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The Journal of Clinical and Aesthetic... Aug 2015The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse... (Review)
Review
BACKGROUND
The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use.
OBJECTIVE
A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment.
METHODS AND MEASUREMENTS
A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile.
RESULTS
Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study.
CONCLUSION
Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel.
PubMed: 26345379
DOI: No ID Found -
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 Chest Surgery Aug 2022Adverse events or emergency situations that are unacceptable in the context of lung transplantation may occur during the procedure. These adverse events and...
Adverse events or emergency situations that are unacceptable in the context of lung transplantation may occur during the procedure. These adverse events and circumstances are not problems that are caused by insufficient experience or can be solved by increasing surgical experience. The purpose of this review is to describe the adverse events and circumstances that occur during lung transplantation and to identify an appropriate surgical approach through an analysis of case reports in the global literature.
PubMed: 35924538
DOI: 10.5090/jcs.22.054 -
Studies in Health Technology and... Jun 2020Harms caused during healthcare encounters are pervasive and occur at an alarming rate; therefore, building a set of computational detection methodologies in the adverse...
Harms caused during healthcare encounters are pervasive and occur at an alarming rate; therefore, building a set of computational detection methodologies in the adverse event area is urgently needed to address this problem. To understand the entire range of adverse event detection methods currently in practice we have developed a computational adverse event detection matrix. This structure is made of methods used presently at US hospitals to detect patient safety events. It contains adverse event 1) concepts and 2) synthesized detection strategies as well as calculations of overlap of coded data in the subset of algorithms implemented completely computationally. Most importantly, this matrix provides a clear picture of coverage gaps in the detection of adverse events.
Topics: Adverse Drug Reaction Reporting Systems; Algorithms; Hospitals; Humans
PubMed: 32570358
DOI: 10.3233/SHTI200134 -
International Journal of Environmental... Mar 2022This study investigated the effects of mindfulness meditation on doctors' mindfulness, patient safety culture, patient safety competency, and adverse events. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
This study investigated the effects of mindfulness meditation on doctors' mindfulness, patient safety culture, patient safety competency, and adverse events.
METHODS
We recruited 91 doctors from a hospital in China and randomized them to mindfulness meditation group ( = 46) and a waiting control group ( = 45). The mindfulness meditation group underwent an 8-week mindfulness meditation intervention, while the control group underwent no intervention. We measured four main variables (mindfulness, patient safety culture, patient safety competency, and adverse event) before and after the mindfulness meditation intervention.
RESULTS
In the experimental group, mindfulness, patient safety culture and patient safety competency were significantly higher compared with those of the control group. In the control group, there were no significant differences in any of the three variables between the pre-test and post-test. Adverse events in the experimental group were significantly lower than in the control group.
CONCLUSIONS
The intervention of mindfulness meditation significantly improved the level of mindfulness, patient safety culture and patient safety competency. During the mindfulness meditation intervention, the rate of adverse events in the meditation group was also significantly lower than in the control group. As a simple and effective intervention, mindfulness meditation plays a positive role in improving patient safety and has certain promotional value.
Topics: Humans; Meditation; Mindfulness; Patient Safety; Physicians; Safety Management
PubMed: 35328968
DOI: 10.3390/ijerph19063282 -
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