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Background: Medications are commonly found in every household. In Syria, where healthcare infrastructure faces significant challenges, improper storage can lead to reduced medication efficacy and increased health risks. Additionally, inappropriate disposal practices pose serious environmental concerns, especially in a region already grappling with environmental degradation. This study aimed to evaluate the knowledge, and practices of Syrian individuals regarding the appropriate storage and disposal of home medications. Method: A cross-sectional study was conducted from September 22 to October 20, 2023, using an online survey distributed via social media apps (WhatsApp, Facebook, and Telegram) in Syria. The questionnaire, adapted from a similar study in Saudi Arabia, was translated to Arabic using the forward–backward translation technique. A convenience sampling technique was used. Inclusion criteria were participants over eighteen with expired or unused medications at home. Descriptive statistics, Chi-square tests, and binary logistic regression analysis were performed using SPSS version 27, with statistical significance defined as p < 0.05. Results: A total of 2,217 responses were analyzed, with the majority of participants being female (79%) and aged between 21–30 years (56%). The study found that 90.7% of respondents dispose of expired medications in the garbage, while 95% keep medications in their original containers. Additionally, 30% consult pharmacists for storage instructions, and 64% read storage information on medication leaflets. Logistic regression analysis revealed that males were less likely to check expiration dates before use (OR: 0.58, 95% CI: 0.40–0.84) and periodically (OR: 0.68, 95% CI: 0.54–0.85). Participants aged 31–40 years were less likely to check expiration dates periodically (OR: 0.46, 95% CI: 0.31–0.68), while those with children under six years old were more likely to do so (OR: 1.29, 95% CI: 1.01–1.67). Males were also less likely to read storage instructions (OR: 0.61, 95% CI: 0.50–0.76) but more likely to ask pharmacists about them (OR: 1.26, 95% CI: 1.01–1.57). There was no significant difference in these practices between medical professionals and the general population. Conclusion: This study reveals gaps in the practices related to the storage and disposal of medications among the Syrian public. The findings suggest a need for targeted public education and awareness programs to improve these practices and reduce the associated health and environmental risks. [ABSTRACT FROM AUTHOR]

Purpose Manipulation of tablet medications to produce a customized dose is common practice, and splitting tablets may reduce the acquisition cost of the medication. However, cost savings may be diminished by the cost of the increased labor and repackaging materials needed when splitting tablets. Splitting tablets may also result in safety concerns if the final products are under (eg, reduced benefit) or over (eg, toxicity) the desired dosage. The purpose of this quality improvement project was to evaluate and recommend changes for all half- and quarter-tablet medications prepared and distributed from the inpatient pharmacy at University of Utah Health (U of U Health). Summary The evaluation included all half- and quarter-tablet medications prepared by pharmacy technicians for administration to patients admitted to U of U Health hospitals. A final list of 173 half- and quarter-tablet dosages was evaluated for opportunities to decrease the total number. On the basis of the developed criteria, 93 half- and quarter-tablet dosages (54%) were recommended to be removed from routine stock in the inpatient pharmacy. Systems remain in place to create customized half and quarter tablets if required for patient care. Conclusion Reducing the number of medications for which half and quarter tablets are used may allow pharmacy technicians to prioritize other patient care tasks and potentially decrease waste. [ABSTRACT FROM AUTHOR]

Objectives: To update an evidence base informing the 2024 Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis (RA) in older adults. Methods: Four clinical questions (CQs) regarding efficacy and safety of drug treatment were evaluated, with CQ1 addressing methotrexate (MTX), CQ2 biological disease-modifying antirheumatic drugs, CQ3 Janus kinase (JAK) inhibitors, and CQ4 glucocorticoids (GCs). Quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system. Results: Observational studies confirmed a pivotal role of methotrexate in the treatment of older RA patients. The meta-analysis showed that tumour necrosis factor inhibitors and JAK inhibitors were unequivocally effective in older RA patients. No data indicated that biological disease-modifying antirheumatic drugs were unsafe for older patients. No safety data for JAK inhibitor use in older patients were available. One randomized controlled trial demonstrated that long-term treatment with low-dose GCs increased risks of GC-associated adverse events. The certainty of overall evidence was very low for all CQs. Conclusions: This systematic review provides the necessary evidence for developing 2024 Japan College of Rheumatology clinical practice guidelines for managing older patients with RA. Continued updates on the evidence of JAK inhibitors and GC are desired. [ABSTRACT FROM AUTHOR]

Purpose In high-acuity situations such as cardiac arrest, clinicians rely on prepared medications stocked in code carts to provide timely and accurate pharmacotherapy. We examined shortage trends for medications commonly used in code carts. Methods Drug shortage data from 2001 to 2022 were retrieved from the University of Utah Drug Information Service (UUDIS) to characterize shortages reported for commonly used code cart medications. Data extracted included the number of shortages, shortage duration, drug characteristics, and reason for the shortage. Results From 2001 to 2022, 71 drug shortages for code cart medications were reported. The number of new shortages peaked in 2010, and the number of total shortages peaked in 2010. At the end of the study period, 61 (84.7%) shortages had been resolved. For resolved shortages, the mean shortage duration was 18.2 months. The drug with the greatest number of reported shortages was dextrose (10 total), the drug with the longest resolved shortage was calcium chloride injection (116 months), and the drug with the longest active shortage was atropine injection (165 months at the end of the study period). Throughout the entire study period, only 2 suppliers provided commercially available prefilled syringes of dextrose for stocking on code carts. The most common reason for shortages, when reported, was manufacturing delays. Conclusion Medications commonly used in code carts were frequently impacted by drug shortages, which have the potential to impact patient care. Institutional protocols for mitigation and larger efforts to promote a more resilient drug supply chain are critical to ensure patient safety and quality care. [ABSTRACT FROM AUTHOR]

Since the FDA's approval of rasburicase use for treatment of tumor lysis syndrome (TLS), multiple cases of rasburicase-induced methemoglobinemia and hemolytic anemia have been reported among patients with G6PD deficiency. This study aims to provide a systematic review of cases reporting such adverse reactions to rasburicase. A literature review of published cases in PubMed, Embase, Cochrane, and Web of Science was conducted. Descriptive studies reporting cases of rasburicase-induced methemoglobinemia and/or hemolytic anemia in English were analyzed and summarized in this study. Forty-three cases, including a case from our institution, were included in this study. Most cases (60.5%) received rasburicase for TLS treatment. Almost all patients (93.8%) were tested for G6PD after rasburicase administration. The median time to symptom onset was 24 h. The median methemoglobin level was 10%, peaking after a median of 24 h. The median hemoglobin nadir was 6.1 g/dL, and most patients (n = 32) required blood transfusion. Out of 39 cases with reported outcomes, 35 patients (89.7%) recovered, while four patients (three females and one male) died. The median time to recovery was 4.5 days while the median time to death was 8 days. Screening for G6PD deficiency among high-risk patients is important but not practical in acutely severe settings. When prior screening for G6PD deficiency is not feasible, close monitoring for methemoglobinemia and hemolytic anemia is recommended. Exchange transfusion is increasingly reported as a potentially successful therapeutic modality. Ascorbic acid may provide limited benefits. Methylene blue should be avoided as it may exacerbate hemolysis among these patients. [ABSTRACT FROM AUTHOR]

Background: Third-generation antiseizure medications, such as brivaracetam, are recognized for their superior safety, tolerability, and pharmacokinetic profiles. However, their potential benefits are often limited in low-income populations because of challenges related to availability and affordability. Objective: We aimed to evaluate the effectiveness and safety of brivaracetam for treating epilepsy in a low-income population, within a real-world setting. Methods: This retrospective cohort study included individuals with epilepsy from a low-income population in Bogotá, Colombia, who were treated with brivaracetam between January 2020 and July 2023. Effectiveness (mean seizure reduction and ≥ 50% seizure reduction) and safety (retention rate and adverse events) were evaluated. Results: A total of 106 individuals were included, with a median age of 33 years (interquartile range: 24–44). Most had focal epilepsy with a median disease duration of 25.4 years (standard deviation: 13.6). The baseline seizure frequency was 4 seizures per month (interquartile range: 2–15) and individuals had previously received a mean of 4.4 (standard deviation: 1.8) antiseizure medications. The mean percentage seizure reduction at 3, 6, and 12 months was 55.3%, 66.9%, and 63.8%, respectively. Additionally, 60%, 63.8%, and 65.9% of individuals achieved a ≥ 50% seizure reduction at 3, 6, and 12 months, respectively. Retention rate at 3 months was 89% (n = 95) and 18.7% (n = 20) reported adverse effects. Conclusions: In a real-world setting, brivaracetam has been shown to be safe and effective for the treatment of epilepsy in individuals from a low-income population. This study suggests that people with epilepsy living in this context can significantly benefit from the use of third-generation antiseizure medications. [ABSTRACT FROM AUTHOR]

Pharmaceutical safety has received increasing attention from governments and corporations, and building a safe and effective pharmaceutical cold supply chain network has become an important issue. This paper proposes a two‐stage pharmaceutical cold supply chain network design problem considering drug safety, in which the drug demand, transportation costs, and drug safety risk costs are assumed to be random variables. Due to the presence of uncertainty and the fact that information about the distribution of uncertain parameters is often only partially known, a distributionally robust optimization method is used to handle the uncertainty. A two‐stage distributionally robust optimization model is constructed, in which the reliability of the estimation of the demand necessary to satisfy the entire cold chain network is ensured to be greater than a certain predetermined level by introducing an ambiguous joint chance constraint. The decision process for the problem can be divided into strategic and operational decisions with the goal of minimizing the total costs related to facility construction, the purchase of raw materials, drug production, transportation, and safety risks. By introducing an ambiguity set with mean and covariance information to describe the uncertain parameters, the two‐stage model is eventually reformulated as a standard second‐order cone program, thus making it computationally tractable. Finally, numerical experiments are presented to demonstrate the effectiveness of the proposed models and optimization methods. [ABSTRACT FROM AUTHOR]

Background: Despite their frequent concurrent use, little is known about the concomitant use of calcium channel blockers (CCBs) and selective serotonin reuptake inhibitors (SSRIs) on fracture risk. We compared risk of fractures in patients concomitantly treated with CCBs and SSRIs versus CCB-only users. We compared risk of fractures among concomitant CCB-SSRI users initiating cytochrome P450 3A4 (CYP3A4)-inhibiting SSRIs versus non–CYP3A4 inhibiting SSRIs. Methods: This retrospective cohort study used IBM MarketScan commercial claims and Medicare Supplemental database (2007-2019). We included adults diagnosed with hypertension and depression, newly initiating SSRIs while being treated with CCBs (ie, concomitant CCB-SSRI users) and those who did not (ie, CCB-only users). Primary outcome was the first occurrence of any fracture. We used stabilized inverse probability of treatment weighting (sIPTW) based on propensity scores to balance baseline risk between groups. Cox proportional hazard regression modeling was used to compare fracture risk. Results: We identified 191 352 concomitant CCB-SSRI and 956 760 CCB-only users (mean age = 56 years, 50.1% males). After sIPTW, compared with CCB-only users, CCBs-SSRIs users had a higher risk of fractures (hazard ratio [HR]: 1.43, 95% confidence interval [CI]: 1.22-1.66). No difference in the risk of fractures between concomitant users of CCB-CYP3A4-inhibiting SSRIs and those of CCB-non–CYP3A4 inhibiting SSRIs (HR: 1.10, 95% CI: 0.87-1.40) was observed. Conclusion and Relevance: Short-term concomitant CCB-SSRI use was associated with increased fracture risk. Concomitant CCBs and CYP3A4-inhibiting SSRIs compared with CCBs and non–CYP3A4 inhibiting SSRIs use was not associated with increased risk. [ABSTRACT FROM AUTHOR]

Ensuring the safety of drugs is a critical aspect of healthcare. Accurate interpretation of drug safety evidence is vital to understand the safety profile and to evaluate the benefits and risks of the medicinal product. However, validity of this evidence has numerous challenges that must be carefully considered, highlighting the need for a heightened appreciation of data interpretation pitfalls. This paper aims to delve into the intricacies of analytic considerations in drug safety data interpretation aiming at providing insights into the safety profile of pharmaceutical interventions. The applicability of these analytic considerations extends to controlled and observational data as well as spontaneously reported individual case reports. Increasing the understanding of scientific underpinnings of evidence interpretation empowers Pharmacovigilance professionals to grasp fundamental concepts, use appropriate terminology, engage in meaningful discussions with colleagues conducting analyses, and critically evaluate evidence. These skills and knowledge enable them to make informed decisions and enhance their expertise in drug safety. By correct utilization of analytic approaches while appreciating their strengths and limitations, one can advance drug safety and benefit-risk research using evidence-based decisionmaking and ultimately ensure better healthcare outcomes for patients. [ABSTRACT FROM AUTHOR]

The process of drug discovery and pre‐clinical testing is currently inefficient, expensive, and time‐consuming. Most importantly, the success rate is unsatisfactory, as only a small percentage of tested drugs are made available to oncological patients. This is largely due to the lack of reliable models that accurately predict drug efficacy and safety. Even animal models often fail to replicate human‐specific pathologies and human body's complexity. These factors, along with ethical concerns regarding animal use, urge the development of suitable human‐relevant, translational in vitro models. [ABSTRACT FROM AUTHOR]

Background: Physiological changes in pregnancy may affect drug safety and efficacy, sometimes requiring dose adjustments. Pregnancy-adjusted doses, however, are missing for most medications. Increasingly, pharmacokinetic models can be used for antenatal dose finding. Given the novelty of this technique and questions regarding dose credibility, the acceptability of model-informed antenatal doses should be explored. Objective: We aimed to assess the willingness-to-use and preferred features for model-informed antenatal doses among healthcare practitioners (HCPs) and pregnant women in European countries. Methods: A cross-sectional, web-based study drawing on two open surveys was performed between 8 September and 30 November 2022. Each survey comprised statements drawn from prior focus groups, associated with Likert- scales. Themes included respondents' information needs, search behaviours along with their willingness-to-use and preferred features for model-informed antenatal doses. The surveys were disseminated through professional societies, pregnancy websites and social media. A descriptive analysis was performed. Results: In total, 608 HCPs from different specialties and 794 pregnant women across 15 countries participated, with 81% of respondents across both groups in the Netherlands or Belgium. Among pregnant women, 31% were medical professionals and 85% used medication during pregnancy. Eighty-three percent of HCPs found current antenatal pharmacotherapy suboptimal and 97% believed that model-informed antenatal doses would enhance the quality of antenatal care. Most HCPs (93%) and pregnant women (75%) would be willing to follow model-informed antenatal doses. Most HCPs desired access to the evidence (88%), including from pharmacokinetic modelling (62%). Most pregnant women (96%) wanted to understand antenatal dosing rationales and to be involved in dosing decisions (97%). Conclusion: Thewillingness-to-usemodel-informed antenatal doses is high among HCPs and pregnant women provided that certain information needs are met. [ABSTRACT FROM AUTHOR]

Introduction: The sustainable implementation of socially assistive robots in a pharmacy setting requires that customers trust the robot. Our aim was to explore young adults' anticipations of and motives for trusting robot medication counseling in a high-stakes scenario. Methods: Through a co-creation approach, we co-designed a prototype application for the Furhat platform together with young adults. In-lab testing of a pharmacy scenario, where the robot provides medication counseling related to emergency contraceptive pills, was conducted to deepen our understanding of some factors driving young adults' initial trust establishment and anticipations of interacting with a robot in a high-stakes scenario. Qualitative data from interviews with six study participants were analyzed using inductive, reflexive thematic analysis and are presented through a narrative approach. Results: We outline five tales of trust characterized by personas. A continuum of different anticipations for consulting a robot in medication counseling is presented, ranging from low to high expectations of use. Driving factors in the initial trust establishment process are position, autonomy, boundaries, shame, gaze, and alignment. Discussion: The article adds to the understanding of the dimensions of the multifaceted trust concept, of driving trust factors, and of the subsequent anticipation to trust robots in a high-stakes pharmacy context. [ABSTRACT FROM AUTHOR]

Older adults are at risk of adverse drug events during transition of care from hospital to community, thus optimal communication about medications at discharge is essential. Standardization of medication discharge plan (MDP) is lacking. This study aimed to (1) create a standardized MDP for older adults using consensus‐based principles, (2) create a short‐version MDP and (3) generate a practical guide. Modified Delphi was used to establish consensus on guiding principles for the MDP. Additionally, participants were asked about guiding principles deemed most essential, patient prioritization, the format and mode of transmission of the MDP. Twenty‐six guiding principles reached consensus, with 17 prioritized for a short‐version MDP. The practical guide includes explanations of the guiding principles, criteria for patient selection and recommendations on the format and mode of transmission. The results of this study will assist implementation of MDPs when older adults are discharged from hospital. [ABSTRACT FROM AUTHOR]

Background: Bullous pemphigoid (BP) is an autoimmune disease characterized by the appearance of very pruritic subepidermal blisters. It appears mostly in the elderly and is associated with multiple comorbidities, which makes its management and treatment difficult. The purpose of this systematic review is to compile current information on published cases of BP treated with omalizumab (omalizumab) and dupilumab (dupilumab) in order to obtain information on clinical efficacy and safety data available. Methods: A literature search of all cases of BP treated with omalizumab/dupilumab published in the literature up to January 2024 was performed using the Pubmed database. After an exhaustive search, a total of 61 studies encompassing 886 patients met the inclusion criteria and were included in the review. Results: The majority of patients with BP treated with omalizumab/dupilumab presented a significant improvement in symptomatology, being very safe drugs with minimal side effects. The main limitation of the presented review is the quality of the included studies, most of them being case series or individual cases. The development of studies with a higher level of scientific evidence in the near future would be of great interest. Conclusions: Both omalizumab and dupilumab appear to be effective options for treating BP in patients refractory to other pharmacological therapies. They are drugs with a good safety profile and the adverse reactions associated with their use are infrequent and generally mild. [ABSTRACT FROM AUTHOR]

Metamizole, or dipyrone, has been used for decades as a non-narcotic analgesic, providing pain relief from musculoskeletal disorders and antipyretic and antispasmolytic properties. Despite being in use since the 1920s, its mechanism of action still needs to be discovered. Despite causing fewer adverse effects when compared to other analgesics, its harmful effects on the blood and lack of evidence regarding its teratogenicity make the usage of the drug questionable, which has led to it being removed from the drug market of various countries. This narrative review aims to provide a detailed insight into the mechanism of action and efficacy, comparing its effectiveness and safety with other classes of drugs and the safety profile of metamizole. [ABSTRACT FROM AUTHOR]

Medication errors, which could often be detected in advance, are a significant cause of patient deaths each year, highlighting the critical importance of medication safety. The rapid advancement of data analysis technologies has made intelligent medication assistance applications possible, and these applications rely heavily on medical knowledge graphs. However, current knowledge graph construction techniques are predominantly focused on general domains, leaving a gap in specialized fields, particularly in the medical domain for medication assistance. The specialized nature of medical knowledge and the distinct distribution of vocabulary between general and biomedical texts pose challenges. Applying general natural language processing techniques directly to the medical domain often results in lower accuracy due to the inadequate utilization of contextual semantics and entity information. To address these issues and enhance knowledge graph production, this paper proposes an optimized model for named entity recognition and relationship extraction in the Chinese medical domain. Key innovations include utilizing Medical Bidirectional Encoder Representations from Transformers (MCBERT) for character-level embeddings pre-trained on Chinese biomedical corpora, employing Bi-directional Gated Recurrent Unit (BiGRU) networks for extracting enriched contextual features, integrating a Conditional Random Field (CRF) layer for optimal label sequence output, using the Piecewise Convolutional Neural Network (PCNN) to capture comprehensive semantic information and fusing it with entity features for better classification accuracy, and implementing a microservices architecture for the medication assistance review system. These enhancements significantly improve the accuracy of entity relationship classification in Chinese medical texts. The model achieved good performance in recognizing most entity types, with an accuracy of 88.3%, a recall rate of 85.8%, and an F1 score of 87.0%. In the relationship extraction stage, the accuracy reached 85.7%, the recall rate 82.5%, and the F1 score 84.0%. [ABSTRACT FROM AUTHOR]

We aimed to map tasks related to medication management and time consumption in Danish home health care. Nursing staff (n = 30) from five municipalities were followed during a 10‐week period and tasks related to medication management, time consumption and information on citizens' medication were registered. A total of 269 courses were registered, including 163 (61%) home visits, 76 (28%) in‐office courses, 29 (11%) in‐clinic courses and 1 (0.4%) acute visit. Of defined categories related to medication management, ‘record‐keeping and communication’ (62%, n = 167), ‘dispensing’ (48%, n = 129) and ‘identification’ (30%, n = 81) were most often performed. During half of courses (55%, n = 147), the nursing staff was interrupted at least one time. The median time spent on medication management was less than the time allocated in most of allocated time slots (82%), with a median excess time of 5.1 min (range 0.02–24 min). Citizens (n = 32) used a median of 11 (interquartile range [IQR] 9–13) regular medications and 2 (IQR 1–4) as‐needed, and 69% (n = 22) used high‐risk situation medications. In conclusion, employees in Danish home health care perform diverse medication‐related tasks and are frequently interrupted in their work. Employees spend less time than allocated but do not fully solve all tasks according to best practice guidance. [ABSTRACT FROM AUTHOR]

Introduction: Depressive spectrum disorders are common and can hinder breastfeeding success. While medications typically pose minimal risk, the concerns persist. This is the first study that investigates the prevalence and characteristics of drug-related problems among breastfeeding mothers with depressive spectrum disorders. We analyzed those problems to understand their nature, severity, and contributing factors. Additionally, we evaluated the outcomes of pharmacist-led interventions in reducing them. Understanding drug-related problems is crucial for informing evidence-based practices to optimize both maternal mental health and breastfeeding success. Materials and methods: This prospective observational study was conducted at a specialized pharmacy office in Poznan, Poland, which focuses on lactation support and medication consultations. 47 breastfeeding patients were enrolled. Pharmaceutical consultations were conducted according to Joint Commission of Pharmacy Practitioners Pharmacists' Patient Care Process standards. Novel MILC Questionnaire was used for efficient and optimal pharmaceutical interview. Drug-related problems were assessed basing on PCNE Classification System version 9.1. For adverse events in lactation, MedDRA v27 nomenclature was used; for causality, Naranjo Scale and LCAT were utilized. CTCAE was used for grading. Results: Among the 47 patients, pharmacist identified 49 medication-related problems, with inadequate treatment effect due to underdosing or not taking the medication at all being the most common (57.1%). Pharmacist interventions focused on medication safety information and counseling. Overall, 78.7% of patients accepted these interventions, resulting in problem resolution for 71.4%. Twelve mothers (25.5%) reported adverse events in their infants, but after causality evaluation, only four (8.5%) might have been linked to maternal medication. None required medical intervention beyond one hospitalization for a serious adverse event possibly connected to maternal medication. Conclusion: The study identified high rates of drug-related problems among breastfeeding mothers with depression, primarily due to non-adherence. Pharmacist interventions significantly improved DRP outcomes. Adverse events were reported, but most were mild and did not require intervention. Our findings suggest that lactating mothers with depressive spectrum disorders may benefit from pharmacist-led support to optimize treatment adherence and address medication safety concern. [ABSTRACT FROM AUTHOR]

Reports suggest possible risks of adverse cardiovascular reactions, including heart failure, associated with non-ergot dopamine agonist (DA) use in Parkinson's disease (PD). The objectives of our review were to evaluate the risk of heart failure and other adverse cardiovascular reactions in PD patients who received a non-ergot DA compared with other anti-PD pharmacological interventions, placebo, or no intervention. Studies were identified via searches of six bibliographic databases. Randomized controlled trials (RCTs) and non-randomized studies (NRS) were eligible for study inclusion. Random-effect meta-analyses were performed to estimate adverse cardiovascular reaction risks. Quality of evidence was assessed using GRADE. In total, forty-four studies (thirty-six RCTs and eight NRS) satisfied our inclusion criteria. A single RCT found no significant difference in the risk of heart failure with ropinirole compared with bromocriptine (odds ratio (OR) 0.39, 95% confidence interval (CI) 0.07 to 2.04; low certainty). Conversely, three case–control studies reported a risk of heart failure with non-ergot DA treatment. The quality of evidence for the risk of heart failure was judged as low or very low. Findings suggest that non-ergot DA use may be associated with adverse cardiovascular outcomes, including heart failure. Studies are needed to better understand cardiovascular risks associated with PD treatment. [ABSTRACT FROM AUTHOR]

Background: In observational medication pregnancy safety studies, children are often followed from birth to 1 year of age. However, some major congenital malformations (MCM) may take longer to diagnose. Objectives: We aimed to investigate the proportion of children with detected MCMs at different lengths of follow‐up and compare them to the proportion detected at 1 year after birth. Methods: This population‐based register study included all singleton children liveborn in Sweden from 2006 to 2016. MCM were identified by ICD‐10 codes in the Medical Birth Register and National Patient Register, aligned to the EUROCAT classification system. Cumulative proportion of children with detected MCM at birth, 90 days, 1, 2, and 3 years was calculated and compared between children born preterm and at term. Results: In 1,138,113 liveborn children, the cumulative proportion of children with a detected MCM increased from 1.9% at birth to 3.1%, 3.9%, 4.4% and 4.7% at 90 days, 1, 2, and 3 years after birth, respectively, and varied by MCM subgroup. MCMs of the eye, ear‐face‐neck, nervous system and genitals were detected with the longest delay, with 31%–59% more detected at 3‐ versus 1‐year follow‐up. Compared to children born at term, the proportion of children with any MCM was 2.5 times higher amongst preterm children, with a higher proportion detected over the first 90 days for most MCM subgroups. Conclusions: The proportion of children with a detected MCM varied by MCM subgroup and follow‐up time. In pharmacoepidemiology studies of medication safety in pregnancy using Swedish national data, the length of child follow‐up should be chosen in accordance with the expected age at detection if a specific subgroup of MCM is under investigation, for example, eye and genital MCM require longer follow‐up for detection than abdominal wall and digestive system MCM. However, in most circumstances, 1 year of follow‐up is sufficient. [ABSTRACT FROM AUTHOR]

Objective: To implement and evaluate the impact of a collaborative pharmacist‐medical officer model of planning discharge prescriptions, Partnered Pharmacist Discharge Prescription Planning (PPDPP) on the safe use of medicines on discharge in an ED short stay unit (SSU). Methods: A prospective pre‐ and post‐intervention study measured the proportion of medication errors on discharge prescriptions from the SSU using the Five Rights (5Rs) method. Pharmacists assessed discharge prescriptions generated by the medical officers (MO) during the pre‐intervention phase (standard practice). During the PPDPP phase, pharmacists planned electronic prescriptions in consultation with MO and completed prescriptions were independently assessed by another pharmacist. Results: There were 163 and 147 prescriptions collected during the pre‐ and post‐intervention phases, respectively. There was a significant difference in the proportion of discharge prescriptions that met all 5Rs between the standard practice (47.2%) and PPDPP phase (91.8%) (P < 0.001). There was no statistical difference seen in the mean time taken from discharge decision to prescriptions given to patients or patients leaving the SSU between the two phases. There was a non‐statically significant trend towards a decrease in time taken for patients to obtain prescriptions by 11% (P = 0.16) and for actual departure time by 6% (P = 0.46). Additionally, the proportion of opioids prescribed as one of the high‐risk medication classes reduced from 23.8% to 16.2% (P = 0.023) with the PPDPP model. Conclusion: The PPDPP model improved medications safety on discharge from the ED SSU. The PPDPP did not impact patient flow parameters as measured in this study. [ABSTRACT FROM AUTHOR]

Background: Provision of a Medication Action Plan (MAP) on admission and a Discharge Medication Record (DMR) are associated with reduced medication‐related harm. Aim: To report factors associated with the provision of MAPs and DMRs in rural and regional hospitals in Queensland, Australia. Method: A literature search, environmental scan and department consultations were conducted to develop Clinical Pharmacy Key Performance Indicators (cpKPIs) and design a cpKPI dashboard. Two of the five KPIs included in the dashboard, relating to medication action plans on admission and medication records on discharge, were reported for all the hospitals and were included in the study. A retrospective, period‐prevalence study was conducted to evaluate the coverage and equity of clinical pharmacy service provision for patients admitted for longer than 24 h. The proportions of patients who received MAPs and DMRs were stratified by age, gender, Indigeneity and hospital type. Statistical analysis used chi‐squared tests and logistic regression in R. This project was exempt due to the local policy requirements that constitute research by the Far North Queensland Human Research Ethics Committee (Reference no: EX/2023/QCH/94383‐1684QA). The justification for this exemption is as follows: the project was determined to be negligible risk research and involved the use of existing collection of data or records that contain only non‐identifiable data about human beings. Results: In total, 13 818 patients (37.9% of admissions) received a MAP and 11 631 patients (32.7% of discharges) received a DMR. The proportion of MAPs and DMRs was significantly higher in rural hospitals than in regional hospitals (MAP 50.6% vs 34.6%, DMR 33.1% vs 31.3%) and for male patients than female patients (MAP 42.2% vs 33.7%, DMR 36.4% vs 29.2%). When stratified by age, First Nations patients received a higher proportion of MAPs and DMRs in each age group, except for age 85 years and over. The proportion of First Nations patients aged 50 years and over who received MAP was lower compared to that for non‐Indigenous patients aged 65 years and over (56.3% vs 59.8%), whilst the proportion for DMRs was similar (50.4% vs 49.3%). Conclusion: The study defined the clinical pharmacy key performance indicators for measuring equity of clinical pharmacy service provision in Australia. When adjusted for a difference in life expectancy, the proportion of MAPs for First Nations patients was lower compared to the proportion of MAPs for non‐Indigenous patients. Further improvements are required to achieve equity of service provision for First Nations patients and female patients. [ABSTRACT FROM AUTHOR]

Background: The omission of time-critical medication doses may result in poor patient outcomes. There are few publications about the influence of electronic medication management (EMM) systems, including automated dispensing cabinets (ADC), on timely medication administration. The study aimed to evaluate the influence of EMM systems, including ADCs, on timely medication administration 6 and 30 months after EMM implementation, focussing on preventable time-critical medication dose omissions and documented reasons for not administering a dose.Methods: Data on doses of regular inpatient medications not administered were obtained from electronic medication records (EMR) over 1 week in March 2019 and 4 weeks in March 2021. An omission was a dose not administered before the next due dose. Time-critical medications were defined using the health service’s guidelines. Reasons for doses not being administered were obtained from nursing documentation in the EMR collated from digital health reports. Reasons for time-critical medication doses not given were defined as ‘valid’ or ‘preventable’.Results: In 2019 and 2021, 620 and 2524 patients with 44,756 and 146,940 scheduled medication doses were reviewed. Of these, 4385 (9.8%) and 19,610 (13.4%) doses were not administered. In 2019 and 2021, there were 593 (1.3%) and 1811 (1.2%), p < 0.0001, time-critical doses not administered. Preventable time-critical dose omissions decreased from 0.20% in 2019 to 0.15% (p = 0.015) in 2021. Wards with ADCs had a significantly lower rate of time-critical dose omissions compared to those without ADCs (1.1% vs 1.3%, p = 0.014).Conclusion: With the introduction of an EMM system, there was a decrease in the rate of time-critical medications not administered, including a reduced rate of preventable omissions over the 24-month period. Regular assessment of time-critical medication administration will help target patient safety improvements. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Comparative effectiveness research provides data on the relative benefits and risks between treatments. In Crohn's disease (CD), however, there are few head-to-head studies comparing advanced therapies and none with long-term follow-up. Real-world effectiveness, defined by treatment persistence, obtained from prospective population-based patient cohorts, may help determine the best sequencing and positioning of biological agents. METHODS: We analyzed the prospectively collected population-based Australian national Pharmaceutical Benefits Scheme dispensing data registry (2005-2019) for CD. There is no mandated biological agent prescribing order, and all citizens and permanent residents are eligible for treatment irrespective of insurance status. Propensity score matching was performed to reduce selection bias. RESULTS: There were 2,029 lines of therapy in 1,446 patients (median age 43 years, interquartile range 34-58, 44% male patients) over the 15-year period with 5,618 patient-years of follow-up. Per line of therapy, 915/2,029 (45.1%) patients used adalimumab, 722/2,029 (35.6%) used infliximab, 155/2,029 (7.6%) used vedolizumab, and 237/2,029 (11.7%) used ustekinumab. When used in biological agent-naive patients, there was no difference in persistence between any agent (P > 0.05). Used after first line in biological agent-experienced CD, ustekinumab had significantly better persistence than non-ustekinumab biological agents (P = 0.0018), vs anti-tumor necrosis factor (TNF) alpha therapy (P = 0.006) or vedolizumab (P < 0.001). Ustekinumab persistence was unaffected by prior biological agent exposure (P = 0.51). After anti-TNF use, ustekinumab had superior persistence to an alternative anti-TNF agent (P = 0.033) and to vedolizumab (P = 0.026). Using a propensity score-matched analysis adjusted for age, immunomodulator use, and bio-exposed status, ustekinumab had superior persistence to anti-TNF (P = 0.01). Multivariate predictors of worse persistence were the use of a non-ustekinumab biological agent (adjusted hazard ratio 2.10, P < 0.001), and bio-experienced status (adjusted hazard ratio 1.23, P < 0.001). DISCUSSION: This large national prospective database with nonhierarchical prescribing of biological agents did not identify superior persistence of any agent in bio-naive CD. However, for patients with bio-experienced CD, persistence was greater with ustekinumab. [ABSTRACT FROM AUTHOR]

Background: Poison centers develop triage threshold guidelines for pediatric metformin ingestions. Our network uses 1700 mg, or 85 mg/kg. Objective: To describe the dose, clinical course, and outcomes for inadvertent metformin ingestions in children 5 years old and younger reported to our statewide poison center network. Methods: We searched the poison center database 2011 to 2021 for metformin ingestions in patients 5 years and younger. Variables included age, sex, weight, dose, symptoms, outcome, and more. We used descriptive statistics with medians and interquartile ranges (IQR) for continuous variables. Results: Of 669 cases, exposures by age were 208 (31.1%) 1 to 2 years, and 275 (41.1%) 2 years. Weight was recorded in 342 (51.1%) (median 13.5 kg; IQR: 3.7 kg), and dose in 149 (22.3%) (median 500 mg; IQR: 500 mg). Milligram/kilogram values were available for 103 (15.4%) with median 42.4 mg/kg, IQR: 39 mg/kg. Most (647, 98.5%) exposures were unintentional. Most (445/669, 66.5%) were managed at a non-healthcare facility, while 204 (30.7%) were already at or referred to a healthcare facility. Of these 204 patients, 169 (82.8%) were evaluated and treated at the emergency department and discharged. Four (2%) were admitted to critical care, and 7 (3.4%) to the ward. Medical outcomes by effect were 5 (0.7%) minor, 2 (0.3%) moderate, 253 (37.8%) none, 292 (43.6%) not followed (minimal effects possible), and no major effects or deaths. Of 20 clinical occurrences reported, vomiting was most common (8, 1.2%). Conclusion: Despite little recorded dosage information, pediatric metformin ingestions under 85 mg/kg had predominantly uneventful medical outcomes. [ABSTRACT FROM AUTHOR]

Background: Medication dosing in overweight and obese children often involves complex weight-based calculations, leading to higher dosing errors, particularly with intravenous drugs. Currently, tools to aid in dosage calculations are lacking for these patients, especially in Thai population. Objective : This study aimed to develop a mobile application with the intent of utilizing it as a tool to enhance the efficiency and accuracy of dosing calculations required for obese and overweight Thai children. Methods: The performance of the application was assessed in 3 key aspects using a sample of 30 healthcare professionals. These key aspects included: 1) the accuracy of dosage calculations, assessed through pre- and posttests comparing manual calculations to app-based calculations using a 10-item questionnaire, 2) the time taken for calculations before and after app usage, 3) user satisfaction, which was measured through a questionnaire. Results: The integration of applications into the calculation demonstrated a significant improvement when compared to the manual calculation in both accuracy (6.10 vs 9.33 out of 10, P <.001) and efficiency (10.40 vs 8.53 minutes per 10 questions, P =.008). Also, the application elicited high levels of satisfaction among users, as reflected by an overall mean satisfaction score of 4.57 on a 5-point scale. Conclusion : The integration of this application to assist in dosage calculations for overweight and obese pediatric Thai patients has yielded favorable outcomes concerning accuracy, efficiency, and user satisfaction. Further development should be pursued within a larger cohort, with an emphasis on real-world implementation in clinical settings. [ABSTRACT FROM AUTHOR]

Naloxone, an opioid receptor antagonist, effectively reverses opioid overdose and opioid-induced respiratory depression. A few side effects were reported after naloxone administration, including arrhythmia and pulmonary edema. Although rare, naloxone-induced pulmonary edema can be a severe and sometimes life-threatening complication requiring mechanical ventilation. This condition is predominantly linked to an upsurge in catecholamines after opioid reversal as part of acute withdrawal syndrome, especially seen in patients who chronically use opioids. In this report, we present a case of a 66-year-old patient who developed pulmonary edema following the administration of multiple doses of intravenous and intranasal naloxone for opioid overdose. This case highlights the potential adverse effects associated with naloxone use and discusses how to employ this life-saving medication with minimal side effects. [ABSTRACT FROM AUTHOR]

Medication harm affects between 5 and 15% of hospitalised patients, with approximately half of the harm events considered preventable through timely intervention. The Adverse Inpatient Medication Event (AIME) risk prediction model was previously developed to guide a systematic approach to patient prioritisation for targeted clinician review, but frailty was not tested as a candidate predictor variable. To evaluate the predictive performance of an updated AIME model, incorporating a measure of frailty, when applied to a new multisite cohort of hospitalised adult inpatients. A retrospective cohort study was conducted at two tertiary Australian hospitals on patients discharged between 1st January and April 31, 2020. Data were extracted from electronic medical records (EMRs) and clinical coding databases. Medication harm was identified using ICD-10 Y-codes and confirmed by senior pharmacist review of medical records. The Hospital Frailty Risk Score (HFRS) was calculated for each patient. Logistic regression analysis was used to construct a modified AIME model. Candidate variables of the original AIME model, together with new variables including HFRS were tested. Performance of the final model was reported using area under the curve (AUC) and decision curve analysis (DCA). A total of 4089 patient admissions were included, with a mean age ± standard deviation (SD) of 64 years (±19 years), 2050 patients (50%) were males, and mean HFRS was 6.2 (±5.9). 184 patients (4.5%) experienced one or more medication harm events during hospitalisation. The new AIME-Frail risk model incorporated 5 of the original variables: length of stay (LOS), anti-psychotics, antiarrhythmics, immunosuppressants, and INR greater than 3, as well as 5 new variables: HFRS, anticoagulants, antibiotics, insulin, and opioid use. The AUC was 0.79 (95% CI: 0.76–0.83) which was superior to the original model (AUC = 0.70, 95% CI: 0.65–0.74) with a sensitivity of 69%, specificity of 81%, positive predictive value of 0.14 (95% CI: 0.10–0.17) and negative predictive value of 0.98 (95% CI: 0.97–0.99). The DCA identified the model as having potential clinical utility between the probability thresholds of 0.05–0.4. The inclusion of a frailty measure improved the predictive performance of the AIME model. Screening inpatients using the AIME-Frail tool could identify more patients at high-risk of medication harm who warrant timely clinician review. [ABSTRACT FROM AUTHOR]

The treatment landscape for relapsed/refractory B-cell lymphomas has evolved rapidly with the advent of immune cell-engaging therapies, including bispecific T-cell engagers (TCEs). In the past 2 years, the FDA has approved bispecific TCEs for the treatment of relapsed/refractory follicular lymphoma (mosunetuzumab-axgb [Lunsumio; Genentech, Inc] and epcoritamab-bysp [Epkinly; Genmab US, Inc]) and diffuse large B-cell lymphomas (epcoritamab and glofitamab-gxbm [Columvi; Genentech, Inc]). Additionally, odronextamab (Regeneron Pharmaceuticals, Inc), another bispecific T-cell-engaging antibody, is being investigated in both follicular and diffuse large B-cell lymphomas. These bispecific TCEs provide novel, non-chemotherapy-based treatment options for a historically difficult-to-treat relapsed/refractory B-cell lymphoma population. This article reviews the efficacy and safety data behind these treatments and highlights practical considerations for implementing these bispecific TCEs across various types of practice sites. [ABSTRACT FROM AUTHOR]

In the United States, Doctor of Pharmacy (PharmD) programs are required to provide advanced pharmacy practice experiences (APPEs) in the core inpatient rotation areas of hospital/health system pharmacy and inpatient general medicine patient care. Colleges and Schools of Pharmacy (C/SOPs) nationwide are increasingly utilizing blended or longitudinal APPE models to offer experiential opportunities; however, there is a gap in the literature to support programs with delineating rotation-specific competencies when integrating two or more rotations together. Utilizing a survey instrument, PharmD students at two C/SOPs reported their onsite inpatient rotation sub-competency activities achieved within the four competency areas of Hospital/Health Pharmacy Systems, Medication Safety and Quality, Clinical Applications, and Professional Practice, which are listed in Appendix C of the 2016 Accreditation Council for Pharmacy Education Standards Guidance Document. Unpaired two-sample t-tests were performed to compare proportions of sub-competency activity occurrence in the two rotation settings. In total, 168 students reported inpatient activities related to the four competency areas, with 95–100% reporting their involvement in one or more sub-competency opportunities within each area. Of the 26 sub-competencies compared, 73% significantly facilitated the development of competency to a greater extent for one APPE inpatient rotation type over the other (p < 0.05). The findings can be utilized by C/SOPs to support the delineation of rotation-specific competencies when blending inpatient experiential opportunities. [ABSTRACT FROM AUTHOR]

Complete medication reconciliation during hospital admission is the rationale for further treatment decisions. A consecutive, controlled intervention study was conducted to assess discrepancies in medication reconciliation performed by nurses of the Urology Department compared to the Best Possible Medication History (BPMH) established by pharmacists. This study included pre-intervention (control group, CG), nursing training as a pharmaceutical intervention, and post-intervention (intervention group, IG) groups. The discrepancies were classified as "Missing" (not recorded but taken), "Added" (additionally recorded) "Strength" (incorrect documented dosage), "Intake" (incorrect intake time/schedule), "Double" (double prescription), and "Others" (no clear assignment). Additionally, high-risk drug subgroup discrepancies were particularly prevalent and were evaluated. Training success was compared concerning discrepancies in the CG and IG. Generally, the percentage of discrepancies per patient found was lower in the IG than in the CG (78.1% vs. 87.5%, significantly). The category most identified was "Missing" (IG, 33.3% vs. CG, 35.2%). Overall, a discrepancy of 7.4% each (discrepancies: IG, 27 vs. CG, 38) was determined for high-risk drugs while "Missing" occurred (77.8% vs. 52.6%, out of 7.4%). Despite nursing training only partially reducing discrepancies, the implementation of medication reconciliation using BPMH by pharmacists could improve the process, especially for high-risk drugs. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (USFDA) communicates new drug safety concerns through drug safety communications (DSCs) and medication guides (MGs), which often challenge patients with average reading abilities due to their complexity. This study assesses whether large language models (LLMs) can enhance the readability of these materials. Methods: We analyzed the latest DSCs and MGs, using ChatGPT 4.0© and Gemini© to simplify them to a sixth-grade reading level. Outputs were evaluated for readability, technical accuracy, and content inclusiveness. Results: Original materials were difficult to read (DSCs grade level 13, MGs 22). LLMs significantly improved readability, reducing the grade levels to more accessible readings (Single prompt – DSCs: ChatGPT 4.0© 10.1, Gemini© 8; MGs: ChatGPT 4.0© 7.1, Gemini© 6.5. Multiple prompts – DSCs: ChatGPT 4.0© 10.3, Gemini© 7.5; MGs: ChatGPT 4.0© 8, Gemini© 6.8). LLM outputs retained technical accuracy and key messages. Conclusion: LLMs can significantly simplify complex health-related information, making it more accessible to patients. Future research should extend these findings to other languages and patient groups in real-world settings. [ABSTRACT FROM AUTHOR]

Pharmacists play a crucial role in medication safety and quality improvement in healthcare, yet face significant challenges due to limited data access, poor data quality, and insufficient data management skills. National pharmacy organizations emphasize the importance of pharmacists using data effectively to improve patient care. This paper suggests several strategies to overcome data challenges, including more widespread adoption of a Chief Pharmacy Informatics Officer (CPIO) role in healthcare institutions, the development and validation of medication safety metrics and dashboards, and the incorporation of data analysis and application skills into pharmacist education and training. The creation of the CPIO position is proposed to lead efforts in data management and use for medication safety. Additionally, establishing clear medication safety metrics and dashboards is recommended to monitor and improve safety practices. To support these roles and tools, enhancing pharmacist training in data analytics is deemed essential. Implementing these strategies aims to empower pharmacists to engage more effectively in proactive medication safety and quality improvement efforts. This approach is expected to address current gaps in data utilization and management, facilitating a more informed method for pharmacists to make healthcare safe for patients. [ABSTRACT FROM AUTHOR]

The development and use of concentrated insulins have increased in recent years. This can pose unique challenges when transitioning to a non‐concentrated insulin during an inpatient admission. There is no clear consensus on the recommended interchange of the various concentrated insulins in the inpatient setting, with suggestions ranging from implementing a 1:1 unit dose conversion, a minimum 20% dose reduction or selecting an approach based on the total daily dose of the concentrated insulin. In a retrospective cohort analysis at a single health system, a greater number of hypoglycemic events occurred when implementing a 1:1 unit conversion of insulin glargine 300 units/mL (iGlar300) to insulin detemir 100 units/mL (iDet100) compared to the same conversion from insulin glargine 100 units/mL (iGlar100) to iDet100. This prompted identification of a standardized approach that would improve patient safety while also being operationally feasible at a multi‐hospital network. The solution of implementing a minimum 20% dose reduction successfully improved hypoglycemia rates upon transitioning from iGlar300 to iDet100, though many logistical challenges were faced. Although iDet100 is being phased off the market, adhering to this minimum 20% dose reduction is the recommended approach when transitioning from iGlar300 to iGlar100, and this challenge persists as a relevant issue. Ensuring health systems are equipped to implement dose reductions when transitioning from concentrated basal insulins to non‐concentrated basal insulin counterparts is paramount for maintaining patient safety. This paper will discuss the limited evidence available supporting optimal dosing when transitioning iGlar300 and insulin degludec 200 units/mL (iDeg200) to non‐concentrated basal insulins and serve as a "how to" implementation guide for other health systems, based on one health system's approach in navigating this emerging patient safety issue. [ABSTRACT FROM AUTHOR]

Objective Data Sources and Study Setting Study Design Data Collection Methods Principal Findings Conclusions To develop, deploy, and evaluate a national, electronic health record (EHR)‐based dashboard to support safe prescribing of biologic and targeted synthetic disease‐modifying agents (b/tsDMARDs) in the United States Veterans Affairs Healthcare System (VA).We extracted and displayed hepatitis B (HBV), hepatitis C (HCV), and tuberculosis (TB) screening data from the EHR for users of b/tsDMARDs using PowerBI (Microsoft) and deployed the dashboard to VA facilities across the United States in 2022; we observed facilities for 44 weeks post‐deployment.We examined the association between dashboard engagement by healthcare personnel and the percentage of patients with all screenings complete (HBV, HCV, and TB) at the facility level using an interrupted time series. Based on frequency of sessions, facilities were grouped into high‐ and low/none‐engagement categories. We modeled changes in complete screening pre‐ and post‐deployment of the dashboard.All VA facilities were eligible for inclusion; excluded facilities participated in design of the dashboard or had <20 patients receiving b/tsDMARDs. Session counts from facility personnel were captured using PowerBI audit log data. Outcomes were assessed weekly based on EHR data extracted via the dashboard itself.Totally 117 facilities (serving a total of 41,224 Veterans prescribed b/tsDMARDs) were included. Before dashboard deployment, across all facilities, 61.5% of patients had all screenings complete, which improved to 66.3% over the course of the study period. The largest improvement (15 percentage points, 60.3%–75.3%) occurred among facilities with high engagement (post‐intervention difference in outcome between high and low/none‐engagement groups was 0.17 percentage points (pp) per week, 95% confidence interval (0.04 pp, 0.30 pp); p = 0.01).We observed significant improvements in screening for latent infections among facilities with high engagement with the dashboard, compared with those with fewer sessions. [ABSTRACT FROM AUTHOR]

Objectives: To employ a drug supply chain information system to optimize drug management practices, reducing costs and improving efficiency in financial and asset management. Methods: A digital artificial intelligence + vendor managed inventory (AI+VMI)-based systemfor drug supply chain information management in hospitals has been established. The system enables digitalization and intelligentization of purchasing plans, reconciliations, and consumption settlements while generating purchase, sales, inventory reports as well as various query reports. The indicators for evaluating the effectiveness before and after project implementation encompass drug loss reporting, inventory discrepancies, inter-hospital medication retrieval frequency, drug expenditure, and cloud pharmacy service utilization. Results: The successful implementation of this system has reduced the hospital inventory rate to approximately 20% and decreased the average annual inventory error rate from 0.425? to 0.025?, significantly boosting drug supply chain efficiency by 42.4%. It has also minimized errors in drug application, allocation, and distribution while increasing adverse reaction reports. Drug management across multiple hospital districts has been standardized, leading to improved access to medicines and enhanced patient satisfaction. Conclusion: The AI+VMI system improves drug supply chain management by ensuring security, reducing costs, enhancing efficiency and safety of drug management, and elevating the professional competence and service level of pharmaceutical personnel. [ABSTRACT FROM AUTHOR]

Eculizumab has improved recovery from ventilatory support in myasthenic crisis (MC) cases. However, the safety and efficacy profiles from prospective studies are still lacking. This study aimed to explore eculizumab's safety and efficacy in a prospective case series of patients with refractory MC. We followed a series of anti-acetylcholine receptor (AChR) antibody-positive myasthenia gravis (MG) patients who received eculizumab as an add-on therapy for 12 weeks during MC to facilitate the weaning process and reduced disease activity. Serum anti-AChR antibodies and peripheral immune molecules associated with the complement pathway were evaluated before and after eculizumab administration. Compared to the baseline Myasthenia Gravis Foundation of America (MGFA)-quantitative MG test (QMG) scores (22.25 ± 4.92) and MG-activities of daily living (MG-ADL; 18.25 ± 2.5) scores at crisis, improvements were observed from 4 weeks (14.5 ± 10.47 and 7.5 ± 7.59, respectively) through 12 weeks (7.5 ± 5.74 and 2.25 ± 3.86, respectively) post-treatment. Muscle strength consistently improved across ocular, bulbar, respiratory, and limb/gross domain groups. One patient died of cardiac failure at 16 weeks. Three cases remained in remission at 24 weeks, with a mean QMG score of 2.67 ± 2.89 and ADL score of 0.33 ± 0.58. No significant side effects were reported. Serum CH50 and soluble C5b-9 levels significantly declined, while there were no significant changes in serum anti-AChR antibody levels, C1q, C5a levels, or peripheral lymphocyte proportions. Eculizumab was well tolerated and showed efficacy in this case series. Large prospective cohort studies with extended follow-up periods are needed to further explore the safety and efficacy profile in real-world practice. [ABSTRACT FROM AUTHOR]

Reporting adverse drug reactions (ADRs) is fundamental in improving medication safety. Community pharmacists (CPs) being the first point of contact for individuals seeking healthcare in a community, play a significant role in ADR reporting. However, this has been poorly implemented in many countries including Nigeria. This paper aims to explore stakeholders' perspectives on current reporting practices and suggest ways to enhance ADR reporting among CPs in Nigeria. This qualitative study employed a purposive sampling approach to identify key informants. Key informant interviews (KIIs) were conducted with 25 carefully selected pharmacists, using a semi-structured interview guide between July 2023 and August 2023. The interview transcripts were analyzed using a thematic content approach. While a low ADR reporting trend was observed among all participating pharmacists, it was notably higher among those with less than five years of experience. The main barriers to ADR reporting, as identified by the interviewed community pharmacists were lack of awareness and knowledge, absence of motivation, and insufficient feedback from National Agency for Food Drug Administration and Control (NAFDAC). Training and awareness campaigns were the most frequently suggested methods for improving ADR reporting. Other proposed strategies included providing motivation, regular feedback, establishing mandatory reporting, and simplifying the reporting process. The study has highlighted the suboptimal ADR reporting practices among CPs in Anambra state. It underscores the significance of training, sensitization, advocacy, and other related interventions as pivotal means to enhance ADR reporting in this group. Furthermore, there is a pressing need for intervention-based studies to delve into and implement these approaches effectively. [ABSTRACT FROM AUTHOR]

Aims and Objectives Background Design Methods Results Conclusion Relevance to Clinical Practice This study investigated the relationship between clinical nurses' critical thinking ability and medication safety competence, as well as the factors related to medication safety competence.Nurses can have an active role in promoting medication safety. However, the main factors associating with nurses' competence in medication safety are uncertain.This was a descriptive, multicenter cross‐sectional survey study.A total of 1196 nurses from four different tertiary hospital in China were included in this study. A demographic information questionnaire, the Critical Thinking Diagnostic for nurses, and the Medication Safety Competence Scale for nurses were used to survey. Descriptive statistics, comparisons, correlation and regression analysis of the collected data were performed using SPSS 26.00 software. The study was reported using STROBE checklist.Included nurses obtained satisfactory scores on the critical thinking and medication safety scales and subscales. There was a strong statistically significant positive correlation between critical thinking ability and medication safety competence.Multiple linear regression analysis indicated that personal critical thinking scores and working years were positively associated with nurses' medication safety scores, accounting for 62.50% of the variance.Clinical nurses' critical thinking ability is positively associated with medication safety competence.As critical thinking ability positively predicts nurses' medication safety competence, hospitals and nursing administrators should consider continuing nursing education and training to improve critical thinking skills, thereby promoting medication safety competence among clinical nurses. [ABSTRACT FROM AUTHOR]

Purpose To examine the degree of left-to-right character overlap in medication names as they appear in real-world computer systems. Methods We programmed a computer to create and automatically analyze left-to-right character overlap in names appearing on 20,020 lists of real-world medication names. The lists varied in length from 100 to 500 medication names and were created by randomly drawing names from a pool of 2,249 medication names extracted from an operating medication use system database. Results Overall maximum left-to-right character overlap varied in lists of 100 to 500 medication names from 4 to 29 characters (mode of 14 characters). For a small subset of names for high-alert medications that must never be administered in error, overall maximum left-to-right character overlap varied from 3 to 10 characters (mode of 6 characters). Further, for users searching for medications by name in computer systems, the keystrokes that do the most work to disambiguate medication names on a list are always the initial few keystrokes. Conclusion Medication name left-to-right character overlap on lists of names searched ranges widely. Instead of requiring all users to type a set number of characters when searching for medications by name, search safety can potentially be improved by upgrading computer systems to dynamically respond to each keystroke entered. Using incremental dynamic search, searchers would often be able to type fewer than 5 characters to isolate a single medication by name but would sometimes have to type many more than 5 characters to do so. [ABSTRACT FROM AUTHOR]

Objective: Adverse events associated with dexmedetomidine were analyzed using data from the FDA's FAERS database, spanning from 2004 to the third quarter of 2023. This analysis serves as a foundation for monitoring dexmedetomidine's safety in clinical applications. Methods: Data on adverse events associated with dexmedetomidine were standardized and analyzed to identify clinical adverse events closely linked to its use. This analysis employed various signal quantification analysis algorithms, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results: In the FAERS database, dexmedetomidine was identified as the primary suspect in 1,910 adverse events. Our analysis encompassed 26 organ system levels, from which we selected 346 relevant Preferred Terms (PTs) for further examination. Notably, adverse drug reactions such as diabetes insipidus, abnormal transcranial electrical motor evoked potential monitoring, acute motor axonal neuropathy, and trigeminal cardiac reflex were identified. These reactions are not explicitly mentioned in the drug's specification, indicating the emergence of new signals for adverse drug reactions. Conclusion: Data mining in the FAERS database has elucidated the characteristics of dexmedetomidine-related adverse drug reactions. This analysis enhances our understanding of dexmedetomidine's drug safety, aids in the clinical management of pharmacovigilance studies, and offers valuable insights for refining drug-use protocols. [ABSTRACT FROM AUTHOR]

Aims: The potential harm associated with medication errors is widely reported, but data on actual harm are limited. When actual harm has been measured, assessment processes are often poorly described, limiting their ability to be reproduced by other studies. Our aim was to design and implement a new process to assess actual harm resulting from medication errors in paediatric inpatient care. Methods: Prescribing errors were identified through retrospective medical record reviews (n = 26 369 orders) and medication administration errors through direct observation (n = 5137 administrations) in a tertiary paediatric hospital. All errors were assigned potential harm severity ratings on a 5‐point scale. Multidisciplinary panels reviewed case studies for patients assigned the highest three potential severity ratings and determined the following: actual harm occurrence and severity level, plausibility of a link between the error(s) and identified harm(s) and a confidence rating if no harm had occurred. Results: Multidisciplinary harm panels (n = 28) reviewed 566 case studies (173 prescribing related and 393 administration related) and found evidence of actual harm in 89 (prescribing = 22, administration = 67). Eight cases of serious harm cases were found (prescribing = 1, administration = 7) and no cases of severe harm. The panels were very confident in 65% of cases (n = 302) where no harm was found. Potential and actual harm ratings varied. Conclusions: This harm assessment process provides a systematic method for determining actual harm from medication errors. The multidisciplinary nature of the panels was critical in evaluating specific clinical, therapeutic and contextual considerations including care delivery pathways, therapeutic dose ranges and drug–drug and drug–disease interactions. [ABSTRACT FROM AUTHOR]

AbstractAdvances in the field of bioactivation have significantly contributed to our understanding and prediction of drug-induced liver injury (DILI). It has been established that many adverse drug reactions, including DILI, are associated with the formation and reactivity of metabolites. Modern methods allow us to detect and characterize these reactive metabolites in earlier stages of drug development, which helps anticipate and circumvent the potential for DILI. Improved in silico models and experimental techniques that better reflect in vivo environments are enhancing predictive capabilities for DILI risk. Further, studies on the mechanisms of bioactivation, including enzyme interactions and the role of individual genetic differences, have provided valuable insights for drug optimizations. Cumulatively, this progress is continually refining our approaches to drug safety evaluation and personalized medicine. [ABSTRACT FROM AUTHOR]

Azithromycin is used for children with cystic fibrosis (CF) for its immunomodulatory and anti-inflammatory action. This study investigated the short-term alterations in QTc interval associated with azithromycin prophylaxis in pediatric patients with CF. This study included 121 patients with mild CF, of whom 76 received azithromycin (patient group) and 45 did not receive azithromycin (control group). The patient and control groups were categorized according to age as under 12 years of age and over 12 years of age. The first presentation measured all the patient and control groups at basic QTc time intervals. The QTc intervals of all patients were then remeasured systemically at 1, 3, and 6 months. Age categories and QTc intervals that were calculated at each month in the patient and control groups were compared statistically. A statistically significant difference was detected in the patient group between the initial QTc interval time and the electrocardiogram (ECG) findings in the first and third months after prophylaxis treatment (p < 0.001; p = 0.01). However, no statistically significant difference was detected in the sixth month (p > 0.05) in all groups. Almost all of the children's QTc intervals were within normal range and within the safety zone (under 0.44 s). No statistically significant difference was detected in the control group between the initial ECG and the QTc intervals measured at 1, 3, and 6 months. Short-term use of azithromycin prophylaxis in pediatric patients with mild CF slightly increased the QTc interval in the first and third months of follow-up. Nevertheless, all QTc interval changes fell within the safety zone. Notably, 1 month of follow-up treatment should be performed to check for any alteration in the QTc interval. If increased QTc interval duration is not detected in the first month, azithromycin prophylaxis can be safely prescribed. [ABSTRACT FROM AUTHOR]

Background and Aim: The intricate healing process involves distinct sequential and overlapping phases in thermal injury. To maintain the zone of stasis in Jackson's burn wound model, proper wound intervention is essential. The extent of research on the histoarchitecture of thermal wound healing and the application of mesenchymal stem cell (MSC)-free-based therapy is limited. This study aimed to assess the efficacy of MSC-secretome-based hydrogel for treating partial-thickness cutaneous thermal burn wounds. Materials and Methods: Eighteen male Wistar rats were divided into three groups, namely the hydrogel base (10 mg), hydrogel secretome (10 mg) and Bioplacenton™ (10 mg) treatment groups. All groups were treated twice a day (morning and evening) for 7 days. Skin tissue samples from the animals were processed for histological evaluation using the formalin-fixed paraffin-embedded method on days 3 and 7. Results: This study's findings showed that secretome hydrogel expedited thermal burn wound healing, decreasing residual burn area, boosting collagen deposition and angiogenesis, guiding scar formation, and influencing the inflammation response facilitated by polymorphonuclear leukocytes and macrophages. Conclusion: The secretome hydrogel significantly improves healing outcomes in partial-thickness cutaneous thermal burn wounds. The administration of secretome hydrogel accelerates the reduction of the residual burn area and promotes fibroblast proliferation and collagen density. The repairment of histo-architecture of the damaged tissue was also observed such as the reduction of burn depth, increased angiogenesis and epidermal scar index while the decreased dermal scar index. Furthermore, the secretome hydrogel can modulate the immunocompetent cells by decreasing the polymorphonuclear and increasing the mononuclear cells. Thus, it effectively and safely substitutes for thermal injury stem cell-free therapeutic approaches. The study focuses on the microscopical evaluation of secretome hydrogel; further research to investigate at the molecular level may be useful in predicting the beneficial effect of secretome hydrogel in accelerating wound healing. [ABSTRACT FROM AUTHOR]

As sex-gender differences have been described in the responses of patients to certain medications, we hypothesized that the responses to medications recommended for neuropathic pain may differ between men and women. We conducted a literature review to identify articles reporting potential sex-gender differences in the efficacy and safety of these medications. Only a limited number of studies investigated potential sex-gender differences. Our results show that women seem to achieve higher blood concentrations than men during treatment with amitriptyline, nortriptyline, duloxetine, venlafaxine, and pregabalin. Compared to men, higher rates of women develop side effects during treatment with gabapentin, lidocaine, and tramadol. Globally, the sex-gender differences would suggest initially administering smaller doses of these medications to women with neuropathic pain compared to those administered to men. However, most of these differences have been revealed by studies focused on the treatment of other diseases (e.g., depression). Studies focused on neuropathic pain have overlooked potential sex-gender differences in patient responses to medications. Despite the fact that up to 60% of patients with neuropathic pain fail to achieve an adequate response to medications, the potential role of sex-gender differences in the efficacy and safety of pharmacotherapy has not adequately been investigated. Targeted studies should be implemented to facilitate personalized treatments for neuropathic pain. [ABSTRACT FROM AUTHOR]

Objectives: The paediatric intensive care unit changed heparin infusion dosing from a variable weight-based concentration to a fixed concentration strategy, when smart pump-based drug library was introduced. This change meant significantly lower rates of infusion were needed for the same dose of heparin in the neonatal population. We performed a safety and efficacy assessment of this change. Methods: We performed a retrospective single-centre evaluation based on data from respiratory VA-extracorporeal membrane oxygenation (ECMO) patients weighing ≤5 kg, pre and post the change to fixed strength heparin infusion. Efficacy was analysed by distribution of activated clotting times (ACT) and heparin dose requirements between the groups. Safety was analysed using thrombotic and haemorrhagic event rates. Continuous variables were reported as median, interquartile ranges, and non-parametric tests were used. Generalised estimating equations (GEE) were used to analyse associations of heparin dosing strategy with ACT and heparin dose requirements in the first 24 h of ECMO. Incidence rate ratios of circuit related thrombotic and haemorrhagic events between groups were analysed using Poisson regression with offset for run hours. Results: 33 infants (20 variable weight-based, 13 fixed concentration) were analysed. Distribution of ACT ranges and heparin dose requirements were similar between the two groups during the ECMO run and this was confirmed by GEE. Incidence rate ratios of thrombotic (fixed v weight-based) (1.9 [0.5–8], p =.37), and haemorrhagic events (0.9 [0.1–4.9], p =.95) did not show statistically significant differences. Conclusions: Fixed concentration dosing of heparin was at least equally effective and safe compared to a weight-based dosing. [ABSTRACT FROM AUTHOR]

Introduction: The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI). Methods: The development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed. Results: The RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the 'intervention') and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies. Conclusions: The RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science. [ABSTRACT FROM AUTHOR]