Compounding Pharmacies The Unsung Heroes Of Healthcare

Compounding Pharmacies The Unsung Heroes Of Healthcare

You’re listening to Radio Health Journal, the trusted news source for medicine, science and technology. I’m Elizabeth Westfield. I’m Mayan Vasta Betancourt.

And I’m Greg Johnson. This week, are weight loss drugs the answer to alcohol addiction? If the GLP-1 drugs are kind of able to engage both, both the periphery and the central mechanisms, that might be an effective way to reduce drinking. But first, the health care resource you may have used without ever knowing about it.

An incredible number of patients really benefit from having medications compounded for them. This is a necessary industry. It’s not going anywhere, nor should it go anywhere.

All that and more this week on Radio Health Journal. Mmm, that smells good, Ma. What you making? Just a little something.

Collard greens, cornbread, fried chicken and peach cobbler. Some leftovers. Some leftovers? Listen, I’ve been meaning to talk to you about some new COVID information I saw online.

See, because you’re always on that phone. I’m serious. I read that three out of four adults in the United States have a high risk factor for severe COVID-19.

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Brought to you by Pfizer. With a majority of Americans taking at least one medication every day, we’re no strangers to prescriptions. But what happens when the medication you need isn’t offered in the right dosage? Or you’re allergic to a binding ingredient in the FDA-approved drug? That’s when you call a compounding pharmacist.

While FDA-approved products are always the first choice of treatment, these specialists are able to create a new version of the drug that fits a patient’s specific needs. An instance in which they might not be appropriate is, say, if a patient has a child and can’t swallow a tablet. The only approved medication is available in a tablet, so the pharmacist can custom-formulate it into a liquid version for the child to take.

Another instance might be if a patient needs a different dosage form than what’s commercially available, or a different route of administration, or they’re allergic to an excipient, and a lot of animal drugs are compounded. There’s not that many FDA-approved drugs for animals that can treat the range of animal sizes that exist, so from tiny kittens to giant elephants, compounding pharmacists are able to formulate medications to treat all of those different species. That’s Tenille Davis, chief advocacy officer for the Alliance for Pharmacy Compounding.

As a compounding pharmacist herself for 16 years, Davis says it’s the avenue for patients when there are no options left. That could be due to an allergy, like she mentioned, but compounding pharmacists also come into play when the FDA-approved drugs simply aren’t available. When a drug goes on the FDA’s drug shortage list, a compounding pharmacist can come in and essentially create what’s called essentially a copy of that formulation to treat a patient.

We’ve seen that a lot in the last couple of years when really popular GLP-1 drugs were on shortage. A lot of compounding pharmacies were able to fill in that gap for patients. Compounding pharmacists are nothing new.

In fact, before there were mass-produced pharmaceuticals, your local pharmacist would be the go-to for any treatment needed. A town doctor would say, oh, this patient needs tincture of whatever. And the pharmacist would say, OK, I have these bulk ingredients, let me mix up tincture of whatever for this patient.

And that’s essentially compounding at its root. And then kind of as processes became standardized through industrialization and, you know, there’s an explosion of different medications available, the medications begin to be produced in mass. And so pharmacists were no longer having to do compounding all the time.

They were having to dispense previously manufactured pharmaceuticals. That’s Dr. James Watson, an emergency physician and medical toxologist at Maine Medical Center. He says that this shift in the pharmacist’s role was amplified even more in the 1930s.

A product called Elixir sulfanilamide was made as an antibiotic. And since it was for kids, it had a raspberry flavoring added to it. It turns out when you take the raspberry flavoring and you take the sulfanilamide and you put them together, they don’t dissolve into a liquid.

And so you need a diluent, something that you can mix those two things in so that it’ll dissolve. And so they chose this thing called DEG, which turns out is incredibly toxic. People like maybe had the beginning of an understanding that it was toxic at that time.

But my understanding of the narrative is that it was a genuine mistake and not, you know, just not understanding this is a toxic thing to be mixing the medication in. But at that time, there’s no kind of FDA oversight of pharmaceuticals. And so they didn’t have to do any testing, safety testing, animal models, anything like that.

They just kind of mix this batch up and then they distributed it nationally. Just over 100 patients died. It was one of the most impactful mass poisonings of the 20th century, because one year later, Congress passed the 1938 Federal Food, Drug and Cosmetic Act.

At its core, this law requires proof of a drug’s safety before being released to the public. However, while this gave the FDA oversight of pharmaceutical companies, it didn’t include small compounding pharmacies. That was like a very different type of practice than bulk manufacturing pharmaceuticals.

And so there was no kind of realization or insight at that time that the FDA would also need to oversee these people who are doing kind of bespoke one-off compounding. But then as we move through like the middle into the second half of the 20th century, there are a variety of different kind of advancements in medical practice that led to the need to compound more frequently and in larger quantities. Cardiac surgery is one example of this.

New medicines were needed to temporarily stop a patient’s heart during surgery, but those weren’t yet being manufactured on a large scale. And so they would look to compounding to put together these specific formularies or TPN, total parenteral nutrition, you know, for people who can’t take food by mouth and need to get food injected into a vein. So that started to have to be compounded.

The idea of people going on long term IV antibiotics, chemotherapeutics, things like that through the 50s, 60s and 70s. And so all of a sudden, there are more and more people who needed these kind of custom made or slightly alternative formulations of medications. And so pharmacies started to make things in bulk, right, in batch.

But these larger operations soon caught the attention of the FDA. In the 1990s, in 1997, there is the FDA, M.A. or Food Drug Administration Modernization Act, and that essentially said that the FDA was going to have expanded regulatory role over compounding pharmacies. And they were going to take compounding pharmacies that, you know, kind of adhered to certain criteria that just stick to doing bespoke stuff or promise they’re not going to try to market like a wonder drug to the nation without, you know, any regulatory oversight processes.

As long as pharmacies promise that they weren’t going to do that, then they could adhere to lower standards. Watson says these expectations created a gray area that ultimately set the stage for a pivotal moment in 2012. At the time, the New England Compounding Center was registered to make patient specific prescriptions, but in reality had been shipping drugs in bulk across the nation for more than a decade without any FDA oversight.

One of these products was a steroid designed to be injected into the spine to treat pain and inflammation. And it turned out that methylprednisolone was contaminated with fungus and it led to an outbreak nationally of fungal meningitis. The United States Attorney’s Office reports that around 800 people were affected and more than 100 patients died as a result.

Because of this mercury regulatory space that everyone was operating in, the FDA was able to do walkthroughs, but they had no real enforcement power, which was handled more by the state boards of pharmacy. And so in the trials that came after of New England Compounding Center, it came out that the FDA had actually investigated this facility three times and identified issues with their sterility, but they weren’t able to enforce anything or issue any penalties because there was like this contest over their jurisdiction. The public outcry in the wake of this disaster led to the Compounding Quality Act in 2013.

It basically split compounding pharmacies into the two groups we have today. The small, bespoke pharmacies are regulated under Section 503A of the Food, Drug and Cosmetic Act, while the larger, bulk manufacturing facilities operate under Section 503B. Essentially, the smaller 503A are state licensed pharmacies.

They’re primarily regulated by state boards of pharmacy. There are FDA rules they follow, but their primary regulators are state boards, where 503B outsourcing facilities are primarily regulated by the FDA. The 503B outsourcing facilities make larger batches, typically of drugs and shortage, that are sent to like hospitals and clinics rather than treating one patient here and there, which is what 503A pharmacies.

The difference in oversight mainly stems from expectations that 503A pharmacies are only creating a medication when a prescription comes in for a specific patient. And so they would take that prescription and say, OK, I’m going to mix this up for this patient once I receive the prescription. They’re not allowed to anticipate that the prescription is going to come for that patient and make it in advance.

They can’t anticipate that they’re going to get a variety of these prescriptions for different patients and make them kind of in bulk. They have to do it kind of one for one. Davis says that the FDA still has a little oversight on the smaller operations.

For example, though compounded drugs are not FDA approved, the drug powders used to mix compounded medications have to come from FDA registered facilities. They have to come with a valid certificate of analysis. And most state boards of pharmacy have adopted what’s called the USP or United States Pharmacopeia chapters on compounding, which is a standard that’s set by USP about what goes into compounded medications.

So that legal requirement is set by state boards of pharmacy, not by the FDA to follow those USP standards, which cover everything from training to cleaning to monitoring to testing, like all of the things that go into creating medication. On the other hand, 503B pharmacies have to adhere to current good manufacturing practices and are inspected by the FDA. Despite this update in regulatory oversight, Watson says it’s still somewhat of a patchwork system where things can fall through the cracks.

People make mistakes, you know, and if you’re not going to be upheld to the same regulatory expectations, you know that you’re not going to get the same level of oversight. Things, standards can slip. I’m not saying that they do necessarily, but mistakes can happen, you know, and it can be something as simple as, you know, there’s a case where somebody was getting acid blocking medicine compounded for them and it had to be mixed with something called bicarbonate.

And it turns out that bicarbonate and baclofen, which is a heavy sedative, sit next to each other on the shelf. A simple error of grabbing baclofen instead of bicarbonate led to that patient receiving baclofen, which led to hospitalization and bad clinical outcome. So, you know, that’s a human error, right? Humans are expected to make errors and there need to be systems developed to accommodate that and account for the inevitability of human error.

Watson compares this expectation to how we view doctors. It’s understood that physicians may make a medical error. So there are systems and safety standards in place to protect patients.

In an ideal world, there would be, you know, there would be equivalent regulatory oversight from the FDA applied to outsourcing facilities and bulk compounders as is applied to, you know, any of the big brand name pharmaceutical companies who are making pills or IV solutions en masse. I think that’s kind of the gold standard and we should strive towards that. But that’s a difficult task, especially when the FDA’s resources are already being spread thin.

Still, that doesn’t mean we won’t get there one day. Pharmaceutical compounding is a crucial part of health care, and making small improvements over time will eventually build a system that has the most protection for consumers. I think that compounding is necessary.

It’s absolutely necessary. And an incredible number of patients really benefit from having medications compounded for them. This is a necessary industry.

It’s not going anywhere, nor should it go anywhere. You can find more information about Tennille Davis, Dr. James Watson and all of our guests on our website, RadioHealthJournal.org. Our writer producer is Kristen Farrah. Our executive producer is Amir Zaveri.

I’m Elizabeth Westfield. Coming up, how Ozempic could help your dry January goals when Radio Health Journal returns. A KFC tale in the pursuit of flavor, the holidays were tricky for the colonel.

He loved people, but he also loved peace and quiet. So he cooked up KFC’s 4.99 chicken pot pie, warm, flaky with savory sauce and vegetables. It’s a tender chicken filled excuse to get some time to yourself and step away from decking the halls, whatever that means.

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Enjoy the go with Charmin. With more than half of Americans reporting that they consume alcohol, drinking is a big part of American culture. Happy hours dominate corporate get-togethers and sporting events rake in millions of dollars from beer sales.

Even light drinkers may still enjoy a glass of wine with dinner. But with such popularity comes a greater risk for misuse. The 2024 National Survey on Drug Use and Health reports that nearly 28 million people ages 12 and older had alcohol use disorder in the past year.

That’s one in every 10 people. And yet barely any of them receive treatment, despite the fact that there are multiple FDA approved medications to reduce alcohol intake. So one of them kind of stops the breakdown of one of those byproducts that makes you feel ill when you drink alcohol.

So that byproduct accumulates and then you drink and you feel bad, right? Other ones act in the brain, really more on the reward system, trying to reduce the effects of alcohol. That’s Alex DeFelice-Antonio, an appetitive neuroscientist and associate professor at the Fralin Biomedical Research Institute at Virginia Tech University. It’s estimated that only 2 percent of people with alcohol use disorder use these medications.

Experts say that part of the problem is stigma, while the other factor is simply a lack of knowledge about these options. However, a potential new treatment could change all of this. GLP-1 receptor agonists like Ozempic have never been more popular with people across the board, from celebrities to your next door neighbor.

And though these products are known for their weight loss effects, DeFelice-Antonio says researchers have noticed a side effect of these medications that could make it a new option for alcohol addiction. Preclinical literature, the rodent literature, has actually been around for a long time. So people were examining Exendin-4, which is similar to Exenatide, one of the very early GLP-1 medications, and giving that to rodents and noticing that they were drinking less.

And unlike the current medications used to reduce alcohol intake that only act on one system, GLP-1s are showing early signs of working both in the brain and other parts of the body. We know, or at least in our study, we’re observing some of these peripheral effects. We have evidence from other RCTs that there might be central effects in the brain.

And so it’s possible, you know, we don’t have enough data to conclude this, but if the GLP-1 drugs are kind of able to engage both, both the periphery and the central mechanisms, that might be an effective way to reduce drinking. Again, this is early research, so there’s still more studies that need to be done. In fact, DeFelice-Antonio says there’s still some debate within the neuroscience field about how much a GLP-1 drug can get into the brain.

They definitely have effects in the brain. Some of their effects of nausea are in the area of postrema. There’s other effects of not, for it’s kind of feeling of fullness.

Also in the brainstem. But there’s a little more argument as to how these drugs are having their central effects. We know that there are GLP-1 receptors expressed throughout the brain, but how much of the drug is really getting into the brain is something that there’s kind of less really good evidence on.

However, she says recent research shows that semiglutides change the level of activity in reward-related areas of the brain in response to alcohol cues. And so even though we might not be able to really definitively point to and say, okay, like it’s the action of, you know, the drug is definitely getting to this part of the brain and it’s acting on this receptor, what’s happening, the downstream effects, whether those are coming from the periphery or from the brain, are impacting the reward system. Meaning that it’s changing how alcohol makes someone feel.

DeFelice-Antonio recently published her own study in Scientific Reports on the effects GLP-1 medications have during alcohol consumption. Her team specifically studied the pharmacokinetics, which refers to four core processes, absorption, distribution, metabolism, and excretion of substances. So the reason we’re talking about pharmacokinetics there is that for potentially addictive drugs, every potentially addictive substance, part of its abuse liability is how fast it gets to the brain.

And so a really good illustration of this is nicotine. Because nicotine in a cigarette, we know is an addictive substance. That same amount of nicotine in a transdermal patch is a smoking cessation aid, right? And so the drug is the same, but the route of administration is changing how fast it gets into your body and therefore how fast it gets into your brain.

And so when we’re thinking about a drug’s abuse liability, we do have to think about route of administration. And then if we’re thinking about things that can alter, even if we’re in the same route of administration, thinking about things that can alter the rewarding effects of a drug, slowing down how fast it gets to the brain is a way that should be able to do that. 20% of the alcohol you drink is absorbed into the bloodstream through the stomach lining.

Then the rest is absorbed after it leaves the stomach and moves into the small intestine. Once in the bloodstream, it gets to the brain within minutes. But we can slow down how fast alcohol gets to the blood by spending more time in the stomach, right? Because in the stomach, it’s not going to be absorbed as well.

You need to empty from the stomach to the upper intestine to really get that excellent absorption into the blood. And so if we change that, we can change potentially the rewarding effects of the drug based on this idea of the faster it getting to the brain, the kind of more rewarding it is, the higher the abuse liability. Which is where GLP-1s are coming into play.

The hormone regulates blood sugar levels and appetite partially by slowing down gastric emptying, which is the process that transfers food in the stomach into the small intestine. For DeFelice Antonio’s study, participants were split in two groups. One where everyone was on a maintenance dose of a GLP-1 and the other group served as a control.

Both were given a standard serving of alcohol to see how fast their breath alcohol concentration would get to 0.08%. We saw a slower rise in the breath alcohol and people taking GLP-1 medications compared to weight match controls for not taking those medications. The big difference is in that first 20 to 30 minutes. And that’s that first 20 to 30 minutes, both in our measurements of blood alcohol and in our subjective effects.

And so it’s not that, oh, people are getting less alcohol in their blood and they’re saying, oh, I feel just as intoxicated. They also feel less intoxicated. So that kind of is lining up nicely as far as their subjective effects, how they are experiencing the drug matches up with their blood alcohol.

But it’s delayed. And it’s that really first 20 to 30 minutes that’s really different. And then the lines start to come together.

The team believes this gap is due to the alcohol spending more time in the stomach and not being able to be absorbed into the bloodstream as fast as usual. But there’s also an idea that increased nausea could play a part since that’s a main side effect of many of these GLP-1s. However, DeFelice Antonio says they didn’t find any differences in nausea between the two groups.

Still, she says it could just be the nature of who was participating. We were recruiting people who had been on GLP-1 medications and had been on their maintenance dose, right? And people who feel a lot of nausea from the GLP-1 medications, they don’t make it to the maintenance dose, right? They often stop taking the drug. And so it could be really different, right? If we captured some of those people who are maybe kind of stepping up to their maintenance dose.

The effects that we saw in our particular, this study in person, we also had people rate the kind of aversive effects of alcohol, like, are you feeling bad from the alcohol? And we didn’t see any differences. We mainly saw differences in the subjective experience of being drunk. Though this research is still in the early stages, it’s an exciting avenue for addiction medicine.

You can find more information about Alex DeFelice Antonio and all of our guests on our website, RadioHealthJournal.org. Our writer-producer is Kristen Farah. Our production manager is Jason Dickey. I’m Greg Johnson.

RadioHealth Journal returns in just a moment. If you’ve been diagnosed with moderate to severe plaque psoriasis, this is what it sounds like to be a million miles away. Imagine being a million miles away.

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When impossible odors get stuck in. Medical Notes this week. Will we ever truly get rid of forever chemicals? They’re hard to remove and destroy once they’re in the environment and our current removal technology is slow and inefficient.

Thankfully, a new innovation published in Advanced Materials removes large amounts of forever chemicals from water within minutes, about 100 times faster than commercial filters. Your smartwatch is good for more than just counting steps. A new study published in Plus One examined how effective this technology is at alerting medical professionals to veterans experiencing PTSD.

Though this was only a preliminary study, researchers are happy with the veterans’ willingness to participate and believe it could be a major step towards bettering their mental health. And finally, the truth on how to get better sleep. The CDC reports that one in three adults don’t get the recommended amount of sleep, which can lead to worse physical, mental, and mood outcomes.

Experts say it’s important to leave all your screens out of the bedroom and ditch alcohol or caffeine. And that’s Medical Notes this week. I’m Mayan Vos, Tibetan Court.

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Febreze Air starts working instantly to fight even your toughest odors so you go from fish to fresh like that. Now all you have to worry about is Pam cheating at charades. Thank you for joining us this week and every week as we break down the science stories you need to know.

You can find all of our past segments and guests on our website, RadioHealthJournal.org or wherever you listen to podcasts. Follow us on Instagram, Facebook, and X for daily content and tune in next week for another edition of Radio Health Journal.