Generic Drugs Problem or Solution?
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- Опубліковано 11 тра 2024
- Prior to 1984, generic drugs in the US had to undergo the same application process as brand name drugs, demonstrating safety and efficacy. Consequently they made up less than 20% of the medication market. The Hatch-Waxman Act changed the rules, so that generic drugs now only need to show that they bioequivalent to brand name drugs. Now 90% of medications consumed in the US are generic.
Generics must contain the active ingredient of the drug, but are actually (by trademark law) required to look different. They may also have different colorants or other “inactive” ingredients. Bioequivalence is measured by the peak concentration and the total amount of drug delivered, and the generic levels can be as low as 80% and as high as 125% of the brand name product.
Generic drugs can provide huge cost savings, since the company generally needs to cover just manufacturing costs, not research, development and marketing. But generic versions of medications whose action is very sensitive to peak concentrations, or the rate of absorption, may result in different experiences for patients. In psychiatry the generic drugs for which patients most frequently report problems include the stimulants (versions of Adderall and Ritalin) and the anti-anxiety benzodiazepines (Valium, Xanax, Ativan, and others.)
For many drugs, multiple pharmaceutical companies produce generic versions. An individual who has problems with one manufacturer’s product (which is required to be identified on the pill bottle label) can request that the company’s product be avoided on subsequent fillings.
(The original of this video is a UA-cam Live, and contains several additional minutes of Q&A. It can be found in the Live section of this UA-cam Channel.)
References:
FDA Bioequivalence Guide
www.fda.gov/media/70115/download
Generic Drugs in the United States: Policies to Address Pricing and Competition (2019)
www.ncbi.nlm.nih.gov/pmc/arti....
‘Inactive’ ingredients in oral medications (2019)
www.ncbi.nlm.nih.gov/pmc/arti...
Update: Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies (2014)
www.fda.gov/drugs/postmarket-...
IF YOU WANT TO HEAR THE Q & A THAT FOLLOWED THIS VIDEO, A LONGER VERSION IS IN THE "LIVE" SECTION OF THIS CHANNEL.
Great Information.....looks like its Business before Public Health...Oh well !
Thank you
you're welcome.
You've such a great content around ADHD and CBT, Doc, one of internet's best, yet the sound of many of your videos is such a dampener. Not this video in particular, but over the years
An ardent follower since long but can't follow the voice while multitasking, precisely because of sound quality. Please take care all and stay super
I agree. One of my long term plans is to redo some of the old videos, but that has remained on the back burner for quite awhile.
Hey, looks like you managed to post your live streams in video form, awesome!
I'm glad others will be able to benefit from watching the past years live streams! Let me know if I can help in any other way.
Just one detail, the second link in your references in the description doesn't seem to work for the ''Policies to Address Pricing and Competition (2019)'', you might want to edit that link.
I was just about to say this aswell
I'm glad that people like you are reading and listening closely, and thanks for catching the bad link about the Pricing Policy article, which I have fixed.
@@DrJohnKruse
In case you missed it, I responded in the other comment exchange about making youtube videos from your livestreams, i'll post it here again just in case:
''I just recorded myself making a walkthrough video so that you can follow along step by step to see how to do it.
I can't post links in comments, but you'll find it as the last video on my youtube profile called ''Save livestream as new video - Walkthrough''.
One thing to note, once you finish a livestream it takes some time before you can edit it and save it, because youtube needs to fully process the video, it usually takes 1 day or 2, but you should be able to do this on any older livestream.''
@@FlynnaUA-cam I really appreciate your help. I'm traveling this week and next (my kids are home from college) and I know that I will have to find a chunk of time to follow your guidance and try to get these videos moved from live to the video section, and I just haven't found the time to devote to this project yet, but I will. Thank you!
@@DrJohnKruse No problem, feel free to ask if you need any help!
Safe travels
I’ve heard people say brand name Zenzedi is far superior to generic Dexedrine. Not sure if this is something people have experienced.
I have worked with some people who love generic Dexedrine, and some who hadn't. I haven't so far come across people praising Zenzedi, but I'll keep an ear out, and if anyone reading this is a fan of Zenzedi, let me know.
@@DrJohnKrusethat’s interesting. I’ve found adderall or Dexedrine, 2.5 hours is all she’s got. Even with taking medication holidays. XR of both dex and adderall doesn’t last much longer. It’s as if all the beads dissolve all at once. Watching this again makes me wonder if my generic XR/ER could be the problem. I’m sure my high metabolism doesn’t help the cause. 😔