Last data update: Oct 07, 2024. (Total: 47845 publications since 2009)
Records 1-30 (of 60 Records) |
Query Trace: Budnitz DS[original query] |
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Changes in provider perceptions and practices regarding dosing units for oral liquid medications
Lind JN , Lovegrove MC , Paul IM , Shonna Yin H , Budnitz DS . Acad Pediatr 2023 OBJECTIVE: A 2015 survey of primary care providers (PCPs) found that while many believed that milliliter (mL)-only dosing was safest for oral liquid medications, few would use mL alone in dosing instructions. Since 2015, many recommendations have promoted "mL-only" dosing. In 2019, a follow-up survey was conducted to assess if PCP perceptions and practices have changed. METHODS: Pediatricians, family medicine physicians, nurse practitioners, and internists participating in the 2015 and 2019 DocStyles cross-sectional, web-based surveys were asked about their perceptions and practices regarding dosing units for oral liquid medications. RESULTS: In 2019, among 1392 respondents, the proportion of PCPs who reported they believed using mL-only is the safest dosing instruction ranged from 55.1% of internists to 80.8% of pediatricians. While fewer PCPs believed patients/caregivers prefer dosing instructions in mL-only (23.9% of nurse practitioners to 48.4% of pediatricians), more held this belief in 2019 compared to 2015; pediatricians had the greatest absolute increase (+14.4%) and family medicine physicians had the smallest increase (+1.3%). While 61.6% of pediatricians reported they would use mL-only dosing, only 36.0% of internists, 36.6% of nurse practitioners, and 42.5% of family medicine physicians reported they would do so. After controlling for age, gender, region, and specialty, 2019 PCP survey participants were more likely to report that they would use mL-only dosing compared to 2015 participants (adjusted odds ratio 1.51, 95% confidence interval 1.29-1.77). CONCLUSIONS: Broader educational efforts may be necessary to reach non-pediatricians, to encourage prescribing and communication with patients/caregivers using mL-only dosing. |
Surveillance of COVID-19 vaccination in US nursing homes, December 2020-April 2021 (preprint)
Geller AI , Budnitz DS , Dubendris H , Gharpure R , Soe M , Wu H , Kalayil EJ , Benin AL , Patel SA , Lindley MC , Link-Gelles R . medRxiv 2021 2021.05.14.21257224 Monitoring COVID-19 vaccination coverage among nursing home (NH) residents and staff is important to ensure high coverage and guide patient-safety policies. With the termination of the federal Pharmacy Partnership for Long-Term Care Program, another source of facility-based vaccination data is needed. We compared numbers of COVID-19 vaccinations administered to NH residents and staff reported by pharmacies participating in the temporary federal Pharmacy Partnership for Long-Term Care Program with those reported by NHs participating in new COVID-19 vaccination modules of CDC’s National Healthcare Safety Network (NHSN). Pearson correlation coefficients comparing the number vaccinated between the two approaches were 0.89, 0.96, and 0.97 for residents and 0.74, 0.90, and 0.90 for staff, in the weeks ending January 3, 10, and 17, respectively. Based on subsequent NHSN reporting, vaccination coverage with ≥1 vaccine dose reached 77% for residents and 50% for staff the week ending January 31 and plateaued through April 2021.Three-question summary boxWhat is the current understanding of the subject?Because of high risk of disease, nursing home residents and staff were prioritized for COVID-19 vaccination when doses were limited.What does this report add to the literature?National monitoring of nursing home residents and staff vaccination coverage through the CDC National Healthcare Safety Network (NHSN) correlated with vaccination administration reports from the federal Pharmacy Partnership for Long-Term Care Program in January 2021. NHSN-reported vaccination coverage rates plateaued from February through April 2021.What are the implications for public health practice?NHSN can track COVID-19 vaccination in nursing homes and help guide efforts to increase vaccine uptake in residents and staff.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThe authors received no financial support for the research, authorship, and/or publication of this article.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy (See e.g., 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. section 241(d); 5 U.S.C. section 552a; 44 U.S.C. section 3501 et seq.).All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData supporting the findings of the study are found in the manuscript and/or supplementary files. Any other data can be furnished upon request. |
Trends in emergency department visits for unsupervised pediatric medication exposures
Lovegrove MC , Weidle NJ , Geller AI , Lind JN , Rose KO , Goring SK , Budnitz DS . Am J Prev Med 2023 64 (6) 834-843 Introduction: Emergency department visits and hospitalizations for unsupervised medication exposures among young children increased in the early 2000s. Prevention efforts were initiated in response. Methods: Nationally representative data from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project collected from 2009 to 2020 were analyzed in 2022 to assess overall and medication-specific trends in emergency department visits for unsupervised exposures among children aged ≤5 years. Results: From 2009 to 2020, there were an estimated 677,968 (95% CI=550,089, 805,846) emergency department visits for unsupervised medication exposures among children aged ≤5 years in the U.S. Most visits involved children aged 1–2 years (2009–2012 [70.3%], 2017–2020 [67.4%]), and nearly one half involved prescription solid medications (2009–2012 [49.4%], 2017–2020 [48.1%]). The largest declines in estimated numbers of annual visits from 2009–2012 to 2017–2020 were for exposures involving prescription solid benzodiazepines (–2,636 visits, –72.0%) and opioids (–2,596 visits, –53.6%) and over-the-counter liquid cough and cold medications (–1,954 visits, –71.6%) and acetaminophen (–1,418 visits, –53.4%). The estimated number of annual visits increased for exposures involving over-the-counter solid herbal/alternative remedies (+1,028 visits, +65.6%), with the largest increase for melatonin exposures (+1,440 visits, +421.1%). Overall, the estimated number of visits for unsupervised medication exposures decreased from 66,416 in 2009 to 36,564 in 2020 (annual percentage change= –6.0%). Emergent hospitalizations for unsupervised exposures also declined (annual percentage change= –4.5%). Conclusions: Declines in estimated emergency department visits and hospitalizations for unsupervised medication exposures from 2009 to 2020 coincided with renewed prevention efforts. Targeted approaches may be needed to achieve continued declines in unsupervised medication exposures among young children. © 2023 |
Bleeding related to oral anticoagulants: Trends in US emergency department visits, 2016-2020
Geller AI , Shehab N , Lovegrove MC , Weidle NJ , Budnitz DS . Thromb Res 2023 225 110-115 BACKGROUND: Clinical trials suggest lower rates of major bleeding with direct-acting oral anticoagulants (DOACs) than with warfarin, but anticoagulant-related bleeding remains one of the most common outpatient adverse drug events. METHODS: We estimated the number of emergency department (ED) visits and subsequent hospitalizations for oral anticoagulant-related bleeding in 2016-2020 based on active surveillance in a nationally representative, size-stratified probability sample of 60 U.S. hospitals. We estimated rates of ED visits using a nationally-projected retail prescription dispensing database. RESULTS: Based on 19,557 cases, oral anticoagulant-related bleeding resulted in an estimated 1,270,259 (95 % Confidence Interval [CI], 644,686-1,895,832) ED visits for the five years 2016-2020, of which 47.8 % (95 % CI, 40.6 %-55.0 %) resulted in hospitalization. Oral anticoagulant-related bleeding resulted in an estimated 230,163 (95% CI, 109,598-350,728) ED visits in 2016 and 301,433 (95% CI, 138,363-464,503) in 2020. During 2016-2020, ED visits for DOAC-related bleeding increased by an average of 27.9 % (95 % CI, 24.0 %-32.0 %; p < .001) per year, while ED visits for warfarin-related bleeding decreased by an average of 8.8 % (95 % CI, -10.7 % to -7.0 %; p = .001) per year. The estimated rate of bleeding visits per 100 patients dispensed oral anticoagulants at least once in 2016-2020 was highest for patients aged ≥ 80 years (13.1; 95 % CI, 6.2-20.0) and lowest for those aged <45 years (4.0; 95 % CI, 2.6-5.5); it was 5.9 visits per 100 patients dispensed DOACs [95 % CI, 2.5-9.2] and 13.0 visits per 100 patients dispensed warfarin [95 % CI, 7.4-18.7]. CONCLUSIONS: Although the rates of ED visits for anticoagulant-related bleeding may be lower for DOACs than for warfarin, persistently large numbers of patients requiring ED visits for anticoagulant-related bleeding despite increased use of DOACs and declining use of warfarin suggest that efforts to improve appropriate prescribing and monitoring of anticoagulants remain important. |
National estimates of emergency department visits for medication-related self-harm: United States, 2016-2019
Geller AI , Ehlman DC , Lovegrove MC , Budnitz DS . Inj Prev 2022 28 (6) 545-552 BACKGROUND: Medication 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. METHODS: Cross-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. RESULTS: Based 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. CONCLUSIONS: Medication-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. |
Surveillance of COVID-19 Vaccination in Nursing Homes, United States, December 2020-July 2021.
Geller AI , Budnitz DS , Dubendris H , Gharpure R , Soe M , Wu H , Kalayil EJ , Benin AL , Patel SA , Lindley MC , Link-Gelles R . Public Health Rep 2022 137 (2) 333549211066168 Monitoring COVID-19 vaccination coverage among nursing home residents and staff is important to ensure high coverage rates and guide patient-safety policies. With the termination of the federal Pharmacy Partnership for Long-Term Care Program, another source of facility-based vaccination data is needed. We compared numbers of COVID-19 vaccinations administered to nursing home residents and staff reported by pharmacies participating in the temporary federal Pharmacy Partnership for Long-Term Care Program with the numbers of COVID-19 vaccinations reported by nursing homes participating in new COVID-19 vaccination modules of the Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN). Pearson correlation coefficients comparing the number vaccinated between the 2 approaches were 0.89, 0.96, and 0.97 for residents and 0.74, 0.90, and 0.90 for staff, in the weeks ending January 3, 10, and 17, 2021, respectively. Based on subsequent NHSN reporting, vaccination coverage with ≥1 vaccine dose reached 73.7% for residents and 47.6% for staff the week ending January 31 and increased incrementally through July 2021. Continued monitoring of COVID-19 vaccination coverage is important as new nursing home residents are admitted, new staff are hired, and additional doses of vaccine are recommended. |
Assessment of International Classification of Diseases, Tenth Revision, Clinical Modification (icd-10-cm) code assignment validity for case finding of medication-related hypoglycemia acute care visits among medicare beneficiaries
Yang TH , Ziemba R , Shehab N , Geller AI , Talreja K , Campbell KN , Budnitz DS . Med Care 2022 60 (3) 219-226 OBJECTIVE: Administrative claims are commonly relied upon to identify hypoglycemia. We assessed validity of 14 International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code assignments to identify medication-related hypoglycemia leading to acute care encounters. RESEARCH DESIGN AND METHODS: A multisite, retrospective medical record review study was conducted in a sample of Medicare beneficiaries prescribed outpatient diabetes medications and who received hospital care between January 1, 2016 and September 30, 2017. Diagnosis codes were validated with structured medical record review using prespecified criteria (clinical presentation, blood glucose values, and treatments for hypoglycemia). Sensitivity, specificity, and positive and negative predictive value (PPV, NPV) were calculated and adjusted using sampling weights to correct for partial verification bias. RESULTS: Among 990 encounters (496 cases, 494 controls), hypoglycemia codes demonstrated moderate PPV (69.2%; 95% confidence interval: 65.0-73.0) and moderate sensitivity (83.9%; 95% confidence interval: 70.0-95.5). Codes performed better at identifying hypoglycemic events among emergency department/observation encounters compared with hospitalizations (PPV 92.9%, sensitivity 100.0% vs. PPV 53.7%, sensitivity 71.0%). Accuracy varied by diagnosis position, especially for hospitalizations, with PPV of 95.6% versus 46.5% with hypoglycemia in primary versus secondary positions. Use of adverse event/poisoning codes did not improve accuracy; reliance on these codes alone would have missed 97% of true hypoglycemic events. CONCLUSIONS: Accuracy of International Classification of Diseases, Tenth Revision codes in administrative claims to identify medication-related hypoglycemia varied substantially by encounter type and diagnosis position. Consideration should be given to the trade-off between PPV and sensitivity when selecting codes, encounter types, and diagnosis positions to identify hypoglycemia. |
US Emergency Department Visits for Acute Harms from Over-the-Counter Cough and Cold Medications, 2017-2019
Mital R , Lovegrove MC , Moro RN , Geller AI , Weidle NJ , Lind JN , Budnitz DS . Pharmacoepidemiol Drug Saf 2021 31 (2) 225-234 BACKGROUND AND PURPOSE: Characterization of emergency department (ED) visits for acute harms related to use of over-the-counter cough and cold medications (CCMs) by patient demographics, intent of CCM use, concurrent substance use, and clinical manifestations can help guide prevention of medication harms. METHODS: Public health surveillance data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project were used to estimate numbers and population rates of ED visits from 2017-2019. RESULTS: Based on 1,396 surveillance cases, there were an estimated 26,735 (95% CI, 21,679-31,791) US ED visits for CCM-related harms annually, accounting for 1.3% (95% CI, 1.2%-1.5%) of all ED visits for medication adverse events. Three fifths (61.4%, 95% CI, 55.6%-67.2%) of these visits were attributed to non-therapeutic CCM use (nonmedical use, self-harm, unsupervised pediatric exposures). Most visits by children aged <4 years (74.0%, 95% CI, 59.7%-88.3%) were for unsupervised CCM exposures. Proportion hospitalized was higher for visits for self-harm (76.5%, 95% CI, 68.9%-84.2%) than for visits for nonmedical use (30.3%, 95% CI, 21.1%-39.6%) and therapeutic use (8.8%, 95% CI, 5.9%-11.8%). Overall, estimated population rates of ED visits for CCM-related harms were higher for patients aged 12-34 years (16.5 per 100,000, 95% CI, 13.0-20.0) compared with patients aged <12 years (5.1 per 100,000, 95% CI, 3.6-6.5) and ≥35 years (4.3 per 100,000, 95% CI, 3.4-5.1). Concurrent use of other medications, illicit drugs, or alcohol was frequent in ED visits for nonmedical use (61.3%) and self-harm (75.9%). CONCLUSIONS: Continued national surveillance of CCM-related harms can assess progress toward safer use. |
US emergency department visits attributed to medication harms, 2017-2019
Budnitz DS , Shehab N , Lovegrove MC , Geller AI , Lind JN , Pollock DA . JAMA 2021 326 (13) 1299-1309 IMPORTANCE: Assessing the scope of acute medication harms to patients should include both therapeutic and nontherapeutic medication use. OBJECTIVE: To describe the characteristics of emergency department (ED) visits for acute harms from both therapeutic and nontherapeutic medication use in the US. DESIGN, SETTING, AND PARTICIPANTS: Active, nationally representative, public health surveillance based on patient visits to 60 EDs in the US participating in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project from 2017 through 2019. EXPOSURES: Medications implicated in ED visits, with visits attributed to medication harms (adverse events) based on the clinicians' diagnoses and supporting data documented in the medical record. MAIN OUTCOMES AND MEASURES: Nationally weighted estimates of ED visits and subsequent hospitalizations for medication harms. RESULTS: Based on 96 925 cases (mean patient age, 49 years; 55% female), there were an estimated 6.1 (95% CI, 4.8-7.5) ED visits for medication harms per 1000 population annually and 38.6% (95% CI, 35.2%-41.9%) resulted in hospitalization. Population rates of ED visits for medication harms were higher for patients aged 65 years or older than for those younger than 65 years (12.1 vs 5.0 [95% CI, 7.4-16.8 vs 4.1-5.8] per 1000 population). Overall, an estimated 69.1% (95% CI, 63.6%-74.7%) of ED visits for medication harms involved therapeutic medication use, but among patients younger than 45 years, an estimated 52.5% (95% CI, 48.1%-56.8%) of visits for medication harms involved nontherapeutic use. The proportions of ED visits for medication harms involving therapeutic use were lowest for barbiturates (6.3%), benzodiazepines (11.1%), nonopioid analgesics (15.7%), and antihistamines (21.8%). By age group, the most frequent medication types and intents of use associated with ED visits for medication harms were therapeutic use of anticoagulants (4.5 [95% CI, 2.3-6.7] per 1000 population) and diabetes agents (1.8 [95% CI, 1.3-2.3] per 1000 population) for patients aged 65 years and older; therapeutic use of diabetes agents (0.8 [95% CI, 0.5-1.0] per 1000 population) for patients aged 45 to 64 years; nontherapeutic use of benzodiazepines (1.0 [95% CI, 0.7-1.3] per 1000 population) for patients aged 25 to 44 years; and unsupervised medication exposures (2.2 [95% CI, 1.8-2.7] per 1000 population) and therapeutic use of antibiotics (1.4 [95% CI, 1.0-1.8] per 1000 population) for children younger than 5 years. CONCLUSIONS AND RELEVANCE: According to data from 60 nationally representative US emergency departments, visits attributed to medication harms in 2017-2019 were frequent, with variation in products and intent of use by age. |
Disparities in COVID-19 Vaccination Coverage Among Health Care Personnel Working in Long-Term Care Facilities, by Job Category, National Healthcare Safety Network - United States, March 2021.
Lee JT , Althomsons SP , Wu H , Budnitz DS , Kalayil EJ , Lindley MC , Pingali C , Bridges CB , Geller AI , Fiebelkorn AP , Graitcer SB , Singleton JA , Patel SA . MMWR Morb Mortal Wkly Rep 2021 70 (30) 1036-1039 Residents of long-term care facilities (LTCFs) and health care personnel (HCP) working in these facilities are at high risk for COVID-19-associated mortality. As of March 2021, deaths among LTCF residents and HCP have accounted for almost one third (approximately 182,000) of COVID-19-associated deaths in the United States (1). Accordingly, LTCF residents and HCP were prioritized for early receipt of COVID-19 vaccination and were targeted for on-site vaccination through the federal Pharmacy Partnership for Long-Term Care Program (2). In December 2020, CDC's National Healthcare Safety Network (NHSN) launched COVID-19 vaccination modules, which allow U.S. LTCFs to voluntarily submit weekly facility-level COVID-19 vaccination data.* CDC analyzed data submitted during March 1-April 4, 2021, to describe COVID-19 vaccination coverage among a convenience sample of HCP working in LTCFs, by job category, and compare HCP vaccination coverage rates with social vulnerability metrics of the surrounding community using zip code tabulation area (zip code area) estimates. Through April 4, 2021, a total of 300 LTCFs nationwide, representing approximately 1.8% of LTCFs enrolled in NHSN, reported that 22,825 (56.8%) of 40,212 HCP completed COVID-19 vaccination.(†) Vaccination coverage was highest among physicians and advanced practice providers (75.1%) and lowest among nurses (56.7%) and aides (45.6%). Among aides (including certified nursing assistants, nurse aides, medication aides, and medication assistants), coverage was lower in facilities located in zip code areas with higher social vulnerability (social and structural factors associated with adverse health outcomes), corresponding to vaccination disparities present in the wider community (3). Additional efforts are needed to improve LTCF immunization policies and practices, build confidence in COVID-19 vaccines, and promote COVID-19 vaccination. CDC and partners have prepared education and training resources to help educate HCP and promote COVID-19 vaccination coverage among LTCF staff members.(§). |
Increase in Outpatient Ivermectin Dispensing in the US During the COVID-19 Pandemic: A Cross-Sectional Analysis.
Lind JN , Lovegrove MC , Geller AI , Uyeki TM , Datta SD , Budnitz DS . J Gen Intern Med 2021 36 (9) 1-3 Ivermectin is an antiparasitic medication approved by the US Food and Drug Administration (FDA) for use in humans. Ivermectin oral tablets are used worldwide for treatment of certain parasitic infections. An in vitro study has shown that ivermectin inhibits the replication of SARS-CoV-2 in tissue cell cultures.1 Some observational studies and clinical trials have evaluated ivermectin for the treatment and prevention of COVID-19 in humans; however, most had incomplete information and methodological limitations.2 Human data from well-designed and well-conducted clinical trials with robust sample sizes are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment or prevention of COVID-19. |
Trends in Prescribing of Antibiotics and Drugs Investigated for COVID-19 Treatment in U.S. Nursing Home Residents During the COVID-19 Pandemic.
Gouin KA , Creasy S , Beckerson M , Wdowicki M , Hicks LA , Lind JN , Geller AI , Budnitz DS , Kabbani S . Clin Infect Dis 2021 74 (1) 74-82 BACKGROUND: Trends in prescribing for nursing home (NH) residents, which may have been influenced by the COVID-19 pandemic, have not been characterized. METHODS: Long-term care pharmacy data from 1,944 U.S. NHs were used to evaluate trends in prescribing of antibiotics and drugs that were investigated for COVID-19 treatment, including hydroxychloroquine, famotidine, and dexamethasone. To account for seasonal variability in antibiotic prescribing and decreased NH occupancy during the pandemic, monthly prevalence of residents with a prescription dispensed per 1,000 residents serviced was calculated from January - October and compared as relative percent change from 2019 to 2020. RESULTS: In April 2020, prescribing was significantly higher in NHs for drugs investigated for COVID-19 treatment than 2019; including hydroxychloroquine (+563%, 95% confidence interval (CI) 5.87, 7.48) and azithromycin (+150%, 95% CI 2.37, 2.63). Ceftriaxone prescribing also increased (+43%, 95% CI 1.34, 1.54). Prescribing of dexamethasone was 36% lower in April (95% CI 0.55, 0.73) and 303% higher in July (95% CI 3.66, 4.45). Although azithromycin and ceftriaxone prescribing increased, total antibiotic prescribing among residents was lower from May (-5%, 95% CI 0.94, 0.97) through October (-4%, 95% CI 0.94, 0.97) in 2020 compared to 2019. CONCLUSIONS: During the pandemic, large numbers of residents were prescribed drugs investigated for COVID-19 treatment, and an increase in prescribing of antibiotics commonly used for respiratory infections was observed. Prescribing of these drugs may increase the risk of adverse events, without providing clear benefits. Surveillance of NH prescribing practices is critical to evaluate concordance with guideline-recommended therapy and improve resident safety. |
Outpatient insulin-related adverse events due to mix-up errors: Findings from two national surveillance systems, United States, 2012-2017
Geller AI , Conrad AO , Weidle NJ , Mehta H , Budnitz DS , Shehab N . Pharmacoepidemiol Drug Saf 2021 30 (5) 573-581 PURPOSE: We used data from two public health surveillance systems for national estimates and detailed descriptions of insulin mix-up errors resulting in emergency department (ED) visits and other serious adverse events to help inform prevention efforts. METHODS: ED visits involving patients seeking care for insulin medication errors collected by the NEISS-CADES project in 2012-2017 and voluntary reports of serious insulin medication errors submitted to the U.S. Food and Drug Administration (FDA) in 2016-2017 were analyzed. National estimates of insulin product prescriptions dispensed from retail pharmacies were obtained from IQVIA National Prescription Audit. RESULTS: Between 2012 and 2017, based on 514 NEISS-CADES cases, there were an estimated 5,636 (95% CI, 4,143-7,128) ED visits annually for insulin mix-up errors; overall, over three-quarters (77.5%; 95% CI, 71.6%-83.3%) involved taking rapid-acting instead of long-acting insulin. Between 2012 and 2017, the proportion of mix-up errors among all estimated ED visits for all insulin errors decreased by 60%; concurrently, the proportion of pens among all insulin package types dispensed increased by 50%. Among 58 voluntary reports submitted to FAERS, over one-half (56.9%) of cases involved taking rapid- instead of long-acting insulin. Among 27 cases with documented contributing factors, approximatley one-half involved patients having difficulty differentiating products. CONCLUSIONS: Among all ED visits for insulin errors collected by NEISS-CADES in 2012-2017, the proportion involving mix-up errors has declined. Continued reductions may require additional prevention strategies, including improving insulin distinctiveness, particularly for rapid- vs. long-acting insulins. Ongoing national surveillance is important for identifying the impact of interventions. This article is protected by copyright. All rights reserved. |
Assessment of Outpatient Dispensing of Products Proposed for Treatment or Prevention of COVID-19 by US Retail Pharmacies During the Pandemic.
Geller AI , Lovegrove MC , Lind JN , Datta SD , Budnitz DS . JAMA Intern Med 2021 181 (6) 869-872 This cross-sectional study examines changes in the outpatient retail dispensing frequency of proposed treatments for coronavirus disease 2019 after the March 13, 2020, declaration of a national emergency due to the pandemic. |
Trends in U.S. outpatient antibiotic prescriptions during the COVID-19 pandemic.
King LM , Lovegrove MC , Shehab N , Tsay S , Budnitz DS , Geller AI , Lind JN , Roberts R , Hicks LA , Kabbani S . Clin Infect Dis 2020 73 (3) e652-e660 BACKGROUND: The objective of our study was to describe trends in U.S. outpatient antibiotic prescriptions from January through May 2020 and compare with trends in previous years (2017-2019). METHODS: We used data from the IQVIA Total Patient Tracker to estimate the monthly number of patients dispensed antibiotic prescriptions from retail pharmacies in January 2017-May 2020. We averaged estimates from 2017-2019 and defined expected seasonal change as the average percent change from January to May 2017-2019. We calculated percentage point and volume changes in the number of patients dispensed antibiotics from January to May 2020 exceeding expected seasonal changes. We also calculated average percent change in number of patients dispensed antibiotics per month in 2017- 2019 versus 2020. Data were analyzed overall and by agent, class, patient age, state, and prescriber specialty. RESULTS: From January to May 2020, the number of patients dispensed antibiotic prescriptions decreased from 20.3 to 9.9 million, exceeding seasonally expected decreases by 33 percentage points and 6.6 million patients. The largest changes in 2017-2019 versus 2020 were observed in April (-39%) and May (-42%). The number of patients dispensed azithromycin increased from February to March 2020 then decreased. Overall, beyond-expected decreases were greatest among children (≤19 years) and agents used for respiratory infections, dentistry, and surgical prophylaxis. CONCLUSIONS: From January 2020 to May 2020, the number of outpatients with antibiotic prescriptions decreased substantially more than would be expected due to seasonal trends alone, possibly related to the COVID-19 pandemic and associated mitigation measures. |
Reply
Lovegrove MC , Agarwal M , Geller RJ , Budnitz DS . J Pediatr 2020 222 264 We thank Dr. Bryant et al. for sharing recent local poison center data on hospitalizations for unsupervised pediatric exposures,1 which provide further support for targeting pediatric poisoning prevention messages to grandparents2 and emphasizing the risk of pediatric medication ingestions when using pill organizers in the presence of young children.3 | | Focusing on exposures requiring hospitalization (i.e., those potentially most serious), Bryant and colleagues found that when grandparents were involved, a higher percentage of cases involved medications accessed from pill organizers or involved antihypertensive medications, compared with exposures without grandparent involvement. The proportion of cases involving ICU admission was also higher for pediatric exposures with grandparent involvement, although it is unclear if the reported differences were statistically significant. | | The findings reported by Bryant et al. are important and suggest the need for additional studies to further investigate how medication use and storage practices of grandparents contribute to pediatric exposures with severe outcomes. Additional information on why medications are removed from original packaging, why medications are transferred to other containers, and how those containers are stored could help identify innovative interventions that promote both improved medication adherence among adults and improved child safety. | | Grandparents’ medications and pill organizers are only part of the problem of unsupervised pediatric exposures. Bryant et al. provide additional evidence that it may be necessary to raise awareness among grandparents that most pill organizers are not child resistant and can be easily opened by young children, but parents and other caregivers should be reminded as well. Targeted messaging could encourage caregivers of young children to keep medicines in child-resistant containers, fully secure child-resistant closures, and keep all medications (including those in purses, pockets, bags, or pill organizers) up and away and out of the sight and reach of young children.4 |
COVID-19 Investigational Treatments in Use Among Hospitalized Patients Identified Through the US Coronavirus Disease 2019-Associated Hospitalization Surveillance Network, March 1-June 30, 2020.
Acosta AM , Mathis AL , Budnitz DS , Geller AI , Chai SJ , Alden NB , Meek J , Anderson EJ , Ryan P , Kim S , Como-Sabetti K , Torres S , Dufort E , Bennett NM , Billing LM , Sutton M , Keipp Talbot H , George A , Pham H , Hall AJ , Fry A , Garg S , Kim L . Open Forum Infect Dis 2020 7 (11) ofaa528 Using a coronavirus disease 2019 (COVID-19)-associated hospitalization surveillance network, we found that 42.5% of hospitalized COVID-19 cases with available data from March 1-June 30, 2020, received ≥1 COVID-19 investigational treatment. Hydroxychloroquine, azithromycin, and remdesivir were used frequently; however, hydroxychloroquine and azithromycin use declined over time, while use of remdesivir increased. |
Hydroxychloroquine and Chloroquine Prescribing Patterns by Provider Specialty Following Initial Reports of Potential Benefit for COVID-19 Treatment - United States, January-June 2020.
Bull-Otterson L , Gray EB , Budnitz DS , Strosnider HM , Schieber LZ , Courtney J , García MC , Brooks JT , Mac Kenzie WR , Gundlapalli AV . MMWR Morb Mortal Wkly Rep 2020 69 (35) 1210-1215 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. |
Electronic measurement of a clinical quality measure for inpatient hypoglycemic events: A multicenter validation study
Santos CAQ , Conover C , Shehab N , Geller AI , Guerra YS , Kramer H , Kosacz NM , Zhang H , Budnitz DS , Trick WE . Med Care 2020 58 (10) 927-933 BACKGROUND: Hypoglycemia related to antidiabetic drugs (ADDs) is important iatrogenic harm in hospitalized patients. Electronic identification of ADD-related hypoglycemia may be an efficient, reliable method to inform quality improvement. OBJECTIVE: Develop electronic queries of electronic health records for facility-wide and unit-specific inpatient hypoglycemia event rates and validate query findings with manual chart review. METHODS: Electronic queries were created to associate blood glucose (BG) values with ADD administration and inpatient location in 3 tertiary care hospitals with Patient-Centered Outcomes Research Network (PCORnet) databases. Queries were based on National Quality Forum criteria with hypoglycemia thresholds <40 and <54 mg/dL, and validated using a stratified random sample of 321 BG events. Sensitivity and specificity were calculated with manual chart review as the reference standard. RESULTS: The sensitivity and specificity of queries for hypoglycemia events were 97.3% [95% confidence interval (CI), 90.5%-99.7%] and 100.0% (95% CI, 92.6%-100.0%), respectively for BG <40 mg/dL, and 97.7% (95% CI, 93.3%-99.5%) and 100.0% (95% CI, 95.3%-100.0%), respectively for <54 mg/dL. The sensitivity and specificity of the query for identifying ADD days were 91.8% (95% CI, 89.2%-94.0%) and 99.0% (95% CI, 97.5%-99.7%). Of 48 events missed by the queries, 37 (77.1%) were due to incomplete identification of insulin administered by infusion. Facility-wide hypoglycemia rates were 0.4%-0.8% (BG <40 mg/dL) and 1.9%-3.0% (BG <54 mg/dL); rates varied by patient care unit. CONCLUSIONS: Electronic queries can accurately identify inpatient hypoglycemia. Implementation in non-PCORnet-participating facilities should be assessed, with particular attention to patient location and insulin infusions. |
Notes from the field: Emergency visits for complications of injecting transmucosal buprenorphine products - United States, 2016-2018
Tanwar S , Geller AI , Lovegrove MC , Budnitz DS . MMWR Morb Mortal Wkly Rep 2020 69 (32) 1102-1103 The opioid partial agonist buprenorphine is a critical component of medication-assisted treatment for opioid use disorder and is associated with improved treatment adherence and decreased illicit opioid use (1). Combination buprenorphine/naloxone transmucosal products are designed to deter injection owing to the opioid-antagonist actions of naloxone and can reduce the desired effects and precipitate rapid withdrawal when these products are administered intravenously; nonetheless, injection of transmucosal buprenorphine/naloxone has been reported (2,3). During 2016–2017, 14.6% of approximately 127,000 emergency department (ED) visits for nonmedical use* of prescription opioids involved buprenorphine products, commonly for injection-related complications (4). ED visits for nonmedical use of buprenorphine involved less severe overdose morbidity (e.g., unresponsiveness or cardiorespiratory failure) than did those involving other opioids (4). Complications of injecting transmucosal buprenorphine products represent a potentially preventable source of morbidity from nonmedical use of buprenorphine. Further description of complications related to buprenorphine injection can help prevent these complications while preserving access to this effective therapy for opioid use disorder. |
Prevention of unintentional medication overdose among children: Time for the promise of the poison prevention packaging act to come to fruition
Budnitz DS , Lovegrove MC , Geller RJ . JAMA 2020 324 (6) 550-551 As the US struggled to address the rapid increase in prescription drug overdoses among adults in the 2000s, the number of medication overdoses among young children also increased from an estimated 57 000 emergency department (ED) visits among children younger than 6 years in 2004 to an estimated 81 000 in 2010.1 In contrast to adult overdoses, however, medication overdoses among young children have significantly declined since 2010, to an estimated 46 000 ED visits in 2018 (CDC unpublished data, February 2020). The vast majority of these overdoses (95%) involved unintentional exposures by children, and 5% involved errors from adults administering medications to children. While prescription status and owner of the medication were not always specified, the estimated proportions of these overdoses specifically related to prescription medications and over-the-counter (OTC) medications were 41% and 28%, respectively, for medications intended for use by adults and 6% and 11%, respectively, for medications intended for use by children (CDC unpublished data, February 2020). |
US Hydroxychloroquine, Chloroquine, and Azithromycin Outpatient Prescription Trends, October 2019 Through March 2020.
Shehab N , Lovegrove M , Budnitz DS . JAMA Intern Med 2020 180 (10) 1384-1386 This study examines how the prescription of hydroxychloroquine and chloroquine to outpatients has changed in the United States during the coronavirus disease 2019 pandemic. |
Emergency department visits attributed to adverse events involving benzodiazepines, 2016-2017
Moro RN , Geller AI , Weidle NJ , Lind JN , Lovegrove MC , Rose KO , Goring SK , McAninch JK , Dowell D , Budnitz DS . Am J Prev Med 2020 58 (4) 526-535 INTRODUCTION: Characterization of emergency department visits attributed to adverse events involving benzodiazepines can be used to guide preventive interventions. This study describes U.S. emergency department visits attributed to adverse events involving benzodiazepines by intent, patient characteristics, and clinical manifestations. METHODS: Data from the 2016-2017 National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project were analyzed in 2019 to calculate estimated annual numbers and rates of emergency department visits attributed to adverse events involving benzodiazepines, by intent of benzodiazepine use. RESULTS: Based on 6,148 cases, there were an estimated 212,770 (95% CI=167,163, 258,377) emergency department visits annually attributed to adverse events involving benzodiazepines. More than half were visits involving nonmedical use of benzodiazepines (119,008; 55.9%, 95% CI=50.0%, 61.9%), one third were visits involving self-harm with benzodiazepines (64,721; 30.4%, 95% CI=25.6%, 35.2%), and a smaller proportion of visits involved therapeutic use of benzodiazepines (29,041; 13.6%, 95% CI=11.4%, 15.9%). The estimated population rate of visits was highest for nonmedical use of benzodiazepines by patients aged 15-34 years (7.4 visits per 10,000 people). Among visits involving nonmedical use of benzodiazepines, 54.8% (95% CI=49.8%, 59.8%) were made by patients aged 15-34 years, 82.7% (95% CI=80.1%, 85.4%) involved concurrent use of other substances (illicit drugs, alcohol, prescription opioids, and/or other pharmaceuticals), and 24.2% (95% CI=17.7%, 30.6%) involved cardiorespiratory arrest or unresponsiveness. CONCLUSIONS: These findings support recommendations to assess for and address substance use disorder before initiating or continuing benzodiazepines and reinforce the need for validated self-harm risk assessment tools for clinicians. |
Circumstances involved in unsupervised solid dose medication exposures among young children
Agarwal M , Lovegrove MC , Geller RJ , Pomerleau AC , Sapiano MRP , Weidle NJ , Morgan BW , Budnitz DS . J Pediatr 2020 219 188-195 e6 OBJECTIVE: To identify types of containers from which young children accessed solid dose medications (SDMs) during unsupervised medication exposures and the intended recipients of the medications to advance prevention. STUDY DESIGN: From February to September 2017, 5 US poison centers enrolled individuals calling about unsupervised solid dose medication exposures by children </=5 years. Study participants answered contextually directed questions about exposure circumstances. RESULTS: Sixty-two percent of eligible callers participated. Among 4496 participants, 71.6% of SDM exposures involved children aged </=2 years; 33.8% involved only prescription medications, 32.8% involved only over-the-counter (OTC) products that require child-resistant packaging, and 29.9% involved >/=1 OTC product that does not require child-resistant packaging. More than one-half of exposures (51.5%) involving prescription medications involved children accessing medications that had previously been removed from original packaging, compared with 20.8% of exposures involving OTC products (aOR, 3.39; 95% CI, 2.87-4.00). Attention deficit hyperactivity disorder medications (49.3%) and opioids (42.6%) were often not in any container when accessed; anticonvulsants (41.1%), hypoglycemic agents (33.8%), and cardiovascular/antithrombotic agents (30.8%) were often transferred to alternate containers. Grandparents' medications were involved in 30.7% of prescription medication exposures, but only 7.8% of OTC product exposures (aOR, 3.99; 95% CI, 3.26-4.87). CONCLUSIONS: Efforts to reduce pediatric SDM exposures should also address exposures in which adults, rather than children, remove medications from child-resistant packaging. Packaging/storage innovations designed to encourage adults to keep products within child-resistant packaging and specific educational messages could be targeted based on common exposure circumstances, medication classes, and medication intended recipients. |
Changes in emergency department visits for zolpidem-attributed adverse drug reactions after FDA Drug Safety Communications
Geller AI , Zhou EH , Budnitz DS , Lovegrove MC , Dal Pan GJ . Pharmacoepidemiol Drug Saf 2020 29 (3) 352-356 Purpose: To identify possible changes in the 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. Method(s): 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 the joinpoint regression. For comparison, we repeated these analyses for sedating antidepressants commonly used to treat disordered sleep (trazodone, doxepin, and mirtazapine). Result(s): 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. Conclusion(s): 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. Copyright Published 2020. This article is a U.S. Government work and is in the public domain in the USA. |
The role of unit-dose child-resistant packaging in unintentional childhood exposures to buprenorphine-naloxone tablets
Hampp C , Lovegrove MC , Budnitz DS , Mathew J , Ho A , McAninch J . Drug Saf 2019 43 (2) 189-191 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]. Buprenorphine–naloxone products are available as sublingual tablets and, since August 2010, as sublingual film dispensed in child-resistant unit-dose packaging (UDP). Buprenorphine–naloxone tablets are dispensed in multidose bottles and, since July 2013, also in UDP. Several studies have detected decreasing rates of childhood exposures for buprenorphine–naloxone products since the introduction of the film [2, 4], and lower rates associated with the film compared to the tablet [3]. However, only one study distinguished between the effects of the dosage form and UDP. Wang et al. [4] detected a statistically significant decline in poison control calls for childhood exposures to buprenorphine–naloxone tablets with increasing UDP use; however, the extent of decline far exceeded the UDP dispensing rate. To further investigate the effects of UDP, we compared ED visit rates for pediatric ingestion of buprenorphine–naloxone tablets prior to the introduction of UDP (2008–2011) with rates after the introduction of UDP (2015–2017), excluding a transition period. |
Emergency visits for oral anticoagulant bleeding
Geller AI , Shehab N , Lovegrove MC , Rose KO , Weidle NJ , Goring SK , Budnitz DS . J Gen Intern Med 2019 35 (1) 371-373 Warfarin was the mainstay of outpatient antithrombotic management for decades, but in 2010, direct-acting oral anticoagulants (DOACs) were introduced with fixed dosing and without requirements for laboratory monitoring.1 Clinical trials suggested lower rates of major bleeding with DOACs than with warfarin.2, 3 The number of patients prescribed DOACs has been increasing, yet the number treated for emergent DOAC-related bleeding in the USA is unknown.4 |
Swallowing problems and dietary supplements: Data From U.S. Food and Drug Administration Adverse Event Reports, 2006-2015
Punzalan C , Budnitz DS , Chirtel SJ , Geller AI , Jones OE , Mozersky RP , Wolpert B . Ann Intern Med 2019 171 (10) 771-773 To facilitate ease of swallowing and promote patient adherence, the U.S. Food and Drug Administration (FDA) has provided voluntary guidance for the size of generic drug tablets and capsules (1). This guidance recommends that generic products should not exceed 17 millimeters (mm) in a single dimension. If a branded product already exceeds 17 mm, then the generic product should be no larger. No tablets or capsules should exceed 22 mm. Currently, no similar guidance for dietary supplements exists; however, supplements are implicated in swallowing problems, particularly among adults aged 65 years or older (2). |
Diabetes-related emergency medical service activations in 23 states, United States 2015
Benoit SR , Kahn HS , Geller AI , Budnitz DS , Mann NC , Dai M , Gregg EW , Geiss LS . Prehosp Emerg Care 2018 22 (6) 705-712 OBJECTIVE: The use of emergency medical services (EMS) for diabetes-related events is believed to be substantial but has not been quantified nationally despite the diverse acute complications associated with diabetes. We describe diabetes-related EMS activations in 2015 among people of all ages from 23 U.S. states. METHODS: We used data from 23 states that reported >/=95% of their EMS activations to the U.S. National Emergency Medical Services Information System (NEMSIS) in 2015. A diabetes-related EMS activation was defined using coded EMS provider impressions of "diabetes symptoms" and coded complaints recorded by dispatch of "diabetic problem." We described activations by type of location, urbanicity, U.S. Census Division, season, and time of day; and patient-events by age category, race/ethnicity, disposition, and treatment with glucose. Crude and age-adjusted diabetes-related EMS patient-level event rates were calculated for adults >/=18 years of age with diagnosed diabetes using the Behavioral Risk Factor Surveillance System to estimate the population denominator. RESULTS: Of 10,324,031 relevant EMS records, 241,495 (2.3%) were diabetes-related activations, which involved over 235,000 hours of service. Most activations occurred in urban or suburban environ- ments (86.4%), in the home setting (73.5%), and were slightly more frequent in the summer months. Most patients (72.6%) were >/=45 years of age and over one-half (55.4%) were transported to the emergency department. The overall age-adjusted diabetes-related EMS event rate was 33.9 per 1,000 persons with diagnosed diabetes; rates were highest in patients 18-44 years of age, males, and non-Hispanic blacks and varied by U.S. Census Division. CONCLUSIONS: Diabetes results in a substantial burden on EMS resources. Collection of more detailed diabetes complication information in NEMSIS may help facilitate EMS resource planning and prevention strategies. |
Assessment of ICD-10-CM code assignment validity for case finding of outpatient anticoagulant-related bleeding among Medicare beneficiaries
Shehab N , Ziemba R , Campbell KN , Geller AI , Moro RN , Gage BF , Budnitz DS , Yang TH . Pharmacoepidemiol Drug Saf 2019 28 (7) 951-964 PURPOSE: To assess performance of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code assignments for identifying bleeding events resulting in emergency department visits and hospitalizations among outpatient Medicare beneficiaries prescribed anticoagulants. METHODS: Performance of 206 ICD-10-CM code assignments indicative of bleeding, five anticoagulant adverse effect/poisoning codes, and five coagulopathy codes (according to Medicare Parts A and B claims) as assessed among Medicare fee-for-service beneficiaries prescribed anticoagulants between October 1, 2015 and September 30, 2016 (according to Part D claims). Structured medical record review was the gold standard for validating the presence of anticoagulant-related bleeding. Sensitivity was adjusted to correct for partial verification bias due to sampling design. RESULTS: Based on the study sample of 1166 records (583 cases, 583 controls), 57 of 206 codes yielded the optimal performance for anticoagulant-related bleeding (diagnostic odds ratio, 51; positive predictive value (PPV), 75.7% [95% CI, 72.0%-79.1%]; adjusted sensitivity, 70.0% [95% CI, 63.2%-77.7%]). Codes for intracranial bleeding demonstrated the highest PPV (85.0%) and adjusted sensitivity (91.0%). Bleeding codes in the primary position demonstrated high PPV (86.9%), but low adjusted sensitivity (36.0%). The adjusted sensitivity improved to 69.5% when codes in a secondary position were added. Only one adverse effect/poisoning code was used, appearing in 7.8% of cases and controls (PPV, 71.4% and adjusted sensitivity, 6.8%). CONCLUSIONS: Performance of ICD-10-CM code assignments for bleeding among patients prescribed anticoagulants varied by bleed type and code position. Adverse effect/poisoning codes were not commonly used and would have missed over 90% of anticoagulant-related bleeding cases. |
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