Narrator - Dr. Abel  00:00
Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. This podcast

Narrator - ?  00:11
is provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy.

Narrator - Dr. Abel  00:17
This podcast contains general information for educational purposes only. This is not professional advice and should not be used in lieu of obtaining advice from a qualified health care provider.

Unknown Speaker  00:27
And now on to the show.

Dr. Sean Kane  00:31
Welcome to HelixTalk episode 45 I'm your co host, Dr. Kane, and I'm Dr. Schuman, and today we have a very special guest with us today. Dr. Lauren Angelo, thank you for allowing me to be here today. And we actually brought you in because we wanted to cover an OTC topic. And as I'm sure you're familiar with, you are the course director of the self care course and the curriculum here at Rosalind Franklin University. And one of the reasons why this is a common topic that gets brought up is that oftentimes in our curriculum and other pharmacy curriculums. Pharmacy students get kind of the OTC care very early on in their pharmacy career, and then as they kind of approach graduation, many students do end up in a retail oriented environment, and then they want some of a bit of a review, if you will, of some of these common OTC ailments and treatments and things like that. And we

Speaker 1  01:20
hear time and again from our fourth year students that they wish they had more self care and OTC later on in the curriculum, and be helpful to have updates. And so I think this is a good opportunity to provide some of that information to that audience.

Dr. Sean Kane  01:34
Kind of the focus of today's episode is going to be on two very common OTC gastrointestinal disorders. The first is going to be heartburn and dyspepsia, and then the second is going to be constipation. And when we think about self care of gastrointestinal disorders, there's actually a number of different topics that we could potentially cover, but we just don't have the time to do that. So our goal today is not to be comprehensive, but to cover some of the clinical pearls and some of the key details of these two disease states in terms of, you know what to think about when you're recommending over the counter therapy to patients. So by all means, is not comprehensive, but it's a way to kind of briefly review some of the key points.

Speaker 2  02:13
And always a good place to start with is when not to do it. So what we're talking about right off the bat is, what are we not talking we're not talking about self care in situations like with heartburn, dyspepsia, if there's any kind of difficulty or painful swallowing, if there's any kind of choking, coughing, wheezing, hoarseness, or especially any kind of a chest pain, the shortness of breath, sweating. So we have a concern, maybe for an MI, and then also if it's frequent heartburn lasting longer than three months. But getting that out of the way, the other situations will then be places where there might be a nice intervention. For example here,

Dr. Sean Kane  02:44
and you know, this is a very common complaint, that patients are going to have heartburn. And the good news is that, you know, most of our therapies are dramatically effective when we think about heartburn, number needed to treat for let's say PPIs and heartburn is in the single digits. And it's very, very rare that we actually have drug therapies that have a single digit number needed to treat. So it's kind of impressive how effective our drug therapy is for this disease state. But before we even get to the drug therapy, like you said, Dr. Schuman, we have to make sure that a, the patient's appropriate for self care and then B, really, before we're recommending drug therapies, we have to think about non pharmacologic things that maybe the patient can avoid, either the cost of drug therapy or the side effects of drug therapy. And with a

Speaker 1  03:27
lot of these conditions, we look at things that could be causing the heartburn, dyspepsia. A lot of it does revolve around diet and lifestyle, and it may also be due to other medications you mentioned doing a comprehensive medication review that is something we'd want to look for and make sure that these are not side effects that patients are experiencing from other medications they might be taking a lot of drugs can cause heartburn, dyspepsia and constipation. So we just want to make sure we are checking for that.

Dr. Sean Kane  03:54
Dr. Schuman, what are some of the drugs that come to mind when you think about drugs that cause dyspepsia or heartburn,

Speaker 2  04:01
things like caffeine, ethanol, even nicotine, things like that that can relax that lower esophageal sphincter and then allow for some of that, the peptic acid, to come bubbling up through. And then another big one we think about is going to be something like bisphosphonates are going to be a big one. You can sometimes have different things like nausea, again, in the psych world, SSRIs and sometimes cause either nausea or, you know, some some irritation there of the gastric lining that you can even receive that from some of the serotonergic effects and anticholinergic effects. Yeah.

Dr. Sean Kane  04:32
So like we said, terms of non pharmacologic therapy, we have to think about meds that could be causing trouble. We have to think about diet in terms of trigger foods, but also just not overdoing it in terms of diet. So making sure that you're not eating, you know, very large meals, trying to keep it smaller, meals, more frequent, things like that, not going to bed after you have a meal. The good news is that many of these lifestyle modifications are fairly simple to do, as opposed to, let's say, losing weight, which is a very difficult non-pharmacologic intervention to recommend, but the bad news is that many patients will proceed to drug therapy. So what are some of our drug therapy options

Speaker 1  05:07
that we have? We're looking at antacids, and that's a popular route that patients take. The problem with antacids and we think of Tums, calcium, magnesium, aluminum. They work pretty quick, but they don't last that long, so we've got about an hour of relief. And so patients who you're using those really shouldn't be using them. If they have persistent heartburn, we'll have to look at some other therapies, and that's where you mentioned PPIs already, those would come into play. And so those are great when we're dealing with more chronic symptoms throughout the week. And then we've got the h2 blockers, so it's definitely an option for patients with more frequent heartburn.

Speaker 2  05:44
One of the things I actually talk about in some of my I just want to lecture on electrolyte abnormalities, is one of the things you have to be careful of with Tums because of or these different antacids, they contain a number of different salts. You have calcium, magnesium or aluminum salts. And so depending upon how much you're using, you can actually get your you can, you know, up or down on your own. Hypermagnesemia, hypercalcemia, can occasionally occur in an elderly population if there's a change in clearance, combined with somebody who is relying on these day in and day out for their primary treatment of dyspepsia.

Dr. Sean Kane  06:16
So I think in terms of these antacids, we can say this is going to be for very infrequent, fairly mild patients who probably are having heartburn because they had a big bowl of chili that they typically don't have something like that, versus the patient that has it more frequently, another agent that I personally don't even really consider for heartburn management, but it is covered, you know, in terms of an indication, is Pepto Bismol or bismuth subsalicylate. So this is kind of the the agent that has the five different indications for it, nausea, heartburn, indigestion, upset stomach and diarrhea. And this is interesting because it's actually a salicylate derivative, kind of like aspirin that gets kind of converted in the body to a salicylate derivative plus bismuth. And we don't really know exactly how it works for all of these different indications, but it is approved as an over the counter drug. And really the big thing to know about it are a couple fold one it has aspirin or an aspirin like substance in it. So if you're allergic to aspirin, you know, asthmatics, as an example, are typically not great candidates for this. And also, if you're young, so if you're less than 17 years old, you have to be very careful about Reye's syndrome, which is kind of a multi organ failure caused by an immune response to the aspirin. So we kind of want to avoid Pepto Bismol in those cases. But interestingly, there are other Pepto Bismol products that would be okay for children.

Speaker 1  07:38
So I know there's that children's Pepto that we see on the shelves, and I know that is one thing we would call a manufacturer's line extension. And so when you pick up that package and take a look at the active ingredients, you will not see bismuth subsalicylate, but you'll see calcium carbonate. So in essence, this would be an antacid with that calcium salt,

Dr. Sean Kane  07:57
so it would cover that indigestion problem. But if you think of it as a consumer, how confusing is that, that you have basically this branded product that you think is Pepto Bismol, but you have completely different active ingredients.

Speaker 1  08:10
So we have to be so careful and make sure we are picking those products up off the shelf and taking a look at what's in them. Yep.

Speaker 2  08:15
The other interesting counseling point on this one is the either the black, hairy tongue or the darkening of the stool, that sometimes it can be scary to patient if you got that. Oh, yeah. And that's one of those, yeah, is, I think always is a huge counseling point. When I was in school, as well as in patient population, we use this is, if you see these symptoms, you know, you again, you want to be aware of it, that it's something should go away. But if it's, you know, and then also want to distinguish from other real, common or real, serious issue. So if it was to occur with bloody or black coffee, ground looking stools in those cases, you don't just ignore and say, Oh, it's probably just the Bismuth. But if it's something to that extent, you need to go ahead and, you know, we're concerned maybe about an upper GI bleed in those cases. So you would go need to see a primary care provider. But initially, you may get very disconcerted by the side of, you know, my tongue is black.

Dr. Sean Kane  09:04
So, you know, we do have some issues in terms of some of these unique adverse effects. Kinetically, it doesn't last very long, just like our antacids. The kind of, the only benefit to the bismuth subsalicylate is that it does have some of these other indications, like upset stomach. That might be nice if you just overate and that is causing you to have, you know, the heartburn, so it can cover multiple symptoms, which may be advantageous, but generally, I wouldn't, you know, reach for the Pepto Bismol. What I would reach for, and what for me personally, that I would typically reach for because I don't have frequent heartburn, is an h2 blocker,

Speaker 1  09:39
so we've got agents such as ranitidine and famotidine on the market, and there's also the one product called cimetidine, which we can talk about here in a little bit with respect to drug interactions. So but I think the ones we most commonly recommend are going to be Ranitidine, which is commonly known as Zantac, and the famotidine, which is Pepcid AC.

Dr. Sean Kane  09:58
And a couple things to know about. These guys is they are renally eliminated. So if you have a patient with renal impairment, you really shouldn't exceed one dose per day. If you have great kidneys, you can do two doses per day. Generally, it works fairly fast, not as fast as the antacids, but it's going to kick in probably within 30 to 60 minutes, and it should last at least a half a day, if not a full day, depending on the severity of your symptoms and how good or bad your renal function is. It actually works fairly well, kind of as a PRN medication, because it does have a fairly fast onset, so you can take it when you're having these symptoms, and it, like I said, it does last, you know, a good amount of the day to kind of cover you where you're not having to redose yourself,

Speaker 2  10:37
yeah, just just to kind of go off of what Dr. Kane mentioned, I believe they either revised or added material to the beers list, for example, in this newer phase of it, talking specifically about some of the renal elimination of these anti nausea or dyspepsia medications. So I'm glad, I'm glad you brought that up. That's something for again, for those that haven't looked over the guidelines in a while, make sure to look through them and see what they specifically say about these medications

Dr. Sean Kane  10:59
in their dosing. So Dr. Angelo, what can you tell me about this h2 blocker that's kind of the black sheep of the h2 blockers called cimetidine, or a common brand name? Is Tagamet, sure?

Speaker 1  11:10
Well, with cimetidine, if you look up in some of our online resources, you will see well over 100 drug interactions with this particular agent. And so we do have to be really careful with our patients, especially those taking multiple medications, and this cimetidine product. And so I know Dr. Kane, you teach our GI in self care, and one of your slides, and take home message is, do not recommend this particular product for that reason when we have safer options for our patients. All right, so I

Speaker 2  11:38
think now we're ready to kind of talk about one of the classes that if you, if you, if you think about the one class that everyone really, really knows about, probably from marketing or products. And we call it things, the purple pill we have, we have names for all these. Is the proton pump inhibitors. So think about Prilosec OTC, which is omeprazole; lansoprazole (Prevacid 24HR); esomeprazole (Nexium 24HR); or even the omeprazole combo with sodium bicarbonate (Zegerid). All those are available in over-the-counter forms. So anything different about them? Think the big

Speaker 1  12:13
one is the Zegerid you mentioned, and so that has an added agent of sodium bicarbonate. And we can look at, I guess, some of the reasons they've added that to the product. But when you look at the manufacturer's statements, they've really put the claim on there that it helps with omeprazole absorption. I think my take home message would be the sodium content in that particular product. So we do want to be careful if a patient is using this, if they have a sodium restricted diet, or they have heart failure where they don't want to exceed their sodium limits.

Dr. Sean Kane  12:43
It's kind of beyond the scope of this episode, but it's actually really interesting. Some of the pharmaceutics of why they, you know, added the sodium bicarbonate, versus some of the other agents, why they don't have it, and it all deals with the drug structure can be broken down in the stomach if it's exposed to acid. So all of the products, except for zegrid, have a delayed release formulation, so the drug is protected through the stomach. But with the bicarb, you don't need the delayed release formulation, because the sodium bicarb acts as an antacid to protect the drug during the transit through the GI tract. So it's interesting that they've done it that way. Kind of the added benefit, I guess, is that you do have the antacid combo. So you do have a quick onset of the antacid, although the PPI is going to take a long time to really start kicking in. And that's probably one of the biggest misconceptions that I see when patients take PPIs, is that they take them kind of PRN, but as we know, the onset is a day, if not a couple days, in terms of the peak effect of our PPIs for heartburn therapy. So taking it as needed PRN is really not a very smart option. When we have something like an h2 blocker, that it's much more efficacious as a PRN agent. Yes, and

Speaker 2  13:51
that's, again, a very easy point of recommendation for any students other, if you're talking about consistency, taken once every day, we've got a couple options. But if it's a PRN you're looking for, you're probably bouncing back up to the H2s. Our is that, again, it doesn't seem that Zantac gets as much, maybe as much love, or people immediately start thinking these newer ones. But again, very, very good medication there.

Unknown Speaker  14:10
So what patients would be appropriate for a ppi?

Dr. Sean Kane  14:12
If it takes a couple days to work, you're really limited in terms of initial therapy for patients who have frequent heartburn, and that means that they have two or more symptoms per week of heartburn. That's the kind of patient who would be indicated for ppi. If they have infrequent heartburn, so one episode or fewer per week on average, then they really should be starting with an alternative agent aside from ppi. The other thing to know about the PPIs is kind of the dosing recommendations. It's very unique and probably not intuitive for someone who doesn't look at the back of the box to see how you're supposed to be taking over the counter PPIs. And there's two facets to it. One is that you take it once a day, according to the OTC labeling, shouldn't be taking it twice a day, which is very common for prescription PPIs. Second, the course of it is only a 14 day course. And after you complete that 14 day course of once daily PPI therapy, you need to wait four months to be able to initiate another course. And part of this is probably covering the fact that if you have such frequent heartburn that you need a very aggressive therapy, that you probably should be evaluated for by a physician for other causes of your heartburn. And I'm sure that there's other reasons behind that as well, but it's important to know, as a pharmacist, know what is the packaging say? Knowing that many patients will kind of violate the packaging guidelines, but they're there for a reason.

Speaker 1  15:30
So if a patient is using this for frequent heartburn, and they're only supposed to use it for two weeks, what are the odds that their heartburn will be eradicated by the end of that two week course of therapy.

Dr. Sean Kane  15:42
Well, within the two weeks that probably is pretty effective, as we talked about, the number needed to treat is very, very low, so we're talking around four, let's say, in terms of relief of heartburn symptoms. But if they did have severe heartburn, it's likely that they're going to need longer term therapy than just that 14 day course.

Speaker 2  15:58
And again, I think what this does is it's supposed to kind of set up a dialog so that if you're an individual who is having heartburn for that period of time, again, it may be episodic, but then in the event, it's not. We also then look at the non pharmacologic methods we've discussed as ways to say, Hey, I'm having this recurrent heartburn. I should go see the doctor. But I should also look at some of these, maybe these factors that led to this. Have I been changing my diet? Have I, you know, am I using those substances, such as, you know, alcohol or caffeine or nicotine, or these other things there, you know, and start to think about them internally as well. And so it's just kind of be that that two fold about getting it further looked at, but then also thinking, what am I doing differently? And again, realistically, that doesn't always happen, but it's an important counseling

Dr. Sean Kane  16:37
point with them. One of the things also to think about with the PPIs are adverse effects. So typically, we think of PPIs as fairly benign, but there's a good amount of data, although it's not high quality, randomized, controlled trial type data, but there's a good amount of data that suggests that chronic use of PPIs may have some detrimental effects. And a lot of these detrimental effects relate to poor nutrient absorption or poor eradication of pathogens that go through the GI tract. So Clostridium difficile, diarrhea, which is an infectious diarrhea, is one of the implicated long term adverse effects that you may be at a higher risk for that high risk for osteoporosis because of poor calcium absorption and a number of other nutritional deficiencies that can cause problems down the road if your stomach pH isn't what it should be. And you know, normal physiologic conditions,

Speaker 1  17:26
that's a great counseling point. If you've got someone on a PPI long term and they are taking calcium to recommend calcium citrate, which is much better absorbed and doesn't rely on the acidic pH for absorption.

Speaker 2  17:38
Yeah. And then just a couple of other ones it's interesting. Is more and more. Dr. Kane, as you mentioned, within the last couple of years, this research has come out. So I know in our facility some of the previous residency projects looking at magnesium and that association between hypomagnesemia and use of the PPI, and then that also as magnesium roll in some of this calcium balancing, again, that also goes into some of the concerns with bone health, for example. And then also some of the B 12 and iron and pneumonia being another interesting one, as we would hear time and time again again in school about, okay, you know, if you've got acid going on, you start to have, for example, an aspiration and now with the pH is then change, or we have an increased rate of something like an aspiration pneumonia, for example. And it is that a concern in this individual?

Dr. Sean Kane  18:19
Yeah, and I think that at least for this 14 day, course, you know, these are basically non existent adverse effects. But as patients are using them outside of the labeling without, you know, a prescriber, kind of evaluating why they're having the heartburn, it's something that you know should be considered by the patient to kind of wrap up the heartburn section, though. I think really what we have to think about is, is it frequent or not so frequent is two or more episodes per week? If it is frequent, you get a two week course of a ppi, where you take it once a day. If it's infrequent, you can kind of pick many of our other options. For me, I really like famotidine and ranitidine. But you know, antacids are fine too, depending on the patient and the frequency and severity and things like that. If they do fail that 14 day course of a ppi, or if they're still having heartburn despite pretty aggressive therapy, they really need to be evaluated by a physician. What about any kind of other population concerns?

Speaker 1  19:10
Dr. Angelo, well, we know that pregnancy is commonly linked to heartburn, and so we definitely want to make sure their healthcare provider, from the obstetrician side, is on board. But a lot of times they can use the antacids that contain calcium and magnesium to treat heartburn. Breastfeeding would be another example of a special population, and antacids and h2 blockers are also appropriate in this population.

Dr. Sean Kane  19:37
Hey, HelixTalk listeners, this is Dr. Kane, so because this episode ran a little bit long, we're going to split this into two different parts, Episode 45 and then self care constipation will be covered in Episode 46 so three weeks from now, you'll be able to listen to the second half of this episode. If you haven't done so already, please give us a five star review on iTunes so we can climb the charts so that other health care. Providers and students are better able to find the podcast with that, I'm Dr. Kane. Study hard.

Narrator - Dr. Abel  20:07
If you enjoyed the show, please help us climb the iTunes rankings for medical podcasts by giving us a five star review in the iTunes Store. Search for HelixTalk and place your review there

Narrator - ?  20:19
to suggest an episode or contact us or online at HelixTalk.com thank you for listening to this episode of HelixTalk. This is an educational production copyright Rosalind Franklin University of Medicine and Science.