While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like.
OTC manufacturers have been framing the new paradigm within the existing two-drug-class system, suggesting that the diagnostic tools that already are available in the marketplace significantly could help expand which medicines are considered appropriate in the OTC space.
Retail pharmacists, on the other hand, are advocating for the creation of a third class of drugs.
Pharmacists advocate that third-class codification primarily to create a set of clinical standards that would help identify which medicines would require a pharmacist intervention, and define exactly what that role would be — whether that intervention would be in tandem with a primary care physician, for example, or establish a treatment protocol exclusive of the PCP.
Reimbursement also is a concern for pharmacists. Codifying exactly what kind of clinical intervention by the pharmacist would be required to successfully switch a new-paradigm medicine would be used to justify appropriate compensation for services rendered.
However, a behind-the-counter class of drugs could become problematic as it establishes a new regulatory bucket in which pre- existing OTC medicines can be thrown. Worried that your child may be chugging dextromethorphan with their friends? That sounds like a good BTC candidate. Feeling exasperation that basement meth cooks still are figuring out how to feed their pseudoephedrine need from retail? Require that it be sold BTC.
PSE already is mandated for sale from behind the counter, of course. But it took an act of Congress to make that happen.
There is one theme around which the two groups agree — expanding the switch paradigm must serve to broaden access to appropriate medicines. And the reasons driving those switches must be clinical in nature, as opposed to regulatory or legislative.