Publications

Inappropriate urinary tract infection diagnosis in patients with neurogenic bladder 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 urinary tract infections. A previous study collected signs and symptoms recorded in electronic medical records of patients with neurogenic bladder due to spinal cord injury/disorder, multiple sclerosis, and Parkinson's disease with at least one urinary tract infection diagnosis between 2017-2018 at four medical centers. In this study, 23 veterans from this cohort with urinary tract infection diagnoses in the previous year participated in focus groups conducted May 2021-May 2022. Transcripts were coded using mixed deductive and inductive coding. Qualitative data were compared to electronic medical records data to give a comprehensive picture of signs and symptoms. Both providers and patients attributed nonspecific symptoms like urine changes to urinary tract infection, 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 urinary tract infection care for patients with neurogenic bladder could involve improving patient-provider communication about urinary tract infection signs and symptoms and emphasizing thorough elicitation and evaluation of all signs and symptoms.

BACKGROUND: Per capita spending on drugs in the United States is double that of Canada. One commonly debated point when comparing the 2 countries is whether this additional spending allows residents of the United States access to valuable therapies not available in Canada.

OBJECTIVE: To characterize the therapeutic value of prescription drugs used in the United States that are not marketed in Canada.

METHODS: This cross-sectional study used IQVIA Multinational Integrated Data Analysis System data to identify drugs purchased in the United States but not in Canada from 2017 to 2021. Drug listing and regulatory review statuses were obtained. We categorized the drugs into 8 mutually exclusive groups: listing status in Canada ("cancelled post-market" or "dormant; approved but not marketed; cancelled pre-market"), other alternatives available ("formulation unavailable," "existing drug class," or "therapeutically similar"), "pre-approval," "atypical access available," or "unavailable without alternatives marketed" in Canada. Therapeutic value assessments of drugs in the last category were obtained from 3 international organizations.

RESULTS: 2,084 products were purchased in the United States but not in Canada from 2017 to 2021; 1,685 were excluded because they were not prescription drugs, were combinations in which each active pharmaceutical ingredient was already available in the United States as a separate drug, had been discontinued in the United States by August 30, 2023, or were marketed in Canada by August 30, 2023. After exclusions, there were 399 drugs; 120 (30%) were "cancelled post-market," 38 (10%) were "dormant; approved but not marketed; cancelled pre-market," 49 (12%) were "formulation unavailable," 130 (33%) were "existing drug class," 35 (9%) were "therapeutically similar," 3 (1%) were "preapproval," 15 (4%) were "atypical access available," and 9 (2%) were "unavailable" in Canada. 6 of the 9 drugs had been evaluated by 1 or more independent organizations, and all 6 were rated as offering minor to no additional therapeutic value compared with existing drugs.

CONCLUSIONS: There was similar access to important prescription drug therapies in the United States and Canada. Overall, the additional spending in the United States may not have necessarily translated into access to important therapeutic innovations.

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.

Control of carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa spread in healthcare settings begins with timely and accurate laboratory testing practices. Survey results show most Veterans Affairs facilities are performing recommended tests to identify these organisms. Most facilities report sufficient resources to perform testing, though medium-complexity facilities report some perceived barriers.

OBJECTIVE: The American Association of Colleges of Pharmacy's Social and Administrative Sciences Section and the American Pharmacists Association-Academy of Pharmaceutical Research and Science's Economic, Social and Administrative Sciences Section formed a Gender Equity Task Force to determine if there is evidence to suggest that there is gender disparity in pay; responsibilities; treatment by peers/colleagues, students, and administration; leadership opportunities; and rank, tenure status, and career advancement for Section members; and to develop recommendations to address existing disparities.

METHODS: A Qualtrics survey was emailed in December 2020 to all American Association of Colleges of Pharmacy's Social and Administrative Sciences and American Pharmacists Association-Academy of Pharmaceutical Research and Science's Economic, Social and Administrative Sciences Section members. The questionnaire included items regarding favorability toward men or women in various academic domains (research, teaching, service, recruitment, mentoring, and advancement). Participants were asked if they had experienced gender inequity, and if so, at what type of institution and academic rank. The χ2 tests of independence and post hoc comparisons were used to assess item responses according to gender.

RESULTS: Of the respondents, 72% indicated that they had experienced gender inequity. Women and persons of color were more likely to do so. Women commonly reported that men received more favorable treatment in nearly all academic domains, whereas men reported that women and men were treated equally.

CONCLUSION: Pharmacy faculty specializing in social and administrative sciences reported experiences of gender inequity and perceptions of gender inequity. Perception gaps existed between male and female faculty in numerous academic domains. Colleges and schools of pharmacy should increase awareness of, and strive to self-assess, gender inequity in their institutions.

IMPORTANCE: Drug shortages are a persistent public health issue that increased during the COVID-19 pandemic. Both the US and Canada follow similar regulatory standards and require reporting of drug-related supply chain issues that may result in shortages. However, it is unknown what proportion are associated with meaningful shortages (defined by a significant decrease in drug supply) and whether differences exist between Canada and the US.

OBJECTIVE: To compare how frequently reports of drug-related supply chain issues in the US vs Canada were associated with drug shortages.

DESIGN, SETTING, AND PARTICIPANTS: Longitudinal cross-sectional study conducted from January 2023 to March 2024 using drug-related reports of supply chain issues from 2017 to 2021 that were less than 180 days apart in Canada and the US. Shortages were assessed using data from the IQVIA Multinational Integrated Data Analysis database, comprising 89% of US and 100% of Canadian drug purchases.

EXPOSURE: Country (Canada vs US), timing of report issuance (before vs after the COVID-19 pandemic), and characteristics of the supply chain prior to the reports of drug-related supply chain issues (including World Health Organization essential medicine status, Health Canada tier 3 medicine [moderate risk classification], whether there was sole-source manufacturing of the drug, the formulation, the price per unit, ≥20 years since drug approval, and the number of therapeutic alternatives).

MAIN OUTCOMES AND MEASURES: A drug shortage (a decrease of ≥33% in monthly purchased standardized drug units) within 12 months, relative to the average units purchased during the 6 months prior to the report of supply chain issues to a US or Canadian reporting system.

RESULTS: Among the 104 drug-related reports of supply chain issues in both countries, 49.0% (95% CI, 39.3%-59.7%) were associated with drug shortages in the US vs 34.0% (95% CI, 25.0%-45.0%) in Canada (adjusted hazard ratio [HR], 0.53 [95% CI, 0.36-0.79]). The lower risk of drug shortages in Canada vs the US was consistent before the COVID-19 pandemic (adjusted HR, 0.47 [95% CI, 0.30-0.75]) and after the pandemic (adjusted HR, 0.31 [95% CI, 0.15-0.66]). After combining reports of supply chain issues in both countries, the shortage risk was double for sole-sourced drugs (adjusted HR, 2.58 [95% CI, 1.57-4.24]) and nearly half for Canadian tier 3 medicines (moderate risk) (adjusted HR, 0.56 [95% CI, 0.32-0.98]).

CONCLUSIONS AND RELEVANCE: Drug-related reports of supply chain issues were 40% less likely to result in meaningful drug shortages in Canada compared with the US. These findings highlight the need for international cooperation between countries to curb the effects of drug shortages and improve resiliency of the supply chain for drugs.

BACKGROUND: Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans.

METHODS: We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged ≥18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects.

RESULTS: We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1).

CONCLUSIONS: Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits.

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.