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The Journal of Pediatrics Jan 2022To determine the frequency, type, and severity of adverse events (AEs) during intrahospital transport of newborn infants and to identify associated factors. (Observational Study)
Observational Study
OBJECTIVE
To determine the frequency, type, and severity of adverse events (AEs) during intrahospital transport of newborn infants and to identify associated factors.
STUDY DESIGN
We conducted a prospective observational study in a tertiary care academic neonatal unit. All patients hospitalized in the neonatal unit and undergoing intrahospital transport between June 1, 2015, and May 31, 2017 were included. Transports from other hospitals and the delivery room were not included.
RESULTS
Data from 990 intrahospital transports performed in 293 newborn infants were analyzed. The median postnatal age at transport was 13 days (Q1-Q3, 5-44). Adverse events occurred in 25% of transports (248/990) and were mainly related to instability of cardiovascular and respiratory systems, agitation, and temperature control. Adverse events were associated with no harm in 207 transports (207/990, 21%), mild harm in 37 transports (37/990, 4%), and moderate harm in 4 transports (4/990, 0.4%). There was no severe or lethal adverse event. Hemodynamic support with catecholamines, the presence of a central venous catheter, and a longer duration of transport were independent predictors for the occurrence of adverse events during transport.
CONCLUSIONS
Intrahospital transports of newborns are associated with a substantial proportion of adverse events of low-to-moderate severity. Our data have implications to inform clinical practice, for benchmarking and quality improvement initiatives, and for the development of specific guidelines.
Topics: Critical Illness; Female; Humans; Infant, Newborn; Male; Patient Safety; Patient Transfer; Prospective Studies; Switzerland
PubMed: 34480917
DOI: 10.1016/j.jpeds.2021.08.074 -
Autism : the International Journal of... Feb 2021In this study, we looked at published research on interventions for young autistic children that did not involve administering medication. We were interested in...
In this study, we looked at published research on interventions for young autistic children that did not involve administering medication. We were interested in determining how often studies reported on whether adverse events (i.e. physical or psychological distress to the participants) or adverse effects (i.e. adverse events that are thought to be caused by the intervention) had occurred. We found that of the 150 reports we examined, only 11 mentioned adverse events. One of these studies reported adverse events occurred, and three reported that adverse effects occurred. We also reviewed the studies to examine the reasons that were given to explain why any participants dropped out of the intervention (termed "withdrawal"), to determine if any of these reasons could be considered adverse events or adverse effects. Fifty-four studies described reasons for withdrawal, and 10 of these studies had reasons that could be categorized as an adverse event, 8 studies had reasons that could be categorized as an adverse effect, and an additional 12 studies had reasons that were too vaguely described to determine whether they were adverse events or not. We recommend that autism intervention researchers develop more systematic methods of looking for and reporting adverse events and effects, so that professionals and families can be better informed when choosing to enroll their autistic children in interventions.
Topics: Autism Spectrum Disorder; Autistic Disorder; Child; Humans
PubMed: 33076682
DOI: 10.1177/1362361320965331 -
Frontiers in Pharmacology 2022Triazole antifungal drugs (TAD) are widely used to treat invasive fungal infections due to their broad antifungal spectrum and low toxicity. Despite their preference in...
UNLABELLED
Triazole antifungal drugs (TAD) are widely used to treat invasive fungal infections due to their broad antifungal spectrum and low toxicity. Despite their preference in the clinic, multiple Adverse Events (AE) are still reported each year.
OBJECTIVE
We aimed to characterize the distribution of Adverse Events associated with Triazole antifungal drugs in different systems and to identify Important Medical Events (IME) signals for Triazole antifungal drugs.
METHODS
The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) was queried for Adverse Events related to Triazole antifungal drugs from 2012 to 2022. The Adverse Events caused by all other drugs and non-TAD antifungal drugs were analyzed as references. Reporting odds ratio and Bayesian confidence propagation neural network of information components were used to evaluate the association between Triazole antifungal drugs and Important Medical Events. Visual signal spectrum is mapped to identify potential adverse reaction signals.
RESULTS
Overall, 10,262 Adverse Events were reported to be associated with Triazole antifungal drugs, of which 5,563 cases were defined as Important Medical Events. Common adverse drug reactions (ADR) mentioned in the instructions such as delirium and hypokalemia were detected, as well as unlabeled ADRs such as rhabdomyolysis and hepatitis fulminant. Cholestasis, drug-induced liver injury, QT interval prolongation and renal impairment have notable signals in all Triazole antifungal drugs, with 50 percent of patients developing a severe clinical outcome. Isavuconazole had the lowest signal intensity and demonstrated a superior safety profile.
CONCLUSION
Most results are generally consistent with previous studies and are documented in the prescribing instructions, but some IMEs are not included, such as hepatitis fulminant. Additional pharmaco-epidemiological or experimental studies are required to validate the small number of unlabeled ADRs. TAD-related Important Medical Eventshave a considerable potential to cause clinically serious outcomes. Clinical use of Triazole antifungal drugs requires more attention.
PubMed: 36588707
DOI: 10.3389/fphar.2022.1039867 -
Pharmaceuticals (Basel, Switzerland) Sep 2021Some effective drugs have been approved or issued an Emergency Use Authorization for the treatment of COVID-19 in hospitalized patients, but post-market surveillance is... (Review)
Review
Some effective drugs have been approved or issued an Emergency Use Authorization for the treatment of COVID-19 in hospitalized patients, but post-market surveillance is warranted to monitor adverse events. We reviewed clinical trials and case reports in patients with moderate-to-severe COVID-19 infection who received remdesivir, baricitinib, tocilizumab, or sarilumab. The drug-specific pharmacokinetics, toxicity, and drug interactions are summarized in this study. Remdesivir and baricitinib are small-molecule drugs that are mainly metabolized by the kidneys, while tocilizumab and sarilumab are monoclonal antibody drugs with metabolic pathways that are currently not fully understood. The most common adverse events of these drugs are alterations in liver function, but serious adverse events have rarely been attributed to them. Only a few studies have reported that remdesivir might be cardiotoxic and that baricitinib might cause thromboembolism. Biological agents such as baricitinib, tocilizumab, and sarilumab could inhibit the pathway of inflammatory processes, leading to immune dysregulation, so the risk of secondary infection should be assessed before prescribing. Further recognition of the pathogenic mechanism and risk factors of adverse events is essential for optimizing treatment strategies.
PubMed: 34681179
DOI: 10.3390/ph14100955 -
Cancers Nov 2021The advent of multikinase inhibitors has changed the treatment of advanced, metastatic, unresectable thyroid cancers, refractory to available treatments. These drugs... (Review)
Review
BACKGROUND
The advent of multikinase inhibitors has changed the treatment of advanced, metastatic, unresectable thyroid cancers, refractory to available treatments. These drugs cause new adverse events that should be prevented and treated for long periods, and sometimes beyond their discontinuation. The purpose of this narrative review was the description, prevention, and nursing management of the most frequent adverse events of locally advanced or metastatic differentiated thyroid cancer with sorafenib and lenvatinib, and medullary Thyroid cancer with vandetanib and cabozantinib treatment.
METHODS
A narrative literature review.
RESULTS
Studies included in this narrative review suggest that over 90% of patients treated with tyrosine kinase inhibitors experience at least 1 adverse event of any grade affecting their quality of life. Patients treated with tyrosine kinase inhibitors experienced at least one adverse event at any grade in ≥90% of cases, with a higher incidence in the first 6-8 weeks of treatment. The most frequent adverse events that can affect a patients' quality of life are dermatological, gastrointestinal, cardiovascular, and metabolic.
CONCLUSIONS
Early assessment of risk factors and identification of adverse events can help nurses support these patients throughout their clinical-therapeutic pathway, increasing the benefits of treatment and reducing reduction/discontinuation.
PubMed: 34885070
DOI: 10.3390/cancers13235961 -
Clinical Trials (London, England) Feb 2021Current adverse event reporting practices do not document longitudinal characteristics of adverse effects, and alternative methods are not easily interpretable and have...
BACKGROUND
Current adverse event reporting practices do not document longitudinal characteristics of adverse effects, and alternative methods are not easily interpretable and have not been employed by clinical trials. Introducing time parameters in the evaluation of safety that are comprehensive yet easily interpretable could allow for a better understanding of treatment quality. In this study, we developed and applied a novel adverse event reporting method based on longitudinal adverse event changes to aid describing, summarizing, and presenting adverse event profile. We termed it the "Adverse Event Load, Onset, and Maximum Grade" method.
METHODS
We developed two adverse event summary metrics to complement the traditional maximum grade report. Onset time indicates the time period in which the maximum grade for a specific adverse event occurred and was defined as "early" (i.e. maximum grade happened for the first time before 6 weeks) or "late" (i.e. after the 6 week). Adverse event load indicates the overall severity of a specific adverse event over the entire treatment. Higher adverse event load indicates a worse overall experience. These metrics can be calculated for adverse events with different maximum grades, in treatments with planned changes (e.g. dosage changes), using data sets with different number of adverse event data points between treatments (e.g. treatments with longer cycle lengths may have less adverse event data points) and on data sets with different adverse event data availability (e.g. cycle basis and patient-outcome reports). We tested the utility of this method using individual patient data from two major backbone therapies ("Irinotecan" and "Oxaliplatin") from the N9741 trial available in the Fondation ARCAD database (fondationarcad.org). We investigated profiles of diarrhea, neutropenia/leukopenia, and nausea/vomiting.
RESULTS
Our method provided additional information compared to traditional adverse event reports. For example, for nausea/vomiting, while patients in Irinotecan had a higher risk of experiencing maximum grade 3-4 (15.6% vs 7.6%, respectively; p < 0.001), patients in both groups experienced similar severity over time (adverse effect load = 0.102 and 0.096, respectively; p = 0.26), suggesting that patients in Oxaliplatin experienced a lower-grade but more persistent nausea/vomiting. For neutropenia/leukopenia, more patients in Irinotecan experienced their maximum grade for the first time early in the treatment compared to patients in Oxaliplatin (67.9% vs 41.7%; p < 0.001), regardless of maximum grade. Longitudinal information can help compare treatments or guide clinicians on choosing appropriate interventions for low-grade but persistent adverse event or early adverse event onset.
CONCLUSION
We developed an adverse event reporting method that provides clinically relevant information about treatment toxicity by incorporating two longitudinal adverse event metrics to the traditional maximum grade approach. Future research should establish clinical benchmarks for metrics included in this adverse event reporting method.
Topics: Adverse Drug Reaction Reporting Systems; Antineoplastic Agents; Clinical Trials as Topic; Female; Humans; Irinotecan; Male; Neoplasms; Oxaliplatin
PubMed: 32998522
DOI: 10.1177/1740774520959313 -
The American Journal of Managed Care Jun 2023To compare the frequency of self-reported gaps in care coordination and self-reported preventable adverse events among adults with vs without diabetes.
OBJECTIVES
To compare the frequency of self-reported gaps in care coordination and self-reported preventable adverse events among adults with vs without diabetes.
STUDY DESIGN
Cross-sectional analysis of REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants 65 years and older who completed a survey on health care experiences in 2017-2018 (N = 5634).
METHODS
We analyzed the association of diabetes with self-reported gaps in care coordination and with preventable adverse events. Gaps in care coordination were assessed using 8 validated questions. Four self-reported adverse events were studied (drug-drug interactions, repeat medical tests, emergency department visits, and hospitalizations). Respondents were asked if they thought these events could have been prevented with better communication among providers.
RESULTS
Overall, 1724 (30.6%) participants had diabetes. Among participants with and without diabetes, 39.3% and 40.7%, respectively, reported any gap in care coordination. The adjusted prevalence ratio (aPR) for any gap in care coordination for participants with vs without diabetes was 0.97 (95% CI, 0.89-1.06). Any preventable adverse event was reported by 12.9% and 8.7% of participants with and without diabetes, respectively. The aPR for any preventable adverse event for participants with vs without diabetes was 1.22 (95% CI, 1.00-1.49). Among participants with and without diabetes, the aPRs for any preventable adverse event associated with any gap in care coordination were 1.53 (95% CI, 1.15-2.04) and 1.50 (95% CI, 1.21-1.88), respectively (P comparing aPRs = .922).
CONCLUSIONS
Interventions to improve quality of care for patients with diabetes could incorporate patient-reported gaps in care coordination to aid in preventing adverse events.
Topics: Adult; Humans; Cross-Sectional Studies; Diabetes Mellitus; Hospitalization; Emergency Service, Hospital; Communication
PubMed: 37341980
DOI: 10.37765/ajmc.2023.89374 -
Frontiers in Pharmacology 2023Methotrexate (MTX) is an essential anti-rheumatic drug used to treat rheumatoid arthritis (RA). Prevention or management of adverse reactions, including interstitial...
Methotrexate-related adverse events and impact of concomitant treatment with folic acid and tumor necrosis factor-alpha inhibitors: An assessment using the FDA adverse event reporting system.
Methotrexate (MTX) is an essential anti-rheumatic drug used to treat rheumatoid arthritis (RA). Prevention or management of adverse reactions, including interstitial lung disease (ILD), hepatotoxicity, myelosuppression, and infection, remains fundamental for safe MTX therapy. Using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) (JAPIC AERS), we performed disproportionality analyses of adverse events related to MTX use and the impact of concomitant medications. Upon analyzing all reported cases in FAERS between 1997 and 2019, the crude reporting odds ratios (cRORs; 95% confidence intervals) for ILD, hepatotoxicity, myelosuppression, and tuberculosis (TB) in relation to MTX use were 4.00 (3.83-4.17), 1.99 (1.96-2.02), 3.66 (3.58-3.74), and 7.97 (7.65-8.3), respectively. Combining MTX with folic acid (FA) or tumor necrosis factor-alpha inhibitors (TNFis) tended to reduce cRORs for these adverse events (except for TB). Multiple logistic regression analysis in patients with RA was conducted to calculate adjusted reporting odds ratios (aRORs) for age, sex, and MTX treatment patterns (MTX alone and combined with FA and TNFi). Higher age (except for hepatotoxicity) and male sex were significantly associated with adverse events. Combining FA or TNFi with MTX reduced aRORs for MTX-related hepatotoxicity and myelosuppression; in contrast, the effect of FA was not obvious in ILD or TB. Although studies assessing spontaneous reporting systems have limitations such as reporting bias, data from our logistic regression analysis demonstrated that adding FA to MTX-based therapy could help reduce the dose-dependent adverse events of MTX, thereby providing clinical evidence that supports the beneficial effect of FA. This study also demonstrated the usefulness of FAERS in comparing adverse events based on treatment patterns.
PubMed: 36909171
DOI: 10.3389/fphar.2023.1030832 -
International Journal of Sports... Feb 2020There is a paucity of literature about the adverse events associated with Therapeutic Dry Needling (TDN). Much of the literature surrounding adverse events associated...
BACKGROUND
There is a paucity of literature about the adverse events associated with Therapeutic Dry Needling (TDN). Much of the literature surrounding adverse events associated with TDN has been extrapolated from the acupuncture literature. Given that acupuncture and TDN are distinctly different in their application and proposed mechanisms, adverse events associated with TDN should be examined specifically.
PURPOSE
To determine and report the type of adverse events associated with the utilization of TDN.
STUDY DESIGN
Prospective Questionnaire.
METHODS
Four hundred and twenty physical therapists participated in this study. Information related to minor and major adverse events that occurred during 20,464 TDN treatment sessions was collected. Each physical therapist respondent was asked to fill out two weekly self-reported electronic surveys over a six-week period. One survey was related to "minor adverse events" (i.e. pain, bleeding, bruising), while the other was related to "major adverse events" (i.e. pneumothorax, excessive bleeding, prolonged aggravation). Following the six-week period, descriptive statistics were used to describe the adverse events (AE) associated with TDN and calculate the frequencies of those events.
RESULTS
A total of 7,531 minor AE's were reported, indicating that 36.7% of the reported TDN treatments resulted in a minor AE. The top three minor AE's were bleeding (16%), bruising (7.7%), and pain during dry needling (5.9 %). The average ratio of minor AE's for all respondents across all weeks was 0.53 or approximately one event for every two patients. Twenty major AE's were reported out of the 20,494 treatments for a rate of <0.1% (1 per 1,024 TDN treatments). No associations were noted between the frequency of adverse events and the number of patients treated, practitioner age, level of education, years in practice, level of training or months experience with dry needling.
CONCLUSION
Expected minor AE's such as mild bleeding, bruising, and pain during TDN were common and major AE's were rare. Physical therapists and other medical practitioners need to be aware of the risks of TDN. Based on the findings of this study the overall risk of a major adverse event during TDN is small.
LEVEL OF EVIDENCE
3, survey research.
PubMed: 32089962
DOI: No ID Found -
Journal of Cannabis Research May 2023There is an expanding unregulated market for a psychotropic compound called ∆-Tetrahydrocannabinol (delta-8-THC) that is being derived from hemp, but a summary of...
BACKGROUND
There is an expanding unregulated market for a psychotropic compound called ∆-Tetrahydrocannabinol (delta-8-THC) that is being derived from hemp, but a summary of adverse events related to delta-8-THC has not been publicly reported.
METHODS
This case series assessed adverse events reported by delta-8-THC users on the Reddit forum r/Delta8 and compared these to delta-8-THC AEs in the US Food and Drug Administration Adverse Event Reporting System (FAERS). Delta-8-THC and cannabis AEs reported in FAERS were also compared. The r/Delta8 forum was selected because it includes a large sample of 98,700 registered individuals who publicly discuss their experiences using delta-8-THC. All r/Delta8 posts were obtained from August 20, 2020, through September 25, 2022. A random sample of r/Delta8 posts was drawn (n = 10,000) and filtered for posts in which delta-8-THC users reported an adverse event (n = 335). FAERS reports that listed delta-8-THC (N = 326) or cannabis (N = 7076) as a suspect product active ingredient were obtained. Adverse events claimed to result from delta-8-THC use were coded using Medical Dictionary for Regulatory Activities to system organ class and preferred term categories.
RESULTS
The absolute number of delta-8-THC adverse event reports (N = 2184, 95% CI = 1949-2426) and serious adverse event reports (N = 437; 95% CI = 339-541) on r/Delta 8 were higher than the adverse event reports (N = 326) and serious adverse event reports (N = 289) to FAERS. Psychiatric disorders were the most frequently cited system organ class in r/Delta8 adverse event reports, mentioned in 41.2% (95% CI = 35.8%-46.3%) of reports, followed by respiratory, thoracic and mediastinal disorders (29.3%, 95% CI = 25.1%-34.0%) and nervous system disorders (23.3%, 95% CI = 18.5%-27.5%). Anxiety (16.4%, 95% CI = 12.8-20.6), Cough (15.5%, 95% CI = 11.9-20.0) and Paranoia (9.3%, 95% CI = 6.3-12.5) were the most frequently cited preferred terms in adverse event reports. The overall prevalence of AEs reported for cannabis and delta-8-THC on FAERS were also similar when analyzed by system organ class (Pearson's r = 0.88).
CONCLUSIONS
The findings of this case series suggest that most of the adverse events reported by delta-8-THC users are like those reported during acute cannabis intoxication. This finding suggests that health care professionals follow similar treatment and management protocols, and that jurisdictions should clarify whether delta-8-THC can be sold as a hemp product.
PubMed: 37217977
DOI: 10.1186/s42238-023-00191-y