Magazine article Drug Topics

Rx-to-OTC Switches: Reflections and Projections

Magazine article Drug Topics

Rx-to-OTC Switches: Reflections and Projections

Article excerpt


In 1973, in the book Remarkable Pharmacists, pharmacist and former Vice President of the United States Hubert Humphrey reflected for several pages on his political career. He made no mention, however, of the Durham-Humphrey Drug Prescription Act, which bore his name and which forever changed pharmacy practice and "the drug business." Indeed, the legislation didn't create much of a stir in pharmacy professional circles at the time, and who could have known where it would lead?

Where it led, of course, was to some 30 years of federal regulations and restrictions on the use of medications by the American people. In the last 10 years or so, something equally dramatic has occurred-notably, the Rx-toOTC shift phenomenon-but the drama may have been lost because of the gradual nature of the changes.

Hydrocortisone topical preparations might be considered the first shot in the revolution, but ibuprofen was certainly the loudest. Since those early switches, scores of medications have followed the trend. In the last several years alone, the H2 antagonists, smoking cessation aids, and a variety of antihistamine drugs have followed. There is talk of switching cholesterol-reducing agents, products for various types of infections, and asthma medications.

The revolution is well under way. And I am not sure pharmacy has totally joined the fray.

Pharmacists today have on their shelves the most powerful and effective nonprescription medications in history. It is good to remember that switched products originally required a prescription because, in the official view of the Food & Drug Administration, they could not be used safely without professional supervision. Today, there is one professional available, and we all know who that is-the pharmacist.


The revolution brought about by Rx-toOTC switching has had an enormous effect on the OTC marketplace. Table 1 illustrates this with data estimating a $4.6 billion market at retail by the year 2001. With an 11.8% annual growth rate, this is a very attractive market! Further, the sales of products in the categories listed in Table 1 can be projected to be nearly $100,000 per pharmacy, per year, by 2001.

In Table 2, we have provided data on specific products. Reported are sales of switched products as a part of the total sales of the top-selling OTCs on the U.S. market. It can be seen that the nine switched products accounted for nearly two-fifths of the dollar sales among the top 21 products. Considering the age and past success of the other products on the top 21 list, this is a significant achievement. (Note that use of brand names should not be considered an endorsement by the author, the publisher, or the sponsor of this article.)

Table 3 provides a "report card" on some of the switched products, based on market performance (total dollar sales, market share, etc.). Not all switched products succeed, as these data indicate. Nor do all market analysts agree about what makes a switch successful, as the "mini-case" (see box on page 71 ) demonstrates.

What does the future hold for switches? Much, of course, depends on the FDA, whose policies are discussed below. There is no shortage of prognostication, however.

Table 4 provides a list of possible switches for the future. Practicing pharmacists will know that if even half of these switch candidates make the change, the impact on both Rx and OTC markets will be very large.


In 1 997, the Nonprescription Drug Manufacturers Association (NDMA) published the report of a study conducted by Kline & Co. and subtitled "Economic Benefits of SelfMedication." The report focused on data from OTC categories that "together comprise approximately 59% of the OTC market in the United States." These categories are:



Minor pain

Certain dermatologic conditions

The economic analysis focused on direct savings, such as lower costs for OTC versus Rx medications, and on avoided costs, such as physician visits and loss of work wages. …

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