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51 result(s) for "Budnitz, Daniel S."
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Emergency Hospitalizations for Adverse Drug Events in Older Americans
This national study estimated that nearly 100,000 elderly patients were hospitalized for adverse drug events annually from 2007 through 2009. Most resulted from use of common medications such as warfarin and insulin, and only 1% from medications designated as high-risk. Decreasing the number of preventable rehospitalizations by 20% by the end of 2013 is a goal of the $1 billion federal initiative Partnership for Patients, and the pursuit of this goal represents an opportunity to reduce harm to patients and reduce health care costs. 1 , 2 Adverse drug events are a direct consequence of clinical care and a key focus of the partnership. Hospitalizations for adverse drug events are likely to increase as Americans live longer, have greater numbers of chronic conditions, and take more medications. Among adults 65 years of age or older, 40% take 5 to 9 medications and . . .
Emergency Department Visits for Antibiotic-Associated Adverse Events
Background.Drug-related adverse events are an underappreciated consequence of antibiotic use, and the national magnitude and scope of these events have not been studied. Our objective was to estimate and compare the numbers and rates of emergency department (ED) visits for drug-related adverse events associated with systemic antibiotics in the United States by drug class, individual drug, and event type. Methods.We analyzed drug-related adverse events from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project (2004–2006) and outpatient prescriptions from national sample surveys of ambulatory care practices, the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey (2004–2005). Results.On the basis of 6614 cases, an estimated 142,505 visits (95% confidence interval [CI], 116,506–168,504 visits) annually were made to US EDs for drug-related adverse events attributable to systemic antibiotics. Antibiotics were implicated in 19.3% of all ED visits for drug-related adverse events. Most ED visits for antibiotic-associated adverse events were for allergic reactions (78.7% of visits; 95% CI, 75.3%–82.1% of visits). One-half of the estimated ED visits were attributable to penicillins (36.9% of visits; 95% CI, 34.7%–39.2% of visits) and cephalosporins (12.2%; 95% CI, 10.9%–13.5%). Among commonly prescribed antibiotics, sulfonamides and clindamycin were associated with the highest rate of ED visits (18.9 ED visits per 10,000 outpatient prescription visits [95% CI, 13.1–24.7 ED visits per 10,000 outpatient prescription visits] and 18.5 ED visits per 10,000 outpatient prescription visits [95% CI, 12.1–25.0 ED visits per 10,000 outpatient prescription visits], respectively). Compared with all other antibiotic classes, sulfonamides were associated with a significantly higher rate of moderate-to-severe allergic reactions (4.3% [95% CI, 2.9%–5.8%] vs. 1.9 % [95% CI, 1.5%–2.3%]), and sulfonamides and fluoroquinolones were associated with a significantly higher rate of neurologic or psychiatric disturbances (1.4% [95% CI, 1.0%–1.7%] vs. 0.5% [95% CI, 0.4%–0.6%]). Conclusions.Antibiotic-associated adverse events lead to many ED visits, and allergic reactions are the most common events. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients.
Emergency Department Visits for Adverse Events Related to Dietary Supplements
On the basis of estimates from a nationally representative sample of U.S. emergency departments from 2004 through 2013, approximately 23,000 emergency department visits annually are attributed to adverse events related to dietary supplements. Herbals (botanical products), complementary nutritionals (e.g., amino acids), and micronutrients (vitamins and minerals) are all considered to be dietary supplements by the Dietary Supplement Health and Education Act of 1994. 1 Although supplements cannot be marketed for the treatment or prevention of disease, they are often taken to address symptoms or illnesses, as well as to maintain or improve overall health. 2 The estimated number of supplement products increased from 4000 in 1994 3 to more than 55,000 in 2012 (the most recent year for which data are publicly available), 4 and approximately half of all adults in the United States report having used . . .
Hydroxychloroquine and Chloroquine Prescribing Patterns by Provider Specialty Following Initial Reports of Potential Benefit for COVID-19 Treatment — United States, January–June 2020
Hydroxychloroquine and chloroquine, primarily used to treat autoimmune diseases and to prevent and treat malaria, received national attention in early March 2020, as potential treatment and prophylaxis for coronavirus disease 2019 (COVID-19) (1). On March 20, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate in the Strategic National Stockpile to be used by licensed health care providers to treat patients hospitalized with COVID-19 when the providers determine the potential benefit outweighs the potential risk to the patient.* Following reports of cardiac and other adverse events in patients receiving hydroxychloroquine for COVID-19 (2), on April 24, 2020, FDA issued a caution against its use† and on June 15, rescinded its EUA for hydroxychloroquine from the Strategic National Stockpile.§ Following the FDA's issuance of caution and EUA rescindment, on May 12 and June 16, the federal COVID-19 Treatment Guidelines Panel issued recommendations against the use of hydroxychloroquine or chloroquine to treat COVID-19; the panel also noted that at that time no medication could be recommended for COVID-19 pre- or postexposure prophylaxis outside the setting of a clinical trial (3). However, public discussion concerning the effectiveness of these drugs on outcomes of COVID-19 (4,5), and clinical trials of hydroxychloroquine for prophylaxis of COVID-19 continue.¶ In response to recent reports of notable increases in prescriptions for hydroxychloroquine or chloroquine (6), CDC analyzed outpatient retail pharmacy transaction data to identify potential differences in prescriptions dispensed by provider type during January-June 2020 compared with the same period in 2019. Before 2020, primary care providers and specialists who routinely prescribed hydroxychloroquine, such as rheumatologists and dermatologists, accounted for approximately 97% of new prescriptions. New prescriptions by specialists who did not typically prescribe these medications (defined as specialties accounting for ≤2% of new prescriptions before 2020) increased from 1,143 prescriptions in February 2020 to 75,569 in March 2020, an 80-fold increase from March 2019. Although dispensing trends are returning to prepandemic levels, continued adherence to current clinical guidelines for the indicated use of these medications will ensure their availability and benefit to patients for whom their use is indicated (3,4), because current data on treatment and pre- or postexposure prophylaxis for COVID-19 indicate that the potential benefits of these drugs do not appear to outweigh their risks.Hydroxychloroquine and chloroquine, primarily used to treat autoimmune diseases and to prevent and treat malaria, received national attention in early March 2020, as potential treatment and prophylaxis for coronavirus disease 2019 (COVID-19) (1). On March 20, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate in the Strategic National Stockpile to be used by licensed health care providers to treat patients hospitalized with COVID-19 when the providers determine the potential benefit outweighs the potential risk to the patient.* Following reports of cardiac and other adverse events in patients receiving hydroxychloroquine for COVID-19 (2), on April 24, 2020, FDA issued a caution against its use† and on June 15, rescinded its EUA for hydroxychloroquine from the Strategic National Stockpile.§ Following the FDA's issuance of caution and EUA rescindment, on May 12 and June 16, the federal COVID-19 Treatment Guidelines Panel issued recommendations against the use of hydroxychloroquine or chloroquine to treat COVID-19; the panel also noted that at that time no medication could be recommended for COVID-19 pre- or postexposure prophylaxis outside the setting of a clinical trial (3). However, public discussion concerning the effectiveness of these drugs on outcomes of COVID-19 (4,5), and clinical trials of hydroxychloroquine for prophylaxis of COVID-19 continue.¶ In response to recent reports of notable increases in prescriptions for hydroxychloroquine or chloroquine (6), CDC analyzed outpatient retail pharmacy transaction data to identify potential differences in prescriptions dispensed by provider type during January-June 2020 compared with the same period in 2019. Before 2020, primary care providers and specialists who routinely prescribed hydroxychloroquine, such as rheumatologists and dermatologists, accounted for approximately 97% of new prescriptions. New prescriptions by specialists who did not typically prescribe these medications (defined as specialties accounting for ≤2% of new prescriptions before 2020) increased from 1,143 prescriptions in February 2020 to 75,569 in March 2020, an 80-fold increase from March 2019. Although dispensing trends are returning to prepandemic levels, continued adherence to current clinical guidelines for the indicated use of these medications will ensure their availability and benefit to patients for whom their use is indicated (3,4), because current data on treatment and pre- or postexposure prophylaxis for COVID-19 indicate that the potential benefits of these drugs do not appear to outweigh their risks.
National Estimates of Emergency Department Visits for Antibiotic Adverse Events Among Adults—United States, 2011–2015
BackgroundDetailed, nationally representative data describing high-risk populations and circumstances involved in antibiotic adverse events (AEs) can inform approaches to prevention.ObjectiveDescribe US burden, rates, and characteristics of emergency department (ED) visits by adults for antibiotic AEs.DesignNationally representative, public health surveillance of adverse drug events (National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance [NEISS-CADES]) and a nationally projected database of dispensed prescriptions (QuintilesIMS), 2011–2015.PatientsAntibiotic-treated adults (≥ 20 years) seeking ED care.Main MeasuresEstimated annual numbers and rates of ED visits for antibiotic AEs among outpatients treated with systemically administered antibiotics.Key ResultsBased on 10,225 cases, US adults aged ≥ 20 years made an estimated 145,490 (95% confidence interval, 115,279–175,701) ED visits for antibiotic AEs each year in 2011–2015. Antibiotics were implicated in 13.7% (12.3–15.2%) of all estimated adult ED visits for adverse drug events. Most (56.6%; 54.8–58.4%) antibiotic AE visits involved adults aged < 50 years, and 71.8% (70.4–73.1%) involved females. Accounting for prescriptions dispensed from retail and long-term care pharmacies, adults aged 20–34 years had twice the estimated rate of ED visits for oral antibiotic AEs compared with those aged ≥ 65 years (9.7 [7.6–11.8] versus 4.6 [3.6–5.7] visits per 10,000 dispensed prescriptions, respectively). Allergic reactions accounted for three quarters (74.3%; 70.0–78.6%) of estimated ED visits for antibiotic AEs. The three most frequently implicated antibiotic classes in ED visits for antibiotic AEs were oral sulfonamides (23.2%; 20.6–25.8%), penicillins (20.8%; 19.3–22.4%), and quinolones (15.7%; 14.2–17.1%). Per-prescription rates declined with increasing age group.ConclusionsAntibiotics are a common cause of ED visits by adults for adverse drug events and represent an important safety issue. Quantifying risks of AEs from specific antibiotics for specific patient populations, such as younger adults, provides additional information to help clinicians assess risks versus benefits when making the decision to prescribe or not prescribe an antibiotic. AE rates may also facilitate communication with patients about antibiotic risks.
National estimates of emergency department visits for medication-related self-harm: United States, 2016–2019
BackgroundMedication poisoning is a common form of self-harm injury, and increases in injuries due to self-harm, including suicide attempts, have been reported over the last two decades.MethodsCross-sectional (2016–2019) data from 60 emergency departments (EDs) participating in an active, nationally representative public health surveillance system were analysed and US national estimates of ED visits for medication-related self-harm injuries were calculated.ResultsBased on 18 074 surveillance cases, there were an estimated 269 198 (95% CI 222 059 to 316 337) ED visits for medication-related self-harm injuries annually in 2016–2019 compared with 1 404 090 visits annually from therapeutic use of medications. Population rates of medication-related self-harm ED visits were highest among persons aged 11–19 years (58.5 (95% CI 45.0 to 72.0) per 10 000) and lowest among those aged ≥65 years (6.6 (95% CI 4.4 to 8.8) per 10 000). Among persons aged 11–19 years, the ED visit rate for females was four times that for males (95.4 (95% CI 74.2 to 116.7) vs 23.0 (95% CI 16.4 to 29.6) per 10 000). Medical or psychiatric admission was required for three-quarters (75.1%; 95% CI 70.0% to 80.2%) of visits. Concurrent use of alcohol or illicit substances was documented in 40.2% (95% CI 36.8% to 43.7%) of visits, and multiple medication products were implicated in 38.6% (95% CI 36.8% to 40.4%). The most frequently implicated medication categories varied by patient age.ConclusionsMedication-related self-harm injuries are an important contributor to the overall burden of ED visits and hospitalisations for medication-related harm, with the highest rates among adolescent and young adult females. These findings support continued prevention efforts targeting patients at risk of self-harm.
US Emergency Department Visits for Acute Harms From Prescription Opioid Use, 2016–2017
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.
The Role of Unit-Dose Child-Resistant Packaging in Unintentional Childhood Exposures to Buprenorphine–Naloxone Tablets
Dear Editor, Buprenorphine-naloxone was among the most commonly implicated exposures in pediatric emergency department (ED) visits for unsupervised oral prescription medication ingestions in 2007-2011, resulting in high hospitalization rates [1, 2] and several deaths [3]. Ethical approval This project meets the definition of a public health surveillance activity described in the US Code of Federal Regulations (CFR), 45 CFR 46.102(l)(2), and does not require human subjects review or institutional review board (IRB) approval. Published online: 20 November 2019 © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2019 The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Food and Drug Administration (FDA) or the Centers for Disease Control and Prevention (CDC).