title: Transitioning the second-generation antihistamines to over-the-counter status: a cost-effectiveness analysis.
abstract: BACKGROUND
  A U.S. Food and Drug Administration advisory committee deemed the second-generation antihistamines (SGA) safe for over-the-counter use against the preliminary opposition of the manufacturers. As a result, loratadine is now available over-the-counter. First-generation antihistamines (FGA) are associated with an increased risk of unintentional injuries, fatalities, and reduced productivity. Access to SGA over-the-counter could result in decreased use of FGA, thereby reducing deleterious outcomes. The societal impact of transitioning this class of medications from prescription to over-the-counter status has important policy implications.
  
  
  OBJECTIVE
  To examine the cost-effectiveness of transitioning SGA to over-the-counter status from a societal perspective.
  
  
  METHODS
  A simulation model of the decision to transition SGA to over-the-counter status was compared with retaining prescription-only status for a hypothetical cohort of individuals with allergic rhinitis in the United States. Estimates of costs and effectiveness were obtained from the medical literature and national surveys. Sensitivity analysis was performed using a second-order Monte Carlo simulation.
  
  
  METHODS
  Discounted, quality-adjusted life-years saved as a result of amelioration of allergic rhinitis symptoms and avoidance of motor vehicle, occupational, public and home injuries and fatalities; discounted direct and indirect costs.
  
  
  RESULTS
  Availability of SGA over-the-counter was associated with annual savings of 4 billion dollars (2.4-5.3 billion dollars) or 100 dollars (64-137 dollars) per allergic rhinitis sufferer and 135,061 time-discounted quality-adjusted life years (84,913-191,802). The sensitivity analysis provides evidence in support of these results.
  
  
  CONCLUSIONS
  Making SGA available over-the-counter is both cost-saving and more effective for society, largely as a result of reduced adverse outcomes associated with FGA-induced sedation. Further study is needed to determine the differential impact on specific vulnerable populations.
authors.affiliation: Pharmaceutical Outcomes Research Program, Department of Clinical Pharmacy, University of Colorado School of Pharmacy, Denver, Colorado 80262, USA. Patrick.Sullivan@UCHSC.edu
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Sullivan
authors.forename: Sheryl L
authors.initials: SL
authors.lastname: Follin
authors.forename: Michael B
authors.initials: MB
authors.lastname: Nichol
mesh_terms: D000059:Accidents / Q000191:economics / Q000706:statistics & numerical data; D000704:Analysis of Variance; D017046:Cost Savings; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D017277:Drug Approval / Q000458:organization & administration*; D004363:Drug Utilization; D004526:Efficiency; D006302:Health Services Research; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D009010:Monte Carlo Method; D004366:Nonprescription Drugs / Q000191:economics*; D010818:Practice Patterns, Physicians' / Q000191:economics; D019057:Quality-Adjusted Life Years; D012220:Rhinitis / Q000188:drug therapy / Q000191:economics / Q000523:psychology; D018570:Risk Assessment; D012307:Risk Factors; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration; D014947:Wounds and Injuries / Q000139:chemically induced / Q000191:economics / Q000453:epidemiology
chemical_list: D039563:Histamine H1 Antagonists, Non-Sedating; D004366:Nonprescription Drugs