36 & 37. A Pharmacist’s Take:
Part 1: Navigating Diabetes Drug Shortage
SOUNDBITE:
Dr. Heather P. Whitley
It goes back to supply and demand where we have had a boost of more patients and providers using the GLP-1s.
00:09
Dr. Jane Caldwell
Welcome to the On Medical Grounds podcast, where you can find an authentic, audible blend of timely scientific and medical knowledge. Today On Medical Grounds, we will be speaking with Dr. Heather Whitley. Dr. Whitley is a clinical professor in the Department of Pharmacy Practice at the Auburn University Harrison College of Pharmacy. She is a board certified pharmacotherapy specialist and a certified diabetes educator.
Dr. Whitley is well published, predominantly on diabetes-related research. Earlier this year, Dr. Whitley spoke with us about screening for diabetes in high-risk individuals. Today, she is back to talk about some new things going on in the diabetes and pharmacy world.
This is part 1 of a two part series.
Hello, Dr. Whitley. Welcome to On Medical Grounds.
Dr. Heather P. Whitley
Thank you so much for having me. It’s great to see you again.
01:08
Dr. Jane Caldwell
Recently, you co-authored a special report in the journal, Clinical Diabetes. It was titled, “Potential Strategies for Addressing GLP-1 and Dual GLP-1/GIP Receptor Agonist Shortages.” We’d like to discuss your findings and learn more about how pharmacists and patients can cope with drug shortages. For those, thank you. For those unfamiliar with medical terms, what are GLP-1 and dual GLP-1/GIP receptor agonists, and what are they used for?
Dr. Heather P. Whitley
Sure, well thank you again for having me. It’s great to be here and it’s a pleasure to be able to share this information, particularly as it relates to the shortages of these important and valuable products for your listeners. First I’ll start off by saying that GLP-1 and GIP are hormones that are made in your body. Everyone should make them, they’re released from the small intestine and they help regulate blood sugar and then they also help regulate satiety. So these naturally produced hormones in your body helps with managing those two aspects. And they’ve since been developed as medications that we can give exogenously. So typically injected to help manage diabetes, mostly type 2 diabetes. And then some of the medications are also FDA approved for managing weight as well.
02:36
Dr. Jane Caldwell
Alright, thank you. What are the trade names consumers might recognize for these products?
Dr. Heather P. Whitley
Okay, so for the GLP-1s, and so those are the medications that are just mimicking that one hormone, that’s an incretin hormone, there is dulaglutide, which is Trulicity®, there is semaglutide, and that is available as two different forms. One is an injectable form of Ozempic®, the other is an oral formulation, it’s the only orally available product of the class called Rybelsus®.
There is exenatide, there’s two formulations of that. Byetta® is the twice daily injectable, and then Bydureon® or Bydureon BCise® is the once weekly injectable product. Liraglutide, and that is a once daily injected as Victoza®. That brand is FDA approved for type 2 diabetes, Saxenda®, it’s approved for weight loss.
And then tirzepatide, and tirzepatide is a dual, is the only dual GLP-1 GIP, incretin mimetic, and that one is marketed as Mounjaro® for diabetes, and it was just recently FDA approved for weight loss called Zepbound®. And then also back to semaglutide, when it is approved, we’re used as a weight loss that is Wegovy®. So we have a handful of different medications, and some of them have dual indications for treating diabetes and then also weight management as well.
04:15
Dr. Jane Caldwell
Wow, that was quite a mouthful. For our listeners, I’d like you to know that we will have a slide which summarizes all the different consumer names and what their mode of action is. Your new clinical diabetes special report states that we’re experiencing national shortages of these drugs. Can you explain to our listeners why this is happening?
Dr. Heather P. Whitley
Yes, this seemed to emerge around this time last year and where we just people, patients were coming to us in clinic. I work in a family medicine doctor’s office to take care of patients that have type 2 and type 1 diabetes. And I had so many patients coming to clinic that were saying they couldn’t access the products. We were having a national shortage. And lots of questions were emerging about how to manage this time of lack of access. And so that’s where the publication came. I wrote it in collaboration with my co-authors, Joshua Neumiller and Jen Trujillo. And we hope that would be helpful to our clinical colleagues for them to help manage the shortages that they’re experiencing. But here we are a year later and we’re still having these shortages and we’re still having these questions surrounding, well, how do we manage these challenges? It seems like it goes back to supply and demand where we have had a boost of more patients and providers using the GLP-1 and dual GLP-GIP receptor agonist class, which is great. These are fantastic products. They have a handful of benefits that we can provide our patients.
And it’s expanded beyond just those with type 2 diabetes to also include patients that are wanting to facilitate weight loss, which I think that’s where that increased demand is coming from. And I honestly believe that we didn’t, the manufacturers didn’t quite expect the boom that we received and the number of patients and providers that want to utilize these medications and the supply just hasn’t been able to meet that demand that we’re experiencing.
06:24
Dr. Jane Caldwell
Do you think that providers and pharmacies should be able to prioritize those specific prescriptions for patients with diabetes rather than weight loss?
Dr. Heather P. Whitley
That’s a tricky question. I think it’s an ethical question. In the prescriber hands, we always want to do, and dispensing, we always want to do the best that we can for our patients. We want to provide them the right product for any given patient. And when I’m seeing patients in clinic, I’m not just prescribing one anti-hyperglycemic for my patients, but I’m really thinking about every class and within any particular class, I’m thinking about the individual agents, talking to the patient at hand to identify what the right product is for that patient. That said, with this time of shortage, you do have to kind of jockey a bit and think about, well, what’s available, what’s not available. Now at the community level, at the dispensing side for the pharmacist, there’s going to be a time where you only have so many vials or so many syringes or so many pins of a given GLP-1, but more prescriptions coming in than that.
And that’s a tricky situation. I can appreciate from the community side how you want to be able to ideally provide those prescriptions to everybody that has been appropriately given a prescription, but you just don’t always have that supply. I think pharmacists should use their discretion when dispensing those to give them to the right patient and the best patient, but they don’t always have the objective information to discern severity of disease. For example, they might not have the different A1Cs for a patient with type 2 diabetes, so when that has a very high A1C that’s uncontrolled is critical that we bring that blood sugar down to avoid a possible hospital admission versus somebody that is at a better control level. Still, they both need them because they’re using that drug therapy to manage it.
And then on the side of obesity or weight management, that’s a legitimate chronic disease too. And it has impact on a handful of different complications that can develop from there. So I think it’s very hard at that point of the dispensing pharmacist to discern one patient needs it over somebody else. And it does put them in a very tricky position.
08:52
Dr. Jane Caldwell
So for patients who can’t access their anti-hyperglycemic drugs due to these shortages, what are their alternatives?
Dr. Heather P. Whitley
Yeah, they need to manage their blood sugar. They need to continue to keep it in a reasonable range for risk of precipitating an emergency room visit or complications that can result from that. I think it’s very important for them to have open, direct conversation with their healthcare providers, both their pharmacists to say, well, do you know when it might be coming in? Do they have an idea of how long they might be without and then communicate that back with their health care provider to say, I’m without whatever therapy, this is the last time I took that product or I have five more doses available. So I expect that I’ll run out by a certain date. So that the patient and that health care provider can consider all their avenues of how to manage that hyperglycemia during this interval of not having that particular therapy. Good communication and be proactive about it too. Don’t wait till you run out and haven’t had it for two or three weeks. Be upfront, be aware of how much medication you have available and so that you can get ahead of the problem.
10:11
Dr. Jane Caldwell
So what happens to patients with diabetes if they miss just a single dose?
Dr. Heather P. Whitley
Well, it does depend on which GLP-1 they’re using. So the rapid acting GLP-1s like Byetta®, which I don’t think are taken or used as often, but they will have a postprandial rise pretty quickly within a matter of, so it’s a twice daily medication. So in a matter of missing a few days, they’re going have an increase in their after meal blood sugar values.
On the other hand, using some of the medications that are longer acting therapies, particularly the once weekly products, they’re going to have, they’re going to give a dose one week. They have a whole week until they’re going to miss that second dose. Those products have a longer half-life, so a longer duration in the body. So it’s going to stick around a bit longer. As soon as they get the product, go ahead and administer it. If they’re a few days late on that, a once weekly product, I don’t think they’re going to see a profound change in their blood sugar, but certainly they are if they miss several weeks at a time.
11:16
Dr. Jane Caldwell
So what happens if they miss their doses for an extended period?
Dr. Heather P. Whitley
Their blood sugar will go up. And how high it goes up depends on how much, how controlled their blood sugar is at baseline and how much medication or the dose that they have to use to control it. So for example, if a patient’s blood sugar is near goal and they’re using the low dose of that GLP-1 to control that, their sugar will certainly bounce up, but I wouldn’t say it would necessarily go sky high.
But if they’re using a high dose of that GLP-1 to control their blood sugar, and maybe even it’s not doing a full job of controlling their blood sugar, maybe they’re still a little bit higher at baseline, then it has a much greater risk of it increasing to a point where they absolutely are going to need additional therapy and might need to be more cautious about making sure that they don’t flip into one of those concerning diseases of like diabetic ketoacidosis where it’s a medical emergency.
12:19
Dr. Jane Caldwell
Can you talk more about re-initiating, taking these GLP-1 receptor agonists? Is there a step-wise dosage? How do you do that?
Dr. Heather P. Whitley
Sure. So the most common adverse events that we see from this class of medications is gastrointestinal in nature, predominantly nausea, vomiting. And that happens in about 10 to 20% of people. So not all people, it’s just, it’s a low, moderate range. But for that reason, when we initiate those therapies, we start at the lowest dose. We always start at the lowest dose to allow their body to get used to that adverse event before increasing the dose. So when we start that dose and we increase, if the patient has been off of it for a while, when the therapy is re-initiated, they might have re-emergent of that nausea, vomiting, tolerability issue. So the question comes into play is if they have been on a consistent use of a higher dose that they have slowly graduated up to, and then they miss a handful of those doses, do we reinitiate all the way at the very starting dose again? Or can we start at that high dose right away and not expect to experience that gastrointestinal intolerability? So that’s where the question emerges with the challenges that we’re seeing with the shortage.
So, if I can give some guidance about that, talking with the manufacturers to try to find some information which we outline in that article from Clinical Diabetes. There’s guidelines in the package inserts, but when we evaluate a little bit further, there’s a bit more wiggle room. And so for me as a rule of thumb without like looking at the table that’s available in that article, I kind of think of a patient has missed two doses or less that they can reinitiate at the dose that they were on. If they missed three to four doses, we can probably start at the step two, like not the very bottom dose, but the second step up in the dosing scale. And then if they’ve missed five doses or more, then we probably have to initiate all the way back at that starting dose, all for the purposes of avoiding that emergent gastrointestinal challenges.
14:51
Dr. Jane Caldwell
That’s very useful information. Can you also interchange the different GLP-1 receptor agonists if one product is available while another one isn’t? Can they pivot to a different one?
Dr. Heather P. Whitley
Yes, and that has been a technique that I’ve used a lot in my clinic to help manage these shortages is I will go from if the patient hasn’t missed any doses I will go from whatever the dose is of their primary GLP-1 to a glycemic equivalent dose of another GLP-1 so across the board as opposed to you don’t have to start all the way down at the starting dose of the second GLP one but more of a glycemic equivalent dose.
15:31
Dr. Jane Caldwell
Are there alternative drug types or combinations of drugs which can be used in place of GLP-1s?
Dr. Heather P. Whitley
Yes, so certainly we have a variety of different other pharmacologic options to use when we can’t use a GLP-1. And I would say you need to start by considering why you’re using the GLP-1 in the first place.
The most common reasons to use the GLP-1 is either for blood sugar control, so that’s in type 2 diabetes, for weight management, or for cardio renal benefits, one of those three different reasons, and then selecting your alternative therapy based on that indication. So for example, if we’re managing cardio renal benefits, that’s why we’re using the GLP-1, then the only other class of medications that we could select from is the SGLT2 inhibitor class. So those are products like Jardiance®, which is empagliflozin, Farxiga®, which is dapagliflozin, or Invokana®, which is canagliflozin. And there’s a few other products in the class too, but those are the three that have been proven to have some of those cardio renal benefits. If we are using the GLP-1 receptor agonist for weight reduction, likewise that SGLT2 inhibitor class is the only other class that has proven benefit to facilitate weight loss. And of course there’s a collection of other products that we can use for managing weight outside of these anti-hyperglycemic classes. And then in type 2 diabetes, if we’re only just trying to manage their blood sugar, we just pick another product, another anti-hyperglycemic that all have those benefits while considering what their side effect profile is, what might work best in our given patient.
17:16
Dr. Jane Caldwell
It’s nice to know that there are alternatives that patients can consider. Some patients are sourcing their own medications online because they can’t get them at the pharmacy. What are some of the dangers of online sources of these particular drugs?
Dr. Heather P. Whitley
That is not ideal and certainly I will say that through this time of managing the shortages that we have seen with the GLP-1s, no alternative is the ideal alternative. And so we’re trying to identify other avenues that we can move towards to help continue to maintain the therapeutic goal that we’re working to achieve with the GLP-1. Online sources are tricky because you don’t always have that clear patient provider relationship in my opinion. I think that when you’re dealing with a provider online, sometimes there’s a lack of just miscommunication that can happen through the telephone or text message or email, beyond even video. If the product is not manufactured in the United States, which is common, but it’s also not under good manufacturing procedures, you have risk of having more contaminants or even getting a product that isn’t what it’s sold to be. And so I think as the user, you have to be very savvy and thoughtful about where you’re getting those products, where those products are coming from to make sure that you are in fact getting what you’re purchasing.
18:50
Dr. Jane Caldwell
What about compounded products?
Dr. Heather P. Whitley
We have seen a tremendous boom in the utilization of compounded GLP-1s during this shortage for several different reasons. One is it’s a protein, a big bulky protein, which we cannot easily manufacture in the lab, but FDA is reasonable to compound when it is under short supply. And we’ve had so many people wanting to use these products, particularly for weight loss. And so they are looking to gain access through different means if they’re not able to get them directly from the typical dispensing pharmacy to get the manufacturer’s variety of that product. So we have these compounding pharmacies that are producing these products. But I pause because if the product is in short supply where the pharmacies getting these products to make, to compound the product in the first place. So I am curious if that’s probably not the product is not coming from the manufacturer themselves.
So we are seeing increased manufacturing compounding products of different salt formulations of the products. So for example, in the manufacturer of Ozempic® or Wegovy®, semaglutide, we’re seeing compounded products of a salt formulation like semaglutide sodium or semaglutide acetate. That is not the version that was studied in all of the different clinical trials to bring the product to market that demonstrated not only efficacy, but safety. So there’s some unknowns in that area. Whereas a clinician, I cannot tell a patient that with certainty, we know it will have the same benefit or even the same safety profile of what was studied. There have been reports to the FDA of some adverse events that have occurred with using the compounded products that has not been openly disclosed. I’ve heard a conversation that it just simply increased in blood pressure. And certainly we know that high blood pressure is a silent killer because of its increased risk of causing heart attack and stroke when it is very high. And so if we’re adding a lot of salt into it, that’s in a compounded product, that salt is known to increase blood pressure. So I think there’s a risk there.
Although I’m just not in a fully educated position to be able to say, well, how much salt is in those compounded products, if that is how it is compounded to be able to determine the full risk. So there’s a lot of unknowns currently in the area of compounded products. So I recommend great caution to people when they are deciding to utilize those therapies that are compounded.
21:51
Dr. Jane Caldwell
How do you personally manage your patient’s expectations and concerns?
Dr. Heather P. Whitley
I work with my patients to have clear and open dialogue so they appreciate the reason for why we’re initiating the GLP-1 and what our ultimate goal is. Sometimes that is for the purpose of managing blood sugar, sometimes it’s for weight loss, sometimes it’s for redesigning their therapeutic regimen that will give them an overall improved quality of life because of a decreased medication-related burden.
And sometimes it’s for those cardiorenal benefits. So I make sure that they understand the reason why we’re implementing this therapy. I tell them about risks. I tell them that the most common adverse event is gastrointestinal. It’s typically nausea, possibly some vomiting. It only happens in about 10 to 20% of people. Typically when we talk about the most common side effect, they think that means everybody or nearly everybody gets it, but that’s not the case. And so I make sure I’m clear that it’s only about two and 10 people that experiencing nausea in the first place. I let them know that upfront. So when it emerges, they can have some ideas about how to manage it. I remind them that nausea is typically mild to moderate in intensity, and it does go away with continued use.
So that encourages them to stick with the therapy. And then I remind them of things that they can do to help reduce that risk. So typically when we sit down to eat, we have a perspective of how much food we need to put on our plate to fill our stomachs. And with the GLP-1s, one of the ways it works is to improve satiety so that we feel fuller faster. And so it’s important for patients to know that they’re not going to be able to eat that same volume of food that they did before starting the GLP-1. So I might tell them to fill half of your plate instead of a full plate. Eat slowly. And when you start feeling full, push back from the table. Wait a minute. Assess whether you want some more food or not.
And if you feel full, go ahead, wrap up that plate, put it in the refrigerator and come back to it later on because that GLP-1 making you feel fuller, if they continue to eat, that is when that nausea will most likely emerge. Typically, patients really appreciate having those anticipatory recommendations that they know how to mitigate those adverse events. One other thing I tell them is that these medications do not typically work fast. So the injection or the dose that they take today is not going to dramatically improve their blood sugar tomorrow or the next day, but rather it takes some time to build up in their bodies. That way if they’re managing and they’re watching their blood sugar or they’re watching their weight, they know it’s not an overnight miracle that it does take some time to achieve those results that they’re wanting and that helps them stick with it as well.
Dr. Jane Caldwell
Dr. Whitley had much more to say about drug shortages. Tune in to part 2 of this series where we discuss pharmacy deserts and the pharmacist’s role in patient care.
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Dr. Heather P. Whitley
It goes back to supply and demand where we have had a boost of more patients and providers using the GLP-1s.
00:09
Dr. Jane Caldwell
Welcome to the On Medical Grounds podcast, where you can find an authentic, audible blend of timely scientific and medical knowledge. Today On Medical Grounds, we will be speaking with Dr. Heather Whitley. Dr. Whitley is a clinical professor in the Department of Pharmacy Practice at the Auburn University Harrison College of Pharmacy. She is a board certified pharmacotherapy specialist and a certified diabetes educator.
Dr. Whitley is well published, predominantly on diabetes-related research. Earlier this year, Dr. Whitley spoke with us about screening for diabetes in high-risk individuals. Today, she is back to talk about some new things going on in the diabetes and pharmacy world.
This is part 1 of a two part series.
Hello, Dr. Whitley. Welcome to On Medical Grounds.
Dr. Heather P. Whitley
Thank you so much for having me. It’s great to see you again.
01:08
Dr. Jane Caldwell
Recently, you co-authored a special report in the journal, Clinical Diabetes. It was titled, “Potential Strategies for Addressing GLP-1 and Dual GLP-1/GIP Receptor Agonist Shortages.” We’d like to discuss your findings and learn more about how pharmacists and patients can cope with drug shortages. For those, thank you. For those unfamiliar with medical terms, what are GLP-1 and dual GLP-1/GIP receptor agonists, and what are they used for?
Dr. Heather P. Whitley
Sure, well thank you again for having me. It’s great to be here and it’s a pleasure to be able to share this information, particularly as it relates to the shortages of these important and valuable products for your listeners. First I’ll start off by saying that GLP-1 and GIP are hormones that are made in your body. Everyone should make them, they’re released from the small intestine and they help regulate blood sugar and then they also help regulate satiety. So these naturally produced hormones in your body helps with managing those two aspects. And they’ve since been developed as medications that we can give exogenously. So typically injected to help manage diabetes, mostly type 2 diabetes. And then some of the medications are also FDA approved for managing weight as well.
02:36
Dr. Jane Caldwell
Alright, thank you. What are the trade names consumers might recognize for these products?
Dr. Heather P. Whitley
Okay, so for the GLP-1s, and so those are the medications that are just mimicking that one hormone, that’s an incretin hormone, there is dulaglutide, which is Trulicity®, there is semaglutide, and that is available as two different forms. One is an injectable form of Ozempic®, the other is an oral formulation, it’s the only orally available product of the class called Rybelsus®.
There is exenatide, there’s two formulations of that. Byetta® is the twice daily injectable, and then Bydureon® or Bydureon BCise® is the once weekly injectable product. Liraglutide, and that is a once daily injected as Victoza®. That brand is FDA approved for type 2 diabetes, Saxenda®, it’s approved for weight loss.
And then tirzepatide, and tirzepatide is a dual, is the only dual GLP-1 GIP, incretin mimetic, and that one is marketed as Mounjaro® for diabetes, and it was just recently FDA approved for weight loss called Zepbound®. And then also back to semaglutide, when it is approved, we’re used as a weight loss that is Wegovy®. So we have a handful of different medications, and some of them have dual indications for treating diabetes and then also weight management as well.
04:15
Dr. Jane Caldwell
Wow, that was quite a mouthful. For our listeners, I’d like you to know that we will have a slide which summarizes all the different consumer names and what their mode of action is. Your new clinical diabetes special report states that we’re experiencing national shortages of these drugs. Can you explain to our listeners why this is happening?
Dr. Heather P. Whitley
Yes, this seemed to emerge around this time last year and where we just people, patients were coming to us in clinic. I work in a family medicine doctor’s office to take care of patients that have type 2 and type 1 diabetes. And I had so many patients coming to clinic that were saying they couldn’t access the products. We were having a national shortage. And lots of questions were emerging about how to manage this time of lack of access. And so that’s where the publication came. I wrote it in collaboration with my co-authors, Joshua Neumiller and Jen Trujillo. And we hope that would be helpful to our clinical colleagues for them to help manage the shortages that they’re experiencing. But here we are a year later and we’re still having these shortages and we’re still having these questions surrounding, well, how do we manage these challenges? It seems like it goes back to supply and demand where we have had a boost of more patients and providers using the GLP-1 and dual GLP-GIP receptor agonist class, which is great. These are fantastic products. They have a handful of benefits that we can provide our patients.
And it’s expanded beyond just those with type 2 diabetes to also include patients that are wanting to facilitate weight loss, which I think that’s where that increased demand is coming from. And I honestly believe that we didn’t, the manufacturers didn’t quite expect the boom that we received and the number of patients and providers that want to utilize these medications and the supply just hasn’t been able to meet that demand that we’re experiencing.
06:24
Dr. Jane Caldwell
Do you think that providers and pharmacies should be able to prioritize those specific prescriptions for patients with diabetes rather than weight loss?
Dr. Heather P. Whitley
That’s a tricky question. I think it’s an ethical question. In the prescriber hands, we always want to do, and dispensing, we always want to do the best that we can for our patients. We want to provide them the right product for any given patient. And when I’m seeing patients in clinic, I’m not just prescribing one anti-hyperglycemic for my patients, but I’m really thinking about every class and within any particular class, I’m thinking about the individual agents, talking to the patient at hand to identify what the right product is for that patient. That said, with this time of shortage, you do have to kind of jockey a bit and think about, well, what’s available, what’s not available. Now at the community level, at the dispensing side for the pharmacist, there’s going to be a time where you only have so many vials or so many syringes or so many pins of a given GLP-1, but more prescriptions coming in than that.
And that’s a tricky situation. I can appreciate from the community side how you want to be able to ideally provide those prescriptions to everybody that has been appropriately given a prescription, but you just don’t always have that supply. I think pharmacists should use their discretion when dispensing those to give them to the right patient and the best patient, but they don’t always have the objective information to discern severity of disease. For example, they might not have the different A1Cs for a patient with type 2 diabetes, so when that has a very high A1C that’s uncontrolled is critical that we bring that blood sugar down to avoid a possible hospital admission versus somebody that is at a better control level. Still, they both need them because they’re using that drug therapy to manage it.
And then on the side of obesity or weight management, that’s a legitimate chronic disease too. And it has impact on a handful of different complications that can develop from there. So I think it’s very hard at that point of the dispensing pharmacist to discern one patient needs it over somebody else. And it does put them in a very tricky position.
08:52
Dr. Jane Caldwell
So for patients who can’t access their anti-hyperglycemic drugs due to these shortages, what are their alternatives?
Dr. Heather P. Whitley
Yeah, they need to manage their blood sugar. They need to continue to keep it in a reasonable range for risk of precipitating an emergency room visit or complications that can result from that. I think it’s very important for them to have open, direct conversation with their healthcare providers, both their pharmacists to say, well, do you know when it might be coming in? Do they have an idea of how long they might be without and then communicate that back with their health care provider to say, I’m without whatever therapy, this is the last time I took that product or I have five more doses available. So I expect that I’ll run out by a certain date. So that the patient and that health care provider can consider all their avenues of how to manage that hyperglycemia during this interval of not having that particular therapy. Good communication and be proactive about it too. Don’t wait till you run out and haven’t had it for two or three weeks. Be upfront, be aware of how much medication you have available and so that you can get ahead of the problem.
10:11
Dr. Jane Caldwell
So what happens to patients with diabetes if they miss just a single dose?
Dr. Heather P. Whitley
Well, it does depend on which GLP-1 they’re using. So the rapid acting GLP-1s like Byetta®, which I don’t think are taken or used as often, but they will have a postprandial rise pretty quickly within a matter of, so it’s a twice daily medication. So in a matter of missing a few days, they’re going have an increase in their after meal blood sugar values.
On the other hand, using some of the medications that are longer acting therapies, particularly the once weekly products, they’re going to have, they’re going to give a dose one week. They have a whole week until they’re going to miss that second dose. Those products have a longer half-life, so a longer duration in the body. So it’s going to stick around a bit longer. As soon as they get the product, go ahead and administer it. If they’re a few days late on that, a once weekly product, I don’t think they’re going to see a profound change in their blood sugar, but certainly they are if they miss several weeks at a time.
11:16
Dr. Jane Caldwell
So what happens if they miss their doses for an extended period?
Dr. Heather P. Whitley
Their blood sugar will go up. And how high it goes up depends on how much, how controlled their blood sugar is at baseline and how much medication or the dose that they have to use to control it. So for example, if a patient’s blood sugar is near goal and they’re using the low dose of that GLP-1 to control that, their sugar will certainly bounce up, but I wouldn’t say it would necessarily go sky high.
But if they’re using a high dose of that GLP-1 to control their blood sugar, and maybe even it’s not doing a full job of controlling their blood sugar, maybe they’re still a little bit higher at baseline, then it has a much greater risk of it increasing to a point where they absolutely are going to need additional therapy and might need to be more cautious about making sure that they don’t flip into one of those concerning diseases of like diabetic ketoacidosis where it’s a medical emergency.
12:19
Dr. Jane Caldwell
Can you talk more about re-initiating, taking these GLP-1 receptor agonists? Is there a step-wise dosage? How do you do that?
Dr. Heather P. Whitley
Sure. So the most common adverse events that we see from this class of medications is gastrointestinal in nature, predominantly nausea, vomiting. And that happens in about 10 to 20% of people. So not all people, it’s just, it’s a low, moderate range. But for that reason, when we initiate those therapies, we start at the lowest dose. We always start at the lowest dose to allow their body to get used to that adverse event before increasing the dose. So when we start that dose and we increase, if the patient has been off of it for a while, when the therapy is re-initiated, they might have re-emergent of that nausea, vomiting, tolerability issue. So the question comes into play is if they have been on a consistent use of a higher dose that they have slowly graduated up to, and then they miss a handful of those doses, do we reinitiate all the way at the very starting dose again? Or can we start at that high dose right away and not expect to experience that gastrointestinal intolerability? So that’s where the question emerges with the challenges that we’re seeing with the shortage.
So, if I can give some guidance about that, talking with the manufacturers to try to find some information which we outline in that article from Clinical Diabetes. There’s guidelines in the package inserts, but when we evaluate a little bit further, there’s a bit more wiggle room. And so for me as a rule of thumb without like looking at the table that’s available in that article, I kind of think of a patient has missed two doses or less that they can reinitiate at the dose that they were on. If they missed three to four doses, we can probably start at the step two, like not the very bottom dose, but the second step up in the dosing scale. And then if they’ve missed five doses or more, then we probably have to initiate all the way back at that starting dose, all for the purposes of avoiding that emergent gastrointestinal challenges.
14:51
Dr. Jane Caldwell
That’s very useful information. Can you also interchange the different GLP-1 receptor agonists if one product is available while another one isn’t? Can they pivot to a different one?
Dr. Heather P. Whitley
Yes, and that has been a technique that I’ve used a lot in my clinic to help manage these shortages is I will go from if the patient hasn’t missed any doses I will go from whatever the dose is of their primary GLP-1 to a glycemic equivalent dose of another GLP-1 so across the board as opposed to you don’t have to start all the way down at the starting dose of the second GLP one but more of a glycemic equivalent dose.
15:31
Dr. Jane Caldwell
Are there alternative drug types or combinations of drugs which can be used in place of GLP-1s?
Dr. Heather P. Whitley
Yes, so certainly we have a variety of different other pharmacologic options to use when we can’t use a GLP-1. And I would say you need to start by considering why you’re using the GLP-1 in the first place.
The most common reasons to use the GLP-1 is either for blood sugar control, so that’s in type 2 diabetes, for weight management, or for cardio renal benefits, one of those three different reasons, and then selecting your alternative therapy based on that indication. So for example, if we’re managing cardio renal benefits, that’s why we’re using the GLP-1, then the only other class of medications that we could select from is the SGLT2 inhibitor class. So those are products like Jardiance®, which is empagliflozin, Farxiga®, which is dapagliflozin, or Invokana®, which is canagliflozin. And there’s a few other products in the class too, but those are the three that have been proven to have some of those cardio renal benefits. If we are using the GLP-1 receptor agonist for weight reduction, likewise that SGLT2 inhibitor class is the only other class that has proven benefit to facilitate weight loss. And of course there’s a collection of other products that we can use for managing weight outside of these anti-hyperglycemic classes. And then in type 2 diabetes, if we’re only just trying to manage their blood sugar, we just pick another product, another anti-hyperglycemic that all have those benefits while considering what their side effect profile is, what might work best in our given patient.
17:16
Dr. Jane Caldwell
It’s nice to know that there are alternatives that patients can consider. Some patients are sourcing their own medications online because they can’t get them at the pharmacy. What are some of the dangers of online sources of these particular drugs?
Dr. Heather P. Whitley
That is not ideal and certainly I will say that through this time of managing the shortages that we have seen with the GLP-1s, no alternative is the ideal alternative. And so we’re trying to identify other avenues that we can move towards to help continue to maintain the therapeutic goal that we’re working to achieve with the GLP-1. Online sources are tricky because you don’t always have that clear patient provider relationship in my opinion. I think that when you’re dealing with a provider online, sometimes there’s a lack of just miscommunication that can happen through the telephone or text message or email, beyond even video. If the product is not manufactured in the United States, which is common, but it’s also not under good manufacturing procedures, you have risk of having more contaminants or even getting a product that isn’t what it’s sold to be. And so I think as the user, you have to be very savvy and thoughtful about where you’re getting those products, where those products are coming from to make sure that you are in fact getting what you’re purchasing.
18:50
Dr. Jane Caldwell
What about compounded products?
Dr. Heather P. Whitley
We have seen a tremendous boom in the utilization of compounded GLP-1s during this shortage for several different reasons. One is it’s a protein, a big bulky protein, which we cannot easily manufacture in the lab, but FDA is reasonable to compound when it is under short supply. And we’ve had so many people wanting to use these products, particularly for weight loss. And so they are looking to gain access through different means if they’re not able to get them directly from the typical dispensing pharmacy to get the manufacturer’s variety of that product. So we have these compounding pharmacies that are producing these products. But I pause because if the product is in short supply where the pharmacies getting these products to make, to compound the product in the first place. So I am curious if that’s probably not the product is not coming from the manufacturer themselves.
So we are seeing increased manufacturing compounding products of different salt formulations of the products. So for example, in the manufacturer of Ozempic® or Wegovy®, semaglutide, we’re seeing compounded products of a salt formulation like semaglutide sodium or semaglutide acetate. That is not the version that was studied in all of the different clinical trials to bring the product to market that demonstrated not only efficacy, but safety. So there’s some unknowns in that area. Whereas a clinician, I cannot tell a patient that with certainty, we know it will have the same benefit or even the same safety profile of what was studied. There have been reports to the FDA of some adverse events that have occurred with using the compounded products that has not been openly disclosed. I’ve heard a conversation that it just simply increased in blood pressure. And certainly we know that high blood pressure is a silent killer because of its increased risk of causing heart attack and stroke when it is very high. And so if we’re adding a lot of salt into it, that’s in a compounded product, that salt is known to increase blood pressure. So I think there’s a risk there.
Although I’m just not in a fully educated position to be able to say, well, how much salt is in those compounded products, if that is how it is compounded to be able to determine the full risk. So there’s a lot of unknowns currently in the area of compounded products. So I recommend great caution to people when they are deciding to utilize those therapies that are compounded.
21:51
Dr. Jane Caldwell
How do you personally manage your patient’s expectations and concerns?
Dr. Heather P. Whitley
I work with my patients to have clear and open dialogue so they appreciate the reason for why we’re initiating the GLP-1 and what our ultimate goal is. Sometimes that is for the purpose of managing blood sugar, sometimes it’s for weight loss, sometimes it’s for redesigning their therapeutic regimen that will give them an overall improved quality of life because of a decreased medication-related burden.
And sometimes it’s for those cardiorenal benefits. So I make sure that they understand the reason why we’re implementing this therapy. I tell them about risks. I tell them that the most common adverse event is gastrointestinal. It’s typically nausea, possibly some vomiting. It only happens in about 10 to 20% of people. Typically when we talk about the most common side effect, they think that means everybody or nearly everybody gets it, but that’s not the case. And so I make sure I’m clear that it’s only about two and 10 people that experiencing nausea in the first place. I let them know that upfront. So when it emerges, they can have some ideas about how to manage it. I remind them that nausea is typically mild to moderate in intensity, and it does go away with continued use.
So that encourages them to stick with the therapy. And then I remind them of things that they can do to help reduce that risk. So typically when we sit down to eat, we have a perspective of how much food we need to put on our plate to fill our stomachs. And with the GLP-1s, one of the ways it works is to improve satiety so that we feel fuller faster. And so it’s important for patients to know that they’re not going to be able to eat that same volume of food that they did before starting the GLP-1. So I might tell them to fill half of your plate instead of a full plate. Eat slowly. And when you start feeling full, push back from the table. Wait a minute. Assess whether you want some more food or not.
And if you feel full, go ahead, wrap up that plate, put it in the refrigerator and come back to it later on because that GLP-1 making you feel fuller, if they continue to eat, that is when that nausea will most likely emerge. Typically, patients really appreciate having those anticipatory recommendations that they know how to mitigate those adverse events. One other thing I tell them is that these medications do not typically work fast. So the injection or the dose that they take today is not going to dramatically improve their blood sugar tomorrow or the next day, but rather it takes some time to build up in their bodies. That way if they’re managing and they’re watching their blood sugar or they’re watching their weight, they know it’s not an overnight miracle that it does take some time to achieve those results that they’re wanting and that helps them stick with it as well.
Dr. Jane Caldwell
Dr. Whitley had much more to say about drug shortages. Tune in to part 2 of this series where we discuss pharmacy deserts and the pharmacist’s role in patient care.
And thank you for listening to the On Medical Grounds podcast. Be sure to click the subscribe button to be alerted when we post new content. If you enjoyed this podcast, please rate and review it and share it with your friends and colleagues. At OnMedicalGounds.com, we provide perks to all posted podcasts by linking content so you can drink in more if you choose.
This podcast is protected by copyright and may be freely used without modification for educational purposes. To find more information or to inquire about commercial use, please visit our website OnMedicalGrounds.com.
Part 2: Pharmacy Deserts and Patient Care
SOUNDBITE:
Dr. Heather P. Whitley
It’s putting these little pharmacies that are already functioning on a very narrow margin in a position where they no longer can make ends meet. And I think that’s why we’re seeing a lot of these independent small pharmacies go out of business, which is hurting particularly the rural areas.
00:22
Dr. Jane Caldwell
Today On Medical Grounds we will be speaking with Dr. Heather Whitley for part two of our discussion. In part 1 we explored options for patients with diabetes who can’t obtain their GLP-1 receptor agonist drugs due to a nationwide storage. In part 2 we expand this conversation by bringing in the concept of pharmacy deserts and the pharmacist’s role in patient care.
Dr. Whitley is a Clinical Professor in the Department of Pharmacy Practice at the Auburn University Harrison College of Pharmacy. She is a Board Certified Pharmacotherapy Specialist and a Certified Diabetes Educator. Earlier this year, Dr. Whitley spoke with us about screening for diabetes in high-risk individuals. Dr. Whitley is well published—predominantly in diabetes related research. Let’s get back to where we left off in part 1.
So I’d like to have a broader conversation about the role of the pharmacy in patient care. We often think about pharmacies as handing out medications and we don’t consider how they help nationwide drug shortages or patient testing or even immunizations. Importantly, we also don’t think about what happens in smaller communities when pharmacies close. First, I’d like to ask about general drug shortages. We’ve discussed the GLP-1 receptor agonists, but it seems to me like news reports are updated weekly with various medications that are out of stock in pharmacies. How much of this are you seeing in your practice?
Dr. Heather P. Whitley
Yes, we have. With as many drugs that we have available there, it’s no wonder we’re having drug shortages, but it does seem to have increased a good bit, particularly since the COVID timeframe. And it does ebb and flow, I will say, for a given product where we’ll have a drug shortage, we’ll have to manage off of that. That’s in the retail community setting, but also in the hospital setting too. There’s certainly drug shortages of antibiotics or pain medications, or chemotherapeutics and they have to jockey in those positions as well. And then there’ll be a recovery time, we’ll get an influx of that therapy, but it seems to ebb and flow for therapies over time. For the GLP-1s, we have the shortage that we experienced over the winter and spring last year. It seemed like we had some recovery in the late spring, early summer, and then it just seems like a new emergent wave that we’ve been experiencing in our clinic and that I think many of my pharmacy colleagues have been experiencing across the country where we’ve had to re-jockey this supply challenge. And so I appreciate being able to provide this education to your listeners so that we can talk about these ways of how to manage these challenges.
03:09
Dr. Jane Caldwell
Are there some other medications that are suffering from a shortage right now?
Dr. Heather P. Whitley
There is, there always seems to be, and some are antibiotics, some are pain medications, we see chemotherapeutics, it seems to be across the board. Thankfully, I haven’t seen any full class being depleted, even within the GLP-1 receptor agonist class, when we have a shortage of one. Usually there’s availability of another one, so you can kind of jockey those doses, as we discussed, among two, or between two different GLP-1s. And I think it’s the same way for many of the other products, you just have to be thoughtful about your available alternatives, be thoughtful about how to dose it differently in a given patient. And a very important part is to educate the patient about how this new product might affect them differently. So within the GLP-1s, they are all delivered through different injectable devices. So it’s important for that class to educate the patient that while we’re switching from this product to that product. The new therapy might be in a very different delivery method or delivery device, and we need to take that time to educate them about how to use that. I suspect that might be similar among other classes of medications too.
If you’re interested in looking to see if a particular drug is in a short supply, you can go search up FDA drug shortage and they have a comprehensive list of medications that are in short supply, and it will drill down all the way to which doses are available, which doses are not available. And then there’s another list through a SHP, which is a pharmacy-specific website, and that will give comparable information for a listener that’s interested in a particular product that might be in short supply.
04:46
Dr. Jane Caldwell
Okay, we’ll get copies of those websites and put those in our references. So it seems to me that patients need to be proactive if they are on life-saving medications and should have a backup plan with their pharmacy and provider in case they can’t get their prescriptions.
Dr. Heather P. Whitley
It’s always thoughtful to know what needs to come next. And as a provider, I’m always kind of thinking in that way. I’m always talking to my patients when I’m meeting with them saying, okay, here’s where we are, here’s where we need to go, here’s a possible plan of how we get there. And that’s just typical of how I function within the clinic setting and working with my patients. But when there’s a time of a drug shortage, we might have to take a detour if you will, take a different route to get to that end place. So having that clear communication from me, to my patients, from me, to my physician colleagues, and then patients as well is very important. Sometimes you don’t know that a drug shortage is coming until you’re up on it. And so from a patient perspective, I truly believe the best thing that they can do is refill their medications in a timely fashion proactively before they completely run out. And if they, when they get to the point where they need new refills, which is common, have that the pharmacist can either reach back out to the prescriber or the patient can be proactive to help facilitate that communication as well so they don’t go without. And if they can stay up on top of their regular refills and taking their medications, when there’s a time of a drug shortage, they will always already have established that good communication with their pharmacist and their prescriber to help figure out that detour around the missing therapy.
06:46
Dr. Jane Caldwell
As a pharmacist, how much of your time or your organization’s time is spent trying to source medications that are in low supply?
Dr. Heather P. Whitley
It really depends, Jane, on what product is out and how commonly we use that particular product. As I’ve said these shortages that happened this time last year and now we’re kind of entering in that, it seems again, I’m spending a good bit of my time reworking a patient’s pharmacotherapy regimen or trying to figure out which pharmacies might have a given product available or other alternatives. During the summer when they were in supply, it was smooth sailing. So it really does seem to ebb and flow depending on what products are out, how commonly utilized those products are, and we just have to take it from there.
07:40
Dr. Jane Caldwell
It seems to me that production isn’t tied in any way to demand. Is there any way to have a positive feedback to production?
Dr. Heather P. Whitley
I have been aware that some of the manufacturers of these GLP-1s have started establishing new manufacturing facilities in the United States. I know that some have come up or emerged in North Carolina. I think there’s a few others across the country. But as you might expect, it takes time to build those facilities and start the manufacturing of it. I believe that some of these GLP-1 producing companies were surprised a bit surprised of that the shortage gap happened with how fast the demand caught on for these products, particularly once data came out, not only about their cardio renal benefits, but truly about their impressive weight loss components. And then they’ve had to try to rebalance that. So I was encouraged to see the new establishment of some manufacturing plants in this country to help meet that supply and hopefully their production will start helping to overcome that burden.
08:54
Dr. Jane Caldwell
You mentioned North Carolina. I remember earlier this year, there was a tornado that hit a drug manufacturing plant and it was down. Do we need more redundancy in production with these plants?
Dr. Heather P. Whitley
I think that can always help. Just like anything else in life, it’s kind of an insurance policy of having redundancy in whatever that component is. I think having more manufacturing of these valuable products in our country is a good way to go. That way that helps to cut out a lot of the other challenges that we experience when they’re manufactured elsewhere.
09:34
Dr. Jane Caldwell
So let’s pivot slightly. I know many people have heard of food deserts. These are areas that have limited access to affordable nutritious foods. Now we have a new issue on the public health horizon, the pharmacy desert. In October of this year, The Washington Post reported that over 1,500 closures by major pharmacies such as Rite Aid, CVS, and Walgreens leave many Americans without easy access to pharmacies.
And in the past several years, these retail pharmacies often have bought out the smaller independent pharmacies in their areas. And now with these closures, millions will be living in these so-called pharmacy deserts. What are your thoughts and potential strategies for patients living in pharmacy deserts?
Dr. Heather P. Whitley
That has been very challenging, to be honest. I used to work in rural communities in what we call the Black Belt of Alabama, most rural portions of Alabama. And there we would have only one pharmacy for a very large territory, and patients would have to travel miles, many miles, just to get their monthly refills of their products. And it has hurt these rural communities when we’ve had the loss of pharmacies. And truthfully, it seems like the loss of those pharmacies are often the independent pharmacies, those mom and pop shops that are providing not only medications to their patients, but lots of other care, their immunizations or screenings, their over-the-counter products, just with a very patient-centered and friendly and warm support of those patients they provide. And I do believe a big challenge and a big reason for why we’ve had that impact is from the pharmacy benefit managers. These are the unseen, kind of invisible to the public, middle man in the managing of medications from the manufacturer to the pharmacy that they are truly the ones that are manipulating and controlling the cost of drugs. And they can bundle products, they can increase the cost of a product for any given particular pharmacy. When a patient comes in, with one insurance versus another, the pharmacy might make $4 on a medication, they might make $50 on dispensing the medication, or they might take a $75 loss. It’s completely across the board, and these independent pharmacies, like large chain pharmacies also, are in a position where they cannot tell the patient that they can’t fill a product because they’re going to take a tremendous financial loss on it.
They are expected to fill it.
And it’s putting these little pharmacies that are already functioning on a very narrow margin in a position where they no longer can make ends meet. And I think that’s why we’re seeing a lot of these independent small pharmacies go out of business, which is hurting particularly the rural areas. Now these corporations that you mentioned, they have many, many pharmacies under their belt. And so they’re able to manage on a much larger budget and have more flexibility to maintain control. But I’ll also say that some of these pharmacies actually are the owners of PBMs, these pharmacy management managers. And so they have that other avenue of cash flow. I think that there needs to be some significant federal evaluation of the PBMs to consider how this is dramatically monopolizing the cost of our drugs and figure out a more transparent way for patients to appreciate the flow of that money and the ultimate cost. I believe that the independent pharmacies should be able to not only charge for dispensing, but also be able to charge for their clinical services that they’re already providing, but providing for free. So when you or I go to the pharmacy to pick up a prescription, that pharmacist is not just putting that 30 tablets in a bottle with a label on it. They’re looking at your comprehensive medication profile to consider whether there are any drug interactions, any duplicates, and if it is based on the information available to them, the right medication for a given patient. And then they’re counseling the patient not only about how to use the product properly, but about potential adverse events, whether they’re tolerability or they’re significant and a safety concern. All of that is not being reimbursed to the pharmacy, which would dramatically improve the pharmacists and the pharmacy’s ability to stay open and continue to provide the services to these patients including in rural areas that need to have them remain present.
14:23
Dr. Jane Caldwell
Amazon has entered the healthcare arena with Amazon One Medical and Amazon Pharmacy. Is this disruptive technology what we need to reduce healthcare disparities in diagnosis and treatment?
Dr. Heather P. Whitley
It’s a double edged sword, isn’t it? So on one hand, if there is a gap in care, say in a rural area, if a patient, first of all, has high speed internet, broadband access, then they can be able to access the medical services through Amazon. But that can also short out those local pharmacies and those small mom and pop facilities to be able to provide that care. So a patient might start using Amazon instead, and then that depletes that small mom and pop independent pharmacy or for that matter, doctor’s office in a rural area from being for providing those services and then they go under. So on one hand, I can see the benefit of it, but on the other hand, I can also see how it’s undercutting those local community services that are already present and facilitating the demise of some of these valuable local services.
15:40
Dr. Jane Caldwell
If there’s one thing that you could tell providers and patients about what pharmacies can do for patient care, what would it be?
Dr. Heather P. Whitley
Pharmacists really have a wealth of knowledge, which sometimes I believe is underutilized, particularly in the community setting. And so I’d say for the patient, talk to your pharmacist, go in and ask questions about your drugs. Don’t just blindly pick up the prescription and go home. Sometimes as a patient, you might not know what to ask. And so ask a general question, like what is the most important thing I need to know about taking this medication?
And that will just open the door for that pharmacist to stop and share some of the knowledge that they have about that individual product. Realize that pharmacist is in a position to be your advocate. They can help connect you to your prescriber or to other local resources that can help mitigate risk for a given patient. And so have those open conversations with them. And lastly, I’ll say every study that has evaluated an interdisciplinary approach to healthcare as opposed to just a single discipline approach, meaning the addition of not only a physician, but a pharmacist and a dietician and these other health specialties coming together, the patient always benefits, no matter what research study that is. So having a clinical pharmacist or pharmacist on your team is a valuable resource because each one of those individual disciplines has a unique depth of knowledge that the other one only has a superficial depth on. So having a comprehensive team of different healthcare professionals to guide that care for any one patient is always going to be provided, proven to be beneficial.
Dr. Jane Caldwell
That’s great advice. Dr. Whitley, thank you for educating health care professionals and their patients on these important issues, and for taking time from your busy schedule to speak with us. It was wonderful to have you back On Medical Grounds.
Dr. Heather P. Whitley
My pleasure, great to see you again.
Dr. Jane Caldwell
And thank you for listening to the On Medical Grounds podcast. Be sure to click the subscribe button to be alerted when we post new content. If you enjoyed this podcast, please rate and review it and share it with your friends and colleagues. At OnMedicalGounds.com, we provide perks to all posted podcasts by linking content so you can drink in more if you choose.
This podcast is protected by copyright and may be freely used without modification for educational purposes. To find more information or to inquire about commercial use, please visit our website On Medical Grounds.
SOUNDBITE:
Dr. Heather P. Whitley
It’s putting these little pharmacies that are already functioning on a very narrow margin in a position where they no longer can make ends meet. And I think that’s why we’re seeing a lot of these independent small pharmacies go out of business, which is hurting particularly the rural areas.
00:22
Dr. Jane Caldwell
Today On Medical Grounds we will be speaking with Dr. Heather Whitley for part two of our discussion. In part 1 we explored options for patients with diabetes who can’t obtain their GLP-1 receptor agonist drugs due to a nationwide storage. In part 2 we expand this conversation by bringing in the concept of pharmacy deserts and the pharmacist’s role in patient care.
Dr. Whitley is a Clinical Professor in the Department of Pharmacy Practice at the Auburn University Harrison College of Pharmacy. She is a Board Certified Pharmacotherapy Specialist and a Certified Diabetes Educator. Earlier this year, Dr. Whitley spoke with us about screening for diabetes in high-risk individuals. Dr. Whitley is well published—predominantly in diabetes related research. Let’s get back to where we left off in part 1.
So I’d like to have a broader conversation about the role of the pharmacy in patient care. We often think about pharmacies as handing out medications and we don’t consider how they help nationwide drug shortages or patient testing or even immunizations. Importantly, we also don’t think about what happens in smaller communities when pharmacies close. First, I’d like to ask about general drug shortages. We’ve discussed the GLP-1 receptor agonists, but it seems to me like news reports are updated weekly with various medications that are out of stock in pharmacies. How much of this are you seeing in your practice?
Dr. Heather P. Whitley
Yes, we have. With as many drugs that we have available there, it’s no wonder we’re having drug shortages, but it does seem to have increased a good bit, particularly since the COVID timeframe. And it does ebb and flow, I will say, for a given product where we’ll have a drug shortage, we’ll have to manage off of that. That’s in the retail community setting, but also in the hospital setting too. There’s certainly drug shortages of antibiotics or pain medications, or chemotherapeutics and they have to jockey in those positions as well. And then there’ll be a recovery time, we’ll get an influx of that therapy, but it seems to ebb and flow for therapies over time. For the GLP-1s, we have the shortage that we experienced over the winter and spring last year. It seemed like we had some recovery in the late spring, early summer, and then it just seems like a new emergent wave that we’ve been experiencing in our clinic and that I think many of my pharmacy colleagues have been experiencing across the country where we’ve had to re-jockey this supply challenge. And so I appreciate being able to provide this education to your listeners so that we can talk about these ways of how to manage these challenges.
03:09
Dr. Jane Caldwell
Are there some other medications that are suffering from a shortage right now?
Dr. Heather P. Whitley
There is, there always seems to be, and some are antibiotics, some are pain medications, we see chemotherapeutics, it seems to be across the board. Thankfully, I haven’t seen any full class being depleted, even within the GLP-1 receptor agonist class, when we have a shortage of one. Usually there’s availability of another one, so you can kind of jockey those doses, as we discussed, among two, or between two different GLP-1s. And I think it’s the same way for many of the other products, you just have to be thoughtful about your available alternatives, be thoughtful about how to dose it differently in a given patient. And a very important part is to educate the patient about how this new product might affect them differently. So within the GLP-1s, they are all delivered through different injectable devices. So it’s important for that class to educate the patient that while we’re switching from this product to that product. The new therapy might be in a very different delivery method or delivery device, and we need to take that time to educate them about how to use that. I suspect that might be similar among other classes of medications too.
If you’re interested in looking to see if a particular drug is in a short supply, you can go search up FDA drug shortage and they have a comprehensive list of medications that are in short supply, and it will drill down all the way to which doses are available, which doses are not available. And then there’s another list through a SHP, which is a pharmacy-specific website, and that will give comparable information for a listener that’s interested in a particular product that might be in short supply.
04:46
Dr. Jane Caldwell
Okay, we’ll get copies of those websites and put those in our references. So it seems to me that patients need to be proactive if they are on life-saving medications and should have a backup plan with their pharmacy and provider in case they can’t get their prescriptions.
Dr. Heather P. Whitley
It’s always thoughtful to know what needs to come next. And as a provider, I’m always kind of thinking in that way. I’m always talking to my patients when I’m meeting with them saying, okay, here’s where we are, here’s where we need to go, here’s a possible plan of how we get there. And that’s just typical of how I function within the clinic setting and working with my patients. But when there’s a time of a drug shortage, we might have to take a detour if you will, take a different route to get to that end place. So having that clear communication from me, to my patients, from me, to my physician colleagues, and then patients as well is very important. Sometimes you don’t know that a drug shortage is coming until you’re up on it. And so from a patient perspective, I truly believe the best thing that they can do is refill their medications in a timely fashion proactively before they completely run out. And if they, when they get to the point where they need new refills, which is common, have that the pharmacist can either reach back out to the prescriber or the patient can be proactive to help facilitate that communication as well so they don’t go without. And if they can stay up on top of their regular refills and taking their medications, when there’s a time of a drug shortage, they will always already have established that good communication with their pharmacist and their prescriber to help figure out that detour around the missing therapy.
06:46
Dr. Jane Caldwell
As a pharmacist, how much of your time or your organization’s time is spent trying to source medications that are in low supply?
Dr. Heather P. Whitley
It really depends, Jane, on what product is out and how commonly we use that particular product. As I’ve said these shortages that happened this time last year and now we’re kind of entering in that, it seems again, I’m spending a good bit of my time reworking a patient’s pharmacotherapy regimen or trying to figure out which pharmacies might have a given product available or other alternatives. During the summer when they were in supply, it was smooth sailing. So it really does seem to ebb and flow depending on what products are out, how commonly utilized those products are, and we just have to take it from there.
07:40
Dr. Jane Caldwell
It seems to me that production isn’t tied in any way to demand. Is there any way to have a positive feedback to production?
Dr. Heather P. Whitley
I have been aware that some of the manufacturers of these GLP-1s have started establishing new manufacturing facilities in the United States. I know that some have come up or emerged in North Carolina. I think there’s a few others across the country. But as you might expect, it takes time to build those facilities and start the manufacturing of it. I believe that some of these GLP-1 producing companies were surprised a bit surprised of that the shortage gap happened with how fast the demand caught on for these products, particularly once data came out, not only about their cardio renal benefits, but truly about their impressive weight loss components. And then they’ve had to try to rebalance that. So I was encouraged to see the new establishment of some manufacturing plants in this country to help meet that supply and hopefully their production will start helping to overcome that burden.
08:54
Dr. Jane Caldwell
You mentioned North Carolina. I remember earlier this year, there was a tornado that hit a drug manufacturing plant and it was down. Do we need more redundancy in production with these plants?
Dr. Heather P. Whitley
I think that can always help. Just like anything else in life, it’s kind of an insurance policy of having redundancy in whatever that component is. I think having more manufacturing of these valuable products in our country is a good way to go. That way that helps to cut out a lot of the other challenges that we experience when they’re manufactured elsewhere.
09:34
Dr. Jane Caldwell
So let’s pivot slightly. I know many people have heard of food deserts. These are areas that have limited access to affordable nutritious foods. Now we have a new issue on the public health horizon, the pharmacy desert. In October of this year, The Washington Post reported that over 1,500 closures by major pharmacies such as Rite Aid, CVS, and Walgreens leave many Americans without easy access to pharmacies.
And in the past several years, these retail pharmacies often have bought out the smaller independent pharmacies in their areas. And now with these closures, millions will be living in these so-called pharmacy deserts. What are your thoughts and potential strategies for patients living in pharmacy deserts?
Dr. Heather P. Whitley
That has been very challenging, to be honest. I used to work in rural communities in what we call the Black Belt of Alabama, most rural portions of Alabama. And there we would have only one pharmacy for a very large territory, and patients would have to travel miles, many miles, just to get their monthly refills of their products. And it has hurt these rural communities when we’ve had the loss of pharmacies. And truthfully, it seems like the loss of those pharmacies are often the independent pharmacies, those mom and pop shops that are providing not only medications to their patients, but lots of other care, their immunizations or screenings, their over-the-counter products, just with a very patient-centered and friendly and warm support of those patients they provide. And I do believe a big challenge and a big reason for why we’ve had that impact is from the pharmacy benefit managers. These are the unseen, kind of invisible to the public, middle man in the managing of medications from the manufacturer to the pharmacy that they are truly the ones that are manipulating and controlling the cost of drugs. And they can bundle products, they can increase the cost of a product for any given particular pharmacy. When a patient comes in, with one insurance versus another, the pharmacy might make $4 on a medication, they might make $50 on dispensing the medication, or they might take a $75 loss. It’s completely across the board, and these independent pharmacies, like large chain pharmacies also, are in a position where they cannot tell the patient that they can’t fill a product because they’re going to take a tremendous financial loss on it.
They are expected to fill it.
And it’s putting these little pharmacies that are already functioning on a very narrow margin in a position where they no longer can make ends meet. And I think that’s why we’re seeing a lot of these independent small pharmacies go out of business, which is hurting particularly the rural areas. Now these corporations that you mentioned, they have many, many pharmacies under their belt. And so they’re able to manage on a much larger budget and have more flexibility to maintain control. But I’ll also say that some of these pharmacies actually are the owners of PBMs, these pharmacy management managers. And so they have that other avenue of cash flow. I think that there needs to be some significant federal evaluation of the PBMs to consider how this is dramatically monopolizing the cost of our drugs and figure out a more transparent way for patients to appreciate the flow of that money and the ultimate cost. I believe that the independent pharmacies should be able to not only charge for dispensing, but also be able to charge for their clinical services that they’re already providing, but providing for free. So when you or I go to the pharmacy to pick up a prescription, that pharmacist is not just putting that 30 tablets in a bottle with a label on it. They’re looking at your comprehensive medication profile to consider whether there are any drug interactions, any duplicates, and if it is based on the information available to them, the right medication for a given patient. And then they’re counseling the patient not only about how to use the product properly, but about potential adverse events, whether they’re tolerability or they’re significant and a safety concern. All of that is not being reimbursed to the pharmacy, which would dramatically improve the pharmacists and the pharmacy’s ability to stay open and continue to provide the services to these patients including in rural areas that need to have them remain present.
14:23
Dr. Jane Caldwell
Amazon has entered the healthcare arena with Amazon One Medical and Amazon Pharmacy. Is this disruptive technology what we need to reduce healthcare disparities in diagnosis and treatment?
Dr. Heather P. Whitley
It’s a double edged sword, isn’t it? So on one hand, if there is a gap in care, say in a rural area, if a patient, first of all, has high speed internet, broadband access, then they can be able to access the medical services through Amazon. But that can also short out those local pharmacies and those small mom and pop facilities to be able to provide that care. So a patient might start using Amazon instead, and then that depletes that small mom and pop independent pharmacy or for that matter, doctor’s office in a rural area from being for providing those services and then they go under. So on one hand, I can see the benefit of it, but on the other hand, I can also see how it’s undercutting those local community services that are already present and facilitating the demise of some of these valuable local services.
15:40
Dr. Jane Caldwell
If there’s one thing that you could tell providers and patients about what pharmacies can do for patient care, what would it be?
Dr. Heather P. Whitley
Pharmacists really have a wealth of knowledge, which sometimes I believe is underutilized, particularly in the community setting. And so I’d say for the patient, talk to your pharmacist, go in and ask questions about your drugs. Don’t just blindly pick up the prescription and go home. Sometimes as a patient, you might not know what to ask. And so ask a general question, like what is the most important thing I need to know about taking this medication?
And that will just open the door for that pharmacist to stop and share some of the knowledge that they have about that individual product. Realize that pharmacist is in a position to be your advocate. They can help connect you to your prescriber or to other local resources that can help mitigate risk for a given patient. And so have those open conversations with them. And lastly, I’ll say every study that has evaluated an interdisciplinary approach to healthcare as opposed to just a single discipline approach, meaning the addition of not only a physician, but a pharmacist and a dietician and these other health specialties coming together, the patient always benefits, no matter what research study that is. So having a clinical pharmacist or pharmacist on your team is a valuable resource because each one of those individual disciplines has a unique depth of knowledge that the other one only has a superficial depth on. So having a comprehensive team of different healthcare professionals to guide that care for any one patient is always going to be provided, proven to be beneficial.
Dr. Jane Caldwell
That’s great advice. Dr. Whitley, thank you for educating health care professionals and their patients on these important issues, and for taking time from your busy schedule to speak with us. It was wonderful to have you back On Medical Grounds.
Dr. Heather P. Whitley
My pleasure, great to see you again.
Dr. Jane Caldwell
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