Impact of cost on prescribing diabetes medications for older adults with type 2 diabetes in the outpatient setting.

BACKGROUND: Newer diabetes medications have cardiorenal benefits beyond blood sugar lowering that make them a preferred treatment option in many patients. Despite this, studies have shown that prescribing of these medications remains suboptimal with medication costs being hypothesized as a reason for underutilization. OBJECTIVE: To understand clinicians' decision-making processes for prescribing diabetes medications in older adults, focusing on higher cost medications. METHODS: Observations of patient encounters and semi-structured interviews were conducted with clinicians from primary care, endocrinology, and geriatrics to elucidate themes into diabetes medication prescribing. A qualitative descriptive approach was used to analyze the data from interviews using an inductive coding scheme with themes derived from the data. RESULTS: Twenty-one interviews were conducted. Five themes were identified: 1) out-of-pocket costs drive prescribing decisions 2) out-of-pocket costs can be variable due to changing insurance plans or changing coverage 3) clinicians have difficulty with determining patient-specific out-of-pocket costs 4) clinicians manage the tradeoffs existing between cost, efficacy, and safety and 5) clinicians can use cost-modifying strategies such as patient assistance. CONCLUSION: Addressing the challenges that medication costs pose to prescribing evidence-based medications for type 2 diabetes is necessary to optimize diabetes care for older adults.

Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review.

INTRODUCTION: Acute kidney injury (AKI) resulting from nephrotoxic medication use is prominent in hospitalized patients and is attributable to overall increases in mortality and costs of care. Serum creatinine (SCr), the current standard for identifying drug-induced AKI (DIAKI) is often delayed in its response to kidney insult by 26-36 h. OBJECTIVE: This systematic review seeks to evaluate the clinical utility of several novel kidney damage and stress biomarkers for the prediction/timely detection of DIAKI, in comparison with traditional methods. METHODS: A systematic review of the CINAHL, Cochrane Library, Embase, and PubMed databases was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines, for articles analyzing the use of ß2-microglobulin (B2M), interleukin (IL)-18, kidney injury molecule-1 (KIM-1), liver-type fatty acid-binding protein (L-FABP), neutrophil gelatinase-associated lipocalin (NGAL), and tissue inhibitor of metalloproteinase-2 * insulin-like growth factor-binding protein 7 [TIMP-1]*[IGFBP-7], for identifying DIAKI. Primary outcomes included time to DIAKI diagnosis using traditional methods and the time to significant difference in biomarker concentrations between DIAKI and non-AKI study subjects. Secondary outcomes included biomarker concentrations at the time of significant difference between the AKI status groups. RESULTS: Fifteen unique articles were identified from the literature search. Twelve studies consisted of strictly hospitalized patient populations and three studies included hospitalized patients and patients discharged to home treatment. No studies reported values for urine volume output. Seventy-three percent of studies reported earlier times to significant difference of novel biomarker concentrations between the AKI and non-AKI groups than diagnosis of DIAKI by SCr alone. Significant variation was observed for individual urine biomarker concentrations at time of significant difference between the AKI status groups. CONCLUSIONS: All analyzed biomarkers showed potential for use as early clinical markers of DIAKI, however further consensus on threshold urine concentrations for DIAKI is needed for meaningful implementation of these biomarkers in clinical practice.

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications.

Importance: Drug safety communications released by the US Food and Drug Administration (FDA) are often based on limited evidence on safety signals after approval. Varenicline may serve as a relevant case study because it was the target of several FDA communications in 2008 and 2009; ultimately, the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) dismissed safety concerns on increased suicidal thoughts and aggressive and erratic behavior on December 16, 2016. Objective: To examine the association between FDA drug safety communications and the use of varenicline. Design, Setting, and Participants: Retrospective, longitudinal, cross-sectional study of Veterans Health Administration (VHA) outpatient data from October 1, 2001, through December 31, 2018, and Medicaid drug state use data from July 1, 2006, through September 30, 2018, on varenicline prescribing. Main Outcomes and Measures: Prescribing records for varenicline and nicotine replacement therapy (NRT) in the VHA were extracted, and the number of unique varenicline and NRT users in the VHA per quarter was measured. An interrupted time series analysis was performed to describe the association between FDA safety warnings and the use of varenicline and NRT. To test the generalizability of the findings, similar analyses were conducted using the number of prescriptions reimbursed for varenicline by Medicaid every quarter in 2006-2018. Results: After its addition to the VHA national drug formulary in January 2007, varenicline use presented a steady increase, reaching a peak of 32 581 quarterly unique users in the first quarter of 2008. Within 12 months of the February 1, 2008, public health advisory, quarterly varenicline use in VHA patients decreased by 68.7% (from 32 581 to 10 182 patients; P < .001 for slope change), and NRT use increased by 32.1% (from 55 728 to 73 629 patients; P < .001 for slope change). In Medicaid prescriptions, varenicline use decreased by 38.0% (from 109 308 to 67 761 prescriptions; P < .001 for slope change) within 12 months of the 2008 public health advisory. Twelve months after the publication of the EAGLES trial, which showed no significant increase in psychiatric/behavioral effects with varenicline relative to NRT, use of varenicline increased by 42.7% in VHA patients (from 9251 to 13 199 patients; P = .01 for slope change) and by 26.0% in Medicaid prescriptions (112 063 to 141 122; P = .26 for slope change ). Conclusions and Relevance: With use of varenicline as a case study, early communications from the FDA and VHA followed by a labeling change appeared to be associated with a considerable decrease in drug use, which may have been associated with negative public health consequences.