Adverse Drug Reactions Events Research Articles

Poisoning and envenomation linkage to evaluate outcomes and clinical variation in Australia (PAVLOVA): a longitudinal data-linkage cohort of acute poisonings, envenomations, and adverse drug reactions in New South Wales, Australia, 2011-2020.

Poisoning is a leading cause of morbidity and mortality that is increasing in many countries. Better data are needed to understand epidemiology and outcomes of poisoning. This work describes a new poisoning data linkage cohort in New South Wales, Australia (population approximately 8 million). This is a longitudinal health record linkage, 2011-2020, including data from: ambulance call-outs, emergency department presentations, hospital admissions, death registrations, the poisons centre, and four tertiary toxicology units. Individuals with poisoning, venomous animal/plant exposures, or adverse drug reaction events were included. There were 845,217 linkable events relating to 400,642 ambulance, 688,484 emergency department, 682,013 admission, 40,456 toxicology, and 11,879 death records. There were 572,841 people with events; the median age at the time of first event was 57 years, and 51.9% were female. Events leading to patient admission were most commonly adverse drug reactions (n = 511,263), intentional poisonings (n = 68,646), unintentional poisonings (n = 54,840) and animal/plant exposures (n = 11,092). Demographics varied by cause: intentional poisoning (median age 33 years, 64% female); unintentional poisoning/animals/plants (median age 43 years, 45%); and adverse drug reactions (median age 70 years, 54%). Adolescent females had highest rates of intentional poisoning, while unintentional poisoning had a bimodal distribution, highest in children <5 years old and males aged 20 to 50 years. Substance use disorders were documented comorbidities for 44% of intentional poisoning, 29% of unintentional poisoning, and 13% of adverse drug reaction-related admissions; mood disorders were documented for 54%, 17% and 10% of these admissions, respectively. Poisonings and hospitalised adverse drug reactions are common in New South Wales, affecting approximately 8% of the population in 10 years. This linkage improves understanding of poisoning risks and outcomes in Australia. This novel data linkage provides a unique opportunity to study poisoning across multiple settings for an individual over an extended period.

Adverse drug reactions reported over 5 years in a regional university hospital

Adverse drug reactions (ADRs) are closely associated with increased morbidity and mortality rates, prolonged hospitalization durations, and higher healthcare costs. This study aimed to estimate the incidence, clinical features, and reporting status of ADRs to improve the current ADR reporting system and prevent recurrent ADRs in hospitals. This retrospective study was conducted at a regional referral hospital. Patients diagnosed with ADRs over a 5-year period (2009-2014) were recruited for this study. An ADR was identified as an ADRrelated diagnosis in a patient’s medical record or an ADR registered through the inhospital ADR reporting system. The incidence, culprit drug, clinical manifestations, reporting source, severity, related management, and recurrence rate were assessed. Among 1,112 patients, 1,375 ADR events were collected, an estimated 0.06% of the total number of patient visits. Diagnostic contrast agents (46.4%) were the most common culprit drugs, followed by antibiotics (22.0%), nonsteroidal anti-inflammatory drugs (9.9%), and opioids (4.5%). Skin reactions (67.5%) such as rashes and hives were the most frequent manifestations. Additional ADR-related medical attention was necessary in two thirds of cases. One hundred eighty ADR events (13.1%) were categorized as severe, and 19 patients (1.4%) experienced re-exposure to the culprit drugs. Four patients (0.3%) experienced fatal ADRs. Physicians were the most frequent ADR reporters in the in-hospital ADR reporting system. In conclusion, many ADR events may be overlooked, and re-exposure to causative drugs commonly occurs. Continuous education and maintenance of a reporting system may be important for preventing recurrent ADRs.

Oral phosphodiesterase type 5 inhibitors and priapism: A VigiBase analysis.

To explore the differences of priapism events among a diverse cohort taking erectogenic medicines (i.e., phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal drugs). We queried the World Health Organization global database of individual case safety reports (VigiBase) for records of the adverse drug reactions (ADR) with sildenafil, tadalafil, avanafil, vardenafil, papaverine, and alprostadil. Disproportionality analyses (case/non-case approach) were performed to assess the reporting odds ratio (ROR) of priapism reporting in PDE5i consumers compared to intracavernousal drug recipients. From a total of 133 819 ADR events for erectogenic medications, 632 were priapism (PDE5is: n = 550, 0.41%; intracavernousal drugs: n = 82, 9.92%). Priapism disproportionality signals from intracavernousal drugs were 25 times stronger than PDE5is (ROR = 34.7; confidence interval [CI] 95%: 27.12-43.94 vs. ROR = 1.38; 95% CI: 1.24-1.54). For all PDE5i agents, the 12-17 years age group had the highest ROR (9.49, 95% CI: 3.76-19.93) followed by 2-11 years (4.31, 95% CI: 1.57-9.4). Disproportionality signals for consumers under 18 for both all PDE5is as a whole (ROR = 4.57, 95% CI: 2.48-7.73) and sildenafil (ROR = 4.89, 95% CI: 2.51-8.62) were stronger than individuals 18 or older (ROR = 1.06, 95% CI: 0.93-1.21 and ROR = 1.08, 95% CI: 0.91-1.26, respectively). PDE5i use shows disproportionate priapism signals which are higher in young patients.

Effectiveness and Safety of Prochlorperazine in Indian Patients with Acute Vertigo: Results from a Large, Prospective, Post-marketing Observational Study

AimTo assess the efficacy and safety of prochlorperazine in Indian patients with acute vertigo.MethodsIn this prospective, multicenter, open-label, post-marketing observational study, patients with acute peripheral vertigo of different etiologies received 5 mg prochlorperazine thrice a day for 5 days. The primary endpoints were percentage of patients with improvement in (1) vertigo symptoms and (2) clinical response as per scale for vestibular vertigo severity level and clinical response evaluation (SVVSLCRE) from baseline to end of treatment (Day 6). The key secondary endpoints were (1) improvement in nystagmus grading, and (2) safety and tolerability Efficacy of prochlorperazine by route of administration of first prochlorperazine dose (oral or intramuscular) was also assessed.ResultsOf 1716 enrolled patients (mean [standard deviation, SD]) age (42.0 [12.95] years; 53.6% men), 57.4% were diagnosed with Meniere’s disease, followed by vestibular neuritis (17.4%), labyrinthitis (16.7%), or ear surgery (8.5%). In the overall population, 91.1% of patients showed improvement in clinical response per SVVSLCRE grading at Day 6 (p < 0.0001 vs. non-responders). Nystagmus grading was improved in 99.7% (of patients. No adverse drug reactions events were reported. Tolerability of prochlorperazine was rated as good, very good, and excellent by 43.6%, 32.9% and 20.7% of patients, respectively. Among patients with postoperative vertigo, 80.1% showed improvement in clinical response. In the intramuscular and oral subsets, 85.5% and 92.1% of patients showed improved clinical response, respectively.ConclusionProchlorperazine showed improvement in severity of symptoms and clinical response in all subsets of vertigo patients, with a good safety and tolerability profile.Trial Registration NumberCTRI/2022/01/039287.Date of Registration10 January 2022.

Research on named entity recognition of adverse drug reactions based on NLP and deep learning.

Introduction: Adverse drug reactions (ADR) are directly related to public health and become the focus of public and media attention. At present, a large number of ADR events have been reported on the Internet, but the mining and utilization of such information resources is insufficient. Named entity recognition (NER) is the basic work of many natural language processing (NLP) tasks, which aims to identify entities with specific meanings from natural language texts. Methods: In order to identify entities from ADR event data resources more effectively, so as to provide valuable health knowledge for people, this paper introduces ALBERT in the input presentation layer on the basis of the classic BiLSTM-CRF model, and proposes a method of ADR named entity recognition based on the ALBERT-BiLSTM-CRF model. The textual information about ADR on the website "Chinese medical information query platform" (https://www.dayi.org.cn) was collected by the crawler and used as research data, and the BIO method was used to label three types of entities: drug name (DRN), drug component (COM), and adverse drug reactions (ADR) to build a corpus. Then, the words were mapped to the word vector by using the ALBERT module to obtain the character level semantic information, the context coding was performed by the BiLSTM module, and the label decoding was using the CRF module to predict the real label. Results: Based on the constructed corpus, experimental comparisons were made with two classical models, namely, BiLSTM-CRF and BERT-BiLSTM-CRF. The experimental results show that the F 1 of our method is 91.19% on the whole, which is 1.5% and 1.37% higher than the other two models respectively, and the performance of recognition of three types of entities is significantly improved, which proves the superiority of this method. Discussion: The method proposed can be used effectively in NER from ADR information on the Internet, which provides a basis for the extraction of drug-related entity relationships and the construction of knowledge graph, thus playing a role in practical health systems such as intelligent diagnosis, risk reasoning and automatic question answering.

Overlapping risk factors for diabetic ketoacidosis in patients with type 1 diabetes on ipragliflozin: case analysis of spontaneous reports in Japan from a pharmacovigilance safety database

ABSTRACT Background In patients with type 1 diabetes mellitus (T1D), sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with an increased risk of diabetic ketoacidosis (DKA). Ipragliflozin is an SGLT2 inhibitor approved in Japan in combination with insulin for patients with T1D. Research design and methods Spontaneous safety reports of ipragliflozin adverse drug reactions (ADRs) in patients with T1D were collected during early post-marketing phase vigilance (EPPV; 21 December 2018–20 June 2019). For patients with T1D prescribed ipragliflozin who experienced DKA, we examined DKA event data registered in the manufacturer’s safety database (21 December 2018–31 December 2021), including patient background characteristics. Results During EPPV, there were 189 total events (45 serious) of ADRs, including 32 serious events of ketoacidosis. From 2018 to 2021, the major DKA risk factors were sick days, stopping or inappropriately decreasing insulin, insulin pump trouble, and low carbohydrate diet, with substantial overlap among these factors. Conclusions In Japanese patients with T1D using ipragliflozin, DKA events were linked to several overlapping factors, including sick days and reduced dose/interruption of insulin, whether intentional or unexpected. These results highlight the need for improved patient education regarding ipragliflozin use and appropriate self-management of ketosis from an early stage.

Outcomes of a quality improvement project integrating an EHR (electronic health record) for improved adverse drug reaction (ADR) communication at an adult outpatient cancer infusion center.

372 Background: An adult oncology practice achieved 41% compliance with communication of ADRs involving infusion drugs to ordering provider during the year 2020. We aim at achieving communication of ADRs to ordering provider with a goal compliance rate of 75% over a period of 8 months. Methods: We assembled an interdisciplinary team comprising of medical oncologists, fellows, clinical nurse managers, infusion &amp; clinic nurses, information technology (IT))providers and a clinical pharmacist. We reviewed ADRs occurring between April-December of 2021 in adult patients receiving outpatient infusion therapy at our institution. We created a current-state process map of ADRs in our infusion center. We identified issues that needed to be addressed including no clear standard for documenting or reporting an infusion reaction, no standard process was in place for proper notification to all parties involved nor was there a consistent location in the EHR regarding the description of events that took place. Acknowledgment by ordering provider to an ADR was used as a primary outcome measure. The RL6 (internal tracking system) patient safety events reported was used as a process measure. PDSA cycle 1 January 2021:We implemented a new flowsheet section in the EHR titled “Adverse Drug Reaction”. We created a smart phrase for clarification of documentation, when used will pull information from the flowsheet section into the note. Education was provided to nursing on this new standardized process. Clinicians were educated where to find this information as a standardized location within the EHR. The ordering provider was notified when an ADR occurred by having the infusion nurse document a clinical support note that is routed to the provider’s EHR in-basket. PDSA cycle 2 June 2021: Once nursing documented an ADR, an automated message was sent to all the care-team members via the ADR event folder within the EHR in-basket. The nursing staff then would add the ADR orders group to the treatment plan for clinician review. An alert was generated which prompted the clinician to acknowledge the ADR within the Beacon plan thereby alerting the nursing team if any changes were made. Results: In 2021 there were 73 ADR events that have occurred in Infusion Services. Our interventions were associated with an 80% improvement in communication of ADRs to ordering providers and 35% increase in reporting ADR within our internal tracking system. Conclusions: Developing a standardized ADR process enhanced communication of ADRs to the ordering providers as our intervention was associated with an 80% improvement in communication of ADRs over a 8-month period. Involving all major stakeholders, especially the staff working in information technology services, resulted in exponential results demonstrating the potential future solutions within the EHR.

Pattern of adverse drug reactions to anticancer drugs at an apex hospital in south India: A retrospective study

Cancer chemotherapy is rampant as cancer is the 2nd most common cause of global mortality. It is challenged by a horde of adverse drug reactions (ADRs) and adverse events. A proper study of these ADRs is very crucial to limit their occurrences and thereby ameliorate the sufferings of the patients. Our study was to assess the frequency, nature and profile of the ADRs with anticancer drugs. A retrospective analysis of the ADR data collected over a period of 5 years was considered. Demography, drug related changes and clinical details of the patients were recorded and analysed. A total of 1145 ADR events were reported during the study period of January 01, 2017 to December 31st 2021 of which 232 cases (20.26 %) were due to anticancer drugs. The majority of the ADRs were accounted in females and in the elderly age group (&amp;#62;60 years). The commonly reported ADRs included breathing difficulty, chest discomfort, itching all over the body, numbness, neuropathy, mucositis and hand foot syndrome. The most common drugs that caused ADRs were Platinum coordination complex drugs, Taxanes, Rituximab and pyrimidine antagonists like Capecitabine and Gemcitabine. Causality assessment done using WHO-Uppsala Monitoring Centre causality assessment scale which showed 69.4% cases as “probable”, 29.3% cases as “possible” and 1.3% as “certain”. Severity assessed using the modified Hartwig and Siegel scale showed most of the cases as of moderate severity. Most of the ADR events in our study was manageable although a few required the withdrawal of the causative drug. Rigorous monitoring and adequate reporting are very crucial for the prompt identification, assessment and timely management of ADRs in the patients receiving chemotherapy so as to improve the quality of life in these patients.

Pharmacogenomic Profile of Amazonian Amerindians.

Given the role of pharmacogenomics in the large variability observed in drug efficacy/safety, an assessment about the pharmacogenomic profile of patients prior to drug prescription or dose adjustment is paramount to improve adherence to treatment and prevent adverse drug reaction events. A population commonly underrepresented in pharmacogenomic studies is the Native American populations, which have a unique genetic profile due to a long process of geographic isolation and other genetic and evolutionary processes. Here, we describe the pharmacogenetic variability of Native American populations regarding 160 pharmacogenes involved in absorption, distribution, metabolism, and excretion processes and biological pathways of different therapies. Data were obtained through complete exome sequencing of individuals from 12 different Amerindian groups of the Brazilian Amazon. The study reports a total of 3311 variants; of this, 167 are exclusive to Amerindian populations, and 1183 are located in coding regions. Among these new variants, we found non-synonymous coding variants in the DPYD and the IFNL4 genes and variants with high allelic frequencies in intronic regions of the MTHFR, TYMS, GSTT1, and CYP2D6 genes. Additionally, 332 variants with either high or moderate (disruptive or non-disruptive impact in protein effectiveness, respectively) significance were found with a minimum of 1% frequency in the Amazonian Amerindian population. The data reported here serve as scientific basis for future design of specific treatment protocols for Amazonian Amerindian populations as well as for populations admixed with them, such as the Northern Brazilian population.

Evaluation of Medication Instruction Sheets for Patients Undergoing R-CHOP Therapy in Non-Hodgkin's Lymphoma.

High-dose chemotherapy is frequently administered to patients with hematologic malignancies, thereby causing severe adverse drug reactions (ADRs) at a relatively high frequency. To precisely monitor ADRs, we developed a medication instruction sheet (MIS) for patients who received rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) combination therapy for non-Hodgkin's lymphoma (NHL). Herein, we evaluated the usefulness of the MIS for managing ADRs in patients who received R-CHOP therapy. We included patients aged ≥20 years who received R-CHOP therapy as first-line treatment for NHL at the Department of Hematology, Kyushu University Hospital, between August 2014 and December 2018. Medical professionals evaluated the possible occurrence of ADRs according to the present MIS and ADRs were graded according to the Common Toxicity Criteria, version 4.0 (National Cancer Institute, Bethesda, MD, USA). Finally, the accuracy of the MIS in predicting the occurrence of ADRs of different grades and during definite periods was evaluated. Seventy-five patients with NHL were included in the present study. Overall, 359 ADR events were monitored, which were predicted ADR items listed in the MIS. Among these, 254 (71%) events occurred during the same period as those listed in the MIS. The onset timing of any grade of an infusion reaction and peripheral neuropathy precisely matched those listed in the MIS. However, the accuracy of the MIS was reduced in patients with thrombocytopenia (42%). The present MIS could be useful for monitoring ADRs in patients with cancer undergoing R-CHOP therapy.

English

The pharmacovigilance practices aim to improve the safety and care of patient in relation to the utilization of medications, as well as other medical and paramedical interventions. Due to emergence of outbreaks of infections, the sub-Saharan African countries have been widely utilizing the trial drugs, which have been increasing the events of Adverse Drug Reactions (ADRs) in the region. This systematic literature review aims to examine the characteristics, knowledge, attitude and pharmacovigilance practices performed by health care professionals in sub-Saharan Africa. This systematic review included N=7 studies, published between 2010 and 2020, and dealing with characteristics, knowledge, attitude and pharmacovigilance practices performed by health care professionals of sub-Saharan African region were extracted from CINAHL, Science Direct, and PubMed. Seven journal articles were selected through PRISMA research tool to identify the key factors which included inadequate training, under-reporting, knowledge assessment, practice, and good attitude. All selected studies were published in sub-Saharan Africa for this systematic review. The healthcare professionals working in the region of sub-Sahara Africa lack expertise in pharmacovigilance practices, due to lack of awareness, unavailability of support, and several other factors. Pharmacovigilance practices can be improved by arranging education, training, and role-play sessions for them. Key words: Pharmacovigilance, adverse drug reactions, knowledge, attitude, practice, sub-Saharan Africa, KAP.

Medical students as junior adverse drug event managers facilitating reporting of ADRs.

The Junior Adverse Drug Event Manager (J‐ADEM) team is a multifaceted intervention focusing on real‐life education for medical students that has been shown to assist healthcare professionals in managing and reporting suspected adverse drug reactions (ADRs) to the Netherlands Pharmacovigilance Centre Lareb. The aim of this study was to quantify and describe the ADRs reported by the J‐ADEM team and to determine the clinical potential of this approach. The J‐ADEM team consisted of medical students tasked with managing and reporting ADRs in hospitalized patients. All ADRs screened and reported by J‐ADEM team were recorded anonymously, and categorized and analysed descriptively. From August 2018 through January 2020, 209 patients on two wards in an academic hospital were screened for ADR events. The J‐ADEM team reported 101 ADRs. Although most ADRs (67%) were first identified by healthcare professionals and then reported by the J‐ADEM team, the team also reported an additional 33 not previously identified serious ADRs. In 10% of all reported ADRs, the J‐ADEM team helped optimize ADR treatment. The ADR reports were largely well‐documented (78%), and ADRs were classified as type A (66%), had a moderate or severe severity (85%) and were predominantly avoidable reactions (69%). This study shows that medical students are able to screen patients for ADRs, can identify previously undetected ADRs and can help optimize ADR management. They significantly increased (by 300%) the number of ADR reports submitted, showing that the J‐ADEM team can make a valuable clinical contribution to hospital care.

Patient-reported effectiveness and safety of Pamidronate in NSAIDs-refractory chronic recurrent multifocal osteomyelitis in children

To evaluate patient-reported effectiveness, safety and social influence of Pamidronate in the therapy of NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis in children. Authors reviewed self-created questionnaires, which asked patients for symptoms alleviation, adverse drug reactions frequency and degree of severity and daily activities self-reliance. Only surveys with complete answers, which were returned to authors by an e-mail from juvenile patients treated for NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at the University Children’s Hospital of Cracow were analyzed. Between 2010 and 2019, 61 children were diagnosed with NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at our department. Out of 61 requests sent, 42 complete replies (33 females, 9 males) were gathered and analyzed. All patients included in this research were administered with at least one set of Pamidronate intravenously in the dose of 1 mg/kg/day for 3 consecutive days. Our analysis shows remarkable in terms of patient’s impressions decrease of pain intensity after 2.5 series of Pamidronate on average, and total pain resolution after 5.9 series on average. Overall number of adverse drug reaction events reported by responders was 105. One patient developed drug-dependent renal insufficiency in the course of therapy. Outcome assessment indicates that nearly 50% of the studied population was more eager to participate in social life just after the first infusion of the drug. 95% of the surveyed unanimously agreed to recommend Pamidronate therapy to cure NSAIDs-refractory CRMO. 39 out of 42 (93%) patients considered Pamidronate effective at the end of the treatment. Onset of Pamidronate’s action is gradual and differs in terms of symptoms alleviation between sexes. The therapy can induce considerable number of adverse drug reactions (2.5 per patient). Only 3 out of 42 (7%) patients were free from any ADRs. To demonstrate the impact of the use of Pamidronate on daily activities more precisely, further research with quantification of the quality of life is warranted.

Relative Risk Analysis of Liver-related Adverse Drug Reactions in Children Based on China’s National Spontaneous Reporting System

To compare the risk of liver-related adverse drug reactions (ADRs) in children and adults. A case/non-case analysis on spontaneous reports based on the China National Adverse Drug Reactions Monitoring System database were conducted, focusing on events of liver-related ADRs in children younger than 14years of age. Both the relative risk of liver-related ADRs in children vs entire population and the risk stratification in children were expressed as a measure of disproportionality using the reporting odds ratio (ROR). There were 1206 cases of pediatric liver-related ADRs identified from 2012 to 2016, accounting for 2.82% of the entire population. The greatest ROR values in children from 0 to 14years vs the entire population were observed for analgesics (3.97, 95% CI 3.27-4.81), respiratory (2.60, 95% CI 1.04-6.43), antineoplastic (2.29, 95% CI 2.02-2.58), immunomodulatory (1.91, 95% CI 1.44-2.53), and antimicrobial agents (1.47, 95% CI 1.33-1.63). Notably, infants aged 0-1years showed significantly greater risk (3.14, 95% CI 2.85-3.48) of liver-related ADRs than the other age groups of children. For infants, analgesics (3.21, 95% CI 2.20-4.66) and antimicrobials (3.15, 95% CI 2.50-3.97) agents were found to have the greatest adjusted RORs than other drug categories. The highest RORs were found for meropenem, amoxicillin, fluconazole, vancomycin, cefaclor, and ceftazidime in the antimicrobial agents for infants. Children are sensitive to liver-related ADRs caused by several specific drug categories, and infants are the most sensitive.

GAR: Graph adversarial representation for adverse drug event detection on Twitter

Adverse drug reaction events have become one of the main causes of patient death. Since traditional post-marketing surveillance systems based on spontaneous reports have a serious underreporting issue, in recent years research on the detection of adverse reaction events using social media such as Twitter as a data source has attracted increasing attention in recent year. Deep learning models usually rely on a large number of training samples. However, due to the characteristics of user-generated content and the time-consuming data annotation process, related research is faced with the problems caused by small-scale annotated datasets, which restricts deep learning models in achieving satisfactory results. Accordingly, we introduce two regularization methods are introduced at the representation level, i.e., graph embedding-based data augmentation and adversarial training, to improve the performance of detecting adverse events under such conditions. Besides, the applicable scope of these two methods is analyzed and discussed through experiments. Combined with the convolutional neural network, this paper proposes an adverse drug event detection framework that can make full use of the methods.

Characteristics of adverse drug reactions associated with antiepileptics at a tertiary children’s hospital in Japan: A retrospective observational cohort study

ObjectiveThe aim of this study was to explore the prescription pattern of antiepileptics and the relationship between antiepileptics and adverse drug reactions (ADRs) in a Japanese population. MethodsA retrospective observational cohort study was conducted by reviewing the medical records of patients who visited or were admitted to a single tertiary care center between January 2011 and June 2019, were treated with antiepileptics, and developed allergic ADRs associated with these drugs. ResultsIn total, 14,230 unique patients received antiepileptics during the study period. Diazepam was the most frequently used antiepileptic drug (74.8 %), followed by phenobarbital (14.3 %), valproic acid (11.4 %), fosphenytoin (10.0 %), and carbamazepine (7.3 %). Although a trend of increasing prevalence of newer generation antiepileptics was noted, most patients are still treated with older generation antiepileptics. Thirty-two (0.22 %) unique patients experienced ADRs associated with antiepileptics, and the antiepileptic drug most frequently associated with ADRs was carbamazepine, at a rate of 1.4 %. Three patients developed Stevens-Johnson syndrome/toxic epidermal necrolysis, in two of which carbamazepine was implicated. Most patients experienced ADRs associated with aromatic antiepileptics (84.4 %) or older generation antiepileptics (81.3 %). SignificanceThis is the first study to assess the relationship between ADRs and antiepileptics at a tertiary care center in Japan. Based on our results, most patients were prescribed older generation antiepileptics, and most ADR events were linked to the administration of drugs in this category; thus, identification of patients at risk of developing ADRs is critical in order to prevent such events.

Real‐world safety of the novel, free radical scavenger edaravone for amyotrophic lateral sclerosis patients: Data from the post‐marketing surveillance SUNRISE Japan

AbstractBackgroundTreatment options for amyotrophic lateral sclerosis (ALS) are limited. SUNRISE Japan is an ongoing post‐marketing surveillance evaluating the long‐term efficacy and safety of edaravone, a novel neuroprotectant agent, and free radical scavenger, in patients with ALS.AimThis study aims to describe the real‐word safety results of ALS patients enrolled in SUNRISE Japan.MethodsPatients diagnosed with ALS and prescribed edaravone for the first time during the surveillance period were included. Patients were prescribed edaravone according to the prescribing information. The incidence of adverse drug reactions (ADRs) reported up to 1 year of follow‐up was evaluated.ResultsOf 805 patients enrolled up to April 2020, 800 were included in the safety analysis set. Patients had a mean age of 66.3 years, 55.1% were male, and they had a mean disease duration of 1.8 years. In total, 97 patients (12.1%) reported at least one ADR, with a total of 148 ADR events reported. Thirty patients (3.8%) reported at least one serious ADR with a total of 42 serious ADR events reported. Hepatic function abnormal was the most frequently reported ADR, with an incidence of 4.4% (35/800). A higher incidence of ADRs was observed in patients with percent forced vital capacity ≥80%, and those with previous/concomitant treatment with riluzole.ConclusionIn this surveillance study, hepatic ADRs were the most frequently reported events. These ADRs have also been reported previously in patients receiving standard therapy. No new safety concerns were raised with real‐world use of edaravone.

Cross Talk between COVID-19 and Breast Cancer.

Cancer patients are more susceptible to COVID-19; however, the prevalence of COVID-19 in different types of cancer is still inconsistent and inconclusive. Here, we delineate the intricate relationship between breast cancer and COVID-19. Breast cancer and COVID-19 share the involvement of common comorbidities, hormonal signalling pathways, gender differences, rennin- angiotensin system (RAS), angiotensin-converting enzyme-2 (ACE-2), transmembrane protease serine 2 (TMPRSS2) and dipeptidyl peptidase-IV (DPP-IV). We also shed light on the possible effects of therapeutic modalities of COVID-19 on breast cancer outcomes. Briefly, we conclude that breast cancer patients are more susceptible to COVID-19 in comparison with their normal counterparts. Women are more resistant to the occurrence and severity of COVID-19. Increased expressions of ACE2 and TMPRSS2 are correlated with occurrence and severity of COVID-19, but higher expression of ACE2 and lower expression of TMPRSS2 are prognostic markers for overall disease free survival in breast cancer. The ACE2 inhibitors and ibuprofen therapies for COVID-19 treatment may aggravate the clinical condition of breast cancer patients through chemo-resistance and metastasis. Most of the available therapeutic modalities for COVID-19 were also found to exert positive effects on breast cancer outcomes. Besides drugs in clinical trend, TMPRSS2 inhibitors, estrogen supplementation, androgen deprivation and DPP-IV inhibitors may also be used to treat breast cancer patients infected with SARS-CoV-2. However, drug-drug interactions suggest that some of the drugs used for the treatment of COVID-19 may modulate the drug metabolism of anticancer therapies which may lead to adverse drug reaction events.

Adverse drug reactions among new sputum positive pulmonary tuberculosis patients on daily treatment regimen: a prospective study from Haryana, India

Background: Daily regimen anti-tuberculosis treatment was adopted by Revised National Tuberculosis Control Programme (RNTCP) as a step to achieve tuberculosis elimination by 2025 in India. The change was implemented prior to completion of pilot study, which necessitated this study to note the self-reported Adverse Drug Reactions (ADRs).Methods: A prospective study with concurrent sampling design was carried on from June 2018 to June 2020 in the state of Haryana, India. Pre-tested semi-structured schedule was used to collect data based on RNTCP outcome definitions through two monthly (four visits) home visits. Mean±standard deviation, percentage, proportion and chi-square test was used. The p-value of &lt;0.05 was considered as statistically significant.Results: Amongst 122 study participants 74 (60.7%) were males and 48 (39.3%) were females with mean age of 39.4±18.9 years. Majority were urban residents 87 (71.3%) and 35 (28.7%) rural residents. There were 25 (20.5%) tobacco smokers, nine (7.4%) alcohol consumers, and three (2.5%) smokeless tobacco users. Forty-five participants had ADRs and 54 ADR events had occurred, but none required change in treatment regimen. Sixteen (13.1%) reported loss of appetite followed by 10 (8.2%), flu-like symptoms, eight (6.6%) nausea, seven (5.7%) pain in joints, three (2.5%) abdomen pain, three (2.5%) headache, two (1.6%) itching and rash, one (0.8%) burning in hands and feet and one (0.8%) giddiness. Daily regimen ADR cases (36.9%) and events (44.3%) when comparatively higher than intermittent regimen (25.6%).Conclusions: The ADRs cases and events had occurred in higher proportion but were mild and hence did not require any regimen change.

Evaluation of adverse drug reactions of anti-tubercular drugs in the treatment of tuberculosis in tertiary care hospital

Background: Adverse drug reactions are very common among patients on anti-tubercular treatment. Hence, the current study was done to evaluate the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT).Methods: A 6 months prospective, cross-sectional observational study was performed in collaboration with Pulmonology Medicine department. WHO-UMC scale and Naranjo scale was used to evaluate the ADRs.Results: Ninety-two patients receiving ATT presented with 113 adverse drug events (ADE). Males were more affected than females. DOTS category-1 regimen was mostly responsible for ADE. Addition of drugs for the management of ADR events was done.Conclusions: The study results show more ADRs related to ATT demanding increased collaboration between NTEP 2020 and Pharmacovigilance Programme of India to enhance drug safety in this field.