scholarly journals Crowdsourcing sugammadex adverse event rates using an in-app survey: feasibility assessment from an observational study

2018 ◽  
Vol 9 (7) ◽  
pp. 331-342 ◽  
Author(s):  
Craig S. Jabaley ◽  
Francis A. Wolf ◽  
Grant C. Lynde ◽  
Vikas N. O’Reilly-Shah
Keyword(s):  
Adverse Events ◽  
Mobile Applications ◽  
Global Assessment ◽  
Adverse Drug Reaction Reporting ◽  
Clinical Decision ◽  
Reporting Rate ◽  
Feasibility Assessment ◽  
Anesthesia Providers ◽  
Event Rates ◽  
Reporting Rates

Background: Mobile applications (apps) have become a ubiquitous source of clinical decision support. We sought to ascertain the feasibility of using an app platform to obtain a crowdsourced measure of adverse drug reaction reporting rates associated with sugammadex administration and compare it with traditionally-derived estimates. Methods: Using the widely-distributed anesthesia calculator app, ‘Anesthesiologist’, we surveyed anesthesia providers regarding their experience with adverse drug reactions associated with sugammadex administration. Results: Data were analyzed from 2770 participants in 119 countries responding between March 2016 and May 2017, who were estimated to have administered between 1.6–2.9 million doses (588–1040 administrations per participant). A low and high-end reporting rate of adverse events was estimated based on respondents’ reported frequency and duration of sugammadex use. The estimated reporting rate of anaphylaxis due to sugammadex was 0.0055–0.098%, similar in range to previously published estimates. Conclusions: Use of an in-app survey facilitated a global assessment of anesthesia providers and could have useful applications in monitoring adverse events and estimating their rates. Further work is needed to validate this approach for other medications and clinical domains.

Surveillance of adverse events following immunisation in Australia annual report, 2017

2019 ◽  
Vol 43 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Rona Hiam ◽  
Nicholas Wood ◽  
...  
Keyword(s):  
Adverse Events ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
National Immunisation Program ◽  
Conjugate Vaccination ◽  
Reporting Rates ◽  
To Receive

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.

scholarly journals Surveillance of adverse events following immunisation in Australia: annual report, 2018

2020 ◽  
Vol 44 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
Program Schedule ◽  
National Immunisation Program ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.

scholarly journals Surveillance of adverse events following immunisation in Australia annual report, 2019

2021 ◽  
Vol 45 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Clinical Findings ◽  
Reporting Rate ◽  
Influenza Vaccines ◽  
Causal Association ◽  
Site Reaction ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.

scholarly journals Assessing safety of Ontario’s publicly funded MMR and MMRV immunization programs, 2012 to 2016

2019 ◽  
Vol 25 (6) ◽  
pp. 358-364
Author(s):  
Chi Yon Seo ◽  
Mohammed Rashid ◽  
Tara Harris ◽  
Jody Stapleton ◽  
Shelley L Deeks
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Public Confidence ◽  
Publicly Funded ◽  
Systemic Reactions ◽  
Event Category ◽  
Reporting Rates ◽  
Surveillance Database ◽  
Routine Immunization Schedule

Abstract Background The combined measles, mumps, rubella (MMR) and measles, mumps, rubella, and varicella (MMRV) vaccines are part of Ontario’s routine immunization schedule. Objective To assess adverse events following immunization (AEFIs) reported in Ontario following administration of MMR and MMRV vaccines between 2012 and 2016. Methods Reports of AEFIs were extracted from the provincial surveillance database on May 9, 2017. Events were grouped by provincial surveillance definitions. Reporting rates were calculated using provincial population estimates or net doses distributed as the denominator. A serious AEFI is defined as an AEFI that resulted in an in-patient hospitalization or death. Results Overall, 289 AEFIs were reported following administration of MMR (n=246) or MMRV (n=43) vaccines, for annualized reporting rates of 16.6 and 8.8 reports per 100,000 distributed doses, respectively. The highest age-specific reporting rate was in children aged 1 to 3 years for MMR (7.7 per 100,000 population) and children aged 4 to 9 years for MMRV (0.8 per 100,000 population). Systemic reactions were the most frequently reported event category, while rash was the most frequently reported event for both vaccines. There were 22 serious AEFIs, 19 following MMR and 3 following MMRV (1.3 and 0.6 per 100,000 doses distributed, respectively). Conclusions Our assessment found a low reporting rate of adverse events following MMR and MMRV vaccines in Ontario. No safety concerns were identified. Our findings are consistent with the safety profiles of these vaccines. Continued monitoring of vaccine safety is necessary to maintain timely detection of unusual postvaccine events and public confidence in vaccine safety.

scholarly journals Surveillance for Adverse Events following Immunization from 2008 to 2011 in Zhejiang Province, China

2012 ◽  
Vol 20 (2) ◽  
pp. 211-217 ◽  
Author(s):  
Yu Hu ◽  
Qian Li ◽  
Luoya Lin ◽  
Enfu Chen ◽  
Yaping Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Injection Site Reaction ◽  
Influenza Virus Vaccine ◽  
H1n1 Influenza ◽  
Reporting Rate ◽  
Zhejiang Province ◽  
The Individual ◽  
Zhejiang Provincial ◽  
Two Peaks ◽  
Reporting Rates

ABSTRACTThis study summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the National AEFI Surveillance System (NASS) in Zhejiang province and describes reporting trends from 2008 to 2011. AEFI reporting rates were calculated using denominator data from the Individual Immunization Information System and the Zhejiang provincial Bureau of Statistics. A total of 6,265 AEFI records were reported; the overall reporting rate was 9.2 per 100,000 doses. There were two peaks of reporting rates, which were associated mainly with the introduction of the pandemic H1N1 influenza virus vaccine (pH1N1) in 2009 and the measles-mumps vaccine (MM) campaign in 2010. The majority of the AEFI described nonserious events. Fifteen deaths were recorded, but only one was possibly related to immunization. The most frequently reported reactions were fever and injection site reaction. Vaccines distributed in Zhejiang province have proven to be generally safe. The data on AEFI surveillance provide a reference point for ongoing reporting of trends and illustrate the value of the NASS database as a surveillance tool for monitoring of AEFI.

scholarly journals OP0163 COMPARATIVE ANALYSIS OF ETANERCEPT BIOSIMILAR AND ORIGINATOR USE IN CLINICAL PRACTICE: DATA FROM THE GERMAN BIKER-REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 98.1-98
Author(s):  
G. Horneff ◽  
D. Windschall ◽  
T. Hospach ◽  
S. Mrusek ◽  
M. Rühlmann ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Disease Activity ◽  
Special Interest ◽  
Global Assessment ◽  
Drug Exposure ◽  
Disease Onset ◽  
Injection Site Reaction ◽  
Physician Global Assessment ◽  
First Line

Background:In 2017, 2 Etanercept biosimilars became approved. Comparative studies performed in adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriasis by extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with Etanercept biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Etanercept biosimilars in clinical practice.Methods:In this retrospective analysis patients exposed to ETA were identified in the German BIKER-registry and grouped into cohorts according to initiation of treatment after 2017, use of the originator and of biosimilars. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 2917 JIA patients were reported to have received Etanercept. Since January 1 2017, in 39 centres treatment with Etanercept was started in 439 patients (377 (85.9%) started with the originator and 62 (14.1%) started a Biosimilar). Biosimilars were prescribed n 17 centres (44%). In 12 centres (31%), Etanercept biosimilars were used first line in 62 patients. In 17 centres (44%), 63 patients switched for the originator to a biosimilar. 3 patients reswitched from the biosimilar to the originator. 4 patient switched from a biosimilar to the originator). 22 centres (56%) had not prescribed a biosimilars so far.In not a single centre, initiation of a biosimilar was more frequent than of the originator.The patients’ characteristics and disease activity parameters were widely comparanble. Patients receiving biosimilar first line were slightly older at disease onset and had a longer disease duration. Patients receiving biosimilar first line had more often rheumatoid factor (RF) negative polyarthritis while extended oligoarthritis was more frequent in the originator cohort. In the switching cohort, more patients had extended oligoarthritis and fewer had RF negative polyarthritis and ERA JIA.No difference in disease activity parameters was noted, neither at baseline, during the course of treatment nor at last observation upon treatment. A decrease of the JADAS10 indicates improvement in both groups (Figure 1). At the time of switching, 68% had JADAS minimal disease activity (MDA) and 43% were in JASDAS remission. At month 6 and 12 these numbers increased to 74%/65% and 62%/50%.In total, 66 adverse events (AE) were reported in 45 patients upon biosimilar treatment.33 patients had 1, 5 patients 2, 5 patients had 3 and 2 reported 4 events. Adverse event of special interest were hypersensitivity n=1, injection site reaction n=1, new onset of psoriasis n=1, celiac disease n=1, Crohn‘s diesease n=1, elevated transaminases n=2, depression n=1 and disease deterioration (arthritis flare) in n=21. In 20 patients, the etanercept biosimilar was discontinued.Conclusion:This analysis is the first attempt to present a large data sample on JIA patients exposed to Etanercept biosimilars. Biosimilar were used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis. Until today, the use of the originator is by far exceeding the use of biosimilars. The prescription of a biosimilar either first line or by switching from the originator is limited to a part of centres. Differences in efficacy between first line biosimilar users and originator users could not be observed. Also, after switching, no loss of efficacy was observed.Disclosure of Interests:Gerd Horneff Speakers bureau: Pfizer, Daniel Windschall: None declared, Toni Hospach: None declared, Sonja Mrusek: None declared, Michael Rühlmann: None declared, Ariane Klein: None declared

scholarly journals The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

2021 ◽  
pp. bmjqs-2020-011122 ◽  
Author(s):  
Warren Connolly ◽  
Natasha Rafter ◽  
Ronan M Conroy ◽  
Cornelia Stuart ◽  
Anne Hickey ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Positive Impact ◽  
Retrospective Chart Review ◽  
Published Data ◽  
National Programmes ◽  
Event Rates ◽  
Hospital Associated Infections ◽  
Design And Methods ◽  
The Impact

ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

Parenteral Iron Therapy: A Single Institution's Experience Over a 5-Year Period

2005 ◽  
Vol 3 (6) ◽  
pp. 791-795 ◽  
Author(s):  
Christopher A. Laman ◽  
Scott B. Silverstein ◽  
George M. Rodgers
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Iron Dextran ◽  
Serious Adverse Events ◽  
Exact Test ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy ◽  
Event Rates

Many patients require parenteral iron therapy for optimal correction of anemia, including cancer patients who require erythropoietic drugs. Available parenteral iron therapy options include iron dextran, iron gluconate, and iron sucrose. The purpose of this study is to summarize our institution's experience with parenteral iron therapy over a 5-year period, with a focus on comparative safety profiles. All patients receiving parenteral iron therapy over this period were included in the analysis. Chi-squared test and Fisher's exact test were used to compare the adverse event rates of each product. A total of 121 patients received 444 infusions of parenteral iron over this period. Iron dextran was the most commonly used product (85 patients) and iron sucrose was the least used (2 patients). Iron gluconate was used by 34 patients. Overall adverse event rates per patient with iron dextran and iron gluconate were 16.5% and 5.8%, respectively (P = .024). Premedication with diphenhydramine and acetaminophen before infusions of iron dextran reduced adverse event rates per infusion from 12.3% to 4.4% (P = .054). Test doses of iron dextran were used 88% of the time for initial infusions of iron dextran. All adverse events for all parenteral iron products were mild or moderate. There were no serious adverse events and no anaphylaxis was observed. Our results suggest that, if test doses and premedications are used, iron dextran is an acceptable product to treat iron deficiency.

Abstract WP6: Cerebral Mechanical Thrombectomy Device Related Adverse Events: Analysis of the Manufacturer and User Facility Device Experience Database

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Wondwossen G Tekle ◽  
Malik M Adil ◽  
Derya Uluduz ◽  
Basit Rahim ◽  
Tauhid Awan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Internal Carotid ◽  
Reporting Rate ◽  
Event Description ◽  
Device Malfunction ◽  
First Pass ◽  
User Facility ◽  
Multiple Devices ◽  
Thrombectomy Device ◽  
Solitaire Fr

Background: There is paucity of knowledge regarding the spectrum of neurothrombectomy(NT) device-related complications. Objective: To report the characteristics and proportions of reported adverse-events(AE) related to NT devices used in endovascular treatment of acute ischemic stroke (AIS). Methods: We identified NT device-related AE reported by voluntary sources, user facility reports, and distributor and manufacturer reports to the Manufacturer and User Facility Device Experience Database(MAUDE) from the year 2004 through 2012 to identify patients. Frequency of specific reported AE and associated factors were extracted from the “event description” on the three NT devices currently in use for AIS treatment -Merci Retriever, Penumbra System, and Solitaire-FR stentriever. Results: A total of 706 reported NT device-related AEs were identified with a continual increase in reporting rate since 2004. Of the 706, device malfunction (kink, twist, difficult advancing, fracture, or retention) was the most common reported complication(56%), followed by hemorrhages(23%), dissection(6.8%), vasospasm(6.2%), and distal embolism(2.7%). Intra-arterial(IA) thrombolytic was used in 70%(111/159), intravenous(IV) thrombolytic in 16%, and both IA and IV in 13% of the reported cases. Middle cerebral artery(MCA) was involved in 56%(220/392), internal carotid artery(ICA) in 16 %, and both MCA and ICA in about 21% of cases where the occluded vessel was reported. Multiple devices were used in majority(71%) of reported cases(n=564). The first “pass”(recanalization-attempt) was associated with 34% of reported adverse event per-device(n= 119), 2-passes(29%), and 3-passes(28%). Recanalization was complete in 52 %(266/513) reported cases, and partial in 14%(71/513). Patients’ condition was unchanged in 63%(220/349), worsened in 29%(101/349), and improved in 8%(28/349) of reported cases. Twenty three percent(77/342) mortality was reported among those patients whose final outcome was known and reported. Conclusions: Reports of NT device-related AE have significantly increased over the last 8 years. Proportionally higher-rates of reported device malfunction do not necessarily represent adverse patient outcomes.

scholarly journals 0471 24-Month Post Marketing Safety Surveillance Data of a Novel Continuous Release and Absorption Melatonin (CRA-Melatonin) Delivery System, Confirms Favorable Safety Profile

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A180-A181
Author(s):  
D Brodner ◽  
P Corsino
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Call Center ◽  
First Generation ◽  
Surveillance Period ◽  
Continuous Release ◽  
Safety Surveillance ◽  
Post Marketing ◽  
Favorable Safety ◽  
Reporting Rates

Abstract Introduction The awareness of sleep disorders having negative health consequences, including hypertension, diabetes, obesity, depression, heart attack and stroke, has sharply escalated in recent years. Traditional treatments, including benzodiazepenes, non-benzodiazepenes, anti-depressants and non-prescription first-generation antihistamines, come with limitations in efficacy, safety and tolerability. The search for non-drug alternatives continues. The novel, well tolerated CRA-melatonin was shown in a randomized, crossover, pharmacokinetic (PK) study versus the leading marketed melatonin to achieve quick uptake and then continuous release and absorption for up to 7 hours. No safety or tolerability issues were observed. The Remfresh Safety Update at 24 months (REMSU24), a real-world safety surveillance study was conducted to confirm the previously observed safety profile of CRA-melatonin. Methods An independent call center with pharmacovigilance-trained health care personnel in accordance with FDA guidelines on properly reporting events, was retained to receive and record customer questions, product issues and adverse events (AEs). The study was conducted from March 9, 2017 to March 9, 2019. Results An estimated 320,255 patients used CRA-melatonin during the surveillance period. There were no serious AEs. The self-reporting rates of non-serious AEs were low with only 51 events recorded, a 0.016% event rate. The two most frequent AEs, headaches and nightmares are known comorbidities of insomnia. As background, there had been no treatment emergent adverse events for CRA-melatonin in the PK trial. Conclusion CRA-melatonin’s extended 7-hour PK profile may be an effective and well-tolerated baseline therapy to improve sleep. These results confirm the favorable safety and tolerability trend observed in the PK study. In REMSU24, the scatter of reported adverse events could not be separated from what could be expected in the untreated general population. Support This study was supported by Physician’s Seal LLC

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