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WHAT IT MEANS AND WHY IT'S IMPORTANT — There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle. And that's the call for a codified third class of drugs, made more or less by both the National Association of Chain Drug Stores and the National Community Pharmacists Association in their written submissions to the Food and Drug Administration on expanding the switch paradigm. The Consumer Healthcare Products Association, in its written comments, maintains the current two-class drug system, not three-class, is the way to go.
(THE NEWS: NACDS expresses to FDA cautious optimism on the 'new paradigm' for third class of drugs. For the full story, click here.)
During a CHPA Annual meeting in 2007, then FDA commissioner and keynote speaker Andrew von Eschenbach captured every executive's immediate and rapt attention when he advocated the creation of a codified third class of drugs. It was like he was advocating dog fighting at a PETA convention. Every person in that room stopped what they were doing and asked themselves, "Did he just say what I think he said?"
That's because there is a significant danger associated with establishing a legal definition for a third class of drugs — one that would restrict access as opposed to broaden access to appropriate medicines in the self-care space, one that would prove as a disincentive to any potential switch applicant as the prospect of recouping any research and development expenditures, not to mention a profit, quickly dwindles.
There already is a stark example of a medicine that's mandated by law to be merchandised from behind the pharmacy counter: pseudoephedrine. There are no pharmacological reasons for that "reverse switch," no safety and efficacy concerns that would preclude availability on the shelf and without a pharmacist intervention. It's sold behind the counter because a small percentage of criminals use PSE cold tablets as one of the raw ingredients in their backyard recipes for methamphetamine. When PSE went from OTC to behind the counter, sales plummeted.
PSE also happens to serve as a good example as to why retail pharmacy would be a lot more comfortable with the inclusion of the pharmacist in any switch paradigm if there were actually a codified third class of drugs. Because the fact is many pharmacists have to "dispense" that PSE product upon request; they have to process that transaction after checking a photo ID, after obtaining the appropriate signatures and after running that transaction through the appropriate vetting system. It's a consultation to be sure, but it's not a consultation where pharmacists see any kind of reimbursement for their time.
Neither retail pharmacy nor consumer healthcare companies would advocate replicating this "reverse switch" example with another medicine. But that's one danger in a codified third class of drugs. It would make it easier to take any OTC medicine that presented adverse results when misused or abused, and place that medicine into BTC status. Worried that your children are chugging dextromethorphan? Make it BTC. Concerned about those acute overdoses of acetaminophen, whether by accident or with purpose? Make it BTC.
To be sure, both DXM and APAP could be mandated behind-the-counter today. But today it takes an act of Congress to do it; there is no fast and easy mechanism that can be used to quickly move medicines back and forth between drug classes.
Retail pharmacy's concerns are not unfounded, however. Pharmacists already play a significant role in moving the needle toward better healthcare outcomes; and in more and more cases, they are getting appropriately compensated for that professional intervention. And that needs to continue: Broader inclusion of the pharmacist in any patient's disease-state protocol represents a big savings opportunity for health care. But they're not volunteers; they are learned health professionals who have the same six-year-plus student loans to pay off as their nurse and doctor counterparts.
So what's the solution? How do you create a switch protocol that a) expands access without inadvertently restricting access, b) prevents pre-existing OTC therapies from being "reverse switched" or prevents switch applicants to be forever trapped in a transitory BTC status and c) includes a mechanism through which a pharmacist can be appropriately compensated for their time? Sound off below! Or send comments to senior OTC editor Mike Johnsen at email@example.com.