Search all AHRQ sites
Menu
SHARE:
AHRQ Research Studies
Sign up: 
AHRQ Research Studies Email updates
Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 25 of 311 Research Studies DisplayedMarcaccio 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
Zhang J, Kummerfield E, Hultman G
Application of causal discovery algorithms in studying the nephrotoxicity of remdesivir using longitudinal data from the EHR.
Researchers analyzed the role of remdesivir in the mechanism and optimal treatment of the development of acute kidney injury (AKI) in the setting of COVID. Applying causal discovery machine learning techniques, they built multifactorial causal models of COVID-AKI; risk factors and renal function measures were represented in a temporal sequence using longitudinal data from Electronic Health Records. Their results indicated a need for assessment of renal function on second- and third-day use of remdesivir, and also showed that remdesivir may pose less risk to AKI than existing conditions of chronic kidney disease.
AHRQ-funded; HS024532.
Citation: Zhang J, Kummerfield E, Hultman G .
Application of causal discovery algorithms in studying the nephrotoxicity of remdesivir using longitudinal data from the EHR.
AMIA Annu Symp Proc 2023 Apr 29; 2022:1227-36..
Keywords: COVID-19, Electronic Health Records (EHRs), Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events
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
Gamyroulas EM, Jones AE, Saunders JA
Trends in antiplatelet strategies 12-months following coronary stent placement in anticoagulated patients.
The guidelines for antithrombotic management in individuals undergoing percutaneous coronary interventions (PCIs) who also necessitate anticoagulant treatment are continually developing. The purpose of this study is to examine adjustments to antithrombotic regimens and correlated outcomes within a year following PCI in patients needing continued anticoagulation therapy. Data from patients discovered through electronic medical record searches were manually assessed to validate alterations in antithrombotic treatment from discharge up to one year post-PCI, as well as episodes of significant bleeding, clinically relevant non-major bleeding (CRNMB), major adverse cardiovascular or neurological events (MACNE), and all-cause mortality outcomes during an extra six-month follow-up period. The study found that one year after PCI, patients (n = 120) undergoing anticoagulation treatment were categorized based on their antiplatelet therapy status: no antiplatelet therapy (n = 16), single antiplatelet therapy (SAPT) (n = 85), or dual antiplatelet therapy (DAPT) (n = 19). Between 12 and 18 months post-PCI, there were two significant bleeds, seven CRNMB events, six MACNE incidents, two venous thromboembolisms, and five fatalities. All but one bleeding occurrence transpired in the SAPT group. The likelihood of maintaining DAPT at 12 months was elevated in patients who underwent PCI for acute coronary syndrome and those who experienced MACNE within one year post-PCI; however, these associations did not reach statistical significance.
AHRQ-funded; HS027960
Citation: Gamyroulas EM, Jones AE, Saunders JA .
Trends in antiplatelet strategies 12-months following coronary stent placement in anticoagulated patients.
BMC Cardiovasc Disord 2023 Mar 8;23(1):117. doi: 10.1186/s12872-023-03161-7.
Keywords: Blood Thinners, Medication, Heart Disease and Health, Cardiovascular Conditions, Adverse Drug Events (ADE), Adverse Events
Hansten PD, Tan MS, Horn JR
Colchicine drug interaction errors and misunderstandings: recommendations for improved evidence-based management.
Colchicine serves as an effective therapy for the management and prevention of gout and various other medical conditions. As a substrate for CYP3A4 and P-glycoprotein (P-gp), its simultaneous use with CYP3A4/P-gp inhibitors can lead to critical drug-drug interactions (DDIs) that may result in pancytopenia, multiorgan dysfunction, and cardiac irregularities. Additionally, colchicine's potential for myotoxicity could elevate the risk of myopathy and rhabdomyolysis when combined with other myotoxic medications. Numerous sources of DDI information, encompassing journal articles, product labels, and online resources, contain inaccuracies or vague statements regarding colchicine's interactions with other drugs and subpar guidance on managing DDIs to minimize patient harm. Moreover, assessments of the clinical significance of specific colchicine DDIs can differ substantially between sources. The purpose of this study was to present an evidence-based analysis of drugs that are likely to interact with colchicine, as well as those that have been cited to interact but are improbable to do so. Based on these assessments, the researchers proposes strategies to mitigate the risk of severe adverse consequences from colchicine DDIs. The frequent recommendation to decrease colchicine dosage when administered with CYP3A4/P-gp inhibitors may, in some cases, lead to colchicine toxicity or therapeutic failure. An exhaustive evaluation of nearly 100 documented instances of colchicine DDIs is provided in a table within the electronic supplementary material. While colchicine is a beneficial medication, enhancements to the available information on colchicine DDIs are necessary to reduce the risk of serious adverse events.
AHRQ-funded; HS025984
Citation: Hansten PD, Tan MS, Horn JR .
Colchicine drug interaction errors and misunderstandings: recommendations for improved evidence-based management.
Drug Saf 2023 Mar;46(3):223-42. doi: 10.1007/s40264-022-01265-1.
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Medical Errors, Evidence-Based Practice
Stone CA, Jr., Robinson LB, Li L
Clinical phenotypes of immediate first-dose reactions to mRNA COVID-19: a multicenter latent class analysis.
The objectives of this retrospective study were to define distinct clinical phenotypes of immediate reactions after dose 1 of mRNA COVID-19 vaccination, and to assess the relation of clinical phenotype to mRNA COVID-19 vaccine second dose tolerance. Researchers identified 265 patients who experienced dose-1 immediate reactions with 3 phenotype clusters: limited or predominantly cutaneous, sensory, or systemic. Of these, 223 patients received a second dose and 200 tolerated the second dose; sensory cluster (numbness or tingling) was associated with a higher likelihood of second dose intolerance, but this finding did not persist when accounting for objective signs.
AHRQ-funded; HS026395.
Citation: Stone CA, Jr., Robinson LB, Li L .
Clinical phenotypes of immediate first-dose reactions to mRNA COVID-19: a multicenter latent class analysis.
J Allergy Clin Immunol Pract 2023 Feb;11(2):458-65.e1. doi: 10.1016/j.jaip.2022.08.048.
Keywords: COVID-19, Medication, Adverse Drug Events (ADE), Adverse Events, Infectious Diseases, Vaccination
Ehmann MR, Mitchell J, Levin S
Renal outcomes following intravenous contrast administration in patients with acute kidney injury: a multi-site retrospective propensity-adjusted analysis.
The purpose of this retrospective study was to investigate the relationship between intravenous contrast media (CM) administration and persistent acute kidney injury (AKI) in patients with pre-existing AKI. The researchers used propensity-weighted and entropy-balanced observational cohort analysis of consecutive hospitalized patients aged 18 years or older who met the Kidney Disease Improving Global Outcomes (KDIGO) creatinine-based criteria for AKI upon arrival at one of three emergency departments between 7/ 2017 and 6/2021. Patients either received or did not receive intravenous CM. The analysis included 14,449 patient encounters, with 12.8% admitted to the intensive care unit (ICU). The study found that CM was administered in 18.4% of all encounters. AKI resolved before hospital discharge in 69.1% of cases. No association between intravenous CM administration and persistent AKI was found after unadjusted multivariable logistic regression modeling, propensity weighting, and entropy balancing. Similar results were obtained from sub-group analysis of patients admitted to the ICU. Initiation of dialysis within 180 days occurred in 5.4% of the cohort, with no observed association between CM administration and increased risk of dialysis within this timeframe.
AHRQ-funded; HS027793; HS02664002.
Citation: Ehmann MR, Mitchell J, Levin S .
Renal outcomes following intravenous contrast administration in patients with acute kidney injury: a multi-site retrospective propensity-adjusted analysis.
Intensive Care Med 2023 Feb; 49(2):205-15. doi: 10.1007/s00134-022-06966-w..
Keywords: Kidney Disease and Health, Adverse Drug Events (ADE), Adverse Events, Outcomes
Encinosa W, Moon K, Figueroa J
Complications, adverse drug events, high costs, and disparities in multisystem inflammatory syndrome in children vs COVID-19.
This cross-sectional study’s goal was to determine outcomes from multisystem inflammatory syndrome in children (MIS-C) after COVID-19. Outcomes examined were 50 complications, adverse medication events, costs, and the Social Vulnerability Index. An analysis was conducted using data from the 2021 HCUP in individuals younger than 21 years from 31 states. There were 4107 individuals hospitalized with MIS-C (median age 9 years, 59.5% male, 38.1% White) and 23,686 hospitalizations for COVID-19 without MIS-C (median age 15 years, 54.5% female, 44.1% White). Hospitalization rate for MIS-C was 1.48 per 100,000 children, ranging from 0.97 hospitalizations per 100 for White and 1.99 hospitalizations per 100 for Black children. Outcomes were worse when organ dysfunction increased from 2 to 8 organs, with deaths increasing from less than 1% to 5.8% for MIS-C, and 1% to 17.2% for COVID-19. Median length of stay increased from 4 to 8 days for MIS-C, and 3 to 16 days for COVID-19. Median costs for MIS-C increased from $16,225 to $53 359 and from $6474 to $98,643 for COVID-19. The percentage of MIS-C cases in Black children doubled from 16.2% to 31.7% as organ dysfunction increased, remaining unchanged with COVID-19.
AHRQ-authored.
Citation: Encinosa W, Moon K, Figueroa J .
Complications, adverse drug events, high costs, and disparities in multisystem inflammatory syndrome in children vs COVID-19.
JAMA Netw Open 2023 Jan;6(1):e2244975. doi: 10.1001/jamanetworkopen.2022.44975..
Keywords: Healthcare Cost and Utilization Project (HCUP), Children/Adolescents, COVID-19, Medication, Adverse Drug Events (ADE), Adverse Events, Healthcare Costs, Disparities, Racial and Ethnic Minorities
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
Gibbons RD, Hur K, Lavigne JE
Association between folic acid prescription fills and suicide attempts and intentional self-harm among privately insured US adults.
This paper describes a large-scale pharmacoepidemiologic study of folic acid prescription fills to determine if there is a decreased risk of suicide attempt. Data were collected from a pharmacoepidemiologic database of US medical claims (MarketScan) for 866,586 patients with private health insurance who filled a folic acid prescription from 2012 to 2017. In the cohort 81.3% were female, and 10.42% were 60 years and older. Overall, there were 261 suicidal events during covered by a folic acid prescription for a rate of 4.73 per 100,000 person-months, compared with 895 suicidal events during months without folic acid for a rate of 10.61 per 100,000 person-months. Adjusting for age and sex, diagnoses related to suicidal behavior, diagnoses related to folic acid deficiency, folate-reducing medications, history of folate-reducing medications, and history of suicidal events, the hazard ratio (HR) for folic acid for suicide events was 0.56, with similar results for the modal dosage of 1 mg of folic acid per day and women of childbearing age. The same association with the negative control cyanocobalamin found no association with suicide attempt.
AHRQ-funded; HS016973.
Citation: Gibbons RD, Hur K, Lavigne JE .
Association between folic acid prescription fills and suicide attempts and intentional self-harm among privately insured US adults.
JAMA Psychiatry 2022 Nov;79(11):118-1123. doi: 10.1001/jamapsychiatry.2022.2990..
Keywords: Medication, Behavioral Health, Adverse Drug Events (ADE), Adverse Events
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
Jiang Y, Mason M, Cho Y
Tolerance to oral anticancer agent treatment in older adults with cancer: a secondary analysis of data from electronic health records and a pilot study of patient-reported outcomes.
The purpose of this study was to explore the tolerance of capecitabine oral chemotherapy among older adults with cancer and investigate factors associated with related side effects and treatment changes. The researchers combined data from electronic health records and a pilot study of patient-reported outcomes, and found that older adults were more likely to experience fatigue and experienced more severe fatigue and hand-foot syndrome (HFS) than younger adults. The severity of fatigue and HFS were associated with the number of outpatient medications and the duration of treatment respectively. Female sex, breast cancer diagnosis, capecitabine monotherapy, and severe HFS were found to be associated with subsequent dose reductions. The study concluded that older adults were less likely to tolerate capecitabine treatment and had different co-occurring side effects compared to younger adults.
AHRQ-funded; HS027846.
Citation: Jiang Y, Mason M, Cho Y .
Tolerance to oral anticancer agent treatment in older adults with cancer: a secondary analysis of data from electronic health records and a pilot study of patient-reported outcomes.
BMC Cancer 2022 Sep 3;22(1):950. doi: 10.1186/s12885-022-10026-3..
Keywords: Elderly, Cancer, Medication, Adverse Drug Events (ADE), Adverse Events, Electronic Health Records (EHRs), Health Information Technology (HIT)
Wei YJ, Chen C, Cheng TD
Association of injury after prescription opioid initiation with risk for opioid-related adverse events among older Medicare beneficiaries in the United States: a nested case-control study.
This study’s objectives were to examine the association between incident injury after prescription opioid initiation and subsequent risk of opioid-related adverse events (ORAEs) and to assess whether the association differs by recency of injury among older patients. The researchers observed that incident diagnosis of injury following opioid initiation was associated with subsequent increased risk of ORAEs, and the risk was only significant among patients with injury in the month before the index date. They recommended regular monitoring for injury in order to identify older opioid users at high risk for ORAEs.
AHRQ-funded; HS027230.
Citation: Wei YJ, Chen C, Cheng TD .
Association of injury after prescription opioid initiation with risk for opioid-related adverse events among older Medicare beneficiaries in the United States: a nested case-control study.
PLoS Med 2022 Sep;19(9):e1004101. doi: 10.1371/journal.pmed.1004101..
Keywords: Opioids, Medication, Adverse Drug Events (ADE), Substance Abuse, Elderly, Adverse Events
Miano TA, Hennessy S, Yang W
Association of vancomycin plus piperacillin-tazobactam with early changes in creatinine versus cystatin C in critically ill adults: a prospective cohort study.
The purpose of this study was to test the hypothesis that the association between vancomycin + piperacillin-tazobactam and increased acute kidney injury (AKI) risk by contrasting changes in creatinine concentration after antibiotic initiation with changes in cystatin C concentration. The researchers included patients enrolled in the Molecular Epidemiology of SepsiS in the ICU (MESSI) prospective cohort who were treated for greater than or equal to 48 h with vancomycin + piperacillin-tazobactam or vancomycin + cefepime. The kidney function biomarkers of blood urea nitrogen (BUN), creatinine, and cystatin C were measured before antibiotic treatment and again on day two after initiation. Creatinine-defined AKI and dialysis were evaluated through day14, and mortality was assessed through day 30. The study found that in the 739 patients vancomycin + piperacillin-tazobactam was associated with a higher percentage increase of creatinine at day-two and a higher incidence of creatinine-defined AKI: rate ratio. Vancomycin + piperacillin-tazobactam was not associated with change in alternative biomarkers. The researchers concluded that the study supports the hypothesis that vancomycin + piperacillin-tazobactam effects on creatinine represent pseudotoxicity.
AHRQ-funded; HS027626.
Citation: Miano TA, Hennessy S, Yang W .
Association of vancomycin plus piperacillin-tazobactam with early changes in creatinine versus cystatin C in critically ill adults: a prospective cohort study.
Intensive Care Med 2022 Sep;48(9):1144-55. doi: 10.1007/s00134-022-06811-0..
Keywords: Critical Care, Medication, Kidney Disease and Health, Adverse Drug Events (ADE), Adverse Events
Koo G, Yu R, Phillips E
Retrospective stratification of cephalosporin allergy label risk using validated penicillin allergy frameworks.
The purpose of this study was to validate whether a history-based risk criteria used for penicillin allergy labels (PALs) is applicable to cephalosporin allergy labels (CALs), or whether there are additional features that require evaluation. From 2014 to 2019, the researchers evaluated a total of 322 patients with a total of 384 CALs in their outpatient drug allergy clinic for a completion of skin testing or a direct oral challenge. A total of 77.1% of patients had a negative testing result and were challenged. A total of 99.1% oral challenges were tolerated, leading to label removal, with 2 failures. 4.9% of patients had negative skin testing results and were delabeled afterward due to reported tolerance of a relevant cephalosporin since their index reaction. 5.6% of patients with negative skin testing result did not undergo oral challenge initially, but subsequently tolerated a cephalosporin treatment, which would trigger delabeling. Therefore, 94.8% of patients included for analysis had a complete cephalosporin allergy evaluation up to the level of either known tolerance or positive testing. Only 5.2% of included patients had complete, negative skin testing result and unknown tolerance of a challenge or treatment. The researchers concluded that history-based risk stratification of CALs appears to be acceptable using the existing validated criteria for penicillin allergy, with the additional note that a reported reaction to an IV cephalosporin may be inherently more likely to test positive, and should be evaluated more carefully.
AHRQ-funded; HS026395.
Citation: Koo G, Yu R, Phillips E .
Retrospective stratification of cephalosporin allergy label risk using validated penicillin allergy frameworks.
J Allergy Clin Immunol Pract 2022 Sep;10(9):2472-75.e1. doi: 10.1016/j.jaip.2022.05.032..
Keywords: Antibiotics, Medication, 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
Khouja T, Zhou J, Gellad WF
Serious opioid-related adverse outcomes associated with opioids prescribed by dentists.
This study’s objective was to evaluate adverse outcomes and persistent opioid use (POU) after opioid prescriptions by dentists, based on whether opioids were overprescribed or within recommendations. A cross-sectional analysis of adults with dental visit and corresponding opioid prescription from 2011 to 2017 within a nationwide commercial claims database was conducted. As per CDC guidelines, opioid overprescribing was defined as >120 morphine milligram equivalents. Of 633,387 visits, 16.6% had POU and 2.6% experienced an adverse outcome. POU was higher when opioids were overprescribed with visits associated with mild pain and those with substance use disorders having the highest risk of both outcomes.
AHRQ-funded; HS025177.
Citation: Khouja T, Zhou J, Gellad WF .
Serious opioid-related adverse outcomes associated with opioids prescribed by dentists.
Pain 2022 Aug 1;163(8):1571-80. doi: 10.1097/j.pain.0000000000002545..
Keywords: Opioids, Dental and Oral Health, Substance Abuse, Behavioral Health, Practice Patterns, Pain, Medication, Adverse Drug Events (ADE), Adverse Events
Banerji A, Norton AE, Blumenthal KG
Rapid progress in our understanding of COVID-19 vaccine allergy: a cause for optimism, not hesitancy.
This paper is a review of current understanding of COVID-19 vaccine allergy. Rapid progress has been made over the past several years in large part due to important research efforts from individuals in the allergy community. Better data has shown safety of repeat vaccination despite an initial reaction. The review ran from December 2020 through early 2022.
AHRQ-funded; HS026395; HS025375
Citation: Banerji A, Norton AE, Blumenthal KG .
Rapid progress in our understanding of COVID-19 vaccine allergy: a cause for optimism, not hesitancy.
J Allergy Clin Immunol 2022 Jul;150(1):12-16. doi: 10.1016/j.jaci.2022.03.023..
Keywords: COVID-19, Vaccination, Adverse Drug Events (ADE), Adverse Events
Reese T, Wright A, Liu S
Improving the specificity of drug-drug interaction alerts: can it be done?
A lack of accuracy and specificity of medication alerts have an impact on alert fatigue, high rates of override, and harm to the patient. The drugs that activate alerts are frequently grouped inconsistently into value sets, and alerts for drug-drug interactions (DDI) often do not account for the factors that could decrease risk. The purpose of this proof-of-concept study was to identify and bring attention to the inconsistency of drug value sets for activating alerts, as well as provide a method of classifying factors that can be utilized to alter the risk of harm from a DDI. The researchers included 15 well-known DDIs, and utilized 3 drug interaction references to isolate 2 drug value sets as well as order- and patient-related factors for each DDI. The study reported 30 value sets, with 56% of value sets (17) having nonsignificant agreement, with average moderate agreement among the remaining 13 value sets. Thirty-three factors were identified that could decrease risk in 93% (14) of the 15 DDIs. The researchers concluded that the study shows the value of improving the consistency of DDI-alerting drug value sets, and ways in which alert usefulness and specificity can be improved.
AHRQ-funded; HS025984; HS023826.
Citation: Reese T, Wright A, Liu S .
Improving the specificity of drug-drug interaction alerts: can it be done?
Am J Health Syst Pharm 2022 Jun 23;79(13):1086-95. doi: 10.1093/ajhp/zxac045..
Keywords: Adverse Drug Events (ADE), Adverse Events, Medication, Clinical Decision Support (CDS), Health Information Technology (HIT)
