Experts Discuss How Over-The-Counter Medication Has Changed Since 2020

Daniel Krinsky, MS, owner and president of EduCare4U and PGx101, and Stefanie Ferreri, PharmD, Smith and Olsen Distinguished professor at the Eshelman School of Pharmacy in the University of North Carolina, discuss the additions, removals, and changed to OTC products in the past 2 years.

Q: What are some were some of the most notable OTC products that were removed or that entered the marketplace since 2020?

Daniel Krinsky: That’s a great question because there are a lot of products that have been removed over the last couple of years. Most of these products were removed for a couple different reasons. One was that they had contamination. The other was that they included unapproved new medications, so that was a lot of supplements that were marketed in this country that should not have been.

I don't know that there's any significant, real big brand name products other than there were some sunscreen products that had benzene in them, lotrimin and tinactin. The over-the-counter fungal antifungal sprays also had benzene. There were some odor eater products that had benzene. Some other sunscreens like Neutrogena and Aveeno that also had benzene. So, there were a number of products that had contaminants in them potentially dangerous.

A couple other products that were removed that were more common. In the OTC area, there was an opera seltzer product that was mislabeled where the ingredients information was not accurate. That was an ibuprofen, children's Advil product that was removed because proper dosing device was included, and the markings were incorrect.

There were a few other OTCs, a lot of the products that are removed each year are products in the categories of weight loss, weight management, sexual enhancement products, the products that have ingredients that are prescription that are included in overseas products that are brought to this country and sold and when the FDA does their evaluations of some of these. They find that these ingredients are in there, and they're immediately removed.

But as far as products that were removed over the last year or so those are the main ones that were taken off the market.

As far as new products are concerned, there were some new products that were introduced that I think have some great value in the self-care area. The first is the diclofenac gel, and that's the topical pain reliever. It can be used up to 4 times a day for a number of different areas of the body for pain. It's a great counselling opportunity for pharmacists to make sure that the entire spectrum of pain management is being addressed.

There were a few products that were introduced the old patenting eyedrops as the ophthalmic antihistamines were recently introduced. There's interesting product that was brought to markets. A little over 2 years ago, what was new to us to introduce, in this year's meeting, product called Advil dual action as both acetaminophen and ibuprofen. There was also an AleveX, which is a topical analgesic that does not have the typical ingredients that approximate it's in a lead, so it's one of those brand extensions that they're using. It has menthol and camphor in it. It's a topical product, but we have to be careful with the brand extension and the naming of those things.

There was another type of aspirin product called Vazalore that was introduced. It's a liquid filled capsule that's claimed to have a better disillusion distribution than some of the more traditional aspirin products. It has a lasting, intranasal antihistamine was brought to markets. So those are the main ones that he saw that were introduced more recently that have some therapeutic value in the OTC section.

As always, there's a lot of immune support products and other products that fit in that category of natural products and supplements that were introduced that were are being promoted for immune support, a lot of new CBD products that you know people need to be aware of. So we're seeing a lot of new things being introduced, and we just need to make sure that we're on top of this stuff and we're taking the opportunity to counsel our patients.

Q: Are there any new therapeutic updates to OTC products?

Stefanie Ferreri: Probably the biggest area for the new therapeutic updates is in the area of antihistamines. A lot of antihistamines have been introduced to the market that are relatively new, olopatadine is one and for eyedrops that we're starting to see. We have the long-acting, we also have short acting also azelastine, the nasal spray, so we're getting more and more allergy relief from intranasal and intraocular things to help that have really been introduced in the market in the last 2 to 3 years, and a lot of MI2s and so things that the pharmacists really need to be more aware of.

Then probably the other notable thing not as many options but the topical NSAIDs are now being introduced. They've been available in other countries for long periods of time, but now they're slowly to be introduced in the United States. So that's another option for pharmacists in the US to be aware of with the diclofenac sodium topical gel.

Q: What other updates should pharmacists be aware of?

Stefanie Ferreri: Things that are weak, that didn't quite make the new products yet but are emerging within the self-care category or within the OTC realm that pharmacists need to be aware of is that we're starting to see hormonal contraceptives getting a lot more statewide recognition. So many more states are recognizing OTC hormonal contraceptives and whether that's the oral, whether it's a vaginal, whether it's a patch, you're starting to see pharmacists providing and also prescribing hormonal contraception. So that's something that, depending on the state that people are practicing, and you might need to be staying up to date on,

We're also starting to see more legislative action around a cigarettes, where more and more states are starting to pull the flavored versions of the e-cigarettes and getting more legislation around vaping as well as e-cigarettes just like we had with the typical tobacco cigarettes.

So that's another area that pharmacists are starting to get engaged in upcoming, Dan can probably speak to this a little bit more, but we're starting to see more community pharmacists getting engaged in OTC hearing aids. I know that that's something that has entered the market, and so you're starting to see little kiosks related to hearing aids and also related to kiosk or also starting to see vending machines. So vending machines with things such as Naloxone kits and needle exchanges, condoms, Plan B. So lots of things that are starting to emerge in community pharmacies that we need to be aware of.

Daniel Krinsky: There's a few other things that I'll mention, more states are starting to restrict sales of dextromethorphan, just because of the safety issues, so they're restricting is similar to what we're seeing with pseudoephedrine. If we see more states that are restricting access to that it's primarily because of safety issues with that product and some of the potential that we've seen with abuse.

Then we're starting to see some additional recommendations on limiting the use of low dose aspirin to specific patient populations and making sure that folks that are taking the product are actually candidates for the product and not folks that just kind of decide on their own that they think they need low dose aspirin when in more detailed assessment would determine that they're probably not a candidate for low dose aspirin at this particular time.

Then you always worried about the potential interactions, even with low dose aspirin with other medications that can cause bleeding. There are patients that are on anticoagulants in a platelet agents and those types of things. We just need to pay a little bit more attention for interacting with our patients.

Q: What are some of the most common OTC products for patients?

Stefanie Ferreri: We see that allergies are really an area that are very commonly purchased over-the-counter which coincides with many of our new products in the last 1 to 2 years. So a lot of allergy medications, not just oral, but also intranasal interocular, lots of places emerging there.

In addition to allergies, we also have analgesics, we also have antifungal. During COVID, we've been seeing a lot of cough, cold, flu, now COVID as well, so a lot of upper respiratory sort of things over the counter. In addition, we have lower GI, where you think more constipation, we also have upper GI, where you think more heartburn or indigestion.

A lot of patients come in seeking information on sleep. They want a magic pill that's going to help them with sort of sleep. Smoking cessation is another one we just discussed, and then we also have people come in looking for medicated skin, so like first aid or anti age products. Those are probably the 9 most common categories of why patients interact with their pharmacist on OTC medications.

Daniel Krinsky: Exactly what Stefanie said, I'll just add a couple of other areas. Some testing as an area, we're seeing tremendous growth. We're seeing a lot of people with wearable devices that are able to take more proactive approach to things like hypertension, even diabetes, AFib and conditions like that. Then the whole area of CAM and natural products and supplements is huge. We see so many people that are taking products that have been recommended to them through health care providers, but more often been recommended by friends and neighbors and internet advertising sites that might not be so reputable. So it's a great opportunity for us to make sure that we're collecting all that information and evaluating for potential interactions and safety issues because there are a lot of those types of issues with that category of products.

Q: More broadly, what should pharmacists know about OTC products in general? What is essential for pharmacists to help patients?

Daniel Krinsky: Well, I'm a firm believer in a structured patient assessment process, and I know it takes time and I know community pharmacists are extremely busy, and you've got that challenge with what you want to do versus what you feel you can do. But again, I think that we need to practice pharmacy, first and foremost, and we need to be able to assess our patients carefully before determining which, if any OTC products are appropriate for that individual. So I'm, like I said, I'm a firm believer in a patient assessment process, I use what's called a quest scholar, which allows us to systematically go through and collect information and then determine if they're a candidate, and if so, which products might be appropriate for them? How do we counsel them on those products? What type of response should they expect them what kind of follow up we want to do?

Then just, I think, even if you don't know a lot about the products, just taking the time to read product labeling is important because products change so much. We see a lot of brand extensions. We were not going to know everything but knowing where to look and where to get information, just helping patients to read labels and understand what they should be doing when they take that product home is extremely important. I think, half of health care is self-care. And I think we have a responsibility to address those needs.

Stefanie Ferreri: I think of OTC medications very similar to prescription medicines. Many of these medicines were prescription medicines that made the switch to nonprescription. So I think there is a falsehood among patients as well as some health care providers that OTC medicines because they don't require a prescription are deemed safe. That is, when they are taking correctly, yes, they are safe. And it's really the pharmacist’s role and responsibility by doing that pharmacist patient centered process that Dan was mentioning to make sure it's the right drug for the right patient and they're taking it at the right time and making sure that there's no drug interactions or adverse events depending on different special populations because as we age, certain OTC medications are affect our bodies differently, pediatric patients, or if you have another disease state, it can affect their body differently.

So again, I think the pharmacists are the ones who have, most of the time, have all of the medications for that 1 patient in 1 location. So being that central repository for making sure the patients know to go to them regarding their OTCs, as well as their prescriptions, as well as their herbals and their dietary supplements, and making sure that they check for any drug-drug interactions for safety and efficacy.

Q: What is the value of the pharmacist to patient in terms of OTC products?

Stefanie Ferreri: The one thing I always tell when I work on interprofessional teams, many other health care providers don't get classes and nonprescription drugs. We are probably the only health care provider that does get education in nonprescription drugs, and so to me, that is really the value that we bring to the team. We're the medication therapy experts, and so we think about the medications and how the medications affect that patient, and that patient alone, again, that patient has a lot of things going on. So utilizing a pharmacist patient care process, we need to be thinking about all medications, not just OTC medications, but which medications are safe and effective, and that's what we the pharmacy, pharmacists bring to the health care team for our patients.

Daniel Krinsky: I would just add with the last line of defense, once people get to us, they're going home, and if we don't catch something, if we don't take advantage of an opportunity, that could be very serious. Once the patient gets home, it's going to be really unusual for somebody else to be able to step in before that product is consumed and the patient begins that therapy. We should take that responsibility very seriously, and we do have all the products in the pharmacy and they're relatively close to the pharmacy. I'm a firm believer and shelf talkers and helping engage patients and getting them to ask us questions, and we should initiate that conversation as well. Being the last line of defense, I think we should take that responsibility very seriously, and I know a lot of our colleagues do take it very seriously which is a great thing.

Q: Any closing thoughts?

Stefanie Ferreri: My last-minute thoughts regarding pharmacists being involved in nonprescription products and self-care in general for our patients is that there is growing opportunities around self-care. There's a lot of emerging opportunities, and really self-care. Most patients want to take care of themselves first before they interact with the hospital before they interact with going to a primary care provider, and many times they come into a community pharmacy as the first point of care within the health care system. They might try to take care of it by themselves and they may get it right. They may not get it right, but many times pharmacist are the first-time health care providers that they interact with.

I think that's really important for us to recognize that we have to help patients navigate their health on whether or not they are a self-care candidate or whether or not they should be referred to a primary care provider to get a work that workup a diagnosis if something more serious is going on. We have a lot of great opportunities to engage with our patients, and I think that we need to remember that and make sure that our patients also advocate on our behalf for all the things that we do for them.

Daniel Krinsky: I think we can empower our pharmacy technicians a little bit more to free up a little bit of time to help us in the self-care area. I think too often pharmacists feel tied to that computer, tied to the pharmacy, when there's people at the OTC section that could really use our assistance. I think if we empower our technicians and provide them with some additional training and have confidence in their abilities that it will free us up to spend more time in self-care area. I only see this area continuing to grow.

As Stefanie mentioned, more people are wanting to take more control over their health. I think of all the self-testing devices and all the products that are available collectively, they have those opportunities, but they need a little guidance and assistance and I think we can be that person to do that. I love the area of self-care. I love the area of empowering patients with the correct information to better manage their lives. It's all about improving their quality of life, and I think we can do that a lot through self-care.