroscopy, the ED90 Ce of remifentanil combined with propofol was determined to be 2.75 ng/mL (95% CI, 2.50-3.00 ng/mL). The incidence of peri-operative adverse effects of anaesthesia was relatively low. All the patients had satisfactory VAS, Ramsay sedation, and modified Aldrete scores in the PACU.

Conclusion: Remifentanil at a Ce of 2.75 ng/mL is recommended for TIVA combined with propofol in outpatient hysteroscopic surgery.

Trial registration: http://www.chictr.org.cn (ChiCTR2200062284; 31/7/2022).

Background: The administration of either alfentanil or sufentanil as a single injection, combined with target-controlled infusion (TCI) of propofol, represents a frequently employed anesthetic regimen for daytime hysteroscopy.

Objectives: This study was designed to evaluate and compare the safety and efficacy of alfentanil and sufentanil in the context of daytime hysteroscopy.

Design: A total of 160 patients, scheduled for daytime hysteroscopy, were randomly allocated into two groups: Group A and Group S respectively received alfentanil 10 μg/kg or sufentanil 0.15 μg/kg as a single intravenous injection. Both groups were given propofol with TCI for sedation.

Methods: Monitoring of vital signs was conducted from pre-anesthesia through to 2 h postoperatively. The primary outcome measured was hypoxemia, defined as SpO₂ levels below 92% for a duration of 30 s, which necessitated manual positive pressure ventilation. Secondary outcomes included various perioperative complications, such as postoperative nausea and vomiting (PONV) occurring 2 h after surgery, as well as hemodynamic indicators, NRS scores for pain, and other anesthesia-related data. This comprehensive dataset was meticulously documented and subsequently analyzed for comparative purposes.

Results: The analyses revealed that Group A had a significantly lower incidence of hypoxemia (p = 0.002) and PONV (p = 0.021). Additionally, group A demonstrated overall more stable blood pressure and heart rate, as well as higher SpO₂ levels.

Conclusion: For daytime hysteroscopy, alfentanil at a dose of 10 μg/kg is safer than sufentanil at a dose of 0.15 μg/kg when combined with propofol TCI.

Trial registration: This study was registered with the Chinese Clinical Trial Registry (The URL of registration is https://www.chictr.org.cn/showproj.html?proj=177784; registration number: ChiCTR2200063939). The date of first registration was September 21, 2022.

Background: Self-treatment of dietary supplements may contribute to interactions and severe side effects. Limited studies have constructed a scale that can measure the disclosure practice of supplements to healthcare providers and the influencing factors.

Objective: The study aims to investigate the supplement disclosure practice among the public in the UAE using a developed and validated supplement disclosure assessment scale tool.

Design: A cross-sectional survey study that targeted those residing in the United Arab Emirates (UAE) aged 18 years and above from both genders through an online survey.

Methods: A novel scale tool was developed and examined for its validity and reliability through three pilot studies.

Results: The study included three validity and reliability pilot studies before the main study evaluation: pilot 1 (n = 104), pilot 2 (n = 101), pilot 3 (n = 37), and study data (n = 407). A total of 407 respondents provided feedback from which 137 stated that they consumed supplements. A significant indirect effect of healthcare provider initiation of enquiry (HPE) on patient-informing practice (PI) was observed through two mediating variables, patient's beliefs (PB) and pharmacist counseling regarding supplements interactions (PC) (B = 0.106, t = 2.120, p = 0.03 and B = 0.077, t = 2.011, p = 0.04, respectively). Most respondents were not asked about their supplement consumption by the hospital and community pharmacists (52.94 and 50.74, respectively). Most respondents (54.89%) stated that pharmacists did not counsel them about any possible interaction of supplements with laboratory tests. The mean construct scores were 1.096 for PI, 2.618 for PC, 1.552 for HPE, and 1.412 for PB.

Conclusion: The instrument demonstrates desirable validity and reliability. The study results revealed a direct effect of PB and PC on the supplement disclosure practice. HPE indirectly affected PI through two mediating variables: PB and PC. The results showed a moderate HPE and PC and an excellent PB and PI construct.

Background: As prostaglandin medications, crucial in glaucoma treatment, become more widely used, their local adverse events are increasingly observed.

Objectives: To evaluate the common adverse events of four clinically commonly used prostaglandin F (FP) receptor agonists in the treatment of glaucoma in the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Design: We screened and analyzed the generic and brand names of latanoprost, bimatoprost, travoprost, and tafluprost in the FAERS database and summarized and cleaned the baseline information of subjects receiving the above-mentioned drugs.

Methods: Perform descriptive statistical analysis on the baseline information of subjects using the drugs. Conduct disproportionality analysis of drug-related adverse events. The criteria for positive signals of adverse events are established by simultaneously meeting the thresholds set by four methods: the ratio of reported odds, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Additionally, assess the cumulative risk curves for drug-induced time of the aforementioned drugs and use one-way ANOVA to compare differences in drug-induced time across different groups.

Results: The study included 1567 latanoprost, 1517 bimatoprost, 696 travoprost, and 82 tafluprost subjects. Adverse events mainly affected eye disorders, with significant issues in iris hyperpigmentation, ocular pemphigoid, corneal endothelial cell loss, periorbital fat atrophy, corneal irritation, eyelash growth, and ocular hyperemia. The time to onset varied among drugs, with latanoprost showing the longest (mean days = 344.37) and bimatoprost the shortest duration (mean days = 155.65; p < 0.001).

Conclusion: Although signal detection analysis based on the FAERS database cannot establish a definitive causal relationship, our study found that FP receptor agonists used in glaucoma can cause various adverse events. Assessing their clinical suitability and potential side effects is crucial for providing personalized treatment and ensuring medication safety.

Background: Deprescription of medications for older people in long-term care settings is crucial to enhance medication safety by reducing polypharmacy and minimizing related adverse events. Nurses as the member of the multidisciplinary healthcare team can support deprescription initiatives, but there is a gap in comprehensive knowledge about their roles.

Objectives: To investigate the role and contribution of nurses in deprescribing medications within the multidisciplinary pharmaceutical care context of long-term healthcare for older people.

Design: A systematic review utilizing an integrative approach was performed.

Methods: Multiple databases were searched, including PubMed (covering MEDLINE), Scopus, CINAHL, ProQuest and Embase, focusing on studies published in English from 2014 to 2024. The preliminary search yielded 4872 studies, which were then refined to 32 qualitative and quantitative studies chosen for data analysis and narrative synthesis. Thematic comparisons and analysis led to the creation of meaningful categories integrating the studies' findings to meet the review's objective.

Results: The review findings were classified into categories: 'necessity and benefits of deprescribing', 'multidisciplinary collaboration for deprescribing', 'nurse role in deprescribing', 'identified challenges to deprescribing', 'involvement of older people and families in deprescribing'. They illustrated and exemplified various aspects of nurses' roles and contributions in deprescription initiatives within the multidisciplinary pharmaceutical care team, such as support for reducing doses, discontinuing medications or transitioning to safer alternatives, as well as factors influencing this process.

Conclusion: The main dimensions of nurses' roles and contributions in deprescription initiatives encompass monitoring, communicating and educating. Challenges to nurses' active participation in deprescribing, such as the need for increased knowledge, confidence and inclusion in team discussions, should be addressed through education, training and changing attitudes. These steps are essential for improving the safety of medication deprescribing in long-term care settings.

Trial registration: The review was registered under PROSPERO ID: CRD42023486484, and can be accessed at crd.york.ac.uk/PROSPERO/display_record.php?RecordID=486484.

Background: Closed-loop electronic medication management systems are effective measures for preventing medication errors (MEs). However, there is limited evidence supporting this, and few studies have evaluated the long-term effects of these systems on safe medication.

Objective: To evaluate the long-term effects of implementing a closed-loop medication order executive system on the safe clinical use of medications.

Design: A quasi-experimental design.

Method: Data from 2017 to 2023 were extracted and retrospectively analyzed. The primary outcome indicator was the ME rate. Secondary outcome indicators were the accuracy of order verification and patient identification and the implementation rate of fresh medicine dispensing. The autoregressive integrated moving average (ARIMA) model in time-series analysis was used to evaluate the level and trend changes in ME rates using SPSS 25.0 before and after system implementation. Root cause analysis and descriptive statistics were used to assess changes in types, stages, and causes of ME rates. The independent samples t-test was used to analyze secondary outcomes.

Results: Overall, 295 MEs were reported with a mean of 0.26 ± 0.26 ME rates per month during 2017-2023. The ARIMA model showed a decrease in the average level of ME rates after system implementation, with no statistically significant decrease in the long term, and a significant drop in the ME rate in the short and medium term (p < 0.01). Nurses' administration accounted for more than 60% of errors post-implementation, and lack of communication was a prominent factor. The accuracy of order verification and patient identification and the implementation rate of fresh medicine dispensing all increased after implementation.

Conclusion: Adopting a closed-loop executive system is beneficial for ensuring patient medication safety, but a single integrated system does not completely eliminate MEs. Optimizing system functionalities and applying structured handoff tools are recommended to meet clinical needs and enhance system usability.

Background: Adverse drug reactions (ADRs) contribute significant clinical and economic burden to the country's healthcare system globally. Prompt reporting of ADRs by the community pharmacist is essential to the active pharmacovigilance program.

Objectives: This study assesses private community pharmacists' knowledge, attitude, and practice (KAP) about ADRs and reporting.

Design: A cross-sectional, qualitative study was performed using a pre-validated self-administered questionnaire.

Methods: This self-administered questionnaire was conducted at community pharmacies between March and July 2022. The data collected were analyzed using the Mann-Whitney and Kruskal-Wallis tests to examine the differences in overall KAP scores with a subgroup of sociodemographic characteristics of the study participants. Logistic regression analysis was used to analyze the predictors of practice.

Results: In total, 156 fully completed questionnaires were collected by the community pharmacists. A positive association between the designation, qualification, and work experience with the total scores of the respondents was observed (p < 0.05). Among the predictors of ADR reporting practice, a significant association was observed with knowledge score (⩾6, p = 0.0219), designation (pharmacists, p = 0.0102), qualification (masters, p = 0.0002), and work experience (⩾11 years, p = 0.0184). Most community pharmacists had good knowledge and attitude but poor practice toward reporting ADRs. Uncertainty of how and where to report, lack of training, lack of reporting forms, and insufficient clinical knowledge were the practice-based barriers in the ADR reporting process.

Conclusion: Though the study found sufficient understanding and favorable views on ADR reporting, participants reported poor practices and barriers to reporting ADR. Therefore, structured continuing professional development programs for community pharmacists are needed to overcome the barriers and enhance the practice of ADR reporting.