Drug, Healthcare and Patient Safety最新文献

{"title":"The Impact of Sacubitril/Valsartan on Heart Failure Patient with Reduced Left Ventricular Ejection Fraction: Single Center Retrospective Study in Saudi Arabia.","authors":"Sultan Al Raddadi, Majed Almutairi, Kholoud AlAamer, Abdulmahsen Alsalman, Maram Albalawi, Meshary Almeshary, Hisham A Badreldin, Hind Almodaimegh","doi":"10.2147/DHPS.S471867","DOIUrl":"10.2147/DHPS.S471867","url":null,"abstract":"<p><strong>Background: </strong>Sacubitril/valsartan (S/V) is used in managing heart failure with reduced ejection fraction (HFrEF), reducing morbidity and mortality while improving symptoms and prognosis. This study aims to evaluate the effectiveness of S/V in patients with reduced left ventricular ejection fraction (LVEF) and its safety.</p><p><strong>Methods: </strong> This retrospective cohort study included adult patients aged ≥18 years diagnosed with HFrEF, receiving S/V, and followed up at a tertiary hospital in Riyadh. Primary outcomes included improvements in LVEF on echocardiography and the number of hospitalizations due to acute decompensated heart failure (ADHF). Secondary outcomes assessed the safety profile of S/V. Multinomial logistic regression analysis was performed with statistical significance set at P < 0.05. .</p><p><strong>Results: </strong>The study included 107 patients: 80 with LVEF < 30% and 27 with LVEF 30-40%. Six-month follow-up, LVEF improvement was categorized into three groups: no improvement, LVEF increased by 1 to <10 points, and LVEF increased by ≥10 points. The LVEF was similar across groups (P = 0.59). Although hospitalizations due to ADHF were not significantly different between groups, they numerically decreased after initiating S/V (P = 0.1). S/V was generally well tolerated.</p><p><strong>Conclusion: </strong>This study suggests no significant benefit from S/V regarding LVEF improvement. It is recommended that heart failure clinics assess and titrate S/V to the maximum tolerated dose.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11451457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380276","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 [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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":"Rapid Onset and Recovery Linezolid-Induced Thrombocytopenia: A Large-Sample, Single-Center Retrospective Cohort Study","authors":"Zahra Al Qamariat, Amnah Aljaffar, Zahra Alabdulaal, Fatima Alnezir, Weaam Al-Zawad, Mohammed Alqattan, Abdulmohsen Almahdi","doi":"10.2147/dhps.s458284","DOIUrl":"https://doi.org/10.2147/dhps.s458284","url":null,"abstract":"Introduction: Thrombocytopenia is a common and potentially severe adverse effect of linezolid, but the time to onset during treatment has varied substantially across studies. Moreover, the time to recovery after linezolid withdrawal has not been examined in a larger patient sample. Objective: The first objective of this study was to measure the mean time to linezolid-induced thrombocytopenia (LIT) and the second was to measure the mean time to recovery after linezolid discontinuation. Methods: A retrospective observational cohort study was conducted between January 2017 and December 2022 at Dammam Medical Complex using the medical records of hospitalized adults with normal baseline platelet counts receiving intravenous linezolid for a minimum of 48 hours. All patients included in the analyses received daily platelet count monitoring for up to 14 days after linezolid initiation and 14 days after discontinuation. Thrombocytopenia was defined as a drop in platelet count to <150 × 10 9 /L or <50% of baseline within 14 days. The dose duration–risk relationship and recovery rate were analyzed by constructing Kaplan–Meier survival curves. Results: In total, 334 patients met study inclusion criteria. The mean time to develop thrombocytopenia after starting linezolid was five days, and the mean time of recovery was also 5 days. The cumulative risk of thrombocytopenia reached 100% by day six of therapy, and cumulative recovery reached 100% by day six after linezolid withdrawal, with half of the study population recovering by day four. Conclusion: Thrombocytopenia can develop rapidly during linezolid treatment, but recovery after discontinuation is also rapid. Rapid thrombocytopenia is a common adverse effect of linezolid that must be considered prior to prescription, and routine monitoring of platelet count is recommended so that linezolid treatment can be discontinued, if thrombocytopenia occurs.","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141137286","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":"Response to Osilodrostat Therapy in Adrenal Cushing’s Syndrome","authors":"M. Stasiak, Przemysław Witek, Emilia Adamska-Fita, Andrzej Lewiński","doi":"10.2147/DHPS.S453105","DOIUrl":"https://doi.org/10.2147/DHPS.S453105","url":null,"abstract":"Abstract Cushing’s disease (CD) is the most common cause of endogenous hypercortisolism. Osilodrostat was demonstrated to be efficient in treating CD, and the mean average dose required for CD control was <11 mg/day. Potential differences in osilodrostat treatment between cortisol-producing adenoma (CPA) and CD have not been reported. The aim of this study was to present two patients with CPA in whom significant differences in the response to therapy compared to CD were found. We demonstrated a case of inverse response of cortisol levels with adrenal tumor progression during the initial dose escalation (Case 1). Simultaneously, severe exaggeration of hypercortisolism symptoms and life-threatening hypokalemia occurred. A further rapid dose increase resulted in the first noticeable cortisol response at a dose of 20 mg/day, and a full response at a dose of 45 mg/day. We also present a case that was initially resistant to therapy (Case 2). The doses required to achieve the first response and the full response were the same as those for Case 1. Our study demonstrated that osilodrostat therapy in patients with CPA may require a different approach than that in CD, with higher doses, faster dose escalation, and a possible initial inverse response or lack of response.","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140778198","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}