Cannabidiol (CBD) is ubiquitous in state-based medical cannabis programs and consumer products for complementary health or recreational use. CBD has intrinsic pharmacologic effects and associated adverse drug events (ADEs) along with the potential for pharmacokinetic and pharmacodynamic drug–drug interactions (DDIs). Given CBD use among patients with complex conditions and treatment regimens, as well as its expanded consumer use, awareness of potential safety issues with CBD is needed. Prescribing information for federally approved products containing CBD were reviewed. Data on ADEs and DDIs were extracted and summarized. Nearly one-half of CBD users experienced ADEs, which displayed a general dose-response relationship. Common ADEs include transaminase elevations, sedation, sleep disturbances, infection, and anemia. Given CBD effects on common biological targets implicated in drug metabolism (e.g., CYP3A4/2C19) and excretion (e.g., P-glycoprotein), the potential for DDIs with commonly used medication is high. General clinical recommendations of reducing substrate doses, monitoring for ADEs, and finding alternative therapy should be considered, especially in medically complex patients. CBD is implicated as both a victim and perpetrator of DDIs and has its own ADE profile. These effects should be considered in the risk-benefit assessment of CBD therapy and patients and consumers made aware of potential safety issues with CBD use.

OBJECTIVES To compare the predictive validity of the 2003 Beers, 2012 Beers, and STOPP Criteria. DESIGN Retrospective cohort. SETTING Managed care administrative claims data from 2006 to 2009 PARTICIPANTS 174,275 commercially insured persons 65 and older in the United States. MEASUREMENTS Association between adverse drug events, emergency department (ED) visits, and hospitalization outcomes and inappropriate medications using time-varying Cox proportional hazard models. Measures of model discrimination (c-index) and hazard ratios (HR) were calculated to compare unadjusted and adjusted models for associations. RESULTS The prevalence of inappropriate prescribing was 34.1%, 32.2%, and 27.6% for the 2012 Beers, 2003 Beers, and the STOPP Criteria. Each criteria modestly discriminated ADEs in unadjusted analyses: STOPP Criteria (HR=2.89 [2.68–3.12]; C-index=0.607), 2012 Beers Criteria (HR=2.51 [2.33–2.70]; C-index=0.603), 2003 Beers Criteria (HR=2.65 [2.46–2.85]; C-index=0.605). Similar results were observed for ED visits and hospitalizations. Adjusted analyses increased the c-indices to between 0.65 and 0.70. The kappa for agreement between criteria was 0.80 for the 2003 and 2012 Beers Criteria, 0.58 for the 2012 Beers and STOPP Criteria, and 0.59 for the 2003 Beers and STOPP Criteria. For the three outcomes, the 2012 Beers Criteria had the highest sensitivity (61.2%–71.2%) and the lowest specificity (41.2%–70.7%) while the STOPP Criteria had the lowest sensitivity (53.8%–64.7%) but the highest specificity (47.8%–78.1%). CONCLUSIONS All three criteria were modestly prognostic for ADEs, EDs, and hospitalizations with the STOPP Criteria slightly outperforming both Beers Criteria. With low sensitivity, low specificity, as well as low agreement between the criteria, these criteria can be used in a complementary fashion to enhance sensitivity of detecting ADEs.

BACKGROUND Few studies have assessed adherence to non-vitamin K antagonist oral anticoagulants (NOACs), especially using contemporary data now that multiple NOACs are available. OBJECTIVE To compare adherence and treatment patterns among NOACs for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). METHODS Incident and treatment-naive NVAF patients were identified during 2013–2014 from a large claims database in this retrospective cohort study. Patients were included who initiated rivaroxaban, dabigatran, or apixaban within 30 days after diagnosis. Adherence to the index medication and adherence to any oral anticoagulant was assessed using the proportion of days covered (PDC) at 3, 6, and 9 months. The number of switches and gaps in therapy were also evaluated. Analyses were stratified by stroke risk scores, and a logistic regression model was used to control for factors that may predict high adherence. RESULTS Dabigatran had lower adherence (PDC = 0.76, 0.64, 0.57) compared with rivaroxaban (PDC = 0.83, 0.73, 0.66; P < 0.001) and apixaban (PDC = 0.82, 0.72, 0.66; P < 0.001) at 3, 6, and 9 months of follow-up and twice the number of switches to either other anticoagulants or antiplatelet therapy. Adherence was higher overall as stroke risk increased, and dabigatran had consistently lower adherence compared with the other NOACs. Multivariable logistic regression predicting PDC ≥ 0.80 showed rivaroxaban users with higher odds of high adherence compared with dabigatran or rivaroxaban across all time periods. Adjusted analyses showed that increasing age and comorbid hypertension and diabetes were associated with higher adherence. CONCLUSIONS In this real-world analysis of adherence to NOACs, rivaroxaban and apixaban had favorable unadjusted adherence profiles compared with dabigatran, while rivaroxaban users had higher odds of high adherence (PDC ≥ 0.80) among the NOACs in adjusted analyses. Clinicians and managed care organizations should consider the implications of lower adherence on clinical outcomes and quality assessment.