Adverse Drug Events Research Articles

Protocol for the development and validation of a trigger tool for antiretroviral ADE detection among adult HIV/AIDS patients: A short communication

Antiretroviral therapy (ART) is a lifelong combination therapy which has been very promising in managing HIV/AIDs but reported to have several adverse events on the recipients, affecting the desired antiretroviral therapeutic goals. Adverse drug event detection and prevention therefore become very important safety culture maintenance tools among patients living with HIV/AIDS. The designed protocol provided step by step approaches to develop and validate a trigger tool for detection of adverse drug events (ADE) among adult HIV/AIDS patients. The approaches involved include a baseline (Pre-trigger tool development) retrospective clinical record review to establish a baseline ADE detection capacity of a conventional non-trigger tool method; the Delphi panel process to develop the trigger tool in question; Face and content validity approach for validation of the developed trigger tool; Pilot test of the trigger tool using small clinical record sample; determining the effectiveness of the developed trigger tool through the retrospective clinical record review of same samples reviewed at the baseline. Finally, the protocol described the process of determining the feasibility of the developed trigger tool through the survey of the clinical record review team members.

Therapeutic efficacy and safety of artemether-lumefantrine combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria at Teda Health Centre, Northwest Ethiopia, 2022/23

BackgroundThe emergence of Plasmodium falciparum drug resistance against artemisinin-based combination therapy has threatened malaria control efforts. Since malaria control and elimination plans are dependent on these drugs, they must remain efficacious. However, resistance to these drugs was detected in low-transmission settings and is predicted to emerge in high-transmission settings, including in unspecified areas of Ethiopia. Therefore, this study aimed to assess the therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria.MethodsA single-arm prospective observational study was conducted at Teda Health Centre, Northwest Ethiopia, by following the 2009 World Health Organization efficacy study guidelines from September 2022 to February 2023. Patients with uncomplicated falciparum malaria were conveniently selected and treated with a standard dose of artemether-lumefantrine, along with a single low dose of primaquine. Then clinical and parasitological responses and haemoglobin levels were assessed during the 28-day scheduled follow-up. Blood films were examined and asexual parasites were quantified; axillary temperature was measured; and drug adverse events were assessed throughout the follow-up. Finally, the drug efficacy (adequate clinical and parasitological response) was determined by Kaplan–Meier and per-protocol analyses. The data were analysed using the WHO Excel spreadsheet and SPSS version 25 software.ResultsThe success rates of PCR uncorrected and corrected Kaplan–Meier analysis on day 28 were 95.8% (95% CI 87.5–98.6) and 97.3% (95% CI 89.4–99.3), respectively. The per-protocol PCR uncorrected and corrected adequate clinical and parasitological responses were 95.5% (95% CI 87.5–99.1) and 97% (95% CI 89.5–99.6), respectively. On day-3, 97% of study participants were free of asexual parasitaemia, and all of them were fever-free on day-2. All of the gametocyte-positive patients at baseline were found to be negative for gametocytes on day-2. Moreover, the baseline mean hemoglobin of 13.10 g/dl increased slightly on day-14 to 13.27 g/dl but significantly on day-28 to 13.69 g/dl in a paired sample t test. All adverse events reported were mild.ConclusionArtemether-lumefantrine continued to be an efficacious and safe drug for the treatment of uncomplicated Plasmodium falciparum malaria at the Teda Health Centre.Trial registration: unique ID# PACTR202309773069812 at https://pactr.samrc.ac.za on September 1, 2023.

Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system

ABSTRACT Background Our study utilized the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) to analyze and study the adverse event (AEs) signals of second-generation antipsychotic drug lumateperone, providing a reference for clinical safety monitoring in the treatment of schizophrenia. Methods The International Dictionary of Medical Terminology (version 26.0) was used to standardize the preferred system organ category (SOC) and preferred terminology (PT) for adverse drug events (ADE) data related to lumateperone. ADE signals were classified and described using four algorithms: reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence-propagation neural network (BCPNN) and Multinomial gamma-poisson shrinkage (MGPS). Result Among the 2542 case reports collected from the FAERS database, 1762 reports with lumateperone as a ‘principal suspect(PS)’ AEs were identified. Lumateperone-induced AEs occurred in 26 system organ categories (SOC). A total of 118 significant disproportionate preferred terms (PTs) meeting the requirements of 4 algorithms were retained, and unexpected major events, such as burning sensation, tremor, migraine etc. may also occur. The median time to onset of lumateperone-related adverse events was 9 days (interquartile range [IQR] 2–31.25 days), and most AEs occurred within the first 10 days and 1 month after initiation of lumateperone therapy. Conclusion Our research may provide a better understanding of the potential adverse events that may be caused by lumateperone and those not recorded in the drug instructions, providing valuable signals for clinical use.

Evaluation of Antipsychotic-Induced Neuroleptic Malignant Syndrome Using a Self-Organizing Map.

Introduction In neuropsychiatric pharmacotherapy, neuroleptic malignant syndrome (NMS) is a potentially serious side effect of antipsychotics characterized primarily by fever, disorientation, extrapyramidal disorders, and autonomic nervous system imbalance, which can lead to death if left untreated. We visualized the NMS profile of antipsychotics using a self-organizing map (SOM). We combined it with decision tree analysis to discriminate between 31 antipsychotics in more detail than typical antipsychotic (TAP) and atypical antipsychotic (AAP) classifications. Method A total of 20 TAPs and 11 AAPs were analyzed. We analyzed NMS reports extracted from the Japanese Adverse Drug Event Report (JADER) database based on standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (Standardized MedDRA Queries (SMQ) code: 20000044, including 68 preferred terms). The SOM was applied using the SOM package in R version 4.1.2 (RFoundation for Statistical Computing, Vienna, Austria). Results The Japanese Adverse Drug Event Report (JADER) database contained 887,704 reports published between April 2004 and March 2024. The numbers of cases of NMS (SMQ code: 20000044) reported for risperidone, aripiprazole, haloperidol, olanzapine, and quetiapine were 1691, 1294, 1132, 1056, and 986, respectively. After the antipsychotics were classified into six units using SOM, they were adapted for decision tree analysis. First, 31 antipsychotics branched off into groups with loss of consciousness, with one group (10 TAPs) consisting entirely of TAPs, and the other consisting of antipsychotics that were further separated into two groups with coma induced by TAPs and AAPs. Conclusion The results of this study provide a reference for healthcare providers when predicting the NMS characteristics induced by each drug in patients, thereby facilitating the effective treatment of schizophrenia.

Medication Errors in Saudi Arabian Hospital Settings: A Systematic Review.

Background and Objectives: Medication errors significantly impact patient safety, potentially causing adverse drug events (ADEs), increasing morbidity and mortality and prolonging hospital stays. This systematic review aimed to identify common medication errors in Saudi hospitals, their contributing factors, and effective prevention strategies. Materials and Methods: Following PRISMA-P guidelines, a comprehensive review of the literature published after 2019 was conducted. Inclusion criteria focused on peer-reviewed articles in English addressing medication errors in Saudi hospitals. Exclusion criteria eliminated reviews, opinion pieces, and non-peer-reviewed sources. A narrative synthesis identified common themes, and a descriptive analysis organized the data. Results: Searches yielded 22 articles from Embase (n = 4), PubMed (n = 10), and Web of Science (n = 8). After removing duplicates and one review article, twelve studies remained. Hand-searching references added 16 more, totaling 28 articles. Of the 28 included studies, 20 (71.4%) reported the types of medication errors observed. Wrong dose and improper dose errors are among the most frequently reported across multiple studies, while prescribing errors remain consistently high, indicating a critical area for intervention. Although less frequent, omission errors still hold significance. Conclusions: This review emphasizes the importance of comprehensive, proactive approaches to preventing medication errors. Integrating evidence-based strategies, fostering a safety culture, and continuously monitoring and evaluating interventions can significantly enhance medication safety and improve patient outcomes in Saudi Arabian hospitals.

A Real-World Pharmacovigilance Study of the FDA Adverse Event Reporting System Events for Trametinib.

This research investigates adverse drug events (ADEs) linked to trametinib, utilizing data from the FDA Adverse Event Reporting System (FAERS) database, covering the period from Q2 2013 to Q4 2023. We gathered data on ADEs associated with trametinib from the second quarter of 2013 to the fourth quarter of 2023. After standardizing the data, we applied various analytical methods to quantify signals, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation for Neural Networks (BCPNN), and multi-item gamma Poisson shrinker (MGPS). In our examination of 2200 ADE reports with trametinib cited as the primary suspect, we identified 191 adverse reaction terms across 23 system organ classifications. The most frequently reported classifications were general disorders and administration site conditions, with 1254 cases (ROR 0.83, PRR 0.85, IC -0.23, EBGM 0.85), followed by neoplasms (benign, malignant, and unspecified, including cysts and polyps) with 802 cases (ROR 3.59, PRR 3.32, IC 1.73, EBGM 3.32), and investigations with 794 cases (ROR 1.74, PRR 1.66, IC 0.73, EBGM 1.66). Notably, this study also uncovered previously unlabeled adverse reactions such as cheilitis, lobular panniculitis, ulcerative keratitis, and stridor. While trametinib provides therapeutic advantages, it is associated with several potential adverse reactions. It is crucial for healthcare providers to closely monitor patients for symptoms such as cheilitis, lobular panniculitis, ulcerative keratitis, stridor, and other adverse events (AEs) during treatment.

Exploring gastrointestinal manifestations in childhood onset systemic lupus erythematosus - Insights from a multicenter study.

Systemic lupus erythematosus (SLE) constitutes an autoimmune disorder with potential involvement of the gastrointestinal system (GIS). Our objective was to assess the gastrointestinal (GI) manifestations in patients diagnosed with childhood onset SLE. The study cohort consisted of 123 patients with childhood onset-SLE and GIS involvement from 16 referral departments of pediatric rheumatology. All participants met the Systemic Lupus International Collaborating Clinics criteria. Out of 123 patients, 78 (63.4%) exhibited GIS involvement at the initial SLE diagnosis, whereas the remaining 45 (36.6%) developed GI symptoms after a median duration of 12 (3-140) months. Eighty-two (66.7%) individuals experienced symptoms related to the GI tract, whereas the remaining patients received a diagnosis of GI involvement through laboratory assessments. The predominant initial GIS involvement symptom was abdominal pain, observed in 77 (62.6%) patients, followed by elevated hepatic transaminases in 70 (56.9%), hepatomegaly in 40 (32.5%), diarrhea in 26 (21.1%), and jaundice in 11 (8.9%) patients. The GIS involvement was associated with SLE in 82 (78.6%), while it resulted from drug-related adverse events in 35 (28.5%) patients or comorbidities in 6 (0.5%) patients. GIS involvement should be considered in all childhood onset-SLE patients, especially in the presence of suggestive symptoms or elevated hepatic transaminases. It is also crucial to consider SLE in the differential diagnosis of GIS manifestations in children. Apart from GIS involvement directly associated with SLE, adverse events of drugs should be kept in mind.

Unveiling severe adverse events of antithyroid drugs in patients with graves' disease; a real-world multicenter cohort study

Unveiling severe adverse events of antithyroid drugs in patients with graves' disease; a real-world multicenter cohort study

Medication reviews by emergency department pharmacists in patients hospitalised for an adverse drug event: a cost study

ObjectiveTo perform a cost study of pharmacist-led medication reviews in patients with an acute hospitalization for adverse drug events.MethodEmergency department pharmacists performed medication reviews in patients hospitalized after visiting the emergency department for an adverse drug event (ADE). Control patients were hospitalized after an emergency department visit not related to an ADE and received usual care. The costs of the intervention were labour costs of the junior emergency department pharmacist and the cost savings consisted of costs of medication that was stopped or reduced during six months after the intervention. Sensitivity analyses were performed to evaluate different scenarios.ResultsIn the intervention group (n = 104) 113 medication changes led to stopping or reducing medication, accounting for averted costs of €22,850. In the control group (n = 112) 39 medication changes led to stopping or reducing medication, accounting for averted costs of €299. The mean labour costs of the intervention were €138 per patient, resulting in saved costs of €61 per patient per six months. Sensitivity analyses showed that if the intervention would be performed by a senior clinical pharmacist, there are no cost savings (€-21), if parts of the intervention would be executed by pharmacy technicians (e.g. administrative tasks), cost savings would be augmented to €87, if outliers in costs associated with medication reduction would be excluded, there are no cost savings (€-35) and if the costs of reduced medication were extrapolated to one year, cost savings would be €260.ConclusionIn this study, medication reviews by junior emergency department pharmacists in patients hospitalized after an emergency department visit for an ADE lead to a cost reduction over a six month period.Trial registrationThe main study is registered on the ISRCTN registry with trial ID ISRCTN12506329 on 06-03-2022.

A randomised controlled clinical study of standard triple therapy, bismuth-based quadruple therapy and sequential therapy for Helicobacter pylori infection in children

Background and aimBismuth and non-bismuth quadruple therapy are the guideline-recommended first-line therapy in children with Helicobacter pylori infection in areas with high antibiotic resistance. However, their efficacy in children is uncertain and there are few well-designed studies. Here, we evaluated the eradication rates of standard triple therapy, bismuth-based quadruple therapy and sequential therapy in children with H. pylori infection.MethodsA randomised controlled trial was conducted in children infected with H. pylori in West China Second Hospital. They were randomly assigned to 14-day standard triple therapy (omeprazole + amoxicillin + clarithromycin), 14-day bismuth quadruple therapy (bismuth + omeprazole + amoxicillin + clarithromycin) and 10-day sequential therapy (omeprazole + amoxicillin for 5 days followed by omeprazole + clarithromycin + metronidazole for 5 days). The eradication rate was assessed by a 13C-urea breath test 4 to 6 weeks after therapy completion. Symptom improvement and adverse events were compared among the groups.ResultsIn total, 132 patients were enrolled. The eradication rates of 14-day standard triple therapy, 14-day bismuth quadruple therapy and 10-day sequential therapy were 70.0%, 78.9% and 50.0% in per-protocol analysis and 63.6%, 68.2% and 43.2% in intention-to-treat analysis, respectively. Symptom improvement and adverse drug event rates were similar in the three groups.ConclusionThe three therapeutic regimens evaluated in this study are equally not recommendable for H. pylori infection treatment due to unsatisfactory eradication rates. The high prevalence of clarithromycin resistance makes the use of clarithromycin-based quadruple therapy not advisable, even in combination with amoxicillin and bismuth salts.

Reuse of Adverse Effect Reports from the French National Agency of Medicines: A Visual Analytic Tool to Improve Patient Safety.

Adverse drug reaction are defined as "harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product". In France, adverse effects due to medicines are reported to the French National Agency of Medicines (ANSM) by the healthcare professionals or consumers. The objective of this study was to implement a tool that facilitates the utilization of ANSM reports by synthesizing information to effectively inform prescribers and users. We focused on 3 psychotropic classes: antidepressants, antipsychotics and anxiolytics. We extracted relevant data from the ANSM website through a webscraping process, based on the names of molecules in these 3 classes: antidepressants, antipsychotics, and anxiolytics. We implemented a web interface with R Shiny that provides three panels: (i) a presentation of the active ingredient with the fewest reports for a selected adverse effect category, (ii) the adverse reactions for a selected active ingredient ranked in descending order, and (iii) a comparison of two active ingredients where, for each adverse effect, the active ingredient with the fewest reported adverse drug events (ADEs) is displayed. Our application allows for synthesizing information to effectively inform prescribers and users. In the ANSM existing interface, molecules can only be viewed one by one, and the ratio needs to be calculated manually, making it difficult to compare molecules. It is important to note that this is not a prescription assistance device but rather for informational purposes. In the future, the application may be expanded to include other categories of molecules. Finally, the indicators provided by our tool could be compared to those from other pharmacovigilance databases.

Comparing a Large Language Model with Previous Deep Learning Models on Named Entity Recognition of Adverse Drug Events.

The ability to fine-tune pre-trained deep learning models to learn how to process a downstream task using a large training set allow to significantly improve performances of named entity recognition. Large language models are recent models based on the Transformers architecture that may be conditioned on a new task with in-context learning, by providing a series of instructions or prompt. These models only require few examples and such approach is defined as few shot learning. Our objective was to compare performances of named entity recognition of adverse drug events between state of the art deep learning models fine-tuned on Pubmed abstracts and a large language model using few-shot learning. Hussain et al's state of the art model (PMID: 34422092) significantly outperformed the ChatGPT-3.5 model (F1-Score: 97.6% vs 86.0%). Few-shot learning is a convenient way to perform named entity recognition when training examples are rare, but performances are still inferior to those of a deep learning model fine-tuned with several training examples. Perspectives are to evaluate few-shot prompting with GPT-4 and perform fine-tuning on GPT-3.5.

Comprehensive Analysis of Drug-Induced Parkinson-like Events.

Specific drugs are well known to have the capacity to induce Parkinson-like symptoms. Parkinson-like events are side effects that may persist for an extended period even after drug administration is discontinued. Although these events can be triggered by various drugs, the mechanisms underlying their diverse symptoms remain largely unclear. To investigate this, we used the Japanese Adverse Drug Event Reporting Database, which is maintained by the Pharmaceuticals and Medical Devices Agency, to analyze the risk factors associated with Parkinson-like events along with the associated drug trends and characteristics. Our findings indicate that similar to Parkinson's disease, age-related differences affect the onset of these reported events, with older individuals being more susceptible. Hierarchical clustering and principal component analysis revealed that the mechanisms triggering these Parkinson-like events are consistent across reports, suggesting a common underlying cause. However, even with a consistent mechanism, the side effects can vary depending on the site of action. These insights underline the importance of the swift identification of the drugs suspected of causing these events and the implementation of measures to reduce their side effects.

Urinary and gynecologic adverse events associated with SSRI use

Background Selective Serotonin Receptor Inhibitors (SSRIs) are the most prescribed psychiatric drug in the United States. However, the adverse effects of SSRIs related to the genitourinary and reproductive systems in real-world settings remains unclear. The aim of this study is to identify a comprehensive profile of adverse events (AEs) associated with SSRIs in females using data from the FDA Adverse Events Reporting System (FAERS) and variability of adverse events across individual SSRIs. Methods A software designed to analyze adverse drug events, OpenVigil 2.1, was used to query the FAERS data. We defined 445 genitourinary and reproductive system related adverse events related to genitourinary and reproductive systems. Proportional reporting ratio (PRR) was utilized to assess the strength of association between adverse events and SSRIs. Subgroup analysis was conducted to stratify adverse events by age. Results The majority of AEs were related to sexual dysfunction, such as issues of arousal, libido, and orgasm. Additional significant findings were related to gynecologic bleeding, urinary retention and incontinence, and hypersexuality. Citalopram exhibited the strongest signal strengths, as evidenced by the highest proportional reporting ratios (PRRs), particularly in relation to sexual dysfunction. The strongest signals related to sexual dysfunction were found in the 40-59 years age group. Urinary symptoms were most prevalent in the over 60 years age group. Conclusion According to our findings, the potential for genitourinary and reproductive system related AEs of SSRIs warrants further investigation of underlying mechanisms and monitoring in clinical practice. AEs are important considerations for clinical practice as side effects of SSRIs can impact treatment compliance and patient quality of life.

Promoting medication safety for older adults upon hospital discharge: Guiding principles for a medication discharge plan.

Older adults are at risk of adverse drug events during transition of care from hospital to community, thus optimal communication about medications at discharge is essential. Standardization of medication discharge plan (MDP) is lacking. This study aimed to (1) create a standardized MDP for older adults using consensus-based principles, (2) create a short-version MDP and (3) generate a practical guide. Modified Delphi was used to establish consensus on guiding principles for the MDP. Additionally, participants were asked about guiding principles deemed most essential, patient prioritization, the format and mode of transmission of the MDP. Twenty-six guiding principles reached consensus, with 17 prioritized for a short-version MDP. The practical guide includes explanations of the guiding principles, criteria for patient selection and recommendations on the format and mode of transmission. The results of this study will assist implementation of MDPs when older adults are discharged from hospital.

Assessment of practice and perceptions of healthcare professionals regarding the contribution of inappropriate pharmaceutical compounding to adverse drug events (ADEs) and antimicrobial resistance (AMR)

IntroductionPharmaceutical compounding, a practice of tailoring medications to individual patient needs, is integral to healthcare but poses potential risks, including adverse drug events (ADEs) and antimicrobial resistance (AMR). Understanding healthcare professionals' knowledge and perceptions on these issues is crucial for enhancing patient safety.ObjectivesThis study aimed to assess the practice and perceptions of healthcare professionals regarding the contribution of inappropriate pharmaceutical compounding to ADEs and AMR at Pawi General Hospital in the Metekel Zone, Benishangul-Gumuz Region.MethodsA crossectional study design was employed, involving a self-administered questionnaire distributed to healthcare professionals, including pharmacists, physicians, and nurses. STATA version 17 was used for analysis. Descriptive Analysis was used to summarize demographic characteristics of participants. The normality of the data was tested using a Shapiro wilk test. The mean standard deviations (SD) and percentages (%) of the variables were calculated.ResultsThe study was conducted among 120 healthcare professionals actively involved in patient care and pharmaceutical services within the hospital. The result of the study indicates varying levels of practice among healthcare professionals. The perceptions on the contribution of inappropriate compounding to ADEs and AMR differ across disciplines. The majority (75.83%) of the respondents deemed compounded medications in patient care as very important. A significant majority (61.67%) of respondents expressed being very concerned about the contribution of inappropriately compounded medication to AMR and ADEs.ConclusionsThis study indicated the need for targeted educational interventions to enhance healthcare professionals' understanding of inappropriate pharmaceutical compounding risks. The development of standardized training programs, regular updates on best practices, and collaborative efforts among healthcare professionals is essential for promoting patient safety, minimizing adverse events, and contributing to effective antimicrobial stewardship.

Digital Guardians: The Role of Technology in Preventing Adverse Drug Events in Community Pharmacies

These adverse drug events, also known as ADEs, are a major cause for concern in the healthcare industry since they are a contributor to morbidity, mortality, and increased healthcare expenditures. Community pharmacies, which serve as the primary point of contact for a large number of patients, play an essential part in the process of identifying and preventing adverse drug reactions (ADEs). The implementation of technology in these contexts presents a number of interesting options that have the potential to improve patient safety and drug management capabilities. Within the context of community pharmacy, this research investigates the impact that various technological improvements have had on the prevention and monitoring of adverse drug reactions (ADEs). Telepharmacy, clinical decision support systems (CDSS), automated dispensing systems, and electronic health records (EHRs) are some of the key technologies that are mentioned. Through this analysis, the benefits, challenges, and future directions of technology-driven pharmacovigilance in community pharmacies are highlighted. Additionally, the review emphasises the necessity of continuous innovation and adaptation in order to enhance patient outcomes and the efficiency of healthcare.

Optimizing Pain Management in Cardiac Surgery: A Review of Analgesic Adjuvants.

Pain management following cardiac surgery is a critical component in optimizing both short- and long-term patient outcomes, with poor pain management associated with significant acute and chronic opioid use, opioid dependence and a significant rate of opioid related adverse drug events. The significant burden of both acute and chronic pain following cardiac surgery has given rise to the need for multimodel analgesic strategies, to optimize outcomes and minimize side effects. While significant research has focused recently on the additive value of peripheral nerve blocks, less emphasis has been given to the value of non-opioid based analgesics in preference to traditional opioid based anesthetic and analgesic strategies. In this review, we examine the evidence for several common analgesics, highlighting the evidence supporting efficacy following cardiac surgery, as well as the safety concerns with each agent. We demonstrate the value of a multimodal analgesic strategy to reduce pain scores and improve patient-centered outcomes, and highlight the need for further studies of combination analgesic strategies.

Lessons from enriching Tanzania’s clinical research ethics clinical trials oversight and pharmacovigilance through the ASCEND project

Engaging in clinical trials in Africa not only enhances researchers' comprehension of local health concerns but also plays a crucial role in tackling global health challenges. In Tanzania, there has been a surge of clinical research for the past 10 years indicating a need to improve ethical and clinical trial regulatory capacity. Several initiatives to address the clinical trial regulatory and ethics challenges have been done. Lessons from such initiatives are important to inform evidence-based decision-making for sustainability. The ASCEND project with the theme of “Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the Next Level: Fostering Medicine Quality, Safety and Good Clinical Practice (GCP) on Clinical Trials” was implemented in Tanzania Mainland and Zanzibar from November 2020 to December 2023. A thorough review of the project implementation reports and on deliverables was conducted to identify the lessons learned. Inductive content analysis was used to analyze the information. A total of seven lessons were deduced from the reviewed documents. These include capacity building through training on clinical trials review and approval process, research ethics and GCP inspection which cannot be overlooked; engaging the community in reporting adverse drug events is worth considering; digitalization of electronic systems enhances clinical trial control and creates a dynamic regulatory ecosystem; compliance to requirements for clinical trials conduct is enhanced by training of early and mid-career researchers; networking and broad stakeholders’ engagement and participation in ethics and regulations governing clinical trials is a cornerstone for strengthening collaboration between researchers and regulators; the need for electronic systems for monitoring and evaluation of the project is inevitable and the need for adhering to project timelines is crucial for successful implementation of the project. Sustainability is the take-home message from the ASCEND project and should inform stakeholders for future improvement. Continuous investment and advancement in research ethics and regulatory oversight across Africa should be prioritized.

QTc Interval Prolongation as an Adverse Event of Azole Antifungal Drugs: Case Report and Literature Review.

QTc prolongation and torsade de pointes (TdP) are significant adverse events linked to azole antifungals. Reports on QTc interval prolongation caused by these agents are limited. In this study, we report a case of a 77-year-old male with cardiovascular disease who experienced QTc prolongation and subsequent TdP while being treated with fluconazole for Candida albicans-induced knee arthritis. Additionally, a literature review was conducted on cases where QTc prolongation and TdP were triggered as adverse events of azole antifungal drugs. The case study detailed the patient's experience, whereas the literature review analyzed cases from May 1997 to February 2023, focusing on patient demographics, underlying diseases, antifungal regimens, concurrent medications, QTc changes, and outcomes. The review identified 16 cases, mainly in younger individuals (median age of 29) and women (75%). Fluconazole (63%) and voriconazole (37%) were the most common agents. Concurrent medications were present in 75% of cases, and TdP occurred in 81%. Management typically involved discontinuing or switching antifungals and correcting electrolytes, with all patients surviving. Risk assessment and concurrent medication review are essential before starting azole therapy. High-risk patients require careful electrocardiogram monitoring to prevent arrhythmias. Remote monitoring may enhance safety for patients with implanted devices. Further studies are needed to understand risk factors and management strategies.