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Research Studies is a monthly compilation of research articles funded by AHRQ or authored by AHRQ researchers and recently published in journals or newsletters.
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1 to 25 of 299 Research Studies DisplayedTan 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
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
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)
Vallamkonda S, Ortega CA, Lo YC
Identifying and reconciling patients' allergy information within the electronic health record.
The authors examined the prevalence of incompleteness, inaccuracy, and redundancy of allergy information within the electronic health record (EHR) for patients with a clinical encounter at any Mass General Brigham facility between January 1 and December 31, 2018. They identified 4 key places in the EHR containing reconcilable allergy information and determined that 45.2% of the patients had an active allergy entry, with 37.1% indicating a need for reconciliation.
AHRQ-funded; HS025375.
Citation: Vallamkonda S, Ortega CA, Lo YC .
Identifying and reconciling patients' allergy information within the electronic health record.
Stud Health Technol Inform 2022 Jun 6;290:120-24. doi: 10.3233/shti220044..
Keywords: Electronic Health Records (EHRs), Health Information Technology (HIT), Medication, Adverse Drug Events (ADE), Adverse Events
Villa Zapata L, Subbian V, Boyce RD
Overriding drug-drug interaction alerts in clinical decision support systems: a scoping review.
The authors reviewed published data on the rate of Drug-Drug Interactions (DDI) alert overrides and medications involved in the overrides. Among 34 eligible studies, they found that the override rate of DDI alerts ranged from 55% to 98%, with more than half of the studies reporting the most common drug pairs or medications involved in acceptance or overriding of alerts. They recommended decision support systems that take user, drug, and institutional factors into consideration, as well as actionable metrics to better characterize harm associated with overrides.
AHRQ-funded; HS025984; HS023826.
Citation: Villa Zapata L, Subbian V, Boyce RD .
Overriding drug-drug interaction alerts in clinical decision support systems: a scoping review.
Stud Health Technol Inform 2022 Jun 6;290:380-84. doi: 10.3233/shti220101..
Keywords: Clinical Decision Support (CDS), Health Information Technology (HIT), Adverse Drug Events (ADE), Adverse Events, Medication
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
Giannouchos TV, Gómez-Lumbreras A, Malone DC
Risk of tizanidine-induced adverse events after concomitant exposure to ciprofloxacin: a cohort study in the U.S.
This study’s aim was to assess the risk of hypotension with coadministration of tizanidine (a painkiller medicine) and ciprofloxacin (an antibiotic). An observational nested cohort study was conducted using patients 18 years or older on tizanidine using data from electronic health records from 2000 to 2018 in the US. The analysis included 70,110 encounters across 221 hospitals. Most encounters were female (65.7%), whites (82.4%) with an average age of 56 years and an Elixhauser comorbidity index of 1.6. Only 2487 encounters (3.6%) had a co-administration of ciprofloxacin. An increased likelihood of hypotension was associated with co-administration compared to patients who did not receive ciprofloxacin.
AHRQ-funded; HS025984.
Citation: Giannouchos TV, Gómez-Lumbreras A, Malone DC .
Risk of tizanidine-induced adverse events after concomitant exposure to ciprofloxacin: a cohort study in the U.S.
Am J Emerg Med 2022 May;55:147-51. doi: 10.1016/j.ajem.2022.03.008..
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Risk
Butler AM, Durkin MJ, Keller MR
Association of adverse events with antibiotic treatment for urinary tract infection.
The purpose of this study was to compare the risk of relative harms associated with different antibiotics prescribed for the treatment of uncomplicated urinary tract infection (UTI). The researchers identified 1,169,033 healthy, nonpregnant women between the ages of 18 to 44 who had an uncomplicated UTI and who initiated an oral antibiotic regimen for the treatment of common uropathogens between July 2006 and September 2015. The study found that of the two first-line treatments, the drug trimethoprim-sulfamethoxazole (versus nitrofurantoin) was associated with a higher risk of adverse drug-related events including: hypersensitivity, acute renal failure, skin rash, urticaria, abdominal pain, and nausea/ vomiting, but a similar risk of adverse possible microbiome-related events. When researchers compared non-first line drugs with nitrofurantoin, the non-first line drugs were associated with a greater risk of adverse drug events and possible microbiome-related adverse events including non-Clostridium difficile diarrhea, C. difficile infection, vaginitis/vulvovaginal candidiasis, and pneumonia. The duration of the treatment influenced the risk of possible microbiome-related adverse events. The study concluded that the risk of adverse events differs widely by both antibiotic drug and duration of regimen.
AHRQ-funded; HS019455.
Citation: Butler AM, Durkin MJ, Keller MR .
Association of adverse events with antibiotic treatment for urinary tract infection.
Clin Infect Dis 2022 Apr 28;74(8):1408-18. doi: 10.1093/cid/ciab637..
Keywords: Antibiotics, Medication, Urinary Tract Infection (UTI), Adverse Drug Events (ADE), Adverse Events, Clostridium difficile Infections
Barkun AN, Douketis J, Noseworthy PA
Management of patients on anticoagulants and antiplatelets during acute gastrointestinal bleeding and the peri-endoscopic period: a clinical practice guideline dissemination tool.
The American College of Gastroenterology and the Canadian Association of Gastroenterology jointly created recommendations on the management of anticoagulants and antiplatelets during acute gastrointestinal (GI) bleeding and the elective per-endoscopic period. The clinical practice guideline (CPG) panel was restricted in making strong recommendations regarding some relevant clinical questions because of the limited certainty of evidence in the literature. The purpose of this paper was to describe a clinical practice guideline dissemination tool for the management of patients on anticoagulants and antiplatelets during acute gastrointestinal bleeding and the peri-endoscopic period. The dissemination tool addresses provider concerns about limited certainty of evidence in the literature by providing clinicians with a companion piece to execute recommendations with contextual guidance and practical algorithms. The patient’s risks of a thromboembolic event versus the procedural risk of GI bleeding is taken into account in the implementation of the tool. The authors concluded that the clinical practice guideline dissemination tool provides both contextual information in interpreting the clinical guideline panel’s recommendations and algorithmic guidance for common scenarios encountered during endoscopic practice.
AHRQ-funded; HS025402.
Citation: Barkun AN, Douketis J, Noseworthy PA .
Management of patients on anticoagulants and antiplatelets during acute gastrointestinal bleeding and the peri-endoscopic period: a clinical practice guideline dissemination tool.
Am J Gastroenterol 2022 Apr;117(4):513-19. doi: 10.14309/ajg.0000000000001688..
Keywords: Blood Thinners, Medication, Adverse Drug Events (ADE), Adverse Events, Evidence-Based Practice, Guidelines
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
Yunusa I, Gagne JJ, Yoshida K
Risk of opioid overdose associated with concomitant use of oxycodone and selective serotonin reuptake inhibitors.
Oxycodone is a potent prescription opioid. Some Selective Serotonin Reuptake Inhibitors (SSRIs) inhibit oxycodone metabolism in the body, but the clinical consequences of this interaction on overdose risk have not been adequately determined. The study researchers compared the rates of opioid overdoses in patients who had initiated oxycodone while taking enzyme-inhibiting SSRIs with the overdose rates of patents who had initiated oxycodone while taking non-enzyme inhibiting SSRIs. Data from 3 U.S. health insurance databases was used to analyze a cohort of adults who initiated oxycodone while receiving SSRI therapy between the years 2000 and 2020. Of the total of 2,037,490 who initiated oxycodone, 69.6% were receiving SSRIs at the time of the initiation of the oxycodone. One-thousand-thirty-five overdose events were observed during this time, and the resulting incidence rate in those initiating oxycodone while using enzyme-inhibiting SSRI’s was higher than in those using other SSRIs. The researchers concluded that in the study cohort of U.S. adults, there is a small increased risk of opioid overdose when initiating oxycodone in patients taking enzyme-inhibiting SSRIs.
AHRQ-funded; HS027623.
Citation: Yunusa I, Gagne JJ, Yoshida K .
Risk of opioid overdose associated with concomitant use of oxycodone and selective serotonin reuptake inhibitors.
JAMA Netw Open 2022 Feb;5(2):e220194. doi: 10.1001/jamanetworkopen.2022.0194..
Keywords: Opioids, Medication, Risk, Depression, Adverse Drug Events (ADE), Adverse Events
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
Herzig SJ, Anderson TS,, Jung y
Risk factors for opioid-related adverse drug events among older adults after hospital discharge.
This study examined patient- and prescribing-related risk factors for opioid-related adverse drug events (ADEs) after hospital discharge among medical patients. Administrative billing codes and medication claims were used to define potential opioid-related ADEs within 30 days of hospital discharge. Findings showed that potential opioid-related ADEs occurred in 7% of older adults discharged from a medical hospitalization with an opioid prescription. Recommendations included using identified risk factors to inform physician decision-making, having conversations with older adults about risk, and increasing development and targeting of harm reduction strategies.
AHRQ-funded; HS026215.
Citation: Herzig SJ, Anderson TS,, Jung y .
Risk factors for opioid-related adverse drug events among older adults after hospital discharge.
J Am Geriatr Soc 2022 Jan;70(1):228-34. doi: 10.1111/jgs.17453..
Keywords: Elderly, Opioids, Risk, Adverse Drug Events (ADE), Adverse Events, Medication, Hospital Discharge
Nanji KC, Shaikh SD, Jaffari A
A Monte Carlo simulation to estimate the additional cost associated with adverse medication events leading to intraoperative hypotension and/or hypertension in the United States.
This study’s objective was to estimate the rates of clinically significant intraoperative hypotension and hypertension. Systematic literature reviews were conducted to estimate incidence and additional costs of acute kidney injury (AKI), acute myocardial injury, and stroke after intraoperative hypotension and hypertension. The authors used Monte Carlo simulation to estimate annual costs to the U.S. healthcare system. Intraoperative hypotension occurred in 11 of 277 operations (3.97%), a >30% drop in baseline mean arterial pressure hypotension in patients with coronary artery disease in 9 operations (3.25%), and hypertension in 14 operations (5.05%). After hypertension, incremental stroke incidence was 4.76%. The authors estimated 11,513 cases of AKI, 5914 cases of acute myocardial injury, 345 cases of stroke after intraoperative hypotension, and 47,774 cases of stroke after intraoperative hypertension. Estimated costs were $1.7 billion, of which $923 million are preventable.
AHRQ-funded; HS024764.
Citation: Nanji KC, Shaikh SD, Jaffari A .
A Monte Carlo simulation to estimate the additional cost associated with adverse medication events leading to intraoperative hypotension and/or hypertension in the United States.
J Patient Saf 2021 Dec 1;17(8):e758-e64. doi: 10.1097/pts.0000000000000926..
Keywords: Medication, Adverse Drug Events (ADE), Adverse Events, Healthcare Costs
