Rui Feng Li, Liang Fen Wang, Hai Ying Zhang, Meng Jie He
{"title":"Acute Niclofolan Intoxication Led to Stillbirth: A Case Report.","authors":"Rui Feng Li, Liang Fen Wang, Hai Ying Zhang, Meng Jie He","doi":"10.2147/DHPS.S491648","DOIUrl":"10.2147/DHPS.S491648","url":null,"abstract":"<p><p>Niclofolan is a commonly used veterinary drug worldwide. We reported a case of acute niclofolan intoxication in a pregnant woman. We recorded in detail her toxic symptoms, including nausea, vomiting, asthenia, blurred vision, and aberrant blood values. Notably stillbirth was recorded for the first time as indicating its human reproductive toxicity. We also found that an oral therapeutic dosage as described in the literature was likely to lead to stillbirth. Furthermore, we described the treatments received by the patient, including critical care, drug therapy, and plasma exchange, the outcomes of which were excellent. By studying this case, we aimed to enhance recognition and treatment of niclofolan intoxication and to raise concern regarding veterinary drug abuse and exposure risk.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"17 ","pages":"1-6"},"PeriodicalIF":2.2,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970061","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":"A Cross-Sectional Evaluation of Opioid Dispensing Competencies in Final-Year Pharm-D Students: A Multicenter Study from Punjab, Pakistan.","authors":"Naeem Mubarak, Fatima Rahman Rana, Taheer Zahid, Umm-E-Barirah Ijaz, Afshan Shabbir, Ahtesham Ghulam Bari, Bisma Niaz, Sabba Kanwal, Nasira Saif-Ur-Rahman, Zahid Iqbal, Asad Majeed Khan, Che Suraya Zin, Khalid Mahmood, Mohamed Hassan Elnaem, Saba Tariq","doi":"10.2147/DHPS.S491717","DOIUrl":"10.2147/DHPS.S491717","url":null,"abstract":"<p><strong>Background: </strong>The opioid crisis continues to be a public health concern worldwide due to the high rates of misuse and associated mortality. Opioid dispensing competencies are critical for pharmacy graduates to promote the rational use of opioids.</p><p><strong>Purpose: </strong>To evaluate the opioids dispensing competencies among the final year Pharm-D students in Punjab, Pakistan.</p><p><strong>Design: </strong>A multicenter cross-sectional study.</p><p><strong>Methods: </strong>A validated survey was used to evaluate 11 competencies related to opioid use from the final year Pharm-D students from diversely located accredited institutes. On a summative scale, correct response to each survey item was worth a score/point. Descriptive statistics was used for categorical variables while independent <i>t</i>-test computed group differences.</p><p><strong>Results: </strong>A total of n = 661 final year Pharm-D students from 28 institutes (8 public and 20 private) completed the survey with an overall response rate of 78.5%. Comparatively, the students who had either completed a community or hospital internship, or studying in the educational institutions located in the provincial capital demonstrated a significant higher competency score. There was no significant difference in the overall mean competency scores based on gender or system of assessment used in the Pharm-D degree programs. Among eleven opioid competencies, students received the lowest scores for \"opioid overdose management\", \"opioid monitoring\" and \"therapeutic uses of opioids\".</p><p><strong>Conclusion: </strong>Pharm-D students in Pakistan require additional training and skills on many of the opioids related competencies to ensure patient's safety in healthcare settings. There is a need to revise the curriculum and teaching methodologies to improve the competencies of Pharm-D students in opioid dispensing.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"133-144"},"PeriodicalIF":2.2,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11693936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142920996","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}
Mary K Awuonda, Ghada Alem, Brittany Olbert, Medha Reddy, Monika Daftary, La'Marcus Wingate, Earl Ettienne
{"title":"Predictors of Using Pharmacists as a Medication Safety Information Resource Among Women of Reproductive Age.","authors":"Mary K Awuonda, Ghada Alem, Brittany Olbert, Medha Reddy, Monika Daftary, La'Marcus Wingate, Earl Ettienne","doi":"10.2147/DHPS.S412786","DOIUrl":"10.2147/DHPS.S412786","url":null,"abstract":"<p><strong>Background: </strong>Medication use during pregnancy is prevalent with notable increases in the use of over-the-counter medications. In this era of information proliferation, it is important to understand where women of reproductive age obtain information on medication safety.</p><p><strong>Objective: </strong>The main objective of this study was to determine the predictive factors associated with the utilization of pharmacists as a medication information safety resource among reproductive age women.</p><p><strong>Methods: </strong>A cross-sectional evaluation of baseline characteristics, collected during an online knowledge intervention study, was conducted among women aged 18-44 who were living in the United States in 2018 to 2019. Descriptive statistics for all study variables were estimated. Logistic regression analyses were done to assess the predictors of the utilization of pharmacists as a medication safety resource.</p><p><strong>Results: </strong>A total of 210 women of reproductive age were included in the study. The average age was 32.4 ± 6.5 years and the majority were White (69.5%), married (61.4%), and had at least a high school education level (86%). Fifty four percent of participants reported using pharmacists as a medication safety information resource. Findings from the multivariable analyses showed that women who reported difficulty understanding written medical information (p = 0.018) and those who were Black or African American (p = 0.008) had less odds of utilizing pharmacists as a medication information source.</p><p><strong>Conclusion: </strong>Despite pharmacists being one of the most accessible health care professionals on medication information, only 54.3% of women surveyed utilized them as medication information sources. It was also found that women who had difficulty understanding written information and those who were Black or African American were less likely to utilize pharmacists as a medication safety information resource. Findings show opportunities for pharmacists to increase perceived value as medication safety experts among women of childbearing age. Additional studies need to be conducted given the study's limited generalizability.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"16 ","pages":"125-132"},"PeriodicalIF":2.2,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812541","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}
Sultan Al Raddadi, Majed Almutairi, Kholoud AlAamer, Abdulmahsen Alsalman, Maram Albalawi, Meshary Almeshary, Hisham A Badreldin, Hind Almodaimegh
{"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":"16 ","pages":"117-124"},"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}
Fawzi Thomas, Onome T Abiri, Joyce M Kallon, Desmond Maada Kangbai, Thomas A Conteh, Sally-Mattu Conteh, Edna G Samuels, Olufunsho Awodele
{"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}
Erick Acocal-Juárez, Luis Márquez-Domínguez, Verónica Vallejo-Ruíz, Lilia Cedillo, Gerardo Santos-López
{"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}
Francis Kachidza Chiumia, Frider Chimimba, Happy Magwaza Nyirongo, Elizabeth Lusungu Kampira, Adamson Sinjani Muula, Felix Khuluza
{"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}
Fawzi Thomas, Onome T Abiri, Joyce M Kallon, Desmond Maada Kangbai, Thomas A Conteh, Sally-Mattu Conteh, Edna G Samuels, Olufunsho Awodele
{"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}