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Purpose: Costs of hospitalization due to severe adverse drug reactions (ADRs) were previously estimated within the Veterans Health Administration (VHA), but additional analyses are needed to infer potential interventions to mitigate these negative outcomes. The objective of this study was to compare specific adverse reaction-related hospitalization costs between medications with similar indications., Methods: Mean hospitalization costs associated with the same ADR symptom were compared for different drugs with similar indications using adjusted generalized linear models with a Bonferroni correction for multiple comparisons as well as a gamma distribution., Results: Overall, hospitalization costs between medications with similar indications were not significantly different for specific adverse reactions. However, gastrointestinal hemorrhage-associated costs were higher for warfarin versus nonsteroidal anti-inflammatory drugs (model estimate of mean cost, $18,114 [range of lower and upper model estimates, $12,522-$26,202] vs $14,255 [estimate range, $9,710-$20,929]). Similarly, the estimated mean hospitalization cost associated with angioedema was higher for losartan versus lisinopril or lisinopril/hydrochlorothiazide: $14,591 (range, $9467-$22,488) versus $8,935 (range, $6,301-$12,669) and $8,022 (range, $5,424-$11,865), respectively., Conclusion: Although we found few differences in the cost of hospitalization when comparing drugs with similar indications and the same adverse reaction, there were specific drug-ADR pairs that merit attention and consideration of interventions to improve safe and appropriate medication use. Evaluation of the effect of those interventions on the incidence of ADRs is an area for future study., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2023.)

Purpose: To examine the reporting rates of adverse drug events (ADEs) with apixaban and empagliflozin as reports move up to the next level of spontaneous reporting., Methods: This was a retrospective cohort study of outpatients who discontinued apixaban or empagliflozin within 3 years of Food and Drug Administration (FDA) approval. We enriched the sample using an active surveillance strategy to identify subsets of patients with International Classification of Diseases (ICD) codes possibly associated with an ADE. Stratified random samples of charts were reviewed to determine if patients discontinued the medication due to an ADE. If so, we ascertained whether these were uploaded into the Veterans Administration (VA) electronic health record reporting system (Adverse Reaction Tracking System [ARTS]), VA national Web-based system (VA Adverse Drug Event Reporting System [VA ADERS]), and FDA MedWatch., Results: From the cohort of 2,973 patients who discontinued apixaban, 321 patients (10.8%) were randomly sampled for chart review (including 61 patients with relevant ICD codes). During chart review, 88 ADEs were identified, with 40/61 (65.6%) from the subset with ICD codes. Of the total of 88 ADEs, 18.2%, 10.2%, and 6.8% were reported in ARTS, VA ADERS, and MedWatch, respectively. Of the 1,555 patients who discontinued empagliflozin, 179 patients (11.5%) were randomly sampled for chart review (40 patients with relevant ICD codes). During chart review, 78 ADEs were identified, with 19/40 (47.5%) from the subset with ICD codes. Of the 78 ADEs, 28.2%, 19.2%, and 7.7% were reported in ARTS, VA ADERS, and MedWatch, respectively., Conclusion: We found substantial underreporting of apixaban and empagliflozin ADEs that became worse at each higher level of spontaneous reporting., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019.)

Purpose: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost., Methods: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added., Results: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16., Conclusion: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019.)

Purpose: Results of a study to estimate the prevalence of look-alike/sound-alike (LASA) medication errors through analysis of Veterans Affairs (VA) administrative data are reported., Methods: Veterans with at least 2 filled prescriptions for 1 medication in 20 LASA drug pairs during the period April 2014-March 2015 and no history of use of both medications in the preceding 6 months were identified. First occurrences of potential LASA errors were identified by analyzing dispensing patterns and documented diagnoses. For 7 LASA drug pairs, potential errors were evaluated via chart review to determine if an actual error occurred., Results: Among LASA drug pairs with overlapping indications, the pairs associated with the highest potential-error rates, by percentage of treated patients, were tamsulosin and terazosin (3.05%), glipizide and glyburide (2.91%), extended- and sustained-release formulations of bupropion (1.53%), and metoprolol tartrate and metoprolol succinate (1.48%). Among pairs with distinct indications, the pairs associated with the highest potential-error rates were tramadol and trazodone (2.20%) and bupropion and buspirone (1.31%). For LASA drug pairs found to be associated with actual errors, the estimated error rates were as follows: lamivudine and lamotrigine, 0.003% (95% confidence interval [CI], 0-0.01%); carbamazepine and oxcarbazepine, 0.03% (95% CI, 0-0.09%); and morphine and hydromorphone, 0.02% (95% CI, 0-0.05%)., Conclusion: Through the use of administrative databases, potential LASA errors that could be reviewed for an actual error via chart review were identified. While a high rate of potential LASA errors was detected, the number of actual errors identified was low., Competing Interests: DisclosuresThe authors have declared no potential conflicts of interest., (Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Deprescribing, which includes stopping or reducing the dosage of medications, is designed to improve safety and prevent adverse drug reactions in older patients. To date, there has been limited work on measuring decreases in dosage intensity, or deintensification, across therapeutic classes of medications. Given the ongoing focus on central nervous system (CNS) medications and the frequency with which providers encounter hypertension and diabetes in older nursing home patients, the objective of this expert review is to describe and critique innovative composite dosage intensity measures that have been, or could be, applied to quantify deintensification within three therapeutic medication targets commonly encountered in nursing home patients: CNS agents, antihypertensive therapy, and antidiabetic therapy and the extent to which they are associated with health outcomes. Composite measures for CNS medication intensity considered dividing a patient's daily dose by defined daily dosage (DDD), or the minimum effective adult or geriatric daily dosage. In contrast, composite measures for antihypertensives used either DDD or maximum recommended daily dosage in the denominator. We were not able to identify any composite measure of intensity for antidiabetic classes. There was a paucity of interventional studies that showed reducing the dosage intensity resulted in improved health outcomes. In conclusion, we identified several innovative composite measures of dosage intensity for CNS and antihypertensive medications, and discussed possible approaches for developing an antidiabetic regimen composite measure. It is critical for future research to compare and contrast various measures and to determine their impact on important clinical outcomes.

Background: Although gatifloxacin is no longer available, other fluoroquinolones may significantly interfere with glucose homeostasis. The objective of the present study was to compare the risk of severe hypo- and hyperglycemia in a cohort of patients treated with gatifloxacin, levofloxacin, ciprofloxacin, or azithromycin., Methods: This was a retrospective inception cohort study of outpatients with a new prescription for gatifloxacin, levofloxacin, ciprofloxacin, or azithromycin from 1 October 2000 through 30 September 2005 in the Veterans Affairs health care system. For patients who received one of these antibiotics, we identified outcomes of hospitalization with a primary diagnosis of hypo- or hyperglycemia. Multivariable logistic regression was used to determine the odds of hypo- and hyperglycemia with the individual fluoroquinolones versus azithromycin., Results: The crude incidence rates for severe hypo- and hyperglycemia among those who received gatifloxacin, levofloxacin, ciprofloxacin, and azithromycin were 0.35 and 0.45, 0.19 and 0.18, 0.10 and 0.12, and 0.07 and 0.10 cases per 1000 patients, respectively. Among patients with diabetes, the odds ratios for hypoglycemia compared with azithromycin were 4.3 (95% confidence interval [CI], 2.7-6.6) for gatifloxacin, 2.1 (95% CI, 1.4-3.3) for levofloxacin, and 1.1 (95% CI, 0.6-2.0) for ciprofloxacin. The odds ratios for hyperglycemia were 4.5 (95% CI, 3.0-6.9) for gatifloxacin, 1.8 (95% CI, 1.2-2.7) for levofloxacin, and 1.0 (95% CI, 0.6-1.8) for ciprofloxacin., Conclusions: The odds of severe hypo- and hyperglycemia were significantly greater with gatifloxacin and levofloxacin, but not ciprofloxacin, than with azithromycin. Thus, the risk of a clinically relevant dysglycemic event appears to vary among the fluoroquinolones.

The detection of adverse drug reactions (ADRs) by a traditional passive reporting system and by a method involving patient and provider interviews was studied. The study sample consisted of randomly selected outpatients seen by their primary care provider during scheduled appointments in January and February 2001 at a Veterans Affairs medical center. After ambulatory care clinic sessions, patients and providers were asked (by telephone and in person, respectively) to identify potential ADRs. Also obtained were demographic data, information about drug regimens, and the severity and management of each ADR. A standardized ADR-assessment tool was used to determine the severity of each reported reaction and its causal relationship with the medication. A total of 198 patients were included. Of these, 51 (26%) had one or more ADRs. The patient and provider interviews identified a total of 83 ADRs, compared with 1 ADR identified by the passive reporting system. When providers were made aware of the ADRs they had not identified, changes were made to the patient's medication regimen in 34% of cases. The risk of an ADR was not associated with age, number of medications, or provider type. Direct patient and provider interviews yielded a significantly higher rate of ADR detection in an ambulatory care setting than did a passive ADR-reporting system.