Drug, Healthcare and Patient Safety最新文献

Background: Parental perceptions and concerns about vaccine safety and 'adverse effects following immunisation' (AEFI) are the reasons for vaccine hesitancy. This study aimed to understand how these vaccine-related concerns have become significant determinants of vaccine decision-making among non-vaccinating parents in the Alappuzha district of Kerala, India. The healthcare providers' views in this regard are also reported.

Methods: This is a qualitative study. In-depth interviews were conducted with informants from 110 households having non-immunised/partly-immunised children. In addition, 18 healthcare providers were interviewed. Thematic analysis using the reflective thematic method was carried out.

Results: Parents reported incidences of minor events of AEFI and are hesitant to continue vaccination in circumstances when children need medical treatment. AEFI incidents within the family have seriously hampered the trust in vaccines. Parents have concerns about multiple vaccinations and have misconceptions about the content of vaccines. Other concerns that lead to hesitancy are vaccine-related infertility, polio infection after polio vaccination and autism due to vaccination. Healthcare providers reported that there were no serious incidents that needed hospitalisation. Health workers opined that informing parents about AEFIs and preparing them is better.

Conclusion: The study reported that AEFIs are a barrier to vaccine acceptance. It warrants the need to build trust in vaccines and the vaccination process. Transparent communication with the beneficiaries is crucial. AEFI monitoring and reporting should be an essential component of efforts to minimise vaccination hesitancy.

Background: The 4th World Patient Safety Day (WPSD) 2024 commemoration in Uganda, themed "Improving Diagnosis for Patient Safety", highlighted critical challenges and opportunities in reducing diagnostic errors within healthcare systems. This review synthesizes key insights from the event, focusing on factors contributing to diagnostic inaccuracies, systemic gaps, and actionable strategies for improvement.

Methods: Using a qualitative synthesis approach guided by the Consolidated Criteria for Reporting Qualitative Research (COREQ), we analyzed data from a hybrid webinar (210 participants) and a four-day medical camp (600+ patients served). Thematic analysis identified four key areas: (i) factors influencing diagnostic errors, (ii) the role of laboratory and imaging services in diagnosis error prevention, (iii) existing health system interventions, and (iv) patient empowerment in the diagnostic process.

Results: Diagnostic errors in Uganda stem from cognitive biases, systemic inefficiencies (eg, understaffing, inadequate equipment), and financial barriers in private healthcare. Strengthening laboratory capacity, digitizing health records, and enhancing provider-patient communication emerged as pivotal solutions. The Ministry of Health's initiatives such as laboratory accreditation, the 5S quality improvement framework, and patient feedback mechanisms demonstrate progress but require scaling.

Recommendations: We propose a multi-level approach: (1) national policies for error reporting and patient safety frameworks, (2) expanded supportive supervision and digitization (eg, EHRs with decision support), (3) stricter regulation of private healthcare, and (4) community engagement to improve health literacy and early care-seeking.

Conclusion: Reducing diagnostic errors demands systemic reforms, technological integration, and collaborative stakeholder engagement. Uganda's WPSD 2024 insights offer a model for similar low-resource settings to enhance diagnostic accuracy and patient safety.

Purpose: To compare the impact of sodium-glucose cotransporter 2 inhibitor (SGLT2 inhibitor), glucagon-like peptide-1 receptor agonist (GLP-1 RA), with or without metformin, on out of pocket and total prescription expenditure and health-related quality of life (HRQoL) for patients with type 2 diabetes mellitus (T2DM).

Patients and methods: This observational study utilized 2017-2021 Medical Expenditure Panel Survey (MEPS) data from patients with T2DM (≥18 years) on SGLT2 inhibitor, GLP-1 RA, with or without metformin, from payer and self-perspective. HRQoL was assessed using physical (PCS) and mental component summary (MCS) scores based on Veterans Rand 12. This study estimated survey-weighed out-of-pocket (OOP) costs for prescription refills and total prescription expenditures. Propensity score matching was used to mitigate selection bias and health expenditures, and HRQoL were compared using the Mann-Whitney U-test. P-value thresholds were recalculated using Bonferroni adjustment (Total prescription expenditure or OOP, PCS, and MCS: p=0.017).

Results: Patients on GLP-1 RA alone had significantly higher OOP costs than those on SGLT2 inhibitor alone (median: $166.50 vs $81.00, p<0.01). No significant difference existed between the two treatments for total prescription expenditures (median: $9831.53vs. $9458.80, p=0.059), MCS (median:52.41 vs 53.48, p=0.40), or PCS (median: 45.22 vs 44.54, p=0.19). Patients on metformin with GLP-1 RA had higher OOP costs compared to those on SGLT2 inhibitor with metformin (median: $140.40 vs $107.33, p <0.01). There is a significant difference between the combination treatments for total prescription expenditure (median: $9453.96 vs $6711.47, p<0.01), MCS (median: 54.19 vs 54.30, p=0.70), or PCS (median: 45.69 vs 46.08, p=0.55).

Conclusion: Even though patients on GLP-1 RA have higher OOP costs, the difference in PCS or MCS scores between GLP-1 RA and SGLT2 inhibitor was not significant. Further investigation is needed to study the long-term impact on HRQoL and clinical outcomes.

Rhabdomyolysis is a pathophysiological process characterized by the destruction of muscle cells and the release of intracellular contents into the systemic circulation, which can lead to acute kidney injury (AKI) and failure. Causes are classified mainly as traumatic and non-traumatic, with statin-induced rhabdomyolysis being widely recognized. Other causes are seldomly reported, one being red yeast rice (RYR) or its active ingredient, monacolin K. We present a life-threatening case of fulminant rhabdomyolysis with severe hyperkalemia, accompanied by ECG changes, tetraparesis, impending compartment syndrome, and liver injury requiring intensive care treatment. Prompt renal replacement therapy was commenced, initially for the treatment of hyperkalemia and subsequently for myoglobin adsorption using the CytoSorb membrane. High doses of corticosteroids were administered as the trigger factor was initially unknown. The condition gradually improved, and the patient regained full functionality. The diagnosis of toxic rhabdomyolysis was confirmed only after the patient was discharged from the intensive care unit. An over-the-counter supplement containing red yeast rice (RYR) was identified as the sole possible triggering factor, with symptoms occurring two days after beginning the self-treatment.

Purpose: Vitamin B6 is a crucial water-soluble vitamin found in many foods and is involved in numerous physiological processes, including neurotransmitter synthesis and nervous system function. Although essential for overall health, both deficiency and excessive intake of vitamin B6 may lead to health complications, particularly peripheral neuropathy. This consensus statement aims to provide healthcare professionals with clear guidance on the safe and effective use of vitamin B6, focusing on its benefits, risks, recommended dosages, and treatment course.

Methods: This consensus statement was developed using a Delphi approach involving a panel of six experts from various medical specialties. This process includes a comprehensive literature review, two rounds of anonymous online surveys, and a virtual expert roundtable discussion. The GRADE approach was used to assess the quality of evidence for each recommendation.

Results: The expert panel reached consensus on five key statements. These key recommendations encompass the function of vitamin B6, complications due to vitamin B6 deficiency, dosage recommendations, adverse events, and monitoring guidance throughout the course of treatment. A washout period of 20-40 days for the complete clearance of vitamin B6 was calculated based on pharmacokinetic parameters. A clinical pathway for managing patients who might benefit from vitamin B6 treatment was proposed.

Conclusion: This consensus statement highlights the importance of recognizing the benefits and potential risks of vitamin B6. While the therapeutic dosage of vitamin B6 can be beneficial to treat deficiency, excessive intake can lead to adverse effects. This statement emphasizes the need for individualized patient care considering factors such as medical history, lifestyle, and potential drug interactions. Further research is needed to establish clearer dosage guidelines, understand the mechanisms of vitamin B6-induced neurological side effects, and optimize patient outcomes.

Background: The high prevalence of chronic diseases, workforce challenges, and growing polypharmacy adversely impact the quality use of medicines (QUM) and health outcomes in Saudi Arabia (SA). The SA Ministry of Health (MOH) has initiated several programs and policies to enhance QUM including a National Medication Safety Program, national clinical guidelines, and technology-based strategies.

Objective: To assess the published literature on the range, quality, and effectiveness of QUM methods in the SA health system.

Methods: Comprehensive search of electronic databases Scopus, Medline, and PubMed for papers reporting evaluation of QUM interventions or programs in SA.

Results: QUM programs involving medication reconciliation, interventions by hospital pharmacists, antibiotics stewardship, technology and staff training are the most commonly used programs reported in SA. Evaluations of several QUM interventions found a significant positive impact on health outcomes, prescribing patterns, chronic disease management, medication safety, and healthcare costs. Medication reconciliation programs reduced discrepancies by up to 20% in some studies. Hospital pharmacist interventions showed high acceptance rates (up to 92%) and improved medication safety. Antibiotic stewardship programs effectively reduced antimicrobial use and costs. Health information technology implementations like electronic health records (EHR), and computerized physician order entry (CPOE) showed mixed results but generally improved medication safety and efficiency. Staff training initiatives enhanced healthcare professionals' knowledge and skills in medication management.

Conclusion: While SA has national QUM policies and programs, and evidence that individual QUM interventions have significant positive local impact, more large-scale, multi-center studies are needed to provide a comprehensive view of QUM practices. More rigorous evaluations of existing programs and expansion of the range of QUM programs to align with international ones could further improve medication safety and patient outcomes in Saudi Arabia.

Background: Cholinesterase inhibitors (ChEIs) are recognized as first-line therapies for patients with mild-to-moderate dementia. However, there is limited comparative evidence regarding antipsychotic initiation risk among individual ChEIs to manage behavioral symptoms of dementia.

Objective: This study aims to evaluate and compare the risk of antipsychotic initiation among dementia patients prescribed individual ChEIs.

Methods: This is a retrospective cohort study using the 2009-2018 TriNetX electronic medical records data. Dementia patients aged over 60 years who were incident users of rivastigmine, donepezil, or galantamine with a 12-month washout period were included. Patients with a history of antipsychotic use during baseline and 30 days post-initiation of ChEIs were excluded. Patients were followed up to 12 months to identify the antipsychotic use. A generalized boosted model-based inverse probability treatment weights-adjusted Cox Proportional Hazard (CPH) model was applied to compare the risk of antipsychotic initiation across the different ChEIs.

Results: Among the 7,878 eligible dementia patients initiating ChEIs, 89.40% (n=7,043) were incident donepezil users, followed by 8.13% of (n=641) rivastigmine users, and 2.46% (n=194) galantamine users. During the 12-month follow-up, 807 patients (10.24%) initiated antipsychotics. The CPH model showed that rivastigmine users were at an increased risk of antipsychotic use compared to donepezil users (adjusted hazard ratio=1.45, 95% confidence interval: 1.11-1.88). No significant difference was observed in the risk of antipsychotic initiation between galantamine and donepezil users.

Conclusion: This study found that rivastigmine users were more likely to initiate antipsychotics compared to donepezil users, while no significant difference between galantamine and donepezil users was observed. These findings emphasize the importance of careful medication monitoring and management to prevent prescribing cascades and reduce related adverse effects in dementia patients.

Background: Respiratory failure (RF) after trauma is one of the major causes of patients being admitted to the ICU and leads to a high mortality rate. However, we cannot predict mortality rates based on patients' various indicators. The aim of this study is to develop and validate a nomogram for predicting mortality in patients in the intensive care unit (ICU).

Methods: A total of 377 patients from the Medical Information Mart for Intensive Care (MIMIC)-IV database were included in the study. All participants were systematically divided into a development cohort for modelling and a validation cohort for internal validation at a ratio of 7:3. Following patient admission, a comprehensive collection of 30 clinical indicators was performed. The least absolute shrinkage and selection operator (LASSO) regression technique was employed to discern pivotal risk factors. A multivariate Cox regression model was established, and a receiver operating curve (ROC) was plotted, and the area under the curve (AUC) was calculated. Furthermore, the decision curve analysis (DCA) was performed, and the nomogram was compared with the acute physiology score III (APSIII) and Oxford acute severity of illness score (OASIS) scoring systems to assess the net clinical benefit.

Results: The indicators included in our model were age, OASIS score, SAPS III score, respiratory rate (RR), blood urea nitrogen (BUN) and hematocrit. The results demonstrated that our model yielded satisfied performance on the development cohort and on internal validation. The calibration curve underscored a robust concordance between predicted and actual outcomes. The DCA showed a superior clinical utility of our model in contrast to previously reported scoring systems.

Conclusion: In summary, we devised a nomogram for predicting mortality during the ICU stay of RF patients following trauma and established a prediction model that facilitates clinical decision making. However, external validation is needed in the future.

Background: Fluoroquinolones (FQs) are among the most popular antimicrobials that are highly effective against various infections. Although FQs are the most frequently used and generally tolerated, there are issues with their safety. This study assessed the rate, severity, seriousness, outcomes, and types of FQs adverse drug reactions (ADRs) in reports submitted to a regional spontaneous ADR database.

Methods: This was a retrospective cross-sectional observational study involving all patients with reported ADRs related to FQs or other antibiotics (ABs) that were submitted to the Regional Pharmacovigilance Center (PVC) database between January 2019 and December 2022. Data were extracted in the form of Saudi ADR from the PVC database, which is consistent with the MedWatch ADR form of the U.S Food and Drug Authority (FDA).

Results: In total, 605 ADRs related to antibiotic use were reported. ADRs caused by FQs use were the most frequently reported (177; 29.3%), followed by penicillin (100; 23.4%) and cephalosporin (90; 21%). There was no significant difference in ADRs caused by FQs between men (104; 58%) and women (OR 1.17, 95% CI 0.82-1.67, p=0.386). FQ-related ADRs were more frequent among those over 40 years-old (OR 1.56, 95% CI 1.09-2.22, p=0.015). Most of the detected FQ-related ADRs were of moderate severity (157; 88.7%), required interventions (83; 46.9%), and recovered after receiving medical interventions (154; 87%). Patients who received FQs were fourfold more likely to experience neurological adverse events (OR 4.15, 95% CI 2.48-6.93, p <0.001).

Conclusion: The FQs drug class exhibited a higher incidence of ADRs than other ABs. Regularly assessing the safety of ABs is crucial to improve public and healthcare providers' awareness of the correct utilization of ABs and to limit the use of FQs to infections that cannot be effectively managed with alternative ABs.

Objective: This review summarized the real-world effectiveness outcomes of Janus kinase inhibitors (JAKi) for rheumatoid arthritis (RA) based on observational studies.

Methods: A systematic review followed PRISMA guidelines, with searches conducted in PubMed, Embase, and CINAHL from each database's inception to June 2, 2023. Studies were included if they evaluated real-world effectiveness outcomes of JAKi for US RA patients. Search terms included "RA", "JAKi", and "real-world". All citations were imported into COVIDENCE platform. Two reviewers independently performed title/abstract screening and full-text eligibility. For each article, study characteristics and effectiveness measures focusing on treatment pattern, clinical response, and patient-reported outcomes (PROs) of JAKi were extracted. Newcastle-Ottawa Scale (NOS) was utilized to assess the quality of the included articles.

Results: In total, 35 studies representing 252-30,556 patients were included. A majority used the administrative claims datasets (n=23, 65.71%), followed by 9 studies using electronic medical record (EMR) data and 3 studies using patient registry databases. Across claims-based studies, adherence, persistence, and effectiveness of JAKi were common outcomes. Adherence rates varied, with a proportion of days covered (PDC) ranging from 0.53 to 0.83 across 11 studies. Persistence of JAKi in RA patients was reported in 14 studies, where the median persistence time in treatment was reported to be between 121-516 days. Six studies applied effectiveness algorithms, with 14.8-26% of patients meeting effective treatment criteria. In addition, the most common measure of clinical response throughout the studies was Clinical Disease Activity Index (CDAI), with 10 articles reporting mean CDAI changes between -4.7 and 5.1. Across 12 studies that measured the PROs, the most prevalent PRO was pain, with the mean change in pain ranging from -9.3 to 8.9 across these studies.

Conclusion: Real-world studies on JAKi for RA reflect a range of effectiveness measures, illustrating the expanding role of JAKi in clinical practice.