Pub Date : 2023-11-03eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S350763
George P Allen, Haley L Morrill
Gonorrhea, a sexually transmitted infection caused by Neisseria gonorrhoeae, 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 N. gonorrhoeae, coupled with a lack of diverse treatment alternatives and the limited pipeline of new antimicrobials, is a significant threat to the treatment of gonorrhea.
{"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}
Pub Date : 2023-11-01eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S436458
Riham M Hamadouk, Einass Mahmoud Alshareif, Huda M Hamad, Bashir A Yousef
Background: 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.
Objective: This study aims to assess the prevalence and severity of potential drug-drug interactions (PDDIs) in the internal medicine ward at Soba Teaching Hospital.
Methods: 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.
Results: 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.
Conclusion: 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.
{"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<sup>®</sup> 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}
Pub Date : 2023-09-20eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S425858
Fahmi Y Al-Ashwal, Mohammed Zawiah, Lobna Gharaibeh, Rana Abu-Farha, Ahmad Naoras Bitar
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
{"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}
Purpose: 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.
Patients and methods: 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).
Results: 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.
Conclusion: 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.
{"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, Joackim Ssesanga, Bhavana Reddy Bommireddy, Durga Prasad Thammisetty, Veerabhadrappa Kasturi Vishwanathasetty, Joseph Obiezu Chukwujekwu Ezeonwumelu, 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}
Pub Date : 2023-09-12eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S339170
Juan Antonio García-Carmona, Sofia Pappa
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.
帕利培酮棕榈酸酯3个月(PP3M)是一种经批准的精神分裂症患者维持治疗方法,是第一种每年只需四次给药的长效抗精神病药物注射(LAI)。在此,我们旨在回顾迄今为止关于其在精神分裂症治疗中的可用证据,并强调关键的研究结果,以便对当前临床实践经验进行平衡的概述。为此,2023年3月对PubMed、Embase和Web of Science的可用文献进行了广泛搜索。来自真实世界研究的新数据似乎表明,使用PP3M的好处可能远远超出了对患者的明显便利和服务的资源效率,实际上可能与提高疗效和患者满意度有关。来自澳大利亚、欧洲和美国的大型自然主义研究比较了新型LAI和/或口服抗精神病药物的治疗持续性,结果表明,接受PP3M治疗的患者依从性更高,持续使用时间更长。几项队列研究表明,与PP1M和其他LAI相比,PP3M的复发、再次住院和住院天数的风险也较低。此外,与其他LAI相比,接受PP3M治疗的患者使用的苯二氮卓类药物和伴随的口服抗精神病药物剂量较低。此外,PP3M似乎对患者的满意度和生活质量产生了积极影响,有助于实现长期目标。事实上,最近的研究记录了更好的生活质量调整年限,减少了耻辱感,提高了社会可接受性,并促进了向PP3M过渡的患者的康复。精神科医生和护理人员对PP3M的总体满意度也较高,他们报告的总体担忧较少。总之,到目前为止,临床暴露和越来越多的证据加强了PP3M的使用,以提高患者的疗效,同时提高个人经验和治疗的持久性。
{"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, 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}
Pub Date : 2023-09-11eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S348727
Shaun O'Hagan, Niamh Galway, Michael D Shields, Peter Mallett, Helen E Groves
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.
{"title":"Review of the Safety, Efficacy and Tolerability of Palivizumab in the Prevention of Severe Respiratory Syncytial Virus (RSV) Disease.","authors":"Shaun O'Hagan, Niamh Galway, Michael D Shields, Peter Mallett, 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}
Pub Date : 2023-05-19eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S395037
Alemayehu Assefa, Alfoalem Araba Abiye, Tamrat Assefa Tadesse, Minyahil Woldu
Background: Despite its importance as a major risk factor for cardiovascular disease, dyslipidemia remains poorly characterized in the African population.
Objective: To assess the prevalence and factors associated with dyslipidemia in people with HIV/AIDS in follow-up at Zewditu Memorial Hospital, Addis Ababa, Ethiopia.
Materials and methods: 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.
Results: 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.
Conclusion: 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.
{"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/m<sup>2</sup> (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}
Pub Date : 2023-01-29eCollection Date: 2023-01-01DOI: 10.2147/DHPS.S391857
Teresa A Simon, John H Simon, Erin G Heaning, Andres Gomez-Caminero, Jahan P Marcu
Purpose: 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.
Methods: A case-series design was used.
Results: 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.
Conclusion: 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.
{"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}
Maja Johanne Søndergaard Knudsen, Ingrid Maria Cecilia Rubin, Andreas Munk Petersen
Introduction The aim of this systematic review of randomized clinical trials (RCTs) was to examine the efficacy, safety, and tolerability of vancomycin for treatment of recurrent Clostridioides difficile infection (rCDI). Methods The PubMed database was searched from inception to August 23, 2022. An initial screening was performed followed by a full-text evaluation of the papers. Inclusion criteria were RCTs investigating vancomycin for treatment of rCDI. Results A total of six studies and 269 patients were included in the review. Three studies used a fixed dose regimen of vancomycin, one study used pulse regimen, one study used a taper-and-pulse regimen, and one study used a taper-and-pulse regimen for the participants with two or more recurrences. The resolution of infection varied from 19% to 58.3% in five of six studies reporting this as an outcome. Four out of six studies reported new episodes of rCDI as an intervention outcome, in those studies 50–63% of participants experienced rCDI. Regarding the safety and tolerability of vancomycin treatment for rCDI, one study described several adverse events regarding gastrointestinal discomfort along with fatigue and skin rash. There were no records of serious adverse events in the included studies. Conclusion While oral vancomycin is mostly safe and well tolerated in the RCTs reviewed here, the efficacy for treating rCDI varies greatly from 19–58.3%, and 50–63% of participants experienced new episodes of rCDI.
{"title":"The Clinical Efficacy, Safety, and Tolerability of Vancomycin for the Treatment of Recurrent <i>Clostridioides difficile</i> Infection - A Systematic Review.","authors":"Maja Johanne Søndergaard Knudsen, Ingrid Maria Cecilia Rubin, Andreas Munk Petersen","doi":"10.2147/DHPS.S348501","DOIUrl":"https://doi.org/10.2147/DHPS.S348501","url":null,"abstract":"Introduction The aim of this systematic review of randomized clinical trials (RCTs) was to examine the efficacy, safety, and tolerability of vancomycin for treatment of recurrent Clostridioides difficile infection (rCDI). Methods The PubMed database was searched from inception to August 23, 2022. An initial screening was performed followed by a full-text evaluation of the papers. Inclusion criteria were RCTs investigating vancomycin for treatment of rCDI. Results A total of six studies and 269 patients were included in the review. Three studies used a fixed dose regimen of vancomycin, one study used pulse regimen, one study used a taper-and-pulse regimen, and one study used a taper-and-pulse regimen for the participants with two or more recurrences. The resolution of infection varied from 19% to 58.3% in five of six studies reporting this as an outcome. Four out of six studies reported new episodes of rCDI as an intervention outcome, in those studies 50–63% of participants experienced rCDI. Regarding the safety and tolerability of vancomycin treatment for rCDI, one study described several adverse events regarding gastrointestinal discomfort along with fatigue and skin rash. There were no records of serious adverse events in the included studies. Conclusion While oral vancomycin is mostly safe and well tolerated in the RCTs reviewed here, the efficacy for treating rCDI varies greatly from 19–58.3%, and 50–63% of participants experienced new episodes of rCDI.","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"63-71"},"PeriodicalIF":1.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6b/8e/dhps-15-63.PMC10039659.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9567921","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}
Background: The safety attitudes questionnaire (SAQ) short form (2006) is important for assessing patient safety culture in clinical environments. However, little is known about its validity and applicability in Uganda. This study validated the SAQ short form (2006) for use in assessing patient safety culture in critical care settings of hospitals in the Ugandan context.
Methods: Using a sequential exploratory mixed-methods research design, the face, content and construct validity for the SAQ short form (2006) was assessed in a multi-phased approach. A panel of eight (8) purposively selected experts assessed the face and content validity in rounds 1 and 2, respectively, while construct validity was assessed in round 3 using data from a cross-sectional survey of 256 frontline health workers in critical care settings of the selected hospitals. Analysis of survey data followed confirmatory factor analysis. Cronbach's alpha examined internal reliability.
Results: Of the 36 items in the tool's original version, 33 were rated clear, with a score of 100% on face validity. The use of contextual vocabulary and formatting issues arose as concerns. The S-CVI/Ave was 100%, and S-CVI/UA was 86.1%. Four new items added on effective communication as another dimension of patient safety culture. The survey had KMO=0.8605, the a priori-based model had a scale Cronbach's alpha=0.8881, with unsatisfactory goodness of fit (RMSEA=0.051, 90% CI: 0.044-0.057, pclose=0.427; chi-square=694.28, p <0.001; CFI=0.884, TLI=0.871). The modified final model had a scale Cronbach's alpha =0.8967 and satisfactory goodness of fit (RMSEA=0.030, 90% CI: 0.019-0.039, pclose=1.000; chi-square=424.98, p=0.002; CFI=0.966, TLI=0.960).
Conclusion: In the tool's original form, the face validity was lacking despite satisfactory scores on item clarity. Content validity was adequate, while construct validity required modifications in construct specifications. Reliability was adequate before and after specification modifications. The modified version has adequate psychometric properties for Uganda.
{"title":"Validation of the Safety Attitudes Questionnaire for Assessing Patient Safety Culture in Critical Care Settings of Three Selected Ugandan Hospitals.","authors":"Joseph Atukwatse, Vallence Niyonzima, Cliff Asher Aliga, Jalia Nakandi Serwadda, Rosemary Nankunda, Catherine Nakiganda, Peninah Komugabe, Hanifah Nantongo","doi":"10.2147/DHPS.S389978","DOIUrl":"https://doi.org/10.2147/DHPS.S389978","url":null,"abstract":"<p><strong>Background: </strong>The safety attitudes questionnaire (SAQ) short form (2006) is important for assessing patient safety culture in clinical environments. However, little is known about its validity and applicability in Uganda. This study validated the SAQ short form (2006) for use in assessing patient safety culture in critical care settings of hospitals in the Ugandan context.</p><p><strong>Methods: </strong>Using a sequential exploratory mixed-methods research design, the face, content and construct validity for the SAQ short form (2006) was assessed in a multi-phased approach. A panel of eight (8) purposively selected experts assessed the face and content validity in rounds 1 and 2, respectively, while construct validity was assessed in round 3 using data from a cross-sectional survey of 256 frontline health workers in critical care settings of the selected hospitals. Analysis of survey data followed confirmatory factor analysis. Cronbach's alpha examined internal reliability.</p><p><strong>Results: </strong>Of the 36 items in the tool's original version, 33 were rated clear, with a score of 100% on face validity. The use of contextual vocabulary and formatting issues arose as concerns. The S-CVI/<sub>Ave</sub> was 100%, and S-CVI/<sub>UA</sub> was 86.1%. Four new items added on effective communication as another dimension of patient safety culture. The survey had KMO=0.8605, the a priori-based model had a scale Cronbach's alpha=0.8881, with unsatisfactory goodness of fit (RMSEA=0.051, 90% CI: 0.044-0.057, <i>p</i>close=0.427; chi-square=694.28, <i>p</i> <0.001; CFI=0.884, TLI=0.871). The modified final model had a scale Cronbach's alpha =0.8967 and satisfactory goodness of fit (RMSEA=0.030, 90% CI: 0.019-0.039, <i>p</i>close=1.000; chi-square=424.98, <i>p</i>=0.002; CFI=0.966, TLI=0.960).</p><p><strong>Conclusion: </strong>In the tool's original form, the face validity was lacking despite satisfactory scores on item clarity. Content validity was adequate, while construct validity required modifications in construct specifications. Reliability was adequate before and after specification modifications. The modified version has adequate psychometric properties for Uganda.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"13-23"},"PeriodicalIF":1.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a7/dc/dhps-15-13.PMC9885870.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10642161","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}