-
Pharmacoepidemiology and Drug Safety Jun 2012The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which... (Review)
Review
PURPOSE
The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting.
METHODS
ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed.
RESULTS
Demographic and other objective data that can be easily derived from EHRs were both present in the submitted reports and relevant to the reported adverse drug event (ADE), but other data, such as an informative description of the ADE, dates that support a temporal relationship between the product and the event, and relevant laboratory data, were often either conflicting or lacking. Most of the ADEs captured in the ASTER pilot and reported to FDA are known events (i.e. included in product labeling) for the suspect drugs.
CONCLUSION
Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Pilot Projects; Quality Assurance, Health Care; United States; United States Food and Drug Administration
PubMed: 22359404
DOI: 10.1002/pds.3223 -
QJM : Monthly Journal of the... Apr 2015Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in... (Review)
Review
Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in prolonged hospitalization, disability or death, caused by healthcare management). Apart from having a significant impact on patient morbidity and mortality, adverse events also result in increased healthcare costs due to longer hospital stays. Furthermore, a substantial proportion of adverse events are preventable. Through identifying the nature and rate of adverse events, initiatives to improve care can be developed. A variety of methods exist to gather adverse event data both retrospectively and prospectively but these do not necessarily capture the same events and there is variability in the definition of an adverse event. For example, hospital incident reporting collects only a very small fraction of the adverse events found in retrospective chart reviews. Until there are systematic methods to identify adverse events, progress in patient safety cannot be reliably measured. This review aims to discuss the need for a safety culture that can learn from adverse events, describe ways to measure adverse events, and comment on why current adverse event monitoring is unable to demonstrate trends in patient safety.
Topics: Data Collection; Hospitalization; Humans; Learning; Medical Errors; Organizational Culture; Patient Safety; Safety Management
PubMed: 25078411
DOI: 10.1093/qjmed/hcu145 -
Annals of Surgery May 2017To investigate adverse event free admissions as a potential, patient-centered indicator aligned directly with the goal of patient safety-freedom from harm.
OBJECTIVE
To investigate adverse event free admissions as a potential, patient-centered indicator aligned directly with the goal of patient safety-freedom from harm.
BACKGROUND
Preventable adverse event rates in healthcare could be further reduced. These are generally measured separately, one adverse event at a time. However, this does not reveal whether different patients are affected or the same patients are experiencing multiple events.
METHODS
We examined Medicare inpatient hospital administrative datasets for 2009 to 2011, processed using standard criteria. Events were (i) death within 30 days, (ii) unplanned readmissions within 30 days, (iii) long length of stay, (iv) healthcare acquired infections, and (v) established patient safety indicators not present on admission. We defined adverse event free admissions as those without record of any of these events. National rates were calculated by diagnosis group. Risk-adjusted hospital-specific rates of adverse event free admissions were calculated using colorectal procedures as an example.
RESULTS
There were 23,991,193 admissions after exclusions. Approximately, 64% went through the acute inpatient Medicare system without record of anything untoward. Multiple events were recorded in 22·7% admissions; 15% of these experienced more than 2 adverse events. Risk-adjusted hospital-specific rates of adverse event free admissions for colorectal procedures showed 131 out of 3786 hospitals below the 99·8% lower control limit of the national upper quartile.
CONCLUSIONS
Overall, only 60% of admissions were recorded as adverse event free. Multiple adverse events were common. Even if events are under recorded, this measure could provide an easily understandable and useful baseline for clinicians and managers.
Topics: Aged; Aged, 80 and over; Colorectal Surgery; Cross-Sectional Studies; Databases, Factual; Female; Humans; Inpatients; Male; Medicare; Outcome Assessment, Health Care; Patient Admission; Patient Readmission; Postoperative Complications; Quality Indicators, Health Care; Retrospective Studies; Risk Assessment; United Kingdom; United States
PubMed: 27192350
DOI: 10.1097/SLA.0000000000001792 -
Pharmaceutical Statistics Jul 2016When analysing primary and secondary endpoints in a clinical trial with patients suffering from a chronic disease, statistical models for time-to-event data are commonly... (Randomized Controlled Trial)
Randomized Controlled Trial
When analysing primary and secondary endpoints in a clinical trial with patients suffering from a chronic disease, statistical models for time-to-event data are commonly used and accepted. This is in contrast to the analysis of data on adverse events where often only a table with observed frequencies and corresponding test statistics is reported. An example is the recently published CLEOPATRA study where a three-drug regimen is compared with a two-drug regimen in patients with HER2-positive first-line metastatic breast cancer. Here, as described earlier, primary and secondary endpoints (progression-free and overall survival) are analysed using time-to-event models, whereas adverse events are summarized in a simple frequency table, although the duration of study treatment differs substantially. In this paper, we demonstrate the application of time-to-event models to first serious adverse events using the data of the CLEOPATRA study. This will cover the broad range between a simple incidence rate approach over survival and competing risks models (with death as a competing event) to multi-state models. We illustrate all approaches by means of graphical displays highlighting the temporal dynamics and compare the obtained results. For the CLEOPATRA study, the resulting hazard ratios are all in the same order of magnitude. But the use of time-to-event models provides valuable and additional information that would potentially be overlooked by only presenting incidence proportions. These models adequately address the temporal dynamics of serious adverse events as well as death of patients. Copyright © 2016 John Wiley & Sons, Ltd.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Humans; Models, Theoretical; Receptor, ErbB-2; Survival Rate; Time Factors
PubMed: 27313144
DOI: 10.1002/pst.1758 -
Drug Discoveries & Therapeutics Jul 2023The development of new anti-HIV drugs and advances in antiretroviral therapy (ART) regimens have enabled longer and more effective treatments in people living with HIV...
Characteristics of adverse event reports among people living with human immunodeficiency virus (HIV) in Japan: Data mining of the Japanese Adverse Drug Event Report database.
The development of new anti-HIV drugs and advances in antiretroviral therapy (ART) regimens have enabled longer and more effective treatments in people living with HIV (PLWH). However, the aging of PLWHs is another issue that needs to be addressed. In addition to ART, many PLWHs frequently receive medications for various comorbidities. However, real-world data on the occurrence of adverse events in PLWHs and their causative drugs are rare. Therefore, this study aimed to clarify the characteristics of adverse event reports among PLWHs in Japan. PLWH cases with adverse events were comprehensively searched and analyzed using the Japanese Adverse Drug Event Report database (JADER). Despite changes in guideline-recommended ART regimens, anti-HIV drugs were the main cause of adverse events in PLWHs throughout the study period. However, considerable variations have been observed in the reporting rate of anti-HIV drug classes registered as causative drugs in JADER, especially for anchor drugs. In other words, the reporting rate of integrase strand transfer inhibitors has increased in recent years, while that of protease inhibitors and non-nucleoside reverse transcriptase inhibitors has decreased. Immune reconstitution inflammatory syndrome was the most reported adverse event and was frequently noticed by healthcare providers managing patients with HIV infections. The trends in adverse event reports for female and older patients differed from those for the overall population. This study may provide insights that can help in the establishment of optimal management strategies for PLWHs.
Topics: Humans; Female; HIV Infections; HIV; Japan; East Asian People; Drug-Related Side Effects and Adverse Reactions; Anti-HIV Agents; Data Mining
PubMed: 37331810
DOI: 10.5582/ddt.2023.01007 -
The Laryngoscope May 2020To identify U.S. Food and Drug Administration (FDA)-reported adverse events related to electrosurgical devices during tonsillectomy and characterize the most common...
OBJECTIVES
To identify U.S. Food and Drug Administration (FDA)-reported adverse events related to electrosurgical devices during tonsillectomy and characterize the most common devices and patient/provider sequelae.
STUDY DESIGN
Retrospective analysis of FDA database of device-related adverse events.
METHODS
Data were extracted from the OpenFDA database for all adverse events reported for electrosurgical devices used in tonsillectomies from January 2008 to December 2017. Adverse events were classified by device, event type, etiology, complication severity, and patient disposition.
RESULTS
Six hundred fifty-two adverse events were identified, with 195 events (30%) leading to known bodily injury to patient/provider. Device failure was the most common adverse event (202 events, 31%), followed by burns in 187 patient (98% of burns) and three provider events (2%). Burn injuries occurred most frequently with coblation devices (78 events, 42% of burns), monopolar electrocautery (48 events, 25%), and electrosurgical generators (23 events, 13%). Burn injuries most commonly occurred in the oral cavity (144 events, 76% of burn events) and were most commonly first-degree (28 events, 15%). Complications related to burns were managed conservatively for 36% of burn events (68 events), and secondary surgery was rarely required (8 events, 4%). Postoperative bleeding (173 events, 26%; 3 deaths) and intraoperative fire (73 events, 11%) were also reported. Device failures caused significant OR delay or cancellation in 17% of occurrences (35 events).
CONCLUSION
Numerous complications may occur with various devices used during tonsillectomy and can result in significant patient/provider harm and sequelae. Surgeons must understand the nature of such complications to facilitate safe perioperative care and inform preoperative patient discussions.
LEVEL OF EVIDENCE
NA Laryngoscope, 130:1138-1143, 2020.
Topics: Electrosurgery; Humans; Postoperative Complications; Product Surveillance, Postmarketing; Retrospective Studies; Tonsillectomy; United States; United States Food and Drug Administration
PubMed: 31294839
DOI: 10.1002/lary.28181 -
Surgery For Obesity and Related... Aug 2020
Topics: Cohort Studies; Gastric Bypass; Humans; Obesity, Morbid; Quality of Life
PubMed: 32475756
DOI: 10.1016/j.soard.2020.04.029 -
BMC Medical Research Methodology Jan 2024In any single-arm trial on novel treatments, assessment of toxicity plays an important role as occurrence of adverse events (AEs) is relevant for application in clinical... (Review)
Review
BACKGROUND
In any single-arm trial on novel treatments, assessment of toxicity plays an important role as occurrence of adverse events (AEs) is relevant for application in clinical practice. In the presence of a non-fatal time-to-event(s) efficacy endpoint, the analysis should be broadened to consider AEs occurrence in time. The AEs analysis could be tackled with two approaches, depending on the clinical question of interest. Approach 1 focuses on the occurrence of AE as first event. Treatment ability to protect from the efficacy endpoint event(s) has an impact on the chance of observing AEs due to competing risks action. Approach 2 considers how treatment affects the occurrence of AEs in the potential framework where the efficacy endpoint event(s) could not occur.
METHODS
In the first part of the work we review the strategy of analysis for these two approaches. We identify theoretical quantities and estimators consistent with the following features: (a) estimators should address for the presence of right censoring; (b) theoretical quantities and estimators should be functions of time. In the second part of the work we propose the use of alternative methods (regression models, stratified Kaplan-Meier curves, inverse probability of censoring weighting) to relax the assumption of independence between the potential times to AE and to event(s) in the efficacy endpoint for addressing Approach 2.
RESULTS
We show through simulations that the proposed methods overcome the bias due to the dependence between the two potential times and related to the use of standard estimators.
CONCLUSIONS
We demonstrated through simulations that one can handle patients selection in the risk sets due to the competing event, and thus obtain conditional independence between the two potential times, adjusting for all the observed covariates that induce dependence.
Topics: Humans; Bias; Models, Statistical; Probability; Research Design; Clinical Trials as Topic
PubMed: 38172810
DOI: 10.1186/s12874-023-02123-z -
JAMA Mar 2024
Topics: Adverse Drug Reaction Reporting Systems; Communication; United States; Vaccines
PubMed: 38407864
DOI: 10.1001/jama.2024.1757 -
BMC Health Services Research Nov 2013Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug...
BACKGROUND
Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data.
METHODS
We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data.
RESULTS
Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0-11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%).
CONCLUSIONS
Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.
Topics: Canada; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Humans; Male; Middle Aged; Prospective Studies
PubMed: 24219303
DOI: 10.1186/1472-6963-13-473