Pub Date : 2024-06-19eCollection Date: 2024-01-01DOI: 10.2147/DHPS.S466039
Fawzi Thomas, Onome T Abiri, Joyce M Kallon, Desmond Maada Kangbai, Thomas A Conteh, Sally-Mattu Conteh, Edna G Samuels, Olufunsho Awodele
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
{"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}
Pub Date : 2024-06-05eCollection Date: 2024-01-01DOI: 10.2147/DHPS.S372239
Steven J Cassady, Jose Alejandro N Almario, Gautam V Ramani
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.
{"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}
Pub Date : 2024-03-06eCollection Date: 2024-01-01DOI: 10.2147/DHPS.S438510
Wei Tang, Wenlai Zhou, Xiangde Zheng
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.
{"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}
Background: 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.
Methods: 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.
Results: 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%).
Conclusion: 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.
{"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}
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.
{"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}
Introduction: Drug therapy is a crucial component of health care and plays a vital role in preserving life. However, the irrational utilization of medications is a worldwide issue, particularly in developing nations.
Objective: To assess the prescription patterns of medications based on the World Health Organization's prescribing indicator among patients who were admitted with COVID-19 to Eka Kotebe General Hospital in Addis Ababa, Ethiopia, in June 2021.
Methods: A retrospective cross-sectional analysis was conducted to evaluate the prescription patterns of medications in patients admitted with COVID-19 at Eka Kotebe General Hospital from June 2021 to September 15, 2021. The data were extracted using card review formats and prescription assessment questionnaires, and a systematic random sampling procedure was employed to collect the data. Finally, the data were coded and analyzed using SPSS version 26 to meet the study's objectives. Descriptive statistics were employed to determine the frequency and prevalence, and the results were presented using tables and figures.
Results and discussion: The average number of medications prescribed per encounter was 2.64, which is above the WHO standard. The percentage of encounters in which antibiotics and injections were prescribed was 80.20% and 99.2%, which exceeds the upper limit of WHO standard range (20-26.8%) and (13.4-24.1%), respectively. All medications were prescribed using generic names and were included in Eka Kotebe General Hospital's essential drug list, which is in line with WHO standards.
Conclusion: The degree of polypharmacy and the prescription practices for antibiotics and injections at Eka Kotebe General Hospital deviated from the World Health Organization's standards. As a result, there is a need to enhance medical education programs to rationalize the prescription of antibiotics and injection use.
{"title":"Assessment of Medication Prescribing Pattern in COVID-19 Admitted Patients by Using WHO Prescribing Indicators at Eka Kotebe General Hospital, Addis Ababa, Ethiopia; Retrospective Cross-Sectional Study.","authors":"Belete Birhanu, Solomon Debebe, Tsegaye Nigussie, Alemayehu Dandana","doi":"10.2147/DHPS.S416310","DOIUrl":"10.2147/DHPS.S416310","url":null,"abstract":"<p><strong>Introduction: </strong>Drug therapy is a crucial component of health care and plays a vital role in preserving life. However, the irrational utilization of medications is a worldwide issue, particularly in developing nations.</p><p><strong>Objective: </strong>To assess the prescription patterns of medications based on the World Health Organization's prescribing indicator among patients who were admitted with COVID-19 to Eka Kotebe General Hospital in Addis Ababa, Ethiopia, in June 2021.</p><p><strong>Methods: </strong>A retrospective cross-sectional analysis was conducted to evaluate the prescription patterns of medications in patients admitted with COVID-19 at Eka Kotebe General Hospital from June 2021 to September 15, 2021. The data were extracted using card review formats and prescription assessment questionnaires, and a systematic random sampling procedure was employed to collect the data. Finally, the data were coded and analyzed using SPSS version 26 to meet the study's objectives. Descriptive statistics were employed to determine the frequency and prevalence, and the results were presented using tables and figures.</p><p><strong>Results and discussion: </strong>The average number of medications prescribed per encounter was 2.64, which is above the WHO standard. The percentage of encounters in which antibiotics and injections were prescribed was 80.20% and 99.2%, which exceeds the upper limit of WHO standard range (20-26.8%) and (13.4-24.1%), respectively. All medications were prescribed using generic names and were included in Eka Kotebe General Hospital's essential drug list, which is in line with WHO standards.</p><p><strong>Conclusion: </strong>The degree of polypharmacy and the prescription practices for antibiotics and injections at Eka Kotebe General Hospital deviated from the World Health Organization's standards. As a result, there is a need to enhance medical education programs to rationalize the prescription of antibiotics and injection use.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"171-177"},"PeriodicalIF":1.6,"publicationDate":"2023-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71520808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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}