50 results on '"Nadine Shehab"'
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2. Building the Evidence Base for Automating Public Health Surveillance through a Nationwide Medication Safety Surveillance Use Case.
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Andrew I. Geller, Nadine Shehab, Rick Geimer, Yauheni Solad, Shuai Zheng, and Dani Robinson-Holland
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- 2022
3. Bleeding related to oral anticoagulants: Trends in US emergency department visits, 2016-2020
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Andrew I. Geller, Nadine Shehab, Maribeth C. Lovegrove, Nina J. Weidle, and Daniel S. Budnitz
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History ,Polymers and Plastics ,Hematology ,Business and International Management ,Industrial and Manufacturing Engineering - Published
- 2023
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4. Electronic Measurement of a Clinical Quality Measure for Inpatient Hypoglycemic Events: A Multicenter Validation Study.
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Carlos A. Q. Santos, Craig Conover, Nadine Shehab, Andrew I. Geller, Yannis Guerra, Holly Kramer, Nicole M. Kosacz, Huiyuan Zhang, Daniel S. Budnitz, and William E. Trick
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- 2020
5. 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
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Tsu-Hsuan, Yang, Robert, Ziemba, Nadine, Shehab, Andrew I, Geller, Karan, Talreja, Kyle N, Campbell, and Daniel S, Budnitz
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Adult ,Aged, 80 and over ,Male ,Public Health, Environmental and Occupational Health ,Reproducibility of Results ,Middle Aged ,Medicare ,Sensitivity and Specificity ,Hypoglycemia ,United States ,Young Adult ,International Classification of Diseases ,Predictive Value of Tests ,Ambulatory Care ,Diabetes Mellitus ,Humans ,Hypoglycemic Agents ,Female ,Aged ,Retrospective Studies - Abstract
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.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.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.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.
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- 2022
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6. Trends in US Outpatient Antibiotic Prescriptions During the Coronavirus Disease 2019 Pandemic
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Daniel S. Budnitz, Jennifer N. Lind, Andrew I. Geller, Sarah Kabbani, Maribeth C. Lovegrove, Laura M King, Sharon Tsay, Lauri A. Hicks, Nadine Shehab, and Rebecca M. Roberts
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0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Respiratory tract infections ,Coronavirus disease 2019 (COVID-19) ,medicine.drug_class ,business.industry ,030106 microbiology ,Antibiotics ,Pharmacy ,Azithromycin ,03 medical and health sciences ,Surgical prophylaxis ,0302 clinical medicine ,Infectious Diseases ,Pandemic ,Emergency medicine ,medicine ,030212 general & internal medicine ,Medical prescription ,business ,medicine.drug - Abstract
Background The objective of our study was to describe trends in US 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 from January 2017 through May 2020. We averaged estimates from 2017 through 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 because of seasonal trends alone, possibly related to the coronavirus disease 2019 pandemic and associated mitigation measures.
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- 2020
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7. Electronic Measurement of a Clinical Quality Measure for Inpatient Hypoglycemic Events
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Yannis S Guerra, Holly Kramer, Daniel S. Budnitz, Nicole M. Kosacz, Huiyuan Zhang, Andrew I. Geller, Craig Conover, Nadine Shehab, Carlos A. Q. Santos, and William E. Trick
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Adult ,Male ,medicine.medical_specialty ,Validation study ,Hospitalized patients ,Hypoglycemia ,Tertiary care ,Article ,Tertiary Care Centers ,03 medical and health sciences ,0302 clinical medicine ,Chart review ,Internal medicine ,parasitic diseases ,medicine ,Electronic Health Records ,Humans ,Hypoglycemic Agents ,Insulin ,030212 general & internal medicine ,Clinical quality ,Aged ,Quality Indicators, Health Care ,Inpatients ,business.industry ,030503 health policy & services ,Public Health, Environmental and Occupational Health ,Middle Aged ,medicine.disease ,Confidence interval ,Outcomes research ,0305 other medical science ,business - Abstract
BACKGROUND: Hypoglycemia related to anti-diabetic drugs (ADDs) is an important iatrogenic harm in hospitalized patients. Electronic identification of ADD-related hypoglycemia may be an efficient, reliable method to inform quality improvement. OBJECTIVES: Develop electronic queries of electronic health records (EHRs) 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 three tertiary-care hospitals with Patient Centered Outcomes Research Network (PCORnet) databases. Queries were based on National Quality Forum (NQF) criteria with hypoglycemia thresholds
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- 2020
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8. US Emergency Department Visits Attributed to Medication Harms, 2017-2019
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Daniel A. Pollock, Daniel S. Budnitz, Nadine Shehab, Jennifer N. Lind, Andrew I. Geller, and Maribeth C. Lovegrove
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,Adolescent ,Drug-Related Side Effects and Adverse Reactions ,Substance-Related Disorders ,Population ,Histamine Antagonists ,Nonprescription Drugs ,Benzodiazepines ,Young Adult ,Age Distribution ,Public health surveillance ,Diabetes mellitus ,medicine ,Confidence Intervals ,Humans ,Hypoglycemic Agents ,Public Health Surveillance ,Young adult ,Sex Distribution ,education ,Adverse effect ,Child ,Aged ,Original Investigation ,education.field_of_study ,business.industry ,Medical record ,Age Factors ,Anticoagulants ,General Medicine ,Emergency department ,Analgesics, Non-Narcotic ,Middle Aged ,medicine.disease ,Confidence interval ,United States ,Anti-Bacterial Agents ,Hospitalization ,Child, Preschool ,Emergency medicine ,Acute Disease ,Barbiturates ,Female ,business ,Emergency Service, Hospital - Abstract
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.
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- 2021
9. Assessment of ICD-10-CM code assignment validity for case finding of outpatient anticoagulant-related bleeding among Medicare beneficiaries
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Andrew I. Geller, Kyle N. Campbell, Robert Ziemba, Ruth N. Moro, Brian F. Gage, Daniel S. Budnitz, Tsu Hsuan Yang, and Nadine Shehab
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Adult ,Male ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,Epidemiology ,medicine.drug_class ,Hemorrhage ,Medicare ,030226 pharmacology & pharmacy ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Outpatients ,medicine ,Coagulopathy ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Diagnosis-Related Groups ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Pharmacoepidemiology ,Medical record ,Anticoagulant ,Anticoagulants ,Reproducibility of Results ,ICD-10 ,Gold standard (test) ,Emergency department ,Middle Aged ,medicine.disease ,United States ,Diagnostic odds ratio ,Female ,Diagnosis code ,business - Abstract
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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- 2019
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10. Outpatient Insulin-related Adverse Events Due to Mix-up Errors: Findings from Two National Surveillance Systems, United States, 2012–2017
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Hina Mehta, Nadine Shehab, Daniel S. Budnitz, Ariane O. Conrad, Nina J. Weidle, and Andrew I. Geller
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medicine.medical_specialty ,Epidemiology ,medicine.medical_treatment ,Psychological intervention ,Pharmacy ,030226 pharmacology & pharmacy ,Article ,03 medical and health sciences ,0302 clinical medicine ,Public health surveillance ,Outpatients ,medicine ,Humans ,Insulin ,Medication Errors ,Pharmacology (medical) ,030212 general & internal medicine ,Medical prescription ,Adverse effect ,business.industry ,United States Food and Drug Administration ,Emergency department ,Pharmacoepidemiology ,United States ,Emergency medicine ,business ,Emergency Service, Hospital - Abstract
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.
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- 2021
11. U.S. Compounding Pharmacy-Related Outbreaks, 2001–2013: Public Health and Patient Safety Lessons Learned
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Megan N. Brown, Nadine Shehab, Alexander J. Kallen, and Joseph F. Perz
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medicine.medical_specialty ,Leadership and Management ,Drug Compounding ,Poison control ,Pharmacy ,030204 cardiovascular system & hematology ,Computer security ,computer.software_genre ,History, 21st Century ,Article ,Occupational safety and health ,Disease Outbreaks ,03 medical and health sciences ,Patient safety ,0302 clinical medicine ,Environmental health ,Injury prevention ,Health care ,Humans ,Medicine ,030212 general & internal medicine ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,Outbreak ,United States ,Pharmaceutical Services ,Patient Safety ,Public Health ,Drug Contamination ,business ,computer - Abstract
OBJECTIVES: Pharmacy-compounded sterile preparations (P-CSPs) are frequently relied upon in U.S. health care but are increasingly being linked to outbreaks of infections. We provide an updated overview of outbreak burden and characteristics, identify drivers of P-CSP demand, and discuss public health and patient safety lessons learned to help inform prevention. METHODS: Outbreaks of infections linked to contaminated P-CSPs that occurred between January 1, 2001, and December 31, 2013, were identified from internal Centers for Disease Control and Prevention reports, Food and Drug Administration drug safety communications, and published literature. RESULTS: We identified 19 outbreaks linked to P-CSPs, resulting in at least 1000 cases, including deaths. Outbreaks were reported across two-thirds of states, with almost one-half (8/19) involving cases in more than 1 state. Almost one-half of outbreaks were linked to injectable steroids (5/19) and intraocular bevacizumab (3/19). Non-patient-specific compounding originating from nonsterile ingredients and repackaging of already sterile products were the most common practices associated with P-CSP contamination. Breaches in aseptic processing and deficiencies in sterilization procedures or in sterility/endotoxin testing were consistent findings. Hospital outsourcing, preference for variations of commercially available products, commercial drug shortages, and lower prices were drivers of P-CSP demand. CONCLUSIONS: Recognized outbreaks linked to P-CSPs have been most commonly associated with non-patient-specific repackaging and nonsterile to sterile compounding and linked to lack of adherence to sterile compounding standards. Recently enhanced regulatory oversight of compounding may improve adherence to such standards. Additional measures to limit and control these outbreaks include vigilance when outsourcing P-CSPs, scrutiny of drivers for P-CSP demand, as well as early recognition and notification of possible outbreaks. Language: en
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- 2018
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12. US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011–2015
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Andrew I. Geller, Katherine E. Fleming-Dutra, Nadine Shehab, Daniel S. Budnitz, Mathew R. P. Sapiano, and Maribeth C. Lovegrove
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Male ,medicine.medical_specialty ,Adolescent ,Drug-Related Side Effects and Adverse Reactions ,medicine.drug_class ,Antibiotics ,Psychological intervention ,Pharmacy ,Article ,Drug Hypersensitivity ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Antibiotic resistance ,030225 pediatrics ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Medical prescription ,Child ,Adverse effect ,0303 health sciences ,Pediatric Emergency Medicine ,030306 microbiology ,business.industry ,Age Factors ,Amoxicillin ,Infant ,General Medicine ,Emergency department ,United States ,Anti-Bacterial Agents ,Hospitalization ,Infectious Diseases ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Emergency medicine ,Female ,Emergency Service, Hospital ,business ,medicine.drug - Abstract
Background Antibiotics 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. Methods Frequencies 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). Results On 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). Conclusions Antibiotic 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.
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- 2018
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13. National Estimates of Emergency Department Visits for Antibiotic Adverse Events Among Adults—United States, 2011–2015
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Lauri A. Hicks, Mathew R. P. Sapiano, Nadine Shehab, Maribeth C. Lovegrove, Daniel S. Budnitz, and Andrew I. Geller
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Adult ,medicine.medical_specialty ,medicine.drug_class ,Antibiotics ,Pharmacy ,01 natural sciences ,03 medical and health sciences ,Patient safety ,0302 clinical medicine ,Public health surveillance ,Internal Medicine ,medicine ,Humans ,030212 general & internal medicine ,0101 mathematics ,Medical prescription ,Adverse effect ,Original Research ,business.industry ,010102 general mathematics ,Emergency department ,United States ,Anti-Bacterial Agents ,Hospitalization ,Pharmaceutical care ,Emergency medicine ,Emergency Service, Hospital ,business - Abstract
BACKGROUND: Detailed, nationally representative data describing high-risk populations and circumstances involved in antibiotic adverse events (AEs) can inform approaches to prevention. OBJECTIVE: Describe US burden, rates, and characteristics of emergency department (ED) visits by adults for antibiotic AEs. DESIGN: Nationally 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. PATIENTS: Antibiotic-treated adults (≥ 20 years) seeking ED care. MAIN MEASURES: Estimated annual numbers and rates of ED visits for antibiotic AEs among outpatients treated with systemically administered antibiotics. KEY RESULTS: Based 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
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- 2018
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14. Emergency Visits for Oral Anticoagulant Bleeding
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Maribeth C. Lovegrove, Andrew I. Geller, Nina J. Weidle, Kathleen O. Rose, Nadine Shehab, Sandra K. Goring, and Daniel S. Budnitz
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medicine.medical_specialty ,business.industry ,MEDLINE ,Administration, Oral ,Anticoagulants ,Hemorrhage ,Emergency medicine ,Internal Medicine ,Oral anticoagulant ,Humans ,Medicine ,Emergency Service, Hospital ,business ,Concise Research Report - Published
- 2019
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15. Investigation of Events Related to Laboratory-Confirmed Contamination of Pharmaceutical Products: Summary of CDC Consultation
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Melissa K. Schaefer, Kiran M. Perkins, Lina I Elbadawi, Nadine Shehab, Jennifer N. Lind, and Alexander J. Kallen
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Microbiology (medical) ,Infectious Diseases ,Epidemiology ,business.industry ,Medicine ,Medical emergency ,Contamination ,business ,medicine.disease - Abstract
Background: Contaminated pharmaceutical products pose serious infection risks to patients and can lead to significant morbidity and mortality. Contamination at the point of manufacturing or compounding (intrinsic contamination) has the potential to affect large numbers of patients. Public health plays a critical role in detecting and investigating such events. We identified investigations involving intrinsically contaminated pharmaceuticals to characterize the burden and scope of harm associated with these events. Methods: We reviewed Centers for Disease Control and Prevention records to identify US investigations between January 1, 2009, and December 31, 2018, involving laboratory-confirmed contamination of manufactured medications and pharmacy-compounded preparations (P-CPs), using relevant search terms (eg, “medication contamination”). Laboratory confirmation was defined as identification of a pathogen from a manufactured medication or P-CP. We determined the number and type of patient infections associated with these investigations, the number of states involved, pathogens identified, type of medication (sterile or nonsterile), route of administration, and how the contamination event was first identified. We excluded investigations when the mode of production was unknown. Results: We identified 20 investigations in at least 20 states involving laboratory-confirmed contamination of manufactured medications (n = 12) and P-CPs (n = 8). Patient infections were identified in 16 (80%) investigations (9 involving manufactured medications and 7 involving P-CPs) resulting in at least 1,183 infections and at least 73 deaths. Bloodstream infections were the most common infection type (n = 7, 44%). Waterborne pathogens (eg, Serratia marcescens, Burkholderia cepacia) were cultured from medications in 83% (n = 10) of investigations involving manufactured medications and 75% (n = 6) of investigations involving P-CPs. Contamination of sterile pharmaceutical products occurred in 14 (70%) investigations; 11 (79%) of these involved injectables. Information regarding how contaminated pharmaceuticals were first identified was documented for 18 investigations; most cases (n = 14, 78%) started with investigation of patient infections by facilities, public health, or both, which led to laboratory testing of pharmaceuticals and confirmation of contamination. Conclusions: The events summarized here likely underestimate the frequency of intrinsic contamination of pharmaceutical products in the United States. These events can have devastating consequences that impact patients across the country. Waterborne pathogens appear to be the most frequently identified source of contamination in both manufactured medications and P-CPs.Detection, investigation, control, and prevention of pharmaceutical contamination events benefit from collaboration between state and federal public health authorities; without public health intervention. Such contamination may have gone undetected and could have harmed additional patients.Funding: NoneDisclosures: None
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- 2020
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16. Anticoagulation Across Care Transitions: Identifying Minimum Data to Maximize Drug Safety
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Daniel S. Budnitz, Nadine Shehab, and Jeffrey L. Greenwald
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Patient Transfer ,Drug ,Leadership and Management ,media_common.quotation_subject ,030204 cardiovascular system & hematology ,Article ,03 medical and health sciences ,Medication Reconciliation ,0302 clinical medicine ,Text mining ,Humans ,Medicine ,030212 general & internal medicine ,Care Transitions ,Quality of Health Care ,media_common ,business.industry ,Communication ,Anticoagulants ,Continuity of Patient Care ,medicine.disease ,Quality Improvement ,Patient Discharge ,United States ,Checklist ,Patient Safety ,Medical emergency ,business - Published
- 2018
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17. American Society of Hematology 2018 guidelines for management of venous thromboembolism:optimal management of anticoagulation therapy
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Jane Skov, Meha Bhatt, Nadine Shehab, Mark Crowther, Rasha Khatib, Tarra Myers, John J. Riva, Gordon H. Guyatt, Juliet Mock, Arnav Agarwal, Francesco Dentali, Yuan Zhang, Jack Ansell, Robby Nieuwlaat, Nathan P. Clark, Anne Holbrook, and Daniel M. Witt
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medicine.medical_specialty ,ATP Binding Cassette Transporter, Subfamily B ,Vitamin K ,medicine.drug_class ,Point-of-Care Systems ,MEDLINE ,Administration, Oral ,030204 cardiovascular system & hematology ,Medication Adherence ,03 medical and health sciences ,0302 clinical medicine ,Cytochrome P-450 Enzyme System ,INR self-monitoring ,Health care ,medicine ,Humans ,030212 general & internal medicine ,Dosing ,International Normalized Ratio ,Intensive care medicine ,Evidence-Based Medicine ,business.industry ,Heparin ,Anticoagulant ,Anticoagulants ,Hematology ,Evidence-based medicine ,Guideline ,Venous Thromboembolism ,Vitamin K antagonist ,Heparin, Low-Molecular-Weight ,business ,Clinical Guidelines - Abstract
Background:Clinicians confront numerous practical issues in optimizing the use of anticoagulants to treat venous thromboembolism (VTE).Objective:These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians and other health care professionals in their decisions about the use of anticoagulants in the management of VTE. These guidelines assume the choice of anticoagulant has already been made.Methods:ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment.Results:The panel agreed on 25 recommendations and 2 good practice statements to optimize management of patients receiving anticoagulants.Conclusions:Strong recommendations included using patient self-management of international normalized ratio (INR) with home point-of-care INR monitoring for vitamin K antagonist therapy and against using periprocedural low-molecular-weight heparin (LMWH) bridging therapy. Conditional recommendations included basing treatment dosing of LMWH on actual body weight, not using anti–factor Xa monitoring to guide LMWH dosing, using specialized anticoagulation management services, and resuming anticoagulation after episodes of life-threatening bleeding.
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- 2018
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18. Emergency Department Visits and Hospitalizations for Digoxin Toxicity
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Scott R. Kegler, Daniel S. Budnitz, S. Raja Laskar, Isaac See, and Nadine Shehab
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Adult ,Male ,Digoxin ,medicine.medical_specialty ,Pediatrics ,Poison control ,Article ,Sex Factors ,Ambulatory care ,Risk Factors ,Ambulatory Care ,medicine ,Humans ,Medical prescription ,Adverse effect ,Aged ,Retrospective Studies ,Aged, 80 and over ,Heart Failure ,business.industry ,Age Factors ,Disease Management ,Retrospective cohort study ,Emergency department ,Middle Aged ,United States ,Hospitalization ,Emergency medicine ,Ambulatory ,Female ,Emergency Service, Hospital ,Cardiology and Cardiovascular Medicine ,business ,Anti-Arrhythmia Agents ,medicine.drug - Abstract
Background— Recent data on digoxin prescribing and adverse events are lacking but could help inform the management of digoxin in contemporary heart failure treatment. Methods and Results— We determined nationally representative numbers and rates of emergency department (ED) visits for digoxin toxicity in the United States using 2005 to 2010 reports from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project and the National Ambulatory (and Hospital Ambulatory) Medical Care Surveys. Based on 441 cases, an estimated 5156 (95% confidence interval [CI], 2663–7648) ED visits for digoxin toxicity occurred annually in the United States; more than three fourths (78.8% [95% CI, 73.5%–84.1%]) resulted in hospitalization. Serum digoxin level was ≥2.0 ng/mL for 95.8% (95% CI, 93.2%–98.4%) of estimated ED visits with levels reported (n=251 cases). The rate of ED visits per 10 000 outpatient prescription visits among patients ≥85 years was twice that of patients 40 to 84 years (rate ratio, 2.4 [95% CI, 1.2–5.0]); among women, the rate was twice that of men (rate ratio, 2.3 [95% CI, 1.1–4.7]). Digoxin toxicity accounted for an estimated 1.0% (95% CI, 0.6%–1.4%) of ED visits for all adverse drug events among patients ≥40 years, but an estimated 3.3% (95% CI, 2.3%–4.4%) of ED visits and 5.9% (95% CI, 4.0%–7.9%) of hospitalizations for all adverse drug events among patients ≥85 years. Estimated annual ED visits and hospitalizations remained relatively constant from 2005 to 2010. Conclusions— Digoxin toxicity is not declining; more careful prescribing to high-risk groups and improved monitoring of serum levels might be needed to reduce morbidity from outpatient digoxin use.
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- 2014
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19. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014
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Andrew I. Geller, Nina J. Weidle, Kathleen O. Rose, Nadine Shehab, Maribeth C. Lovegrove, and Daniel S. Budnitz
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Drug ,Pediatrics ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,Beers Criteria ,030204 cardiovascular system & hematology ,Article ,Dabigatran ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Outpatients ,Medicine ,Humans ,Medication Errors ,030212 general & internal medicine ,Adverse effect ,media_common ,Rivaroxaban ,business.industry ,Warfarin ,General Medicine ,Emergency department ,Drug class ,business ,medicine.drug - Abstract
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.
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- 2016
20. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates
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Carrie L. Lewis, Steven M. Donn, Nadine Shehab, and Darcie D Streetman
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Drug ,Critical Illness ,media_common.quotation_subject ,Excipient ,Intensive Care Units, Pediatric ,Critical Care and Intensive Care Medicine ,law.invention ,Excipients ,law ,Intensive care ,Humans ,Medicine ,Retrospective Studies ,media_common ,Dose-Response Relationship, Drug ,Cumulative dose ,business.industry ,Infant, Newborn ,Retrospective cohort study ,Propylene Glycol ,Intensive care unit ,Dose–response relationship ,Anesthesia ,Pediatrics, Perinatology and Child Health ,Toxicity ,business ,Benzyl Alcohol ,medicine.drug - Abstract
To document neonatal exposures to the potentially harmful pharmaceutical excipients benzyl alcohol (BA) and propylene glycol (PG) present in parenteral medications routinely administered in the intensive care unit.Retrospective, observational study.Neonatal and pediatric intensive care units of a tertiary care, university hospital.Randomly selected sample of 170 episodes of exposure to parenteral medications containing BA (n = 88) or PG (n = 82).We identified all medication sources of BA or PG administered to study neonates during hospitalization, and calculated cumulative doses (mg/kg/day and mg/day) of BA or PG received as a result of exposure to those medications.We observed a wide range in the cumulative excipient dose received by neonates. Median (range) cumulative dose was 4.5 mg/kg/day (0.6-319.5 mg/kg/day) for BA, and 204.9 mg/kg/day (17.3-9472.7 mg/kg/day) for PG. Patients who received medications via continuous infusion received significantly higher excipient doses than patients who received medications intermittently (p0.0001). In this subset of patients, median cumulative excipient doses (BA, 106.3 mg/kg/day and PG, 4554.5 mg/kg/day) were approximately 21 and 180 times the acceptable daily intakes of BA and PG (5 and 25 mg/kg/day), respectively, and exceeded the doses above which toxicity has been reported in infants. No significant correlation between duration of medication administration and cumulative excipient exposure was identified for BA or PG. Midazolam and lorazepam were involved in over two-thirds of BA and PG exposures, respectively.Critically ill neonates, especially those receiving medications by continuous infusion, are at risk of being exposed to BA and PG at potentially toxic doses during routine medication administration. Given the serious adverse reactions known to be associated with BA and PG, future studies are warranted to determine the clinical consequences associated with this degree of excipient exposure.
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- 2009
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21. Emergency Department Visits for Antibiotic‐Associated Adverse Events
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Nadine Shehab, Priti R. Patel, Daniel S. Budnitz, and Arjun Srinivasan
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Microbiology (medical) ,medicine.medical_specialty ,Pediatrics ,business.industry ,Clindamycin ,Penicillins ,Emergency department ,United States ,Confidence interval ,Anti-Bacterial Agents ,Cephalosporins ,Drug Hypersensitivity ,Infectious Diseases ,Ambulatory care ,Emergency medicine ,Ambulatory ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Medical prescription ,Emergency Service, Hospital ,business ,Adverse effect ,Antibacterial agent ,medicine.drug - Abstract
(See the editorial commentary by Linder on pages 744–6) 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.
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- 2008
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22. Access To Care Among Displaced Mississippi Residents In FEMA Travel Trailer Parks Two Years After Katrina
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Michael Anastario, Nadine Shehab, and Lynn Lawry
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education.field_of_study ,business.industry ,Health Policy ,Trailer ,Population ,Mental illness ,medicine.disease ,Mental health ,Chronic disease ,Full recovery ,Environmental health ,Health care ,Medicine ,business ,education ,human activities ,Health policy - Abstract
The health care needs of Gulf Coast residents displaced by Hurricane Katrina in 2005 who remain in travel trailer parks nearly three years later have not been evaluated. We conducted a population-based assessment of the health care access of residents of these travel trailer parks in Mississippi. Our findings indicate a worsening of chronic disease, mental illness, and barriers to health care access since displacement. Meeting both the chronic disease and the mental health needs of people displaced by the hurricanes of 2005 is essential for ensuring their full recovery and that of the region.
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- 2008
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23. Chronic Disease and Disasters
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Fernando Guerra, Cherise Rohr-Allegrini, Roger Sanchez, Daniel B. Jernigan, Daniel A. Pollock, Michael A. Jhung, and Nadine Shehab
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Chronic care ,education.field_of_study ,Emergency management ,Epidemiology ,business.industry ,Population ,Public Health, Environmental and Occupational Health ,Pharmacy ,Relief Work ,medicine.disease ,Needs assessment ,Health care ,Medicine ,Medical emergency ,business ,Natural disaster ,education - Abstract
Background Preparing for natural disasters has historically focused on treatment for acute injuries, environmental exposures, and infectious diseases. Many disaster survivors also have existing chronic illness, which may be worsened by post-disaster conditions. The relationship between actual medication demands and medical relief pharmaceutical supplies was assessed in a population of 18,000 evacuees relocated to San Antonio TX after Hurricane Katrina struck the Gulf Coast in August 2005. Methods Healthcare encounters from day 4 to day 31 after landfall were monitored using a syndromic surveillance system based on patient chief complaint. Medication-dispensing records were collected from federal disaster relief teams and local retail pharmacies serving evacuees. Medications dispensed to evacuees during this period were quantified into defined daily doses and classified as acute or chronic, based on their primary indications. Results Of 4229 categorized healthcare encounters, 634 (15%) were for care of chronic medical conditions. Sixty-eight percent of all medications dispensed to evacuees were for treatment of chronic diseases. Cardiovascular medications (39%) were most commonly dispensed to evacuees. Thirty-eight percent of medication doses dispensed by federal relief teams were for chronic care, compared to 73% of doses dispensed by retail pharmacies. Federal disaster relief teams supplied 9% of all chronic care medicines dispensed. Conclusions A substantial demand for drugs used to treat chronic medical conditions was identified among San Antonio evacuees, as was a reliance on retail pharmacy supplies to meet this demand. Medical relief pharmacy supplies did not consistently reflect the actual demands of evacuees.
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- 2007
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24. Institutional Experience with Voriconazole Compared with Liposomal Amphotericin B as Empiric Therapy for Febrile Neutropenia
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Emily R. Mackler, Curtis D. Collins, Nadine Shehab, Daryl D. DePestel, Kathleen B. Welch, and Harry P. Erba
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Male ,medicine.medical_specialty ,Antifungal Agents ,Neutropenia ,Fever ,Amphotericin B ,Internal medicine ,Humans ,Medicine ,Pharmacology (medical) ,Adverse effect ,Voriconazole ,Leukopenia ,business.industry ,Retrospective cohort study ,Health Care Costs ,Middle Aged ,Triazoles ,medicine.disease ,Surgery ,Hospitalization ,Pyrimidines ,Treatment Outcome ,Female ,medicine.symptom ,business ,Empiric therapy ,Febrile neutropenia ,medicine.drug - Abstract
Study Objective. To assess the effectiveness, safety, and cost of empiric treatment of febrile neutropenia before and after implementing an algorithm in which voriconazole was substituted for liposomal amphotericin B (L-AmB). Design. Retrospective cohort analysis. Setting. An 850-bed tertiary care hospital, which is also a referral site for patients with acute leukemia. Patients. Fifty-five adult patients who started empiric antifungal therapy for febrile neutropenia between January 1, 2002, and December 31, 2003, encompassing 58 treatment episodes (defined as a hospitalization during which empiric antifungal therapy was administered). Measurements and Main Results. Medical charts, including patients’ pharmacy and laboratory data, were reviewed. Twenty-six and 32 episodes of L-AmB and voriconazole use, respectively, were identified. No significant differences between the L-AmB and voriconazole groups were noted at baseline. Rates of fever resolution (54% vs 59%, p=0.791) and breakthrough invasive fungal infections (11% vs 12%, p>0.999) were similar for the L-AmB and voriconazole episodes. Premature drug discontinuation due to the prescriber’s perceived lack of efficacy occurred most frequently in the voriconazole group (25% vs 8%, p=0.160). Survival was significantly higher in the voriconazole than in the L-AmB group (100% vs 77%, p=0.006). Adverse effects that were significantly more common in the L-AmB group than in the voriconazole group were elevated serum creatinine levels (27% vs 3%, p=0.017) and electrolyte disturbances (19% vs 0%, p=0.014). Adverse effects reported more frequently in the voriconazole group than in the L-AmB group were visual disturbances (9% vs 0%, p=0.245) and elevated hepatic enzyme levels (9% vs 8%, p>0.999). Mean drug expenditures/episode for initial empiric antifungal therapy were lower for voriconazole than for L-AmB ($1593 vs $4144, or $153 vs $380/day). Conclusion. Our institution’s algorithm incorporating voriconazole into the empiric management of febrile neutropenia was associated with effectiveness outcomes comparable to those observed with L-AmB as well as a lower frequency of adverse effects and overall expenditures for antifungal drugs.
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- 2007
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25. Emergency Department Visits for Adverse Events Related to Dietary Supplements
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Robert P. Mozersky, Nadine Shehab, Andrew I. Geller, Daniel S. Budnitz, Nina J. Weidle, Maribeth C. Lovegrove, Beverly J. Wolpert, and Babgaleh B. Timbo
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Adult ,Complementary Therapies ,Pediatrics ,medicine.medical_specialty ,Adolescent ,Iron ,Chest pain ,Young Adult ,Age Distribution ,Weight loss ,medicine ,Palpitations ,Humans ,Micronutrients ,Young adult ,Adverse effect ,Child ,Aged ,business.industry ,General Medicine ,Emergency department ,Middle Aged ,Micronutrient ,Confidence interval ,United States ,Hospitalization ,Child, Preschool ,Population Surveillance ,Dietary Supplements ,Potassium ,Calcium ,Female ,medicine.symptom ,business ,Emergency Service, Hospital ,Phytotherapy - Abstract
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.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.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.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.).
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- 2015
26. Safety of Angiotensin-Converting Enzyme Inhibitors in Patients with Insect Venom Allergies
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Nadine Shehab, Anish C Patel, and Janice L. Stumpf
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Allergy ,MEDLINE ,medicine.medical_treatment ,Bradykinin ,Angiotensin-Converting Enzyme Inhibitors ,Venom ,030204 cardiovascular system & hematology ,Pharmacology ,medicine.disease_cause ,030226 pharmacology & pharmacy ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Hypersensitivity ,medicine ,Humans ,Pharmacology (medical) ,Arthropod Venoms ,Desensitization (medicine) ,biology ,business.industry ,Insect Bites and Stings ,Angiotensin-converting enzyme ,medicine.disease ,Angiotensin II ,chemistry ,Immunology ,Allergic response ,biology.protein ,business ,Anaphylaxis - Abstract
Objective: To review the literature with respect to the safety of angiotensin-converting enzyme (ACE) inhibitors in patients allergic to insect venom and those undergoing venom immunotherapy (VIT). Data Sources: A MEDLINE search was conducted (1966–March 2006) using the following search terms: bee sting, venom, insect stings, ACE inhibitors, angiotensin II receptor blockers, immunotherapy, and desensitization. The bibliographies of qualifying articles were also searched for relevant references. Data Synthesis: Several case reports have described severe allergic reactions, including anaphylaxis, in patients taking ACE inhibitors subsequent to being stung or receiving VIT. Exacerbation of the allergic response by ACE inhibitors is thought to be related to accumulation of bradykinin and inhibition of the formation of angiotensin II. Similar reactions have not been described with angiotensin-receptor blockers, but are theoretically possible. Conclusions: ACE inhibitors may exacerbate the response to insect venom, resulting in potentially life-threatening allergic reactions to insect stings or VIT. Although this risk is difficult to quantify based only on data from case reports, it seems prudent that patients with documented allergic reactions to insect venom avoid ACE inhibitor therapy, if possible. If, after careful consideration of the risks and benefits, ACE inhibitor therapy is deemed warranted, education regarding measures to minimize exposure to insect stings and training on self-administration of epinephrine should be provided, as with any person with venom allergy. In patients in whom VIT is appropriate, temporary discontinuation of the ACE inhibitor prior to each venom injection may prevent subsequent adverse reactions.
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- 2006
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27. Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: A Review of the Literature
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Nadine Shehab, Burgunda V. Sweet, and Norman D. Hogikyan
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Adult ,Male ,Larynx ,medicine.medical_specialty ,Organophosphonates ,Antineoplastic Agents ,Injections, Intralesional ,Neutropenia ,Cytosine nucleoside ,Drug Administration Schedule ,Cytosine ,chemistry.chemical_compound ,medicine ,Humans ,Pharmacology (medical) ,Child ,Adverse effect ,Laryngeal Neoplasms ,Clinical Trials as Topic ,Dose-Response Relationship, Drug ,Papilloma ,business.industry ,Standard treatment ,medicine.disease ,Dermatology ,Rash ,Respiratory Tract Neoplasms ,Surgery ,medicine.anatomical_structure ,chemistry ,Female ,Neoplasm Recurrence, Local ,Recurrent Respiratory Papillomatosis ,medicine.symptom ,business ,Cidofovir - Abstract
Recurrent respiratory papillomatosis (RRP) is a rare but potentially severe disease caused by papillomavirus, most often types 6 and 11. The disease, which occurs in both juvenile and adult forms, is characterized by benign epithelial tumors of the airway that most frequently affect the larynx but can also spread along the entire aerodigestive tract. Recurrent respiratory papillomatosis is the most common benign neoplasm of the larynx in children and the second most frequent cause of childhood hoarseness. Standard treatment, which is palliative only, consists of surgical excision of papillomata to maintain airway patency and improve voice quality. Recurrence despite repeated surgical procedures is the rule. To date, incorporation of adjuvant treatments has not been reliably beneficial in altering the disease course. Several case series have described promising results with cidofovir, a cytosine nucleoside analog with antiviral activity. To evaluate the data available on the safety and efficacy of cidofovir for the treatment of RRP, we conducted a MEDLINE search for all case reports or series from January 1966-August 2004 describing cidofovir therapy in either adults or children with RRP. The bibliographies of qualifying articles were also searched for relevant references. In both adults and children with mild-to-severe RRP, intralesional administration of cidofovir directly into the site of papillomata was associated with partial-to-complete regression of papillomata, improvement in voice quality and airway status, and decreased need for surgery. Wide variation in intralesional cidofovir dose (2-57 mg), frequency (every 2-8 wks), and duration (4 mo-4 yrs) was found. Successful outcomes have also been reported with intravenous cidofovir, but data are limited to three case reports. Rash, headache, and precordialgia were the only adverse effects reported with intralesional cidofovir. Nephrotoxicity and neutropenia secondary to either intralesional or intravenous cidofovir were not observed. Long-term risks associated with intralesional administration remain to be seen. Further studies are necessary to determine the most appropriate dose, frequency, and duration of therapy, and to fully characterize the safety profile profile of cidofovir when given intralesionally.
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- 2005
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28. Relationship of continuous infusion lorazepam to serum propylene glycol concentration in critically ill adults*
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Kevin McCarthy, Nadine Shehab, Alejandro C. Arroliga, and Jeffrey P. Gonzales
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Adult ,Male ,Critical Illness ,Rate of infusion ,Anion gap ,Lorazepam ,Critical Care and Intensive Care Medicine ,Intensive care ,mental disorders ,Humans ,Hypnotics and Sedatives ,Medicine ,Prospective Studies ,Infusions, Intravenous ,Acid-Base Equilibrium ,Osmole ,Dose-Response Relationship, Drug ,business.industry ,Osmolar Concentration ,Metabolic acidosis ,Middle Aged ,medicine.disease ,Propylene Glycol ,Dose–response relationship ,Anesthesia ,Solvents ,Female ,Acidosis ,business ,Osmol gap ,medicine.drug - Abstract
Objectives The primary objective was to evaluate the relationship between high-dose lorazepam and serum propylene glycol concentrations. Secondary objectives were a) to document the occurrence of propylene glycol accumulation associated with continuous high-dose lorazepam infusion; b) to assess the relationship between lorazepam dose, serum propylene glycol concentrations, and propylene glycol accumulation; and c) to assess the relationship between the osmol gap and serum propylene glycol concentrations. Design Prospective, observational study. Setting Tertiary care, medical intensive care unit. Patients Nine critically ill adults receiving high-dose lorazepam (> or =10 mg/hr) infusion. Interventions Cumulative lorazepam dose (mg/kg) and the rate of infusion (mg.kg(-1).hr(-1)) were monitored from initiation of lorazepam infusion until 24 hrs after discontinuation of the high-dose lorazepam infusion. Serum osmolarity was collected at 48 hrs into the high-dose lorazepam infusion and daily thereafter. Serum propylene glycol concentrations were drawn at 48 hrs into the high-dose lorazepam infusion, and the presence of propylene glycol accumulation, as evidenced by a high anion gap (> or =15 mmol/L) metabolic acidosis with elevated osmol gap (> or =10 mOsm/L), was assessed at that time. Measurements and main results The mean cumulative high-dose lorazepam received and mean high-dose lorazepam infusion rate were 8.1 mg/kg (range, 5.1-11.7) and 0.16 mg.kg(-1).hr (-1)(range, 0.11-0.22), respectively. A significant correlation between high-dose lorazepam infusion rate and serum propylene glycol concentrations was observed (r =.557, p =.021). Osmol gap was the strongest predictor of serum propylene glycol concentrations (r =.804, p =.001). Propylene glycol accumulation was observed in six of nine patients at 48 hrs. No significant correlation between duration of lorazepam infusion and serum propylene glycol concentrations was observed (p =.637). Conclusion Propylene glycol accumulation, as reflected by a hyperosmolar anion gap metabolic acidosis, was observed in critically ill adults receiving continuous high-dose lorazepam infusion for > or =48 hrs. Study findings suggest that in critically ill adults with normal renal function, serum propylene glycol concentrations may be predicted by the high-dose lorazepam infusion rate and osmol gap.
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- 2004
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29. Outbreak of Serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy
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Mary G. McIntyre, Heather Moulton-Meissner, Shawn C. Becker, Neil Gupta, Alexander J. Kallen, Kelly Stevens, Rick G. Schnatz, David T. Kuhar, Nadine Shehab, Judith Noble-Wang, Bette Jensen, Eric S. Kastango, and Susan N. Hocevar
- Subjects
Microbiology (medical) ,Adult ,Male ,medicine.medical_specialty ,Parenteral Nutrition ,Genotype ,Drug Compounding ,Pharmacy ,Bacteremia ,Disease Outbreaks ,Serratia Infections ,Bloodstream infection ,Acute care ,Health care ,medicine ,Humans ,Medical prescription ,Intensive care medicine ,Articles and Commentaries ,Serratia marcescens ,Aged ,Aged, 80 and over ,business.industry ,Outbreak ,Middle Aged ,Electrophoresis, Gel, Pulsed-Field ,Molecular Typing ,Infectious Diseases ,Parenteral nutrition ,Compounding ,Female ,business - Abstract
Parenteral nutrition (PN) is widely used in healthcare settings to deliver critical nutrients to patients unable to tolerate enteral feeding. The intravenous formulation is intended to provide all daily nutritional requirements, such as electrolytes, amino acids, dextrose, and lipids, and is considered to be one of the most complex pharmaceuticals to prepare because of the need for careful titration and combination of multiple components [1, 2]. Preparation under rigorous sterile conditions is especially crucial as the nutrient-rich formulation can act as favorable growth media for microorganisms [3, 4] and because the process requires the multistep transfer of several ingredients into a single container, providing opportunities for microbial contamination during the compounding process [5]. In the United States, PN can be compounded in a healthcare facility, outsourced to a compounding pharmacy, or purchased as manufactured, premixed formulations [5]. Healthcare facilities that administer PN to patients often lack the time, expertise, and technology to produce these solutions in their own facilities. As a result, the preparation of PN is frequently outsourced to compounding pharmacies specializing in these practices. In 2011, approximately 43% of 556 US hospitals with >600 beds randomly surveyed reported outsourcing their nutrition support preparations [6]. Compounding pharmacies are expected to adhere to current standards for preparation and handling of compounded sterile preparations (CSPs). One such standard is the United States Pharmacopeia's (USP) General Chapter “Pharmaceutical Compounding—Sterile Preparations,” which details conditions and practices that minimize risks of contamination of CSPs, including PN [7]. Additional standards for compounding PN solutions also exist [8, 9]. The adoption of strict standards for sterile compounding have contributed to a decline in the burden of contaminated PN preparations, and US outbreaks related to mishandling of PN during compounding are rare [2]. However, compounding CSPs, especially using nonsterile active pharmaceutical ingredients (APIs), involves challenging and complex processes, and outbreaks associated with improperly compounded preparations are being increasingly reported [10–20]. In March 2011, the Centers for Disease Control and Prevention (CDC) was notified of 5 patients with Serratia marcescens bloodstream infection (BSI) in one hospital in Alabama. Receipt of PN from a single compounding pharmacy was identified as a potential common source. The pharmacy was an independent, state-licensed compounding pharmacy in Birmingham that was registered with the Alabama State Board of Pharmacy and subject to the state laws and regulations pertaining to the compounding of parenteral therapy [21]. During the outbreak period, the pharmacy supplied PN to 6 healthcare facilities (5 acute care hospitals and 1 long-term acute care hospital), all located within Alabama. Prescriptions for PN were received daily by the pharmacy, and compounded PN preparations were delivered to hospitals each night. On 15 March 2011, after being notified of these S. marcescens BSIs, the pharmacy voluntarily ceased all compounding activities and subsequently recalled all CSPs as a precautionary measure. An investigation was conducted by the Alabama Department of Public Health and CDC to determine the extent of the outbreak, identify risk factors for infection among PN recipients, and review PN compounding practices to identify potential sources of contamination.
- Published
- 2014
30. National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations
- Author
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Kelly N. Weidenbach, Andrew I. Geller, Nadine Shehab, Daniel S. Budnitz, Gina J. Ryan, Maribeth C. Lovegrove, and Scott R. Kegler
- Subjects
Male ,Pediatrics ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,MEDLINE ,Hypoglycemia ,Rate ratio ,Sex Factors ,Public health surveillance ,Diabetes mellitus ,Internal Medicine ,medicine ,Diabetes Mellitus ,National Health Interview Survey ,Humans ,Hypoglycemic Agents ,Insulin ,Medication Errors ,Public Health Surveillance ,Glycemic ,business.industry ,Data Collection ,Age Factors ,Emergency department ,medicine.disease ,United States ,Hospitalization ,Female ,business ,Emergency Service, Hospital - Abstract
Importance Detailed, nationally representative data describing high-risk populations and circumstances involved in insulin-related hypoglycemia and errors (IHEs) can inform approaches to individualizing glycemic targets. Objective To describe the US burden, rates, and characteristics of emergency department (ED) visits and emergency hospitalizations for IHEs. Design, Setting, and Participants Nationally representative public health surveillance of adverse drug events among insulin-treated patients seeking ED care (National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project) and a national household survey of insulin use (the National Health Interview Survey) were used to obtain data from January 1, 2007, through December 31, 2011. Main Outcomes and Measures Estimated annual numbers and estimated annual rates of ED visits and hospitalizations for IHEs among insulin-treated patients with diabetes mellitus. Results Based on 8100 National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance cases, an estimated 97 648 (95% CI, 64 410-130 887) ED visits for IHEs occurred annually; almost one-third (29.3%; 95% CI, 21.8%-36.8%) resulted in hospitalization. Severe neurologic sequelae were documented in an estimated 60.6% (95% CI, 51.3%-69.9%) of ED visits for IHEs, and blood glucose levels of 50 mg/dL (to convert to millimoles per liter, multiply by 0.0555) or less were recorded in more than half of cases (53.4%). Insulin-treated patients 80 years or older were more than twice as likely to visit the ED (rate ratio, 2.5; 95% CI, 1.5-4.3) and nearly 5 times as likely to be subsequently hospitalized (rate ratio, 4.9; 95% CI, 2.6-9.1) for IHEs than those 45 to 64 years. The most commonly identified IHE precipitants were reduced food intake and administration of the wrong insulin product. Conclusions and Relevance Rates of ED visits and subsequent hospitalizations for IHEs were highest in patients 80 years or older; the risks of hypoglycemic sequelae in this age group should be considered in decisions to prescribe and intensify insulin. Meal-planning misadventures and insulin product mix-ups are important targets for hypoglycemia prevention efforts.
- Published
- 2014
31. Dispensing investigational drugs: Regulatory issues and the role of the investigational drug service
- Author
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Helen R. Tamer and Nadine Shehab
- Subjects
Pharmacology ,Service (business) ,medicine.medical_specialty ,Investigational drug ,business.industry ,Drug Storage ,Health Policy ,MEDLINE ,Drugs, Investigational ,United States ,Pharmaceutical Services ,Investigational Drugs ,medicine ,Humans ,Joint Commission on Accreditation of Healthcare Organizations ,Intensive care medicine ,business ,Health policy - Published
- 2004
- Full Text
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32. Emergency hospitalizations for adverse drug events in older Americans
- Author
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Daniel S. Budnitz, Chesley L. Richards, Maribeth C. Lovegrove, and Nadine Shehab
- Subjects
Drug ,Male ,Pediatrics ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,Poison control ,Occupational safety and health ,Age Distribution ,Fibrinolytic Agents ,Injury prevention ,Antithrombotic ,Medicine ,Humans ,Hypoglycemic Agents ,media_common ,Aged ,Aged, 80 and over ,business.industry ,Warfarin ,General Medicine ,Confidence interval ,United States ,Hospitalization ,Population Surveillance ,Oral hypoglycemic agents ,Female ,Drug Overdose ,Emergencies ,business ,Emergency Service, Hospital ,medicine.drug - Abstract
Adverse drug events are important preventable causes of hospitalization in older adults. However, nationally representative data on adverse drug events that result in hospitalization in this population have been limited.We used adverse-event data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (2007 through 2009) to estimate the frequency and rates of hospitalization after emergency department visits for adverse drug events in older adults and to assess the contribution of specific medications, including those identified as high-risk or potentially inappropriate by national quality measures.On the basis of 5077 cases identified in our sample, there were an estimated 99,628 emergency hospitalizations (95% confidence interval [CI], 55,531 to 143,724) for adverse drug events in U.S. adults 65 years of age or older each year from 2007 through 2009. Nearly half of these hospitalizations were among adults 80 years of age or older (48.1%; 95% CI, 44.6 to 51.6). Nearly two thirds of hospitalizations were due to unintentional overdoses (65.7%; 95% CI, 60.1 to 71.3). Four medications or medication classes were implicated alone or in combination in 67.0% (95% CI, 60.0 to 74.1) of hospitalizations: warfarin (33.3%), insulins (13.9%), oral antiplatelet agents (13.3%), and oral hypoglycemic agents (10.7%). High-risk medications were implicated in only 1.2% (95% CI, 0.7 to 1.7) of hospitalizations.Most emergency hospitalizations for recognized adverse drug events in older adults resulted from a few commonly used medications, and relatively few resulted from medications typically designated as high-risk or inappropriate. Improved management of antithrombotic and antidiabetic drugs has the potential to reduce hospitalizations for adverse drug events in older adults.
- Published
- 2011
33. Emergency department visits for antiviral adverse events during the 2009 H1N1 influenza pandemic
- Author
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Elizabeth Crane, Daniel S. Budnitz, Nadine Shehab, Maribeth C. Lovegrove, Kathy Poneleit, and Craig M. Hales
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Drug-Related Side Effects and Adverse Reactions ,Population ,Antiviral Agents ,Disease Outbreaks ,Influenza A Virus, H1N1 Subtype ,Pandemic ,Influenza, Human ,Outpatients ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Intensive care medicine ,Adverse effect ,education ,Child ,Aged ,education.field_of_study ,Practice ,business.industry ,H1N1 influenza ,Public Health, Environmental and Occupational Health ,Pandemic influenza ,Outbreak ,Emergency department ,Middle Aged ,United States ,Population Surveillance ,Female ,business ,Emergency Service, Hospital - Abstract
The 2009 pandemic influenza A (H1N1) outbreak was associated with an increased use of antiviral agents and highlighted the role of population-based monitoring for related adverse drug events (ADEs). An ongoing, nationally representative emergency department-based surveillance system was used to identify and characterize ADEs during the pandemic. Active surveillance for ADEs successfully provided timely, population-based data during the pandemic. Increases in antiviral ADEs paralleled increases in prescribing. Type and severity of ADEs were similar across all seasons.
- Published
- 2011
34. Deriving Measures of Intensive Care Unit Antimicrobial Use from Computerized Pharmacy Data: Methods, Validation and Overcoming Barriers
- Author
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Yosef Khan, James F. Lloyd, R. Scott Evans, Bernard C. Camins, David N. Schwartz, Kurt B. Stevenson, and Nadine Shehab
- Subjects
Microbiology (medical) ,medicine.medical_specialty ,Medical Records Systems, Computerized ,Epidemiology ,Health informatics ,Article ,Medical Records ,Drug Utilization Review ,Anti-Infective Agents ,Intensive care ,Health care ,medicine ,Antimicrobial stewardship ,Humans ,Intensive care medicine ,Antibacterial agent ,Retrospective Studies ,Academic Medical Centers ,business.industry ,medicine.disease ,Data warehouse ,Intensive Care Units ,Infectious Diseases ,Clinical Pharmacy Information Systems ,Electronic data ,Medical emergency ,business ,Pharmacy Service, Hospital ,Software - Abstract
Antimicrobial resistance rendering previously treatable infections unresponsive to most drugs is a significant and growing public health concern.1,2 This threat has been recognized in the most recent national action plan for the prevention of healthcare-associated infections outlined by the Department of Health and Human Services,3 and calls for a coordinated national effort to monitor resistance and implement prevention and control efforts have been longstanding.1,4 The Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America recently published guidelines promoting the implementation of antimicrobial stewardship interventions in hospitals.5 An integral component of evaluating the impact of any of these strategies is the accurate and continuous measurement of antimicrobial utilization over time. The increasingly computerized processes of healthcare delivery have made the automated acquisition of antimicrobial utilization data possible. Indeed, most modern hospitals have universal computerization of laboratory, pharmacy, admission-discharge-transfer (ADT), and patient demographic and financial data. However, just as these data sources have been incorporated into fully functional electronic health records for only a small minority of hospitals,6 the derivation of reliable and accurate reports based on computerized hospital data has generally been difficult to achieve.7 Because these data are stored at each hospital or health system in disparate information systems, procedures required for their collection, extraction, cleaning, validation, and computation are often complex and error-prone.8 With regard to antimicrobial use measures, specifically, published data that have used electronic data sources to derive these estimates have almost exclusively relied on propriety measurement systems and the methods underlying the acquisition, validation, and consolidation of such data have not been well described. We describe our efforts to demonstrate the feasibility and validity of obtaining uniform measures of antimicrobial utilization in selected intensive care units (ICUs) in four academic medical centers by accessing pharmacy and administrative data contained in computerized data warehouses. Despite considerable expertise and relevant experience by healthcare informatics specialists and investigators in accessing such data, we encountered a number of problems that were largely unforeseen and, therefore, may be informative to the development of a standardized approach to deriving antimicrobial measures from electronic data.
- Published
- 2011
35. Adverse events from cough and cold medications after a market withdrawal of products labeled for infants
- Author
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Nadine Shehab, Daniel S. Budnitz, Melissa K. Schaefer, and Scott R. Kegler
- Subjects
Male ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,Poison control ,Common Cold ,Nonprescription Drugs ,Occupational safety and health ,Injury prevention ,Pharmacovigilance ,medicine ,Humans ,Adverse effect ,Child ,Drug Labeling ,Expectorants ,business.industry ,Common cold ,Emergency department ,medicine.disease ,Surgery ,Nasal decongestant ,Antitussive Agents ,Nasal Decongestants ,Product Recalls and Withdrawals ,Cough ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Emergency medicine ,Female ,business - Abstract
OBJECTIVE: A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AEs) among children after the withdrawal. METHODS: Emergency department (ED) visits for CCM-related AEs among children RESULTS: After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children CONCLUSIONS: ED visits for CCM-related AEs among children
- Published
- 2010
36. National Estimates of Emergency Department Visits for Hemorrhage-Related Adverse Events From Clopidogrel Plus Aspirin and From Warfarin
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Laurence S. Sperling, Nadine Shehab, Daniel S. Budnitz, and Scott R. Kegler
- Subjects
Adult ,Male ,medicine.medical_specialty ,Ticlopidine ,Adolescent ,Hemorrhage ,Context (language use) ,Young Adult ,Internal Medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Sex Distribution ,Medical prescription ,Adverse effect ,Aged ,Aged, 80 and over ,Aspirin ,business.industry ,Warfarin ,Anticoagulants ,Emergency department ,Middle Aged ,medicine.disease ,Clopidogrel ,United States ,Hospitalization ,Health Care Surveys ,Relative risk ,Acute Disease ,Ambulatory ,Emergency medicine ,Drug Therapy, Combination ,Female ,Medical emergency ,Emergency Service, Hospital ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Background Dual antiplatelet therapy (DAT) with clopidogrel plus aspirin is a well-established antithrombotic strategy, with hemorrhage being the chief adverse event (AE) of concern. Outside of clinical trials, few published data describe the magnitude and nature of hemorrhage-related AEs from DAT. Methods To estimate the numbers and rates of emergency department (ED) visits for hemorrhage-related AEs (hemorrhage or evaluation for potential hemorrhage) from DAT in the United States and put them in the context of those from warfarin, we analyzed AEs from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project, 2006-2008, and outpatient prescribing from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, 2006-2007. Results Based on 384 cases, there were an estimated 7654 (95% confidence interval [CI], 3325-11 983) ED visits annually for hemorrhage-related AEs from DAT compared with 2926 cases and an estimated 60 575 (36 117-85 033) ED visits from warfarin. Approximately 60% of ED visits for DAT consisted of epistaxis or other minor hemorrhages (eg, bleeding from small cuts). The risk of hospitalization for ED visits involving acute hemorrhages was not significantly different between DAT and warfarin (risk ratio, 0.73; 95% CI, 0.38-1.08). The estimated rate of ED visits involving acute hemorrhages from DAT was 1.2 per 1000 outpatient prescription visits vs 2.5 per 1000 outpatient prescription visits for warfarin (risk ratio, 0.49; 95% CI, 0.15-0.83). Conclusions These findings indicate that the acute hemorrhagic risk with DAT is clinically significant and reinforce the importance of practitioners and patients recognizing and anticipating this risk.
- Published
- 2010
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37. CDC and FDA response to risk of confusion in dosing Tamiflu oral suspension
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Nadine Shehab, Linda L. Lewis, Daniel S. Budnitz, and Debra Birnkrant
- Subjects
Drug ,medicine.medical_specialty ,Oseltamivir ,media_common.quotation_subject ,Administration, Oral ,Pharmacy ,Antiviral Agents ,chemistry.chemical_compound ,Medicine ,Humans ,Medication Errors ,Drug Dosage Calculations ,Dosing ,Intensive care medicine ,Confusion ,media_common ,Drug Labeling ,business.industry ,United States Food and Drug Administration ,General Medicine ,United States ,chemistry ,Emergency medicine ,medicine.symptom ,Centers for Disease Control and Prevention, U.S ,business - Abstract
To the Editor: On September 23, Parker et al.1 described a case in which Tamiflu (oseltamivir) for oral suspension was dispensed with pharmacy instructions to administer the drug in volume units (t...
- Published
- 2009
38. Medication overdoses leading to emergency department visits among children
- Author
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Nadine Shehab, Karen E. Thomas, Daniel S. Budnitz, and Sarah Schillie
- Subjects
Male ,medicine.medical_specialty ,Adolescent ,Drug-Related Side Effects and Adverse Reactions ,Epidemiology ,Poison control ,Suicide prevention ,Occupational safety and health ,Injury prevention ,medicine ,Prevalence ,Adverse Drug Reaction Reporting Systems ,Humans ,Adverse effect ,Child ,business.industry ,Public Health, Environmental and Occupational Health ,Human factors and ergonomics ,Infant ,Emergency department ,medicine.disease ,United States ,Child, Preschool ,Population Surveillance ,Emergency medicine ,Female ,Medical emergency ,Drug Overdose ,business ,Emergency Service, Hospital - Abstract
Background The high prevalence of medication use increases the potential for medication overdoses, especially among children. Purpose This paper describes the burden of unintentional pediatric medication overdoses in order to target new prevention efforts. Methods Data were analyzed in 2007 and 2008 from the National Electronic Injury Surveillance System, collected January 1, 2004, through December 31, 2005, to estimate the number of emergency department visits resulting from unintentional medication overdoses among children aged ≤18 years in the U.S. These data were analyzed by patient demographics, overdose cause, and implicated products, and compared to visits for nonpharmaceutical consumer product poisonings. Results Based on 3034 cases, an estimated 71,224 emergency department visits for medication overdoses were made annually by children aged ≤18 years, representing 68.9% of emergency department visits for unintentional pediatric poisonings. The rate of unintentional poisonings from medications was twice the rate of those from nonpharmaceutical consumer products (9.2 visits per 10,000 individuals per year [95% CI=7.3, 11.0] vs 4.2 per 10,000 individuals per year [95% CI=3.3, 5.0]). Four fifths (82.2%) of visits for medication overdoses were from unsupervised ingestions (children accessing medications on their own); medication errors and misuse resulted in 14.3% of visits. Most visits (81.3%) involved children aged ≤5 years, and commonly available over-the-counter medications were implicated in one third (33.9%) of visits. Conclusions Medication overdoses among children, notably unsupervised ingestions, represent a substantial burden in terms of emergency department visits and hospitalizations. New efforts to prevent pediatric medication overdoses are needed.
- Published
- 2008
39. Access to care among displaced Mississippi residents in FEMA travel trailer parks two years after Katrina
- Author
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Nadine, Shehab, Michael P, Anastario, and Lynn, Lawry
- Subjects
Adult ,Male ,Adolescent ,United States Department of Homeland Security ,Cyclonic Storms ,Health Policy ,Mental Disorders ,Middle Aged ,Health Services Accessibility ,Insurance Coverage ,United States ,Disasters ,Young Adult ,Mississippi ,Surveys and Questionnaires ,Chronic Disease ,Housing ,Humans ,Female ,Survivors ,Aged - Abstract
The health care needs of Gulf Coast residents displaced by Hurricane Katrina in 2005 who remain in travel trailer parks nearly three years later have not been evaluated. We conducted a population-based assessment of the health care access of residents of these travel trailer parks in Mississippi. Our findings indicate a worsening of chronic disease, mental illness, and barriers to health care access since displacement. Meeting both the chronic disease and the mental health needs of people displaced by the hurricanes of 2005 is essential for ensuring their full recovery and that of the region.
- Published
- 2008
40. Adverse events from cough and cold medications in children
- Author
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Melissa K. Schaefer, Daniel S. Budnitz, Adam L. Cohen, and Nadine Shehab
- Subjects
Male ,medicine.medical_specialty ,Pediatrics ,Cross-sectional study ,Psychological intervention ,Risk Assessment ,Age Distribution ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Registries ,Sex Distribution ,Intensive care medicine ,Adverse effect ,Child ,Respiratory Tract Infections ,Expectorants ,business.industry ,Public health ,Incidence ,Infant ,Common cold ,Emergency department ,medicine.disease ,United States ,Nasal decongestant ,Survival Rate ,Antitussive Agents ,Cross-Sectional Studies ,Cough ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Female ,Risk assessment ,business ,Emergency Service, Hospital ,Follow-Up Studies - Abstract
BACKGROUND. Adverse drug events in children from cough and cold medications have been identified as a public health issue with clinical and policy implications. Nationally representative morbidity data could be useful for targeting age-appropriate safety interventions. OBJECTIVE. To describe emergency department visits for adverse drug events from cough and cold medications in children. METHODS. Emergency department visits for adverse drug events attributed to cough and cold medications among children aged RESULTS. Annually, an estimated 7091 patients aged CONCLUSIONS. Timely national surveillance data can help target education, enforcement, and engineering strategies for reducing adverse events from cough and cold medications among children. Engineering innovations could be particularly helpful in addressing unsupervised ingestions, which is the most frequent cause of adverse events. These innovations could be applicable to other children's medications.
- Published
- 2008
41. Medication use leading to emergency department visits for adverse drug events in older adults
- Author
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Scott R. Kegler, Nadine Shehab, Chesley L. Richards, and Daniel S. Budnitz
- Subjects
medicine.medical_specialty ,Digoxin ,Potentially Inappropriate Medication List ,Drug-Related Side Effects and Adverse Reactions ,Cross-sectional study ,Poison control ,Drug Prescriptions ,Occupational safety and health ,Internal Medicine ,medicine ,Outpatient clinic ,Humans ,Hypoglycemic Agents ,Insulin ,Adverse effect ,Aged ,Medical Errors ,business.industry ,Anticoagulants ,General Medicine ,Emergency department ,medicine.disease ,humanities ,United States ,Cross-Sectional Studies ,Emergency medicine ,Medical emergency ,Warfarin ,business ,Emergency Service, Hospital ,Anti-Arrhythmia Agents ,Health care quality - Abstract
The Beers criteria identify inappropriate use of medications in older adults. The number of and risk for adverse events from these medications are unknown.To estimate the number of and risk for emergency department visits for adverse events involving Beers criteria medications compared with other medications.Nationally representative, public health surveillance of adverse drug events and a cross-sectional survey of outpatient medical visits.National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance System, 2004-2005; National Ambulatory Medical Care Survey, 2004; and National Hospital Ambulatory Medical Care Survey, 2004.Persons 65 years of age or older seeking emergency department and outpatient care.Estimated number of and risks for emergency department visits for adverse drug events involving Beers criteria medications and other medications.Among U.S. patients 65 years of age or older, an estimated 177,504 emergency department visits (95% CI, 100,155 to 254,854 visits) for adverse drug events occurred both years. An estimated 3.6% (CI, 2.8% to 4.5%) of these visits were for adverse events medications considered to be always potentially inappropriate, according to the Beers criteria, and 33.3% (CI, 27.8% to 38.7%) of visits were for adverse events from 3 other medications (warfarin [17.3%], insulin [13.0%], and digoxin [3.2%]). Accounting for outpatient prescription frequency, the risk for emergency department visits for adverse events due to these 3 medications was 35 times (CI, 9.6 to 61) greater than that for medications considered to be always potentially inappropriate.Adverse events were identified only in emergency departments.Compared with other medications, Beers criteria medications caused low numbers of and few risks for emergency department visits for adverse events. Performance measures and interventions targeting warfarin, insulin, and digoxin use could prevent more emergency department visits for adverse events.
- Published
- 2007
42. Chronic disease and disasters medication demands of Hurricane Katrina evacuees
- Author
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Michael A, Jhung, Nadine, Shehab, Cherise, Rohr-Allegrini, Daniel A, Pollock, Roger, Sanchez, Fernando, Guerra, and Daniel B, Jernigan
- Subjects
Cardiovascular Agents ,Community Pharmacy Services ,Louisiana ,Relief Work ,Drug Prescriptions ,Texas ,Health Services Accessibility ,Disasters ,Mississippi ,Pharmaceutical Preparations ,Chronic Disease ,Humans ,Sentinel Surveillance ,Needs Assessment - Abstract
Preparing for natural disasters has historically focused on treatment for acute injuries, environmental exposures, and infectious diseases. Many disaster survivors also have existing chronic illness, which may be worsened by post-disaster conditions. The relationship between actual medication demands and medical relief pharmaceutical supplies was assessed in a population of 18,000 evacuees relocated to San Antonio TX after Hurricane Katrina struck the Gulf Coast in August 2005.Healthcare encounters from day 4 to day 31 after landfall were monitored using a syndromic surveillance system based on patient chief complaint. Medication-dispensing records were collected from federal disaster relief teams and local retail pharmacies serving evacuees. Medications dispensed to evacuees during this period were quantified into defined daily doses and classified as acute or chronic, based on their primary indications.Of 4,229 categorized healthcare encounters, 634 (15%) were for care of chronic medical conditions. Sixty-eight percent of all medications dispensed to evacuees were for treatment of chronic diseases. Cardiovascular medications (39%) were most commonly dispensed to evacuees. Thirty-eight percent of medication doses dispensed by federal relief teams were for chronic care, compared to 73% of doses dispensed by retail pharmacies. Federal disaster relief teams supplied 9% of all chronic care medicines dispensed.A substantial demand for drugs used to treat chronic medical conditions was identified among San Antonio evacuees, as was a reliance on retail pharmacy supplies to meet this demand. Medical relief pharmacy supplies did not consistently reflect the actual demands of evacuees.
- Published
- 2007
43. Using preprinted medication order forms to improve the safety of investigational drug use
- Author
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Nadine Shehab and Helen R. Tamer
- Subjects
Pharmacology ,Investigational drug ,business.industry ,Health Policy ,Institute of medicine ,Drugs, Investigational ,medicine.disease ,Drug Prescriptions ,Patient safety ,Order (business) ,Investigational Drugs ,Health care ,medicine ,Medication Errors ,Medical emergency ,Forms and Records Control ,Safety ,business ,health care economics and organizations ,Accreditation - Abstract
Q: How can potential medication errors be minimized when dispensing investigational drugs to better ensure patient safety and improve adherence to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) medication management standard? A : The Institute of Medicine has estimated
- Published
- 2006
44. Emergency Hospitalization for Adverse Drug Events in Older Americans
- Author
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Chesley L. Richards, Maribeth C. Lovegrove, Daniel S. Budnitz, and Nadine Shehab
- Subjects
Drug ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,Emergency medicine ,medicine ,Medical emergency ,business ,medicine.disease ,media_common - Published
- 2012
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45. Calling it ‘multidose’ doesn't make it so: Inappropriate sharing and contamination of parenteral medication vials
- Author
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Melissa K. Schaefer, Joseph F. Perz, and Nadine Shehab
- Subjects
medicine.medical_specialty ,Infectious Diseases ,Epidemiology ,business.industry ,Health Policy ,Public Health, Environmental and Occupational Health ,medicine ,Contamination ,Intensive care medicine ,business ,Vial - Published
- 2010
- Full Text
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46. Responding to Gender-Based Violence in Disasters
- Author
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Nadine Shehab, Michael Anastario, and Lynn Lawry
- Subjects
Injury control ,business.industry ,Accident prevention ,Injury prevention ,Public Health, Environmental and Occupational Health ,medicine ,Human factors and ergonomics ,Poison control ,Medical emergency ,medicine.disease ,business ,Suicide prevention ,Occupational safety and health - Published
- 2009
- Full Text
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47. Time to Change the Paradigm—From 'Potentially Inappropriate' to Real Patient Harms
- Author
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Daniel S. Budnitz and Nadine Shehab
- Subjects
medicine.medical_specialty ,Patient safety ,Potentially Inappropriate Medication List ,business.industry ,Internal Medicine ,medicine ,Medical emergency ,Intensive care medicine ,medicine.disease ,business ,Clostridium difficile infections ,Patient care - Published
- 2011
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48. Is It Safe to Conclude that Beers Criteria Medications Led to Few Adverse Events?
- Author
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Nadine Shehab, Scott R. Kegler, Daniel S. Budnitz, and Chesley L. Richards
- Subjects
medicine.medical_specialty ,business.industry ,Epidemiology ,Internal Medicine ,medicine ,Beers Criteria ,General Medicine ,Medical emergency ,Primary care ,Intensive care medicine ,business ,medicine.disease ,Adverse effect - Published
- 2008
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49. National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events in Children and Adolescents
- Author
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Daniel A. Pollock, Thomas J. Schroeder, Kelly N. Weidenbach, Adam L. Cohen, Nadine Shehab, Daniel S. Budnitz, and Daniel B. Jernigan
- Subjects
Pediatrics ,medicine.medical_specialty ,business.industry ,Psychological intervention ,Emergency department ,medicine.disease ,El Niño ,Computerized physician order entry ,Pediatrics, Perinatology and Child Health ,Ambulatory ,Pharmacovigilance ,medicine ,Adverse effect ,business ,Adverse drug reaction - Abstract
Objective To describe the national scope and magnitude of outpatient adverse drug events (ADEs) that lead to emergency department (ED) visits in children and adolescents. Study design To conduct an active surveillance of patients 18 years of age or younger who came to EDs with ADEs from Jan 1, 2004, to Dec 31, 2005, through a nationally representative, stratified probability sample of 63 US hospitals with EDs. The main outcome measures were national estimates of the number, type, patient demographics, and clinical characteristics of ADEs. Results Annually, an estimated 158,520 patients ≤18 years old (95% CI, 117,745-199,295; 2 per 1000 persons) were treated in EDs for ADEs. Almost half (49.4%) of these visits occurred in patients between 1 and 4 years of age. Unintentional overdoses were the most common type of ADE (44.9%), followed by allergic reactions (35%), and adverse effects (12.6%). Antimicrobial agents, analgesic medications, and respiratory medications accounted for almost half of ADEs (25.2%, 13.7%, and 10.6%, respectively). Fewer than 1 in 10 patients (9.5%) required hospitalization or extended observation. Conclusions Interventions targeting unintentional overdoses of medications commonly given to preschool-aged children would likely have the highest impact in reducing ED visits from outpatient ADEs.
- Published
- 2008
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50. PIN5 COST ANALYSIS OFA FEBRILE NEUTROPENIA ALGORITHM WITH RESPECT TO EMPIRICAL ANTIFUNGAL THERAPY IN ADULT HEMATOLOGY/ONCOLOGY PATIENTS
- Author
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James G. Stevenson, ER Stuntebeck, Nadine Shehab, Curtis D. Collins, Daryl D. DePestel, and Harry P. Erba
- Subjects
Antifungal ,medicine.medical_specialty ,business.industry ,medicine.drug_class ,Health Policy ,Public Health, Environmental and Occupational Health ,medicine ,Cost analysis ,medicine.disease ,business ,Intensive care medicine ,Hematology+Oncology ,Febrile neutropenia - Full Text
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