Q&A: Pharmacists Help Patients Navigate Complexities of OTC Medications

As more drugs shift to over-the-counter (OTC) status, pharmacists face growing challenges helping patients navigate the trade-offs between easier access and higher out-of-pocket costs for various types of medications. Add onto that recent comments from FDA Commissioner Marty Makary, MD, MPH, that “everything should be OTC,” pharmacists continue to emerge as front-line providers suited to address medication access concerns.

“If it’s OTC, gas stations got it, grocery stores got it. It opens up that part, but access also includes cost,” Mark Garofoli, PharmD, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at West Virginia University School of Pharmacy, told Drug Topics. “That's going to differ product to product and that's going to be very confusing for patients, and quite frankly, health care professionals alike.”

In part 2 of our interview, Garofoli explains the weight of Makary’s comments and provides a detailed look into the complexities of drugs moving from prescription-only to OTC. From the potential rise in costs to a new drug category emerging in US community pharmacies, he helps eliminate some ambiguity within the increasingly complex and developing topic of prescription-to-OTC switches.

READ MORE: FDA’s Stance on OTC Drugs Raises Complex Patient Safety Questions

Drug Topics: While OTC status can lower cash prices through competition, it often ends insurance coverage. How should pharmacists advise patients who might see a $10 copay turn into a $30 out-of-pocket cost amid the current push to move prescription drugs to OTC?

Mark Garofoli: Well, that component doesn't make our lives easier as pharmacists, of course, because it's more information to go over that gets very convoluted. When someone's copay is $13.57, I mean, seriously, how do we explain that? There are components that go into it. Then, in a larger picture, like you’re saying, coverage for prescription products; if something's not a prescription, then how does it get covered in a prescription drug plan? We have precedent for that, even in quite volatile topics. The concept of some of the naloxone products being OTC; there was certainly concern across the board in health care for will there be coverage then if it's available OTC?

It comes down to the individual insurance plan—not even the company as a whole, but the multiple plans for each company—to make those formulary decisions. But at the same time, it's not like they're not enabled to make that decision when it's a prescription product either—hence formularies. It just opens up another door of ambiguity. At the same time, though, with potential OTC to prescription, you think about all the efforts for collaborative practice or prescribing for pharmacists. We see many examples of that anymore. Well, if something's OTC, it's not that, but it's almost inherent to that.

Access: part of it can increase because, if it's OTC, gas stations got it, grocery stores got it. It opens up that part, but access also includes cost to the core of your question. That's going to differ product to product and that's going to be very confusing for patients, and quite frankly, health care professionals alike.

Drug Topics: Some suggest the US should automatically allow OTC sales of drugs already available without a prescription in countries like the UK or Australia—where a pharmacist-only drug category has emerged. What are your thoughts on this drug category for pharmaceuticals potentially reaching the US health care system?

Mark Garofoli: It’s a phenomenal conversation; we have to avoid in health care, particularly pharmacy, making it circular. We want action-oriented conversations. Folks are going to [the American Pharmacists Association] or [the American Society of Health-System Pharmacists] or wherever [for] action-oriented [conversations]. [It’s] making a plan to say, ‘what are the benefits’ and ‘what are the potential shortcomings of having an additional classification of medications?’ Access again; well, if a pharmacy's not open, then how do you get that as well? We're talking 2:00 am or whatever. There are certainly 24-hour stores, but not everywhere and not all of them.

But in the big picture, it makes it where then you get some counseling, you get some advice along the way, or at least the opportunity thereof. Including that access, the payment structures—as far as insurance coverage and all that—maybe there could be something involved with that as well too. That's all kinds of brainstorming thoughts right there on all sides. But the general idea is that, this behind the counter status or pharmacist only, it's just the concept that it adds another layer of access. Let's be real: When's the last time any of us, anybody listening, went through our health care system and just was delighted? I'm talking like Disney delighted. It does happen by the way. It's just different. The access needs to be there as well too. There are a lot of hoops; there's a lot of time. My love language is time. I don't like to waste it along the way and I know I'm not alone out there. No matter what, our time is very valuable and we have to look at ways to enable that.

This is going to be a little bit off the wall but a couple months ago; I'm an aging, balding guy from West Virginia. So the algorithms, all of a sudden, a couple months ago, started sending some medications my way in the algorithms of social media as far as ads. Buy a pill and it'll be on your doorstep tomorrow, if not the day after. That's access. Are there safety concerns? Oh my gosh, yes. I let my wife know, ‘Hey, I'm going to click the button to learn more.’ And then of course, that could get a little bit dicey along the way. You've got the hair stuff, the ED things, the little blue pills, and all that stuff. I clicked it and I got 15 more. All of a sudden, that was my entire feed. I screenshotted it and I put it on LinkedIn and was like, ‘Think about this.’ This is actually something we can learn from. Yes, in the safety side of things, but why is it that these recreational things I can get cheap and quick compared to being held hostage for a refill for a seasonal allergy nose spray? I've lived that. It brings up a whole other thing of, again, that access overall.

[Then there’s] that statement from Mr. Makary. Hopefully, there are intentions there of provoking these thoughts. There's a sensationalization to it as well. Everybody loves a little bit of sunshine and limelight and all that stuff. We all get our 15 seconds and some get 15 years. That's inherent; that's what's happening there, of course. It provokes these conversations like we're having here today, though, to get that thought going as well. That's the glass-half-full approach perhaps.

READ MORE: OTC Resource Center

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