4 ms·

Bioequivalence and pharmaceutical equivalence are different. It's true that generic drugs have the same active ingredients in the same dosage and form, and the

Bioequivalence and pharmaceutical equivalence are different. It's true that generic drugs have the same active ingredients in the same dosage and form, and they're tested to have the same general absorption characteristics. This does not necessarily mean that a brand drug and its generic version are completely identical. For example, many patients prefer Synthroid (a brand-name synthetic thyroid hormone) over levothyroxin (its generic equivalent). The inactive ingredients sometimes affect how a drug's active ingredients behave within an individual, and these are allowed to differ between brand and generic drugs. This usually doesn't matter; most of the time, brand drugs and their generic versions are close enough. However, generic drugs aren't exactly just a different label on the same medicine, and the differences can be clinically significant. Thus, the medical world has the ability to specify "dispense as written" on prescriptions and on the corresponding insurance claims.

mkhalil 10y ago
I think you meant: "generic drugs aren't* exactly just a different label on the same medicine"
- willglynn 10y ago
  Fixed.
cmdrfred 10y ago
FDA doesn't seem to make this distinction. They print "FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs." in bold type here[0]. Perhaps 'dispense as written' is better put as 'dispense in a way that I get some sweet pharma kickbacks'. [0]http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusi...
- willglynn 10y ago
  Agreed; my point is that the FDA doesn't make that distinction. The FDA's definition of "same performance" is close, but it's not always close enough. (I once worked on a system that had to special-case pricing for Synthroid specifically because the FDA-approved generics aren't quite the same to a lot of people, and I ended up marrying someone who gets moody when the pharmacy gives her generic Synthroid by mistake.)
  - cmdrfred 10y ago
    Perceived reputation, color and packaging plays a big role in perceived drug efficacy[0], I wonder if a double blinded trial would show the same results you have seen anecdotally. [0] http://www.theatlantic.com/health/archive/2014/10/the-power-of-drug-color/381156/ http://www.theatlantic.com/health/archive/2014/10/the-power-...
    - willglynn 10y ago
      I'd be interested to see results from such a trial. Closer to home, we twice found out that the pharmacy gave her a generic when she developed quirks 4-5 days after she started taking a new bottle. Sort of the reverse of a placebo effect -- she thought she was on the brand all along, and she didn't think to check until things didn't feel right. Humans are complicated.
  - SilasX 10y ago
    Then isn't the FDA's claim false, if people detect different effects from brand name vs generic?
DougWebb 10y ago
My wife had this problem; she took Neoral, a brand-name immuno-suppressant, for many years. CVS, especially their mail-order-specialty pharmacy that my insurance plan forced us to use, kept trying to substitute generic cyclosporine. The problem is that she learned years ago that the generic didn't have the same effect at the same dosage, putting her transplanted liver in jeopardy. Yet month after month, no matter how often her doctors intervened, CVS kept trying to send her the generic. Last year her transplanted liver failed. She was lucky to get another one; she barely survived and she's still recovering. She's on a different immuno-suppresant now, which the hospital arranged for her to get from an affiliated transplant-specialist pharmacy in NY. CVS' horrible service wasn't responsible for her liver failing (transplants don't last forever) but the incorrect medication and missed doses definitely took its toll, and cost us a lot more than it should have when we had to pay out of pocket to buy emergency doses in-store at whatever pharmacy would supply them.
- EdHominem 10y ago
  I wonder if the best way to get them to change though, isn't to sue for damages suffered from their deceptive business practices. It's also definitely a licensing issue for their pharmacists. If they can't store and handle customer records (special needs, interactions, etc) they shouldn't be in business.
  - DougWebb 10y ago
    It's pretty much impossible to gather the resources needed for a lawsuit against a huge corporation that's got health insurance companies in their pocket, when you're trying to acquire the drugs needed to not die this week.

mkhalil 10y ago

I think you meant: "generic drugs aren't* exactly just a different label on the same medicine"

willglynn 10y ago
Fixed.

cmdrfred 10y ago

FDA doesn't seem to make this distinction. They print "FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs." in bold type here[0]. Perhaps 'dispense as written' is better put as 'dispense in a way that I get some sweet pharma kickbacks'. [0]http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusi...

willglynn 10y ago
Agreed; my point is that the FDA doesn't make that distinction. The FDA's definition of "same performance" is close, but it's not always close enough. (I once worked on a system that had to special-case pricing for Synthroid specifically because the FDA-approved generics aren't quite the same to a lot of people, and I ended up marrying someone who gets moody when the pharmacy gives her generic Synthroid by mistake.)
- cmdrfred 10y ago
  Perceived reputation, color and packaging plays a big role in perceived drug efficacy[0], I wonder if a double blinded trial would show the same results you have seen anecdotally. [0] http://www.theatlantic.com/health/archive/2014/10/the-power-of-drug-color/381156/ http://www.theatlantic.com/health/archive/2014/10/the-power-...
  - willglynn 10y ago
    I'd be interested to see results from such a trial. Closer to home, we twice found out that the pharmacy gave her a generic when she developed quirks 4-5 days after she started taking a new bottle. Sort of the reverse of a placebo effect -- she thought she was on the brand all along, and she didn't think to check until things didn't feel right. Humans are complicated.
- SilasX 10y ago
  Then isn't the FDA's claim false, if people detect different effects from brand name vs generic?

DougWebb 10y ago

My wife had this problem; she took Neoral, a brand-name immuno-suppressant, for many years. CVS, especially their mail-order-specialty pharmacy that my insurance plan forced us to use, kept trying to substitute generic cyclosporine. The problem is that she learned years ago that the generic didn't have the same effect at the same dosage, putting her transplanted liver in jeopardy. Yet month after month, no matter how often her doctors intervened, CVS kept trying to send her the generic. Last year her transplanted liver failed. She was lucky to get another one; she barely survived and she's still recovering. She's on a different immuno-suppresant now, which the hospital arranged for her to get from an affiliated transplant-specialist pharmacy in NY. CVS' horrible service wasn't responsible for her liver failing (transplants don't last forever) but the incorrect medication and missed doses definitely took its toll, and cost us a lot more than it should have when we had to pay out of pocket to buy emergency doses in-store at whatever pharmacy would supply them.

EdHominem 10y ago
I wonder if the best way to get them to change though, isn't to sue for damages suffered from their deceptive business practices. It's also definitely a licensing issue for their pharmacists. If they can't store and handle customer records (special needs, interactions, etc) they shouldn't be in business.
- DougWebb 10y ago
  It's pretty much impossible to gather the resources needed for a lawsuit against a huge corporation that's got health insurance companies in their pocket, when you're trying to acquire the drugs needed to not die this week.