Current drug safety最新文献

{"title":"Evaluation of Hospital Antibiotic Consumption during the COVID-19 Pandemic.","authors":"Biljana Lazarova, Biljana Eftimova, Maja Simonoska Crcarevska, Tamara Tashkov, Dijana Miceva, Zorica Naumovska","doi":"10.2174/0115748863385928250911004158","DOIUrl":"https://doi.org/10.2174/0115748863385928250911004158","url":null,"abstract":"<p><strong>Introduction: </strong>Antimicrobial resistance (AMR) is a pressing global health issue exacerbated by the overuse of antibiotics during the COVID-19 pandemic. Despite WHO guidelines against antibiotics for mild-to-moderate COVID-19 cases without bacterial co-infection, significant misuse has been reported globally. This study aimed to evaluate antibiotic consumption during the COVID-19 pandemic at a hospital in North Macedonia and to analyze adherence to WHO guidelines, with a focus on antimicrobial stewardship, using the ATC and WHO AWaRe classification systems.</p><p><strong>Objective: </strong>To analyze antibiotic utilization trends from January 2020 to December 2021 and assess adherence to WHO guidelines, focusing on the potential impact on AMR.</p><p><strong>Method: </strong>This retrospective observational study measured antibiotic consumption in defined daily doses (DDD) per 100 occupied bed-days (DDD/100 OBD) using ATC and WHO AWaRe classifications. Data were obtained only from ICU inpatients treated at the Clinical Hospital in Shtip, North Macedonia. Trends in annual consumption were analyzed, including rate-of-change calculations for individual antibiotics between 2020 and 2021.</p><p><strong>Result: </strong>Total antibiotic consumption decreased from 2902.6 DDD/100 OBD in 2020 to 2286.5 DDD/100 OBD in 2021. A third-generation cephalosporin, ceftriaxone, was the most consumed antibiotic, accounting for 57.62% of total consumption in 2020 and 48.55% in 2021. Tetracycline use slightly increased from 13.88% in 2020 to 15.83% in 2021. Fluoroquinolone use decreased significantly from 15.22% in 2020 to 6.5% in 2021. Carbapenem consumption rose sharply from 1.7% in 2020 to 14.37% in 2021, while azithromycin use declined threefold. Antibiotics in the Access group accounted for less than 20% of total usage, while those in the Watch group predominated.</p><p><strong>Discussion: </strong>The study highlights a continued reliance on broad-spectrum antibiotics during the pandemic, diverging from WHO recommendations emphasizing Access to antibiotics. These trends suggest inadequate implementation of antimicrobial stewardship practices and raise concerns about their long-term impact on AMR. Limitations include the retrospective, single-center design, which may limit the generalizability of the findings.</p><p><strong>Conclusion: </strong>The findings underscore the high dependency on Watch category antibiotics and a limited focus on Access antibiotics, contrary to WHO recommendations. This highlights the urgent need for robust antimicrobial stewardship programs to control inappropriate antibiotic use and combat AMR.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clopidogrel-Induced Liver Injury: Clinical Features, Diagnostic Challenges, and Recovery Time - A Systematic Review of Current Reported Cases.","authors":"Thanathip Suenghataiphorn, Narisara Tribuddharat, Pojsakorn Danpanichkul, Narathorn Kulthamrongsri","doi":"10.2174/0115748863392988250812094745","DOIUrl":"https://doi.org/10.2174/0115748863392988250812094745","url":null,"abstract":"<p><strong>Introduction: </strong>Clopidogrel is a widely used agent in the management of cardiovascular disease. However, there have been reports of liver injury associated with its use, some of which have resulted in death. The atypical presentation of this liver injury has often led to delayed diagnosis and inappropriate treatment. We conducted a systematic review of reported cases to summarize the clinical characteristics, diagnostic approaches, and recovery durations associated with clopidogrel-induced liver injury.</p><p><strong>Method: </strong>Electronic databases, including MEDLINE, OVID, and EMBASE, were used to identify eligible studies from inception to December 2024. Eligible cases were required to have a clear diagnosis of clopidogrel-induced liver injury. Descriptive analysis and Kaplan-Meier analysis were used to explore the clinical features and survival durations.</p><p><strong>Results: </strong>Our systematic review included 29 eligible studies, comprising 29 cases of hepatic abscess with a mean age of 67 years (58% male). Patients presented with abdominal pain in only 24% of cases, fever in 17%, but jaundice in 55%. The median recovery time was 25 days after the final diagnosis. A hepatocellular pattern was reported in 37% of cases. Diagnostic criteria were proposed and summarized based on these findings.</p><p><strong>Conclusion: </strong>Clinicians should be aware of clopidogrel-induced liver injury, as patients can present with a wide range of symptoms. Implementing our proposed diagnostic criteria is recommended to facilitate prompt diagnosis and treatment of clopidogrel-induced liver injury.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global Analysis of Regulatory Frameworks and Drug Safety Standards in the Drug Approval Process.","authors":"Virendra S Gomase, Rupali Sharma, Suchita P Dhamane","doi":"10.2174/0115748863392869250827042742","DOIUrl":"https://doi.org/10.2174/0115748863392869250827042742","url":null,"abstract":"<p><p>The drug approval and review process plays a crucial role in the pharmaceutical industry, aiming to ensure that newly marketed drugs are safe, effective, and of high quality. Regulatory authorities overseeing this process, tailored to geographically distinct needs, include the U.S. FDA, EMA, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), China's National Medical Products Administration (NMPA), and India's Central Drugs Standard Control Organization (CDSCO). This analysis offers insight into the various drug approval processes employed by these authorities and examines the International Council for Harmonisation's ongoing efforts to establish a global consensus on drug regulation standards. It also compares regulatory pathways and highlights current harmonization initiatives. The focus is on analyzing operational aspects of drug regulation and identifying challenges arising from these regulations. The ultimate goal is to present a clear understanding of the intricacies and dynamics of the global drug approval process. Regulating the drug approval process is essential to ensure that new drugs are safe for public consumption, as the introduction of a new drug often faces numerous hurdles beyond safety and efficacy. The challenges highlighted include variations in regulations between authorities, the complexity of modern therapeutics, and the balance between safety and speed. This paper provides an overview of innovations in drug development, their impact on regulatory pathways, ongoing harmonization efforts, and potential obstacles that may arise during the regulatory process.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cisplatin-Based Combinations-Associated Vasculopathy - A Disproportionality Analysis of Real-World Pharmacovigilance Data.","authors":"Krutarth K Pandya, Chitsimran Mann, Wei Fang, Brijesh Patel","doi":"10.2174/0115748863312388240829190436","DOIUrl":"https://doi.org/10.2174/0115748863312388240829190436","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Cisplatin, a platinum-based antineoplastic agent belonging to the alkylating class, is one of the most widely used chemotherapeutic agents in the treatment of solid tumors and hematologic malignancies. Cisplatin works by forming covalent bonds in DNA, resulting in cell cycle arrest, inadequate repair, and ultimately, apoptotic or non-apoptotic cell death. Despite its efficacy, cisplatin is known to be highly toxic, showing nephrological, Gastrointestinal (GI), and hepatotoxicity, but there is limited data on its association with adverse vascular events. Hence, we aimed to investigate the potential risk of drug-related adverse vascular events associated with four cisplatin-based combination therapies using the FDA Adverse Events Reporting System (FAERS).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We used the FDA Adverse Events Reporting System (FAERS) database to look for reported Adverse Events (AEs) for cisplatin-based combinations. In the current study, a case/non-case disproportionality analysis has been performed using the Reporting Odds Ratio (ROR) to investigate whether there is a signal for a potentially increased risk of drug-related vascular AE using the 2016-2020 FAERS datasets. To look for all vascular AEs, we included peripheral vascular events, cerebrovascular events, coronary artery-related events, venothromboembolic events, and other arterial events. \"Cases\" were defined as patients treated with cisplatin and any one of etoposide, gemcitabine, paclitaxel or docetaxel, and 5-fluorouracil or capecitabine, and have reported a composite event. Hence, cases were divided into 4 groups. Reporting Odds Ratio (ROR) and Information Component (IC) were derived to look for signals for these AEs being significant when compared to non-cases. All data processing and statistical analyses were performed using R 4.2.1.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 2016 and 2020, 23,513 AEs were reported for patients who used cisplatinbased combinations, and 6,952,691 AEs in patients who did not. Baseline characteristics, including age, sex, and geographic distribution, were also reported. Looking at ROR and IC, all 4 groups showed statistically significant vasculopathies reported for cisplatin-based combinations, except for cisplatin and paclitaxel/docetaxel where there was a trend in ROR, but it did not reach statistical significance. It also gave the least signal for associated vasculopathy, while cisplatin and gemcitabine gave the highest signal with both ROR and IC for associated vasculopathy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Overall, these increased vasculopathies related to the use of cisplatin-based combinations can be related to the increased pro-thrombotic state in these patients. The results of this study highlight the need for caution when using cisplatin-based chemotherapy and the importance of monitoring patients for thrombotic events and other vasculopathies. Patient-specific factors, such as the type and stage of ca","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144834411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethosomes- Novel Drug Delivery System in Herbal Formulations-A Review.","authors":"Pragati Kumar, Yatendra Singh, Shashi Pratap Singh, Madhup Ojha, Pranay Wal","doi":"10.2174/0115748863382305250725053105","DOIUrl":"https://doi.org/10.2174/0115748863382305250725053105","url":null,"abstract":"<p><p>A transdermal drug delivery system is a convenient drug delivery system where the drug enters the systemic circulation through the protective barrier, i.e., skin. Ethosomes are the ethanolic phospholipid vesicles, which are mainly used for transdermal delivery of medicines. They are nano-vesicular carriers for the topical application of the drugs. The major components of ethosomes are phospholipids, ethanol at relatively high concentrations (up to 50%), and water. The vesicles' composition and structure enhance their ability to entrap molecules with numerous physicochemical characteristics and bring them to the skin's deep layers. Because of their enhanced skin penetration, improved drug delivery, and higher drug entrapment efficiency, ethosomes have become more significant in the field of research. Skin acts as a major target and main barrier for topical or transdermal drug delivery and hence several approaches have been developed to weaken this skin barrier. Vesicular systems like ethosomes are the key approaches to increasing the skin penetration of medicines and various cosmetic components. Ethanol has been added to vesicular systems to create elastic nanovesicles because it is an effective penetration enhancer. For stability and simplicity of use, ethosomal dispersions are added to gels, patches, and creams. This review focuses on research using ethosomal formulations containing natural active compounds for the treatment of skin problems that has been done in vitro, in vivo in animal models, and on people in clinical investigations. Ethosomal systems have been shown to effectively control a variety of skin conditions, including bacterial and fungal infections, inflammation, acne vulgaris, arthritis, skin cancer, etc. Furthermore, ethosomes loaded with various naturally occurring components for cosmetic applications are also reported. The conception of new dermal therapies was made possible by the effective treatments, their good safety profile, and their lack of toxicity or irritation.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-Induced Acute Kidney Injury: Mechanisms, Biomarkers, and Therapeutic Strategies.","authors":"Baban Thawkar, Fariah Rizwani, Khush Jain","doi":"10.2174/0115748863362596250627155607","DOIUrl":"https://doi.org/10.2174/0115748863362596250627155607","url":null,"abstract":"<p><p>Acute kidney injury (AKI) is a severe and life-threatening complication of drug therapy, a significant risk to patient well-being, with high morbidity and death rates. An increasing proportion of AKI cases are mainly caused due to drug-induced nephrotoxicity; despite its prevalence, the exact study of causative drugs is still unclear. AKI is often caused by kidney damage, reducing the kidneys' ability to detoxify, eventually leading to nephrotoxicity. Drug-induced nephrotoxicity often happens through various mechanisms such as crystal nephropathy, oxidative stress, reduced flow to the kidneys, damage to kidney cells, and thrombotic microangiopathy. Epidemiology of drug-induced nephrotoxicity focuses on how prevalent it is and the factors that increase the nephrotoxicity. Specific biomarkers have been found to assess nephrotoxicity for early and accurate diagnosis of kidney damage. This review focuses on explaining drug-induced nephrotoxicity mechanisms for commonly used agents such as non-steroidal anti-inflammatory drugs, immunosuppressants, antibiotics, anticancer agents, and antifungals. It also covers specific biomarkers and respective treatment approaches. Additionally, protective agents and their mechanisms in preventing nephrotoxicity are also analyzed, including their antioxidant and anti-inflammatory potential and other drug-based interventions. This review discusses various therapeutic studies using experimental models, offering invaluable insights into the cellular processes and pathways involved in developing prevention strategies. By advancing our understanding of the mechanisms behind drug-induced nephrotoxicity, it is aimed to improve patient care and reduce health-related complications.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mitochondrial Dysfunction in Neurodegenerative Disorders: Role of Prototype Targeted Drug Delivery Solutions.","authors":"Dilpreet Singh","doi":"10.2174/0115748863375490250626163609","DOIUrl":"https://doi.org/10.2174/0115748863375490250626163609","url":null,"abstract":"<p><p>Mitochondrial dysfunction plays a central role in the pathogenesis of neurodegenerative disorders, including Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease (HD), and Amyotrophic Lateral Sclerosis (ALS). Targeted drug delivery to mitochondria represents a promising therapeutic strategy to mitigate neuronal degeneration and preserve mitochondrial function in these devastating conditions. This review provides a comprehensive overview of recent advances in targeted drug delivery solutions for mitochondrial dysfunction in neurodegenerative disorders. The mechanisms underlying mitochondrial dysfunction in AD, PD, HD, and ALS are explored, highlighting the specific challenges and opportunities for therapeutic intervention. Emerging drug delivery technologies are discussed, including mitochondriaresponsive systems, nanoparticles, peptides, and viral vectors, designed to deliver therapeutic agents directly to mitochondria along with suitable case studies. Furthermore, preclinical and clinical studies evaluating the efficacy and safety of mitochondria-targeted therapeutics are reviewed, and future directions and challenges in the field are outlined. By elucidating the intersection of mitochondrial biology and drug delivery, this review aims to inspire further research and innovation toward effective treatments for neurodegenerative diseases.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Unusual Adverse Drug Reaction to Thalidomide: A Case Report.","authors":"Akshay Sankar Peethambaran, Neel Prabha, Prateek Pujar","doi":"10.2174/0115748863378453250623061903","DOIUrl":"https://doi.org/10.2174/0115748863378453250623061903","url":null,"abstract":"<p><strong>Background: </strong>Thalidomide has emerged as a novel antitumor drug with antiangiogenic and immunomodulatory properties. It was taken off the market in the early 1960s due to its infamous connection with congenital defects. Recently, the FDA approved thalidomide for treating erythema nodosum leprosum, adhering to strict guidelines and safety measures. Sensory peripheral neuropathy and teratogenicity, fatigue, vertigo, headache, gastrointestinal issues, skin eruptions, dizziness, galactorrhoea, decreased libido, and constitutional symptoms like fever, weakness, headaches, and weight loss are the main adverse effects of thalidomide.</p><p><strong>Case report: </strong>We report a case of a 46-year-old female diagnosed with lepromatous leprosy on multibacillary multidrug therapy presenting with unusual adverse reactions, such as generalized burning sensation, breathlessness, and low backache after the intake of thalidomide.</p><p><strong>Conclusion: </strong>We describe an unusual adverse reaction to thalidomide that has not previously been reported in the literature and aim to alert clinicians about the unusual, adverse reaction as an uncommon side effect of thalidomide and to always keep in mind if the patient develops any of these symptoms.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence and Impact of Antibodies Against TNF Alpha Inhibitors in Rheumatoid Arthritis and Spondyloarthritis: Systematic Review and Meta- Analysis with Subgroup Analysis.","authors":"Ines Mahmoud, Selma Bouden, Rim Charfi, Yosr Abid, Chedly Dziri, Mouna Ben Sassi, Leila Rouached, Aicha Ben Tekaya, Raoudha Tekaya, Olfa Saidane, Leila Abdelmoula","doi":"10.2174/0115748863354926250620200719","DOIUrl":"https://doi.org/10.2174/0115748863354926250620200719","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to estimate the global prevalence of anti-drug antibodies (ADAb), their impact on response, and associated factors in adults with rheumatoid arthritis (RA) and spondyloarthritis (SpA) treated by TNF alpha inhibitors (TNF-i).</p><p><strong>Methods: </strong>We searched PubMed, MEDLINE, Cochrane, Web of Science, and Scopus for observational, population-based studies published between Jan 2010 and Sept 2021. We included studies that reported the prevalence of ADAb (our main outcome) and examined their impact on treatment efficacy in adults treated with TNF-i (secondary outcome). To investigate heterogeneity, we used a Q-test and predictive interval.</p><p><strong>Results: </strong>The overall global prevalence of ADAb in RA was 20.8% (95%CI,6.8-25.5) (95%PI,6.12-51.42) and in SpA 24.8% (95%CI,19.1-31.5) (95%PI,7.31-57.98). There was no significant difference in the prevalence of ADAb between infliximab (IFX) and adalimumab (ADA) in RA (p=0.21) nor in SpA (p=0.46). There was a statistically significant difference between IFX and etanercept (ETN) in RA (p<0.0001) as well as in SpA (p=0.001) and, likewise, between ADA and ETN in RA (p<0.0001) and in SpA (p=0.002). Study by subgroups of the impact of immunogenicity on response, according to the type of TNF-i, showed that the mean OR for ADA was 0.152 (CI 95%, 0.054 to 0.427) and for IFX was 0.144 (CI 95%, 0.055 to 0.378). The pairwise comparison of ADA vs IFX was not statistically significant (p=0.94). In subgroup analysis, according to the disease, the mean OR for RA was 0.149 (IC 95% 0.064 to 0.347) and for SpA was 0.303 (IC95% 0.103 to 0.890). The pairwise comparison of RA vs SpA was not statistically significant. The use of methotrexate tends to reduce the development of ADAb in RA and SpA with an OR=0.472 (CI95%,0.324-0.689) (PI95%,0.16-1.39).</p><p><strong>Conclusion: </strong>ADAb were equally prevalent in RA and SpA treated with TNF-i. Immunogenicity was associated with response to treatment and influenced by concomitant use of methotrexate.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144559465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing Pharmacovigilance in Pharmaceutical Companies: A Comparative Study of Electronic Reporting Before and After Implementation.","authors":"Ghita Meknassi Salime, Nihal Bhirich, Abdelghani Asraoui, Moulay El Hassan El Karimi, Younes Rahali, Houda Sefiani","doi":"10.2174/0115748863339571250610103928","DOIUrl":"https://doi.org/10.2174/0115748863339571250610103928","url":null,"abstract":"<p><strong>Background: </strong>Since 2016, Moroccan pharmaceutical companies have been required to report adverse effects linked to their medicines. Initially, reports were submitted using the CIOMS form, sent by normal mail to le Centre Antipoison et de Pharmacovigilance du Maroc, then using XML files in ICH E2B format, sent electronically. In 2021, a \"vigiflow e-reporting for industry\" standardized online reporting system was implemented. The primary objective of this study was to evaluate the pharmaceutical companies' use of electronic reporting. Secondarily, the study aimed to assess the quality of adverse drug reaction reports by comparing completeness scores across the three reporting means.</p><p><strong>Methods: </strong>All individual case safety reports sent by pharmaceutical companies from January 1, 2019, to December 31, 2023, were extracted from Vigibase®. A quantitative and qualitative analysis was conducted, and a statistical comparison of data was performed using p-values. VigiGrade completeness score was calculated for a sample size selected.</p><p><strong>Results: </strong>The highest number of reports were from E-reporting (50%), followed by CIOMS (29%) and E2B (21%). Between 2019 and 2021, CIOMS and E2B notifications decreased along with reporting laboratories. However, after 2021, electronic reporting increased steadily alongside reporting companies. Comparing vigiGrade completeness score across reporting means revealed no statistically significant differences (p = 0.094 > 0.05).</p><p><strong>Conclusion: </strong>Electronic reporting shows quantitative effectiveness and consistent quality. Its adoption remains limited and requires continuous strengthening, particularly through increased awareness among pharmaceutical companies.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}