Transitioning the second-generation antihistamines to over-the-counter status a cost-effectiveness analysis

Medical Care

Volumn 41, Issue 12, 2003, Pages 1382-1395

  Sullivan, Patrick W ^a   Follin, Sheryl L ^a   Nichol, Michael B ^b  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

Cost effectiveness; Prescription to OTC switch; Second generation antihistamines

Indexed keywords

HISTAMINE H1 RECEPTOR ANTAGONIST; NON PRESCRIPTION DRUG;

ACCIDENT; ANALYSIS OF VARIANCE; ARTICLE; CHEMICALLY INDUCED DISORDER; CLINICAL PRACTICE; COST BENEFIT ANALYSIS; COST CONTROL; COST OF ILLNESS; DECISION SUPPORT SYSTEM; DRUG APPROVAL; DRUG UTILIZATION; ECONOMICS; FOOD AND DRUG ADMINISTRATION; HEALTH SERVICES RESEARCH; HUMAN; INJURY; MONTE CARLO METHOD; ORGANIZATION AND MANAGEMENT; PRODUCTIVITY; PSYCHOLOGICAL ASPECT; QUALITY ADJUSTED LIFE YEAR; RHINITIS; RISK ASSESSMENT; RISK FACTOR; SENSITIVITY AND SPECIFICITY; STATISTICS; UNITED STATES;

ACCIDENTS; ANALYSIS OF VARIANCE; COST OF ILLNESS; COST SAVINGS; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; DRUG APPROVAL; DRUG UTILIZATION; DRUGS, NON-PRESCRIPTION; EFFICIENCY; HEALTH SERVICES RESEARCH; HISTAMINE H1 ANTAGONISTS, NON-SEDATING; HUMANS; MONTE CARLO METHOD; PHYSICIAN'S PRACTICE PATTERNS; QUALITY-ADJUSTED LIFE YEARS; RHINITIS; RISK ASSESSMENT; RISK FACTORS; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOUNDS AND INJURIES;

EID: 0642367855     PISSN: 00257079     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.MLR.0000100584.18276.C4     Document Type: Review

References (81)

1. Center for Drug Evaluation and Research, US Food and Drug Administration. Joint Meeting of the Nonprescription Drugs Advisory Committee and Pulmonary-Allergy Drugs Advisory Committee; Gaithersburg, MD; May 11, 2001.
2. Consumer Health Products Association. Talking with stakeholders about FDA modernization. Available at: www.fda.gov/ohrms/dockets/dailys/042799/ c000009.pdf. Accessed October 1, 2002.
3. Deleted in proof.
4. Deleted in proof.
5. Deleted in proof.
6. Deleted in proof.
7. Deleted in proof.
8. Du Buske LM. Clinical comparison of histamine H1-receptor antagonist drugs. J Allergy Clin Immunol 1996;98:S307-S318.
9. Estelle F, Simons R. H1-receptor antagonists: safety issues. Ann Allergy Asthma Immunol 1999;83: 481-488.
10. Weiler JM, Bloomfield JR, Woodworth GG, et al. Effects of fexofenadine, diphenhydramine, and alcohol on driving performance. A randomized, placebo-controlled trial in the Iowa driving simulator. Ann Intern Med 2000;132:354-363.
11. Witek TJ, Canestrari DA, Miller RD, et al. Characterization of daytime sleepiness and psychomotor performance following H1 receptor antagonists. Ann Allergy Asthma Immunol 1995;74:419-426.
12. Aso T, Sakai Y. Effect of terfenadine, a novel antihistamine on actual driving performance. Ann Allergy 1989;62:250.
13. Ramaekers JG, Uiterwijk MM, O'Hanlon JF. Effects of loratadine and cetirizine on actual driving and psychometric test performance, and EEC during driving. Eur J Clin Pharmacol 1992;42:363-369.
14. Cockburn IM, Bailit HL, Berndt ER, et al. Loss of work productivity due to illness and medical treatment. J Occup Environ Med 1999;41:948-953.
15. Kay GG, QM. Impact of sedating antihistamines on safety and productivity. Allergy Asthma Proc 2001;22:281-283.
16. O'Hanlon JF, Ramaekers JG. Antihistamine effects on actual driving performance in a standard test: a summary of Dutch experience, 1989-94. Allergy 1995;50:234-242.
17. Finkle WD, Adams JL, Greenland S, et al. Increased risk of serious injury following an initial prescription for diphenhydramine. Ann Allergy Asthma Immunol 2002;89:244-250.
18. Crystal-Peters J, Crown WH, Goetzel RZ, et al. The cost of productivity losses associated with allergic rhinitis. American Journal of Managed Care 2000;6:373-378.
19. Gaillard AW, Gruisen A, de Jong R. The influence of antihistamines on human performance. Eur J Clin Pharmacol 1988;35:249-253.
20. Gilmore TM, Alexander BH, Mueller BA, et al. Occupational injuries and medication use. Am J Ind Med 1996;30:234-239.
21. Adelsberg BR. Sedation and performance issues in the treatment of allergic conditions. Arch Intern Med 1997;157:494-500.
22. Vuurman EF, van Veggel LM, Uiterwijk MM, et al. Seasonal allergic rhinitis and antihistamine effects on children's learning. Ann Allergy 1993;71:121-126.
23. Gold MR, Siegel JE, Russell LB, et al., eds. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 1996.
24. Dykewicz MS, Fineman S, Skoner DP, et al. Diagnosis and management of rhinitis: complete guidelines of the Joint Task Force on Practice Parameters in Allergy, Asthma and Immunology. American Academy of Allergy, Asthma, and Immunology. Ann Allergy Asthma Immunol 1998;81:478-518.
25. Thomas JS, Heurich AE, Ralph JW, et al. Double-blind, controlled study of clemastine fumarate, chlorpheniramine and placebo in patients with seasonal allergic rhinitis. Ann Allergy 1977;38:169-174.
26. Todd G, Hopkins P, Maclay W. Double-blind trials of clemastine (Tayegil') in allergic rhinitis. Curr Med Res Opin 1975;3:126-131.
27. Sheriff JM, Wallace MG. A comparative study of clemastine ('Tavegil') and chlorpheniramine maleate in the treatment of hay fever. Curr Med Res Opin 1976;4:245-249.
28. Harvey RP, Comer C, Sanders B, et al. Model for outcomes assessment of antihistamine use for seasonal allergic rhinitis. J Allergy Clin Immunol 1996;97:1233-1241.
29. Horak F, Bruttmann G, Pedrali P, et al. A multicentric study of loratadine, terfenadine and placebo in patients with seasonal allergic rhinitis. Arzneimittel-forschung 1988;38:124-128.
30. Del Carpi J, Kabbash L, Turenne Y, et al. Efficacy and safety of loratadine (10 mg once daily), terfenadine (60 mg twice daily), and placebo in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol 1989;84:741-746.
31. Bruttmann G, Charpin D, Germouty J, et al. Evaluation, of the efficacy and safety of loratadine in perennial allergic rhinitis. J Allergy Clin Immunol 1989;83:411-416.
32. Day JH, Briscoe MP, Clark RH, et al. Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis. Ann Allergy Asthma Immunol 1997;79:163-172.
33. Kemp JP, Buckley CE, Gershwin ME, et al. Multicenter, double-blind, placebo-controlled trial of terfenadine in seasonal allergic rhinitis and conjunctivitis. Ann Allergy 1985;54:502-509.
34. Dockhorn RJ, Bergner A, Connell JT, et al. Safety and efficacy of loratadine (Sch-29851): a new non-sedating antihistamine in seasonal allergic rhinitis. Ann Allergy 1987;58:407-411.
35. Lockey RF, Fox RW. Loratadine (SCH 29851) 10 mg OD versus clemastine 1 mg BID in the treatment of perennial allergic rhinitis. Immunol Allergy Pract 1989;11:10-16.
36. Buckley CE, Buchman E, Falliers CJ, et al. Terfenadine treatment of fall hay fever. Ann Allergy 1988;60:123-128.
37. Druce HM, Thoden WR, Mure P, et al. Brompheniramine, loratadine, and placebo in allergic rhinitis: a placebo-controlled comparative clinical trial. J Clin Pharmacol 1998;38:382-389.
38. Alexander M, Small P, Thomson D. Efficacy and tolerability of cetirizine, loratadine and placebo in the treatment of seasonal allergic rhinitis (SAR): a Canadian multicentre study [Abstract]. J Allergy Clin Immunol 1994;93:163.
39. Brandon ML, Weiner M. Clinical investigation of terfenadine, a non-sedating antihistamine. Ann Allergy 1980;44:71-75.
40. Melillo G, D'Amato G, Zanussi C, et al. A multicentre controlled trial of terfenadine, dexchlorpheniramine, and placebo in allergic rhinitis. Arzneimittel-forschung 1982;32:1202-1203.
41. Brostoff J, Lockhart JD. Controlled trial of terfenadine and chlorpheniramine maleate in perennial rhinitis. Postgrad Med J 1982;58:422-423.
42. Backhouse CI, Brewster BS, Lockhart JD, et al. Terfenadine in allergic rhinitis. A comparative trial of a new antihistamine versus chlorpheniramine and placebo. Practitioner 1982;226:347-351.
43. American College of Allergy Asthma and Immunology. Allergy Survey Fact Sheet: RoperASVV, 2002.
44. Roper Starch. Self-Care in the New Millennium: Consumer Healthcare Products Association, 2001.
45. Schering-Plough Research Institute. Briefing Book. Kenilworth, April 11, 2001.
46. Managed Care Measures LLC. Respiratory Benchmarks, 2000.
47. Cauchon D. Fatalities linked to medication-sedation blamed in traffic deaths. USA Today. Available at: http://www.usatoday.com/life/health/ drugs/lhdru106.htm. Accessed June 7, 2002.
48. National Highway Traffic Safety Administration. Traffic Safety Facts 2000. Washington, DC: US Department of Transportation, 2001.
49. Blincoe L, Seay A, Zaloshnja E, et al. The economic impact of motor vehicle crashes, 2000. Washington, DC: National Highway Traffic Safety Administration, US Department of Transportation, 2002.
50. Meltzer EO. The prevalence and medical and economic impact of allergic rhinitis in the United States. J Allergy Clin Immunol 1997;99:S805-S828.
51. Digest of State Alcohol-Highway Safety Related Legislation Current as of January 1,1996. Washington, DC: National Highway Traffic Safety Administration, 1996.
52. Ray WA, Thapa PB, Shorr RI. Medications and the older driver, Clin Geriatr Med 1993;9:413-438.
53. Simpson H. Polydrug effects and traffic safety. Journal of Alcohol Drugs and Driving 1985;l:17-44.
54. Starmer G. Antihistamines and highway safety. Acrid Anal Prev 1985;17:311-317.
55. Gengo FM, Gabos C, Mechtler L. Quantitative effects of cetirizine and diphenhydramine on mental performance measured using an automobile driving simulator. Ann Allergy 1990;64:520-526.
56. Vinson DC, Mabe N, Leonard LL, et al. Alcohol and injury. A case-crossover study. Archives of Family Medicine 1995;4:505-511.
57. Injury Facts. Itasca, IL: National Safety Council, 2000.
58. Statistical abstract of the United States, 2000. Washington, DC: US Department of Commerce Economics and Statistics Administration, Bureau of the Census, 2001.
59. Adams PF, Hendershot GE, Marano MA. Current Estimates From the National Health Interview Survey, 1996. Hyattsville, MD: National Center for Health Statistics, October 1999:10(200).
60. Drugstore.com. Available at: www.drugstore.com. Accessed February 21, 2003.
61. Belshe KS, KJ, Hiehle G, et al. California's Medical Assistance Program, Annual Statistical Report, Calendar Year 1997. Sacramento: California Department of Health Services, 1998.
62. National Compensation Survey: Occupational Wages in the United States. Washington, DC: US Bureau of Labor Statistics, 1999, 2001.
63. The Abbreviated Injury Scale. Des Plaines, IL: Association for the Advancement of Automotive Medicine, 1990.
64. Graham JD, Thompson KM, Goldie SJ, et al. The cost-effectiveness of air bags by seating position. JAMA 1997;278:1418-1425.
65. McMenamin P. Costs of hay fever in the United States in 1990. Ann Allergy 1994;73:35-39.
66. Fryback DG, Dasbach EJ, Klein R, et al. The Beaver Dam Health Outcomes Study-: initial catalog of health-state quality factors. Med Decis Making 1993;13:89-102.
67. MacKenzie EJ, Damiano A, Miller T, et al. The development of the Functional Capacity Index. J Trauma 1996;41:799-807.
68. Warner MBP, Fingerhut LS. Injury and Poisoning Episodes and Conditions: National Health Interview Survey, 1997. Hyattsville, MD: US Department of Health and Human Services Public Health Service, Centers for Disease Control National Center for Health Statistics, 2000.
69. Redelmeier DA, Weinstein MC. Cost-effectiveness of regulations against using a cellular telephone while driving. Med Decis Making 1999;19:1-8.
70. Fryback DG, Stout NK, Rosenberg MA. An elementary introduction to bayesian computing using Win-BUGS. Int J Technol Assess Health Care 2001;17:98-113.
71. Nicholson W. Microeconomic Theory. Basic Principles and Extensions, 7th ed. Fort Worth: Dryden Press, 1998.
72. Leibowitz A, Manning WG, Newhouse JP. The demand for prescription drugs as a function of cost-sharing. Soc Sci Med 1985;21:1063-1069.
73. Keeler TE, Hu T, Keith A, et al. The benefits of switching smoking cessation drugs to over-the-counter status. Health Econ 2002;11:389-402.
74. Taylor H, Leitman R. If-as some are advocating-non-sedating antihistamines go OTC, price-elasticity would limit their use. HarrisInteractive. Available at: http://www.harrisinteractive.corn/news/ allnewsbydate.asp?NewsID=332. Accessed October 1, 2002.
75. Current Population Survey. March 1999 Supplement. Washington, DC: US Bureau of the Census, March 1999.
76. Kaiser Family Foundation. Prescription Drug Trends. Menlo Park, CA: Kaiser Family Foundation, November 2001.
77. Teitelbaum F, Martinez R, Parker A, et al. Drug Trend Report: Express Scripts. June 2001:2002.
78. Motheral BR, Henderson R. The effect of a copay increase on pharmaceutical utilization, expenditures, and treatment continuation. American Journal of Managed Care 1999;5:1383-1394.
79. Fairman KA, MB, Teitelbaum F. Effects of employee salary and chronic disease on response to a drug copayment increase: Office of Research and Development, Express Scripts Inc, August 2001.
80. Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol 2001;108(suppl):S2-S8.
81. American College of Allergy Asthma and Immunology. New survey reveals allergies nearly twice as common as believed-afflicting more than one-third of Americans. Public Communications Inc. Available at: http://allergy.mcg.edu/news/survey.html. Accessed June 6, 2002.