A mixed-methods analysis of provider-documented and patient-reported urinary tract infection symptoms among veterans with neurogenic bladder.

ABSTRACT: Inappropriate urinary tract infection (UTI) diagnosis in patients with neurogenic bladder (NB) may result from ambiguous symptoms experienced by these patients and contributes to antibiotic overuse. Characterization of patient-reported signs and symptoms may help providers more appropriately diagnose UTIs. A previous study collected signs and symptoms recorded in electronic medical records (EMR) of patients with NB due to spinal cord injury/disorder (SCI/D), multiple sclerosis (MS), and Parkinson's Disease (PD) with at least one UTI diagnosis between 2017-2018 at four medical centers. In this study, twenty-three Veterans from this cohort with UTI diagnoses in the prior year participated in focus groups conducted May 2021 - May 2022. Transcripts were coded using mixed deductive and inductive coding. Qualitative data were compared to EMR data to give a comprehensive picture of signs and symptoms. Both providers and patients attributed non-specific symptoms like urine changes to UTI, but there was discordance between patients and providers in the identification of other signs and symptoms. Several patients described providers disregarding symptoms other than fever or chills. Optimizing UTI care for patients with NB could involve improving patient provider communication about UTI signs and symptoms and emphasizing thorough elicitation and evaluation of all signs and symptoms.

Facility- and patient-level factors associated with implementation of contact precautions in hospitalized VA patients with positive CRE cultures.

Decreasing the time to contact precautions (CP) is critical to carbapenem-resistant Enterobacterales (CRE) prevention. Identifying factors associated with delayed CP can decrease the spread from patients with CRE. In this study, a shorter length of stay was associated with being placed in CP within 3 days.

Racial and Ethnic Differences in Health Care Experiences for Veterans Receiving VA Community Care from 2016 to 2021.

BACKGROUND: Prior research documented racial and ethnic disparities in health care experiences within the Veterans Health Administration (VA). Little is known about such differences in VA-funded community care programs, through which a growing number of Veterans receive health care. Community care is available to Veterans when care is not available through the VA, nearby, or in a timely manner. OBJECTIVE: To examine differences in Veterans' experiences with VA-funded community care by race and ethnicity and assess changes in these experiences from 2016 to 2021. DESIGN: Observational analyses of Veterans' ratings of community care experiences by self-reported race and ethnicity. We used linear and logistic regressions to estimate racial and ethnic differences in community care experiences, sequentially adjusting for demographic, health, insurance, and socioeconomic factors. PARTICIPANTS: Respondents to the 2016-2021 VA Survey of Healthcare Experiences of Patients-Community Care Survey. MEASURES: Care ratings in nine domains. KEY RESULTS: The sample of 231,869 respondents included 24,306 Black Veterans (mean [SD] age 56.5 [12.9] years, 77.5% male) and 16,490 Hispanic Veterans (mean [SD] age 54.6 [15.9] years, 85.3% male). In adjusted analyses pooled across study years, Black and Hispanic Veterans reported significantly lower ratings than their White and non-Hispanic counterparts in five of nine domains (overall rating of community providers, scheduling a recent appointment, provider communication, non-appointment access, and billing), with adjusted differences ranging from - 0.04 to - 0.13 standard deviations (SDs) of domain scores. Black and Hispanic Veterans reported higher ratings with eligibility determination and scheduling initial appointments than their White and non-Hispanic counterparts, and Black Veterans reported higher ratings of care coordination, with adjusted differences of 0.05 to 0.21 SDs. Care ratings improved from 2016 to 2021, but differences between racial and ethnic groups persisted. CONCLUSIONS: This study identified small but persistent racial and ethnic differences in Veterans' experiences with VA-funded community care, with Black and Hispanic Veterans reporting lower ratings in five domains and, respectively, higher ratings in three and two domains. Interventions to improve Black and Hispanic Veterans' patient experience could advance equity in VA community care.

Barriers and facilitators to guideline concordant dental antibiotic prescribing in the United States: A qualitative study of the National Dental PBRN.

OBJECTIVES: While factors contributing to dental antibiotic overprescribing have previously been described, previous work has lacked any theoretical behavior change framework that could guide future intervention development. The purpose of this study was to use an evidence-based conceptual model to identify barriers and facilitators of appropriate antibiotic prescribing by dentists as a guide for future interventions aimed at modifying antibiotic prescribing. METHODS: Semi-structured interviews were conducted with dentists from the National Dental Practice Based Research Network (PBRN) exploring patient and practice factors perceived to impact antibiotic prescribing. Audio-recorded telephone interviews were transcribed and independently coded by three researchers. Themes were organized around the COM-B model to inform prospective interventions. RESULTS: 73 of 104 dentists (70.1%) were interviewed. Most were general dentists (86.3%), male (65.7%), and white (69.9%). Coding identified three broad targets to support appropriate dental antibiotic prescribing among dentists: (1) increasing visibility and accessibility of guidelines, (2) providing additional guidance on antibiotic prescribing in dental scenarios without clear guidelines, and (3) education and communication skills-building focused on discussing appropriate antibiotic use with patients and physicians. CONCLUSIONS: The findings from our study are consistent with other studies focusing on antibiotic prescribing behavior in dentists. Understanding facilitators and barriers to dental antibiotic prescribing is necessary to inform targeted interventions to improve appropriate antibiotic prescribing. Future interventions should focus on implementing multimodal strategies to provide the necessary support for dentists to judiciously prescribe antibiotics.

Drug Shortages Prior to and During the COVID-19 Pandemic.

Importance: Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic. Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic. Design, Setting, and Participants: This longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023. Exposure: Presence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP). Main Outcomes and Measures: The main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers). Results: A total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002). Conclusions and Relevance: In this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.

Knowledge, perceptions, and beliefs about urinary tract infections in persons with neurogenic bladder and impacts on interventions to promote person-centered care.

STUDY DESIGN: Qualitative study. OBJECTIVES: To explore how knowledge, perceptions, and beliefs about urinary tract infections (UTIs) among persons with neurogenic bladder (NB) may impact health behaviors and provider management and enhance person-centeredness of interventions to improve UTI management. SETTING: Three Veterans Affairs (VA) medical centers. METHODS: Adults with NB due to spinal cord injury/disorder (SCI/D) or multiple sclerosis (MS) with UTI diagnoses in the prior year participated in focus groups. Transcripts were coded using deductive codes linked to the Health Belief Model and inductive codes informed by grounded theory. RESULTS: Twenty-three Veterans (SCI/D, 78%; MS: 18.5%) participated in discussions. Three themes emerged: (1) UTI knowledge; (2) factors affecting the intervention environment; and (3) factors affecting modes of delivery. Knowledge gaps included UTI prevention, specific symptoms most indicative of UTI, and antibiotic side effects. Poor perceptions of providers lacking knowledge about NB and ineffective patient-provider communication were common in the Emergency Department and non-VA facilities, whereas participants had positive perceptions of home-based care. Participants perceived lower severity and frequency of antibiotic risks compared to UTI risks. Participant preferences for education included caregiver involvement, verbal and written materials, and diverse settings like peer groups. CONCLUSIONS: Identifying patient perspectives enhances person-centeredness and allows for novel interventions improving patient knowledge and behaviors about UTIs. Partnering with trusted providers and home-based caregivers and improving NB knowledge and communication in certain care settings were important. Patient education should address mental risk representations and incorporate preferences for content delivery to optimize self-efficacy and strengthen cues to action.

Buprenorphine dispensing before and after the April 2021 X-Waiver exemptions: An interrupted time series analysis.

BACKGROUND: Until the end of 2022, a special registration, known as the X-waiver, was required to prescribe buprenorphine in the US. Before its removal, US federal regulations trialed an X-waiver exemption, initiated on April 28, 2021, which permitted buprenorphine prescribing for up to 30 patients without additional training. We aimed to understand if these regulatory changes impacted buprenorphine dispensing. METHODS: We conducted an interrupted time series analysis to understand changes in buprenorphine dispensing during the 26 weeks after the X-waiver exemption compared to the expected baseline trend established in the 26 weeks before using the IQVIA Longitudinal Prescription claims database. The primary outcome was number of new buprenorphine prescribers nationwide (defined as no prior buprenorphine prescription dispensed in the last 26 weeks). Segmented regression estimated relative changes in buprenorphine dispensing at 1, 13, and 26 weeks post-X-waiver change. RESULTS: A total of 15,517,525 prescriptions filled for 1,328,172 patients (43.4 % female) ordered by 62,312 providers were included for analysis. At 26 weeks post-X-waiver change, there was no change in the number of new prescribers compared to the expected baseline trend (-2.7 % [95 % CI:-8.3,2.9]). The number of new (15.2 % [4.6,25.8]) and existing (1.7 % [0.9,2.4]) patients and patients per prescriber (4.3 % [3,5.6]) increased. Buprenorphine prescriptions reimbursed by Medicaid increased (7.5 % [6.6,8.4]) while commercial fills decreased (-3.4 % [-5.3,-1.5]). CONCLUSIONS: The number of new prescribers did not increase six months post-X-waiver exemption while new patients continued to enter treatment at higher-than-expected rates. These findings suggest that additional interventions beyond the recent X-waiver removal may be needed to increase access to buprenorphine.

Effects of the valsartan recall on heart failure patients: A nationwide analysis.

BACKGROUND: Valsartan is commonly used for cardiac conditions. In 2018, the Food and Drug Administration recalled generic valsartan due to the detection of impurities. Our objective was to determine if heart failure patients receiving valsartan at the recall date had a greater likelihood of unfavorable outcomes than patients using comparable antihypertensives. METHODS: We conducted a cohort study of Optum's de-identified Clinformatics® Datamart (July 2017-January 2019). Heart failure patients with commercial or Medicare Advantage insurance who received valsartan were compared to persons who received non-recalled angiotensin receptor blockers (ARBs) and angiotensin converting enzyme-inhibitors (ACE-Is) for 1 year prior and including the recall date. Outcomes included a composite for all-cause hospitalization, emergency department (ED), and urgent care (UC) use and a measure of cardiac events which included hospitalizations for acute myocardial infarction and hospitalizations/ED/UC visits for stroke/transient ischemic attack, heart failure or hypertension at 6-months post-recall. Cox proportional hazard models with propensity score weighting compared the risk of outcomes between groups. RESULTS: Of the 87 130 adherent patients, 15% were valsartan users and 85% were users of non-recalled ARBs/ACE-Is. Valsartan use was not associated with an increased risk of all-cause hospitalization/ED/UC use six-months post-recall (HR 1.00; 95% CI 0.96-1.03), compared with individuals taking non-recalled ARBs/ACE-Is. Similarly, cardiac events 6-months post-recall did not differ between individuals on valsartan and non-recalled ARBs/ACE-Is (HR 1.04; 95% CI 0.97-1.12). CONCLUSIONS: The valsartan recall did not affect short-term outcomes of heart failure patients. However, the recall potentially disrupted the medication regimens of patients, possibly straining the healthcare system.

Risk factors for oral infection and dry socket post-tooth extraction in medically complex patients in the absence of antibiotic prophylaxis: A case-control study.

INTRODUCTION: Dry socket and infection are complications of tooth extractions. The objective was to determine risk factors for post-extraction complications in patients without antibiotic prophylaxis stratified by early- and late-complications and complication type (oral infection and dry socket). METHODS: Retrospective, case (with complications)-control (without complications) study of patients (n = 708) who had ≥1 extraction performed at any Veterans Health Administration facility between 2015-2019 and were not prescribed an antibiotic 30 days pre-extraction. RESULTS: Early complication cases (n = 109) were more likely to be female [odds ratio (OR) = 2.06; 95% confidence interval (CI):1.05-4.01], younger (OR = 0.29; 95% CI:0.09-0.94 patients ≥ 80 years old, reference:18-44 years), Native American/Alaska Native (OR = 21.11; 95% CI:2.33-191.41) and have fewer teeth extracted (OR = 0.53 3+ teeth extracted; 95% CI:0.31-0.88, reference:1 tooth extracted). Late complication cases (n = 67) were more likely to have a bipolar diagnosis (OR = 2.98; 95% CI:1.04-8.57), history of implant placement (OR = 8.27; 95% CI:1.63-41.82), and history of past smoking (OR = 2.23; 95% CI:1.28-3.88). CONCLUSION: Predictors for post-extraction complications among patients who did not receive antibiotic prophylaxis were similar to prior work in cohorts who received prophylaxis. Unique factors identified in a medically complex population included being younger, Native American/Alaska Native, having mental health conditions, history of a dental implant, and fewer teeth extracted.

Trends in Phenylephrine and Pseudoephedrine Sales in the US.

This study examines purchasing patterns regarding oral decongestants, concerns about their efficacy, and the need for timelier postmarket evaluation.

Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in adolescents, adults, and older adults: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh, and the University of Pennsylvania.

BACKGROUND: A panel convened by the American Dental Association Science and Research Institute, the University of Pittsburgh, and the University of Pennsylvania conducted systematic reviews and meta-analyses and formulated evidence-based recommendations for the pharmacologic management of acute dental pain after simple and surgical tooth extraction(s) and for the temporary management (ie, definitive dental treatment not immediately available) of toothache associated with pulp and periapical diseases in adolescents, adults, and older adults. TYPES OF STUDIES REVIEWED: The panel conducted 4 systematic reviews to determine the effect of opioid and nonopioid analgesics, local anesthetics, corticosteroids, and topical anesthetics on acute dental pain. The panel used the Grading of Recommendations, Assessment, Development and Evaluation approach to assess the certainty of the evidence and the Grading of Recommendations, Assessment, Development and Evaluation Evidence-to-Decision Framework to formulate recommendations. RESULTS: The panel formulated recommendations and good practice statements using the best available evidence. There is a beneficial net balance favoring the use of nonopioid medications compared with opioid medications. In particular, nonsteroidal anti-inflammatory drugs alone or in combination with acetaminophen likely provide superior pain relief with a more favorable safety profile than opioids. CONCLUSIONS AND PRACTICAL IMPLICATIONS: Nonopioid medications are first-line therapy for managing acute dental pain after tooth extraction(s) and the temporary management of toothache. The use of opioids should be reserved for clinical situations when the first-line therapy is insufficient to reduce pain or there is contraindication of nonsteroidal anti-inflammatory drugs. Clinicians should avoid the routine use of just-in-case prescribing of opioids and should exert extreme caution when prescribing opioids to adolescents and young adults.

Prevalence of unnecessary antibiotic prescriptions among dental visits, 2019.

OBJECTIVE: The US National Action Plan for Combating Antibiotic-Resistant Bacteria established a goal to decrease unnecessary outpatient antibiotic use by 50%. However, data to inform this goal have been limited to medical settings and have not included dental prescribing. Thus, we sought to identify the proportion of antibiotics prescribed inappropriately by dentists to inform outpatient stewardship efforts. METHODS: Cross-sectional analysis of 2019 Veterans' Affairs (VA) national electronic health record data. Antibiotics prescribed by dentists were evaluated for appropriateness based on 2 definitions: one derived from current guidelines (consensus-based recommendations) and the other based on relevant clinical literature (nonconsensus). A clustered binomial logistic regression model determined factors associated with discordant prescribing. RESULTS: In total, 92,224 antibiotic prescriptions (63% amoxicillin; mean supply, 8.0 days) were associated with 88,539 dental visits. Prophylaxis for complications in medically compromised patients was associated with the most (30.9%) antibiotic prescriptions, followed by prevention of postsurgical complications (20.1%) and infective endocarditis (18.0%). At the visit level, 15,476 (17.5%) met the consensus-based definition for appropriate antibiotic usage and 56,946 (64.3%) met the nonconsensus definition. CONCLUSIONS: More than half of antibiotics prescribed by dentists do not have guidelines supporting their use. Regardless of definition applied, antibiotics prescribed by dentists were commonly unnecessary. Improving prescribing by dentists is critical to reach the national goal to decrease unnecessary antibiotic use.

Guideline concordance and antibiotic-associated adverse events between Veterans administration and non-Veterans administration dental settings: a retrospective cohort study.

Background: Antibiotics prescribed as infection prophylaxis prior to dental procedures have the potential for serious adverse drug events (ADEs). However, the extent to which guideline concordance and different dental settings are associated with ADEs from antibiotic prophylaxis is unknown. Aim: The purpose was to assess guideline concordance and antibiotic-associated ADEs and whether it differs by VA and non-VA settings. Methods: Retrospective cohort study of antibiotic prophylaxis prescribed to adults with cardiac conditions or prosthetic joints from 2015 to 2017. Multivariable logistic regression models were fit to assess the impact of ADEs, guideline concordance and dental setting. An interaction term of concordance and dental setting evaluated whether the relationship between ADEs and concordance differed by setting. Results: From 2015 to 2017, 61,124 patients with antibiotic prophylaxis were identified with 62 (0.1%) having an ADE. Of those with guideline concordance, 18 (0.09%) had an ADE while 44 (0.1%) of those with a discordant antibiotic had an ADE (unadjusted OR: 0.84, 95% CI: 0.49-1.45). Adjusted analyses showed that guideline concordance was not associated with ADEs (OR: 0.78, 95% CI: 0.25-2.46), and this relationship did not differ by dental setting (Wald χ^2 p-value for interaction = 0.601). Conclusion: Antibiotic-associated ADEs did not differ by setting or guideline concordance.

Management of Asymptomatic Bacteriuria and Urinary Tract Infections in Patients With Neurogenic Bladder and Factors Associated With Inappropriate Diagnosis and Treatment.

OBJECTIVE: Inappropriate diagnosis and treatment of asymptomatic bacteriuria (ASB) and urinary tract infection (UTI) are leading causes of antibiotic overuse but have not been well-studied in patients with risks for complicated UTI such as neurogenic bladder (NB). Our aim was to describe ASB and UTI management in patients with NB and assess factors associated with inappropriate management. DESIGN: Retrospective cohort study. SETTING: Four Department of Veteran's Affairs (VA) medical centers. PARTICIPANTS: Adults with NB due to spinal cord injury/disorder (SCI/D), multiple sclerosis (MS), or Parkinson disease (PD) and encounters with an ASB or UTI diagnosis between 2017 and 2018. Clinical and encounter data were extracted from the VA Corporate Data Warehouse and medical record reviews for a stratified sample of 300 encounters from N=291 patients. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Prevalence of appropriate and inappropriate ASB and UTI diagnosis and treatment was summarized. Multivariable logistic regression models assessed factors associated with inappropriate management. RESULTS: N=200 UTI and N=100 ASB encounters were included for the 291 unique patients (SCI/D, 39.9%; MS, 36.4%; PD, 23.7%). Most patients were men (83.3%), >65 years (62%), and used indwelling or intermittent catheterization (68.3%). Nearly all ASB encounters had appropriate diagnosis (98%). 70 (35%) UTI encounters had inappropriate diagnosis, including 55 (27.5%) with true ASB, all with inappropriate treatment. Among the remaining 145 UTI encounters, 54 (27%) had inappropriate treatment. Peripheral vascular disease, chronic kidney disease, and cerebrovascular disease were associated with increased odds of inappropriate management; indwelling catheter (aOR 0.35, P=.01) and Physical Medicine & Rehabilitation provider (aOR 0.29, P<.01) were associated with decreased odds. CONCLUSION: Up to half of UTI encounters for patients with NB had inappropriate management, largely due to inappropriate UTI diagnosis in patients with true ASB. Interventions to improve ASB and UTI management in patients with NB should target complex patients with comorbidities being seen by non-rehabilitation providers.

Trajectories of opioid prescribing by general dentists, specialists, and oral and maxillofacial surgeons in the United States, 2015-2019.

BACKGROUND: Despite decreases in opioid prescribing from 2016 through 2019, some dentists (general, specialists, oral and maxillofacial surgeons) in the United States continue to prescribe opioids at high rates. The authors' objective was to define dentists' trajectories of opioid prescribing. METHODS: The authors identified actively prescribing dentists from the IQVIA Longitudinal Prescription data set, from 2015 through 2019. Group-based trajectory modeling identified opioid prescribing trajectories on the basis of dentists' annual prescribing rates for the overall sample (model 1) and for high prescribers (model 2). The authors used χ2 or Mann-Whitney U tests to characterize the model 2 trajectory groups. RESULTS: In model 1 (n = 199,145 prescribers), group-based trajectory modeling identified 8 trajectories that were grouped into 5 categories. A total of 14.8% were nonprescribers who composed less than 1% of all prescriptions, low prescribers (3 groups; 46.0%) prescribed at low rates (2015: 5.5%-16.9%; 2019: 1.5%-11.9%), decliners (7.3%) decreased prescribing rapidly (2015: 29.4%; 2019: 5.1%), moderately high prescribers (2 groups; 28.5%) prescribed moderately (2015: 28.7% and 39.2%; 2019: 18.1% and 28.8%), and consistently high prescribers (3.4%) prescribed at high rates (2015: 54.6%; 2019: 44.7%). In model 2, from consistently high prescribers (n = 6,845), 4 trajectories were identified. Of these 4 groups, 1 group (7.5%) declined prescribing rapidly. The groups did not differ meaningfully; however, the rapid decliners included fewer oral and maxillofacial surgeons (13.0% vs 18.4%), saw more Medicaid patients (2.5% vs 1.0%), and had higher opioid prescribing rates in 2015 (95.5% vs 91.6%) (P < .001 for all). CONCLUSIONS: The authors identified variations in dentists' opioid prescribing rates. Although 60% of dentists decreased prescribing rates by 30% through 83%, 3.4% of dentists consistently prescribed at high rates. PRACTICAL IMPLICATIONS: Some dentists continue to prescribe opioids at high levels, indicating that additional information is needed to better inform policy and clinical decision making.

A Retrospective Cohort Study of the 2018 Angiotensin Receptor Blocker Recalls and Subsequent Drug Shortages in Patients With Hypertension.

BACKGROUND: Valsartan was recalled by the US Food and Drug Administration in July 2018 for carcinogenic impurities, resulting in a drug shortage and management challenges for valsartan users. The influence of the valsartan recall on clinical outcomes is unknown. We compared the risk of adverse events between hypertensive patients using valsartan and a propensity score-matched group using nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors. METHODS AND RESULTS: We used Optum's deidentified Clinformatics Datamart (July 2017-January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers/angiotensin-converting enzyme inhibitors for 1 year before and on the recall date were compared. Primary outcomes were measured in the 6 months following the recall and included: (1) a composite measure of all-cause hospitalization, all-cause emergency department visit, and all-cause urgent care visit, and (2) a composite cardiac event measure of hospitalizations for acute myocardial infarction and hospitalizations/emergency department visits/urgent care visits for stroke/transient ischemic attack, heart failure, or hypertension. We compared the risk of outcomes between treatment groups using Cox proportional hazard models. Of the hypertensive patients, 76 934 received valsartan, and 509 472 received a nonrecalled angiotensin receptor blocker/angiotensin-converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all-cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00-1.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15-1.29]) within 6 months after the recall. CONCLUSIONS: The valsartan recall and shortage affected hypertensive patients. Local- and national-level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.

Early observations of Tier-3 drug shortages on purchasing trends across Canada: A cross-sectional analysis of 3 case-example drugs.

BACKGROUND: To curb the growing impact of drug shortages, Health Canada developed the Tiered Notification and Communication Framework which assigns potential shortages a corresponding tiered status. Tier-3 is assigned to shortages with the greatest potential impact on the healthcare system. This study aims to describe drug purchasing trends in response to Tier-3 shortages using three case-examples. METHODS: We conducted a time-series analysis of monthly purchasing data for three out of 17 Tier-3 drug shortages (hydralazine, sarilumab, and medroxyprogesterone acetate) with publicly available reports in July 2021 and available IQVIA MIDAS data from January 2016 to December 2021. We assessed percent changes in purchasing at 1-, 3-, and 6-months after the onset of each Tier-3 drug shortage and interventional ARIMA modelling was used to assess the statistical significance. RESULTS: Medroxyprogesterone acetate experienced a significant shift (p = 0.0370) in purchasing following its shortage, and the 1-, 3-, and 6-month percent changes were +14.9%, +6.8% and -3.1%, respectively. Hydralazine and sarilumab did not show a significant shift. The 1-, 3-, and 6-month percent changes for hydralazine were +15.5%, +10.2%, and +9.6% respectively and +25.2%, +45.1% and +39.2 for sarilumab. CONCLUSIONS: These results indicate that drugs assigned a Tier-3 status may not show declines in purchasing in the months following status assignment, which may be due to policy responses following the assignment. However, more insight is needed into the mechanisms through which these policy measures impact shortages and whether they are functioning as intended.

Treatment effectiveness of antibiotic therapy in Veterans with multidrug-resistant Acinetobacter spp. bacteremia.

Objective: To describe antimicrobial therapy used for multidrug-resistant (MDR) Acinetobacter spp. bacteremia in Veterans and impacts on mortality. Methods: This was a retrospective cohort study of hospitalized Veterans Affairs patients from 2012 to 2018 with a positive MDR Acinetobacter spp. blood culture who received antimicrobial treatment 2 days prior to through 5 days after the culture date. Only the first culture per patient was used. The association between treatment and patient characteristics was assessed using bivariate analyses. Multivariable logistic regression models examined the relationship between antibiotic regimen and in-hospital, 30-day, and 1-year mortality. Generalized linear models were used to assess cost outcomes. Results: MDR Acinetobacter spp. was identified in 184 patients. Most cultures identified were Acinetobacter baumannii (90%), 3% were Acinetobacter lwoffii, and 7% were other Acinetobacter species. Penicillins-ß-lactamase inhibitor combinations (51.1%) and carbapenems (51.6%)-were the most prescribed antibiotics. In unadjusted analysis, extended spectrum cephalosporins and penicillins-ß-lactamase inhibitor combinations-were associated with a decreased odds of 30-day mortality but were insignificant after adjustment (adjusted odds ratio (aOR) = 0.47, 95% CI, 0.21-1.05, aOR = 0.75, 95% CI, 0.37-1.53). There was no association between combination therapy vs monotherapy and 30-day mortality (aOR = 1.55, 95% CI, 0.72-3.32). Conclusion: In hospitalized Veterans with MDR Acinetobacter spp., none of the treatments were shown to be associated with in-hospital, 30-day, and 1-year mortality. Combination therapy was not associated with decreased mortality for MDR Acinetobacter spp. bacteremia.