FDA Approves First 3D-Printed Drug Tablet 64
An anonymous reader writes: The U.S. Food and Drug Administration has for the first time approved a 3D-printed pill for human consumption. The printing technique allows higher and more precise dosages to be layered into a smaller tablet size. This is an early step toward a new method of drug distribution. Right now, pills are made in a factory and shipped to hospitals. With 3D printers, hospitals could simply store a bulk supply of the drug in a pure form, and then print out tablets — containing whatever dosage they desire — as they need them. If patients needs to increase or decrease their dosage, the hospital can do so without changing the appearance of the pills, which could help those with memory impairments.
Not going to move the needle. (Score:4, Insightful)
The technology to create bespoke pills exists already, major barriers to hospitals incorporating compounding pharmacies today include cost, regulations, and liability, none of which are addressed by this technology.
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mod up
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Yes but 3D printing. End of discussion. If you are not 100% on-board the 3D revolution, you are a Luddite.
It's sad to see the desperate grasping at straws the 3D printing fanbois have to resort to these days. 3D printing is a solidly entrenched hobby. No great social upheaval has happened because of it.
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I remember my boss saying something similar about micro computers in 1980. Probably something similar was said about electricity once or twice, too.
Re:Not going to move the needle. (Score:5, Informative)
Actually, those aren't impossible hurdles.
cost would likely be way less than some of what a hospital buys (e.g. a CT machine), and it could pay for itself over time like any other machine - amortization is your friend in that department. Liability is handled as well, since hospitals (and even their in-house pharmacies in particular) often have to insure against potential drug-related liabilities anyway (misdiagnosis, mislabeling, adverse drug interactions, improper storage procedures, etc).
Now *regulations* are gonna be the big hurdle... no idea what the FDA (or non-US equivalents) are going to demand, but if you think about it, there isn't much difference between this technology and what a pharmacy does right now with compounding [pccarx.com], save for the 'on a computer' aspect (well, machinery too, but you get the idea).
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That's just it, it's NOT much different than conventional compounding, so what's the big attraction? It will have the same regulatory problems, the same liabilities, etc. But it WILL cost more and add complexity, so there's that in it's "favor".
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That's just it, it's NOT much different than conventional compounding, so what's the big attraction? It will have the same regulatory problems, the same liabilities, etc. But it WILL cost more and add complexity, so there's that in it's "favor".
The key question is the reliability and accuracy of this printing method. If there are fewer mistakes with this method than there are with current methods, the liability problem should decrease.
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One major difference is that insurers are reducing coverage of compounding or compounding ingredients.
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Liability is handled as well, since hospitals (and even their in-house pharmacies in particular) often have to insure against potential drug-related liabilities anyway (misdiagnosis, mislabeling, adverse drug interactions, improper storage procedures, etc).
There are a lot of things that can go wrong when manufacturing a pill beyond what goes wrong when you administer a pill. When you make an allergy pill after having made a super-strong heart medication, will the recipient of the allergy pill get their heart slowed down as an added bonus due to cross-contamination?
Also, there are also a lot more storage restrictions on the ingredients that go into pills than on the pills themselves. The pills contain antioxidants, preservatives, antimicrobials, and so on, a
My granny ... (Score:2)
On the one hand, my granny was an apothecary, and I've seen custom pills, powders, tinctures, and syrups being made about 40 years ago. So, yes, the idea (custom dosages) is anything but new.
However I appreciate that labour costs make that sort of thing (customised dosing) infeasible today (except for millionares).
As such I recognise that having a cupboard-size machine that reliably produces dozens of pills in non-standard dosages may well make it economically feasible (again) to admi
Change the dosage without changing looks... (Score:1)
what could go wrong? Is this my high dose or low dose, oh well, better take two just to make sure!
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From TFA . .
I can think of other applications for changing someone's dose without them being aware of it. In fact, you could slip them a custom printed pill that looks just like the rest of the pills in their bottle.
Extra Credit: consider the implications of custom 3D printi
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I can think of other applications for changing someone's dose without them being aware of it. In fact, you could slip them a custom printed pill that looks just like the rest of the pills in their bottle. Extra Credit: consider the implications of custom 3D printing Drug A in Drug B's clothing. (Pill for Drug A looks like it is a pill for Drug B.)
Your unstated assumption is that access to these printers is the only thing stopping people from doing illegal things like murdering a patient in a hospital. I am not convinced that your assumption is correct.
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I work with elder mentally disabled patients and chances in medication can be quite stressful for them. "I ALWAYS have two of those pills, why do I need to take three pills now?" or "This does not look like the medication I usually get, I don't trust this, I'm not taking this!"
It confuses them and at times it can be quite a struggle to get them accustomed to a new medication schedule. So I can see the advantage of changing the dose without changing the appearance or quantity of the pills.
However, even thou
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or "This does not look like the medication I usually get, I don't trust this, I'm not taking this!"
On the other hand, the visible features of a pill are often the only way to differentiate between different doses or different medications. That's why the Physician's Desk Reference [pdr.net] often has pictures of the pills.
It's a SAFETY feature. Your elderly patients are quite right to question the look of the medications they are being given. It is not unheard of for pharmacists or nurses to make mistakes and hand out the wrong pills. ANY patient is right to question.
This idea that you can trick people into taki
Precision (Score:3)
The printing technique allows higher and more precise dosages to be layered into a smaller tablet size.
Are we talking 0.1 mg precision here? because I seriously doubt dosage is calculated in fractions of milligrams . It is usually calculated in mg/kg of body weight. Besides, wont it be slower to print than to stock ? I imagine printing 100 doses .
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Levothyroxine as well as many other drugs are dosed in micrograms not milligrams. It is not uncommon to see dosages of 25/50mcg
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This article was remarkably sparse on details, but I suspect that this is part of some huge manufacturing process analogous to 3D printing, done on an industrial scale. So, the tablets might be built in layers 10,000 at a time over a timespan of a minute or two, or something like that.
It seems like this short article is really two shorter articles in one. There is the specific product approval, which I suspect is for large scale manufacture (but I'm not certain of that), and then some general speculation
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All the drugs a person needs. Maybe a custom morning pill, and evening pill.
Next advance: custom print the pills at home using a device you pick up at your pharmacy. Your doctor remotely updates your prescription.
Next advance: hackers remotely update your prescription.
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Well, I did not RTFA and don't plan to, but it seems to me that if you're creating bespoke pills for people, and you're expecting people to take all of those pills, what you should do is create packets of pills which are all in the same color scheme which is always the same for that patient. I imagine sort of miniature Easter egg-like pills with very distinctive character and with patterns appropriate to the patient, taking into account colorblindness and the like. Perhaps it would even be possible to give
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Lots of drugs are dosed in micrograms. Clonidine, fentanyl clonazepam and LSD, just to name a few.
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The major advantage here appears to be how quickly the pill dissolves compared to standard drugs. The 3D printing allows the structure to be built precisely without compressing the drug and binder. Thus, it can dissolve faster.
http://www.businessinsider.com... [businessinsider.com]
Not AI killer robots (Score:1)
Isn't this one of those "what could possibly go wrong" moments?
Not saying that it is a massive problem, but when custom printing pills, wouldn't it be necessary to measure the end result in some way. It would suck pretty hard if a hickup caused a lethal dose to be printed.
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Isn't this one of those "what could possibly go wrong" moments?
Not saying that it is a massive problem, but when custom printing pills, wouldn't it be necessary to measure the end result in some way. It would suck pretty hard if a hickup caused a lethal dose to be printed.
robots hiccup a lot less often than people do
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That happens right now with alarming regularity... at least for patients of the Veterans' Administration medical system. Such pharmacies often buy from different suppliers, and oftentimes the size, shape, and even color of the pill will change over time - you only find out when you open the bottle.
Just skimmed the article (Score:2)
Maybe I've got a head in the clouds as I've neither been a food or drug engineer in my life, but I kind of wonder how this would be applied.
Like, if you have a 3D printer that prints several different types of tablets, would pharmacists need to add yet another label to prescriptions that says "this drug manufactured in a plant that also processes x, y and z". (I really don't know the difference between compounding and 3D printing, but I imagine printing would need more rigorous cleaning standards in order
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Pretty sure you'd have to sterilize the thing before and after each run...
I believe many pharmaceutical factories do something similar (albeit on much larger scales) where they manufacture many different drugs at a given site. Plus, when they switch out products on a given line, I'm sure there's protocols for that too (though to be fair, that probably happens far less often than this 3D-printing thing would see).
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I would imagine using a different extruder head (or whatever it is) for each compound. Then there's nothing to clean between compounds, because it's always the same compound going through the same extruder.
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This is the sort of thing I'd hope for.
It's one thing to blend colors because you've switched out your filament. It's quite another to blend prescription medications with (and to) nasty side effects.
Optimum pill size (Score:2)
Besides the already mentioned
If patients needs to increase or decrease their dosage, the hospital can do so without changing the appearance of the pills,
translating to it's not possible to know a pills's dosage from their appearance, there is also smaller pills mentioned in the summary.
While I agree that the standard size gelatin capsule is hard to swallow sometimes, there is also a minimum size. The pill should still be large enough that it can be handled by elderly people and moved from the storage to hand to mouth without dropping it to the floor twice. Whoever had the joy of switching nano sims in your phone while travelin
The real purpose? (Score:5, Interesting)
Vicodin used to be hydrocodone/APAP 5/325 until the FDA said that the APAP portion should be lowered to 300 mg. So Vicodin gets reformulated to 5/300 and the price goes up. If I follow FDA guidelines and write a prescription for hydrocodone/APAP 5/300 my patient has a substantial out of pocket cost because the pharmacy has to give them name brand Vicodin. If I write the prescription for 5/325, they can use generic which insurance covers fully, or if they are uninsured costs $5-10.
I suspect that the repackaging has more to do with maintaining the high price than the performance of the medication when packaged by a 3D printer.
Re:The real porpoise? (Score:2)
3D printed pills could create a whole new pill fashion industry.
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Of course, the only purpose of the APAP in this medication is to kill the patient if they dare to abuse it.
There is no reason that the two couldn't be unbundled so that the doctor and patient could work together to ensure that just the right amount of each is administered (likely zero on the APAP front, but the doctor can prescribe it if appropriate). This is just prohibition-style thinking, just like sticking strychnine in industrial alcohol.
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I don't get it. Wouldn't the FDA's requirement apply to the generics manufacturers as well?
Is this just about the period where they've got a bunch of 5/325 on hand that they can't get rid of when docs start writing scripts for 5/300? I wouldn't have expected it to be that big of a problem.
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See http://www.philly.com/philly/b... [philly.com]
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I'm having a bit of trouble following the article. There are a few clear editing errors ("Why not create a generic with only 300 mg of acetaminophen, unlike the generics?"), so I don't think it's just me.
As far as I can tell, it sounds like some kind of patent/regulation thing that prevents the generics makers from making 5/300. Or at least it used to be; another sentence says "Other manufacturers have jumped on the bandwagon since then so the 300 mg product is now generic." So I'm not quite sure why the pr
Price increase excuse (Score:1)
It sounds to me like this is an exercise in finding new ways to jack drug prices up even more. Instead of hospitals charging $5 a pill to take it out of the jar and put it in the little cup, it would become a $100 "manufactured custom medication" charge. Besides having identical pills with different dosages is just plain stupid. I can easily see someone taking 125mg, instead getting the 500mg tablet that is supposed to go to the patient in the next bed.
More bad than good. (Score:1)
Having multiple doses with the same appearance - that's going to create a lot more problems than it solves.
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For that you need Congress.
The Pill Uniformity Act of 2016. Henceforth all pills must have identical appearance. That way it becomes easier and unmistakable to identify whether something is a pill or just a piece of 3D printed candy.
terrible idea (Score:2)
I've overseen family members' hospital stays, making sure that, among other things, drugs and dosages delivered by staff are correct. They aren't correct more frequently than I'd like. This'd make it impossible to tell. Fail.
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They aren't correct more frequently than I'd like. This'd make it impossible to tell. Fail.
The failure is one of your imagination. If the pills were serialized and came accompanied by a printout of what was in them, then you'd have just as much assurance as you do now that the pills are what they say they are.
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If the pills were serialized
A SERIAL NUMBER on each pill?
and came accompanied by a printout of what was in them
"Here's your daily pill Mr. Poo and here are the MSDS sheets for what's in it and here's the certificate of authenticity."
then you'd have just as much assurance as you do now that the pills are what they say they are.
If I have a question about what a pill is, right now I can go to the PDR or any number of other references, or go online to find a picture of what it looks like. Once you start handing out 3D printed versions you have no visual clue that what you are holding is NOT the right thing. It won't take old Mr. Gower very long to send little George Bailey out wit
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then you'd have just as much assurance as you do now that the pills are what they say they are.
If I have a question about what a pill is, right now I can go to the PDR or any number of other references, or go online to find a picture of what it looks like.
And you're taking it on faith that the pill was made correctly, when it often wasn't. So what's going to change?
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And you're taking it on faith that the pill was made correctly, when it often wasn't.
Citation required. "Often" is a bit of hyperbole. Maybe a lot of hyperbole. Manufacturers of pills have quality control systems that verify the output of their pill mills, and if they aren't right the entire batch is dumped. The mistakes take place much more often long after the pill is put in the bottle, by the guy taking the wrong bottle off the shelf. When that happens, what the pill looks like is the only verification the patient has.
Who checks the validity of a hospital's 3D pill printer?
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Citation required. "Often" is a bit of hyperbole. Maybe a lot of hyperbole. Manufacturers of pills have quality control systems that verify the output of their pill mills, and if they aren't right the entire batch is dumped.
Or maybe it's not a lot of hyperbole [fda.gov]. Maybe drug companies don't actually take as much care as you think they do [nytimes.com]. Maybe you're just making unfounded assumptions because they make you feel better.
The truth is that there isn't a recall every time a defective drug is found; and there is no reason to believe that every defect is detected. The drug manufacturers do not take the care that you think they do; at best, some of them do.
Maybe Not (Score:2)
food (Score:1)