WEBVTT 00:00:00.000 --> 00:00:01.379 You ever get that prescription right and you 00:00:01.379 --> 00:00:04.139 see that big old folded up paper? And it's easy 00:00:04.139 --> 00:00:07.480 to think like, okay, that's it, right? Like science 00:00:07.480 --> 00:00:09.859 is done, they figured it out. It's a common thought 00:00:09.859 --> 00:00:13.000 for sure, but it's a lot more complicated than 00:00:13.000 --> 00:00:15.900 that. Yeah, so that's what we're gonna dive into 00:00:15.900 --> 00:00:18.199 today, right? We're gonna look at how those drug 00:00:18.199 --> 00:00:21.679 labels, those drug labels can change, even after 00:00:21.679 --> 00:00:24.690 the FDA gives it the green light. Yep. And we've 00:00:24.690 --> 00:00:26.870 got some really cool stuff to look at today. 00:00:27.410 --> 00:00:30.670 We've got, you know, guides on how a drug is 00:00:30.670 --> 00:00:33.450 developed from its very beginnings and then all 00:00:33.450 --> 00:00:35.329 the way through, like, how it works in your body. 00:00:35.509 --> 00:00:37.750 Ah, the pharmacokinetic stuff. Yeah, all the 00:00:37.750 --> 00:00:40.310 pharmacokinetics, the clinical trials, and all 00:00:40.310 --> 00:00:42.210 the regulations. And so basically, the whole 00:00:42.210 --> 00:00:45.530 shebang. The whole nine yards. Our mission today 00:00:45.530 --> 00:00:50.810 is to figure out why those drug labels, which 00:00:50.810 --> 00:00:53.829 seem so simple, aren't set in stone. Right. They 00:00:53.829 --> 00:00:56.990 can change. They're not just like carved, you 00:00:56.990 --> 00:00:59.170 know? Right. And how do we keep making sure that 00:00:59.170 --> 00:01:01.350 all the meds out there are safe and effective? 00:01:01.429 --> 00:01:04.269 Right. OK, so let's get into it. So what's the 00:01:04.269 --> 00:01:06.530 first thing that could make them change a label? 00:01:07.790 --> 00:01:09.590 After a drug is already out there, like people 00:01:09.590 --> 00:01:12.709 are taking it. Well, the initial approval is. 00:01:13.360 --> 00:01:15.459 It's a huge deal, it's based on a lot of data, 00:01:15.560 --> 00:01:18.200 mostly from those clinical trials. But the thing 00:01:18.200 --> 00:01:20.739 is, those trials are really controlled. They 00:01:20.739 --> 00:01:23.359 use a specific number of patients, and they go 00:01:23.359 --> 00:01:25.500 for a certain amount of time. Right, so kind 00:01:25.500 --> 00:01:28.079 of limited. Very limited, right. So then, when 00:01:28.079 --> 00:01:31.319 the drug's actually out there, it's used by so 00:01:31.319 --> 00:01:33.319 many more people, people with all sorts of different 00:01:33.319 --> 00:01:35.340 health problems. Yeah, all sorts of different 00:01:35.340 --> 00:01:37.840 lifestyles. Lifestyles, everything. And that's 00:01:37.840 --> 00:01:41.000 when sometimes new info pops up. Makes sense, 00:01:41.079 --> 00:01:42.659 right? It's kind of like testing a new phone 00:01:42.659 --> 00:01:46.159 in a lab versus, you know, like using it out 00:01:46.159 --> 00:01:48.599 in the world. Oh, yeah, for sure. Like when it's 00:01:48.599 --> 00:01:50.239 raining, you're juggling groceries, that kind 00:01:50.239 --> 00:01:52.859 of thing. Exactly. So it sounds like, you know, 00:01:53.120 --> 00:01:55.819 that initial approval. It's not the end of this 00:01:55.819 --> 00:01:58.260 story at all. It's really just the beginning. 00:01:59.439 --> 00:02:02.939 OK, cool. So this new information, like what 00:02:02.939 --> 00:02:06.019 exactly can it reveal? What are we talking about 00:02:06.019 --> 00:02:08.800 here? All sorts of things. You know, sometimes 00:02:08.800 --> 00:02:11.460 side effects. like brand new side effects that 00:02:11.460 --> 00:02:14.639 nobody saw in the trials, or maybe side effects 00:02:14.639 --> 00:02:16.800 that were already known, but now they're happening 00:02:16.800 --> 00:02:19.000 way more often than they did in the trials. Or 00:02:19.000 --> 00:02:20.960 maybe they're way worse. Or they're more severe, 00:02:21.340 --> 00:02:25.419 exactly. And any of that can lead to an update 00:02:25.419 --> 00:02:28.599 to that jug label. So when we say update, what 00:02:28.599 --> 00:02:30.599 kind of update are we talking about? Is it just 00:02:30.599 --> 00:02:32.580 changing a word or two, or is it more than that? 00:02:32.620 --> 00:02:36.150 Oh, it's way more than that. one major one is 00:02:36.150 --> 00:02:39.550 safety updates. Like, if there's new data about 00:02:39.550 --> 00:02:41.750 some serious risk or, you know, like we said, 00:02:41.849 --> 00:02:43.590 if side effects are happening more often or they're 00:02:43.590 --> 00:02:45.629 getting worse, that's gonna go right on the label. 00:02:45.810 --> 00:02:48.229 Yeah, you definitely want doctors and patients 00:02:48.229 --> 00:02:51.069 to know about that stuff. Absolutely. Then there's 00:02:51.069 --> 00:02:53.930 what we call new indications. Okay. So that's 00:02:53.930 --> 00:02:56.409 when, you know, more trials are done. And it 00:02:56.409 --> 00:02:58.930 turns out, hey, this drug is also good for something 00:02:58.930 --> 00:03:01.469 else. Something that it wasn't originally... 00:03:01.289 --> 00:03:04.610 approved for. Oh, that's cool. So, you know, 00:03:04.629 --> 00:03:07.409 maybe a drug that was approved for, I don't know, 00:03:07.449 --> 00:03:09.430 like high blood pressure. Right. Ended up helping 00:03:09.430 --> 00:03:13.150 with migraines, too. Exactly. And then there's 00:03:13.150 --> 00:03:15.449 black box warnings. Black box warnings. That 00:03:15.449 --> 00:03:18.770 sounds serious. Those are the big ones. Yeah. 00:03:18.810 --> 00:03:21.310 Those are the most serious warning the FDA can 00:03:21.310 --> 00:03:23.830 give. Wow. They mean there's a chance, you know, 00:03:23.830 --> 00:03:26.289 of a life threatening risk or a really, really 00:03:26.289 --> 00:03:29.069 bad side effect. And you'll see it right on the 00:03:29.069 --> 00:03:30.849 label. It's in a black box. You can't miss it. 00:03:30.969 --> 00:03:33.310 Yeah, I guess that gets your attention. It definitely 00:03:33.310 --> 00:03:36.530 does, both for doctors and for patients. That's 00:03:36.530 --> 00:03:38.270 a little scary to think about that, you know, 00:03:38.270 --> 00:03:41.830 even after a drug is approved, there could still 00:03:41.830 --> 00:03:44.449 be something that serious. Yeah, it's definitely, 00:03:44.469 --> 00:03:46.689 you know, it's something to consider. It makes 00:03:46.689 --> 00:03:48.389 you wonder, like, what does it take for them 00:03:48.389 --> 00:03:51.409 to issue one of those warnings? I mean, the evidence 00:03:51.409 --> 00:03:53.849 must be pretty strong, right? It has to be very 00:03:53.849 --> 00:03:56.789 strong because it means, you know, that for some 00:03:56.789 --> 00:04:00.569 patients, the risk might be bigger than the benefit. 00:04:00.750 --> 00:04:04.250 Okay, that makes sense. So all of this, this 00:04:04.250 --> 00:04:06.210 is part of what they call post -market surveillance, 00:04:06.370 --> 00:04:08.330 right? Exactly. So it's not like the FDA says 00:04:08.330 --> 00:04:11.469 approved and that's the end of it. Nope. They're 00:04:11.469 --> 00:04:13.789 still watching even after it's on the market. 00:04:13.870 --> 00:04:16.009 It's like an ongoing investigation. That's pretty 00:04:16.009 --> 00:04:18.089 reassuring, actually. And they get info from 00:04:18.089 --> 00:04:20.649 all kinds of places. So like what kind of places? 00:04:20.949 --> 00:04:23.509 Well, like healthcare professionals, they can 00:04:23.509 --> 00:04:25.910 report adverse events. Right, if they see something 00:04:25.910 --> 00:04:28.310 going wrong. Exactly, and patients can report 00:04:28.310 --> 00:04:31.269 them too. And then there are special studies 00:04:31.269 --> 00:04:33.930 specifically designed to look at the drug's safety 00:04:33.930 --> 00:04:36.689 over the long term. So they're looking at like 00:04:36.689 --> 00:04:38.790 how it works for different groups of people, 00:04:39.250 --> 00:04:42.310 maybe different doses. Yeah. How long the treatment 00:04:42.310 --> 00:04:44.250 should last. Exactly. Things that they maybe 00:04:44.250 --> 00:04:47.310 couldn't see in their shorter trials before approval. 00:04:47.649 --> 00:04:50.129 So filling in those gaps, basically. Exactly. 00:04:50.410 --> 00:04:53.990 Wow. So it's a lot of moving parts. It is. So 00:04:53.990 --> 00:04:57.230 like if my doctor, let's say, she starts noticing 00:04:57.230 --> 00:04:59.689 that a bunch of her patients who are taking the 00:04:59.689 --> 00:05:02.029 same drug, they're all having the same weird 00:05:02.029 --> 00:05:04.610 side effect that could actually trigger a review. 00:05:04.769 --> 00:05:07.829 It absolutely could. Wow. Because that real world 00:05:07.829 --> 00:05:11.250 observation is so valuable. Makes you feel like 00:05:11.250 --> 00:05:13.089 you're part of the process a little bit. You 00:05:13.089 --> 00:05:16.350 are, absolutely. Okay, so one thing that's important 00:05:16.350 --> 00:05:18.209 to understand, and you kind of touched on this 00:05:18.209 --> 00:05:24.240 before, is that when a label changes, it doesn't 00:05:24.240 --> 00:05:26.139 necessarily mean that something went wrong with 00:05:26.139 --> 00:05:28.699 the initial approval. It's more like, we're learning 00:05:28.699 --> 00:05:32.300 more as we go. It's more about, yeah, our understanding 00:05:32.300 --> 00:05:35.920 is evolving. It's good that it's not set in stone. 00:05:36.040 --> 00:05:38.160 It's a good thing. It means the system is working. 00:05:38.699 --> 00:05:41.540 It's working to keep us safe. Okay, so we know 00:05:41.540 --> 00:05:44.079 the labels can change. We know why they change. 00:05:44.560 --> 00:05:46.879 Let's talk about what the companies, the drug 00:05:46.879 --> 00:05:49.839 companies, what are they required to do after 00:05:49.839 --> 00:05:52.720 the drug is approved? to keep all this info up 00:05:52.720 --> 00:05:55.459 to date. Good question. It's not just, like, 00:05:55.519 --> 00:05:57.480 an honor system, right? Well, there's gotta be 00:05:57.480 --> 00:05:59.600 some rules. There are definitely rules. It usually 00:05:59.600 --> 00:06:02.160 comes with specific obligations. Like, what kind 00:06:02.160 --> 00:06:04.100 of obligations are we talking about? Well, we 00:06:04.100 --> 00:06:06.360 call them post -market commitments. Okay. You 00:06:06.360 --> 00:06:09.160 can think of them like conditions that come with 00:06:09.160 --> 00:06:12.259 the approval. Ah. So they have to do these things. 00:06:12.300 --> 00:06:14.459 They gotta do them. It makes sure that the company 00:06:14.459 --> 00:06:17.660 keeps gathering info, you know, after the drug 00:06:17.660 --> 00:06:19.519 is out there. Keeps an eye on things. And they 00:06:19.519 --> 00:06:21.600 gotta deal with any problems that pop up. Got 00:06:21.600 --> 00:06:23.860 it. So what are the main types of commitments? 00:06:24.019 --> 00:06:26.600 Like, what do they actually have to do? So two 00:06:26.600 --> 00:06:29.939 of the big ones are post -market studies, which 00:06:29.939 --> 00:06:32.420 are often these things called phase four clinical 00:06:32.420 --> 00:06:35.139 trials. Oh. And then there's REMS, which stands 00:06:35.139 --> 00:06:37.740 for risk evaluation and mitigation strategies. 00:06:38.399 --> 00:06:41.600 REMS -S. OK, so post -market studies, I mean, 00:06:41.740 --> 00:06:44.040 we all know about phase one, two, and three trials, 00:06:44.199 --> 00:06:45.819 right? Those are the ones before a drug is approved. 00:06:45.819 --> 00:06:47.439 Right. But what's the point of doing a study 00:06:47.439 --> 00:06:49.360 after it's already out there? Well, phase four 00:06:49.360 --> 00:06:51.740 studies, those happen after the drug is approved. 00:06:51.759 --> 00:06:54.519 OK. And they have a few really important jobs. 00:06:54.939 --> 00:06:57.399 One is they can get even more data about the 00:06:57.399 --> 00:06:59.800 drug's safety. More data. So even after all that 00:06:59.800 --> 00:07:02.980 data they collected before? Even more. Because 00:07:02.980 --> 00:07:06.079 now they can look at a much bigger group of patients, 00:07:06.180 --> 00:07:08.680 and they can look for a longer time. OK. Yeah. 00:07:08.680 --> 00:07:10.899 And they can look at more diverse patients? Exactly. 00:07:11.279 --> 00:07:13.420 Like different ages, different backgrounds, all 00:07:13.420 --> 00:07:15.519 of that. So it's about getting the full picture. 00:07:15.709 --> 00:07:18.389 Really? Exactly. And they can also see how well 00:07:18.389 --> 00:07:20.389 the drug works for different types of patients. 00:07:20.550 --> 00:07:22.470 Oh, right. Because everyone's different. Exactly. 00:07:22.810 --> 00:07:25.009 Like, maybe different doses work better for some 00:07:25.009 --> 00:07:27.829 people, or maybe the treatment should last longer 00:07:27.829 --> 00:07:29.889 for certain groups, that kind of thing. And I 00:07:29.889 --> 00:07:31.730 guess they can also look at really long -term 00:07:31.730 --> 00:07:34.370 effects. Oh, right. Effects that might not show 00:07:34.370 --> 00:07:36.730 up in those shorter trials before approval. That 00:07:36.730 --> 00:07:40.050 makes sense. So it's all about getting more details, 00:07:40.509 --> 00:07:43.019 filling in the gaps. So basically making sure 00:07:43.019 --> 00:07:45.560 it really works the way we think it works. That's 00:07:45.560 --> 00:07:49.279 it. And these studies, sometimes the FDA requires 00:07:49.279 --> 00:07:52.259 them as part of the approval. Ah, so they're 00:07:52.259 --> 00:07:55.680 not optional. Sometimes not. But sometimes companies 00:07:55.680 --> 00:07:58.000 do them voluntarily, too. OK, why would they 00:07:58.000 --> 00:07:59.980 do that if they don't have to? Well, you know, 00:08:00.000 --> 00:08:02.360 they want to learn more about their drug. Maybe 00:08:02.360 --> 00:08:04.839 find new ways to use it. New uses, that's interesting. 00:08:05.139 --> 00:08:07.160 Yeah, could be good for business, too. So it's 00:08:07.160 --> 00:08:09.519 a win -win. They get more info. And maybe they 00:08:09.519 --> 00:08:12.500 can sell more of the drug. It can be. And the 00:08:12.500 --> 00:08:15.959 important thing for us is the findings from these 00:08:15.959 --> 00:08:19.139 phase four studies, those can definitely lead 00:08:19.139 --> 00:08:22.160 to more changes in the drug label. Yeah. So if 00:08:22.160 --> 00:08:24.600 they find out something new, either good or bad, 00:08:25.259 --> 00:08:26.720 they've got to update that label. They've got 00:08:26.720 --> 00:08:28.480 to update it. OK, that makes sense. Now let's 00:08:28.480 --> 00:08:30.720 talk about REMs. That sounds pretty intense. 00:08:30.939 --> 00:08:34.320 REMs are definitely designed to handle those 00:08:34.320 --> 00:08:38.460 serious risks. So this is specifically for drugs 00:08:38.460 --> 00:08:40.840 where there's like a higher chance of something 00:08:40.840 --> 00:08:44.480 bad happening. Exactly. The FDA requires them 00:08:44.480 --> 00:08:48.000 when the risks are big enough that we need to 00:08:48.000 --> 00:08:50.340 take extra steps to make sure the benefits are 00:08:50.340 --> 00:08:52.059 worth it. It's all about balancing the good with 00:08:52.059 --> 00:08:54.299 the bad, right? Exactly. So these REMS programs, 00:08:54.379 --> 00:08:56.519 remember that's R -E -M -S, they're tailored. 00:08:56.679 --> 00:08:58.679 Tailored to the specific drug. Tailored to the 00:08:58.679 --> 00:09:01.720 specific drug and its risks. And they can include 00:09:01.720 --> 00:09:04.799 all sorts of stuff like, one common thing is 00:09:04.799 --> 00:09:07.200 medication guides for patients. Oh, yeah, I've 00:09:07.200 --> 00:09:09.419 seen those. Yeah, they explain things in plain 00:09:09.419 --> 00:09:11.500 language. Right, not all that medical jargon. 00:09:11.559 --> 00:09:13.379 Exactly. They tell you about the warnings, the 00:09:13.379 --> 00:09:15.940 precautions, and how to use the medications safely. 00:09:16.240 --> 00:09:18.299 And those usually come right with the prescription, 00:09:18.399 --> 00:09:19.980 right? Right in the bag. So you get all the info 00:09:19.980 --> 00:09:22.220 right away. It's right there. That's good. RMS 00:09:22.220 --> 00:09:25.500 can also involve, like, communication plans for 00:09:25.500 --> 00:09:27.600 health care providers. So making sure the doctors 00:09:27.600 --> 00:09:30.230 and pharmacists know what's up. Exactly. know 00:09:30.230 --> 00:09:32.509 all about the risks and how to minimize them. 00:09:32.629 --> 00:09:35.830 And sometimes, it sounds like, it can even affect 00:09:35.830 --> 00:09:38.570 how the drug is distributed. That's right. For 00:09:38.570 --> 00:09:41.429 the really serious cases, there might be restricted 00:09:41.429 --> 00:09:44.309 distribution systems. What does that mean, restricted 00:09:44.309 --> 00:09:47.909 distribution? So maybe the drug can only be given 00:09:47.909 --> 00:09:51.429 out by certain pharmacies. Oh, wow. Only ones 00:09:51.429 --> 00:09:54.090 that are specially certified. OK. Or maybe it 00:09:54.090 --> 00:09:56.649 can only be prescribed under very specific conditions. 00:09:56.809 --> 00:09:58.509 So there's a lot of extra hoops to jump through. 00:09:58.679 --> 00:10:01.960 And sometimes there are even monitoring requirements. 00:10:03.279 --> 00:10:05.659 What does that mean, monitoring? So, like, the 00:10:05.659 --> 00:10:08.360 patient might need to get specific tests done. 00:10:08.399 --> 00:10:11.340 Oh, wow. While they're taking the drug. OK. You 00:10:11.340 --> 00:10:13.179 know, to make sure they're not having those bad 00:10:13.179 --> 00:10:14.940 side effects. So they're keeping a really close 00:10:14.940 --> 00:10:17.179 eye on things. Really close. It's all to make 00:10:17.179 --> 00:10:20.019 sure the drug is being used as safely as possible. 00:10:20.179 --> 00:10:22.539 Yeah, it's a balancing act for sure. It is. You 00:10:22.539 --> 00:10:24.919 want people... to be able to get them as they 00:10:24.919 --> 00:10:27.259 need, but you also don't want them to get hurt. 00:10:27.799 --> 00:10:30.519 Exactly, so all these REMs, they're really important. 00:10:30.620 --> 00:10:32.799 They sound important. Okay, so let's say a label 00:10:32.799 --> 00:10:35.679 does change, like we've been talking about. Okay. 00:10:35.820 --> 00:10:38.529 How do they get that new info out? to everyone. 00:10:38.789 --> 00:10:41.809 Right, to the doctors, the pharmacists, and most 00:10:41.809 --> 00:10:43.750 importantly, the patients. Yeah, you got to tell 00:10:43.750 --> 00:10:46.690 everyone. Communication is key. So there are 00:10:46.690 --> 00:10:49.529 a few ways they do it. One big one is these Dear 00:10:49.529 --> 00:10:52.009 Healthcare Professional letters. OK. So those 00:10:52.009 --> 00:10:54.190 are letters that go straight from the drug company 00:10:54.190 --> 00:10:57.669 to the doctors, the pharmacists, everyone who 00:10:57.669 --> 00:10:59.889 prescribes meds. So it's going right to the source, 00:10:59.970 --> 00:11:01.750 right to the people who need to know. Exactly. 00:11:01.870 --> 00:11:05.200 It tells them about any big safety updates or 00:11:05.200 --> 00:11:07.700 other important changes to the label. Makes sense, 00:11:07.720 --> 00:11:10.299 what else? Then there are those updated medication 00:11:10.299 --> 00:11:12.299 guides we talked about. The ones that come with 00:11:12.299 --> 00:11:14.620 the prescription. Right, those are key because 00:11:14.620 --> 00:11:17.360 they explain everything to the patient in simple 00:11:17.360 --> 00:11:19.419 language. So it's not just for the doctors, it's 00:11:19.419 --> 00:11:22.240 for everyone. It's for everyone. And then the 00:11:22.240 --> 00:11:24.860 FDA, they put out public announcements. Public 00:11:24.860 --> 00:11:27.919 service announcements, kinda? Kinda, yeah. They 00:11:27.919 --> 00:11:31.419 let everyone know about any important... Drug 00:11:31.419 --> 00:11:34.120 safety info so they might put it on their website 00:11:34.120 --> 00:11:37.259 or like send out a press release Exactly, and 00:11:37.259 --> 00:11:39.879 that reaches a much wider audience. It does and 00:11:39.879 --> 00:11:42.639 then you've got professional societies You know 00:11:42.639 --> 00:11:45.759 like groups of doctors and medical organizations, 00:11:45.779 --> 00:11:47.980 right? They also tell their members about label 00:11:47.980 --> 00:11:50.539 changes So they might put it in their newsletter 00:11:50.539 --> 00:11:53.480 or talk about it at a conference. That's right. 00:11:53.580 --> 00:11:55.559 So they're really trying to get the word out 00:11:55.559 --> 00:11:57.759 in as many ways as possible. They don't want 00:11:57.759 --> 00:12:00.480 anyone to miss it. Exactly. In all this communication, 00:12:00.519 --> 00:12:03.080 it has to be really clear. Yeah, clear and simple. 00:12:03.440 --> 00:12:05.580 Right. Absolutely. It's got to be easy for everyone 00:12:05.580 --> 00:12:07.500 to understand, not just the doctors, but the 00:12:07.500 --> 00:12:09.399 patients, too. Yeah, because not everyone went 00:12:09.399 --> 00:12:11.379 to medical school. Right. Everyone needs to know 00:12:11.379 --> 00:12:14.159 what's going on. OK. So we've talked about why 00:12:14.159 --> 00:12:17.669 labels change. how they change and how they get 00:12:17.669 --> 00:12:20.649 that info out to everyone. Let's look at some 00:12:20.649 --> 00:12:22.730 real world examples. Yeah. Let's see how this 00:12:22.730 --> 00:12:26.070 works in practice. Can you think of any specific 00:12:26.070 --> 00:12:29.230 cases where there were big label changes that 00:12:29.230 --> 00:12:31.230 really show what we've been talking about? Oh, 00:12:31.389 --> 00:12:34.389 yeah. Like opioids, for example. Opioids. That's 00:12:34.389 --> 00:12:38.090 a big one. It is, and, you know, over time, we've 00:12:38.090 --> 00:12:40.850 learned a lot more about the risks of opioids. 00:12:40.970 --> 00:12:43.110 Yeah, the addiction, the overdoses, all that. 00:12:43.190 --> 00:12:45.129 All of that, and that's led to a lot of changes 00:12:45.129 --> 00:12:47.450 in the labels. Like, what kind of changes? Well, 00:12:47.490 --> 00:12:50.470 they've put much stronger warnings on the labels. 00:12:50.590 --> 00:12:52.950 Mm -hmm, to make people really aware of the risks. 00:12:53.210 --> 00:12:56.350 Exactly, and they've created RM's programs specifically 00:12:56.350 --> 00:12:58.710 for opioids. Right, to try to make sure they're 00:12:58.710 --> 00:13:01.779 being prescribed safely. And they've given doctors 00:13:01.779 --> 00:13:04.100 much more detailed guidance on how to manage 00:13:04.100 --> 00:13:06.820 patients who are taking opioids. So it's really 00:13:06.820 --> 00:13:10.080 a multi -pronged approach. It is. It has to be, 00:13:10.139 --> 00:13:13.039 because it's such a serious problem. Yeah. And 00:13:13.039 --> 00:13:15.360 we've all seen how much attention the opioid 00:13:15.360 --> 00:13:17.840 crisis has gotten. Right. It's a huge public 00:13:17.840 --> 00:13:19.879 health issue. So it makes sense that they would 00:13:19.879 --> 00:13:22.539 use drug labels as one way to try to address 00:13:22.539 --> 00:13:25.159 it. They're a key tool. What about other examples? 00:13:25.340 --> 00:13:28.059 Oh, there are plenty. Like biologics, for instance. 00:13:28.279 --> 00:13:30.000 Biologics, yeah. Those are different from regular 00:13:30.000 --> 00:13:31.919 drugs, right? They are. They're more complex. 00:13:31.980 --> 00:13:34.779 They're made from living organisms. And because 00:13:34.779 --> 00:13:36.960 they're so complex, they can sometimes trigger 00:13:36.960 --> 00:13:39.759 an immune response in the body. Oh, so your body 00:13:39.759 --> 00:13:42.220 might think it's being attacked. Kind of, yeah. 00:13:42.220 --> 00:13:44.799 We call that immunogenicity. Immunogenicity, 00:13:44.860 --> 00:13:48.120 OK. And because of that, their labels often have 00:13:48.120 --> 00:13:51.679 a lot of specific info. More than regular drug 00:13:51.679 --> 00:13:54.440 labels. More details, yeah, like how to give 00:13:54.440 --> 00:13:56.440 the drug. Like how to inject it or whatever. 00:13:56.659 --> 00:13:59.320 Exactly, and how to watch for any immune reactions. 00:13:59.440 --> 00:14:01.769 Yes, those could be serious, right? They could 00:14:01.769 --> 00:14:05.429 be. And the thing is with biologics, new safety 00:14:05.429 --> 00:14:08.190 issues can pop up even after they're approved. 00:14:08.529 --> 00:14:10.289 Oh, wow. So they have to keep updating the label. 00:14:10.350 --> 00:14:13.450 They do. And they also often find new uses for 00:14:13.450 --> 00:14:15.909 biologics. So a drug that was approved for one 00:14:15.909 --> 00:14:18.129 thing might end up being good for something else. 00:14:18.269 --> 00:14:21.269 Right. Because they're often very targeted therapies. 00:14:21.330 --> 00:14:24.769 So they're really specific to certain conditions. 00:14:25.009 --> 00:14:27.230 Exactly. That makes sense. What about other types 00:14:27.230 --> 00:14:29.610 of drugs? Well, let's talk about high risk drugs 00:14:29.610 --> 00:14:31.850 in general. High risk drugs. So these are the 00:14:31.850 --> 00:14:33.889 ones where there's a good chance of serious side 00:14:33.889 --> 00:14:36.649 effects. Exactly. Even when they're used correctly 00:14:36.649 --> 00:14:38.870 at the right dose. So they have to be really 00:14:38.870 --> 00:14:40.990 careful with those. Very careful. And their labels 00:14:40.990 --> 00:14:44.269 are usually super detailed. More so than other 00:14:44.269 --> 00:14:46.289 drugs. They have a lot of info. Yeah, they have 00:14:46.289 --> 00:14:48.470 clear warnings. They tell you when you shouldn't 00:14:48.470 --> 00:14:50.909 use the drug. When it's dangerous to use it. 00:14:51.009 --> 00:14:53.610 Right. And often they come with REMS programs 00:14:53.610 --> 00:14:56.090 too. Right. Those extra safety. All to make sure 00:14:56.090 --> 00:14:59.110 the benefits are worth the risks. So, for these 00:14:59.110 --> 00:15:02.110 high -risk drugs, the label is really important. 00:15:02.429 --> 00:15:05.049 It's crucial. It's like a roadmap for using them 00:15:05.049 --> 00:15:07.769 safely. This has been really eye -opening. I 00:15:07.769 --> 00:15:10.350 never realized how much goes on behind the scenes 00:15:10.350 --> 00:15:13.389 with these drug labels. It's more complicated 00:15:13.389 --> 00:15:15.350 than people think, for sure. Yeah, it's not just 00:15:15.350 --> 00:15:18.169 a piece of paper. It's like a living document. 00:15:18.429 --> 00:15:20.470 It keeps changing. That's a good way to put it. 00:15:20.470 --> 00:15:23.070 It evolves as we learn more. And all this work 00:15:23.070 --> 00:15:24.990 that the companies have to do, these post -market 00:15:24.990 --> 00:15:27.370 commitments, and all those ways they communicate 00:15:27.370 --> 00:15:29.850 the new information, that's all super important. 00:15:29.970 --> 00:15:32.929 It's all about keeping patients safe. Absolutely. 00:15:33.879 --> 00:15:36.539 You know, just learning about all this, it makes 00:15:36.539 --> 00:15:39.480 me feel more informed as a patient. That's the 00:15:39.480 --> 00:15:41.720 goal. It's about empowering people. Yeah, to 00:15:41.720 --> 00:15:43.899 understand what they're taking and what the risks 00:15:43.899 --> 00:15:46.460 are. Exactly. And to be able to talk to their 00:15:46.460 --> 00:15:48.860 doctors and ask good questions. So we're not 00:15:48.860 --> 00:15:51.220 just blindly following orders. Right. It's about 00:15:51.220 --> 00:15:53.240 being an active participant in your own health 00:15:53.240 --> 00:15:57.679 care. I like that. So one last thought. OK. We've 00:15:57.679 --> 00:16:00.240 seen how much we keep learning about a drug, 00:16:00.480 --> 00:16:02.669 even after it's approved. and people are taking 00:16:02.669 --> 00:16:05.769 it. What does that tell us about the whole process 00:16:05.769 --> 00:16:08.909 of scientific discovery? It tells us that science 00:16:08.909 --> 00:16:11.570 is never really finished. It's always evolving. 00:16:11.929 --> 00:16:13.870 Always evolving. We're always learning new things, 00:16:14.169 --> 00:16:16.190 especially when it comes to the human body. Right. 00:16:16.190 --> 00:16:18.330 It's so complex. It's incredibly complex. So 00:16:18.330 --> 00:16:20.610 we have to stay vigilant. We have to keep learning 00:16:20.610 --> 00:16:23.269 and adapting. Yeah. There's always more to discover. 00:16:23.509 --> 00:16:25.450 That's the beauty of it. And that's what makes 00:16:25.450 --> 00:16:27.610 medicine so exciting, right? It's never boring. 00:16:27.730 --> 00:16:28.490 That's for sure.