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PloS One 2022Adverse drug events are significant causes of emergency department visits. Systematic evaluation of adverse drug events leading to emergency department visits by age is... (Observational Study)
Observational Study
Adverse drug events are significant causes of emergency department visits. Systematic evaluation of adverse drug events leading to emergency department visits by age is lacking. This multicenter retrospective observational study evaluated the prevalence and features of adverse drug event-related emergency department visits across ages. We reviewed emergency department medical records obtained from three university hospitals between July 2014 and December 2014. The proportion of adverse drug events among total emergency department visits was calculated. The cause, severity, preventability, and causative drug(s) of each adverse drug event were analyzed and compared between age groups (children/adolescents [<18 years], adults [18-64 years], and the elderly [≥65 years]). Of 59,428 emergency department visits, 2,104 (3.5%) were adverse drug event-related. Adverse drug event-related emergency department visits were more likely to be female and older. Multivariate logistic regression analysis revealed that compared to non- adverse drug event-related cases, adverse drug event-related emergency department visitors were more likely to be female (60.6% vs. 53.6%, p<0.001, OR 1.285, 95% CI 1.025-1.603) and older (50.8 ± 24.6 years vs. 37.7 ± 24.4 years, p<0.001, OR 1.892, 95% CI: 1.397-2.297). Comorbidities such as diabetes, chronic kidney disease, chronic liver disease, and malignancies were also significantly associated with adverse drug event-related emergency department visits. Side effects were the most common type of adverse drug events across age groups, although main types differed substantially depending on age. Serious adverse drug events, hospitalizations, and adverse drug event-related deaths occurred more frequently in the elderly than in adults or children/adolescents. The proportion of adverse drug event-related emergency department visits that were preventable was 15.3%. Causative drugs of adverse drug events varied considerably depending on age group. Adverse drug event features differ substantially according to age group. The findings suggest that an age-specific approach should be adopted in the preventive strategies to reduce adverse drug events.
Topics: Adolescent; Adult; Aged; Child; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Hospitalization; Humans; Male; Prevalence; Retrospective Studies
PubMed: 36121802
DOI: 10.1371/journal.pone.0272743 -
Journal of Pharmaceutical Health Care... 2015Antipsychotics are potent dopamine antagonists used to treat schizophrenia and bipolar disorder. The aim of this study was to evaluate the relationship between...
BACKGROUND
Antipsychotics are potent dopamine antagonists used to treat schizophrenia and bipolar disorder. The aim of this study was to evaluate the relationship between antipsychotic drugs and adverse hyperglycemic events using the FDA Adverse Event Reporting System (FAERS) database. In particular, we focused on adverse hyperglycemic events associated with atypical antipsychotic use, which are major concerns.
FINDINGS
We analyzed reports of adverse hyperglycemic events associated with 26 antipsychotic drugs in the FAERS database from January 2004 to March 2013. The Standardized Medical Dictionary for Regulatory Activities Queries (SMQ) preferred terms (PTs) was used to identify adverse hyperglycemic events. The number of adverse hyperglycemic reports for the top eight antipsychotic drugs, quetiapine, olanzapine, risperidone, aripiprazole, haloperidol, clozapine, prochlorperazine, and chlorpromazine was 12,471 (28.9%), 8,423 (37.9%), 5,968 (27.0%), 4,045 (23.7%), 3,445 (31.5%), 2,614 (14.3%), 1,800 (19.8%), and 1,003 (35.7%), respectively. The reporting ratio increased with co-administration of multiple antipsychotic drugs. For example, adverse hyperglycemic events represented 21.6% of reports for quetiapine monotherapy, 39.9% for two-drug polypharmacy, and 66.3% for three-drug polypharmacy.
CONCLUSION
Antipsychotic drug polypharmacy may influence signal strength, and may be associated with hyperglycemia. After considering the causality restraints of the current analysis, further robust epidemiological studies are recommended.
PubMed: 26819726
DOI: 10.1186/s40780-015-0015-6 -
Epilepsy Research Aug 2022There have been several reports that switching formulations of antiseizure medications (ASMs) has been associated with a deterioration of seizure control, seizure...
There have been several reports that switching formulations of antiseizure medications (ASMs) has been associated with a deterioration of seizure control, seizure relapse or increased adverse effects. Considering recent findings that excipients, namely purported inactive ingredients, may nevertheless exert biological effects, it is possible that the variation in adverse event profile of antiseizure drugs may be related to differences in excipients. To test our hypothesis, we constructed a new research tool to connect FDA-compiled adverse event reports to the excipient in the medicine. Analysis of adverse events to formulations of five different second-generation antiseizure drugs - gabapentin, lamotrigine, levetiracetam, oxcarbazepine, and topiramate - showed several significant associations between specific excipient in the formulations and an adverse event when compared to the same medicine formulated with other excipients. Epilepsy and seizure adverse events were associated with multiple excipients across gabapentin, lamotrigine, and levetiracetam formulations. A different group of excipients were associated with reports of hypersensitivity reactions including urticaria, rash, erythema, and Stevens-Johnson syndrome. Our study provides a novel approach to analyzing post-market surveillance reports by including excipients. It may be useful to clinicians when evaluating select patient groups that may be refractory to pharmacological treatment or experience worsening adverse events when switching formulations of the same antiseizure medicine.
Topics: Anticonvulsants; Drug Compounding; Excipients; Gabapentin; Humans; Lamotrigine; Levetiracetam; Seizures
PubMed: 35661571
DOI: 10.1016/j.eplepsyres.2022.106947 -
Pharmaceuticals (Basel, Switzerland) Nov 2023Adverse events associated with opioid use in palliative care have been extensively studied. However, predicting the occurrence of adverse events based on the specific...
Adverse events associated with opioid use in palliative care have been extensively studied. However, predicting the occurrence of adverse events based on the specific opioid used remains difficult. This study aimed to comprehensively analyze the adverse events related to µ-opioid receptor stimulation of opioids approved in Japan and investigate the tendencies of adverse event occurrence among different opioids. We utilized the FDA Adverse Event Reporting System database to extract reported adverse events for opioids approved in Japan. Cluster analysis was performed on reporting odds ratios (RORs) of adverse event names among opioids to visualize relationships between opioids and adverse events, facilitating a comparative study of their classifications. We calculated the RORs of adverse events for the target opioids. Cluster analysis based on these RORs resulted in five broad clusters based on the reported adverse events: i.e., strong opioids, weak opioids, loperamide, tapentadol, and remifentanil. This study provides a comprehensive classification of the association between μ-opioid-receptor-stimulating opioids and adverse events.
PubMed: 38004407
DOI: 10.3390/ph16111541 -
BMC Medical Research Methodology Mar 2017Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With...
BACKGROUND
Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract.
METHODS
A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract.
RESULTS
Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database.
CONCLUSIONS
While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We recommend the development of standardized definitions and reporting tools for adverse events associated with SMT. Adequate reporting of adverse events associated with SMT will facilitate accurate indexing of these types of manuscripts in the databases.
Topics: Abstracting and Indexing; Databases, Factual; Humans; Information Storage and Retrieval; MEDLINE; Musculoskeletal Manipulations; Randomized Controlled Trials as Topic; Research Design; Spine
PubMed: 28292267
DOI: 10.1186/s12874-017-0320-x -
Medicine Jun 2022Early mobilization decreases the likelihood of negative outcomes for acute-phase inpatients. Adverse events occurring during intensive care unit rehabilitation have...
Early mobilization decreases the likelihood of negative outcomes for acute-phase inpatients. Adverse events occurring during intensive care unit rehabilitation have previously been reported; however, no study has reported the incidence rates for adverse events during the acute rehabilitation phase. This study aimed to investigate the incidence of severe adverse events during acute-phase rehabilitation and evaluate them in detail.Reports of adverse events occurring during acute-phase rehabilitation in a university hospital from April 1, 2011 to March 31, 2018 were retrospectively assessed.Nine severe adverse events occurred during this period (incidence rate, 0.032%), comprising 2 cardiopulmonary arrests, 2 pulseless electrical activity events, 2 deterioration in consciousness events, 1 deterioration in consciousness event due to cerebral infarction, 1 fracture due to a fall, and 1 event involving removal of a ventricular drain. Pulmonary thromboembolism was implicated in 1 adverse event involving pulseless electrical activity and 1 deterioration in consciousness event. The causes for the 6 other adverse events could not be identified. The mean days from admission and the onset of rehabilitation to adverse event occurrence were 22.0 ± 18.2 and 17.9 ± 13.5 days (mean ± standard deviation), respectively. Four of 9 patients died, and 5 patients were discharged home or transferred to other stepdown facilities. When assessed retrospectively, there were no conflicts between patient conditions and the cancellation criteria of rehabilitation by the Japanese Association of Rehabilitation Medicine.The occurrences of severe adverse event may not be related to early mobilization (or onset time of rehabilitation) and compliance status of cancellation criteria.
Topics: Heart Arrest; Hospitalization; Humans; Inpatients; Intensive Care Units; Retrospective Studies
PubMed: 35758395
DOI: 10.1097/MD.0000000000029516 -
Annals of Emergency Medicine Dec 2022The Emergency Department Trigger Tool (EDTT) is a novel approach to adverse event detection in the ED. We previously described the derivation, validation, and high-level... (Observational Study)
Observational Study
STUDY OBJECTIVE
The Emergency Department Trigger Tool (EDTT) is a novel approach to adverse event detection in the ED. We previously described the derivation, validation, and high-level performance of this tool. Here we further detail adverse events detected to demonstrate the utility of the EDTT and how it might be used for quality improvement.
METHODS
This is a secondary analysis of data from a retrospective observational study. We ran the EDTT (a computerized query for triggers) on 13 months of ED visit data, reviewing 5,582 selected records using a typical 2-tiered trigger tool approach. The adverse events detected were categorized by place of occurrence (in the ED versus present on arrival), severity, omission/commission, and type using a taxonomy with categories, subcategories, and up to 3 cross-cutting modifiers. We present adverse event data in detail, focusing in turn on each of these descriptors (severity, event types, and cross-cutting themes) and highlight opportunities identified for targeted improvement.
RESULTS
We identified 458 adverse events occurring in the ED for a 13-month period, 10% of which required urgent intervention. Nearly all (90%) were acts of commission. Events resulting in harm were most often related to medications administered and patient care. Common cross-cutting event types included adverse events related to bleeding, opioids, and the use of propofol. Most adverse events (80%) led to temporary harm.
CONCLUSION
The EDTT identifies a broad spectrum of adverse event types, allowing a review by severity, frequency, and type to better understand existing levels of harm in the ED and identify targets for quality improvement. A multicenter study of the EDTT is currently underway, which will contribute additional power and assess generalizability.
Topics: Humans; Emergency Service, Hospital; Quality Improvement; Retrospective Studies; Analgesics, Opioid
PubMed: 35927115
DOI: 10.1016/j.annemergmed.2022.05.037 -
Biomedica : Revista Del Instituto... Mar 2022Introduction: Adverse events can cause harm to the patient, but they also affect health professionals making them second victims of the event. Interventions have been...
Introduction: Adverse events can cause harm to the patient, but they also affect health professionals making them second victims of the event. Interventions have been focused mostly on patients, but little on professionals, probably due to lack of tools. Objective: To estimate the prevalence of adverse events and describe their manifestations in healthcare personnel to evidence the phenomenon of second victims in a highly complex hospital. Materials and methods: We conducted an analytical cross-sectional study by a survey of 419 healthcare professionals from the hospitalization, emergency, and surgical areas in a highly complex hospital in Medellín in 2019. The frequency of adverse events was estimated and its association with some labor and demographic variables was determined. Results: We found that 93.1% of the participants knew of incident cases and 79% of serious adverse events while 44.4% had been involved in them and 99% of these had feelings as a second victim, mainly the difficulty to concentrate, guilt, fatigue, anxiety, and doubts about decisions; 95% indicated they wanted to receive training to face the consequences of adverse events and know how to inform the patient. Conclusions: Health professionals are frequently exposed to adverse events that can cause negative emotions in them such as guilt, fatigue, anxiety, and insecurity. Most professionals who participate in an adverse event express feelings as a second victim. Informing the patient about an adverse event requires preparation and most professionals requested training on the subject.
PubMed: 35471180
DOI: 10.7705/biomedica.6169 -
Dentistry Journal Jul 2023Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have...
Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have risen in popularity among the general public and sparked debate among dental professionals. Dental professionals argue that using these aligners without an in-person diagnosis and treatment planning protocol set by a licensed dentist or orthodontist may lead to adverse effects on teeth and surrounding structures. The objective of this study is to describe adverse clinical events associated with the use of DTC sequential aligners as reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database. Methods-We searched the MAUDE database from 1 January 2010 to 31 December 2020 for the product code of 'NXC' (sequential aligners). The year, type of adverse event, reporter occupation, and event description were noted. Results-651 reports associated with sequential aligners were found, of which 104 were related to DTC sequential aligners. Fifty-four adverse events were reported in 2019. From the event description, 41.3% comprised bite problems, 29.8% comprised orofacial pain, and 26.6% of patients had some form of periodontal sequelae. Furthermore, 69.2% of the patients followed up after an adverse event with a dentist not associated with DTC aligners. Conclusions-The use of DTC sequential aligners without dental supervision has led to oral health problems, as documented in the MAUDE database. Commonly reported adverse events include bite problems, pain, sensitivity, and periodontal disease, and some adverse events are irreversible.
PubMed: 37504239
DOI: 10.3390/dj11070174