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The Mythbusting Episode | Essential: Pharmacy Compounding Podcast APC · Pharmacy Podcast Network

0:05
Speaker 1: You are listening to the global network of podcasters dedicated
0:09
Speaker 1: to the pharmacy profession Welcome to the Pharmacy podcast Network.
0:25
Speaker 2: Welcome back to Essential, the Pharmacy Compounding Podcast with the
0:30
Speaker 2: latest news and analysis from you know It, the Alliance
0:33
Speaker 2: for Pharmacy Compounding, the voice for compounding pharmacy. I'm your host,
0:38
Speaker 2: Andrew Canter, and after the news, we've got APC's Scott
0:42
Speaker 2: Bruner and Neil Davis to do some serious mythbusting of
0:46
Speaker 2: what's being said about compounding these days.
0:48
Speaker 3: But before we get to the news, I've got a
0:50
Speaker 3: little bit of bragging to do.
0:52
Speaker 2: As of this week, APC's membership has topped seven thousand
0:57
Speaker 2: compounding professionals for the first time like ever. The actual
1:02
Speaker 2: number as of last week was seven four hundred and
1:06
Speaker 2: thirty seven. That's almost seventy five hundred pharmacy compounding professionals
1:11
Speaker 2: who are putting their confidence in us and what we're
1:14
Speaker 2: doing to protect pharmacy compounding.
1:16
Speaker 3: We cannot thank them enough.
1:18
Speaker 2: And if you are involved in pharmacy compounding and you
1:20
Speaker 2: aren't an APC member, pre examine your life choices and
1:25
Speaker 2: join us. All right now we can do the news.
1:38
Speaker 2: It took long enough, but the FDA announced that it's
1:41
Speaker 2: finally removing the infamous boxed warning from hormone replacement therapy products.
1:46
Speaker 2: And I say infamous because all right, I won't go
1:48
Speaker 2: into the nitty gritty of why the warning was problematic.
1:53
Speaker 2: Let's just say it was based on a single study
1:55
Speaker 2: with some remarkably faulty conclusions. The FDA's decision is a
2:00
Speaker 2: big deal for patients and prescribers for sure. Hopefully it'll
2:03
Speaker 2: dial back the whole fear factor that's still lingering over
2:07
Speaker 2: hormone therapy. But this is a compounding pharmacy podcast, So
2:11
Speaker 2: what you may ask does this announcement mean for compounded hormones?
2:16
Speaker 2: Remember compounding pharmacies, they can't make claims about the drugs
2:19
Speaker 2: they prepare, not efficacy, not averse events. So that black
2:23
Speaker 2: box warning it didn't apply to compounded hormone therapy. But
2:28
Speaker 2: the FDA's announcement is potentially good news for compounding simply
2:33
Speaker 2: because it's hopefully a signal that the agency is going
2:36
Speaker 2: to be relying more on better science when it makes
2:39
Speaker 2: its decisions. Like I said, the warning on hormone replacement therapy,
2:43
Speaker 2: it was based on a single flawed study, and it
2:46
Speaker 2: took years after newer, better studies came out before the
2:49
Speaker 2: agency removed that warning. Well, there's another old and flawed
2:54
Speaker 2: study out there. This one was commissioned by the FDA
2:57
Speaker 2: back in twenty nineteen, and that one is about compounded
3:01
Speaker 2: hormone replacement therapy. It was done by the National Academies
3:05
Speaker 2: of Science, Engineering, and Medicine NASUM, and you would think
3:08
Speaker 2: that makes it pretty objective, but it wasn't. To make
3:12
Speaker 2: a long story short, it had a lot of political
3:14
Speaker 2: fingerprints on it, a bit of meddling. Thankfully, the FDA
3:19
Speaker 2: hasn't used that NASOM study to make any decisions about
3:22
Speaker 2: compounded hormones, but it had been dropping some hints that
3:25
Speaker 2: it might, and that's something APC has been pushing back
3:29
Speaker 2: on for years. So seeing that the agency might actually
3:32
Speaker 2: look at objective science at least when it comes to
3:35
Speaker 2: hormone therapy, sorry tailan Al, that's potentially really good news.
3:39
Speaker 2: It's not an exaggeration to say that compounded hormone therapy
3:43
Speaker 2: is life changing stuff. So if you're going to meddle
3:46
Speaker 2: with it, you're going to regulate it, you really need
3:48
Speaker 2: to have science behind you. There was one comment in
3:51
Speaker 2: the press conference that caught our attention. When a reporter
3:54
Speaker 2: asked the FDA commissioner how the hormone decision might apply
3:58
Speaker 2: to compounding, he was pretty clear they didn't want the
4:01
Speaker 2: government to come between patients and their healthcare professionals.
4:04
Speaker 3: Here's a clip.
4:04
Speaker 2: I just remember you asked about compounding, and I didn't
4:07
Speaker 2: answer that question. So there are legal criteria for compounding,
4:10
Speaker 2: and we're going to continue to continue to respect those boundaries,
4:13
Speaker 2: thank you. So, yeah, we're feeling cautiously optimistic about how
4:17
Speaker 2: this might play out on the compounding front. So by now,
4:25
Speaker 2: there's no way you haven't heard about what happened at
4:28
Speaker 2: FDA with doctor George Tidmarsh, the guy who had been
4:31
Speaker 2: head of the agency's drug division. Apparently, or rather allegedly,
4:36
Speaker 2: based on some of Tidmarsh's LinkedIn posts, it kind of
4:39
Speaker 2: came out that he was pushing the FDA to make
4:42
Speaker 2: decisions so he could settle some personal scores. Allegedly, one
4:47
Speaker 2: of those scores happened to be allegedly against the head
4:51
Speaker 2: of a company that makes a thyroid extract, and that
4:54
Speaker 2: allegedly is why the agency pretty much out of the
4:58
Speaker 2: blue and without any science suddenly decided a couple of
5:01
Speaker 2: months ago that it was going to stop companies and
5:04
Speaker 2: compounders from using some natural thyroid products in drugs, including
5:09
Speaker 2: desiccated thyroid extract DTE. So all this time we thought
5:13
Speaker 2: the FDA's decision was pretty weird. It came out of nowhere,
5:16
Speaker 2: it didn't make any scientific sense, and it even went
5:19
Speaker 2: against the agency's own policies. If nothing else, We've never
5:23
Speaker 2: heard of the FDA declaring that a drug is a
5:25
Speaker 2: biologic based on an inactive ingredient, as it has with DTE,
5:30
Speaker 2: So would that mean any drug that uses a gelatin
5:34
Speaker 2: capsule was a biologic. The point is it was just weird,
5:37
Speaker 2: and now we may know why. The whole Tidmarsh drama
5:40
Speaker 2: explains a lot allegedly, And that's why APC just about
5:44
Speaker 2: immediately sent a letter to the FDA demanding that it
5:47
Speaker 2: reverts its decisions decisions plural, both the reclassification of DT
5:53
Speaker 2: as a biologic and the overall ban on natural thyroid products.
5:58
Speaker 2: Now that we know there was this whole person vendetta
6:00
Speaker 2: thing going on allegedly. Oh and what's also interesting and
6:04
Speaker 2: kind of hanging over this whole debacle, is that. It
6:07
Speaker 2: sure does seem it was awfully easy for a single
6:10
Speaker 2: person to change a pretty big FDA policy. It doesn't
6:14
Speaker 2: strike us as the right way to run a federal agency,
6:16
Speaker 2: especially one that's supposed to be protecting folks health. So
6:20
Speaker 2: tune in tomorrow for the next episode of As the
6:23
Speaker 2: FDA Turns Now. How about Days of FDA Anyway? Oh,
6:29
Speaker 2: by the way, if you want to help keep up
6:31
Speaker 2: the pressure on the FDA over the ban on DTE,
6:34
Speaker 2: you'll find a couple of links in the show notes
6:36
Speaker 2: to our tools that make it easy onward. Okay, this
6:42
Speaker 2: is not legal advice. We're not lawyers. This is just
6:45
Speaker 2: a podcast that said, in the name of all that's holy,
6:50
Speaker 2: don't compound with red to true Tide or kuldgrillin Tide. Yes,
6:55
Speaker 2: we know that legitimate pharmacies aren't usually the ones doing this.
6:58
Speaker 2: It's med spas and companies posing as pharmacies that are.
7:02
Speaker 2: But we want to head off even the hint of temptation.
7:05
Speaker 2: So let me say once more with feeling, there is
7:08
Speaker 2: no wiggle room here. There's no loophole. The FDA has
7:12
Speaker 2: been crystal clear read a true Tide and Cagrillentide are
7:15
Speaker 2: not components of any FDA approved drug. They don't have monographs,
7:20
Speaker 2: they're not on the five h three A bulks list,
7:23
Speaker 2: which means you cannot legally compound with them full stop. Yes, yes, yes,
7:27
Speaker 2: there's a lot of interest in peptides like those. And
7:30
Speaker 2: yes there are those illegal pop up shops claiming to
7:33
Speaker 2: sell one or the other. Whoop de doo, it's not legal,
7:36
Speaker 2: don't do it. Oh and while we're ranting, don't compound
7:39
Speaker 2: with research grade API either. But you knew that already, right.
7:45
Speaker 2: There have been a few interesting compounding related things going
7:49
Speaker 2: on at the state level that caught our attention, like
7:52
Speaker 2: in Rhode Island, the Board of Pharmacy there is updating
7:55
Speaker 2: the compounding regulations. One of the things we do here
7:58
Speaker 2: is take a look at stuff like that just in
8:00
Speaker 2: case it's a good thing, Because it seems that the
8:03
Speaker 2: new REGs being proposed in Rhode Island would blur the
8:06
Speaker 2: line between routine IV preparation and complex compounding. That is
8:11
Speaker 2: a recipe for confusion and could even mean some pharmacists
8:15
Speaker 2: being out of compliance even with the best of intentions. Yes, yes,
8:19
Speaker 2: APC will be commenting. And in Maryland there's a new
8:23
Speaker 2: law that requires every pharmacy licensed in this state to
8:27
Speaker 2: submit dispensing data on non controlled substances to the state's
8:31
Speaker 2: Health Information Exchange. Now that's not a big deal. The
8:35
Speaker 2: problem is that Maryland hasn't done a very good job
8:38
Speaker 2: of communicating the new requirement of pharmacies. It's actually been
8:42
Speaker 2: three years since the law was passed, but there's been
8:45
Speaker 2: virtually nothing in any state materials. So a lot of
8:48
Speaker 2: pharmacists feel like they're being blindsided by a pretty major
8:51
Speaker 2: rule that feels like it came out of nowhere. As
8:54
Speaker 2: we wrote to the Maryland Board, what we have here
8:57
Speaker 2: is a failure to communicate, and we hope it'll fix
9:00
Speaker 2: that before it starts enforcing the law. And then there's Texas.
9:05
Speaker 2: The board there is working through updates to its sterile
9:07
Speaker 2: compounding rules, but some of the proposed language, let's just
9:11
Speaker 2: say it creates a bit of uncertainty about what requires
9:15
Speaker 2: sterility testing, the timing of those tests, and how batch
9:18
Speaker 2: size applies. It's a solid draft, for sure, but we
9:21
Speaker 2: think it needs a bit more refinement, so we end
9:24
Speaker 2: up with clearer directions for pharmacies. Now, look, this is
9:27
Speaker 2: a shameless plug. These kinds of state boards we'll call
9:31
Speaker 2: them stumbles. They happen a lot. APC keeps on top
9:34
Speaker 2: of it all and we advise these state boards with
9:37
Speaker 2: comment letters. We actually have a weekly report about all
9:40
Speaker 2: of what's happening in the States, but you can only
9:43
Speaker 2: get it if you're a pharmacy facility member of APC,
9:47
Speaker 2: a PFM, and there's a link to becoming a PFM
9:50
Speaker 2: in the show notes. All right, and now it's time
9:53
Speaker 2: for this episode's deep dive. At least since the.
9:58
Speaker 3: Beginning of the GLP one and then the.
10:01
Speaker 2: GLP one shortages, drug makers have been working pretty hard
10:04
Speaker 2: to attack pharmacy compounding anyway they can. We've reached kind
10:09
Speaker 2: of a surreal point where giant multinational corporations are deliberately,
10:14
Speaker 2: i can't say lying because against lawyers upset. They're deliberately
10:18
Speaker 2: spreading misinformation about compounded drugs and about compounding pharmacists. And
10:23
Speaker 2: it's all to scare regulators and the public and drive
10:26
Speaker 2: their own businesses.
10:27
Speaker 3: And they're doing it big time.
10:29
Speaker 2: Opinion pieces, letters to the editor from people claiming to
10:32
Speaker 2: be independent, letters full of misinformation to pharmacies, to boards
10:36
Speaker 2: of pharmacy. They're filing nuisance lawsuits that they just keep losing.
10:41
Speaker 2: It's actually gotten to the point of absurdity. These companies
10:44
Speaker 2: are even creating fake organizations with real sounding names like
10:49
Speaker 2: I don't know, the American Alliance for Obesity in Freedom
10:52
Speaker 2: and apple Pie. Then someone submits an op ed to
10:55
Speaker 2: a local paper using that fake organization as a credential
11:00
Speaker 2: looked into miraculously sprang into existence this past March. But editors,
11:05
Speaker 2: they don't have time to check on every one of them.
11:08
Speaker 2: So yeah, drug makers are trying to wage a war
11:11
Speaker 2: of misinformation on as many fronts as possible. So let's
11:15
Speaker 2: go through some of what these companies have been saying lately.
11:19
Speaker 2: Joining me today to do a bit of mythbusting are
11:22
Speaker 2: APC MythBuster in chief Scott Brunner and his sidekick, Chief
11:26
Speaker 2: Advocacy Officer to Neil Davis, who also happens to be
11:29
Speaker 2: a practicing pharmacist.
11:30
Speaker 3: Welcome guys.
11:31
Speaker 2: Okay, let's tackle one of the biggest talking points first.
11:35
Speaker 2: According to what the big drug makers are saying, since
11:38
Speaker 2: the FDA resolved the golp one shortages, it's actually illegal
11:42
Speaker 2: for pharmacists to compound them.
11:44
Speaker 3: Is that true?
11:45
Speaker 4: Nonsense? It's not illegal to compound gop ones. Remember that
11:50
Speaker 4: compounding is authorized in a couple of circumstances. Compounders can
11:53
Speaker 4: prepare copies of FDA approved drugs when the drugs are
11:56
Speaker 4: listed as currently in shortage on FDA's Drug Shortage List.
12:00
Speaker 4: Ones are now out of shortage. But the other condition
12:03
Speaker 4: in which compounding is authorized is when a prescriber judges
12:07
Speaker 4: that a custom formulation is needed for an individual patient.
12:11
Speaker 4: Prescribers continue to write for those custom formulations of glp
12:15
Speaker 4: ones as allowed authorized in the Food, Drug and Cosmetic Act.
12:20
Speaker 4: Compounding pharmacies are filling those prescriptions. Drug makers have indeed
12:25
Speaker 4: made that statement in letters and appearances before state boards,
12:29
Speaker 4: a pharmacy, in communication with members of Congress and other regulators.
12:33
Speaker 4: It's just not true.
12:36
Speaker 2: And to be clear, you said that it's a prescriber
12:39
Speaker 2: who decides if a patient needs a compounded version or
12:43
Speaker 2: the drug. So it's not like pharmacy can decide, oh,
12:46
Speaker 2: I'm not going to give you the brand name the
12:48
Speaker 2: FDA proved drug.
12:49
Speaker 3: I'm going to give you a compounded version instead.
12:52
Speaker 4: No, you're exactly right. The prescriber judges when a compounded
12:55
Speaker 4: drug is prescribed. It's not like she writes prescribe, we
12:59
Speaker 4: go v on the and the patient hops down to
13:01
Speaker 4: the pharmacy and the pharmacist says, oh, I don't have
13:03
Speaker 4: any of that. I'm just gonna compound it. No, the
13:06
Speaker 4: prescriber has to write for a compounded drug, so they're
13:10
Speaker 4: not writing for wig govy, they're writing for compounded some
13:13
Speaker 4: of glutide injection. Again, custom formulations are allowed. Now, copies
13:19
Speaker 4: of FDA approved drugs.
13:21
Speaker 2: Are not okay, so copies are not allowed. How about
13:24
Speaker 2: this one that also comes up a lot, these compounded
13:27
Speaker 2: versions of FDA approved drugs. They are not safe because,
13:32
Speaker 2: as the name implies, they aren't actually FDA approved.
13:37
Speaker 3: So is that true?
13:38
Speaker 2: If they're not approved, then how can people be sure
13:41
Speaker 2: they're safe.
13:42
Speaker 5: You're absolutely right. Compounded medications are not FDA approved, but
13:47
Speaker 5: that doesn't mean that they are inherently unsafe, just as
13:51
Speaker 5: FDA approval doesn't guarantee safety. We know that there's been
13:55
Speaker 5: drugs that have been taken off the market that had
13:57
Speaker 5: previously obtained FDA approval in the past. Compound medications can't
14:01
Speaker 5: be FDA approved. They're intended to be custom formulated for
14:05
Speaker 5: an individual patient based on a specific prescribers order to
14:11
Speaker 5: get FDA approval, drug companies have to go through double blind,
14:14
Speaker 5: placebo controlled trials and submit all sorts of data to
14:18
Speaker 5: the FDA. That is impractical to do with the medication
14:22
Speaker 5: that is intended for an end of one or an
14:24
Speaker 5: individual patient.
14:26
Speaker 3: Yeah.
14:26
Speaker 4: And the other thing I would say about that is
14:29
Speaker 4: FDA approved drugs are adherent to current good manufacturing practices
14:35
Speaker 4: for a reason, they are mass produced. This is a
14:37
Speaker 4: drug made for millions. Compounded drugs, as Tanila said, are
14:42
Speaker 4: made for an end of one, for an individual patient.
14:45
Speaker 4: These are not drugs to be mass produced for millions
14:48
Speaker 4: of patients. And so the framework, the compliance framework, the
14:52
Speaker 4: safety framework, the regulatory framework in which these drugs are
14:55
Speaker 4: prepared are appropriate for a medication made for an individual patient.
15:00
Speaker 5: Yeah, FDA approved drugs are always the first choice. First
15:04
Speaker 5: line therapy should be an FDA approved product, And it's
15:07
Speaker 5: only in situations where the FDA approved drug is in
15:10
Speaker 5: shortage or not appropriate for a patient because they need
15:14
Speaker 5: some sort of customized dosage form strength that doesn't exist,
15:17
Speaker 5: combination product, preservative free version, whatever the prescriber determines that
15:22
Speaker 5: patient might need. Those are only appropriate if the FDA
15:26
Speaker 5: approved product is you know, not appropriate for the patient.
15:30
Speaker 2: Instead, so you've got all these versions of compounded drugs,
15:35
Speaker 2: like you said there with different dosages, amounts, or potentially
15:39
Speaker 2: with various other drugs mixed in as is needed.
15:43
Speaker 3: By a particular patient.
15:45
Speaker 2: Okay, that makes sense, But I mean, when it comes
15:48
Speaker 2: down to it, aren't these compounded drugs. I know you
15:51
Speaker 2: don't like the term, but they're knockoffs, right, I mean,
15:53
Speaker 2: they're not the same as as the FDA approved version.
15:58
Speaker 2: They're all right, it's a word, but they're fakes, right,
16:01
Speaker 2: They're not the real thing.
16:04
Speaker 4: No, no, no, that's nonsense as well. FDA calls these
16:09
Speaker 4: essentially copies of FDA approved drugs or custom formulations, and indeed,
16:15
Speaker 4: FDA never refers to them as copycats or knockoffs or
16:19
Speaker 4: any of the pejoratives that we hear reporters from time
16:21
Speaker 4: to time use in their news stories. These aren't handbags
16:26
Speaker 4: laid out on some Manhattan sidewalk somewhere. These are custom
16:30
Speaker 4: medications made in USP compliant compounding laboratories by licensed pharmacists
16:39
Speaker 4: and technicians, and FDA says provided they are made with
16:44
Speaker 4: the active pharmaceutical ingredient that comes from an FDA registered facility,
16:49
Speaker 4: and that's the same as the API in the FDA
16:53
Speaker 4: approved drug. They are absolutely compliant, absolutely legal, and absolutely
16:57
Speaker 4: appropriate when a prescriber judges that an individual patient needs
17:01
Speaker 4: that drug.
17:03
Speaker 3: But here's something that confuses me.
17:05
Speaker 2: Then okay, so the active ingredients you're saying, it's the same.
17:10
Speaker 2: But when glp ones were in shortage, if these same
17:14
Speaker 2: ingredients were available for compounding pharmacists, then why were they
17:20
Speaker 2: in shortage.
17:22
Speaker 4: Well, there is a bit of confusion about how that works.
17:25
Speaker 4: First of all, FDA does not approve API, and the
17:29
Speaker 4: FDA Drug Shortage List does not list APIs. It lists
17:34
Speaker 4: shortages of FDA approved drugs. And so during the entire
17:38
Speaker 4: shortage of some of glue tide, the Novo Nordis product,
17:42
Speaker 4: and churzepetide, the Eli Lilly product, never once was the
17:48
Speaker 4: active pharmaceutical ingredient in shortage. And we know that because,
17:54
Speaker 4: for instance, with some of glue tide, there was never
17:56
Speaker 4: a shortage of ribelsis, the oral version of semaglue tide. No,
18:01
Speaker 4: what was in shortage was the FDA approved drug. And
18:05
Speaker 4: again it's it's hearsay. I don't know that we know,
18:08
Speaker 4: but something in the production process. UH was the hold up,
18:13
Speaker 4: and that's what led the drug to be in shortage,
18:17
Speaker 4: not the lack of the a p I. Compounding pharmacists
18:21
Speaker 4: were acquiring a p I from FDA registered as AT
18:25
Speaker 4: and as it turns out, UH FDA inspected and cg
18:29
Speaker 4: MP compliant UH UH manufacturers, many of those in China.
18:35
Speaker 4: But FDA recently released a green list validating that those
18:41
Speaker 4: UH manufacturers were cGMP compliant had been inspected by h
18:46
Speaker 4: f d A. And so they're using API that FDA
18:49
Speaker 4: seems to have no qualms with. Not once in this
18:53
Speaker 4: GLP one frenzy and the entry of compounding into the
18:58
Speaker 4: GOLP one market has f d A raised a single
19:00
Speaker 4: point of concern about the quality of the active pharmaceutical ingredient.
19:05
Speaker 2: I think you actually headed off my next question, which
19:08
Speaker 2: was we hear a lot that the API that compounding
19:12
Speaker 2: pharmacists are using come from overseas. They come from foreign countries,
19:18
Speaker 2: places like China and India that I guess we can't trust.
19:23
Speaker 2: Is I mean, are the big drug makers getting their
19:26
Speaker 2: ingredients from good old American sources?
19:28
Speaker 3: I mean, how does that work?
19:31
Speaker 2: Why are these companies pushing the fact that compounders are
19:35
Speaker 2: getting their ingredients overseas.
19:39
Speaker 5: I think that it's a misunderstanding as to how a
19:42
Speaker 5: typical compounding pharmacy acquires active pharmaceutical ingredients or API. So
19:48
Speaker 5: most independent, state licensed, legitimate compounding pharmacies are getting active
19:53
Speaker 5: pharmaceutical ingredients from FDA registered wholesalers. Those FDA registered wholesalers
19:59
Speaker 5: and purchase API from FDA registered manufacturers. Many of these
20:05
Speaker 5: wholesalers conduct third party testing on the API that they
20:08
Speaker 5: bring in to sell to independent pharmacies. So pharmacies are
20:12
Speaker 5: not calling up China and ordering a PI to be
20:15
Speaker 5: delivered to their doorstep. Is there a lot of research grade,
20:21
Speaker 5: you know, peptide drugs being sold online without a prescription. Yes,
20:28
Speaker 5: but that's not compounding and it's not pharmacy. So when
20:31
Speaker 5: we're talking about that sort of API, you know, importation
20:35
Speaker 5: into the United States, that's not going to legitimate state
20:38
Speaker 5: licensed compounding pharmacies. And underscored by what Scott was talking
20:42
Speaker 5: about with the with the green list, So FDA came
20:45
Speaker 5: out with a list of manufacturers that it deems to
20:49
Speaker 5: be in compliance with FDA standards for manufacturing GLP ones.
20:54
Speaker 5: The existence of that list underscores the fact that FDA
20:58
Speaker 5: does think that their manufacturer beyond the drug makers that
21:02
Speaker 5: are making appropriately graded API.
21:07
Speaker 4: Yeah, and I do want to add on one of
21:10
Speaker 4: the groups fronted funded I guess by the drug makers,
21:16
Speaker 4: has begun to release a report with some regularity about
21:21
Speaker 4: illicit substances that have been intercepted elicit API that have
21:25
Speaker 4: been intercepted at the US border. There is no doubt
21:30
Speaker 4: that there is a gray market, and there is a
21:32
Speaker 4: market for illicted substances, and those substances are coming into
21:36
Speaker 4: the country and they may or may not be what they.
21:40
Speaker 3: Purport to be.
21:41
Speaker 4: This group has asserted that because some of them have
21:44
Speaker 4: been cleverly marked for use in pharmacy compounding that as
21:48
Speaker 4: to Neil mentioned, they must have been ordered by a
21:50
Speaker 4: state licensed compounding pharmacy and we're somehow making their way
21:54
Speaker 4: into drugs prepared for patients. There's not a shred of
22:00
Speaker 4: evidence that that has happened. And as Taneil said, it
22:03
Speaker 4: misunderstands how the supply chain works. And yet there is
22:08
Speaker 4: this gray market, this black market, these substances that can't
22:12
Speaker 4: be relied upon, and Americans need to take care that
22:17
Speaker 4: they are getting compounded drugs from state licensed compounding pharmacies
22:22
Speaker 4: and not from some address that they found on a
22:26
Speaker 4: Reddit thread or some chat room online, because their health
22:31
Speaker 4: could very well be at risk.
22:34
Speaker 2: Are you saying that they can't trust influencers on TikTok
22:37
Speaker 2: when someone recommends whatever whatever whatever dot com to get
22:42
Speaker 2: their discount semigluetite.
22:45
Speaker 4: Well, I don't know that you can throw every influencer
22:48
Speaker 4: under the bus, but there are many of them with
22:50
Speaker 4: dubious credentials at best. I would suggest that for your
22:54
Speaker 4: healthcare advice, you ought to go to a prescriber, a doctor,
22:58
Speaker 4: nurse practitioner PAH, or your local pharmacist and maybe not
23:02
Speaker 4: rely on something you read on the internet.
23:05
Speaker 3: I want to get back, per second, to the ingredients.
23:08
Speaker 2: So the ingredients, the APIs that legitimate state licensed compounding
23:14
Speaker 2: pharmacies are using, and we're going to use that phrase
23:16
Speaker 2: a bunch.
23:17
Speaker 3: They are safe. Okay, let's let's that's a given.
23:21
Speaker 2: But something I read at least one company, and we'll
23:26
Speaker 2: just say it starts with an N and ends with
23:29
Speaker 2: ovo nordisk uh it says that it's semigluetide. API is
23:34
Speaker 2: better than what compounding pharmacists get because it's recombinant, while
23:39
Speaker 2: the API compounders use is synthetic. I mean, is that
23:43
Speaker 2: a legitimate complaint that the version that compounders compounding pharmacists
23:49
Speaker 2: are using is different because it's synthetic.
23:52
Speaker 5: So Nova Artisk is correct. They do manufacture semaglue tide
23:56
Speaker 5: via recombinant technology, whereas most AP that is semic gluetide
24:01
Speaker 5: in the marketplace is manufactured via synthetic technology.
24:05
Speaker 2: You know.
24:06
Speaker 5: Conversely, all turns eppetite is manufactured via synthetic technology. So
24:10
Speaker 5: the other big drug maker isn't making this argument because
24:14
Speaker 5: their API is also manufactured via synthetic technology. They are
24:19
Speaker 5: different manufacturing processes for sure. But the FDA, when a
24:25
Speaker 5: drug is allowed to become a generic for a medication
24:28
Speaker 5: that is manufactured via recombinant technology, it allows that generic
24:33
Speaker 5: manufacturer to use either recombinant or synthetic manufacturing for its
24:39
Speaker 5: approval as long as it can prove that the API
24:42
Speaker 5: is the same at the end, so that the amino
24:44
Speaker 5: acid chain is the same as the recombinantly produced product.
24:49
Speaker 5: So their argument that the API is inherently different is
24:55
Speaker 5: not necessarily true, but it is true that they're manufactured
24:59
Speaker 5: using different technology to.
25:03
Speaker 4: Know you're saying, FDA doesn't necessarily draw a distinction between
25:06
Speaker 4: recombinant and synthe.
25:09
Speaker 5: Yes, they don't draw a distinction as long as that
25:11
Speaker 5: the company that's applying for the generic that new drug
25:16
Speaker 5: application can prove that the API is the same, the
25:19
Speaker 5: outcome is.
25:20
Speaker 2: The same, all right, So I'll accept that the pharmacies
25:23
Speaker 2: they're safe, the drugs are good, they work, the whole
25:28
Speaker 2: process is safe. But what about when these compounded medications
25:33
Speaker 2: get into patient's hands. Hasn't there been like a lot
25:36
Speaker 2: of problems with patients misdosing themselves what the FDA calls
25:41
Speaker 2: adverse events.
25:42
Speaker 5: So I'm going to jump in and just clarify the
25:45
Speaker 5: definition of the word safe where it comes to compounding
25:48
Speaker 5: pharmacies and FDA approved drugs. Compounded compounded drugs and API
25:54
Speaker 5: can't be technically called quote unquote safe by a compounding
25:57
Speaker 5: pharmacy because terms like safe and effective have a legal
26:01
Speaker 5: definition that is associated with full FDA approval. Since compounded
26:06
Speaker 5: drugs are not FDA approved, compounding pharmacies are not allowed
26:09
Speaker 5: to call them safe or effective. Same with API. API
26:13
Speaker 5: is not FDA approved, only finished dosage forms are, and
26:17
Speaker 5: so it can't be called quote unquote safe by a
26:20
Speaker 5: compounding pharmacy, okay, but as far as the administration dosing errors,
26:26
Speaker 5: so most compounding pharmacies are dispensing these compounded GLP one
26:31
Speaker 5: drugs in a traditional vile and syringe system, just like
26:34
Speaker 5: insulin has been dispensed for years and many other injectable medications.
26:40
Speaker 5: The pen devices that the brand name drug manufacturers sure
26:44
Speaker 5: seem convenient for sure, but as long as the patient
26:47
Speaker 5: has adequate counseling, written directions, and ability to call a
26:52
Speaker 5: pharmacist or a prescriber with questions, they should reasonably be
26:55
Speaker 5: able to draw up the proper doses. I always recommend
26:59
Speaker 5: if you are confused about what dose you need to inject,
27:02
Speaker 5: don't go to Instagram to ask the question about how
27:06
Speaker 5: much to draw up on your syringe. Call a pharmacist.
27:10
Speaker 5: If you're getting a medication from a legitimate, state licensed pharmacist,
27:15
Speaker 5: they are available to you to answer any questions if
27:18
Speaker 5: you're confused.
27:20
Speaker 4: And Tanail, I'm trying to remember back so FDA a
27:23
Speaker 4: while back. I'm sorry the months run together, but FDA
27:27
Speaker 4: did release an alert raising concerns about dosing errors, and
27:35
Speaker 4: I don't think anything in that alert, if I remember correctly,
27:40
Speaker 4: cast doubt about the quality of the compounded drug. It
27:44
Speaker 4: was really, as you say, about some violent syringe dosing
27:49
Speaker 4: errors or some mistaken I guess dosage instructions, dosing instructions
27:58
Speaker 4: from the prescriber himself herself. Am I getting that right?
28:03
Speaker 3: Yeah?
28:03
Speaker 5: You are. They did release a statement about dosing and
28:06
Speaker 5: administration errors and adverse events associated with those, and they
28:10
Speaker 5: focused on several things, but including prescribers that we're escalating
28:15
Speaker 5: doses too fast or starting doses too high, those kind
28:19
Speaker 5: of things. So it's not just about the delivery device.
28:22
Speaker 5: It's about, you know, people maybe making a patient's dose
28:28
Speaker 5: go too high, too fast, and them having some adverse events.
28:32
Speaker 4: Andrew, I do want to raise a myth of my
28:34
Speaker 4: own to bust, and it has to do with adverse
28:39
Speaker 4: events reporting in general, not only for compounded drugs, but for.
28:43
Speaker 3: FDA approved drugs as well.
28:45
Speaker 4: FDA has an adverse events reporting system a website. Anybody
28:52
Speaker 4: at all can report an adverse event. It doesn't have
28:56
Speaker 4: to be serious in many instances. In fact, a multitude
29:02
Speaker 4: of adverse events reports are not themselves adverse events, but
29:06
Speaker 4: are side effects known side effects of drugs. FDA does
29:10
Speaker 4: not investigate these. So you have a scenario where anybody
29:14
Speaker 4: can report anything they want and it's not documented, investigated
29:20
Speaker 4: by FDA. And yet we're seeing again and again drug
29:23
Speaker 4: makers and others rely on data from that adverse events
29:27
Speaker 4: reporting system to suggest that somehow compounded drugs less safe
29:33
Speaker 4: than the FDA approved versions. I would suggest to you
29:38
Speaker 4: that that adverse events system does not demonstrate that, and indeed, FDA,
29:43
Speaker 4: in raising concerns about adverse events, has indicated that these
29:48
Speaker 4: are not investigated. These are simply reported.
29:53
Speaker 2: So if these companies, I want to go back to
29:55
Speaker 2: something we talked about earlier, If these companies are sending
30:00
Speaker 2: or encouraging people to send, for want of a better word,
30:04
Speaker 2: sham letters to editors of newspapers, they're making presentations for
30:09
Speaker 2: boards of pharmacy with misinformation, does it follow that some
30:14
Speaker 2: of these adverse events reports might be encouraged by drug makers.
30:20
Speaker 2: I mean, there's really no way to tell what is
30:23
Speaker 2: a legitimate report and what is just a side effect
30:27
Speaker 2: or user error.
30:29
Speaker 4: Well, to use a Shakespearean phrase, if they're doing that,
30:31
Speaker 4: they're hoist with their own petard because the same conditions
30:36
Speaker 4: apply to adverse events reported about the FDA approved drugs,
30:40
Speaker 4: and there are exponentially more adverse events reports related to
30:45
Speaker 4: the FDA approved glp ones. Now, drug makers, regulators, and
30:50
Speaker 4: others will reply, Oh, but compounding pharmacies don't have to
30:54
Speaker 4: report adverse events, and that is absolutely true.
30:58
Speaker 3: But if there is a serious.
31:00
Speaker 4: Adverse event that causes patient harm, I can guarantee you
31:03
Speaker 4: that the prescriber, or the state board of pharmacy, or
31:07
Speaker 4: the family of the patient are absolutely going to report
31:12
Speaker 4: that to the FDA Adverse Events Reporting system, and generally speaking,
31:19
Speaker 4: a pharmacy will as well, even though they may not
31:21
Speaker 4: be required to do it. Again, I'm talking about serious
31:25
Speaker 4: adverse events. I'm not talking about Oh, I got the
31:28
Speaker 4: injection and I felt nauseous. Well, I'm sorry, that's a
31:31
Speaker 4: known side effect of the drug. It's not an adverse event.
31:36
Speaker 2: But when you are counting the number of adverse events
31:39
Speaker 2: that might actually get counted and tallied as one and
31:43
Speaker 2: held against a pharmacy could be okay, held against the
31:49
Speaker 2: compounded version. Okay, Well, that honestly doesn't make much sense,
31:53
Speaker 2: but that's FDA policy, all right. One, I guess this
31:59
Speaker 2: is a kind of a different, a different angle, a
32:01
Speaker 2: different myth that has come up, and I hope it's
32:04
Speaker 2: a myth. So let's assume, and I totally believe you,
32:09
Speaker 2: that the pharmacy is legit. The compounded versions of drugs
32:13
Speaker 2: are on par, shall we say, with commercial FEA approved versions.
32:18
Speaker 2: But one thing that drug makers have been saying is
32:21
Speaker 2: that it's fine. Yes, the law allows a compounded version
32:26
Speaker 2: of a drug for a specific patient, but there are
32:30
Speaker 2: compounding pharmacies that are going way beyond what the law intended,
32:35
Speaker 2: and that they're saying the meds are personalized, but they're
32:39
Speaker 2: conveniently the same personalization for just about every patient, so
32:43
Speaker 2: they're essentially bulk compounding under the guise of personalization.
32:49
Speaker 3: Is is this something that's actually happening.
32:51
Speaker 4: Well, in a lawsuit they've actually used the expression sham personalization. Look,
32:58
Speaker 4: nothing happens in a compounding pharmacy until a prescription comes in.
33:01
Speaker 4: A prescriber has to judge that an individual patient merits
33:07
Speaker 4: a particular formulation before the compounding pharmacy can prepare that drug. Now,
33:14
Speaker 4: there was a lawsuit that was thrown out against trying
33:20
Speaker 4: to remember which way the thing is will to help
33:22
Speaker 4: a few weeks ago in which the judge indicated that
33:27
Speaker 4: just because something was made in some volume did not
33:32
Speaker 4: mean it was not patient specific. And indeed, when I
33:37
Speaker 4: talked to compounding pharmacy owners, they tell me that they
33:43
Speaker 4: have a large number of formulations custom formulations for say,
33:47
Speaker 4: semaglue tide. They don't have that large number of formulations
33:52
Speaker 4: because they've just on their own decided to create those.
33:54
Speaker 4: They've got a large number of formulations in their formulaarity
33:57
Speaker 4: because prescribers have written for a large number of formulations.
34:02
Speaker 4: You can bet that a particular prescriber is not going
34:06
Speaker 4: to have forty three different formulations to zepetide, but he
34:10
Speaker 4: or she may have four or five and write those
34:13
Speaker 4: four or five consistently. I don't think that cham personalization
34:18
Speaker 4: is absolutely patient specific, and compounding pharmacies are as they
34:23
Speaker 4: should be filling those prescriptions.
34:27
Speaker 3: All right.
34:28
Speaker 2: So it does seem like there's a lot of nonsense
34:32
Speaker 2: being pedled out there, and a lot of it is
34:35
Speaker 2: technical enough that I can understand patients and even regulators
34:39
Speaker 2: or politicians getting confused. So it sounds like you've got
34:43
Speaker 2: your work cut out for you continuing to debunk this
34:47
Speaker 2: kind of stuff, And thank you both for coming here
34:50
Speaker 2: to help do that. I'm hoping that some of the
34:53
Speaker 2: listeners they got at least a few aha moments about
34:57
Speaker 2: what's been going on. We've covered just about all the
35:02
Speaker 2: myths that these drug makers have been spreading, but some
35:05
Speaker 2: of them. Some part of me that thinks there are
35:08
Speaker 2: a lot more of them out there, and we're going
35:10
Speaker 2: to be seeing more of them in the future. I
35:12
Speaker 2: think I just saw a survey that said a big
35:14
Speaker 2: portion of Americans are wary of buying medication online, and
35:19
Speaker 2: that's got me wondering how much of that wariness is
35:22
Speaker 2: due to drug makers muddying the waters.
35:25
Speaker 4: It could be, but I don't want to completely throw
35:28
Speaker 4: drug makers under the bus on that count. Andrew. The
35:31
Speaker 4: National Association of Boards of Pharmacy says that it as
35:34
Speaker 4: much as ninety percent of online pharmacies are bogus. That's
35:41
Speaker 4: scary that there could be that many illicit entities out there,
35:46
Speaker 4: and so if you're going to purchase a drug, whether
35:48
Speaker 4: it's an FT approved drug or a compound of drug,
35:51
Speaker 4: make sure you are working with a legitimate pharmacy. APC
35:54
Speaker 4: has on our website at compounding dot Com a tool.
35:59
Speaker 3: That we call is legit.
36:01
Speaker 4: And if you want to know if the pharmacy, purported
36:04
Speaker 4: pharmacy that your drug comes from is legit or not,
36:08
Speaker 4: go to is it Legit and we provide a shortcut
36:11
Speaker 4: to your state and you can look up the name
36:13
Speaker 4: of the pharmacy there. If it's listed, generally speaking, it
36:17
Speaker 4: is a licensed pharmacy in that state and it is legit.
36:19
Speaker 4: If it's not listed, you may need to do a
36:21
Speaker 4: little more leg work, and it could be that it
36:24
Speaker 4: is one of these bogus entities.
36:27
Speaker 3: And that's for both.
36:29
Speaker 2: You know, Let's say I know a compounding of pharmacy
36:31
Speaker 2: a few towns over, and it's also online pharmacies.
36:35
Speaker 3: I can look them both up.
36:36
Speaker 4: Yeah, online pharmacies. Telehealth platforms and online pharmacies have to
36:43
Speaker 4: be licensed. The pharmacy that is doing the fulfillment for
36:45
Speaker 4: the telehealth platform has to be licensed to Neil, Did
36:49
Speaker 4: I Did I get most of that right? I have
36:52
Speaker 4: to look at doctor Davis to make sure I'm correct.
36:55
Speaker 3: That's all right.
36:55
Speaker 5: But if the pharmacy are the quote unquote pharmacy you're
36:59
Speaker 5: looking to work with is not listed as licensed in
37:02
Speaker 5: the state where they would be shipping the medication, that
37:05
Speaker 5: they're not a legitimate state licensed pharmacy. They're one of
37:08
Speaker 5: these what NABP calls bogus online pharmacies, So best practice
37:13
Speaker 5: don't use those. Only use legitimate state licensed compounding pharmacies
37:17
Speaker 5: for compounded medications or state licensed pharmacies for FDA proved medications.
37:23
Speaker 3: Okay, we'll put that in the show notes.
37:26
Speaker 2: But that was Compounding dot Com is the site and
37:28
Speaker 2: the tool is called is it Legit.
37:31
Speaker 4: Yeah, that's It's up at the top of the website.
37:33
Speaker 4: You'll see is it Legit with a question mark and
37:35
Speaker 4: it'll take you right to the shortcut.
37:37
Speaker 3: Sounds great.
37:38
Speaker 2: All right, thank you again both for being here and
37:41
Speaker 2: doing that bit of mythbusting. Before we play the end music.
37:45
Speaker 2: Something I want to point out if you are a
37:47
Speaker 2: compounding pharmacist or a technician, or you prescribe compounding medications,
37:52
Speaker 2: APC is almost certainly helping you and.
37:55
Speaker 3: Helping your patients.
37:56
Speaker 2: I'm not going to go through everything we do, but
37:58
Speaker 2: I will say that APC is the biggest and in
38:02
Speaker 2: a good way, the loudest trade association for the whole
38:05
Speaker 2: compounding profession. So if you're not a member of APC,
38:08
Speaker 2: you really want to be we're working for you and
38:11
Speaker 2: we'd love to have you on board. Just head over
38:14
Speaker 2: to A four. That's the number four PC dot org.
38:19
Speaker 2: Check us out. All right now, we can play that
38:21
Speaker 2: end music. Thanks for listening.