Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing.

Importance: Transmucosal immediate-release fentanyl (TIRF) drugs are potent, rapid-acting opioids approved to treat breakthrough pain in patients with cancer who are tolerant to other around-the-clock opioid analgesics. In March 2012, a US Food and Drug Administration-approved Risk Evaluation and Mitigation Strategy (REMS) was implemented, mandating prescribers, distributors, pharmacies, and patients to enroll in the REMS to prescribe, dispense, or receive TIRF drugs. Objective: To evaluate the association of the TIRF-REMS Access Program with TIRF prescribing. Design, Setting, and Participants: Cohort study using an interrupted time series analysis of TIRF prescriptions to Medicare Part D beneficiaries nationwide from 2010 to 2014. Data were analyzed from August 2017 through July 2018. Main Outcomes and Measures: Prescribing of TIRF per 100 000 Medicare Part D beneficiaries, overall and stratified by cancer status; percentage of TIRF prescriptions for patients without cancer, overall and by brand; and percentage of TIRF prescriptions for patients without known opioid tolerance, defined as patients prescribed at least 60 morphine milligram equivalents per day, overall and by brand. Results: There were 99 601 TIRF prescriptions written by 8619 clinicians to 10 472 patients. Most of the patients (79%) were younger than 65 years (mean [SD] age, 56 [13] years), and most (67%) did not have cancer. Implementation of TIRF-REMS was associated with a 26.7% relative level decrease in TIRF prescribing (95% CI, -33.3% to -19.4%; P < .001) but was followed by 2.0% monthly increases in prescribing (95% CI, 1.3% to 2.7%; P < .001). Sensitivity analyses that accounted for overall opioid prescribing trends were consistent with these findings. Furthermore, there were no significant changes associated with REMS implementation in the level (0.47%; 95% CI, -5.36% to 4.69%; P = .85) or trend (0.16%; 95% CI, -0.06% to 0.37%; P = .15) of the percentage of prescriptions for patients without cancer. However, a sensitivity analysis that used a broader cancer definition found implementation was associated with a 7.2% (95% CI, -13.5% to -0.48%; P = .04) level decrease in the percentage of TIRF prescriptions for patients without cancer. Lastly, the TIRF-REMS was associated with a 22.5% level decline in the percentage of TIRF prescriptions for patients without known opioid tolerance (95% CI, -36.1% to -5.95%; P = .01) followed by 1.98% monthly decreases (95% CI, -3.19% to -0.80%; P = .001). Conclusions and Relevance: Implementation of the TIRF-REMS Access Program, a restrictive drug distribution program, was associated with a temporary reduction in the rate of TIRF prescribing to Medicare Part D beneficiaries, and with a sustained decrease in the percentage of TIRF prescriptions for patients without known opioid tolerance. Implementation may have also been associated with a temporary decrease in the percentage of TIRF prescriptions for patients without cancer.

Financial Ties Between Emergency Physicians and Industry: Insights From Open Payments Data.

STUDY OBJECTIVE: The Open Payments program requires reporting of payments by medical product companies to teaching hospitals and licensed physicians. We seek to describe nonresearch, nonroyalty payments made to emergency physicians in the United States. METHODS: We performed a descriptive analysis of the most recent Open Payments data released to the public by the Centers for Medicare & Medicaid Services covering the 2014 calendar year. We calculated the median payment, the total pay per physician, the types of payments, and the drugs and devices associated with payments to emergency physicians. For context, we also calculated total pay per physician and the percentage of active physicians receiving payments for all specialties. RESULTS: There were 46,405 payments totaling $10,693,310 to 12,883 emergency physicians, representing 30% of active emergency physicians in 2013. The percentage of active physicians within a specialty who received a payment ranged from 14.6% in preventive medicine to 91% in orthopedic surgery. The median payment and median total pay to emergency physicians were $16 (interquartile range $12 to $68) and $44 (interquartile range $16 to $123), respectively. The majority of payments (83%) were less than $100. Food and beverage (86%) was the most frequent type of payment. The most common products associated with payments to emergency physicians were rivaroxaban, apixaban, ticagrelor, ceftaroline, canagliflozin, dabigatran, and alteplase. CONCLUSION: Nearly a third of emergency physicians received nonresearch, nonroyalty payments from industry in 2014. Most payments were of small monetary value and for activities related to the marketing of antithrombotic drugs.

A model for automated screening of thalassemia in hematology (math study).

BACKGROUND: beta-thalassemia screening is primarily limited to pregnant women. The ratio of the mean corpuscular volume (MCV) and red blood cell count (RBC) can be automatically calculated with any of the newer hematology analyzers. METHODS: The results of 398 patient screens were collected. Data from the set were divided into training and validation subsets. The Mentzer ratio was determined through a receiver operating characteristic (ROC) curve on the first subset, and screened for thalassemia using the second subset. HgbA2 levels were used to confirm beta-thalassemia. RESULTS: We determined the correct decision point of the Mentzer index to be a ratio of 20. Physicians can screen patients using this index before further evaluation for beta-thalassemia (P < .05). CONCLUSION: The proposed method can be implemented by hospitals and laboratories to flag positive matches for further definitive evaluation, and will enable beta-thalassemia screening of a much larger population at little to no additional cost.