Dataset Information

Trends in rates of acetaminophen-related adverse events in the United States.

ABSTRACT: PURPOSE:The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality. METHODS:A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings, including calls to poison centers (2008-2012), emergency department visits (2004-2012), and inpatient hospitalizations (1998-2011). Rates of acetaminophen-related events were calculated per setting, census population, and distributed drug units. RESULTS:Rates of poison center calls with acetaminophen-related exposures decreased from 49.5/1000 calls in 2009 to 43.5/1000 calls in 2012. Rates of emergency department visits for unintentional acetaminophen-related adverse events decreased from 58.0/1000 emergency department visits for adverse drug events in 2009 to 50.2/1000 emergency department visits in 2012. Rates of hospital inpatient discharges with acetaminophen-related poisoning decreased from 119.8/100?000 hospitalizations in 2009 to 108.6/100?000 hospitalizations in 2011. After 2009, population rates of acetaminophen-related events per 1?million census population decreased for poison center calls and hospitalizations, while emergency department visit rates remained stable. However, when accounting for drug sales, the rate of acetaminophen-related events (per 1?million distributed drug units) increased after 2009. Prior to 2009, the rates of acetaminophen-related hospitalizations had been slowly increasing (p-trend?=?0.001). CONCLUSIONS:Acetaminophen-related adverse events continue to be a public health burden. Future studies with additional time points are necessary to confirm trends and determine whether recent risk mitigation efforts had a beneficial impact on acetaminophen-related adverse events. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

SUBMITTER: Major JM

PROVIDER: S-EPMC5676300 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Trends in rates of acetaminophen-related adverse events in the United States.

Major Jacqueline M JM Zhou Esther H EH Wong Hui-Lee HL Trinidad James P JP Pham Tracy M TM Mehta Hina H Ding Yulan Y Staffa Judy A JA Iyasu Solomon S Wang Cunlin C Willy Mary E ME

Pharmacoepidemiology and drug safety 20151103 5

<h4>Purpose</h4>The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality.<h4>Methods</h4>A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings, including calls to poison centers (2008-2012), emergency department visits (2004-2012), and inpatient hospitalizations (1998-2011). Rates of acetaminophen-related ev ...[more]

PMID: 26530380

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Project description:ImportanceIt is known that hospitalized patients who experience adverse events are at greater risk of readmission; however, it is unknown whether patients admitted to hospitals with higher risk-standardized readmission rates had a higher risk of in-hospital adverse events.ObjectiveTo evaluate whether patients with pneumonia admitted to hospitals with higher risk-standardized readmission rates had a higher risk of adverse events.Design, setting, and participantsThis cross-sectional study linked patient-level adverse events data from the Medicare Patient Safety Monitoring System (MPSMS), a randomly selected medical record abstracted database, to the hospital-level pneumonia-specific all-cause readmissions data from the Centers for Medicare & Medicaid Services. Patients with pneumonia discharged from July 1, 2010, through December 31, 2019, in the MPSMS data were included. Hospital performance on readmissions was determined by the risk-standardized 30-day all-cause readmission rate. Mixed-effects models were used to examine the association between adverse events and hospital performance on readmissions, adjusted for patient and hospital characteristics. Analysis was completed from October 2019 through July 2020 for data from 2010 to 2017 and from March through April 2022 for data from 2018 to 2019.ExposuresPatients hospitalized for pneumonia.Main outcomes and measuresAdverse events were measured by the rate of occurrence of hospital-acquired events and the number of events per 1000 discharges.ResultsThe sample included 46 047 patients with pneumonia, with a median (IQR) age of 71 (58-82) years, with 23 943 (52.0%) women, 5305 (11.5%) Black individuals, 37 763 (82.0%) White individuals, and 2979 (6.5%) individuals identifying as another race, across 2590 hospitals. The median hospital-specific risk-standardized readmission rate was 17.0% (95% CI, 16.3%-17.7%), the occurrence rate of adverse events was 2.6% (95% CI, 2.54%-2.65%), and the number of adverse events per 1000 discharges was 157.3 (95% CI, 152.3-162.5). An increase by 1 IQR in the readmission rate was associated with a relative 13% higher patient risk of adverse events (adjusted odds ratio, 1.13; 95% CI, 1.08-1.17) and 5.0 (95% CI, 2.8-7.2) more adverse events per 1000 discharges at the patient and hospital levels, respectively.Conclusions and relevancePatients with pneumonia admitted to hospitals with high all-cause readmission rates were more likely to develop adverse events during the index hospitalization. This finding strengthens the evidence that readmission rates reflect the quality of hospital care for pneumonia.

Project description:BackgroundThe U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety.MethodsWe estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020.ResultsThe study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12-19 per 100,000 person-years), appendicitis (80 vs 117-155), and narcolepsy (38 vs 41-53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March-May 2020 compared with March-May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell's palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019.ConclusionAESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.

Project description:ImportanceThe use of gabapentinoids in multimodal postoperative analgesia is increasing; however, when coadministered with opioids, these drugs may potentiate central nervous system and respiratory depression.ObjectiveTo evaluate the association between perioperative coadministration of gabapentinoids and opioids with inpatient opioid-related adverse events in surgical patients.Design, setting, and participantsThis cohort study used propensity score trimming, stratification, and weighting of adults admitted for a major surgery between October 2007 and December 2017 who were treated with opioids on the day of surgery and included in the Premier Research database. Data analysis was conducted from February to April 2020.ExposureGabapentinoids (gabapentin or pregabalin) coadministered with opioids starting the day of surgery vs opioid therapy without gabapentinoids.Main outcomes and measuresPrimary outcome was opioid overdose. Secondary outcomes included respiratory complications, unspecified adverse effects of opioid use, and a composite of these 3 outcomes. Patients were followed up for as long as 30 days from the day of surgery until deviation from the initial treatment regimen or discharge.ResultsGabapentinoids with opioids were administered to 892 484 of 5 547 667 eligible admissions (16.1%; mean [SD] age, 63.5 [11.8] years; 353 315 [39.6%] men). Among the 4 655 183 patients who received opioids only, the mean (SD) age was 63.7 (14.7) years, and 1 913 284 (41.1%) were men. Overall, 441 overdose events were identified, with absolute risks of 1.4 per 10 000 patients with gabapentinoid exposure and 0.7 per 10 000 patients receiving opioids only. Following propensity score trimming, the cohort included 737 383 patients exposed to gabapentinoids and 3 002 480 patients receiving opioids only. The primary analysis yielded the adjusted hazard ratio of 1.95 (95% CI, 1.49-2.55), and the number needed to treat for an additional overdose to occur was 16 914 patients (95% CI, 11 556-31 537 patients). Adjusted hazard ratios for secondary outcomes were 1.68 (95% CI, 1.59-1.78) for respiratory complications, 1.77 (95% CI, 1.61-1.93) for unspecified adverse effects of opioids, and 1.70 (95% CI, 1.62-1.79) for the composite outcome. The results were consistent across sensitivity analyses and subgroups identified by key clinical factors.Conclusions and relevanceIn this real-world cohort study of patients who underwent major surgery, concomitant use of gabapentinoids with opioids was associated with increased risk of opioid overdose and other opioid-related adverse events; however, the absolute risk of adverse events was low.

Dataset Information

Trends in rates of acetaminophen-related adverse events in the United States.

Publications

Trends in rates of acetaminophen-related adverse events in the United States.

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