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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 -
Journal of Clinical Medicine May 2022For peripheral artery disease (PAD) patients, after endovascular revascularization, it is crucial to manage associated factors that can affect the risk of major adverse...
OBJECTIVE
For peripheral artery disease (PAD) patients, after endovascular revascularization, it is crucial to manage associated factors that can affect the risk of major adverse events. We aimed to investigate the associated factors of major adverse events in these patients.
MATERIALS AND METHODS
We conducted a retrospective longitudinal analysis using the electronic medical records from a tertiary hospital in Korea and included the data of 1263 patients. Eligible patients were categorized into four groups based on diabetes mellitus (DM) and regular exercise. The major adverse events included major adverse limb events and major adverse cardiovascular events. Major adverse events-free survival was assessed using the Kaplan-Meier method, and associated factors of major adverse events were analyzed using Cox proportional hazards analyses.
RESULTS
Kaplan-Meier survival curves showed that patients with DM and non-regular exercise had a shorter major adverse events-free survival. The Cox regression analysis showed that for patients with critical limb ischemia or chronic kidney disease, the risk of major adverse events increased, while group variables were not significant.
CONCLUSION
Target management of patients with DM, critical limb ischemia, and chronic kidney disease is essential to reduce major adverse events after endovascular revascularization in patients with PAD.
PubMed: 35566674
DOI: 10.3390/jcm11092547 -
Bulletin of the World Health... Mar 2020Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.
PROBLEM
Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.
APPROACH
Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority.
LOCAL SETTING
Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme.
RELEVANT CHANGES
From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting.
LESSONS LEARNT
Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting.
Topics: Equipment Safety; Equipment and Supplies; Humans; India; Mandatory Reporting; Product Surveillance, Postmarketing; Registries; Safety Management
PubMed: 32132755
DOI: 10.2471/BLT.19.232785 -
Revista Brasileira de Enfermagem 2022to analyze the effects of nursing professionals' behavior in adverse event following immunization surveillance.
OBJECTIVES
to analyze the effects of nursing professionals' behavior in adverse event following immunization surveillance.
METHODS
a cross-sectional study of 384 participants who received vaccines. Information on vaccination history, administered vaccines and vaccination guidelines were analyzed. Descriptive and bivariate analyzes were performed using simple logistic regression (unadjusted Odds Ratio).
RESULTS
guidelines on events (PR=1.8; p=0.001) and conducts regarding their occurrence (PR=1.7; p=0.001) are activities that influence adverse event following immunization surveillance. More than half of participants did not receive guidance on the vaccines administered, the events and the conduct in case of an occurrence. Only 38.5% were instructed about the vaccines administered and 40.6% about adverse events. In the presence of an event, 29.9% reported that they sought services for notification.
CONCLUSIONS
proper screening, providing guidance on vaccines and adverse events are essential preventive measures to strengthen adverse event following immunization surveillance.
Topics: Cross-Sectional Studies; Humans; Immunization; Immunization Programs; Vaccination; Vaccines
PubMed: 35137883
DOI: 10.1590/0034-7167-2021-0132 -
Human Vaccines & Immunotherapeutics Dec 2022A typhoid Vi capsular-polysaccharide tetanus toxoid conjugate vaccine (Typbar-TCV®) was recommended by the World Health Organization for use in children >6 months of...
A typhoid Vi capsular-polysaccharide tetanus toxoid conjugate vaccine (Typbar-TCV®) was recommended by the World Health Organization for use in children >6 months of age. The present post-marketing surveillance study was intended to assess the clinical safety of approximately 11 million doses of TCV sold till 2019 in a diverse age range Indian population. Both active and passive post-marketing surveillance studies were conducted at multiple centers. Active surveillance was performed in two periods, Period-I: February to October 2016, Period-II: April 2017 to October 2018. In Period-II, the Brighton Collaboration Criteria adverse event case definitions were used. Passive surveillance was performed from February 2016 to December 2019 through voluntary reporting by pediatricians across India. During the active surveillance, 1147 adverse events were reported among 4,991 (23.0%) subjects in Period-I, and 596 adverse events among 3898 (21.3%) subjects in Period-II. The most frequent adverse events were fever (9.2% and 12.02%in Periods I and II, respectively), pain at the injection site (8.3% and 7.33%), and swelling (4.0% and 1.93%). No serious adverse events (SAEs) were reported during either Period. Passive surveillance revealed 235 adverse events, including 25 SAEs requiring hospitalization, of which two were due to typhoid fever. All the events mentioned above occurred within one week of vaccination, and all the subjects have recovered from AEs with medications. All reported adverse events resolved with no clinical sequelae. Observations in this study are consistent with the pre-licensure studies with no additional safety signals detected, confirming that Typbar-TCV® is safe. AE: Adverse event; LMIC: low- and middle-income countries; PMS: Post-marketing surveillance; SAE: Serious adverse event; TCV: Vi-polysaccharide tetanus -toxoid conjugate vaccine (Typbar-TCV®).
Topics: Child; Humans; India; Product Surveillance, Postmarketing; Tetanus Toxoid; Typhoid Fever; Typhoid-Paratyphoid Vaccines; Vaccines, Conjugate
PubMed: 34242128
DOI: 10.1080/21645515.2021.1947761 -
SAGE Open Medicine 2018Several smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes are widely used. We evaluated the...
Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016.
OBJECTIVES
Several smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes are widely used. We evaluated the adverse events related to smoking cessation treatments and electronic cigarettes in the US Food and Drug Administration Adverse Event Reporting System database.
METHODS
We analyzed reports of adverse events associated with smoking cessation treatment and electronic cigarettes terms dated between January 2004 and December 2016. We used the reporting odds ratio with 95% confidence intervals to detect a signal for each adverse event.
RESULTS
In total, 8,867,135 reports in the Food and Drug Administration Adverse Event Reporting System database were analyzed. The numbers of adverse events for nicotine replacement therapy (transdermal, buccal, oral, and respiratory administration) were 1673, 1016, 425, and 56, respectively. Nicotine replacement therapy (transdermal, buccal, and oral) demonstrated adverse events of nausea, nicotine dependence, and dizziness. For nicotine (transdermal) exposure, the top 5 adverse events reported were nausea (149 cases, reporting odds ratio: 2.28 (95% confidence interval: 1.92-2.69)), dizziness (132 cases, reporting odds ratio: 3.04 (95% confidence interval: 2.54-3.63)), application site erythema (108 cases, reporting odds ratio: 32.52 (95% confidence interval: 26.74-39.55)), headache (98 cases, reporting odds ratio: 1.84 (95% confidence interval: 1.50-2.25)), and dyspnea (94 cases, reporting odds ratio: 1.93 (95% confidence interval: 1.57-2.38)). Many cases of improper use of nicotine replacement therapies were reported. Nausea, depression, abnormal dreams, insomnia, and other adverse events were reported for varenicline. Insomnia, rash, anxiety, and dizziness were reported for bupropion. We observed electronic cigarettes-related adverse events such as dizziness, dyspnea, nausea, heart rate increased, and tremor.
CONCLUSION
Our findings suggest that an association exists between nicotine-related adverse events and nicotine replacement therapy. Healthcare professionals should closely monitor smokers trying to quit nicotine use for the misuse of nicotine replacement therapy. These findings may be informative to healthcare professionals in order to improve the management of smoking cessation treatment.
PubMed: 29844912
DOI: 10.1177/2050312118777953 -
Yakugaku Zasshi : Journal of the... 2022Nowadays, medical big data has been developed and made available in a variety of fields such as epidemiology and pharmacovigilance. Spontaneous reporting databases are...
Nowadays, medical big data has been developed and made available in a variety of fields such as epidemiology and pharmacovigilance. Spontaneous reporting databases are one category of medical big data and that has been adequate for analysing events related to side effects that rarely occur in general practice. These data are freely available in several countries. In Japan, the Pharmaceuticals and Medical Devices Agency has developed the Japanese Adverse Drug Event Report (JADER), and the Food and Drug Administration (FDA) developed the FDA Adverse Events Reporting System (FAERS) in the United States. Since the release of these medical big data, many researchers in academic and research setting have accessed them, but it is still difficult for many medical professionals to analyse these data due to costs and operation of requisite statistical software. In this section, we give some tips to study spontaneous reporting databases resulting from our learning experiences.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Software; United States; United States Food and Drug Administration
PubMed: 35370189
DOI: 10.1248/yakushi.21-00178-5 -
Heliyon Nov 2022Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types;...
PURPOSE
Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).
METHODS
The AE data associated with Cervarix, Gardasil, and Gardasil 9 were retrieved from VAERS database respectively. The combinatorial biomedical statistical methods were used to identify the statistically significant AEs. The Gamma-Poisson Shrinker (GPS) model with gender/age stratification was applied to ascertain the serious adverse events (SAEs) related to the three licensed HPV vaccines. The AE profiles were classified and represented by the Ontology of Adverse Events (OAE) for further analysis.
RESULTS
As of July 31, 2020, VAERS recorded 3,112, 31,606, and 6,872 AE case reports for Cervarix, Gardasil, and Gardasil 9, respectively. Our Frequentist statistical methods identified 135 Cervarix-enriched AEs, 55 Gardasil-enriched AEs, and 17 Gardasil 9-enriched AEs. Based on the OAE hierarchical classification, these AEs were clustered in the AEs related to behavioral and neurological conditions, immune system, nervous system, and reproductive system. Combined with GPS modeling, 46 unique statistically significant SAEs were founded to be associated with at least one of the three vaccines.
CONCLUSIONS
Our study led to the better understanding of the AEs associated with the licensed HPV vaccines. The hypotheses on the cause and effect relationships between the HPV vaccination and specific AEs deserve further epidemiological investigations as well as clinical trial studies.
PubMed: 36411908
DOI: 10.1016/j.heliyon.2022.e11515 -
JACC. Cardiovascular Interventions Apr 2022
Review
PubMed: 35393110
DOI: 10.1016/j.jcin.2022.01.021 -
PloS One 2016We aimed to compare the safety of antidepressants for the treatment of persistent depressive disorder (PDD) with each other and with placebo. We conducted a systematic... (Comparative Study)
Comparative Study Meta-Analysis Review
We aimed to compare the safety of antidepressants for the treatment of persistent depressive disorder (PDD) with each other and with placebo. We conducted a systematic electronic search and included randomized controlled trials that investigated antidepressants for the treatment of PDD in adults. Outcomes were the incidence of experiencing any adverse event, specific adverse events and related treatment discontinuations. We analyzed the data using traditional and network meta-analyses. Thirty-four studies that comprised 4,769 patients and examined 20 individual agents in nine substance classes were included. Almost all analyzed substance classes were associated with higher discontinuation rates than placebo including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), antipsychotics, and the serotonin antagonist and reuptake inhibitor (SARI) trazodone. The odds of experiencing any adverse event were significantly higher for TCAs and serotonin noradrenaline reuptake inhibitors (SNRIs) compared to placebo. Pairwise comparisons among the substance classes revealed that more patients receiving TCAs or SNRIs experienced any adverse event and that more patients receiving TCAs or the SARI trazodone discontinued treatment. The complementary treatment with acetyl-l-carnitine showed lower rates of experiencing any adverse event and related discontinuations than all other comparators. TCAs were primarily associated with (anti-)cholinergic and sedating adverse events. SSRIs primarily showed gastrointestinal adverse events. Patients treated with the antipsychotic amisulpride were more likely to manifest weight gain and endocrine adverse events. The comparative evidence for further agents was insufficient or lacking. The identified safety differences may be used to inform the selection among the antidepressants.
Topics: Antidepressive Agents; Depression; Humans
PubMed: 27187783
DOI: 10.1371/journal.pone.0153380