FDA Launches New Adverse Event Look-Up Tool FDA launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

The FDA launched a new unified platform for analyzing adverse event reports. This platform represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
https://post.citiprogram.org/3NBKUTd
#FDA #AdverseEvents

Novo Nordisk is warned by the FDA for failing to report side effects It's the third time in recent weeks that the FDA has admonished Novo Nordisk for different practices.

Novo Nordisk is warned by the FDA for failing to report side effects.. (links to the letter & 483 are here).. statnews.com/pharmalot/20... #pharma #FDA #novonordisk #Ozempic #Wegovy #sideeffects #adverseevents #inspection

#Gardasil #HPV #adverseevents #healthliteracy #USA #CDC

3➡️Un article original comparant l’usage de tigécycline à dose standard et à forte dose dans le traitement de la pneumonie causée par #AcinetobacterBaumannii résistant au carbapénème.

www.sciencedirect.com/science/arti...

#IDSky #IDSkyFr #AdverseEvents #CarbapenemResistance #Tigecycline #Pneumonia

Mechanism and Context: Making Sense of Adverse Events With GLP-1-based Therapy Glucagon-like peptide 1 (GLP-1)-based therapies have reshaped the clinical approach to type 2 diabetes and obesity [1]. Long-acting GLP-1 receptor agonists

Mechanism and Context: Making Sense of Adverse Events With GLP-1-based Therapy. Read more in #JCEMCaseReports: bit.ly/4sPm2qX #AdverseEvents #diabetes #GLP-1BasedTherapy #obesity @endocrinesociety.bsky.social

Patients who report #fatigue at baseline are more likely to experience “severe, life-threatening, and fatal” treatment-related #adverseEvents. Published in @jamaoncology.com.

https://bit.ly/4jz80Fy

Estimating the Frequency of Inpatient Adverse Events Using a 2-Step Retrospective Chart Review: Initial Observational Cohort Study Background: Lower- and middle-income countries bear a disproportionate share of the global burden of adverse events in health care. Despite this, patient safety research is predominantly conducted in high-income countries with well-developed health care systems, resulting in evidence and methodologies that have limited applicability in resource-constrained settings. Objective: This pilot study primarily aimed to identify the most suitable methodology for a full-scale study to detect inpatient adverse events at a tertiary care hospital in a lower- to middle-income country. Second, we aimed to use our experience with this study to further adapt the selected methodology to our setting. Methods: This external pilot study used a 2-step retrospective chart review methodology. Two separate screening tools, tools 1A and 1B, were compared to identify which performed better in our setting. We reviewed the medical records of patients who were discharged between January 1, 2019, and December 31, 2019, from a tertiary care hospital in a lower- to middle-income country in South Asia. The main outcome of interest was the rate of adverse events among hospitalized patients reported as the total number of adverse events experienced per 100 admissions. Results: A total of 100 medical records were screened using tool 1A, with the mean patient age being 39.2 (SD 27.7) years and the mean length of stay being 3.3 (SD 2.8) days. Only 1 adverse event was identified using tool 1A, resulting in an adverse event rate of 1 event per 100 hospital admissions. Tool 1B was also used to screen a total of 100 medical records. The mean patient age was found to be 39.8 (SD 28.4) years, with the mean length of stay being 3.5 (SD 3.4) days. A total of 30 adverse events were identified across 22 patient files, with 18 (60%) considered preventable, resulting in an adverse event rate of 30 events per 100 hospital admissions. Conclusions: This study demonstrates that tool 1B, adapted from the Global Trigger Tool for Measuring Adverse Events, represents an appropriate and sensitive methodology to identify adverse events among hospitalized patients in a lower- to middle-income country. Furthermore, the findings and experiences of this study were used to improve the design and procedures of our research methodology before implementation in a full-scale study.

JMIR Formative Res: Estimating the Frequency of Inpatient Adverse Events Using a 2-Step Retrospective Chart Review: Initial Observational Cohort Study #PatientSafety #HealthCareResearch #AdverseEvents #HealthcareQuality #GlobalHealth

Standard- versus high-dose tigecycline in pneumonia due to carbapenem-resistant Acinetobacter baumannii This study aimed to compare the effectiveness and safety of standard-dose and high-dose tigecycline in pneumonia caused by carbapenem-resistant Acinet…

[Publication] The article "Standard- versus high-dose tigecycline in pneumonia due to carbapenem-resistant Acinetobacter baumannii" is now available.

www.sciencedirect.com/science/arti...

#IDsky #AcinetobacterBaumannii #AdverseEvents #CarbapenemResistance #Tigecycline #Pneumonia

Feeling it doesn’t make you weak.
Caring doesn’t mean you caused it.
And it’s still the good ones who cry. 3/3

#PhysicianWellness #AdverseEvents #SurgSky

A research paper titled, "Multicenter Interspecialty Consensus on Experimental Oncology Drug-Related Ocular Adverse Event Reporting," published in JAMA Ophthalmology. It discusses ocular adverse events and grading scales.

Six new consensus grading scales for #AdverseEvents provide standardized reporting and dosing guidance for ocular toxicity in experimental oncology drug trials.
ja.ma/4pKegw1

NEW: #Patient Participation in Monitoring Potential Adverse Drug Events www.thieme-connect.de/products/ejo...

#MedSky #PatientSafety #AdverseEvents

📝Access CTCAE v6 toxicity grading in seconds in ONCOassist

The CTCAE criteria are designed to standardise adverse event reporting in oncology research and practice.

#ONCOassist #CTCAEv6 #ToxicityGrading #AdverseEvents #OncologyTools #DigitalHealth #CancerCare #ClinicalOncology #OncologyApp

#OncEd #OncologyTools #AdverseEvents #CancerCare #OncologyPractice #HCPTools

Anxiety Increases irAEs but Boosts OS in Cancer Patients Receiving Immunotherapy Study researchers noted that the findings suggest the association between anxiety and improved OS was at least partly related to the higher incidence of irAEs, which implies that, in people with an anxiety disorder, immunotherapy “may result in greater ...

When treated with ICIs, #cancer patients with a pre-existing anxiety diagnosis appear to experience more irAEs and have better OS than those without anxiety.

https://bit.ly/4oyNfLQ

#adverseEvents

Analysis of Safety Data From JADER, FAERS Databases for Antibody-Drug Conjugates - Oncology Nurse Advisor A review of JADER and FAERS databases identified common adverse effects for 3 antibody-drug conjugates with the same type of payload.

Antibody-drug conjugates sharing the same type of payload reportedly also share #adverseEvents in common, but with some differences in patterns associated with AEs.

https://bit.ly/43dNlQx

BREAKING: Study Identifies 86 Serious Neuropsychiatric Safety Signals Linked to COVID-19 Vaccination CDC/FDA safety thresholds breached for 86 adverse events including dementia, schizophrenia, suicidal and homicidal thoughts, stroke, psychosis, depression, cognitive impairment, delusions, and more.

"An immediate global moratorium on COVID-19 vaccination is warranted."

#publicsafety #publichealth #covidvaccine #mRNA #adverseevents #moratorium #Covid19 #informedconsent

www.thefocalpoints.com/p/breaking-s...

FDA Begins Real-Time Reporting of Adverse Event Data - OncoDaily FDA Begins Real-Time Reporting of Adverse Event Data / cancer, FAERS, FDA, FDA Adverse Event Reporting System, OncoDaily, Oncology, public health

FDA Begins Real-Time Reporting of Adverse Event Data
@fda.gov

oncodaily.com/voices/adver...

#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #FDA #AdverseEvents #AEs #FAERS

Baseline seizure frequency is the strongest influencer of successful presurgical LT-VEEG.
doi.org/10.1111/epi....

#epilepsy #epilepsia #ILAE #adverseevents #medicationwithdrawal #presurgical #risk #seizures #success

ADHD medication associated with reduced risk of adverse life events Medication for attention deficit hyperactivity disorder (ADHD) is associated with reduced risk of several adverse life events, such as suicidal behaviour and substance misuse, according to study…

Research published in #BMJ suggests that ADHD medication is associated with reduced risk of several adverse life events, such as suicidal behaviour and substance misuse

#adverseevents #sideeffects #ADHD
buff.ly/vNDpDQv

ICI Retreatment After Severe Toxicities Yields Promising Responses - Oncology Nurse Advisor Results of a retrospective study demonstrated that retreatment with ICIs after severe immune-related adverse events could result in good response for select patients.

Retreatment with ICIs following severe #irAEs demonstrated acceptable safety and meaningful antitumor activity, suggesting viability in carefully selected patients.

bit.ly/4liVYA5

#adverseevents

Frequency and Severity of Common irAEs Play Key Role in Patient Education Needs - Oncology Nurse Advisor A retrospective review of patients with cancer treated with ICIs identified patient education needs by frequency and severity of irAEs.

A key part of managing immune-related #adverseEvents is adequate patient education regarding disease triggers, incidence, and severity. Published in @ascocancer.bsky.social journal JCO Oncology Practice.

bit.ly/4kYVaAz

#irAEs

Recognising adverse events and using the Yellow Card system Introduction  In England, more than 1 billion items are prescribed each year in primary care and more than 1 million people are taking ten or more medicines for longer-term conditions. Almost half of…

Our latest learning article explores how to identify, manage and report adverse events using the Yellow Card scheme

#ukpharmacy #adverseevents

CoCliP-BJI study: cost avoidance of clinical pharmacist-led interventions in patients with bone and joint infections Patients with bone and joint infections (BJI) are part of a complex care pathway. This study aimed to evaluate the economic impact of clinical pharmac…

[Publication] The article "CoCliP-BJI study: cost avoidance of clinical pharmacist-led interventions in patients with bone and joint infections" is now available.

www.sciencedirect.com/science/arti...

#IDsky #BoneAndJointInfection #Antibiotics #ClinicalPharmacy #MedicationSafety #AdverseEvents

Teared up at @lglaucomflecken.bsky.social & @glaucomflecken.bsky.social written reflection on his 2020 cardiac arrest.
“Even if our individual memories are stuck in our own heads, the trauma – and the healing – are collective.”
Such an imp truth for patients AND healthcare workers.
#adverseevents

Vermont establishes Patient Safety Surveillance System to monitor hospital safety events The system aims to enhance patient safety through monitoring and reporting adverse events statewide.

Vermont is taking a bold step toward safer healthcare with a new Patient Safety Surveillance System designed to uncover and address critical safety issues in hospitals.

Learn more here!

#VT #HealthcareQuality #PatientSafety #CitizenPortal #VermontPatientSafety #AdverseEvents

Are All #GenericDrugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing #Location and Serious Drug #AdverseEvents

journals.sagepub.com/doi/10.1177/...

Categorising reported errors and incidents from morbidity and mortality meetings (M&Ms) in a small animal multi‐specialty veterinary teaching hospital Background Errors in veterinary clinical settings can lead to patient harm. Morbidity and mortality meetings (M&Ms) are forums to discuss errors and incidents that can lead or have led to adverse ou.....

#Veterinary #morbidity and #mortality rounds are critical for #patientsafety, so how do we ensure confidentiality while maximising learning from #adverseevents? #humanfactors #rootcauseanalysis #medicationerror #safetyculture
onlinelibrary.wiley.com/doi/10.1111/...

Safety of an Accelerated Ferric Gluconate Inpatient Infusion Regimen - Erica Gray, Tate Parrott, Lauren McCluggage, 2024 Background: Inpatient use of intravenous iron has been increasing. Ferric gluconate is traditionally given once daily. Twice-daily dosing provides faster iron r...

#OnlineFirst & #OpenAccess to start the new year- Gray & colleagues w/Vanderbilt U Medical Center #Pharmacy Dept report reduced length of hospital stay w/o increase in #adverseevents w/twice-daily, vs once-daily, iron infusions
journals.sagepub.com/doi/full/10....
#PharmSky #MedSky

Discussion on understanding the white clots from the covid vaccines Journalist Maria Zeee has put together a group of medically competent people to understand and explain what is driving the thick white clot formation from the covid injections.

#covidvaccine #whiteclots #patientsafety #medicalinformation #sideeffects #adverseevents

patientmaktpatientcv.substack.com/p/discussion...

Needlestick Distal Nerve Injury in Rats Models Symptoms of... : Anesthesia & Analgesia cannot establish causality. Therefore, we, prospectively investigated whether DNIs are sufficient to cause CRPS-like abnormalities in animals. We used needlestick, a cause of human CRPS, to evaluate l...

Needlestick injuries causing #CRPS & #chronicpain follow #nonergodicity, where history & #context drive interindividual variability. Can we truly rule out #adverseevents to justify widespread needling interventions?
#painscience #physio #physicaltherapy #medicine

journals.lww.com/anesthesia-a...