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.

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.

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.

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.

The effect of antibiotic premedication on postoperative complications following dental extractions.

OBJECTIVES: We aimed to evaluate the association between antibiotic prophylaxis and adverse outcomes following tooth extraction within the Veterans Affairs Healthcare System. METHODS: We conducted a retrospective cohort study of patients undergoing dental extractions in 2015-2019. The primary exposure was antibiotic prophylaxis. The primary outcome was post-extraction complication within 7 days (e.g., alveolar osteitis and surgical site infection); the secondary outcome was subsequent medical care relating to a post-extraction oral complication within 7 days. Multivariable logistic regression models assessed the independent effect of antibiotic prophylaxis on each outcome. RESULTS: Of 385,880 visits with a dental extraction, 122,810 (31.8%) received antibiotic prophylaxis. Overall, 3387 (0.9%) experienced a post-extraction complication and 350 (0.09%) received medical care relating to a post-extraction oral complication within 7 days. In multivariable regression, diabetes was a statistically significant (p = 0.01) effect modifier of the association between antibiotic prophylaxis and post-extraction complication. Among visits for patients without diabetes, antibiotic prophylaxis was significantly associated with an increased odds of post-extraction complication (odds ratio [OR] = 1.25, 95% confidence interval [CI]: 1.13-1.38), but among visits for patients with diabetes no significant effect was observed (OR = 1.03, 95% CI: 0.92-1.15). Antibiotic prophylaxis was not significantly associated with post-extraction medical care (OR = 1.04; 95% CI: 0.83-1.30). CONCLUSIONS: In this large retrospective cohort, we observed no significant protective effect of antibiotic prophylaxis on post-extraction complications or subsequent medical care utilization in a setting with low complication rates. These data suggest that use of antibiotic prophylaxis in similar settings may need to be re-evaluated to minimize unnecessary antibiotic use.

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.

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.

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.

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.

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.

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.

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.

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.

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.