Drug, Healthcare and Patient Safety最新文献

{"title":"Adverse Events Following Immunization with Novel Oral Polio Vaccine Type 2, and the Experience and Challenges of Reporting in Sierra Leone [Response to Letter].","authors":"Fawzi Thomas, Onome T Abiri, Joyce M Kallon, Desmond Maada Kangbai, Thomas A Conteh, Sally-Mattu Conteh, Edna G Samuels, Olufunsho Awodele","doi":"10.2147/DHPS.S496511","DOIUrl":"10.2147/DHPS.S496511","url":null,"abstract":"","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"115-116"},"PeriodicalIF":2.2,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371308","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":"Baloxavir Resistance Markers in Influenza A and B Viruses in the Americas.","authors":"Erick Acocal-Juárez, Luis Márquez-Domínguez, Verónica Vallejo-Ruíz, Lilia Cedillo, Gerardo Santos-López","doi":"10.2147/DHPS.S470868","DOIUrl":"https://doi.org/10.2147/DHPS.S470868","url":null,"abstract":"<p><strong>Aim: </strong>Influenza control demands multifaceted strategies, including antiviral drugs. Baloxavir, a recent addition to influenza treatment, acts as an inhibitor of the Polymerase acid (PA) component of the viral polymerase. However, mutations associated with resistance have been identified.</p><p><strong>Purpose: </strong>This study analyzed PA gene sequences of influenza A and B viruses (IAV and IBV, respectively) reported in the Americas, retrieved from databases published until May 2023, to identify primary markers of resistance to baloxavir.</p><p><strong>Patients and methods: </strong>PA gene sequences were obtained from the GISAID and NCBI databases, focusing on countries in the Americas with 500 or more sequences for IAV, and 50 or more sequences for IBV.</p><p><strong>Results: </strong>Of the 58,816 PA sequences analyzed for IAV, only 55 (0.1%) harbored resistance markers, representing approximately 1 in 1000 occurrence. The most frequent markers were I38V (21 cases) and I38M (7 cases) at position 38 of PA, followed by E199G (9 cases) at position 199. For IBV, 14,684 sequences were analyzed, of which only eight presented a resistance marker (0.05%). Five sequences had the M34I marker, while the remaining three had the I38V marker. While frequency of resistance markers in PA is comparable to other regions, these results highlight the need for enhanced sequencing efforts, particularly in Latin America. Such efforts would serve to intensify influenza surveillance and inform public health interventions.</p><p><strong>Conclusion: </strong>While baloxavir demonstrates efficacy against influenza, resistance markers have been identified, including pre-existing ones. Our study adds eight (IAV: six and IBV: two) new spontaneously occurring substitutions to the existing literature, highlighting the need for continued surveillance. Among these, I38M stands out due to its significant tenfold reduction in drug susceptibility. Therefore, vigilant monitoring of these resistance markers in IAV and IBV remains crucial for maintaining baloxavir's effectiveness and informing future public health interventions.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"105-113"},"PeriodicalIF":2.2,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11410037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282076","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":"Adverse Events Following Immunization with Novel Oral Polio Vaccine Type 2, and the Experience and Challenges of Reporting in Sierra Leone [Letter].","authors":"Nuril Endi Rahman","doi":"10.2147/DHPS.S487045","DOIUrl":"10.2147/DHPS.S487045","url":null,"abstract":"","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"103-104"},"PeriodicalIF":2.2,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142157162","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":"Adverse Drug Reactions Related with Antibiotic Medicines in Malawi: A Retrospective Analysis of Prevalence and Associated Factors.","authors":"Francis Kachidza Chiumia, Frider Chimimba, Happy Magwaza Nyirongo, Elizabeth Lusungu Kampira, Adamson Sinjani Muula, Felix Khuluza","doi":"10.2147/DHPS.S468966","DOIUrl":"10.2147/DHPS.S468966","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to assess the occurrence and characteristics of antibiotic-associated adverse drug reactions (ADRs) in Malawi.</p><p><strong>Methods: </strong>We retrospectively reviewed 304 patient records from medical wards in three hospitals in Southern Malawi. A global trigger tool was applied for the detection of suspected ADRs, and we used the Naranjo scale, the World Health Organization classification and the Schumock and Thornton scale for causality, seriousness and preventability assessment respectively. ADRs were also further characterized according to anatomical systems. Statistical analysis was done in STATA 14.1. The Chi-square test was used to determine the association between categorical variables and logistic regression analysis was used to measure the strength of the association between various independent variables and the occurrence of ADRs.</p><p><strong>Results: </strong>Suspected ADRs were detected in 24% (73/304) of patients, of which 1.4% were definite, 15.1% were probable and 83.6% were possible ADRs. Most of the sADRs were gastrointestinal events (42.5%), followed by: musculoskeletal (26.3%); cardiovascular (16.3%); central nervous system (13.8%; and urinary events (1.3%). About 27% of the sADRs were serious events such as convulsions. The geriatric age group (≥65 years) was more likely to experience sADRs as compared to the younger age group, with an adjusted odds ratio (aOR) of 4.53, 95% CI (2.21-9.28), P<0.001. Patients taking more than one antibiotic medicine had a higher risk of developing sADRs as compared to patients who were administered one type of antibiotic medicine, aOR 2.14, 95% CI (1.18-3.90), p < 0.012. A long hospital stay of >3days was associated with a higher risk of sADRs with aOR of 5.11, 95% CI (2.47-10.55), p < 0.001 than those who stayed ≤ 3 days in the hospital.</p><p><strong>Conclusion: </strong>We found a higher prevalence of serious sADRs associated with antibiotic medicines than reported elsewhere. This may, among others, contribute to high patient mortality, poor treatment adherence, antibiotic resistance and increased cost of care.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"89-101"},"PeriodicalIF":2.2,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11283248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787581","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":"Medication-Related Hospital Admission Among Patients Admitted to the Emergency Ward at the University of Gondar, North West Ethiopia: A Cross Sectional Study.","authors":"Saron Naji Gebremariam, Faisel Dula Sema, Abdisa Gemedi Jara, Gizework Alemnew Mekonnen","doi":"10.2147/DHPS.S455990","DOIUrl":"https://doi.org/10.2147/DHPS.S455990","url":null,"abstract":"<p><strong>Background: </strong>Medication-related hospital admission (MRHA) is hospitalization due to drug-related problems. MRHAs have been reported to be on the rise in recent decades.</p><p><strong>Objective: </strong>This study was aimed at determining the prevalence, patterns, and predictors of MRHA among patients visiting the emergency ward of the University of Gondar comprehensive specialized hospital, Ethiopia.</p><p><strong>Methods: </strong>A cross-sectional study was conducted from June 1, 2022, to August 30, 2022 G.C. in the emergency ward at the University of Gondar Comprehensive Specialized Hospital. The AT-HARM 10 tool was used to collect data from participants who fulfilled the inclusion criteria. Data was entered into EpiData Manager 4.6.0.0 and was exported to Statistical Package for Social Sciences (SPSS) version 24 for analysis. Descriptive statistics were presented using frequency and percentage. Binary logistic regression was applied to identify factors associated with MRHAs with a 95% confidence level, and significance was declared at a <i>p-</i>value <0.05.</p><p><strong>Results: </strong>The prevalence of MRHAs was 30.5% (95% CI = 27.7-36.4%). More than half (64.52%) of MRHAs were definitely preventable. The majority of MRHAs (48.39%) were severe. Non-compliance (41.12%), followed by untreated indication (26.61%) and adverse drug reaction (12.09%) were the most frequent causes of MRHAs. Renal impairment (AOR = 2.703, 95% CI: 1.29 to 5.663), chronic disease (AOR = 10.95, 95% CI: 4.691 to 25.559), history of traditional medication use (AOR = 2.089, 95% CI: 1.162 to 3.755), and history of hospitalization (AOR = 4.001, 95% CI: 1.98 to 8.089) were significantly associated with MRHAs.</p><p><strong>Conclusion: </strong>MRHAs were substantially prevalent. Most of the MRHAs were definitely preventable. Renal impairment, chronic disease, history of traditional medication use, and history of hospitalization were predictors of MRHAs. At the university hospital, health care providers should strive to prevent and manage MRHAs appropriately.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"75-88"},"PeriodicalIF":2.2,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11268659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757784","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":"Adverse Events Following Immunization with Novel Oral Polio Vaccine Type 2, and the Experience and Challenges of Reporting in Sierra Leone.","authors":"Fawzi Thomas, Onome T Abiri, Joyce M Kallon, Desmond Maada Kangbai, Thomas A Conteh, Sally-Mattu Conteh, Edna G Samuels, Olufunsho Awodele","doi":"10.2147/DHPS.S466039","DOIUrl":"10.2147/DHPS.S466039","url":null,"abstract":"<p><strong>Background: </strong>The manifestation and spread of neuroinvasive circulating vaccine-derived polioviruses (cVDPVs) across several countries, which led to the emergency use of the novel oral polio vaccine type 2 (nOPV2), raised concerns about adverse events following immunization (AEFI) surveillance. We assessed the attributes of AEFI with nOPV2 and examined stakeholder experiences and challenges in AEFI surveillance in Sierra Leone.</p><p><strong>Methods: </strong>Using a mixed method approach, we retrospectively reviewed passive data collected during a 2021 immunization campaign, and conducted semi-structured, interviews with vaccinators, district AEFI focal persons, and key stakeholders at the national Expanded Program on Immunization and the National Medicines Regulatory Authority. AEFI were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs) and System Organ Class (SOC). Outcomes were stratified as recovered or not, with preventability and causality assessed using the Schumock and Thornton and World Health Organization (WHO) algorithms, respectively.</p><p><strong>Results: </strong>A total of 528 suspected AEFI were documented, predominantly affecting children aged 28 days to 23 months (63.3%). Most reported AEFI were administration site conditions and general disorders, with pyrexia being the predominant PT. Of 80 serious cases, 78 recovered, with 74 having an inconsistent causal relationship with the vaccine. Most serious cases (78) were deemed non-preventable, with only two being probably preventable. AEFI reporting was not routinely carried out across the group of people interviewed. AEFI reporting was not consistently performed, with discrepancies in defining reportable events and confusion over responsibility. Challenges with the open data kit (ODK) platform were noted, along with perceived inadequacies in training.</p><p><strong>Conclusion: </strong>While the nOPV2 is relatively new, the majority of AEFI were not serious, and most serious cases were not causally linked to the vaccine. Participants exhibited variations in experience and awareness of AEFI reporting.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"61-73"},"PeriodicalIF":2.2,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141444100","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":"Therapeutic Potential of Treprostinil Inhalation Powder for Patients with Pulmonary Arterial Hypertension: Evidence to Date.","authors":"Steven J Cassady, Jose Alejandro N Almario, Gautam V Ramani","doi":"10.2147/DHPS.S372239","DOIUrl":"10.2147/DHPS.S372239","url":null,"abstract":"<p><p>Pulmonary arterial hypertension (PAH) is a complex and incurable disease for which pulmonary vasodilators remain the core therapy. Of the three primary pathways that vasodilators target, the prostacyclin pathway was the earliest to be used and currently has the largest number of modalities for drug delivery. Inhaled treprostinil has been introduced as a treatment option in PAH and, more recently, pulmonary hypertension (PH) due to interstitial lung disease (PH-ILD), and the earlier nebulized form has been joined by a dry powder form allowing for more convenient use. In this review, we discuss inhaled treprostinil, focusing on the dry powder inhalation (DPI) formulation, and explore its dosing, applications, and evidence to support patient tolerance and acceptance. Recent trials underpinning the evidence for use of inhaled treprostinil and the most recent developments concerning the drug are discussed. Finally, the review looks briefly into premarket formulations of inhaled treprostinil and relevant early studies suggesting efficacy in PAH treatment.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"51-59"},"PeriodicalIF":1.6,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11162632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141295761","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":"Obstructive Fibrinous Tracheal Pseudomembrane Following Repeated Intratracheal Interventions.","authors":"Wei Tang, Wenlai Zhou, Xiangde Zheng","doi":"10.2147/DHPS.S438510","DOIUrl":"10.2147/DHPS.S438510","url":null,"abstract":"<p><p>Obstructive fibrinous tracheal pseudomembrane (OFTP) is a relatively rare complication of endotracheal intubation. Despite being well documented, the exact pathogenesis of OFTP remains unclear. Some studies suggest that it may arise from the early stage of ischemic tracheal wall injury caused by the cuff pressure during intubation. Diagnosis and treatment of OFTP can be facilitated through therapeutic bronchoscopy. In this case report, we describe a patient who presented with dyspnea following repeated intratracheal interventions and was diagnosed with OFTP. The patient was successfully treated with bronchoscopic cryotherapy and was subsequently discharged from the hospital.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"29-33"},"PeriodicalIF":1.6,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10927874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140109574","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 Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia.","authors":"Adane Flatie Alemu, Addisu Afrassa Tegegne, Nurahmed Seid Getaw","doi":"10.2147/DHPS.S419522","DOIUrl":"10.2147/DHPS.S419522","url":null,"abstract":"<p><strong>Background: </strong>WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia.</p><p><strong>Methods: </strong>Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability.</p><p><strong>Results: </strong>In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55-102.76%).</p><p><strong>Conclusion: </strong>The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"19-28"},"PeriodicalIF":1.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10840544/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691469","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":"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}