Changes in emergency department visits for zolpidem-attributed adverse drug reactions after FDA Drug Safety Communications.
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ABSTRACT: Purpose
To identify possible changes in U.S. emergency department (ED) visits from zolpidem-attributed adverse drug reactions (ADRs) after 2013 Food and Drug Administration (FDA) Drug Safety Communications (DSCs), which notified the public about FDA's new dosing recommendations for zolpidem.Methods
We estimated the occurrence of ED visits from zolpidem-attributed ADRs using nationally representative, public health surveillance of medication harms (National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, 2010-2017). We estimated the number of zolpidem prescriptions using IQVIA National Prescription Audit, 2010-2017. We calculated rates of ED visits for zolpidem-attributed ADRs per 10 000 dispensed zolpidem prescriptions and identified time trends and potential inflection points using joinpoint regression. For comparison, we repeated these analyses for sedating antidepressants commonly used to treat disordered sleep (trazodone, doxepin, and mirtazapine).Results
The best-fit regression model for rates of ED visits for zolpidem-attributed ADRs by 6-month intervals identified a single inflection point in the second half of 2014 (P = .024) with a 6.7% biannual decrease from 2010 to 2014 ([-13.1%, 0.3%], P = .059) and a 13.9% biannual increase from the second half of 2014 through 2017 ([-1.1%, 31.3%], P = .068). No change or inflection points were identified for rates of ED visits for sedating antidepressant-attributed ADRs.Conclusions
While there was a nominal decline in the rate of ED visits for ADRs in the time period before and for 18 months after FDA's 2013 zolpidem DSCs, the decrease was not sustained, and thus questions remain concerning the long-term impact of the zolpidem DSCs on ADRs.
SUBMITTER: Geller AI
PROVIDER: S-EPMC7263461 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
Publications
Changes in emergency department visits for zolpidem-attributed adverse drug reactions after FDA Drug Safety Communications.
Geller Andrew I AI Zhou Esther H EH Budnitz Daniel S DS Lovegrove Maribeth C MC Dal Pan Gerald J GJ
Pharmacoepidemiology and drug safety 20200109 3
<h4>Purpose</h4>To identify possible changes in U.S. emergency department (ED) visits from zolpidem-attributed adverse drug reactions (ADRs) after 2013 Food and Drug Administration (FDA) Drug Safety Communications (DSCs), which notified the public about FDA's new dosing recommendations for zolpidem.<h4>Methods</h4>We estimated the occurrence of ED visits from zolpidem-attributed ADRs using nationally representative, public health surveillance of medication harms (National Electronic Injury Surve ...[more]
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Project description:BackgroundAlcohol consumption may interfere with absorption, distribution, metabolism, and excretion of medications and increase risk of adverse drug reactions (ADR). Studies report increasing prescription medication use over time, with many U.S. drinkers using alcohol-interactive medication. This study identified trends in incidence of U.S. emergency department (ED) visits for ADR with alcohol involvement (ADR-A), compared characteristics and disposition between ADR-A visits and ADR visits without alcohol involvement (ADR-NA), and examined frequency of implicated medications in such visits for 2005 to 2011.MethodsADR visits were identified through the Drug Abuse Warning Network, a national surveillance system monitoring drug-related ED visits. Analysis accounted for sampling design effects and sampling weights. Estimates are presented for totals (ages 12+), age group, and/or sex. Trends were assessed by joinpoint log-linear regression. Differences between ADR-A and ADR-NA visits were compared using two-tailed Rao-Scott chi-square tests.ResultsFrom 2005 to 2011, incidence of ADR-A visits increased for males and females ages 21 to 34 and females ages 55+. An average of 25,303 ADR-A visits ages 12+ occurred annually. Compared with ADR-NA visits, ADR-A visits were more likely to involve males, patients ages 21 to 54, and 2+ implicated drugs. Alcohol involvement increased odds of more serious outcomes from ADR visits. Central nervous system (CNS) agents were the most common medications in ADR-A visits (59.1%), with nearly half being analgesics (mainly opioid). About 13.8% of ADR-A visits involved psychotherapeutic agents, including antidepressants. Besides CNS and psychotherapeutic agents, ADR-A visits involved a higher percentage of genitourinary-tract agents (mainly for impotence) than ADR-NA visits. Sex and age variations were observed with certain implicated medications.ConclusionsED visits for alcohol-drug interactions can be prevented by avoiding alcohol when taking alcohol-interactive medications. Our results underscore the need for healthcare professionals to routinely ask patients about alcohol consumption and warn of ADR risks before prescribing and dispensing alcohol-interactive medications.
| S-EPMC5008983 | biostudies-literature
Project description: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 and 2014. The most common drug classes implicated were anticoagulants, antibiotics, diabetes agents, and opioid analgesics.
| S-EPMC6490178 | biostudies-literature
Project description:BACKGROUND:Various medications are cleared by the kidneys, therefore patients with impaired renal function, especially dialysis patients are at risk for adverse drug events (ADEs). There are limited studies on ADEs in maintenance dialysis patients. METHODS:We utilized a nationally representative database, the Nationwide Emergency Department Sample, from 2008 to 2013, to compare emergency department (ED) visits for dialysis and propensity matched non-dialysis patients. Log binomial regression was used to calculate relative risk of hospital admission and logistic regression to calculate ORs for in-hospital mortality while adjusting for patient and hospital characteristics. RESULTS:While ED visits for ADEs decreased in both groups, they were over 10-fold higher in dialysis patients than non-dialysis patients (65.8-88.5 per 1,000 patients vs. 4.6-5.4 per 1,000 patients respectively, p < 0.001). The top medication category associated with ED visits for ADEs in dialysis patients is agents primarily affecting blood constituents, which has increased. After propensity matching, patient admission was higher in dialysis patients than non-dialysis patients, (88 vs. 76%, p < 0.001). Dialysis was associated with a 3% increase in risk of admission and 3 times the odds of in-hospital mortality (adjusted OR 3, 95% CI 2.7-2.3.3). CONCLUSIONS:ED visits for ADEs are substantially higher in dialysis patients than non-dialysis patients. In dialysis patients, ADEs associated with agents primarily affecting blood constituents are on the rise. ED visits for ADEs in dialysis patients have higher inpatient admissions and in-hospital mortality. Further studies are needed to identify and implement measures aimed at reducing ADEs in dialysis patients.
| S-EPMC6148753 | biostudies-literature
Project description:BackgroundAntibiotics are among the most commonly prescribed medications for children; however, at least one-third of pediatric antibiotic prescriptions are unnecessary. National data on short-term antibiotic-related harms could inform efforts to reduce overprescribing and to supplement interventions that focus on the long-term benefits of reducing antibiotic resistance.MethodsFrequencies and rates of emergency department (ED) visits for antibiotic adverse drug events (ADEs) in children were estimated using adverse event data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project and retail pharmacy dispensing data from QuintilesIMS (2011-2015).ResultsOn the basis of 6542 surveillance cases, an estimated 69464 ED visits (95% confidence interval, 53488-85441) were made annually for antibiotic ADEs among children aged ≤19 years from 2011 to 2015, which accounts for 46.2% of ED visits for ADEs that results from systemic medication. Two-fifths (40.7%) of ED visits for antibiotic ADEs involved a child aged ≤2 years, and 86.1% involved an allergic reaction. Amoxicillin was the most commonly implicated antibiotic among children aged ≤9 years. When we accounted for dispensed prescriptions, the rates of ED visits for antibiotic ADEs declined with increasing age for all antibiotics except sulfamethoxazole-trimethoprim. Amoxicillin had the highest rate of ED visits for antibiotic ADEs among children aged ≤2 years, whereas sulfamethoxazole-trimethoprim resulted in the highest rate among children aged 10 to 19 years (29.9 and 24.2 ED visits per 10000 dispensed prescriptions, respectively).ConclusionsAntibiotic ADEs lead to many ED visits, particularly among young children. Communicating the risks of antibiotic ADEs could help reduce unnecessary prescribing. Prevention efforts could target pediatric patients who are at the greatest risk of harm.
| S-EPMC6467735 | biostudies-literature
Project description:Adverse drug events are significant causes of emergency department visits. Systematic evaluation of adverse drug events leading to emergency department visits by age is lacking. This multicenter retrospective observational study evaluated the prevalence and features of adverse drug event-related emergency department visits across ages. We reviewed emergency department medical records obtained from three university hospitals between July 2014 and December 2014. The proportion of adverse drug events among total emergency department visits was calculated. The cause, severity, preventability, and causative drug(s) of each adverse drug event were analyzed and compared between age groups (children/adolescents [<18 years], adults [18-64 years], and the elderly [≥65 years]). Of 59,428 emergency department visits, 2,104 (3.5%) were adverse drug event-related. Adverse drug event-related emergency department visits were more likely to be female and older. Multivariate logistic regression analysis revealed that compared to non- adverse drug event-related cases, adverse drug event-related emergency department visitors were more likely to be female (60.6% vs. 53.6%, p<0.001, OR 1.285, 95% CI 1.025-1.603) and older (50.8 ± 24.6 years vs. 37.7 ± 24.4 years, p<0.001, OR 1.892, 95% CI: 1.397-2.297). Comorbidities such as diabetes, chronic kidney disease, chronic liver disease, and malignancies were also significantly associated with adverse drug event-related emergency department visits. Side effects were the most common type of adverse drug events across age groups, although main types differed substantially depending on age. Serious adverse drug events, hospitalizations, and adverse drug event-related deaths occurred more frequently in the elderly than in adults or children/adolescents. The proportion of adverse drug event-related emergency department visits that were preventable was 15.3%. Causative drugs of adverse drug events varied considerably depending on age group. Adverse drug event features differ substantially according to age group. The findings suggest that an age-specific approach should be adopted in the preventive strategies to reduce adverse drug events.
| S-EPMC9484687 | biostudies-literature
Project description:ObjectivesThis study describes the proportion of emergency department (ED) returns within 7 days due to adverse events, defined as adverse outcomes related to healthcare received.DesignProspective cohort study.SettingWe used an electronically triggered adverse event surveillance system at a tertiary care ED from May to June 2010 to examine ED returns within 7 days of index visit.ParticipantsOne of three trained nurses determined whether the visit was related to index emergency care. For such records, one of three trained emergency physicians conducted adverse event determinations.Main outcome measureWe determined adverse event type and severity and analysed the data with descriptive statistics, χ(2) tests and logistic regression.ResultsOf 13,495 index ED visits, 923 (6.8%) were followed by ED returns within 7 days. The median age of all patients was 47 years and 52.8% were women. After nursing review, 211 cases required physician review. Of these, 53 visits were adverse events (positive predictive value (PPV)=5.7%, 95% CI 4.4% to 7.4%) and 30 (56.6%) were preventable. Common adverse event types involved management, diagnostic or medication issues. We observed one potentially preventable death and 58.5% of adverse events resulting in transient disability. The PPV of a modified trigger with a cut-off of return within 72 h, resulting in admission was 11.9% (95% CI 6.8% to 18.9%).ConclusionsOur electronic trigger efficiently identified adverse events among 12% of patients with ED returns within 72 h, requiring hospital admission. Given the high degree of preventability of the identified adverse events, this trigger also holds promise as a performance measurement tool.
| S-EPMC4316869 | biostudies-literature
Project description:BACKGROUND:Dietary supplements, such as herbal or complementary nutritional products and micronutrients (vitamins and minerals), are commonly used in the United States, yet national data on adverse effects are limited. METHODS:We used nationally representative surveillance data from 63 emergency departments obtained from 2004 through 2013 to describe visits to U.S. emergency departments because of adverse events related to dietary supplements. RESULTS:On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement-related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits. CONCLUSIONS:An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements. Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults. (Funded by the Department of Health and Human Services.).
| S-EPMC6196363 | biostudies-literature
Project description:In 2011, an estimated 26.8 million US adults used prescription medications for mental illness.To estimate the numbers and rates of adverse drug event (ADE) emergency department (ED) visits involving psychiatric medications among US adults between January 1, 2009, and December 31, 2011.Descriptive analyses of active, nationally representative surveillance of ADE ED visits using the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance system and of drug prescribing during outpatient visits using the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey.Medical records from national probability samples of ED and outpatient visits by adults 19 years or older were reviewed and analyzed.Antidepressants, antipsychotics, lithium salts, sedatives and anxiolytics, and stimulants.National estimates of ADE ED visits resulting from therapeutic psychiatric medication use and of psychiatric medication ADE ED visits per 10,000 outpatient visits at which psychiatric medications were prescribed.From 2009 through 2011, there were an estimated 89,094 (95% CI, 68,641-109,548) psychiatric medication ADE ED visits annually, with 19.3% (95% CI, 16.3%-22.2%) resulting in hospitalization and 49.4% (95% CI, 46.5%-52.4%) involving patients aged 19 to 44 years. Sedatives and anxiolytics, antidepressants, antipsychotics, lithium salts, and stimulants were implicated in an estimated 30,707 (95% CI, 23,406-38,008), 25,377 (95% CI, 19,051-31,704), 21,578 (95% CI, 16,599-26,557), 3620 (95% CI, 2311-4928), and 2779 (95% CI, 1764-3794) respective ADE ED visits annually. Antipsychotics and lithium salts were implicated in 11.7 (95% CI, 10.1-13.2) and 16.4 (95% CI, 13.0-19.9) ADE ED visits per 10,000 outpatient prescription visits, respectively, compared with 3.6 (95% CI, 3.2-4.1) for sedatives and anxiolytics, 2.9 (95% CI, 2.3-3.5) for stimulants, and 2.4 (95% CI, 2.1-2.7) for antidepressants. The commonly used sedative zolpidem tartrate was implicated in 11.5% (95% CI, 9.5%-13.4%) of all adult psychiatric medication ADE ED visits and in 21.0% (95% CI, 16.3%-25.7%) of visits involving adults 65 years or older, in both cases significantly more than any other psychiatric medication.Psychiatric medications are implicated in many ADEs treated in US EDs. Efforts to reduce ADEs should include adults of all ages but might prioritize medications causing high numbers and rates of ED visits.
| S-EPMC4703317 | biostudies-literature
Project description:PurposeTo investigate the characteristics of ADRs in patients admitting at the emergency room of a tertiary hospital.MethodsWe collected the patient records of 1600 emergency room visits of a university hospital in 2018. The patient files were studied retrospectively and all possible ADRs were identified and registered. Patient characteristics, drugs associated with ADRs, causality, severity, preventability, and the role of pharmacogenetics were assessed.ResultsThere were 125 cases with ADRs, resulting in a 7.8% overall incidence among emergency visits. The incidence was greatest in visits among elderly patients, reaching 14% (men) to 19% (women) in the 80-89 years age group. The most common causative drugs were warfarin, acetylsalicylic acid (ASA), apixaban, and docetaxel, and the most common ADRs were bleedings and neutropenia and/or severe infections. Only two of the cases might have been prevented by pharmacogenetic testing, as advised in Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.ConclusionThe same ATC classes, antithrombotics and cytostatics, were involved in ADRs causing university clinic hospitalizations as those identified previously in drug-related hospital fatalities. It seems difficult to prevent these events totally, as the treatments are vitally important and their risk-benefit-relationships have been considered thoroughly, and as pharmacogenetic testing could have been useful in only few cases.
| S-EPMC7935812 | biostudies-literature
Project description:The study aimed to investigate the prevalence of drug-related emergency department (ED) visits and associated risk factors. This retrospective cohort study was conducted in the ED, Diakonhjemmet Hospital, Oslo, Norway. From April 2017 to May 2018, 402 patients allocated to the intervention group in a randomized controlled trial were included in this sub-study. During their ED visit, these patients received medication reconciliation and medication review conducted by study pharmacists, in addition to standard care. Retrospectively, an interdisciplinary team assessed the reconciled drug list and identified drug-related issues alongside demographics, final diagnosis, and laboratory tests for all patients to determine whether their ED visit was drug-related. The study population's median age was 67 years (IQR 27, range 19-96), and patients used a median of 4 regular drugs (IQR 6, range 0-19). In total, 79 (19.7%) patients had a drug-related ED visits, and identified risk factors were increasing age, increasing number of regular drugs and medical referral reason. Adverse effects (72.2%) and non-adherence (16.5%) were the most common causes of drug-related ED visits. Antithrombotic agents were most frequently involved in drug-related ED visits, while immunosuppressants had the highest relative frequency. Only 11.4% of the identified drug-related ED visits were documented by physicians during ED/hospital stay. In the investigated population, 19.7% had a drug-related ED visit, indicating that drug-related ED visits are a major concern. If not recognized and handled, this could be a threat against patient safety. Identified risk factors can be used to identify patients in need of additional attention regarding their drug list during the ED visit.
| S-EPMC9352618 | biostudies-literature