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Switching Pharmaceutical Products from Prescription to Over-the-Counter: The Debate in the U.S.

Published online by Cambridge University Press:  20 January 2017

Richard P. Rozek
Richard P. Rozek*
Affiliation:
National Economic Research Associates, Inc. (NERA), Washington, D.C.
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Type
Reports
Information
European Journal of Risk Regulation , Volume 3 , Issue 4 , December 2012 , pp. 601 - 607
Copyright
Copyright © Cambridge University Press 2012

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References

1 Ingredients & Dosages Transferred from Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975,” February 7, 2011, Consumer Health Products Association (CHPA), available on the Internet at <http://chpa-info.org/media/resources/r_4620.pdf> (last accessed on 31 October 2012).

2 “Utilizing Innovative Technologies and Other Conditions of Safe Use to Expand Access to Nonprescription Drugs,” FDA Hearing, March 22–23, 2012, available on the Internet at <http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm> (last accessed on 31 October 2012). Woodcock, Janet, “Should There be More Flexibility in Our Concept of Non-Prescription Drugs?” Remarks at FDA Hearing on March 22–23, 2012, 3(4) SelfCare (2012), pp.75–77 Google Scholar, available on the Internet at <http://selfcarejournal.com/view.article.php?id=10079> (last accessed on 31 October 2012).

3 Temin, Peter, “Costs and Benefi ts in Switching Drugs From Rx to OTC”, 2 Journal of Health Economics (1983), pp. 187–205 CrossRefGoogle Scholar. Temin, Peter, “Realized Benefits from Switching Drugs”, 35 Journal of Law and Economics (1992), pp. 351–369 CrossRefGoogle Scholar. Jay Patrick Bae, “Economic Analysis of Prescription to Over-the-Counter Conversion of Drugs,” Ph.D., University of California, Los Angeles, 1993. “Advancing Quality Healthcare,” CPHA, available on the Internet at http://chpa-info.org/issues/Quality_Healthcare.aspx (last accessed on 31 October 2012); Kline & Co. “Economic Benefits of Self-Medication, A Final Report to NDMA,” May 15, 1997. CHPA still cites the results of this study. “The Switching Process,” CHPA, available on the Internet at <http://chpa-info.org/scienceregulatory/Switch_Process.aspx> (last accessed on 31 October 2012). Pradel, Francoise, Hartzema, Abraham, Mutran, Elizabeth, and Hanson-Divers, Christine, “Physician Over-The-Counter Drug Prescribing Patterns: An Analysis of the National Ambulatory Medical Care Survey”, 33 The Annals of Pharmacotherapy (1999), pp. 400–405 CrossRefGoogle ScholarPubMed. Andrade, Susan, Gurwitz, Jerry, and Fish, Leslie, “The Effect of an Rx-to-OTC Switch on Medication Prescribing Patterns and Utilization of Physician Services”, 37(4) Medical Care (1998), pp. 424–430 CrossRefGoogle ScholarPubMed. Sandra Levy, “Increased co-pays open door for wider usage of OTC drugs,” Drug Topics Archive, December 1998, available on the Internet at <http://www.pdr.net/consumer/static.htm?path=content/journals/d/toc/1998d7b.htm> (last accessed on 31 October 2012). “OTC Coverage under Rx May Help Restrain Drug Costs-Ford Exec”, 62(21) The Pink Sheet (2000). “OTC Coverage under Rx May Help Restrain Drug Costs-Ford Exec”, 62(21) The Pink Sheet (2000).

4 Ryan, Mandy and Yule, Brian, “Switching Drugs from Prescription Only to Over-the-Counter Availability: Economic Benefits in the United Kingdom”, 16 Health Policy (1990), pp. 233–239 CrossRefGoogle ScholarPubMed. Carlsten, A., Wennberg, M., and Bergendal, L., “The Influence of Rx-to-OTC Changes on Drug Sales. Experience from Sweden 1980–1994”, 21 Journal of Clinical Pharmacy and Therapeutics (1996), p. 423–430 CrossRefGoogle Scholar. Tasch, Rachel, Goeree, Ron, Hennke, Curtis, and O’Brien, Bernie, “Switching the Histamine H2 Receptor Antagonist Famotidine to Nonprescription Status in Canada”, 1 PharmacoEconomics (1996), pp. 61–75.CrossRefGoogle Scholar

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7 Red Book, Thomson PDR, Montvale, NJ, 2003, pp.268 and 638. AWPs are the price that a pharmacy pays for pharmaceutical products. The typical markup from this price for Rx products is 162/3 percent.

8 Managed Care Online, http://www.mcareol.com.

9 WellPoint Health Networks, an insurer, fi led a Citizen's Petition with the FDA requesting that Claritin® be switched from Rx to OTC status. Robert Seidman (Chief Pharmacy Offi cer, WellPoint Health Networks), “Petition to Convert Claritin®, Allegra® and Zyrtec® to OTC Status,” presentation to the FDA Pulmonary and OTC Advisory Committee Meeting, May 11, 2001. <http://www.fda.gov/ohrms/dockets/ac/01/slides/3737s_02_seidman.ppt> (last accessed on 31 October 2012).

10 Mickey Smith, “Rx-to-OTC Switches: Refl ections and Projections,” Drug Topics Archive, July 20, 1998, available on the Internet at <http://www.pdr.net/consumer/static.htm?path=content/journals/d/toc/1998d7b.htm> (last accessed on 31 October 2012).

11 Karen Snyder, “The State of the OTC Marketplace,” Drug Topics Archive, June 2, 1997, available on the Internet at <http://www.pdr.net/consumer/static.htm?path=content/journals/d/toc/1997d7b.htm> (last accessed on 31 October 2012).

12 Robert McCarthy, “OTCs: The Wild Card in Cost Effectiveness,” Business & Health, April 1, 1999, p. 33.

13 Medicaid plans vary by state. The rules governing the specific OTC products covered are determined at the state level.

14 The Medicare drug benefi ts are referred to as Medicare Part D.

15 Steven Pray, “OTC Products: Time Limits for Safe Use,” US Pharmacist, 1994, available on the Internet at <http://www.uspharmacist.com/NewLook/DisplayArticle.cfm?item_num=381> (last accessed on 31 October 2012).

16 Woodcock, p. 76.

17 “States Limit Cold Remedy Sales,” Wall Street Journal, August 24, 1998.

18 Cranston, Joseph and Yoast, Richard, “Abuse of Dextromethorphan”, 8 American Medical Association (1999), pp. 99–100.Google ScholarPubMed

19 Office of Applied Studies, Substance Abuse and Mental Health Services Administration, TEDS – 1.30.99.

20 Office of Applied Studies, “Year-End 1998 Emergency Department Data from the Drug Abuse Warning Network,” Department of Health and Human Services, 1998, p. 23.

21 Year-End 1998 Emergency Department Data from the Drug Abuse Warning Network, p. 23.

22 Year-End 1998 Emergency Department Data from the Drug Abuse Warning Network, p. 23.

23 John Fischman, “Herbs and Prescriptions Can Make a Risky Mixture,” U.S. News and World Report, May 1, 2000, p. 64.

24 “Over-the-Counter Drugs: Safe if Used Wisely”, 2(6) National Policy and Resource Center on Women and Aging Letter (1998).

25 Honig, Peter and Gillespie, Bradley, “Clinical Significance of Pharmacokinetic Drug Interactions with Over-the-Counter (OTC) Drugs”, 35(3) Clinical Pharmacokinetics (1998), pp. 167–171.CrossRefGoogle ScholarPubMed

26 Honig and Gillespie, p. 170.

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29 Christopher Hollenbeak, p. 667.

30 Bae, p. 8.

31 Bae, p. 9.

32 Ryan and Yule, p. 238.