As I reflect over my path to becoming a pharmacist and where I am at in my career today, there are those defining moments that I can relive again and again in my mind as if they just happened. One of those moments came during my second year in pharmacy school. I was working the closing shift at a local community pharmacy. As I was helping a regular patient pick up his medications, we had a discussion about his recent health concern. He had developed bothersome nasal symptoms that coincided with the start of the allergy season. He had tried multiple antihistamines with appropriate dosing and trial duration with minimal reduction in his symptoms. I still recall how hopeless I felt talking to this patient and realizing that I had the knowledge regarding other options such as nasal steroids that would likely bring him relief, but that all I could do at the time was refer him to his physician for an evaluation and likely prescription for one of these other options. Since that time of course the FDA has approved multiple nasal steroids for over-the-counter (OTC) use which has helped a number of patients gain access to a safe class of medications without the barrier of a required prescription. Had nasal steroids been available as an OTC when I had this interaction, both he and I would have had a more satisfying experience that could have led to cost saving for the patient.
This memory came flooding back to me this last week as I read the recent FDA statement on efforts to allow greater access to nonprescription drugs. I was glad to see that this is a priority on the minds of FDA leadership. While I would say a majority of prescription only medications on the market today do require proper diagnosis and supervision during use, there are still a number of medications that could conceivably be used safely without a prescription with the right information and resource. The FDA has proposed a couple of pathways for medications to become available without a prescription that still fits within their current approval processes.
The proposal I am most excited about and that I think could make the biggest impact on consumer access to medications is pairing a medication with some sort of technology that will guide a patient to an appropriate treatment option. This could be something like an app or website that a patient could enter their health information pertinent to their current condition and receive guidance to an OTC medication along with the information or training needed to safely use this medication. The relevant piece of technology would be studied along with all of the other required pieces of an OTC approval to demonstrate that it allows safe use of a medication without the supervision of a provider.
The increased access to medications without the need of a prescription will likely make positive impacts on overall health costs and the budgets of payers. Let’s imagine back to the OTC approval of nasal steroids and what impact it has had. While I do not know of any published numbers, the amount of money saved by payers and patient driven by the decrease in medication costs and fewer visits to prescribers must be significant. Increased OTC access in certain classes of medications, such as those used to treat hyperlipidemia for example, could conceivably lead to increased use and adherence to these medications which could decrease related health care costs and decrease negative outcomes.
Increasing access to medications without a prescription, when properly done, has the potential to positively impact many interested parties. First and foremost, patients will have access to needed medications with potentially less hassle along with out-of-pocket cost. This may in turn lead to better outcomes and decreased cost for payers and consumers. Although OTC access to medications is not a topic discussed all that often within managed care, I believe the potential outcomes should lead us to all support this effort by the FDA.