IMPORTANCE The Patient Protection and Affordable Care Act of 2010 brought attention to adverse drug events in national patient safety efforts. Updated, detailed, nationally representative data describing adverse drug events can help focus these efforts. OBJECTIVE To describe the characteristics of emergency department (ED) visits for adverse drug events in the United States in 2013-2014 and describe changes in ED visits for adverse drug events since 2005-2006. DESIGN, SETTING, AND PARTICIPANTS Active, nationally representative, public health surveillance in 58 EDs located in the United States and participating in the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project. EXPOSURES Drugs implicated in ED visits. MAIN OUTCOMES AND MEASURES National weighted estimates of ED visits and subsequent hospitalizations for adverse drug events. RESULTS Based on data from 42 585 cases, an estimated 4.0 (95% CI, 3.1-5.0) ED visits for adverse drug events occurred per 1000 individuals annually in 2013 and 2014 and 27.3% (95% CI, 22.2%-32.4%) of ED visits for adverse drug events resulted in hospitalization. An estimated 34.5% (95% CI, 30.3%-38.8%) of ED visits for adverse drug events occurred among adults aged 65 years or older in 2013-2014 compared with an estimated 25.6% (95% CI, 21.1%-30.0%) in 2005-2006; older adults experienced the highest hospitalization rates (43.6%; 95% CI, 36.6%-50.5%). Anticoagulants, antibiotics, and diabetes agents were implicated in an estimated 46.9% (95% CI, 44.2%-49.7%) of ED visits for adverse drug events, which included clinically significant adverse events, such as hemorrhage (anticoagulants), moderate to severe allergic reactions (antibiotics), and hypoglycemia with moderate to severe neurological effects (diabetes agents). Since 2005-2006, the proportions of ED visits for adverse drug events from anticoagulants and diabetes agents have increased, whereas the proportion from antibiotics has decreased. Among children aged 5 years or younger, antibiotics were the most common drug class implicated (56.4%; 95% CI, 51.8-61.0%). Among children and adolescents aged 6 to 19 years, antibiotics also were the most common drug class implicated (31.8%; 95% CI, 28.7%-34.9%) in ED visits for adverse drug events, followed by antipsychotics (4.5%; 95% CI, 3.3-5.6%). Among older adults (aged ≥65 years), 3 drug classes (anticoagulants, diabetes agents, and opioid analgesics) were implicated in an estimated 59.9% (95% CI, 56.8%-62.9%) of ED visits for adverse drug events; 4 anticoagulants (warfarin, rivaroxaban, dabigatran, and enoxaparin) and 5 diabetes agents (insulin and 4 oral agents) were among the 15 most common drugs implicated. Medications to always avoid in older adults according to Beers criteria were implicated in 1.8% (95% CI, 1.5%-2.1%) of ED visits for adverse drug events. CONCLUSIONS AND RELEVANCE The prevalence of emergency department visits for adverse drug events in the United States was estimated to be 4 per 1000 individuals in 2013 an...

Objectives Annually, tens of thousands of children are brought to emergency departments for unsupervised medicine ingestions. We assessed whether adding flow restrictors to liquid medicine bottles can provide additional protection against unsupervised medicine ingestions by young children, even when the child-resistant closure is not fully secured. Study Design From April – May 2012, we conducted a block randomized trial with a convenience sample of 110 3- and 4-year-old children from 5 local preschools. Participants attempted to remove test liquid from an uncapped bottle with a flow restrictor and a control bottle without a flow restrictor (with either no cap or an incompletely-closed cap). Results Ninety-six percent (25/26) of open controls and 82% of incompletely-closed control bottles (68/83) were emptied within 2 minutes. Only 6% (7/110) of bottles with flow restrictors were emptied during the 10-minute testing period, none before 6 minutes. Overall, children removed less liquid from bottles with flow restrictors than from open or incompletely-closed controls (both P < .001). All children assigned open controls and 90% assigned incompletely-closed controls removed ≥25 mL liquid. In contrast, 11% of children removed ≥25 mL liquid from uncapped bottles with flow restrictors. Older children (54 – 59 months) were more successful than younger children at removing ≥25 mL liquid (P = .002) from bottles with flow restrictors. Conclusions Findings suggest that adding flow restrictors to liquid medicine bottles limits the accessibility of their contents to young children and could complement the safety provided by current child-resistant packaging.

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Objective To reduce dosing errors when administering orally-ingested over-the-counter (OTC) liquid medications, the US Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) released voluntary recommendations for dosing directions and dosing devices. This study assessed recommendation adherence for national brand-name orally-ingested OTC liquid pediatric analgesics/antipyretics and cough, cold, and allergy medications available after the FDA Guidance was finalized in 2011 in order to identify and prioritize specific improvements to dosing directions and dosing devices. Methods Recommendations were categorized as top tier or low tier based on potential to directly address ≥3-fold dosing errors. Labeled dosing directions and accompanying dosing devices were assessed by 2 independent reviewers for adherence to specific recommendations. Results Of 68 products, 91% of dosing directions and 62% of dosing devices adhered to all top tier recommendations; 57% of products adhered to every top tier recommendation and 93% adhered to all or all but one. A dosing was included with all products. No dosing directions used atypical volumetric units (e.g., drams), and no devices used volumetric units that did not appear in dosing directions. Six products used trailing zeros or failed to use leading zeros with decimal doses and 8 did not use small font for fractions. Product adherence to low tier recommendations ranged from 26% to 91%. Conclusion Products adhered to most recommendations in the final FDA Guidance and CHPA Guideline suggesting that these voluntary initiatives promote adherence to recommendations. Improving adherence to recommendations should be prioritized based on potential to reduce harm.

Objectives. To estimate the number of US emergency department visits for prescription opioid harms by patient characteristics, intent, clinical manifestations, and active ingredient. Methods. We used data from medical record–based surveillance from a nationally representative 60-hospital sample. Results. Based on 7769 cases, there were 267 020 estimated emergency department visits annually (95% confidence interval [CI] = 209 833, 324 206) for prescription opioid harms from 2016 to 2017. Nearly half of visits (47.6%; 95% CI = 40.8%, 54.4%) were attributable to nonmedical opioid use, 38.9% (95% CI = 32.9%, 44.8%) to therapeutic use, and 13.5% (95% CI = 11.0%, 16.0%) to self-harm. Co-implication with other pharmaceuticals and concurrent illicit drug and alcohol use were common; prescription opioids alone were implicated in 31.5% (95% CI = 27.2%, 35.8%) of nonmedical use visits and 19.7% (95% CI = 15.7%, 23.7%) of self-harm visits. Unresponsiveness or cardiorespiratory failure (30.0%) and altered mental status (35.7%) were common in nonmedical use visits. Gastrointestinal effects (30.4%) were common in therapeutic use visits. Oxycodone was implicated in more than one third of visits across intents. Conclusions. Morbidity data can help target interventions, such as dispensing naloxone to family and friends of those with serious overdose, and screening and treatment of substance use disorder when opioids are prescribed long-term.

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