Generic drugs save money, but do they lower the bar?
From what “bioequivalent” really requires to why an authorized generic can look just like the brand name, a lot of what gets assumed about generic drugs hasn’t caught up with how tightly this corner of pharmacy is actually regulated.
In this episode, Don and Steve pick apart the claims pharmacists hear most about generic drugs.
- 🔬 Do generics really get held to a lower approval or quality bar than the brand drug?
- 📦 Is an authorized generic just the brand drug repackaged in a different box?
- 🔄 Is it safe to switch between generics from different manufacturers?
- 📛 Are generic drug names really just made up?
We’ll check the label on the evidence and find out which generic claims are the real deal:
- Generics have lower approval and quality standards.
- Authorized generics are the same product as the brand drug.
- Switching between generics is safe.
- Generic drug names are just made up.
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TRC Healthcare Editor Hosts:
- Stephen Small, PharmD, BCPS, BCPPS, BCCCP, CNSC
- Don Weinberger, PharmD, PMSP
Guest:
- Doug Hoey, RPh, MBA (Chief Executive Officer of the National Community Pharmacists Association, NCPA)
CE Information:
None of the speakers have anything to disclose.
TRC Healthcare offers CE credit for this podcast for subscribers at our platinum level or higher. Log in to your Pharmacist’s Letter, Pharmacy Technician’s Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.
The clinical resources mentioned during the podcast are part of a subscription to Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber Insights:
- Website: Report a Problem to the FDA
- Website: FDA Enforcement Reports
- CE Course: Overview of Generic Substitution
- Chart: Anticipated Availability of First-Time Generics chart
- Podcast: Rumor vs Truth – Color Coded
- FAQ: Facts About Biosimilars
- Podcast: Medication Talk – Biosimilars in Action
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Transcript:
This transcript is automatically generated.
00:00:05 Narrator
Welcome to Rumor vs. Truth, your trusted source for facts, where we dissect the evidence behind risky rumors and reveal clinical truths. Today, we’re giving generic medications a brand-new look.
00:00:21 Steve Small
Don, I really struggled coming up with a creative or witty opening for this episode, and I might not be on my A-game for puns about generic meds today.
00:00:30 Don Weinberger
Don’t worry, Steve. We can just keep the opening generic.
00:00:35 Steve Small
Don saves the day once again. And I’m Steve the pharmacist.
00:00:40 Don Weinberger
And I’m Don the pharmacist. In this episode, we’re looking at common claims around generic medications. Same active ingredient, different label, and apparently enough rumors to need their own shelf.
00:00:50 Steve Small
That’s for sure. And before we dive in, this podcast offers continuing education credit for pharmacists, pharmacy technicians, prescribers, and nurses.
00:00:58 Don Weinberger
That’s right. Just log in your pharmacist letter, pharmacy technician’s letter, or prescriber insights account and look for the title of this podcast and list of available CE courses.
00:01:08 Steve Small
And for the purposes of disclosure today, none of the speakers have anything to disclose.
00:01:13 Don Weinberger
All right, Steve.
00:01:14 Don Weinberger
Did you know that generics account for a huge share of prescriptions? It’s about 90% of those filled in the US. But patients and even some clinicians still ask whether a lower price means lower quality. And that’s an understandable question, especially when the product can look different.
00:01:34 Steve Small
Yeah, and I’ll say the language doesn’t help either here. We have traditional generics, authorized generics, brand drugs, biosimilars, therapeutic equivalents, bioequivalents. That’s enough vocab to make anyone’s head spin.
00:01:47 Don Weinberger
Mine’s definitely spinning, not from the coffee I had earlier anyway. So today we’ll separate 3 different issues. What FDA requires before approval, what happens when a pharmacy changes manufacturers, and what differences may matter for the individual patient.
00:02:02 Don Weinberger
So should we review the claims we’ll be covering?
00:02:06 Steve Small
You betcha. We’ll talk about whether generics are held to lower quality or approval standards than branded drugs,
00:02:12 Steve Small
decode authorized generics and if they’re truly the same product as the brand name med,
00:02:16 Steve Small
see if switching between generic manufacturers is considered safe,
00:02:20 Steve Small
and confirm whether there’s a method to the madness when it comes to giving drugs their official generic name.
00:02:26 Don Weinberger
Those claims are very on brand for this episode.
00:02:32 Steve Small
Let’s start with the rumor hiding behind almost every generic question, if it costs less. Something must be amiss, right? So this claim is that generics have lower approval and quality standards.
00:02:46 Don Weinberger
Okay, so let’s talk about how generics are born. And it doesn’t seem to involve a magical stork.
00:02:55 Steve Small
Exactly right. And very briefly, when a brand manufacturer creates a new med, they submit something called a new drug application or an NDA to the FDA after completing, obviously, clinical trials to prove the drug’s safety and effectiveness, which we’re all used to, right?
00:03:10 Steve Small
Now, generic manufacturers can submit an abbreviated new drug application or ANDA to market their drug after the brand’s patent expires.
00:03:20 Steve Small
And it’s abbreviated because the generic company doesn’t need to repeat all those costly safety and effectiveness studies, although they do need to prove that the med is absorbed to the same rate and extent.
00:03:31 Don Weinberger
Well, lucky them.
00:03:33 Steve Small
Yeah, they get to save a few bucks. But where the misconception happens is that folks think that this means the company also gets to skip over FDA requirements on things like quality manufacturing. And those high standards are still the same here.
00:03:48 Don Weinberger
Yep, but patients may be worried about recent news reports showing that independent labs have found some quality issues, usually generic pills dissolving faster or slower than intended in test tubes.
00:04:02 Steve Small
Right, those reports have come up recently, but I think it’s important here to keep in mind that there isn’t strong evidence that these sporadic lab findings have actually led to therapeutic issues or patient harm.
00:04:14 Steve Small
It’s important to acknowledge that FDA had to postpone many inspections of foreign generic manufacturers early on in the COVID-19 pandemic, and the agency has been short-staffed.
00:04:25 Steve Small
So it is trying to keep up with the backlog of inspections and testing.
00:04:30 Don Weinberger
Yeah, good points. But this doesn’t mean generic drugs are approved under a lower quality standard than brand drugs. Quality issues and recalls deserve attention, whether the label has a famous name or not.
00:04:43 Steve Small
Right, I absolutely agree. So when it comes to this claim that generics have lower quality and approval standards, the verdict is.
00:04:54 Steve Small
Rumor.
00:04:55 Steve Small
So dispel the assumption that generic automatically means inferior here. Useful counseling, one I use is that brand name meds are more expensive because they’re higher quality.
00:05:06 Steve Small
They’re often costing more because the brand manufacturers are covering the costs of research and clinical trials, not to mention advertising, right?
00:05:14 Don Weinberger
Yep, And that they still hold generic meds to high quality standards, when they’re reviewed for approval.
00:05:20 Don Weinberger
Even though generic manufacturers don’t need to run clinical trials, they still must prove their product is pure with safe ingredients and is absorbed to the similar extent as the brand drug.
00:05:30 Steve Small
Yeah, but it is a fact that quality issues occur for both generic and brand drugs alike. So if you or a patient suspects a quality problem with any med, report it ASAP to FDA.
00:05:41 Don Weinberger
And we included a link to FDA’s reporting website in the show notes.
00:05:45 Don Weinberger
Plus we included a link to FDA’s enforcement report webpage where you can sign up for the mailing list to get updates and alerts on product issues if they do occur.
00:05:54 Steve Small
Yeah, I’ll try to sign up today and take our overview of generic substitution CE course to refresh your knowledge around generic drug approvals, marketing, and more.
00:06:04 Don Weinberger
So our next claim sounds almost too simple, you know, which means the terminology is about to make it complicated. And the claim is authorized generics are the same product as the brand drug.
00:06:18 Steve Small
As if typical generics weren’t confusing enough. And this terminology makes other generics almost sound unauthorized.
00:06:26 Don Weinberger
Yeah, tricky choice of words there. So FDA defines an authorized generic as an approved brand name drug marketed without the brand name on its label.
00:06:36 Don Weinberger
These are usually produced by the same brand name drug company or a different company given a license to manufacture the brand drug.
00:06:44 Steve Small
So it’s almost like the brand name drug in disguise.
00:06:49 Don Weinberger
Or more like a brand drug in a typical suit instead of a flashy tuxedo. Another way to think about it. It’s like taking a brand name cereal at a supermarket and repackaging it into a store brand box. Same exact brand product, try to generic label and usually a lower cost.
00:07:06 Steve Small
Now that makes sense. And frankly, now I’m hankering for some cereal, Don.
00:07:10 Steve Small
But it is important to point out that authorized generics generally contain the same active and inactive ingredients as the brand product based on the NDA we talked about. Although sometimes the color or markings can differ.
00:07:24 Don Weinberger
Correct. And traditional generics can have different inactive ingredients like things like binders and fillers and dyes.
00:07:31 Don Weinberger
And going back to what you said about NDAs from the legal side, authorized generics are sold under the brand products existing NDA, not a separate ANDA like we talked about with traditional generics.
00:07:43 Steve Small
Good point. Very interesting. So then this means that authorized generics won’t be listed in FDA’s orange book with ANDA approved therapeutic equivalents, although FDA does maintain a separate list of authorized generics on their own.
00:07:56 Don Weinberger
Yep, you got it. And you will find these authorized generics listed there. Despite this, most states allow dispensing authorized generics for the brand name med, but pharmacy computer systems may not automatically substitute them. So staff may need to configure those manually.
00:08:13 Steve Small
And I’ll admit, Don, we don’t really encounter this issue very much on the hospital side where I practice. So when might authorized generics be useful here? Like what’s their niche when you see them in community practice?
00:08:24 Don Weinberger
Well, they could be useful if a patient has done well on a brand name product, but you know, cost or coverage become a barrier like they sometimes do, right?
00:08:34 Don Weinberger
Authorized generic may offer the same formulation under a different label, although availability and price do vary. So, for example, the inhaler Incruse Ellipta, generic umeclidinium, is marketed by GlaxoSmithKline, but its authorized generic is marketed by Prasco Laboratories.
00:08:54 Steve Small
Good difference to note there. In rarer cases, I suppose it could also be helpful If a patient maybe has a sensitivity to an inactive ingredient in a traditional generic, I guess pharmacists could check if the authorized generic has different inactive ingredients that the patient could tolerate.
00:09:09 Don Weinberger
Correct. So if a generic has, which has maybe has a yellow dye to it, and originally yellow dye, that could be a problem, right? So going back to that claim, authorized generics are the same product as the brand name. The verdict is true.
00:09:29 Steve Small
So the practical pearl here is to distinguish authorized generic from FDA approved traditional generic. So both can be appropriate, but they reach the market through different pathways.
00:09:41 Don Weinberger
And they may provide various options for patients on lower cost compared to the brand product. So bookmark our anticipated availability of first time generics chart to see when options including authorized generics are expected.
00:09:54 Steve Small
Very handy chart. And take a look at the show notes or description. We’ve provided links to that resource along with the FDA reporting website and more.
00:10:01 Don Weinberger
And if you’re not a subscriber, shame on you. But do not miss out on our related resources in pharmacist letter, pharmacy technician’s letter, and prescriber insights. It’s time today to stay ahead with trusted insights and tools.
00:10:13 Steve Small
Now, in this age of drug shortages, I’m sure most pharmacy staff had needed to switch a patient from one manufacturer to another for a generic med.
00:10:22 Steve Small
And some patients understandably have questions about this. So the next claim is switching between generics is safe.
00:10:29 Don Weinberger
So this is an interesting take. For years, discussion has mostly been about whether it’s safe to change from a brand to generic, but the conversation may be less so from generic to generic.
00:10:41 Steve Small
Very true. So for a generic to be approved, it needs to be proven to be bioequivalent to the brand drug. So essentially, it has to have the same rate and extent of absorption. So a good way to picture this is the branded absorption like the center of a bullseye on a dartboard.
00:10:57 Don Weinberger
Brand name darts. I like this analogy already and I get it. FDA doesn’t require.
00:11:03 Don Weinberger
Every generic manufacturer to hit their exact bullseye requires each one’s dart to land somewhere in the accepted ring around it.
00:11:11 Don Weinberger
So that’s roughly 80 to 125% of the brand’s absorption. Maybe our producer could put up a dart board for a visual on that.
00:11:17 Steve Small
But there are nuances and sadly a lot of statistics. So we better hit the big nerd alert button here, Don.
00:11:29 Don Weinberger
Hopefully this is still understandable for those of us who aren’t math lovers.
00:11:34 Steve Small
And we’ve got more analogies that can help. So when a company tests their generic, right, they don’t just get one dart throw.
00:11:41 Steve Small
They run the study in a group of volunteers and measure absorption in each person. So that gives them a whole spread of results.
00:11:48 Don Weinberger
Right, because people absorb drugs a little differently.
00:11:51 Steve Small
Exactly. So statisticians take that spread, calculate the geometric mean, a sort of average, compare that as a ratio to the brand drug, and then calculate a 90% confidence interval.
00:12:05 Don Weinberger
And if you’re not confident in what that means, it simply means if you’re theoretically repeated the study 100 times, 90 of those calculated averages would land on the true number.
00:12:18 Steve Small
And it’s less about here’s the exact number and more here’s the range where the real average almost certainly lives if we look at a large group of patients.
00:12:27 Don Weinberger
Right. So FDA doesn’t look at one perfect dart throw. They’re looking more about how consistently the darts land in the same general area, run after run.
00:12:38 Steve Small
And if the average rate and extent of absorption of a generic is the dart, statistically 90 out of 100 dart throws should be within that ring that we said represents the 80 to 125% of the brand drugs absorption.
00:12:52 Don Weinberger
Yeah, putting our producer to work today with these visuals.
00:12:55 Don Weinberger
And that range sounds broad, but studies show that absorption with generics generally falls very close to the brand, usually around 4%.
00:13:06 Don Weinberger
Okay, nerd alert survived. But now we can see how generics are deemed bioequivalent to brand drugs.
00:13:14 Steve Small
Nobody ever measures whether generic A’s dart and generic B’s dart are close together.
00:13:20 Don Weinberger
Yeah, that’s true. So one could land near the top of the ring and another near the bottom.
00:13:25 Don Weinberger
But both pass.
00:13:27 Steve Small
Right. And one example I found is with bupropion or brand name Wellbutrin, an antidepressant.
00:13:32 Steve Small
A 2019 study looked at bioequivalence of three different generics versus Wellbutrin at a 300 milligram dose. And compared to the brand drug generic A’s, bioequivalence range from 98 to 108%, 92 to 101% for generic B, and 98 to 107% for generic C.
00:13:53 Don Weinberger
Yeah, that’s quite the range. But they’re all within the 80 to 125% range to be considered bioequivalent. But you can, you saw the variation there leading to this generic drift concern when switching. But what can we do about this variation to practice and does it matter?
00:14:13 Steve Small
Yeah, to help us explain that, I reached out to Doug Hoey, CEO of NCPA, the National Community Pharmacists Association. Let’s see what he has to say.
00:14:26 Steve Small
Welcome to the program, Doug, and we’re so glad we could get your community perspective to help us answer this claim. Switching between generics is safe.
00:14:34 Steve Small
So really to jump in here, what are your initial thoughts? Is this generally safe to do from your perspective?
00:14:40 Doug Hoey
First, thanks for the invitation to be on the show.
00:14:42 Doug Hoey
And yes, generally speaking, it is safe to switch from a brand name to a generic product.
00:14:49 Doug Hoey
There are always exceptions to that. As we know, not every patient is the same, not every situation is the same, but most of the time, yes, it is safe to make that switch.
00:15:00 Steve Small
And how about going from then generics to generics? Does that change the equation at all?
00:15:05 Steve Small
Because we’ve heard about the brand to generic question a long time, but now it seems like this is popping up generic to generic since we know that generics aren’t necessarily compared to each other.
00:15:15 Doug Hoey
Yes, it gets more complicated generic to generic. I mean, the answer is still yes, that it is generally safe to switch from one generic to another.
00:15:24 Doug Hoey
However, often the physical appearance of the one generic product to another can be alarming, for patients. And I think all of us in practice have experienced that at one time or another where a patient says, this medication is blue and it was white. It can’t be the same.
00:15:46 Doug Hoey
And the pharmacist, of course, we go out there and explain that it is the same active ingredients and it’s the same medication to reassure them.
00:15:54 Doug Hoey
But it’s actually good to have patients queued up to notice things like that because as pharmacists, we’re not perfect and errors can happen.
00:16:03 Doug Hoey
So to have a patient call out that a drug, a medication looks different is a good thing. When a generic goes to a generic, though, the active ingredients are the same, but some of the other ingredients can be different.
00:16:22 Steve Small
Yeah, that’s a very good point. And I guess some audience members might also be asking, well, does this change with narrow therapeutic index meds, things like anti-seizure meds, immunosuppressants, levothyroxine, you know, for thyroid disorders?
00:16:35 Steve Small
We know these are critical meds with narrow, safe dosing ranges. So would you say small absorption differences matter a whole bunch here?
00:16:43 Doug Hoey
They can. So for an NTI, I definitely would take even more caution and avoid switching those if possible.
00:16:54 Doug Hoey
Once a patient has been stabilized on a narrow therapeutic index drug, we don’t like to change those unless we have to. But a lot of times, especially these days, that’s not in the pharmacist’s hands.
00:17:07 Doug Hoey
The supplier that their health system, their pharmacy, their buying group, their chain uses sometimes is going to change that generic product and the pharmacist does not always have as much ability to say, no, I don’t want to change from the blue to the white pill, even though I as the pharmacist know they’re the same.
00:17:28 Doug Hoey
But especially with narrow therapeutic index drugs. So with those, there’s an extra layer of caution and diligence that goes into talking with the patient, listening to the patient.
00:17:41 Doug Hoey
If they see something, if it’s required, like it’s just unavoidable to switch from one generic to another with an NTI, then monitoring that patient, telling the patient, advising the patient to let their primary care provider know so that they can be on the lookout when they’re doing blood levels and see any changes there.
00:18:04 Doug Hoey
So yeah, the NTI drugs, definitely a higher level of care to go into those drugs for sure.
00:18:13 Steve Small
That’s great. So in general, for most meds, generic to generic? probably very fine to do.
00:18:18 Steve Small
When it comes to narrow therapeutic index meds, have more vigilance, come up with a monitoring plan, and of course, talk with the patient so everyone knows what’s going on.
00:18:27 Steve Small
I think that’s fantastic. Any other takeaway messages you can think that pharmacy staff should think about when it comes to switching meds or generics?
00:18:35 Doug Hoey
Well, on those generic to generic switches, we mentioned that the active ingredients are the same, but the inactive ingredients can be different.
00:18:44 Doug Hoey
And so the likelihood of a patient experiencing having a different effect from a generic to a generic switch is probably greater, is more likely a reaction if there is a difference, which most of the time there won’t be, but if there is, it’s probably more likely a reaction to one of those inactive ingredients than it is to the variability between the active ingredient.
00:19:08 Doug Hoey
The active ingredient from generic to generic, good chance that’s going to be within a small margin of being the same or being bioequivalent.
00:19:17 Doug Hoey
For the inactive ingredients, though, there can be differences. And as we know, we’ve seen one patient, we’ve seen one patient.
00:19:25 Doug Hoey
So the patient may react or respond differently to some of those inactive ingredients.
00:19:31 Doug Hoey
I know we’ve seen this at the counter where the patient comes in, you know it’s atorvastatin, 20 milligrams going from one generic to another. You know it’s the same.
00:19:42 Doug Hoey
They’re saying it’s not working the same. I think one thing as pharmacists, we go, this is psychosomatic. There’s really nothing here.
00:19:51 Doug Hoey
I think listening to that patient, because maybe there is something, maybe it is a reaction to one of the inactive ingredients that’s causing a different response.
00:20:01 Doug Hoey
So it’s a trust that verify with a generic to generic switch and thinking about those inactive ingredients and then even helping the patient track down what’s in, what are the inactive ingredients.
00:20:13 Doug Hoey
So if they know they have an allergy to a certain dye or filler, they can check out the package insert or you can maybe help them with that and see if that’s something that they happen to be sensitive to.
00:20:25 Steve Small
Great points. It’s a great opportunity to dig deeper if those conversations occur.
00:20:29 Steve Small
Love that. And I’m really looking forward to sharing this with Don.
00:20:32 Steve Small
And thank you so much for providing your insight on this interesting question about generic to generic switches.
00:20:36 Steve Small
Thank you so much.
00:20:37 Doug Hoey
For sure. Thanks so much.
00:20:41 Don Weinberger
Wow. Really good interview.
00:20:43 Don Weinberger
And you really hit the mark there and cleared some things up.
00:20:47 Don Weinberger
So in general, generic to generic switches shouldn’t make a clinically significant difference in most cases, despite slight variation.
00:20:56 Don Weinberger
And that was a good point about considering inactive ingredients differences if patients report an intolerance or side effect after a switch.
00:21:04 Steve Small
Right, something to watch for.
00:21:05 Steve Small
And to Doug’s points on narrow therapeutic index drugs, switching when necessary should still be seen as a safe option, but this may deserve extra care to maintain safety, right?
00:21:15 Steve Small
So small absorption differences could matter more with drugs such as warfarin, tacrolimus, and anti-seizure meds, but that doesn’t mean it’s unsafe to switch.
00:21:23 Steve Small
So when it comes to this claim that switching between generics is safe, the verdict is true.
00:21:35 Don Weinberger
So in general, a generic manufacturer switch is not expected to change safety or effectiveness.
00:21:41 Steve Small
I agree. Whenever there is a switch, it’s good practice to use extra communication.
00:21:45 Steve Small
Let the patient know so they aren’t caught off guard, right?
00:21:48 Steve Small
And we also almost consider this to be a true with conditions verdict because you can expect patients to be monitored closer when switching narrow therapeutic index drugs like we talked about.
00:21:59 Steve Small
But the meds are still safe nonetheless, hence true.
00:22:04 Don Weinberger
And reassure patients that changes effect are unlikely, but tell them to alert you if they feel they have a different response, new side effects, things like that.
00:22:15 Steve Small
Great points. And now everyone’s favorite segment, fast facts.
00:22:25 Don Weinberger
So this is where we jump into common bite-sized claims about generic medications and give them a seal of approval or debunk them quickly.
00:22:32 Steve Small
So here we go. First claim, generics have a higher risk for side effects.
00:22:35 Steve Small
And the verdict here is rumor with conditions.
00:22:39 Don Weinberger
So FDA approved generics are expected to have the same safety profile as reference drug.
00:22:44 Don Weinberger
Evidence doesn’t show that generics as a category cause more adverse effects.
00:22:48 Don Weinberger
In some cases, different ingredients may matter to an individual with an allergy or intolerance.
00:22:53 Don Weinberger
So review ingredient lists carefully.
00:22:57 Don Weinberger
And the next one is, because generics look different, they can’t act the same as the brand drug.
00:23:02 Don Weinberger
The verb is, rumor.
00:23:04 Steve Small
Nice.
00:23:05 Steve Small
Color, shape, markings, and packaging can differ with generics, but the active ingredient is still the same.
00:23:11 Steve Small
Stress that appearance differences doesn’t change the clinical action of the med, but keep in mind that colors of meds can change our perceptions of how meds work.
00:23:19 Steve Small
For example, blue meds are often perceived subconsciously as having a sedative or a calming effect.
00:23:24 Steve Small
So check out our color-coded episode from May 2025 where we talk more about this very interesting phenomenon.
00:23:31 Don Weinberger
Blast from the past, Steve.
00:23:33 Steve Small
Yes, and our last fast fact claim, biosimilars are the same as generic drugs.
00:23:37 Steve Small
And the very key is rumor with conditions.
00:23:41 Don Weinberger
So conventional generics are copies of relatively small, chemically synthesized molecules.
00:23:47 Don Weinberger
But biologic meds such as rituximab or infliximab are highly complex molecules made in living cells.
00:23:53 Don Weinberger
So when non-brand versions can’t truly be identical copies in the traditional generic sense, where generic med active ingredients do need to be identical to be approved by the FDA, hence why we use the name biosimilar instead.
00:24:08 Steve Small
We know these semantics can get confusing.
00:24:10 Steve Small
So for a deeper dive, check out our linked facts about biosimilars resource and the October 2025 Biosimilars in Action episode from our sister CE podcast, Medication Talk.
00:24:27 Don Weinberger
Yeah, so that was fun.
00:24:29 Don Weinberger
Three claims I honestly hear quite often.
00:24:32 Don Weinberger
Moving on to our next claim that we hear, especially from patients.
00:24:37 Don Weinberger
And it’s a shout out to everyone who has stared at drug names like hydrochlorothiazide, and maybe thought a cat walked across the keyboard.
00:24:46 Don Weinberger
And that claim is generic drug names are just made-up.
00:24:51 Steve Small
And this claim, Don, makes me think, wasn’t it Shakespeare who asked what’s in a name?
00:24:57 Don Weinberger
Yeah, but thankfully he’s not the one coming up with these med names.
00:25:01 Don Weinberger
They’re even harder to read.
00:25:03 Don Weinberger
We know generic names, they’re invented words pretty much.
00:25:07 Don Weinberger
But they’re not random as some folks may think.
00:25:10 Don Weinberger
So in the US, United States Adopted Names Program, or USAN, works with FDA International Naming System to assign standardized non-proprietary names.
00:25:21 Steve Small
And don’t worry, there is a system to it all.
00:25:23 Steve Small
So many names contained a shared stem that signals something like a drug class, a structure, or a mechanism.
00:25:29 Steve Small
So once clinicians know the stems to these names, I feel like a complicated name starts carrying very useful information.
00:25:36 Don Weinberger
Right. So. Think of one.
00:25:38 Don Weinberger
Take febuxostat, right?
00:25:40 Don Weinberger
The gout medication.
00:25:42 Don Weinberger
So the stat suffix per USAN signifies that’s an enzyme inhibitor.
00:25:46 Don Weinberger
And the XO means it inhibits xanthine oxidase, which relates to XO.
00:25:51 Don Weinberger
Pretty creative, right?
00:25:53 Steve Small
Nice. But what about the FEBU part? What does that mean?
00:25:56 Don Weinberger
I’m going to make you sad. It’s meaningless in this case.
00:25:59 Don Weinberger
So many generic name prefixes are chosen primarily to create distinctive pronounceable name, although some may reference a chemical feature of the drug.
00:26:09 Don Weinberger
For instance, the PROP in propranolol references the propyl group in the drug molecule, while the OLOL signifies it as a beta blocker.
00:26:18 Steve Small
And I assume when generic names are proposed by USAN or proposed to USAN that they screen them to reduce confusion with existing drug names, since we know lookalike and soundalike risks do matter.
00:26:30 Don Weinberger
All right, and because the clever name is not really all that clever if it increases medication errors.
00:26:36 Don Weinberger
So as much as 25% of reported medication errors are due to look-alike sound-alike drug name confusion.
00:26:43 Don Weinberger
So classic one we’re all familiar with and some may have messed up with, me maybe included, is hydroxyzine and hydralazine.
00:26:51 Don Weinberger
That still plagues the pharmacy world even today.
00:26:54 Don Weinberger
And the naming process also tries to harmonize names internationally through the World Health Organization’s international non-proprietary name system.
00:27:02 Don Weinberger
Got that all out.
00:27:03 Don Weinberger
So US international names are often aligned, although differences can occur, you know, such as acetaminophen in US and paracetamol in other countries.
00:27:13 Don Weinberger
So going back to that claim, which is generic drug names are just made-up, the verdict is.
00:27:24 Don Weinberger
Rumor.
00:27:26 Steve Small
So if a generic name sounds like a bag of Scrabble tiles, look at the middle and the ending.
00:27:31 Steve Small
Those parts may tell you more than the brand name ever did.
00:27:35 Don Weinberger
So rest assured that the names are constructed, screened, and standardized.
00:27:39 Don Weinberger
Learning common stems can improve drug recognition and make unfamiliar names less intimidating.
00:27:45 Don Weinberger
But one caution, stems are clues and not a substitute for verifying the complete name, strength, and formulation.
00:27:52 Steve Small
Great call out, Don.
00:27:53 Steve Small
And I had a little fun with AI on this.
00:27:55 Steve Small
I asked AI, summarize this podcast episode as a generic drug name.
00:28:01 Don Weinberger
Oh, dear. Should I be worried of what it said?
00:28:06 Steve Small
Well, actually, I’m surprised. It had some hilarious options.
00:28:08 Steve Small
My favorite was “brandnolol.”
00:28:11 Steve Small
So brand, no, since we’re talking about generics, not brands.
00:28:15 Steve Small
And LOL for laugh out loud, because quote from AI of our humor.
00:28:21 Steve Small
Another one was “rumorvastatin,” since we inhibit generic myths and reduce brand name drama per AI.
00:28:28 Don Weinberger
You know, I would love to change our show to that, but our producer probably would have something to say about it.
00:28:32 Don Weinberger
And I do like those. And also, USAN probably wouldn’t approve those as well.
00:28:37 Steve Small
Wait till you’re the worst one, Don. Get this, “labelcheckumab.”
00:28:44 Don Weinberger
AI for the win or loss, I don’t know there.
00:28:46 Don Weinberger
That one’s a little on the nose.
00:28:48 Steve Small
I agree. And here’s something else we can agree on. The bottom line truth for today’s episode.
00:28:53 Steve Small
FDA approved generics meet rigorous quality requirements and product specific differences call for gathering facts to make clinical decisions, not knee jerk assumptions here.
00:29:03 Don Weinberger
Yeah. So the broad truth is that generic is a regulatory category, not a synonym for cheap quality.
00:29:10 Don Weinberger
Approved generics must match key pharmaceutical characteristics, demonstrate bioequivalence and meet manufacturing standards.
00:29:17 Steve Small
And their known benefits such as lower costs and ability to continue therapy outweigh many of these theoretical concerns we talked about.
00:29:24 Steve Small
So when a product changes for a patient, know that most switches are safe, while selected drugs in patients may deserve closer monitoring.
00:29:31 Steve Small
It’s the same science, just less brand name trauma.
00:29:35 Don Weinberger
So that we’ve given generics a proper label check, claim CE credit and access evidence-based resources from pharmacist’s letter, pharmacy indications letter, or prescriber insights.
00:29:45 Steve Small
And if you’re not yet a subscriber or want to upgrade, you can save 10% with our exclusive listener code, RVT1026 at checkout.
00:29:53 Steve Small
There’s a nice link in the show notes.
00:29:56 Don Weinberger
And if you’re a subscriber, good on you.
00:29:58 Don Weinberger
Tap that claim credit link in the show notes or search your CE organizer for this episode.
00:30:03 Steve Small
And if you have a generic medication question or a good pill switch story, send us a message.
00:30:08 Don Weinberger
Or e-mail us at [email protected] or use send us fan mail in the podcast show notes.
00:30:15 Don Weinberger
We use your suggestions and feedback to plan future episodes.
00:30:19 Steve Small
And join us next time where we’ll tackle one of our most controversial topics yet, vaccines.
00:30:25 Don Weinberger
Okay, well that one will be interesting. We will give that one a shot.
00:30:30 Don Weinberger
So many claims, so little time, right?
00:30:33 Don Weinberger
But we forewarned friends. The discussion will be a serious one.
00:30:38 Don Weinberger
So we’ll be more focused on the evidence and less so on those puns.
00:30:43 Don Weinberger
Thank you for joining us for Rumor vs Truth, your trusted source for facts where we dissect the evidence, behind risky rumors, and reveal clinical truths.
00:30:50 Steve Small
We’ll see you next time.
Rumor vs Truth
