National Healthcare Quality and Disparities Report
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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 25 of 133 Research Studies DisplayedCarroll AR, Johnson JA, Stassun JC
Health literacy-informed communication to reduce discharge medication errors in hospitalized children: a randomized clinical trial.
This study’s objective was to test a health literacy-informed communication intervention to decrease liquid medication dosing errors compared with standard counseling in hospitalized children. This parallel, randomized clinical trial was conducted from June 22, 2021, to August 20, 2022, at a tertiary care, US children's hospital. English- and Spanish-speaking caregivers of hospitalized children 6 years or younger prescribed a new, scheduled liquid medication at discharge were included in the analysis. Observed dosing errors were the main outcome measured, and secondary outcomes included caregiver-reported medication knowledge. Among 198 randomized caregivers (mean age 31.4 years; 186 women [93.9%]; 36 [18.2%] Hispanic or Latino and 158 [79.8%] White), the primary outcome was available for 151 (76.3%). The observed mean (SD) percentage dosing error was 1.0% (2.2 percentage points) among the intervention group and 3.3% (5.1 percentage points) among the standard counseling group (absolute difference, 2.3 percentage points). Twenty-four of 79 caregivers in the intervention group (30.4%) measured an incorrect dose compared with 39 of 72 (54.2%) in the standard counseling group. The intervention enhanced caregiver-reported medication knowledge compared with the standard counseling group for medication dose (71 of 76 [93.4%] vs 55 of 69 [79.7%]), duration of administration (65 of 76 [85.5%] vs 49 of 69 [71.0%], and correct reporting of 2 or more medication adverse effects (60 of 76 [78.9%] vs 13 of 69 [18.8%]).
AHRQ-funded; HS026122.
Citation: Carroll AR, Johnson JA, Stassun JC .
Health literacy-informed communication to reduce discharge medication errors in hospitalized children: a randomized clinical trial.
JAMA Netw Open 2024 Jan 2; 7(1):e2350969. doi: 10.1001/jamanetworkopen.2023.50969..
Keywords: Children/Adolescents, Health Literacy, Communication, Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Clinician-Patient Communication, Hospital Discharge, Medication: Safety
Cohen TN, Berdahl CT, Coleman BL
Medication safety event reporting: Factors that contribute to safety events during times of organizational stress.
This study’s objective was to understand the insights conveyed in hospital incident reports about how work system factors affected medication safety during a coronavirus disease-2019 (COVID-19) surge. The authors randomly selected 100 medication safety incident reports from an academic medical center (December 2020 to January 2021), identified near misses and errors, and classified contributing work system factors using the Human Factors Analysis and Classification System-Healthcare. Results showed that among 35 near misses/errors, incident reports described contributing factors (mean 1.3/report) involving skill-based errors (n = 20), communication (n = 8), and tools/technology (n = 4). Seven of these events were linked to COVID-19.
AHRQ-funded; HS027455.
Citation: Cohen TN, Berdahl CT, Coleman BL .
Medication safety event reporting: Factors that contribute to safety events during times of organizational stress.
J Nurs Care Qual 2024 Jan-Mar; 39(1):51-57. doi: 10.1097/ncq.0000000000000720..
Keywords: Medication: Safety, Medication, Patient Safety, COVID-19, Adverse Drug Events (ADE), Adverse Events, Medical Errors
Kyler KE, Hall M, Antoon JW
Major drug-drug interaction exposure among Medicaid-insured children in the outpatient setting.
This study’s objective was to determine the prevalence of major drug-drug interactions (DDI) exposure and factors associated with higher DDI exposure rates among children in an outpatient setting. The authors performed a cross-sectional study of children aged 0 to 18 years with ≥1 ambulatory encounter, and ≥2 dispensed outpatient prescriptions using the 2019 Marketscan Medicaid database. Primary outcomes were the prevalence and rate of major DDI exposure. Out of 781,019 children with ≥2 medication exposures, 21.4% experienced ≥1 major DDI exposure. The odds of exposure increased with age and with medical and mental health complexity. Frequently mentioned drugs included Clonidine, psychiatric medications, and asthma medications. The highest adverse physiologic effect exposure rate per 100 children included: increased drug concentrations (14.6), central nervous system depression (13.6), and heart rate-corrected QT interval prolongation (9.9).
AHRQ-funded; HS028979.
Citation: Kyler KE, Hall M, Antoon JW .
Major drug-drug interaction exposure among Medicaid-insured children in the outpatient setting.
Pediatrics 2024 Jan; 153(2):e2023063506. doi: 10.1542/peds.2023-063506.
Keywords: Children/Adolescents, Adverse Drug Events (ADE), Adverse Events, Medicaid, Medication: Safety
Kaufman BG, Holland DE, Vanderboom CE
Multicomponent pharmacist intervention did not reduce clinically important medication errors for ambulatory patients initiating direct oral anticoagulants.
The aim of this randomized controlled trial study was to evaluate the effectiveness of a multicomponent intervention for decreasing clinically important medication errors (CIMEs). The researchers included ambulatory patients beginning a DOAC or resuming one after a complication. The intervention included pharmacist evaluation and monitoring based on the implementation of a recently published checklist. The primary measure was anticoagulant-related CIMEs and non-anticoagulant-related CIMEs over 90 days from DOAC initiation. Primary variables included evaluation of the appropriateness of DOAC, need for DOAC affordability assistance, three pharmacist-initiated telephone consultations, access to a DOAC hotline, documented hand-off to the patient's continuity provider, and monitoring of follow-up laboratory tests. A total of 561 patients contributed 479 anticoagulant-CIMEs including 31 preventable and ameliorable ADEs and 448 significant anticoagulant medication errors without subsequent documented ADEs. The most common anticoagulant-related CIMEs were failure to perform required blood tests and concurrent, inappropriate usage of a DOAC with aspirin or NSAIDs despite pharmacist documentation systematically identifying these issues when present. There was no reduction in anticoagulant-related CIMEs among intervention patients or non-anticoagulant-related CIMEs.
AHRQ-funded; HS02592401.
Citation: Kaufman BG, Holland DE, Vanderboom CE .
Multicomponent pharmacist intervention did not reduce clinically important medication errors for ambulatory patients initiating direct oral anticoagulants.
J Gen Intern Med 2023 Dec; 38(16):3526-34. doi: 10.1007/s11606-023-08315-z..
Keywords: Provider: Pharmacist, Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Blood Thinners, Medication: Safety, Patient Safety
Boxley C, Fujimoto M, Ratwani RM
A text mining approach to categorize patient safety event reports by medication error type.
This study examined whether natural language processing can be used to better categorize medication related patient safety event reports. A total of 3,861 medication related patient safety event reports that were previously annotated using a consolidated medication error taxonomy were used to develop three models using the following algorithms: (1) logistic regression, (2) elastic net, and (3) XGBoost. The models were tested and performance was analyzed. The authors found the XGBoost model performed best across all medication error categories. 'Wrong Drug', 'Wrong Dosage Form or Technique or Route', and 'Improper Dose/Dose Omission' categories performed best across the three models. In addition, they identified five words most closely associated with each medication error category and which medication error categories were most likely to co-occur.
AHRQ-funded; HS026481.
Citation: Boxley C, Fujimoto M, Ratwani RM .
A text mining approach to categorize patient safety event reports by medication error type.
Sci Rep 2023 Oct 26; 13(1):18354. doi: 10.1038/s41598-023-45152-w..
Keywords: Health Information Technology (HIT), Patient Safety, Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events
Herzig SJ, Anderson TS, Urman RD
Risk factors for opioid-related adverse drug events among older adults after hospitalization for major orthopedic procedures.
The purpose of this retrospective cohort study was to identify risk factors for opioid-related adverse drug events (ORADEs) after hospital discharge following orthopedic procedures. The participants of this study included a national sample of Medicare beneficiaries who underwent major orthopedic surgery during hospitalization in 2016 and had an opioid prescription filled within 2 days of discharge. The study found that among 30,514 hospitalizations with a major orthopedic procedure and an opioid claim, a potential ORADE requiring hospital revisit occurred in 2.5%. After adjustment for patient characteristics, prior opioid use, co-prescribed sedating medications, and opioid prescription characteristics were not related with ORADEs. Independent risk factors did include age of 80 years or older, female sex, and clinical conditions, including heart failure, respiratory illness, kidney disease, dementia/delirium, anxiety disorder, and musculoskeletal/nervous system injuries.
AHRQ-funded; HS026215.
Citation: Herzig SJ, Anderson TS, Urman RD .
Risk factors for opioid-related adverse drug events among older adults after hospitalization for major orthopedic procedures.
J Patient Saf 2023 Oct 1; 19(6):379-85. doi: 10.1097/pts.0000000000001144..
Keywords: Elderly, Opioids, Adverse Drug Events (ADE), Adverse Events, Hospitalization, Orthopedics, Surgery, Medication, Risk, Medication: Safety, Patient Safety
Langlieb ME, Sharma P, Hocevar M
The additional cost of perioperative medication errors.
The aim of this study was to calculate the additional annual cost to the U.S. healthcare system attributable to preventable medication errors (MEs) in the operating room. The ME types were grouped into 13 categories by their related harm (or potential harm), and researchers calculated the incidence of operations involving each ME category: 1) delayed or missed required perioperative antibiotic; 2) prolonged hemodynamic swings; 3) untreated postoperative pain; 4) residual neuromuscular blockade; 5) oxygen saturation <90% due to ME; 6) delayed emergence; 7) untreated new onset intraoperative cardiac arrhythmia; 8) medication documentation errors; 9) syringe swaps; 10) presumed hypotension with inability to obtain a blood pressure reading; 11) potential for bacterial contamination due to expired medication syringes; 12) untreated bradycardia <40 beats/min; and 13) other. Through a PubMed search, the researchers established the possibility that the ME category would cause downstream patient harm such as surgical site infection or acute kidney injury, and the additional fully allocated cost of care for each potential downstream patient harm event. The cost of the MEs across the U.S. healthcare system was then calculated by scaling the number of MEs to the total number of annual operations in the United States. The total additional fully allocated annual cost of care due to perioperative MEs was estimated to be $5.33 billion U.S. dollars.
AHRQ-funded; HS024764.
Citation: Langlieb ME, Sharma P, Hocevar M .
The additional cost of perioperative medication errors.
J Patient Saf 2023 Oct 1; 19(6):375-78. doi: 10.1097/pts.0000000000001136..
Keywords: Medication: Safety, Medication, Medical Errors, Adverse Drug Events (ADE), Adverse Events, Surgery, Patient Safety
Marcaccio CL, Patel PB, Rastogi V
Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.
This study’s objective was to examine the efficacy and safety of preoperative single antiplatelet therapy (AP) therapy vs double antiplatelet therapy (DAPT) in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). The authors identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. A total of 18,570 tfCAS patients were included, of which 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Y12 inhibitor (P2Yi) only, and 2.9% P2Yi + AP loading dose. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy, ASA only, and ASA + AP loading dose, but was similar with P2Yi only, and P2Yi + AP loading dose. No differences were found in the incidence of bleeding rates between the treatment groups after tfCAS or TCAR. These findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT.
AHRQ-funded; HS027285.
Citation: Marcaccio CL, Patel PB, Rastogi V .
Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.
J Vasc Surg 2023 May; 77(5):1434-46.e11. doi: 10.1016/j.jvs.2022.12.034..
Keywords: Blood Thinners, Medication, Medication: Safety, Cardiovascular Conditions, Stroke, Adverse Drug Events (ADE), Adverse Events, Patient Safety
Taft T, Rudd EA, Thraen I
"Are we there yet?" Ten persistent hazards and inefficiencies with the use of medication administration technology from the perspective of practicing nurses.
The objectives of this study were to characterize persistent hazards and inefficiencies in inpatient medication administration, to explore cognitive attributes of medication administration tasks, and to discuss strategies to reduce technology-related hazards. Researchers interviewed nurses at two urban US health systems. Persistent safety hazards and inefficiencies related to medication administration technology were organized around the perception-action cycle (PAC) cycle. The researchers concluded that errors may persist in medication administration despite successful deployment of Bar Code Medication Administration and Electronic Medication Administration Record. Opportunities to improve would require a deeper understanding of high-level reasoning in medication administration.
AHRQ-funded; HS025136.
Citation: Taft T, Rudd EA, Thraen I .
"Are we there yet?" Ten persistent hazards and inefficiencies with the use of medication administration technology from the perspective of practicing nurses.
J Am Med Inform Assoc 2023 Apr 19; 30(5):809-18. doi: 10.1093/jamia/ocad031..
Keywords: Medication, Electronic Prescribing (E-Prescribing), Health Information Technology (HIT), Patient Safety, Adverse Drug Events (ADE), Medical Errors, Medication: Safety
Grauer A, Rosen A, Applebaum JR
Examining medication ordering errors using AHRQ network of patient safety databases.
Research on the impact of Computerized Physician Order Entry (CPOE) systems on drug order inaccuracies has shown inconsistent results, with CPOE not reliably preventing such mistakes. The study utilized the Network of Patient Safety Databases (NPSD) from the Agency for Healthcare Research and Quality (AHRQ) to explore the frequency and degree of harm associated with reported events during the ordering stage, and to classify them by error type.
The researchers conducted a retrospective analysis of reported safety incidents provided by healthcare systems associated with patient safety organizations from June 2010 to December 2020. All errors related to medication and other substance orders reported to the NPSD using the common format v1.2 during this period were assessed. The researchers grouped and categorized the prevalence of reported medication order errors by error type, harm levels, and demographic data. The study found that during the study period, 12,830 mistakes were reported. Incorrect dosage accounted for 3,812 errors (29.7%), followed by incorrect medicine 2,086 (16.3%), and incorrect duration 765 (6.0%). Out of 5,282 incidents that affected the patient and had a known severity level, 12 resulted in fatalities, 4 led to severe harm, 45 caused moderate harm, 341 led to minor harm, and 4,880 resulted in no harm. The study concluded that the most frequently reported and damaging types of medication order errors were incorrect dose and incorrect medication orders.
The researchers conducted a retrospective analysis of reported safety incidents provided by healthcare systems associated with patient safety organizations from June 2010 to December 2020. All errors related to medication and other substance orders reported to the NPSD using the common format v1.2 during this period were assessed. The researchers grouped and categorized the prevalence of reported medication order errors by error type, harm levels, and demographic data. The study found that during the study period, 12,830 mistakes were reported. Incorrect dosage accounted for 3,812 errors (29.7%), followed by incorrect medicine 2,086 (16.3%), and incorrect duration 765 (6.0%). Out of 5,282 incidents that affected the patient and had a known severity level, 12 resulted in fatalities, 4 led to severe harm, 45 caused moderate harm, 341 led to minor harm, and 4,880 resulted in no harm. The study concluded that the most frequently reported and damaging types of medication order errors were incorrect dose and incorrect medication orders.
AHRQ-funded; HS026121.
Citation: Grauer A, Rosen A, Applebaum JR .
Examining medication ordering errors using AHRQ network of patient safety databases.
J Am Med Inform Assoc 2023 Apr 19; 30(5):838-45. doi: 10.1093/jamia/ocad007..
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Patient Safety, Electronic Prescribing (E-Prescribing), Health Information Technology (HIT), Medication: Safety
Wong CI, Vannatta K, Gilleland Marchak J
Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: a multisite longitudinal assessment.
The goal of this longitudinal study was to characterize rates and types of medication errors and harm to outpatient children with leukemia and lymphoma over seven months of treatment. The study included children taking medications at home for leukemia or lymphoma from three pediatric cancer centers. Ten percent experienced adverse drug events because of outpatient medication errors. Twenty-six percent of caregivers reported miscommunication leading to missed doses or overdoses. The authors concluded that improvements addressing communication with and among caregivers should be based on human-factors engineering and codeveloped with families.
AHRQ-funded; HS024390.
Citation: Wong CI, Vannatta K, Gilleland Marchak J .
Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: a multisite longitudinal assessment.
Cancer 2023 Apr 1;129(7):1064-74. doi: 10.1002/cncr.34651.
Keywords: Children/Adolescents, Cancer, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Ambulatory Care and Surgery, Medication: Safety, Patient Safety
Kravchenko OV, Boyce RD, Gomez-Lumbreras A
Drug-drug interaction between dexamethasone and direct-acting oral anticoagulants: a nested case-control study in the national COVID cohort collaborative (N3C).
This study examined whether there is an association between thromboembolotic events (TEEs) and concomitant use of dexamethasone with either apixaban or rivaroxaban (both direct oral anticoagulants or DOACs) during treatment for COVID-19. The authors used data from the National COVID Cohort Collaborative (N3C) to conduct a nested case-control study. Eligible participants were adults over 18 years who were exposed to a DOAC for 10 or more consecutive days and exposure to dexamethasone at least 5 or more consecutive days. The study did not find a discernible association of TEE in patients concomitantly exposed to dexamethasone and a DOAC.
AHRQ-funded; HS025984.
Citation: Kravchenko OV, Boyce RD, Gomez-Lumbreras A .
Drug-drug interaction between dexamethasone and direct-acting oral anticoagulants: a nested case-control study in the national COVID cohort collaborative (N3C).
BMJ Open 2022 Dec 29; 12(12):e066846. doi: 10.1136/bmjopen-2022-066846..
Keywords: COVID-19, Blood Thinners, Medication, Adverse Drug Events (ADE), Adverse Events, Cardiovascular Conditions, Medication: Safety, Patient Safety
Tan MS, Gomez-Lumbreras A, Villa-Zapata L
Colchicine and macrolides: a cohort study of the risk of adverse outcomes associated with concomitant exposure.
The authors conducted a cohort study using electronic health records comparing encounters with colchicine plus a macrolide and colchicine with an antibiotic non-macrolide, then assessed the relationship between the two groups. They found that heart failure was more frequent in the colchicine plus a macrolide cohort and that there was also a higher mortality rate. As there is a significant increase in the risk of hepatic failure and mortality when colchicine is concomitantly administered with a macrolide, they concluded that colchicine should not be used concomitantly with these antibiotics or should be temporarily discontinued to avoid toxic levels of colchicine.
AHRQ-funded; HS025984.
Citation: Tan MS, Gomez-Lumbreras A, Villa-Zapata L .
Colchicine and macrolides: a cohort study of the risk of adverse outcomes associated with concomitant exposure.
Rheumatol Int 2022 Dec;42(12):2253-59. doi: 10.1007/s00296-022-05201-5..
Keywords: Adverse Drug Events (ADE), Adverse Events, Medication, Risk, Antibiotics, Medication: Safety, Patient Safety
Xiao Y, Smith A, Abebe E
Understanding hazards for adverse drug events among older adults after hospital discharge: insights from frontline care professionals.
The purpose of this study was to utilize a systems approach to examine hazards to medication safety for older adults during care transitions. The researchers interviewed 38 hospital-based professionals (5 hospitalists, 24 nurses, 4 clinical pharmacists, 3 pharmacy technicians, and 2 social workers) from 4 hospitals about ADE risks after hospital discharge among older adults. For each concern the participants provided, the hazard for medication-related harms was coded and grouped by its sources utilizing a human factors and systems engineering model. The study found that the hazards fell into 6 groups: 1) medication tasks related at home, 2) patient and caregiver related, 3) hospital work system related, 4) home resource related, 5) hospital professional-patient collaborative work related, and 6) external environment related. The type of medications indicated most frequently when describing concerns included anticoagulants, insulins, and diuretics. The types of hazards coded the most were: complex dosing, patient and caregiver knowledge gaps in medication management, errors in discharge medications, unaffordable cost, inadequate understanding about changes in medications, and gaps in access to care or in sharing medication information.
AHRQ-funded; HS024436.
Citation: Xiao Y, Smith A, Abebe E .
Understanding hazards for adverse drug events among older adults after hospital discharge: insights from frontline care professionals.
J Patient Saf 2022 Dec 1;18(8):e1174-e80. doi: 10.1097/pts.0000000000001046..
Keywords: Elderly, Adverse Drug Events (ADE), Medication, Medication: Safety, Hospital Discharge, Hospitals, Transitions of Care
Assimon MM, Pun PH, Al-Khatib SM
The modifying effect of the serum-to-dialysate potassium gradient on the cardiovascular safety of SSRIs in the hemodialysis population: a pharmacoepidemiologic study.
This study’s objective was to examine if higher QT-prolonging selective serotonin reuptake inhibitors (SSRIs) causes more cardiac risks to hemodialysis (HD) patients than lower serum-to-dialysate potassium gradient medications. The authors compared 1-year sudden cardiac death (SCD) risk among HD patients newly treated with higher (citalopram, escitalopram) versus lower (fluoxetine, fluvoxamine, paroxetine, sertraline) QT-prolonging potential SSRIs, overall and stratified by baseline potassium gradient. The study included 25,099 patients, with 44.3% newly prescribed higher QT-prolonging potential SSRIs and 55.7% lower QT-prolonging potential SSRIs. Overall, higher versus lower QT-prolonging potential SSRI use was not associated with SCD. However, a greater risk of SCD was associated with higher versus lower QT-prolonging potential SSRI use among patients with baseline potassium gradients ≥4 mEq/l but not among those with gradients <4 mEq/l versus 0.95.
AHRQ-funded; HS026801.
Citation: Assimon MM, Pun PH, Al-Khatib SM .
The modifying effect of the serum-to-dialysate potassium gradient on the cardiovascular safety of SSRIs in the hemodialysis population: a pharmacoepidemiologic study.
Nephrol Dial Transplant 2022 Oct 19;37(11):2241-52. doi: 10.1093/ndt/gfac214..
Keywords: Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events
Lusk C, Catchpole K, Neyens DM
Improving safety in the operating room: medication icon labels increase visibility and discrimination.
The purpose of this study was to assess whether the addition of icons to medication labels in an operating room setting would improve visibility and reduce medication administration errors. The multi-disciplinary team of researchers added icons to medication labels applied to vasoactive medication infusions, and the study found that participants were 1.12 times more likely to correctly identify medications with icons from farther away. In addition, when icons were present on the labels, participants were 2.16 times more likely to be more confident in their identifications.
AHRQ-funded; HS026625.
Citation: Lusk C, Catchpole K, Neyens DM .
Improving safety in the operating room: medication icon labels increase visibility and discrimination.
Appl Ergon 2022 Oct;104:103831. doi: 10.1016/j.apergo.2022.103831..
Keywords: Medication: Safety, Medication, Patient Safety, Medical Errors, Adverse Drug Events (ADE), Adverse Events
Villa-Zapata L, Gómez-Lumbreras A, Horn J
A disproportionality analysis of drug-drug interactions of tizanidine and CYP1A2 inhibitors from the FDA Adverse Event Reporting System (FAERS).
This study’s aim was to examine the occurrence of adverse events reported in the FDA Adverse Event Reporting System (FAERS) involving the combination of tizanidine and drugs that inhibit the metabolic activity of CYP1A2. Tizanidine is used to help control muscle spasticity. From 2004 quarter 1 through 2020 quarter 3 a total of 89 reports were identified mentioning tizanidine, at least one CYP1A2 inhibitor, and one of the adverse events of interest including: hypotension, bradycardia, syncope, shock, cardiorespiratory arrest, and fall or fracture. More than half the reports identified tizanidine as having a suspect or interacting role, and the reports more frequently involved women (65.1%). The median age was 56.1 years. Hypotension had the highest odds for adverse event reports involving tizanidine and a CYP1A2 inhibitor which can lead to falls and fractures.
AHRQ-funded; HS025984.
Citation: Villa-Zapata L, Gómez-Lumbreras A, Horn J .
A disproportionality analysis of drug-drug interactions of tizanidine and CYP1A2 inhibitors from the FDA Adverse Event Reporting System (FAERS).
Drug Saf 2022 Aug;45(8):863-71. doi: 10.1007/s40264-022-01200-4..
Keywords: Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events, Medication: Safety, Patient Safety
Lai LY, Oerline MK, Caram MEV
Risk of metabolic and cardiovascular adverse events with abiraterone or enzalutamide among men with advanced prostate cancer.
Investigators examined the association between the use of abiraterone or enzalutamide and the risk of metabolic or cardiovascular adverse events while on treatment for advanced prostate cancer. They found that, compared with men not receiving abiraterone, men receiving abiraterone were at increased risk of both a major composite adverse event and a minor composite adverse event. Compared with men not receiving enzalutamide, men receiving enzalutamide were at an increased risk of a major composite adverse event but not a minor composite adverse event. They recommended careful monitoring and management of men on abiraterone or enzalutamide through team-based approaches.
AHRQ-funded; HS027507.
Citation: Lai LY, Oerline MK, Caram MEV .
Risk of metabolic and cardiovascular adverse events with abiraterone or enzalutamide among men with advanced prostate cancer.
J Natl Cancer Inst 2022 Aug 8;114(8):1127-34. doi: 10.1093/jnci/djac081..
Keywords: Cardiovascular Conditions, Cancer: Prostate Cancer, Cancer, Risk, Adverse Events, Medication, Adverse Drug Events (ADE), Medication: Safety, Patient Safety
Gonzales HM, Fleming JN, Gebregziabher M
A critical analysis of the specific pharmacist interventions and risk assessments during the 12-month TRANSAFE Rx randomized controlled trial.
The objective of this study was to describe frequency and types of interventions made during a pharmacist-led, mobile health-based intervention of high-risk kidney transplant (KTX) recipients and to assess impact on patient risk levels. Primary pharmacist intervention types were medication reconciliation, patient education, and medication changes. The authors concluded that pharmacist-led mHealth may enhance opportunities for interventions and mitigate risk levels in KTX recipients.
AHRQ-funded; HS023754.
Citation: Gonzales HM, Fleming JN, Gebregziabher M .
A critical analysis of the specific pharmacist interventions and risk assessments during the 12-month TRANSAFE Rx randomized controlled trial.
Ann Pharmacother 2022 Jun; 56(6):685-90. doi: 10.1177/10600280211044792..
Keywords: Provider: Pharmacist, Medication: Safety, Medication, Risk, Transplantation, Kidney Disease and Health, Adverse Drug Events (ADE), Medical Errors, Patient Safety
Yerneni S, Shah S, Blackley SV
Heterogeneity of drug allergies and reaction lists in two U.S. healthcare systems' electronic health records.
This study compared adverse drug reaction (ADRs) picklists for clinicians in the electronic health record (EHR) allergy list for two different healthcare institutions. The authors used data from the EHRs of patients who visited the emergency department or outpatient clinics at Brigham and Women's Hospital (BWH) and University of Colorado Hospital (UCH) from 2013-2018. They investigated the reactions on each picklist and compared the top 40 reactions at each institution, as well as the top 10 reactions within each drug class. Out of 2,160,116 patients sampled, 30% reported active drug allergies. The most commonly reported drug class allergens were similar between the two institutions, however BWH’s picklist had 48 reactions while UCH’s had 160. Twenty-nine reactions were shared by both picklists. There was a lot more granularity with UCH’s picklist so that body locality, swelling and edema were described in much greater detail than for BWH. These picklists may partially explain variations in reported ADRs across healthcare systems.
AHRQ-funded; HS025375.
Citation: Yerneni S, Shah S, Blackley SV .
Heterogeneity of drug allergies and reaction lists in two U.S. healthcare systems' electronic health records.
Appl Clin Inform 2022 May 26;13(3):741-51. doi: 10.1055/a-1862-9425..
Keywords: Electronic Health Records (EHRs), Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events, Medication: Safety, Patient Safety
Marcaccio CL, Patel PB, Wang S
Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia.
This study’s goal was to examine the effects of different postoperative antithrombotic regimens on 3-year clinical outcomes after infrapopliteal bypass for chronic limb-threatening ischemia (CLTI). The authors identified patients who had undergone infrapopliteal bypass for CLTI in the Vascular Quality Initiative (VQI) registry from 2003 to 2017 with linkage to Medicare claims for long-term outcomes. They divided the patients into three cohorts according to the discharge antithrombotic regimen: single-antiplatelet therapy (SAPT; aspirin or clopidogrel), dual antiplatelet therapy (DAPT; aspirin and clopidogrel), or anticoagulation (AC) plus any antiplatelet (AP) agent. To reduce selection bias, they restricted the analysis cohorts to patients treated by providers who discharged >50% of patients with each antithrombotic regimen. Their primary outcome was 3-year major adverse limb events (MALE; major amputation or reintervention). Among 1812 patients with a median follow-up time of >2 years, 693 (38%) were discharged with SAPT, 544 (30%) with DAPT, and 575 (32%) with AC+AP. At 3 years, MALE rates were 75% with DAPT, 74% with AC+AP, and 68% with SAPT. In adjusted analyses with SAPT as the reference group, no differences were found in 3-year MALE with DAPT or AC+AP. Across the treatment groups, we also found no differences in the individual end points of 3-year major amputation (DAPT: aHR, 0.98; AC+AP: aHR, 1.3), reintervention (DAPT: aHR, 1.0; AC+AP: aHR, 1.1), or mortality (DAPT: aHR, 1.1; AC+AP: aHR, 0.95).
AHRQ-funded; HS027285.
Citation: Marcaccio CL, Patel PB, Wang S .
Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia.
J Vasc Surg 2022 May; 75(5):1696-706.e4. doi: 10.1016/j.jvs.2022.01.011..
Keywords: Cardiovascular Conditions, Medication, Adverse Drug Events (ADE), Adverse Events, Patient Safety, Surgery, Medication: Safety
Chen C, Winterstein AG, Lo-Ciganic WH
Concurrent use of prescription gabapentinoids with opioids and risk for fall-related injury among older US Medicare beneficiaries with chronic noncancer pain: a population-based cohort study.
This study compared the risk of fall-related injury in two cohorts who used gabapentinoids concurrently with opioid use and those who used opioids only. The authors created 2 cohorts based on whether concurrent users initiated gabapentinoids on the day of opioid initiation (Cohort 1) or after opioid initiation (Cohort 2). Both cohorts were identified from a sample of older Medicare beneficiaries with chronic non-cancer pain (CNCP). Four concurrent users were matched up with 1 opioid-only user. They identified 6,733 concurrent users and 27,092 matched opioid-only users in Cohort 1 and 5,709 concurrent users and 22,388 matched opioid-only users in Cohort 2. Cohort 1’s incidence rate of fall-related injury was 24.5 per 100 person-users during follow-up and was 18.0 per 100-person-years during follow-up for Cohort 2. Concurrent users had had similar risk of fall-related injury as opioid-only users in Cohort 1 but had higher risk for fall-related injury than opioid-only users in Cohort 2.
AHRQ-funded; HS027230.
Citation: Chen C, Winterstein AG, Lo-Ciganic WH .
Concurrent use of prescription gabapentinoids with opioids and risk for fall-related injury among older US Medicare beneficiaries with chronic noncancer pain: a population-based cohort study.
PLoS Med 2022 Mar;19(3):e1003921. doi: 10.1371/journal.pmed.1003921..
Keywords: Elderly, Opioids, Medication, Medication: Safety, Adverse Drug Events (ADE), Adverse Events, Falls, Patient Safety, Injuries and Wounds, Pain, Chronic Conditions
Tzeng HM, Raji MA, Chou LN
Impact of state nurse practitioner regulations on potentially inappropriate medication prescribing between physicians and nurse practitioners: a national study in the United States.
The American Geriatrics Society regularly updates the Beers Criteria for Potentially Inappropriate Medication (PIM) to improve prescribing safety. This study assessed the impact of nurse practitioner (NP) practices on PIM prescribing across states in the United States and compared the change in PIM prescribing rates between 2016 and 2018. The investigators found that the PIM prescription rate was lower in states with full NP practice and lower among NPs than among physicians; these rates for both physicians and NPs decreased from 2016 to 2018.
AHRQ-funded; HS020642.
Citation: Tzeng HM, Raji MA, Chou LN .
Impact of state nurse practitioner regulations on potentially inappropriate medication prescribing between physicians and nurse practitioners: a national study in the United States.
J Nurs Care Qual 2022 Jan-Mar;37(1):6-13. doi: 10.1097/ncq.0000000000000595..
Keywords: Medication, Medication: Safety, Provider: Nurse, Adverse Drug Events (ADE), Adverse Events, Policy
Wei YJ, Chen C, Lewis MO
Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: a nested case-control study.
This study used a sample of older patients who are Medicare beneficiaries who were newly prescribed opioids to determine rates of 4 prescription opioid dose trajectories and the risk of opioid-related adverse events (ORAEs). A 5% random sample of Medicare beneficiaries from 2011 to 2018 was used to conduct a nested case-control study of patients age 65 and older who were newly diagnosed with chronic noncancer pain (CNCP). Among the cases and controls, 2,192 (70.6%) were women and mean age was 77.1 years. Four prescribed opioid trajectories before the incident ORAE diagnosis or matched date emerged: gradual dose discontinuation (from ≤3 to 0 daily morphine milligram equivalent (MME), 1,456 [23.5%]), gradual dose increase (from 0 to >3 daily MME, 1,878 [30.3%]), consistent low dose (between 3 and 5 daily MME, 1,510 [24.3%]), and consistent moderate dose (>20 daily MME, 1,362 [22.0%]). Less than 5% were prescribed a mean daily dose of ≥90 daily MME during 6 months before diagnosis or matched date. Patients with gradual dose discontinuation versus those with a consistent low or moderate dose, and increase dose were more likely to be 65 to 74 years, Midwest US residents, and receiving no low-income subsidy. Those with gradual dose increase and consistent moderate dose had a higher risk of ORAE, after adjustment for covariates.
AHRQ-funded; HS027230.
Citation: Wei YJ, Chen C, Lewis MO .
Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: a nested case-control study.
PLoS Med 2022 Mar;19(3):e1003947. doi: 10.1371/journal.pmed.1003947..
Keywords: Elderly, Opioids, Medication, Adverse Drug Events (ADE), Adverse Events, Risk, Chronic Conditions, Pain, Substance Abuse, Behavioral Health, Medication: Safety, Patient Safety
Martin BA, Breslow RM, Sims A
Identifying over-the-counter information to prioritize for the purpose of reducing adverse drug reactions in older adults: a national survey of pharmacists.
This study’s objective was to determine which information on over-the-counter (OTC) Drug Facts Labels (DFS) is most critical in reducing adverse drug reactions (ADRs) among older adults and should be placed in front of the label. A national survey of practicing pharmacists knowledgeable about OTC medication use by older adults asked respondents to rank order the importance of the DFL sections to reduce ADRs. A total of 318 responses were analyzed. There was high consensus that uses and purposes, active ingredient, warnings, and directions for use were the most important sections on the label. Two specific warnings “Do not use” and “Ask a doctor or pharmacist” were deemed most important in the warnings section.
AHRQ-funded; HS025386.
Citation: Martin BA, Breslow RM, Sims A .
Identifying over-the-counter information to prioritize for the purpose of reducing adverse drug reactions in older adults: a national survey of pharmacists.
J Am Pharm Assoc 2022 Jan-Feb;62(1):167-75.e1. doi: 10.1016/j.japh.2021.08.019..
Keywords: Elderly, Medication: Safety, Medication, Adverse Drug Events (ADE), Adverse Events, Patient Safety, Health Literacy, Education: Patient and Caregiver