FDA Approves First 3D-Printed Drug Tablet
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.
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.
what could go wrong? Is this my high dose or low dose, oh well, better take two just to make sure!
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 .
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.
I think it may be a problem when a dosage is not visible on the pill.
Usually the pill sits in a blister and is easily recognized by the blister and after unpacking by the color and size.
Now we will have more confusion if the pills mix up. It is possible to switch dosage by mistake...
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 to make something like this work.)
Would it eventually be moved into pharmacist labs or hospitals so that customization is closer to the patient, or is it considerably safer to have only the drug manufacturer do this?
Would this really catch on? There's cost and quality assurance standards to meet, and why change a system that works relatively well now (I don't really hear a lot about problems with the pharma industry; of course this just means I don't know where to look if those problems actually exist).
Anyway, these are my passing thoughts on this. I try not to be cynical and dismiss this sort of thing as an industry trying on a passing fad, because, you never know.
Some people don't believe in fairies. I don't believe in The Patriarchy.
"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."
This is a really bad idea. Different dosages need to have different appearances lest you take the wrong dosage. Take 2x the medication can go from beneficial to deadly. Heck I have seen increases of 20% become really bad for patients. There is a reason why medications have different appearances. So long as this is limited to hospitals where there is a nurse overseeing the application it is fine. It should not ever be extended tot he home where someone can become confused and miss-dose themselves it will lead to a massive liability suit.
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 traveling internationally (optional. waiting at some airport gate without even a proper table) knows what I'm talking about.
yes of course that's more complicated than swallowing a pill, but that's why pills could be sized smaller than a sim card.
bickerdyke
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.
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.
Having multiple doses with the same appearance - that's going to create a lot more problems than it solves.
If Windows is used for the control platform, how could you trust your life to it?
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.
After you visit the doctor, but before you visit the pharmicist, you visit a pill fashion consultant that helps you select the right pill size, shape, taste and colors, even custom color designs that are just right for you.
3D printed pills could create a whole new pill fashion industry.
I'll see your senator, and I'll raise you two judges.
Just how could a hospital have enough machine time availability to 3d print medications? 3d printing is not a fast process and once a machine is set up they would need to make quite a few pills before cleaning up the unit and running a program to produce a different mediation. Imagine how slow it would be if the machine printed one tablet and then had to have a clean up and switch supplies to print a different tablet. Considering the large number of different pills used daily in a hospital we might be looking at more than one 3d printer needed for each patient in the hospital. And they would still need medications for instant use in the ER or for patients who crash while in their rooms.
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 administer individually dosed medication to patients.
It has a much more mundane application too. It could also be used to cut down on the number of pills that patients have to be fed. That's a cost-saver right there. Just consider some elderly patient suffering from a heart condition, and diabetes. They might require as many as 5-6 different pills three to four times a day in different combinations throughout the day.
I've seen nurses prepare a week's worth of pills for people in pill dispensers where you have one dispenser for each day and 4 sections to each dispenser). Filling boxes with 7 x 4 x 5 = 140 pills is a time-consuming chore I can tell you, and you really don't want to make sloppy mistakes filling those dispensers. Now imagine having to dose a ward of 20 patients.
Of course the 3D printing part is bit of a gimmic but it probably makes it cost-efficient to produce accurately dosed customised pills (customised as in all 5 or 6 ingredients put together in 1 pill) pills in series of under 20. Put 'em in boxes with a name and a barcode and you're ready to roll.
The nursing staff will love it, elderly patients will probably find it convenient, and insurers will probably like it too because it's efficient and hence drives down the cost of nursing staff.
Simple and unassuming as it is I can definitely see it becoming entrenched over the next 5-10 years for that reason alone.
healthy food ideas - http://foodsideas.com/healthy-... | Quick food ideas - http://foodsideas.com/quick-fo...