Leaping Across the Pharmacy Counter

In the last 40 years, more than 100 primary product ingredients have moved from behind the counter to OTC status. This translates to more than 700 products made in various combinations and by many manufacturers.¹

How does that happen, you may wonder? These status changes occur only after the FDA Office of Medical Products and Tobacco conducts a data-driven, scientifically rigorous, and highly regulated process. This process’s purpose is to increase Americans’ access to self-care products.

Drugs can be classified in 3 ways:

• Sometimes, a manufacturer files a new drug application (NDA) if there is clinical research that supports an OTC indication or OTC dosage levels.
• Occasionally, a manufacturer files a supplement to the original NDA based on positive postmarketing safety experience that indicates consumers could use the product safely without physician supervision.
• Sometimes, the FDA independently determines that prescription status is unnecessary for safe use of a drug, and files a petition for reclassification.¹

Technically, anyone could submit a Citizen’s Petition to the FDA to switch a product from Rx to OTC status, but the process is complicated.¹ The FDA’s Nonprescription Drugs Advisory Committee assists manufacturers if they start the reclassification process. These procedures, targeted to take 10 months but often taking longer, ensure that products reclassified to OTC status are safe and effective when used by the average consumer (Table).^1-3

Greater Access

Between 1975 and 1994, 30% of new OTC drugs marketed were products that made the leap from prescription status.⁵ This gave consumers greater access to many clinically proven antihistamines, analgesics, heartburn remedies, nicotine replacement therapies, vaginal yeast infection treatments, and most recently, a patch for overactive bladder (Oxytrol for Women) and an inhaler for allergic rhinitis (Nasacort Allergy 24-HR). For a list of drugs that switched since 2000, visit www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106378.htm.

Data show that these switches do what they are intended to do—they increase access to very good therapies. Consider the fact that when nicotine replacement therapies went over the counter, sales increased 150% to 200% in the first year alone. Today, consumers “just want to celebrate” more and more after they kick the smoking habit, although some patients don’t use the products as aggressively as they should.⁶ (Alert to pharmacists: counseling opportunity!) Researchers indicate that public health officials celebrate too; these products confer a $2 billion savings annually.^6,7

Patients’ out-of-pocket costs may increase after product reclassification. Few third-party health insurance payers provide reimbursement for OTC products. But overall health care costs fall.^1,8

Switching histamine₂-receptor antagonists and proton pump inhibitors to OTC status, for example, has saved an average of $174 per year in avoided prescription costs and office visits, and $750 million in related health care system expenses. Researchers at Northwestern University also found that using OTC products to treat certain upper respiratory infections could save $4.75 billion annually.^7,9,10

Final Note

Sales usually soar when drugs are reclassified to OTC status.¹¹ Manufacturers can sometimes extend their patent life when they navigate this process.¹²

Although the pace of switching has slowed in the last few years, advocates and opponents of switching oral contraceptives and statins are trading opinions now.^13-15 Pharmacists should watch this process.

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy.

References

• FAQs About Rx-to-OTC Switch. Consumer healthcare Products Association website. www.chpa.org/FAQsSwitchPP.aspx. Accessed December 17, 2013.
• Newton GD, Pray WS, Popovich NG. New OTC drugs and devices: selected review. Am Pharm. 1995;NS35:35-46.
• Nguyen NT, Cook DM, Bero LA. The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study. Clin Ther. 2006;28:1231-1243.
• Botstein P. Criteria for switching new molecular entities from prescription to over-the-counter. Drug Inf J. 1990;24:29-31.
• Newton G, Popovich NG, Pray WS. Rx-to-OTC switches: from prescription to self-care. J Am Pharm Assoc. 1996;NS36:488-495.
• Shiffman S, Sweeney CT. Ten years after the Rx-to-OTC switch of nicotine replacement therapy: what have we learned about the benefits and risks of non-prescription availability? Health Policy. 2008;86:17-26.
• Lipsky MS, Waters T. The “prescription-to-OTC Switch” movement. Arch Fam Med. 1999;8:197-200.
• Pawaskar MD, Balkrishnan R. Switching from prescription to over-the counter medications: a consumer and managed care perspective. Manag Care Interface. 2007;20:42-47.
• Sullivan PW, Nair KV, Patel BV. The effect of the Rx-to-OTC switch of loratadine and changes in prescription drug benefits on utilization and cost of therapy. Am J Manag Care. 2005;11(6):374-382.
• Spencer HM. The Rx-to-OTC switch of Claritin, Allegra, and Zyrtec: an unprecedented FDA response to petitioners and the protection of public health. Am Univ Law Rev. 2002;51:999-1050.
• Salmo R. Rx to OTC switches curb health care costs. Pharm Times. 1993;59:34, 37.
• Newton GD, Pray WS, Popovich NG. New OTC drugs and devices: selected review. Am Pharm. 1995;NS35:35-46.
• Grossman D, Fuentes L. Over-the-counter access to oral contraceptives as a reproductive healthcare strategy. Curr Opin Obstet Gynecol. 2013;25:500-505.
• Howard DL, Wall J, Strickland JL. Physician attitudes toward over the counter availability for oral contraceptives. Matern Child Health J. 2013;17:1737-1743.
• Nguyen NT, Cook DM, Bero LA. The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study. Clin Ther. 2006;28:1231-1243.