Drug, Healthcare and Patient Safety最新文献

{"title":"Validity of Routine Health Data To Identify Safety Outcomes of Interest For Covid-19 Vaccines and Therapeutics in the Context of the Emerging Pandemic: A Comprehensive Literature Review","authors":"Kirsty Andresen, Marina Hinojosa-Campos, B. Podmore, Myriam Drysdale, Nawab Qizilbash, Marianne Cunnington","doi":"10.2147/DHPS.S415292","DOIUrl":"https://doi.org/10.2147/DHPS.S415292","url":null,"abstract":"Introduction Regulatory guidance encourages transparent reporting of information on the quality and validity of electronic health record data being used to generate real-world benefit-risk evidence for vaccines and therapeutics. We aimed to provide an overview of the availability of validated diagnostic algorithms for selected safety endpoints for Coronavirus disease 2019 (COVID-19) vaccines and therapeutics in the context of the emerging pandemic prior to December 2020. Methods We reviewed the literature up to December 2020 to identify validation studies for various safety events of interest, including myocardial infarction, arrhythmia, myocarditis, acute cardiac injury, vasculitis/vasculopathy, venous thromboembolism, stroke, respiratory distress syndrome (RDS), pneumonitis, cytokine release syndrome (CRS), multiple organ dysfunction syndrome, and renal failure. We included studies published between 2015 and 2020 that were considered high quality assessed with QUADAS and that reported positive predictive values (PPVs). Results Out of 43 identified studies, we found that diagnostic algorithms for cardiovascular outcomes were supported by the highest number of validation studies (n=17). Accurate algorithms are available for myocardial infarction (median PPV 80%; IQR 22%), arrhythmia (PPV range >70%), venous thromboembolism (median PPV: 73%) and ischaemic stroke (PPV range ≥85%). We found a lack of validation studies for less common respiratory and cardiac safety outcomes of interest (eg, pneumonitis and myocarditis), as well as for COVID-specific complications (CRS, RDS). Conclusion There is a need for better understanding of barriers to conducting validation studies, including data governance restrictions. Regulatory guidance should promote embedding validation within real-world EHR research used for decision-making.","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"265 33‐37","pages":"1 - 17"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139395226","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":"Assessment of Medication Prescribing Pattern in COVID-19 Admitted Patients by Using WHO Prescribing Indicators at Eka Kotebe General Hospital, Addis Ababa, Ethiopia; Retrospective Cross-Sectional Study.","authors":"Belete Birhanu, Solomon Debebe, Tsegaye Nigussie, Alemayehu Dandana","doi":"10.2147/DHPS.S416310","DOIUrl":"10.2147/DHPS.S416310","url":null,"abstract":"<p><strong>Introduction: </strong>Drug therapy is a crucial component of health care and plays a vital role in preserving life. However, the irrational utilization of medications is a worldwide issue, particularly in developing nations.</p><p><strong>Objective: </strong>To assess the prescription patterns of medications based on the World Health Organization's prescribing indicator among patients who were admitted with COVID-19 to Eka Kotebe General Hospital in Addis Ababa, Ethiopia, in June 2021.</p><p><strong>Methods: </strong>A retrospective cross-sectional analysis was conducted to evaluate the prescription patterns of medications in patients admitted with COVID-19 at Eka Kotebe General Hospital from June 2021 to September 15, 2021. The data were extracted using card review formats and prescription assessment questionnaires, and a systematic random sampling procedure was employed to collect the data. Finally, the data were coded and analyzed using SPSS version 26 to meet the study's objectives. Descriptive statistics were employed to determine the frequency and prevalence, and the results were presented using tables and figures.</p><p><strong>Results and discussion: </strong>The average number of medications prescribed per encounter was 2.64, which is above the WHO standard. The percentage of encounters in which antibiotics and injections were prescribed was 80.20% and 99.2%, which exceeds the upper limit of WHO standard range (20-26.8%) and (13.4-24.1%), respectively. All medications were prescribed using generic names and were included in Eka Kotebe General Hospital's essential drug list, which is in line with WHO standards.</p><p><strong>Conclusion: </strong>The degree of polypharmacy and the prescription practices for antibiotics and injections at Eka Kotebe General Hospital deviated from the World Health Organization's standards. As a result, there is a need to enhance medical education programs to rationalize the prescription of antibiotics and injection use.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"171-177"},"PeriodicalIF":1.6,"publicationDate":"2023-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71520808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety Aspects and Rational Use of Single Intramuscular Dose Ceftriaxone: Clinical Insights on the Management of Uncomplicated Gonococcal Infections.","authors":"George P Allen, Haley L Morrill","doi":"10.2147/DHPS.S350763","DOIUrl":"10.2147/DHPS.S350763","url":null,"abstract":"<p><p>Gonorrhea, a sexually transmitted infection caused by <i>Neisseria gonorrhoeae</i>, is a grave public health concern. Gonorrhea is the second most reported sexually transmitted infection worldwide. The treatment of uncomplicated gonococcal infections has evolved dramatically in response to the emergence of antimicrobial resistance. Multiple resistance mechanisms (for example, beta-lactamase production, antimicrobial efflux, and target site modification) exist, some of which may cause multidrug-resistance. Ceftriaxone was first recommended as an option for uncomplicated gonococcal infections in 1985, and it is now a mainstay of therapy in all clinical practice guidelines. Ceftriaxone has consistently shown high microbiologic cure rates in clinical trials, and it has demonstrated an excellent safety profile. Although its use may be limited in patients with hypersensitivity to penicillins, the risk of using ceftriaxone in such patients is overestimated. The emergence of reduced ceftriaxone susceptibility in <i>N. gonorrhoeae</i>, coupled with a lack of diverse treatment alternatives and the limited pipeline of new antimicrobials, is a significant threat to the treatment of gonorrhea.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"159-170"},"PeriodicalIF":1.6,"publicationDate":"2023-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629349/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71520809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Prevalence and Severity of Potential Drug-Drug Interactions in Internal Medicine Ward at Soba Teaching Hospital.","authors":"Riham M Hamadouk, Einass Mahmoud Alshareif, Huda M Hamad, Bashir A Yousef","doi":"10.2147/DHPS.S436458","DOIUrl":"https://doi.org/10.2147/DHPS.S436458","url":null,"abstract":"<p><strong>Background: </strong>Multiple drug therapies are commonly used to achieve a desired therapeutic goal, especially in hospitalized patients. However, drug-drug interactions might occur and threaten the patients' safety.</p><p><strong>Objective: </strong>This study aims to assess the prevalence and severity of potential drug-drug interactions (PDDIs) in the internal medicine ward at Soba Teaching Hospital.</p><p><strong>Methods: </strong>A retrospective cross-sectional hospital-based study was carried out in the internal medicine ward at Soba Teaching Hospital from June 2021 to December 2021. The data was collected from patients' medical records. PDDIs were identified using Lexicomp^® drug interaction software.</p><p><strong>Results: </strong>A total of 377 patients were included in this study, and overall prevalence of PDDIs was 62.9%. We have identified 989 potential DDIs and 345 pairs of interacting drugs, the mean of the PDDIs per patient was 4.17 ± 4.079. Among 345 PDDIs most were of moderate interactions 70.1% (n=242) followed by Minor interactions 19.1% (n=66). The most common type of interaction was of category C representing 63.5% (n=219). A significant association was observed between the occurrence of PDDIs with patients' age, presence of chronic diseases, length of hospital stay, and number of medications received by the patients.</p><p><strong>Conclusion: </strong>Drug-drug interactions were highly prevalent in the internal medicine ward. Therefore, certain attempts are required to increase the awareness of the physicians about these interactions and minimize their occurrence.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"149-157"},"PeriodicalIF":1.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10625782/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71479377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Sensitivity, Specificity, and Accuracy of ChatGPT-3.5, ChatGPT-4, Bing AI, and Bard Against Conventional Drug-Drug Interactions Clinical Tools.","authors":"Fahmi Y Al-Ashwal, Mohammed Zawiah, Lobna Gharaibeh, Rana Abu-Farha, Ahmad Naoras Bitar","doi":"10.2147/DHPS.S425858","DOIUrl":"10.2147/DHPS.S425858","url":null,"abstract":"<p><strong>Background: </strong>AI platforms are equipped with advanced ‎algorithms that have the potential to offer a wide range of ‎applications in healthcare services. However, information about the accuracy of AI chatbots against ‎conventional drug-drug interaction tools is limited‎. This study aimed to assess the sensitivity, specificity, and accuracy of ChatGPT-3.5, ChatGPT-4, Bing AI, and Bard in predicting drug-drug interactions.</p><p><strong>Methods: </strong>AI-based chatbots (ie, ChatGPT-3.5, ChatGPT-4, Microsoft Bing AI, and Google Bard) were compared for their abilities to detect clinically relevant DDIs for 255 drug pairs. Descriptive statistics, such as specificity, sensitivity, accuracy, negative predictive value (NPV), and positive predictive value (PPV), were calculated for each tool.</p><p><strong>Results: </strong>When a subscription tool was used as a reference, the specificity ranged from a low of 0.372 (ChatGPT-3.5) to a high of 0.769 (Microsoft Bing AI). Also, Microsoft Bing AI had the highest performance with an accuracy score of 0.788, with ChatGPT-3.5 having the lowest accuracy rate of 0.469. There was an overall improvement in performance for all the programs when the reference tool switched to a free DDI source, but still, ChatGPT-3.5 had the lowest specificity (0.392) and accuracy (0.525), and Microsoft Bing AI demonstrated the highest specificity (0.892) and accuracy (0.890). When assessing the consistency of accuracy across two different drug classes, ChatGPT-3.5 and ChatGPT-4 showed the highest ‎variability in accuracy. In addition, ChatGPT-3.5, ChatGPT-4, and Bard exhibited the highest ‎fluctuations in specificity when analyzing two medications belonging to the same drug class.</p><p><strong>Conclusion: </strong>Bing AI had the highest accuracy and specificity, outperforming Google's Bard, ChatGPT-3.5, and ChatGPT-4. The findings highlight the significant potential these AI tools hold in transforming patient care. While the current AI platforms evaluated are not without limitations, their ability to quickly analyze potentially significant interactions with good sensitivity suggests a promising step towards improved patient safety.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"137-147"},"PeriodicalIF":2.2,"publicationDate":"2023-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/c7/dhps-15-137.PMC10518176.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41111482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Rational Drug Use Based on WHO/INRUD Core Drug Use Indicators in a Secondary Care Hospital: A Cross-Sectional Study in Western Uganda.","authors":"Narayana Goruntla,&nbsp;Joackim Ssesanga,&nbsp;Bhavana Reddy Bommireddy,&nbsp;Durga Prasad Thammisetty,&nbsp;Veerabhadrappa Kasturi Vishwanathasetty,&nbsp;Joseph Obiezu Chukwujekwu Ezeonwumelu,&nbsp;Sarad Pawar Naik Bukke","doi":"10.2147/DHPS.S424050","DOIUrl":"https://doi.org/10.2147/DHPS.S424050","url":null,"abstract":"<p><strong>Purpose: </strong>Rational drug use (RDU) promotes safe, efficient, and cost-effective utilization of medicines in hospital settings. The aim of this study was to assess rational drug use based on the World Health Organization (WHO) and the International Network for Rational Use of Drugs (INRUD) core drug use indicators.</p><p><strong>Patients and methods: </strong>This prospective, descriptive, hospital-based cross-sectional study was conducted among patients attending the Outpatient Department of a secondary care hospital located in the Sheema District of Western Uganda. A total of 450 prescriptions were prospectively collected from eligible patients and subjected to evaluation by using the WHO/INRUD core drug use indicators (prescribing, patient care, and health-facility indicators).</p><p><strong>Results: </strong>The average number of drugs prescribed per encounter was found to be 3.2 (optimal value=1.6-1.8). The percentages of drugs prescribed by their generic name (90.48%) and from the Essential Medicine List (96.23%) were close to the WHO reference (100%). The percentage of antibiotics (66.22%) and injections (25.22%) per encounter exceeded the WHO standards (antibiotics=20.0-26.8; injections=13.4-24.1). Among the patient-care indicators, the average consultation time (5.41 minutes), average dispensing time (131.03 seconds), percentage of medicines dispensed (76.11%), percentage of medicines adequately labeled (59.74%), and percentage of patients with dosage knowledge (49.50%) did not meet the WHO reference. Facility indicators such as the percentage of key medicines available in the stock (66.67%) did not conform to the WHO optimal value. The hospital made the EML hundred percent available to all practitioners.</p><p><strong>Conclusion: </strong>The study concludes that the prescribing, patient care, and health facility indicators at Sheema District Secondary Care Hospital deviate from the optimal values recommended by the WHO. Therefore, this study indicates a need for improvement on these indicators and a requirement for the ongoing educational initiatives focused on rational drug prescribing, dispensing, and patient use in order to comply with the standards set by the WHO.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"125-135"},"PeriodicalIF":1.6,"publicationDate":"2023-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2f/e0/dhps-15-125.PMC10506591.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41113943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cumulative Clinical Experience of the Use of Paliperidone Palmitate 3-Monthly Long-Acting Injection in the Treatment of Schizophrenia: A Critical Appraisal.","authors":"Juan Antonio García-Carmona,&nbsp;Sofia Pappa","doi":"10.2147/DHPS.S339170","DOIUrl":"10.2147/DHPS.S339170","url":null,"abstract":"<p><p>Paliperidone palmitate 3-monthly (PP3M), an approved maintenance treatment for patients with schizophrenia, was the first long-acting antipsychotic injectable (LAI) to require only four administrations per year. Here, we aimed to review the available evidence about its use in the management of schizophrenia to date and highlight key study findings in order to provide a balanced overview of current experience in clinical practice. For that purpose, an extensive search of available literature from PubMed, Embase, and Web of Science was conducted in March 2023. Emerging data from real-world studies appear to signal that the benefits of the use of PP3M may well extent beyond the obvious convenience for patients and resource efficiency for services and may be actually associated with improved effectiveness and patient satisfaction. Large naturalistic studies from Australia, Europe and the US comparing treatment continuation between newer LAIs and/or oral antipsychotics showed that patients treated with PP3M had higher compliance rates and a longer period of continuous use. The risk of relapse, re-hospitalization and number of bed days was also lower with PP3M compared to PP1M and other LAIs as demonstrated by several cohort studies. Furthermore, patients treated with PP3M were using lower doses of benzodiazepines and concomitant oral antipsychotics compared with other LAIs. What is more, PP3M appears to positively impact patients' satisfaction and quality of life, facilitating long-term goals. In fact, recent studies recorded better quality-adjusted life years and decreased stigma, with improved social acceptability and promotion of rehabilitation for patients transitioning to PP3M. The rates of general satisfaction rates with PP3M were also higher among psychiatrists and caregivers who reported overall less concerns. In conclusion, clinical exposure and a growing body of evidence thus far, reinforce the use of PP3M in an effort to enhance patient outcomes alongside individual experience and treatment persistence.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"113-123"},"PeriodicalIF":1.6,"publicationDate":"2023-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/91/8b/dhps-15-113.PMC10504906.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10291325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review of the Safety, Efficacy and Tolerability of Palivizumab in the Prevention of Severe Respiratory Syncytial Virus (RSV) Disease.","authors":"Shaun O'Hagan,&nbsp;Niamh Galway,&nbsp;Michael D Shields,&nbsp;Peter Mallett,&nbsp;Helen E Groves","doi":"10.2147/DHPS.S348727","DOIUrl":"10.2147/DHPS.S348727","url":null,"abstract":"<p><p>Respiratory Syncytial Virus (RSV) is a major global cause of childhood morbidity and mortality. Palivizumab, a monoclonal antibody that provides passive immunity against RSV, is currently licensed for prophylactic use in specific \"high-risk\" populations, including congenital heart disease, bronchopulmonary dysplasia and prematurity. Available research suggests palivizumab use in these high-risk populations can lead to a reduction in RSV-related hospitalization. However, palivizumab has not been demonstrated to reduce mortality, adverse events or length of hospital stay related to RSV. In this article, we review the management of RSV, indications for palivizumab prophylaxis, the safety, cost-effectiveness and efficacy of this preventative medication, and emerging therapeutics that could revolutionize future prevention of this significant pathogen.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"103-112"},"PeriodicalIF":1.6,"publicationDate":"2023-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/60/b2/dhps-15-103.PMC10503506.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10291327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence and Factors Associated with Dyslipidemia Among People Living with HIV/AIDS on Follow-Up Care at a Tertiary Care Hospital in Ethiopia: A Cross-Sectional Study.","authors":"Alemayehu Assefa, Alfoalem Araba Abiye, Tamrat Assefa Tadesse, Minyahil Woldu","doi":"10.2147/DHPS.S395037","DOIUrl":"10.2147/DHPS.S395037","url":null,"abstract":"<p><strong>Background: </strong>Despite its importance as a major risk factor for cardiovascular disease, dyslipidemia remains poorly characterized in the African population.</p><p><strong>Objective: </strong>To assess the prevalence and factors associated with dyslipidemia in people with HIV/AIDS in follow-up at Zewditu Memorial Hospital, Addis Ababa, Ethiopia.</p><p><strong>Materials and methods: </strong>A hospital-based retrospective cross-sectional study evaluated the charts of 288 people living with HIV/AIDS who had received Highly Active Antiretroviral Treatment for at least six months at Zewditu Memorial Hospital from July to September 2021. Sociodemographic and clinical data were collected from the patient's charts. Statistical analysis was performed using the Statistical Package for Social Sciences software version 25.</p><p><strong>Results: </strong>The overall prevalence of dyslipidemia was 55.2% in people living with HIV/AIDS. The prevalence of high-density lipoprotein cholesterol <40 mg/dl in men and <50 in women was 46.9%; total cholesterol ≥200 mg/dl was 22.6%; triglycerides ≥150 mg/dl was 18.8%, and low-density lipoprotein ≥130 mg/dl was 4.9%. Sex [Female adjusted odds ratio (AOR) = 0.595, 95% CI: 0.37-0.956], age greater than 40 years (AOR = 1.026, 95% CI: 1.005-1.048), body mass index >25 kg/m² (AOR = 1.767, 95% CI: 1.099-2.84), viral load >50 (AOR = 0.477, 95% CI: 0.27-0.842), and CD4 <500 (AOR = 1.938, 95% CI: 1.18-3.183) were identified as determinants of dyslipidemia.</p><p><strong>Conclusion: </strong>There was a high prevalence of dyslipidemia among study participants compared to several studies published in a similar population. Being male, older age, higher BMI, low CD4 count, and viral load of < 50 copies/mL were associated with dyslipidemia in people living with HIV/AIDS. Therefore, lipid profile measurements at baseline must be part of routine care to prevent the devastating effects of dyslipidemia.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"93-102"},"PeriodicalIF":2.2,"publicationDate":"2023-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/81/e9/dhps-15-93.PMC10397381.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9954876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.","authors":"Teresa A Simon, John H Simon, Erin G Heaning, Andres Gomez-Caminero, Jahan P Marcu","doi":"10.2147/DHPS.S391857","DOIUrl":"10.2147/DHPS.S391857","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to characterize the frequency of adverse effects where delta-8 tetrahydrocannabinol (D8-THC) was identified as a possible suspect drug in the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>A case-series design was used.</p><p><strong>Results: </strong>A total of 183 cases listed D8-THC as a suspect drug in FAERS as of June 30, 2021. The most common events included dyspnea, respiratory disorder, and seizure. The reporting odds ratios were consistently and significantly greater than 2, a 2-fold increase from 2019 to 2021, indicating a potential safety signal.</p><p><strong>Conclusion: </strong>The first report of D8-THC, in the FAERS database, as a suspect drug appears to be in 2011. Overall, there are 183 total cases listing D8-THC as a suspect drug in the FAERS database as of June 30, 2021. Of the 183 cases, most were respiratory in nature.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"25-38"},"PeriodicalIF":2.2,"publicationDate":"2023-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/95/9f/dhps-15-25.PMC9894081.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10659633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}