title: Effects of Televised Direct-to-Consumer Advertising for Varenicline on Prescription Dispensing in the United States, 2006-2009.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL; ykim96@uic.edu.
authors.forename: Yoonsang
authors.initials: Y
authors.lastname: Kim
authors.affiliation: School of Journalism and Mass Communication, University of Wisconsin-Madison, Madison, WI;
authors.forename: Rachel
authors.initials: R
authors.lastname: Kornfield
authors.affiliation: Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL;
authors.forename: Yaru
authors.initials: Y
authors.lastname: Shi
authors.affiliation: Moores Cancer Center, University of California San Diego, La Jolla, CA;
authors.forename: Lisa
authors.initials: L
authors.lastname: Vera
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; Johns Hopkins Center for Drug Safety and Effectiveness, Baltimore, MD;
authors.forename: Matthew
authors.initials: M
authors.lastname: Daubresse
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; Johns Hopkins Center for Drug Safety and Effectiveness, Baltimore, MD; Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: G Caleb
authors.initials: GC
authors.lastname: Alexander
authors.affiliation: Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL;
authors.forename: Sherry
authors.initials: S
authors.lastname: Emery
mesh_terms: D000067088:Direct-to-Consumer Advertising / Q000706:statistics & numerical data*; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D006801:Humans; D016540:Smoking Cessation / Q000379:methods*; D013690:Television; D014481:United States; D000068580:Varenicline / Q000627:therapeutic use*
chemical_list: D000068580:Varenicline