Generic Medications - Problem or Solution? скачать в хорошем качестве

Generic Medications - Problem or Solution?

Main Chapters: 00:00 Intro – Generic Medications 00:10 Take home message 02:39 Generics Context and Price Comparisons 05:15 Differences Between Generics and Brand Name 09:06 1984 Hatch-Waxman Act 15:50 Problems with Generic Medications 22:15 Conclusion 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. ----- Free link to my Medium Article on Generic Medications: https://medium.com/wise-well/generic-... Follow   / dockruse   on Medium for hundreds of full length articles on this subject and more! Access to Full Medium articles requires paid membership. ----- References: FDA Bioequivalence Guide https://www.fda.gov/media/70115/download Generic Drugs in the United States: Policies to Address Pricing and Competition (2019) https://pubmed.ncbi.nlm.nih.gov/30471... ‘Inactive’ ingredients in oral medications (2019) https://www.ncbi.nlm.nih.gov/pmc/arti... Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies (2014) https://www.fda.gov/drugs/postmarket-... Full Chapter list: 00:00 Intro – Generic Medications 00:10 Take home message 02:39 Generics Context and Price Comparisons 03:03 Adderall Immediate and Extended Releases (IR and XR) 03:45 Vyvanse / Mydayis / Strattera / Prozac 05:15 Differences Between Generics and Brand Name 06:08 Bioequivalence 07:18 Blood Level / Absorption Timing 09:06 1984 Hatch-Waxman Act 09:54 Patent Protections 10:41 Abbreviated New Drug Application (ANDA) 11:26 Patent and Market Exclusivity 14:17 180 Day Generic Drug Exclusivity 15:50 Problems with Generic Medications 17:59 International Manufacturers 18:54 Pill Shape / Size / Color 20:44 Fillers / Additives / Excipients 22:15 Conclusion Streamed live May 8, 2024 ------------------------- Psychiatrist, neuroscientist, and author John Kruse, MD, PhD presents practical, actionable, well-researched information about treatment options that scientists and clinicians recommend for adult ADHD and other mental health conditions. Subscribe if you're curious about how neuroatypical brains can optimize their functioning in our shared, and somewhat strange, world. ADHD topics have a pink background, and those on more general mental health topics have a purple background. A small collection of Politics related videos have an orange background. Dr. Kruse has posted videos in the "Videos", "Live", and "Shorts", sections of this channel. You're welcome to email him with topics you want discussed or people you think he should interview. drjohnkruse@gmail.com #health #mentalhealth #medication #generic