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Background: Hemodialysis (HD) patients frequently experience pain. Previous studies of HD patients suggest increased opioid prescribing through 2010. It remains unclear if this trend continued after 2010 or declined with national trends.Methods: Longitudinal cohort study of 484,745 HD patients in the United States Renal Data System/Medicare data. We used Poisson/negative binomial regression to estimate annual incidence rates of opioid prescribing between 2007 and 2014. We compared prescribing rates with the general US population using IQVIA's National Prescription Audit data. Outcomes included the following: percent of HD patients receiving an opioid prescription, rate of opioid prescriptions, quantity, days supply, morphine milligram equivalents (MME) dispensed per 100 person-days, and prescriptions per person.Results: In 2007, 62.4% of HD patients received an opioid prescription. This increased to 63.2% in 2010 then declined to 53.7% by 2014. Opioid quantity peaked in 2011 at 73.5 pills per 100 person-days and declined to 62.6 pills per 100 person-days in 2014. MME peaked between 2010 and 2012 then declined through 2014. In 2014, MME rates were 1.8-fold higher among non-Hispanic patients and 1.6-fold higher among low-income patients. HD patients received 3.2-fold more opioid prescriptions per person compared to the general US population and were primarily prescribed oxycodone and hydrocodone. Between 2012 and 2014, HD patients experienced greater declines in opioid prescriptions per person (18.2%) compared to the general US population (7.1%).Conclusion: Opioid prescribing among HD patients declined between 2012 and 2014. However, HD patients continue receiving substantially more opioids than the general US population. [ABSTRACT FROM AUTHOR]

Introduction: Televised direct-to-consumer advertising (DTCA) for prescription drugs is controversial, especially for tobacco cessation products such as varenicline, given safety concerns that arose only after its market approval. We aim to quantify the extent to which DTCA influenced varenicline use.Methods: We linked monthly DTCA television ratings with monthly prescription data from IMS Health's National Prescription Audit across top 75 media markets in 2006-2009. We used Poisson models with Generalized Estimating Equations to analyze effects of exposures to DTCA for both varenicline and nicotine replacement therapies on rate of dispensed varenicline prescriptions among smokers, controlling for population characteristics and varenicline-related events.Results: Varenicline prescriptions increased dramatically following DTCA launch and declined sharply after safety risks were publicized and US Food and Drug Administration (FDA) issued an advisory. DTCA had significant impact on new prescription dispensing in the subsequent month: before the FDA advisory, one additional exposure to varenicline DTCA was associated with a 1.8% (rate ratio [RR] = 1.018 [1.015-1.021]) higher rate of new prescriptions; no effect was observed after the advisory (RR = 1.000 [0.997-1.003]). Prior to the advisory, cross-product effects of nicotine replacement therapy advertising on varenicline prescribing were negligible (RR = 1.002 [0.999-1.004]); after the advisory, effects were positive (RR = 1.015 [1.012-1.019]).Conclusions: DTCA for varenicline had a significant impact on varenicline prescribing when the drug's safety profile was not well characterized, supporting arguments to limit DTCA for newly approved products whose real-world safety is unclear.Implications: We examined the fluctuations in varenicline use in association with DTCA for varenicline and other tobacco cessation aids. To our knowledge this is the first study to quantify the effects of televised DTCA for varenicline and other tobacco cessation aids on varenicline prescription dispensing. We believe that understanding these relationships is critical for formulating effective public health policy and interventions. [ABSTRACT FROM AUTHOR]