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Cureus Sep 2022An adverse event is any abnormal clinical finding associated with the use of a therapy. Adverse events are classified by reporting an event's seriousness, expectedness,... (Review)
Review
An adverse event is any abnormal clinical finding associated with the use of a therapy. Adverse events are classified by reporting an event's seriousness, expectedness, and relatedness. Monitoring patient safety is of utmost importance as more and more data becomes available. In reality, very low numbers of adverse events are reported via the official path. Chart review, voluntary reporting, computerized surveillance, and direct observation can detect adverse drug events. Medication errors are commonly seen in hospitals and need provider and system-based interventions to prevent them. The need of the hour in India is to develop and implement medication safety best practices to avoid adverse events. The utility of artificial intelligence techniques in adverse event detection remains unexplored, and their accuracy and precision need to be studied in a controlled setting. There is a need to develop predictive models to assess the likelihood of adverse reactions while testing novel pharmaceutical drugs.
PubMed: 36258971
DOI: 10.7759/cureus.29162 -
Dermatology and Therapy Feb 2021Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for...
INTRODUCTION
Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the United States, brodalumab carries a boxed warning about suicidal ideation and behavior; however, no causal association was established between brodalumab and suicides reported during pivotal trials. We have previously reported results from an analysis of 1-year pharmacovigilance data in patients in the United States who took brodalumab, in which the most commonly reported adverse event was psoriasis flare. There were no completed suicides, suicide attempts, or serious fungal infections. Here, we provide a 2-year US pharmacovigilance report.
METHODS
This analysis summarizes pharmacovigilance data reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017, through August 14, 2019. The most common adverse events listed in the brodalumab package insert (incidence ≥ 1%; arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection-site reactions, influenza, neutropenia, and tinea infections) and adverse events of special interest are reported.
RESULTS
Data were collected from 2677 patients in the United States who took brodalumab, with an estimated exposure of 1656 patient-years. Arthralgia was the most commonly reported adverse event (73 events; 0.04 events per patient-year). No suicide attempts or completed suicides were reported; there were 25 reports of depression. There were 46 serious infections and no serious fungal infections. One event of Crohn's disease was reported, which led to discontinuation. There were 13 malignancies, with none deemed related to brodalumab.
CONCLUSIONS
This pharmacovigilance report supports the safety profile of brodalumab previously reported from long-term analyses of clinical trials and 1-year pharmacovigilance data.
PubMed: 33337520
DOI: 10.1007/s13555-020-00472-x -
Vaccine Jan 2022COVID-19 has spread worldwide and is one of the most threatening infectious diseases in the world. Vaccination is known as an effective method to protect susceptible...
COVID-19 has spread worldwide and is one of the most threatening infectious diseases in the world. Vaccination is known as an effective method to protect susceptible populations against such diseases. The Coronavirus vaccine developed by Sinovac has been shown to have a high protective effect, but it also has potential adverse events. For example, our department saw two patients with reported cases of deafness that occurred after inoculation with the Sinovac Coronavirus vaccine. While deafness is only a rare adverse event from the Coronavirus vaccine, whether other vaccination centers, hospitals, and centers for disease control (CDCs) have encountered similar cases still needs to be investigated, reported, and analyzed.
Topics: COVID-19; COVID-19 Vaccines; Deafness; Humans; SARS-CoV-2; Vaccination
PubMed: 34895936
DOI: 10.1016/j.vaccine.2021.11.091 -
JACC. Cardiovascular Imaging Jul 2018
Topics: Humans; Machine Learning; Myocardial Perfusion Imaging; Prognosis; Tomography, Emission-Computed, Single-Photon
PubMed: 29055636
DOI: 10.1016/j.jcmg.2017.07.025 -
PloS One 2022Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are... (Review)
Review
INTRODUCTION
Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are many reports of adverse events (or undesirable outcomes) following such interventions, there is no common definition for an adverse event or clarity on any severity classification. This impedes advances of patient safety initiatives and practice. This scoping review mapped the evidence of adverse event definitions and classification systems following spinal and peripheral joint manipulation and mobilization for musculoskeletal conditions in adults.
METHODS
An electronic search of the following databases was performed from inception to February 2021: MEDLINE, EMBASE, CINAHL, Scopus, AMED, ICL, PEDro, Cochrane Library, Open Grey and Open Theses and Dissertations. Studies including adults (18 to 65 years old) with a musculoskeletal condition receiving spinal or peripheral joint manipulation or mobilization and providing an adverse event definition and/or classification were included. All study designs of peer-reviewed publications were considered. Data from included studies were charted using a standardized data extraction form and synthesised using narrative analysis.
RESULTS
From 8248 identified studies, 98 were included in the final synthesis. A direct definition for an adverse event and/or classification system was provided in 69 studies, while 29 provided an indirect definition and/or classification system. The most common descriptors to define an adverse event were causality, symptom severity, onset and duration. Twenty-three studies that provided a classification system described only the end anchors (e.g., mild/minor and/or serious) of the classification while 26 described multiple categories (e.g., moderate, severe).
CONCLUSION
A vast array of terms, definition and classification systems were identified. There is no one common definition or classification for adverse events following spinal and peripheral joint manipulation and mobilization. Findings support the urgent need for consensus on the terms, definition and classification system for adverse events related to these interventions.
Topics: Adolescent; Adult; Aged; Humans; Manipulation, Spinal; Middle Aged; Musculoskeletal Diseases; Young Adult
PubMed: 35839253
DOI: 10.1371/journal.pone.0270671 -
PloS One 2022Recognizing the values and norms significant to healthcare organizations (Safety Culture) are the prerequisites for safety and quality care. Understanding the safety...
INTRODUCTION
Recognizing the values and norms significant to healthcare organizations (Safety Culture) are the prerequisites for safety and quality care. Understanding the safety culture is essential for improving undesirable workforce attitudes and behaviours such as lack of adverse event reporting. The study assessed the frequency of adverse event reporting, the patient safety culture determinants of the adverse event reporting, and the implications for Ghanaian healthcare facilities.
METHODS
The study employed a multi-centre cross-sectional survey on 1651 health professionals in 13 healthcare facilities in Ghana using the Survey on Patient Safety (SOPS) Culture, Hospital Survey questionnaire. Analyses included descriptive, Spearman Rho correlation, one-way ANOVA, and a Binary logistic regression model.
RESULTS
The majority of health professionals had at least reported adverse events in the past 12 months across all 13 healthcare facilities. Teamwork (Mean: 4.18, SD: 0.566) and response to errors (Mean: 3.40, SD: 0.742) were the satisfactory patient safety culture. The patient safety culture dimensions were statistically significant (χ2 (9, N = 1642) = 69.28, p < .001) in distinguishing between participants who frequently reported adverse events and otherwise.
CONCLUSION
Promoting an effective patient safety culture is the ultimate way to overcome the challenges of adverse event reporting, and this can effectively be dealt with by developing policies to regulate the incidence and reporting of adverse events. The quality of healthcare and patient safety can also be enhanced when healthcare managers dedicate adequate support and resources to ensure teamwork, effective communication, and blame-free culture.
Topics: Humans; Patient Safety; Ghana; Organizational Culture; Cross-Sectional Studies; Attitude of Health Personnel; Safety Management
PubMed: 36260634
DOI: 10.1371/journal.pone.0275606 -
Current Hematologic Malignancy Reports Apr 2021Reporting of adverse events on hematology clinical trials is crucial to understanding the safety of standard treatments and novel agents. However, despite the importance... (Review)
Review
PURPOSE OF REVIEW
Reporting of adverse events on hematology clinical trials is crucial to understanding the safety of standard treatments and novel agents. However, despite the importance of understanding toxicities, challenges in capturing and reporting accurate adverse event data exist.
RECENT FINDINGS
Currently, adverse events are reported manually on most hematology clinical trials. Especially on phase III trials, the highest grade of each adverse event during a reporting period is typically reported. Despite the effort committed to AE reporting, studies have identified underreporting of adverse events on hematologic malignancy clinical trials, which raises concern about the true understanding of safety of treatment that clinicians have in order to guide patients about what to expect during therapy. In order to address these concerns, recent studies have piloted alternative methods for identification of adverse events. These methods include automated extraction of adverse event data from the electronic health record, implementation of trigger or alert tools into the medical record, and analytic tools to evaluate duration of adverse events rather than only the highest adverse event grade. Adverse event reporting is a crucial component of clinical trials. Novel tools for identifying and reporting adverse events provide opportunities for honing and refining methods of toxicity capture and improving understanding of toxicities patients experience while enrolled on clinical trials.
Topics: Clinical Trials as Topic; Delivery of Health Care; Drug-Related Side Effects and Adverse Reactions; Hematologic Diseases; Humans; Quality Improvement; Risk Management
PubMed: 33786724
DOI: 10.1007/s11899-021-00627-3 -
Journal of Ophthalmic Inflammation and... Feb 2023Immune checkpoint inhibitors (ICIs) have become an important part of the treatment of multiple cancers, especially for advanced melanoma and non-small cell lung cancer.... (Review)
Review
INTRODUCTION
Immune checkpoint inhibitors (ICIs) have become an important part of the treatment of multiple cancers, especially for advanced melanoma and non-small cell lung cancer. Some tumors are capable of escaping immunosurveillance by stimulating checkpoints on T-cells. ICIs prevent activation of these checkpoints and thereby stimulate the immune system and indirectly the anti-tumor response. However, the use of ICIs is associated with various adverse events. Ocular side effects are rare but may have a major impact on the quality of life of the patient.
METHODS
A comprehensive literature search of the medical databases Web of Science, Embase and PubMed was performed. Articles that provided a comprehensive description of a case report containing 1) cancer patient(s) treated with (a combination of) immune checkpoint inhibitors, and 2) assessed occurrence of ocular adverse events, were included. A total of 290 case reports were included.
RESULTS
Melanoma (n = 179; 61.7%) and lung cancer (n = 56; 19.3%) were the most frequent reported malignancies. The primary used ICIs were nivolumab (n = 123; 42.5%) and ipilimumab (n = 116; 40.0%). Uveitis was most the common adverse event (n = 134; 46.2%) and mainly related to melanoma. Neuro-ophthalmic disorders, including myasthenia gravis and cranial nerve disorders, were the second most common adverse events (n = 71; 24.5%), mainly related to lung cancer. Adverse events affecting the orbit and the cornea were reported in 33 (11.4%) and 30 cases (10.3%) respectively. Adverse events concerning the retina were reported in 26 cases (9.0%).
CONCLUSION
The aim of this paper is to provide an overview of all reported ocular adverse events related to the use of ICIs. The insights retrieved from this review might contribute to a better understanding of the underlying mechanisms of these ocular adverse events. Particularly, the difference between actual immune-related adverse events and paraneoplastic syndromes might be relevant. These findings might be of great value in establishing guidelines on how to manage ocular adverse events related to ICIs.
PubMed: 36811715
DOI: 10.1186/s12348-022-00321-2 -
Journal of Psychiatric Research May 2024Neuromodulatory interventions are relatively novel and approaches to studying harms and tolerability have varied. Using a checklist based on guidelines from Good... (Review)
Review
Neuromodulatory interventions are relatively novel and approaches to studying harms and tolerability have varied. Using a checklist based on guidelines from Good Clinical Practice and the Harms Extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement, we identified how adverse events are measured, assessed, and reported in studies evaluating neuromodulation for the treatment of mental and neurodevelopmental disorders among children and adolescents. A systematic literature review identified 56 experimental and quasi-experimental studies evaluating transcranial magnetic stimulation (TMS), transcranial alternating (tACS) or direct (tDCS) current stimulation, transcranial pulse stimulation (TPS), and vagus or trigeminal nerve stimulation (VNS or TNS). For 22 studies (39%), the types of adverse events to be monitored were identified, and for 31 studies (55%), methods for collecting adverse event data were described. Methods for assessing adverse events were less commonly described with 23 studies (41%) having details on assessing event severity, and 11 studies (20%) having details on assessing event causality. Among 31 studies with reported results, headache, skin irritation, and general pain or discomfort were the most reported across studies. Seizure, untoward medical occurrences, and intracranial bleeding, edema, or other intracranial pathology were considered serious events, but these events were not reported as occurring in any results-based papers. Taken together, the findings from this review indicate that most studies of pediatric neuromodulatory interventions did not include descriptions of adverse event monitoring and evaluation. Comprehensive event monitoring and reporting across studies can significantly augment the current knowledge base.
PubMed: 38761518
DOI: 10.1016/j.jpsychires.2024.05.035 -
Current Reviews in Clinical and... 2022Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs, including neuraminidase inhibitors (NIs). However, the...
BACKGROUND
Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs, including neuraminidase inhibitors (NIs). However, the information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify the drugs associated with abnormal behavior using a spontaneous reporting system database.
METHODS
We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed, and the reporting odds ratio at 95% confidence interval were calculated.
RESULTS
A total of 1,144 reports of abnormal behavior were identified. The signals were detected through the association of 4 neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with the abnormal behaviour. These signals were stronger for oseltamivir than other neuraminidase inhibitors. The signals were also detected for acetaminophen and montelukast.
CONCLUSION
Our results should be able to raise physicians' awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.
Topics: Child; Drug-Related Side Effects and Adverse Reactions; Humans; Oseltamivir; Pharmacovigilance; Retrospective Studies; Zanamivir
PubMed: 33588740
DOI: 10.2174/1574884716666210215104540