CEimpact Podcast

OTC Phenylephrine: Is it safe and effective to use?

• CEimpact

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OTC Phenylephrine is in the news!

Join Ashlee and David Brushwood as they navigate the convoluted world of OTC decongestants, and the pivotal roles pharmacists play in ensuring patient safety and medication efficacy.   

During this episode, the two discuss:
1. The role of the FDA in  managing GRASE, Generally Recognized as Safe and Effective, medications.
2. The FDA's original decision to include oral Phenylephrine products in the OTC monograph for decongestants.
3. The  CARES Act of 2020 and its impact on this efficacy and safety issue.
4. The instrumental roles of pharmacists in managing these products and providing the best options to patients. 

To access the FBA briefing document on the efficiency of Oral Phenylephrine as a nasal decongestant, click here. 

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Speaker 1:

David, welcome back. To Level Up, you are our resident best friend over here at CE Impact. We call you possibly every week to say hey, david, what do we do? Help us, help our pharmacy community and really appreciate your expertise and really appreciate you being with me on a Friday afternoon to record this Welcome.

Speaker 2:

Well, thank you, ashley. There's a lot going on right now that's very much of interest, involving the over-the-counter products that contain phenyl ephrin, particularly those that are orally administered and are single ingredient decongestant products, with that single ingredient being phenyl ephrin or PE. You see all those PE products out front in the pharmacy because the pseudo ephrin that products that are very effective have been taken behind the counter and we understand why that is. And so we have PE products that are out front because phenyl ephrin is not a methamphetamine precursor. You can't cook meth with phenyl ephrin, so it's available for general sale. Phenyl ephrin is considered by FDA to be GRACE G-R-A-S-E a state of GRACE it's sometimes called because that acronym stands for generally recognized as safe and effective. What that means is that it can be marketed without a new drug application, because any drug that is generally recognized as safe and effective is considered not new and can be marketed without an NDA.

Speaker 2:

The Food and Drug Administration has chosen to include phenyl ephrin orally administered products on the OTC monograph for decongestants. That's a controversial thing for them to have done and there are some pharmacists who examined the data pharmacists from the University of Florida, my former colleagues who examined the data and submitted a citizen's petition the FDA. Any citizen of the United States of America who wishes to do so may petition their Food and Drug Administration. They work for us and we may petition them and say here is something we would like you to do and here is why. Here is the evidence to support this request we are making, and these two pharmacists from the University of Florida College of Pharmacy made a submitted a petition years ago. As it turns out, the regulatory mechanism for hearing, considering, implementing what they requested was very cumbersome until recently. The CARA Act of 2020 created a streamlined mechanism for the Food and Drug Administration to modify their OTC over-the-counter OTC monographs and what these two pharmacists did most recently is said.

Speaker 2:

we'd like you to use that streamlined mechanism. The FDA doesn't do things without getting advice from experts in the field. The FDA is located in offices in Metro District of Columbia. They don't think they know everything. They think they can benefit from hearing from, as it turns out in this case, both physicians and pharmacists who are actually taking care of patients and have some input to provide about the safety, but primarily the efficacy of these single ingredient or multiple ingredient phenyl ephrin products to be orally administered.

Speaker 1:

So before we started chatting on the podcast, you gave another example of something similar that had happened in your career in the past, talking about the opposite more of the safety that the FDA pulled, or we're questioning one of the medications that was on that race. Can you allude to that a little bit?

Speaker 2:

Okay, well, gosh, a lot of people remember this. Some probably may not pharmacists this has been 15, maybe 20 years, I can't remember. The Food and Drug Administration can't just withdraw a drug from the market immediately. Well, unless there's an imminent hazard to public health. Right, it's hard to establish an imminent hazard to public health.

Speaker 2:

There was a combination of products that we refer to as FENFEN for weight loss that turned out to be killing patients who used it. It took the FDA, through their deliberative process, some months to consider the evidence that FENFEN was not only not beneficial because it really wasn't helping people lose that much weight and there were many alternative ways to lose weight than to use drugs but also unsafe, because people were dying from primary pulmonary hypertension. So during the deliberative process, there were many pharmacies that said we've looked at the data, we don't really need to be told by the federal government what is and isn't good for our patients. Under some circumstances, as responsible healthcare professionals, we can decide. We're not going to provide this to our patients because, even though FDA has to take a period of time to consider the evidence and make an official decision, we need not take that time. Sure so, but that was a safety issue.

Speaker 2:

That wasn't an efficacy issue. That's very important about that is the safety rather than efficacy aspect. So this is different.

Speaker 1:

Yeah.

Speaker 2:

And, having submitted this citizen's petition, the FDA turned to an advisory board of 16 people all practitioners, all people who see patients, physicians and pharmacists seeing patients on a regular basis and the evidence that they had for the efficacy of fennel effrin, and the result of the committee was to recommend 16 to zero. Yeah, that the FDA modify the decongestants OTC monograph to exclude oral fennel effrin from the monograph and that would mean that it is no longer grace, that it is no longer generally recognized as safe and effective. If it's not generally recognized as safe and effective, then it is a new drug.

Speaker 1:

Okay.

Speaker 2:

If it's not a new drug you must need. You need to have an approved NDA, which is unlikely for this product. So that's really where we are at this point. The CARA Act of 2020 facilitates the activity by the FDA that can more quickly result in a decision, but it still requires a notice and an opportunity to be heard. That's called due process.

Speaker 2:

Under the Constitution, the United States of America, the government, can't take property away, and the property right in marketing these products is something that we hold dear to ourselves In the United States. We don't just take something away without telling the person whose product it is or whose thing it is. We intend to do this, but we're going to give you an opportunity to explain to us why you think we should not do this. So that's called notice and an opportunity to be heard. What the CARA Act requires is, first of all, that a proposed rule be published by the Food and Drug Administration and that there be a 45-day waiting period before a final rule can be promulgated by FDA. To my knowledge, today as we talk, they have not published the proposed rule. Yeah, we have at least 45 days to go.

Speaker 1:

I started seeing this in early September, so I started seeing it in pop-up in the media and all the news outlets. Even APHA gave out a statement, I think early September, so we were expecting something mid to end of October.

Speaker 2:

Well, they have received advice from the advisory committee, and advice is just that it has happened that the Food and Drug Administration has rejected the advice of the advisory committee.

Speaker 1:

OK.

Speaker 2:

That's unlikely. In this situation, a 16 to 0 vote is unlikely to be rejected. But they don't just say well, we have 16 knowledgeable physicians and pharmacists, we will allow them to substitute their judgment for hours. Sure, the FDA is responsible. I'm sure right now they're working on it. This minute they are working on how they want to react to this advice that they welcomed, that they requested, that they received, and my guess is that soon there will be a notice of a proposed rule. 45 days after that there will be a final rule and we will know what the result is. And I don't think it's difficult to predict what that result will be. But there was a waiting game we played in the interim.

Speaker 2:

My advice is any pharmacist who's wondering well, what should I do? What should I do? Look at the evidence. Go, look at the scientific evidence and make a decision yourself about what's best for your patients. You don't need David or Ashley or the FDA or anybody else to tell you what's best for your patients. You decide, you make your own decision. And certainly one thing you might want to do is find some means to make pseudo-affederant available to people who need it. We have created a barrier to its acquisition by people who would use it for nefarious, illegal purposes, and that's a good thing, but to a certain degree that has also created a barrier for people who need it, and community pharmacies are not always easy to negotiate.

Speaker 2:

Sometimes there's a long line of people waiting to pick up their prescriptions. My suggestion is have a different place for the people who need behind the counter drugs, of which they're going to be more and more and more. The trend we have for the future is many of these drugs that have been prescription only and maybe a few of them that have been OTC, they're going to go behind the pharmacy counter. If we stand in the way of acquisition of those medications, then we aren't serving the public. So let's figure out a way to make pseudoaffrediment available. We might also choose to ask some questions about hypertension, for example, of a person who and we might choose to look at their medication administration record and see if we are dispensing to them an antihypertensive medication as we sell to them pseudoaffedron, which we know can have some complications, produce some complications. So we're simply in a waiting game right now. I realize there are some lawsuits that have been filed representing people who believe that there has been a deceptive business practice that has been engaged in by retailers of phenylaphrin products, and it's just impossible for us to know what the result will be of those lawsuits. I don't know whether it was a deceptive business practice. That's actually. That's not for you and me to decide. The court systems will deal with that at another time.

Speaker 2:

We do have one case that's sort of of note that is kind of relevant, and that is a case involving some homeopathic remedies that some pharmacies were stocking and at least an allegation by a group representing patients who said and this is what they allege, we're, you and I are not endorsing their utterance of this, but their allegation is that these drugs don't work, they lack efficacy, homeopathic drugs are not efficacious and that by stocking them in a pharmacy which is a healthcare business, the pharmacy is in effect endorsing them under the sign in the aisle that says decongestants. Well, if you have a sign that says decongestant and the products below it aren't decongestants, then the plaintiffs are arguing this is a deceptive business practice. The defendants in this homeopathy lawsuit said gosh, no, we're not being deceptive. What we're doing is simply providing the opportunity for people to purchase whatever product they wish. It's their decision. We shouldn't be interfering with their decision. This can't be a deceptive business practice.

Speaker 2:

And the court in that case said we disagree with you, retailers. We think it may be a deceptive business practice. We'll let the jury decide whether it's a deceptive business practice. We're not going to decide as a matter of law. So that message that this homeopathy lawsuit conveys to us is that pharmacists should make a deliberate decision about the products that are stocked out in front of the pharmacy department for patients to purchase, and perhaps look at the evidence that's available and make their own decision about what it is that's best for their patients.

Speaker 1:

When you say deliberate, you mean educational, intentional use of the products that they are not encouraging, but providing the option to purchase from.

Speaker 2:

Sure, by deliberate, I mean they shouldn't listen to me, they shouldn't listen to you. They should themselves investigate, and it should be a thorough investigation of whatever product they have, whether it's fennel, efferent or any other that may be subject to criticism criticism for its efficacy. I think individual pharmacists are educated, they are empowered, they have the skill to do this, they have abundant resources available to them to inform themselves and, with that information, share what they think is relevant for each individual patient, based on what that person's level of expertise is in decision making. And then do let that person decide, absolutely Let that person decide, but don't let people make a foolish choice.

Speaker 1:

Right, yeah, this is so helpful.

Speaker 1:

I mean, the thing is about delivering education like this and providing resources, and the reason why we have this show and this podcast and these recordings is to just serve everything on the golden platter here. This is exactly what you need to do Now. Go do it. This is to be a resource of holistically helping the pharmacists understand our individual role in serving the community and at patients at large. So by bringing on experts like yourself, bringing on people who know the inner workings of the profession, and then providing resources and tools in our impact courses and our advanced training programs and our I mean you've done dozens, if not more, training programs on regulatory affairs, on legal, ethical PIC. We talked about the PICBU camp a couple weeks, a couple months ago, so I think that's a really important piece to take away from here is that not everything is going to be. This is exactly what you need to do and this is exactly what you don't need to do. It is about using your professional judgment and taking the resources and helping your patients, because you ultimately patients best.

Speaker 2:

Yeah, and, as they say, this is not rocket science. Phenoliferin is not a brand new drug. I know some drugs are brand new and they're difficult to understand and their mechanism of action is, as a curiosity, as perplexing. The inactivation of drugs in the gut and the first pass effect are not a new concept to any pharmacist. This drug is not a new concept to any pharmacist. De congestion is not a new concept to any pharmacist. So I don't think there's a need to go back to pharmacy school and take more courses in order to understand. It's just a matter of reading the available literature, and APHA has made some of that literature available. So I and I don't. There are other excellent sources of information that APHA, but the American Pharmacist Association. But just do a do an internet search.

Speaker 1:

Yeah, and I provide some links. We can provide some links in our, in our recording to make those easily readily available to the people who are listening. But, yeah, I think, I think it's. We just really appreciate your insight because, as a pharmacist, I'm envisioning myself working in a community setting, hearing the allegations not from, maybe, my employer, but also just going home, driving home and hearing on the radio, or hearing on social media or on the five o'clock news. That final effort is in the media. When, then, what? What the pharmacist is going to say is well, how do I manage this? What do I say my patients? And I think you've given a really good groundwork on how to, how to, how to triage and how to answer some of these questions, and I think that is the most important part of this podcast. It is giving you the resources and the tools on how to answer these gray areas, because at the moment, no one has the answer. Well, we probably have the answer, but it's not, it's not crystal clear on what exactly that that's going to look like.

Speaker 2:

Yet yeah, government move slowly sometimes and we want government to. We would rather have government get it right. Then do it quick. That's a trite saying, I suppose, but we don't want any rush to judgment by the FDA or anyone else. The jury is still out, one could say using another trite phrase. But that's just for individual pharmacists to decide for the best in the best interest of their patients, and depending on who the patient is, the decision might be different.

Speaker 1:

For sure.

Speaker 2:

Depending on what they want to do Right.

Speaker 1:

Yeah, I agree with you. Well, that's why there's options to. So the pharmacist can it be, should be, and I want to encourage you to be empowered to provide options to the patients who want them. I don't believe it like that.

Speaker 2:

I thought you summarized it nicely there. So good, good, okay, good Well.

Speaker 1:

David love having you. You are so thorough and I didn't even have to interview you.

Speaker 1:

You just interviewed yourself. You just took us from point a to point last points and I just sat here and listen and you're an excellent storyteller, so we really appreciate your time and expertise and I think it is. It is not the sexy topics that we want to talk about. Right last week I interviewed someone about mentorship and the week before we talked about veterinary medicine. This isn't exactly glamorous, but it's essential to managing the day to day operations and legality around the profession, so really want to appreciate you for this. You're always ready to provide knowledge and we we love working with you, so thanks again. I appreciate your time.

Speaker 2:

Thank you, ashley, it's been a pleasure.