Rev Panam Salud Publica. 2024 Dec 16;48:e127. doi: 10.26633/RPSP.2024.127. eCollection 2024.

ABSTRACT

In Honduras, health systems have been faced with a duty and a need to establish surveillance mechanisms in order to understand the pathways of health and disease in the population. The objective of this article is to describe the process of analysis and the strategies used during development of a robust information system for vaccine safety surveillance, which can also be replicated for other forms of surveillance. For this purpose, agile development methods and open-source tools were used to design and develop a baseline monitoring system, incorporating recognized standards for information coding, validation, and verification. This successful implementation of a reliable, stable, and scalable information system that will be used for the surveillance of events supposedly attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI) should allow the timely and agile capture of surveillance data and facilitate data analysis.

PMID:39687261 | PMC:PMC11648060 | DOI:10.26633/RPSP.2024.127

Rev Panam Salud Publica. 2024 Dec 16;48:e89. doi: 10.26633/RPSP.2024.89. eCollection 2024.

ABSTRACT

OBJECTIVE: To describe the implementation and pioneering work of a vaccine pharmacovigilance committee in the state of São Paulo, Brazil, for the analysis of events supposedly attributable to vaccination or immunization (ESAVI) during the COVID-19 pandemic.

METHODS: This is a retrospective, mixed-methods (qualitative and quantitative) case study focusing on the work carried out by the pharmacovigilance committee in the years 2021 and 2022. The minutes of committee meetings were used to describe how the committee operates. ESAVI cases discussed and addressed at expert meetings were recorded. The number of vaccine doses applied during the period of analysis, as well as the number of ESAVIs reported within that period, was obtained from statewide information systems.

RESULTS: Over 55 pharmacovigilance committee meetings held in 2021-2022, 118 ESAVI cases-most related to COVID-19 vaccines-were discussed. A total of 126,778,252 doses of COVID-19 vaccines were administered during this period, with 42,893 ESAVI reported. Among the cases selected for discussion, 71.2% occurred after the first dose of vaccine, 32.8% represented neurological events, and only 5% were deemed to have a causal relationship with the vaccine.

CONCLUSIONS: The pharmacovigilance committee played a significant role in the ESAVI surveillance system during the period of analysis by assisting in the evaluation of more complex cases. It shows potential to contribute positively to strengthening the immunization program, especially within the safe vaccination system framework.

PMID:39687259 | PMC:PMC11648197 | DOI:10.26633/RPSP.2024.89

Rev Panam Salud Publica. 2024 Dec 16;48:e91. doi: 10.26633/RPSP.2024.91. eCollection 2024.

ABSTRACT

OBJECTIVE: To describe the experiences of the National Advisory Commission on Serious Events Supposedly Attributable to Vaccination or Immunization (ESAVI) implemented in Ecuador for the period 2020-2023.

METHODS: A report analyzing the implementation, operations, and results of the National Advisory Commission on Serious ESAVI in Ecuador was prepared. A quantitative analysis of vaccination records was carried out, as well as a qualitative analysis based on expert interviews, reflecting the direct experiences and operational challenges faced by the members of the Commission.

RESULTS: Implementation of the Commission has allowed for the systematic recording and analysis of serious ESAVIs. Of 256 reported cases, 139 were analyzed: 59% were considered coincident events; 16.6%, unclassifiable; 6.5%, indeterminate; 5%, stress-related; 3.6% as events related to a programmatic error; and 9.4% as vaccine-related, which included allergic reactions, Guillain-Barré syndrome, and thrombosis, among others. The experts highlighted the need to improve staff training and technology infrastructure, and noted that the Commission played a crucial role in monitoring vaccine safety, as well as in increasing public confidence in vaccination processes.

CONCLUSIONS: The National Advisory Commission has played an essential role in vaccine safety surveillance in Ecuador by ensuring reporting, causality analysis, and investigation of serious ESAVIs. Challenges were identified and will need to be addressed to maintain public trust in immunization programs.

PMID:39687254 | PMC:PMC11648176 | DOI:10.26633/RPSP.2024.91

J Cosmet Dermatol. 2024 Dec 16:e16732. doi: 10.1111/jocd.16732. Online ahead of print.

ABSTRACT

BACKGROUND: While oral minoxidil (OM) has been associated with pericardial effusion (PE), its etiology is presently inconclusive.

AIMS: We characterized patient- and drug-related factors across reports from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) for PE and OM.

METHODS: Our observation period spanned 18.5 years. Parametric and non-parametric analyses were used; we stratified our findings according to two groups of adverse events (AEs), namely, PE and all other AEs.

RESULTS: Across reports of OM (n = 2747), positive dechallenge (complete resolution or subsiding of AE upon discontinuation of OM) was significantly more likely to occur for PE than for all other AEs (p < 0.05). Furthermore, OM was significantly more likely to play a primary role in PE compared to all other AEs (p < 0.05). The proportion of men was significantly higher in OM reports of PE than in OM reports of all other AEs (p < 0.05). We also identified six reports of PE and topical minoxidil.

CONCLUSIONS: Though findings from spontaneously reported data never prove causality, our findings on dechallenge and purported role may suggest one. There were no reports of PE at a dose < 2.5 mg/day, 2/35 reports at 2.5 mg/day, and 8/35 reports at 5 mg/day. Overall, the results of statistical analyses support that the relationship between OM and PE is dose independent. Caution should also be taken when applying minoxidil topically because of reports of PE associated with this route of administration.

PMID:39686699 | DOI:10.1111/jocd.16732

Mol Cancer Ther. 2024 Dec 17. doi: 10.1158/1535-7163.MCT-24-0378. Online ahead of print.

ABSTRACT

ABY-029, an anti-epidermal growth factor receptor (EGFR) Affibody® molecule conjugated to IRDye 800CW, recently underwent first-in-human testing in soft-tissue sarcoma (STS). FDA Exploratory Investigational New Drug status was obtained for the Phase 0 clinical trial in which study objectives were to determine whether biological variance ratio (BVR) of 10 was achievable, fluorescence intensity correlated with EGFR expression, and doses were well tolerated. Patients (N=12) with STS were recruited based on positive EGFR immunohistochemical staining of diagnostic biopsies. ABY-029 was administered at micro- (30 nanomole, n=3), medium (90 nanomole, n=3), or high dose (171 nanomole, n=6), 1-3 hours prior to surgery. Following tumor resection, ex vivo tissue was imaged to determine mean fluorescence intensity (MFI), BVR, and other contrast measures. EGFR expression was correlated with immunohistochemistry. For micro-, medium, and high doses, mean BVR (SD) in cross-sectional slices were 4 (4), 10 (6), and 7 (8), respectively, for the whole tumor region and 6 (5), 13 (11), and 8 (6), respectively, for pathology-confirmed regions-of-interest. Strong linear correlations were found between all ABY-029 contrast metrics and total EGFR (r≥0.86, p<0.029) in cross-sectional tissue slices, and MFI and EGFR percent area (r=0.63, p<0.0001) in excised region-of-interest tissue sections. No ABY-029 related adverse events were observed. When administered above the microdose, ABY-029 demonstrated high correlation to EGFR expression and contrast values that were encouraging for translation to clinical practice. Contrast was similar to those observed with antibody agents, but with substantially reduced imaging-to-resection time, and no drug-related adverse events.

PMID:39686611 | DOI:10.1158/1535-7163.MCT-24-0378

Int J Mol Sci. 2024 Nov 22;25(23):12541. doi: 10.3390/ijms252312541.

ABSTRACT

Doxorubicin (DOX), an anticancer drug, is used to treat several types of tumors, but it has detrimental side effects that restrict its therapeutic efficacy. One is the iron-dependent form of ferroptosis, which is characterized by elevated ROS production and iron overload. Syzygium aromaticum has a diverse range of biological and pharmaceutical actions due to their antioxidant properties. This study investigated the effect of S. aromaticum extract (SAE) on hepatotoxicity caused by DOX in rats. Phytochemical analysis was performed to assess compounds in SAE. The ADMETlab 2.0 web server was used to predict the pharmacokinetic properties of the most active components of SAE when DOX was injected into rats. Molecular docking studies were performed using AutoDock Vina. Forty male Sprague Dawley rats were divided into four groups of ten rats each (G1 was a negative control group, G2 was given 1/10 of SAE LD50 by oral gavage (340 mg/kg), G3 was given 4 mg/kg of DOX intraperitoneally (i.p.) once a week for a month, and G4 was administered DOX as in G3 and SAE as in G2). After a month, biochemical and histopathological investigations were performed. Rats given SAE had promising levels of phytochemicals, which could significantly ameliorate DOX-induced hepatotoxicity by restoring biochemical alterations, mitigating ferroptosis, and upregulating the NRF-2-SLC7A-11-GPX-4 signaling pathway. These findings suggest that SAE could potentially alleviate DOX-induced hepatotoxicity in rats.

PMID:39684253 | DOI:10.3390/ijms252312541

Expert Opin Investig Drugs. 2024 Dec 16. doi: 10.1080/13543784.2024.2443756. Online ahead of print.

ABSTRACT

BACKGROUND: GR1603 is a monoclonal antibody targeting the type I interferon receptor. The aim of this study was to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of GR1603 in healthy volunteers.

METHODS: Healthy adults (≥18 years old) were enrolled in a placebo control, dose-escalation Phase I clinical trial receiving a single injectable dose of GR1603. Follow-up was 12 weeks. Adverse event (AE) profiles, vital signs, and blood samples were collected for assessment of safety, PK, and expression of type I interferon inducible genes.

RESULTS: Of the 46 subjects, 44 completed treatment. In the experimental group of 34 subjects (mean age 26.6 years), 30 experienced treatment-emergent adverse events (TEAEs), with a total of 102 occurrences, resulting in an incidence rate of 88.2%. The most commonly reported drug-related AEs were upper respiratory tract infection (17.6%), all of which were ≤ grade 2. GR1603 exhibits non-linear PK in the dose range of 0.1 mg/kg to 9 mg/kg. All samples were negative for anti-drug antibodies before and after dosing. The degrees of IFN gene signature were significantly inhibited in the higher dose groups.

CONCLUSION: The safety/tolerability, PK and exploratory metrics observed in this study support further clinical development of GR1603.

PMID:39681526 | DOI:10.1080/13543784.2024.2443756

Hum Vaccin Immunother. 2024 Dec 31;20(1):2439031. doi: 10.1080/21645515.2024.2439031. Epub 2024 Dec 16.

ABSTRACT

This post-marketing surveillance study evaluated the safety of the adjuvanted recombinant zoster vaccine (RZV) in Chinese adults, given the limited country-specific safety data accumulated since the 2019 licensure of RZV in China for adults ≥ 50 years of age (YOA). This descriptive, prospective cohort study enrolled adults ≥ 50 YOA who voluntarily received RZV per routine clinical practice in six centers in China. The primary outcomes were occurrence, intensity, and causal relationship to vaccination of medically attended adverse events (MAEs) within 30 days post-any dose. The occurrence and causal relationship to RZV of serious AEs (SAEs) within 30 days post-any dose, and of SAEs and potential immune-mediated diseases (pIMDs) from dose 1 until 12 months post-last dose were secondary outcomes. The exposed set included 3,300 adults (mean age [standard deviation]: 61.2 [7.4] years; 67.1% female), of whom 3,175 completed the study. Fifty-six MAEs were recorded in 42 (1.3%, 95% confidence interval [CI]: 0.9-1.7%) participants; ≥1 grade 3 MAE was reported in six (0.2%, 0.1-0.4%) participants; 15 MAEs (in nine [0.3%, 0.1-0.5%] participants) were considered RZV-related. Within 30 days post-any dose, 12 SAEs were reported in 10 (0.3%, 0.1-0.6%) participants, while 29 SAEs in 22 (0.7%, 0.4-1.0%) participants were reported from post-dose 1 until 12 months post-last dose. The three reported fatal SAEs were not considered RZV-related. Three of the total seven pIMDs were considered RZV-related. The observed descriptive patterns of MAEs, SAEs, and pIMDs did not indicate safety concerns following RZV administration among Chinese adults ≥ 50 YOA.

PMID:39681337 | DOI:10.1080/21645515.2024.2439031

J Eval Clin Pract. 2025 Feb;31(1):e14276. doi: 10.1111/jep.14276.

ABSTRACT

INTRODUCTION: Artificial intelligence (AI) has significant transformative potential across various sectors, particularly in health care. This study aims to develop a protocol for the content analysis of a method designed to assess AI applications in drug-related information, specifically focusing on contraindications, adverse reactions, and drug interactions. By addressing existing challenges, this preliminary research seeks to enhance the safe and reliable integration of AI into healthcare practices.

METHODS: A study protocol was developed for the creation of the method, followed by an initial content analysis conducted by an expert panel. The method was established in phases: (1) Analysis of drug-related databases and form development; (2) AI configuration; (3) Expert panel review and initial validation.

RESULTS: In Phase 1, the Micromedex, UpToDate, and Medscape databases were reviewed to establish terminology and classifications related to contraindications, adverse reactions, and drug interactions, resulting in the development of a questionnaire for the AI. Phase 2 involved configuring the Gemini AI tool to enhance response specificity. In Phase 3, AI responses to 30 questions were validated by an expert panel, yielding a 76.7% agreement rate for appropriateness, while 23.3% were deemed inappropriate, particularly concerning contraindicated drug interactions.

CONCLUSION: This preliminary study demonstrates the potential for using an AI-powered tool to standardize drug-related information retrieval, particularly for contraindications and adverse reactions. While AI responses were generally appropriate, improvements are needed in identifying contraindicated drug interactions. Further research with larger datasets and broader evaluations is required to enhance AI's reliability in healthcare settings.

PMID:39679434 | DOI:10.1111/jep.14276

Int J Nanomedicine. 2024 Dec 9;19:13235-13251. doi: 10.2147/IJN.S484575. eCollection 2024.

ABSTRACT

INTRODUCTION: Ulcerative colitis (UC) is a chronic intestinal disease characterized by spleen-lung qi deficiency and dampness-pathogenic obstruction. Although there are various treatment options available, patients frequently encounter significant drug-related side effects. Previous studies have shown the potential of Codonopsis Radix polysaccharides A (CPA) in treating UC, but their limited bioavailability has restricted their clinical use. Therefore, the objective of this study was to develop a novel formulation that can address the aforementioned limitations and assess its potential advantages.

METHODS AND RESULTS: We synthesized a negatively charged amphipathic prodrug called CPA-SA-DHA (CSD), which consists of CPA as the hydrophilic component, and succinic anhydride and docosahexaenoic acid as the hydrophobic segments. The CSD nanoparticles obtained had a particle size of 180.0 ± 3.2 nm, a negative zeta potential of -29.8 ± 5.3 mV, and a uniform shape with a PDI index of 0.230 ± 0.003. The interaction between positive and negative charges significantly increased the retention time of CSD nanoparticles in the colonic microenvironment. Furthermore, CSD nanoparticles demonstrated enhanced bioavailability in UC mice compared to CPA. Additionally, we observed that CSD nanoparticles exhibited therapeutic effects on DSS-induced UC mice by regulating the diversity and abundance of gut microbiota. This effect may be mediated by the inhibition of pro-inflammatory signaling pathways TLR4/NF-κB.

CONCLUSION: These findings confirm the potential of CSD nanoparticles as a promising treatment option for UC.

PMID:39679251 | PMC:PMC11645468 | DOI:10.2147/IJN.S484575

Clin Interv Aging. 2024 Dec 11;19:2099-2108. doi: 10.2147/CIA.S483118. eCollection 2024.

ABSTRACT

BACKGROUND: Behavioral and psychological symptoms of dementia (BPSD), as neuropsychiatric manifestations within dementia, constitute core features of dementia. However, there remains a gap in understanding the recognition of BPSD in China. Our current study was to explore the clinical awareness and treatment approaches for BPSD in China, focusing especially on the perspectives of neurologists and psychiatrists.

METHODS: A multicenter national survey was designed and a semi-structured questionnaire was distributed to healthcare professionals including doctors and nurses across all provinces of China. The questionnaire incorporated either closed (yes/no) and multiple-choice questions. The questions centered on the following areas: the perceived global frequency and relevance of BPSD; the assessment tools employed for evaluating BPSD; pharmacological approaches for addressing psychosis, apathy, agitation, aggression, depression, anxiety, sleep, and nutrition disorders; drug-related side effects; non-pharmacological treatment strategies. The anonymity of questionnaire responses was maintained to encourage participants to candidly express their viewpoints.

RESULTS: The majorities of respondents recognized the importance of BPSD. There were apparent differences in the perception of BPSD between neurologists and psychiatrists, encompassing variances in symptoms recognition, diagnostic approaches, and treatment strategies. A notable high percentage of neurology (27.8%) and psychiatry staff (23.6%) would not choose non-pharmacological interventions. Meanwhile, antipsychotics was overused in China. For aggression and agitation, more than half of neurologist and psychiatrist preferred antipsychotics. For psychosis, more than 80% of doctors chose antipsychotics. Nearly one-third of the medical staff expressed a preference for traditional Chinese medicine including ginkgo biloba extract.

CONCLUSION: In summary, this study in China has shed light on the features related to perception, recognition, management, treatment options, and observed side effects associated with BPSD. Our findings have the potential to significantly enhance the understanding of BPSD characteristics among medical practitioners and offering valuable insights into improved management and treatment strategies of neuropsychic symptoms of dementia in China.

PMID:39678144 | PMC:PMC11646383 | DOI:10.2147/CIA.S483118

Expert Opin Drug Saf. 2024 Dec 14. doi: 10.1080/14740338.2024.2443106. Online ahead of print.

ABSTRACT

BACKGROUND: Dementia is a global public health challenge. Certain medications, such as anticholinergics and benzodiazepines, have been linked to an increased dementia risk. However, most studies focused on a limited range of drugs, lacking a comprehensive overview. This article addressed this gap by analyzing drugs associated with dementia using data from the FDA Adverse Event Reporting System (FAERS).

RESEARCH DESIGN AND METHODS: The FAERS database was queried using Open Vigil 2.1 to extract reports of drug-induced dementia events from January 2004 to September 2023. Signal detection was performed using Reporting Odds Ratio (ROR) and Proportional Reporting Ratio methods.

RESULTS: We analyzed 21,509 reports. There were 163 drugs positively associated with dementia, included neurological drugs (52 drugs, 31.9%), cardiovascular drugs (25 drugs, 15.3%), alimentary tract/metabolism drugs (24 drugs, 14.7%) and genito urinary system/sex hormones drugs (15 drugs, 9.2%). Besides neurological drugs, the drugs with the highest number of reports are apixaban, valsartan and atorvastatin.

CONCLUSION: We found that tamsulosin, alfuzosin, and megestrol may be associated with an increased risk of dementia, and further research is required to clarify these relationships. In clinical practice, it is important to monitor the cognitive status of patients when using drugs that may increase the risk of dementia.

PMID:39673546 | DOI:10.1080/14740338.2024.2443106

Ophthalmol Ther. 2024 Dec 14. doi: 10.1007/s40123-024-01069-9. Online ahead of print.

ABSTRACT

INTRODUCTION: This work aimed to evaluate the safety and efficacy of hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricating drops in Indian subjects with dry eye disease (DED).

METHODS: This prospective, open-label, single-arm, phase IV study was conducted in India.

INCLUSION CRITERIA: Adults (18-65 years) with an average total ocular surface staining (TOSS) score ≥ 4, best-corrected visual acuity of ≥ 20/40 in each eye, tear break-up time (TBUT) ≤ 10 s, and dry eye questionnaire (DEQ-5) score ≥ 6. Subjects received the first dose of HPG-HA eye drops on day 1 and self-administered 1-2 drops four times daily for 90 ± 5 days.

PRIMARY ENDPOINTS: Frequency and characteristics of treatment-emergent adverse events (TEAEs) throughout the study and TOSS score at day 90. Secondary/other endpoints: Dry eye symptoms score (through dry eye questionnaire [DEQ-5]) and TBUT.

RESULTS: Of 175 subjects, 36 (20.6%) had ≥ 1 TEAE, and 27 (15.4%) of this reported ≥ 1 mild drug-related TEAE (eye irritation [n = 9], eye pruritus [n = 8], blurred vision [n = 6], increased lacrimation [n = 4], ocular hyperemia [n = 3], and ocular discomfort [n = 1]). One subject discontinued due to TEAEs, and none led to drug interruptions. No serious adverse events were reported. The mean TOSS score reduced from day 1 (6.12 ± 1.69, OU [both eyes]) to day 90 (2.40 ± 1.97, OU). The mean DEQ-5 score reduced from day 1 (11.50 ± 2.27) to day 90 (5.50 ± 2.50). TBUT increased from day 1 (right eye [OD], 5.70 ± 1.94; left eye [OS], 5.70 ± 1.96) to day 90 (OD, 9.51 ± 3.08; OS, 9.63 ± 3.01).

CONCLUSIONS: HPG-HA dual-polymer eye drop was safe and effective in relieving signs and symptoms of DED over 90 days in Indian subjects.

TRIAL REGISTRATION: Clinical Trial Registry India, CTRI/2022/03/041175.

PMID:39673038 | DOI:10.1007/s40123-024-01069-9

Pac Symp Biocomput. 2025;30:457-472.

ABSTRACT

Adverse drug responses (ADRs) result in over 7,000 deaths annually. Pharmacogenomic studies have shown that many ADRs are partially attributable to genetics. However, emerging data suggest that epigenetic mechanisms, such as DNA methylation (DNAm) also contribute to this variance. Understanding the impact of DNA methylation on drug response may minimize ADRs and improve the personalization of drug regimens. In this work, we identify DNA methylation sites that likely impact drug response phenotypes for anticoagulant and cardiometabolic drugs. We use instrumental variable analysis to integrate genome-wide association study (GWAS) summary statistics derived from electronic health records (EHRs) within the U.K. Biobank (UKBB) with methylation quantitative trait loci (mQTL) data from the Genetics of DNA Methylation Consortium (GoDMC). This approach allows us to achieve a robust sample size using the largest publicly available pharmacogenomic GWAS. For warfarin, we find 71 DNAm sites. Of those, 8 are near the gene VKORC1 and 48 are on chromosome 6 near the human leukocyte antigen (HLA) gene family. We also find 2 warfarin DNAm sites near the genes CYP2C9 and CYP2C19. For statins, we identify 17 DNAm sites. Eight are near the APOB gene, which encodes a carrier protein for low-density lipoprotein cholesterol (LDL-C). We find no novel significant epigenetic results for metformin.

PMID:39670389

Pac Symp Biocomput. 2025;30:360-376.

ABSTRACT

Patients experiencing adverse drug events (ADE) from polypharmaceutical regimens present a huge challenge to modern healthcare. While computational efforts may reduce the incidence of these ADEs, current strategies are typically non-generalizable for standard healthcare systems. To address this, we carried out a retrospective study aimed at developing a statistical approach to detect and quantify potential ADEs. The data foundation comprised of almost 2 million patients from two health regions in Denmark and their drug and laboratory data during the years 2011 to 2016. We developed a series of multistate Cox models to compute hazard ratios for changes in laboratory test results before and after drug exposure. By linking the results to data from a drug-drug interaction database, we found that the models showed potential for applications for medical safety agencies and improved efficiency for drug approval pipelines.

PMID:39670382

Arch Acad Emerg Med. 2024 Nov 11;13(1):e16. doi: 10.22037/aaem.v13i1.2470. eCollection 2025.

ABSTRACT

INTRODUCTION: Drug therapy-related problems (DTRP) can lead to avoidable negative health consequences, particularly during hospital admissions. This study aimed to assess the frequency, causes, and associated factors of DTRPs, which are detected by clinical pharmacists' interventions.

METHODS: This is a prospective cross-sectional study of patients admitted to the medical wards of Fakeeh University Hospital, UAE, over a three-month period from September 2022 to December 2022. The data of patients who were assessed by clinical pharmacists regarding the pretense and causes of DTRPs were collected and analyzed using SPSS version 27.0.

RESULTS: 310 patients with the mean age of 33.43 ± 19.98 years were studied (53.9% male). The highest percentage of patients were Asian (31.0%) and Arabs (30.6%). 79 (25.4%) cases had no DTRPs, while 231 (74.6) had DTRPs. The surgical ward had the highest frequency of DTRPs (41.0%). Improper drug selection with 79 cases, drug use without indication with 73 cases, and sub-therapeutic dosage with 26 cases were among the most common causes of DTRPs. Alcohol intake (p= 0.03), food allergy (p = 0.02), age group 31-40 years (p = 0.04), presence of co-morbidities (p = 0.01), family history of diseases (p = 0.02), and admission to the intensive care unit (ICU) (p = 0.01) were amongst the significantly associated factors of DTRPs. The acceptance status for clinical pharmacists' interventions were complete in 90.0% of cases, partial in 4.1 %, and rejection in 5.9%.

CONCLUSION: The study findings show a high prevalence of DTRPs due to drug/dose selection and drug use without indication. It seems that the participation of clinical pharmacists in multidisciplinary teams together with the presence of closed loop medication management facilitates the detection and correction of DTRPs.

PMID:39670239 | PMC:PMC11635537 | DOI:10.22037/aaem.v13i1.2470

Rev Bras Ginecol Obstet. 2024 Dec 4;46:e-rbgo77. doi: 10.61622/rbgo/2024rbgo77. eCollection 2024.

ABSTRACT

OBJECTIVE: An in-depth evaluation of the published evidence is needed on self-medication, specifically the evidence focusing on vulnerable groups, such as pregnant women. This scoping review aims to provide an overview of the differences in self-medication prevalence and study characteristics among different groups, while identifying gaps in the literature.

METHODS: A literature search was performed in PubMed and Web of Science, including articles published in the last 10 years for the pregnant women group (PWG) and the general population group (GPG). Data on study design, self-medication prevalence, medications used, and other variables were collected, tabulated, and summarized.

RESULTS: From 2888 screened articles, 75 were considered including 108,559 individuals. The self-medication (SM) in the PWG ranged from 2.6 to 72.4% and most studies had an SM prevalence between 21 and 50% and in the GPG, 32 from 50 studies had a SM prevalence higher than 50%. The reviewed studies varied considerably in methodology, requiring careful interpretation. While most of the studies assessed self-medication during the entire pregnancy, self-medication definition was often inconsistent between studies. Acetaminophen was the most used medication and headache was the most frequent symptom leading to self-medication initiation in the PWG.

CONCLUSIONS: Self-medication among pregnant women showed a lower prevalence when compared to the general population. The medications used and symptoms reported were similar between groups. However, methodological differences must be carefully considered. Pregnant women should carefully follow their physicians' advice before initiating self-medication to avoid preventable maternal and fetal adverse effects.

PMID:39669310 | PMC:PMC11637455 | DOI:10.61622/rbgo/2024rbgo77

J Int Med Res. 2024 Dec;52(12):3000605241302304. doi: 10.1177/03000605241302304.

ABSTRACT

OBJECTIVE: This systematic review aimed to provide a comprehensive overview of the application of machine learning (ML) in predicting multiple adverse drug events (ADEs) using electronic health record (EHR) data.

METHODS: Systematic searches were conducted using PubMed, Web of Science, Embase, and IEEE Xplore from database inception until 21 November 2023. Studies that developed ML models for predicting multiple ADEs based on EHR data were included.

RESULTS: Ten studies met the inclusion criteria. Twenty ML methods were reported, most commonly random forest (RF, n = 9), followed by AdaBoost (n = 4), eXtreme Gradient Boosting (n = 3), and support vector machine (n = 3). The mean area under the summary receiver operator characteristics curve (AUC) was 0.76 (95% confidence interval [CI] = 0.26-0.95). RF combined with resampling-based approaches achieved high AUCs (0.9448-0.9457). The common risk factors of ADEs included the length of hospital stay, number of prescribed drugs, and admission type. The pooled estimated AUC was 0.72 (95% CI = 0.68-0.75).

CONCLUSIONS: Future studies should adhere to more rigorous reporting standards and consider new ML methods to facilitate the application of ML models in clinical practice.

PMID:39668733 | DOI:10.1177/03000605241302304

Int J Older People Nurs. 2025 Jan;20(1):e70003. doi: 10.1111/opn.70003.

ABSTRACT

BACKGROUND: Age, polypharmacy and comorbidity are examples of known factors that increase the risk of adverse drug reactions in patients. The use of high-risk medication also entails a heightened risk of harm. There is currently no information available on the home care patients' experiences and medication burden experienced due to their high-risk medication use and how they manage their medication. Further investigation with regard to this combination is necessary. The patient's experiences and medication burden related to high-risk medication use can be taken into account when drawing up guidelines and standards of care for healthcare professionals.

OBJECTIVES: To describe home care patients' experiences and medication burden related to high-risk medication use, more specifically how patients manage their high-risk medication use, which professional support they receive and which potential adverse drug reactions they experience.

DESIGN: A cross-sectional study of home care patients in Belgium, aged 65 years and older who took at least one high-risk medication.

RESULTS: In our population of 106 home care patients, a median use of 8 medications per patient is reported, of which 2 can be considered high-risk medication. Metformin, insulin and lormetazepam are the most frequently used high-risk medications. Home care patients believe their medication is important to them, are able to manage the intake and seem to have a high level of therapy adherence. Most patients do not believe their medication intake implies a certain risk. Most patients are supported by a home care nurse for the preparation of their medication. A mean number of 5 symptoms/potential adverse drug reactions is reported out of the 21 potential adverse drug reactions questioned. The potential adverse drug reaction most frequently attributed to medication use was bleeding.

CONCLUSIONS: Practice guidelines with detailed medicine-specific protocols are needed to enhance (high-risk) medication-related care in an overall high-risk medication policy. Understanding the patient's risk experiences and communicating with the patient is important to ensure safe medication care but also to identify patients at risk for nonadherence and adverse reactions. The patient's experiences with their medication intake provide rich information for healthcare providers and should therefore be included in patient observations. Home care nurses should closely follow up on the home care patient's medication therapy with respect for the patient's autonomy.

PMID:39663656 | DOI:10.1111/opn.70003

JAMA Dermatol. 2024 Dec 11. doi: 10.1001/jamadermatol.2024.5059. Online ahead of print.

ABSTRACT

IMPORTANCE: Psoriasis is a chronic, immune-mediated skin disease with an unmet need for biologic treatment options.

OBJECTIVE: To assess the safety, pharmacokinetics, and efficacy of QX004N in healthy individuals and patients with moderate to severe plaque psoriasis in China.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was composed of 2 parts. Part 1 was a first-in-human, single-ascending-dose, phase 1a clinical trial conducted from November 2, 2021, to January 16, 2023. Part 2 was a double-blind, multiple dose-escalation, phase 1b clinical trial conducted from February 15, 2023, to January 5, 2024, at 5 clinical centers in China, involving patients with moderate to severe plaque psoriasis.

INTERVENTIONS: In part 1, healthy participants in each cohort were assigned in a 4:1 ratio to receive a single subcutaneous injection of QX004N (ranging from 10 mg to 600 mg) or placebo. In part 2, patients in each cohort were assigned in a 4:1 ratio to receive QX004N or placebo at doses of 150 mg, 300 mg, and 600 mg once every 2 weeks.

MAIN OUTCOMES AND MEASURES: For part 1, the primary outcome was the safety of a single dose of QX004N in healthy participants, and the secondary outcome was the pharmacokinetic profile. For part 2, the primary efficacy end point was the proportion of patients achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) by week 12; other efficacy end points were considered secondary.

RESULTS: The phase 1a clinical trial (part 1) enrolled 55 healthy participants (mean [SD] age, 35.9 [6.0] years; 30 [54.5%] female), and the phase 1b clinical trial (part 2) enrolled 30 patients with moderate to severe plaque psoriasis. The mean (SD) age of QX004N-treated participants in part 2 was 41.4 (7.5) years, and 19 of 24 QX004N-treated participants (79.2%) were male. The mean (SD) age of the placebo cohort in part 2 was 35.3 (8.4) years, and 5 of 6 placebo-treated participants (83.3%) were male. QX004N exhibited linear pharmacokinetics and was tolerated well in both healthy participants and patients with psoriasis. Most adverse events were mild to moderate in severity, with no drug-related serious adverse events reported. The proportion of patients receiving QX004N who achieved PASI 75 at week 12 and PASI 90 (90% improvement in PASI) at week 16 in the 150-mg, 300-mg, and 600-mg cohorts was 100%, significantly higher than that in the placebo cohorts (33.3%). The maximum proportion of patients achieving Investigator's Global Assessment score of 0 or 1 was 100% in the 3 QX004N cohorts.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, QX004N was well tolerated and demonstrated superior efficacy compared to placebo in patients with moderate to severe plaque psoriasis.

TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: CTR20212313 and CTR20223457.

PMID:39661362 | DOI:10.1001/jamadermatol.2024.5059