Debate over generic drug use heats up - Some prescription switches can cause problems

[Bozita]

Source: Detroit Free Press

Debate over generic drug use heats up
Some prescription switches can cause problems
BY PATRICIA ANSTETT • FREE PRESS MEDICAL WRITER • JUNE 8, 2009


Busy with other chores, Kathryn Pauley asked her 16-year-old to pick up younger daughter Cheyenne's seizure medicine at a pharmacy.

To her surprise, Pauley found a generic drug, not Lamictal, a brand-name drug that had effectively controlled most of Cheyenne's seizures. In the next week, Cheyenne, 11, had 21 seizures -- many more than usual.

The switch occurred even though Cheyenne's doctor had written "dispense as written," or "DAW," on the prescription. Cheyenne's Medicaid policy refused to fill the prescription until her doctor challenged it, said Pauley of Belleville.

A fierce legislative campaign is playing out in Michigan and other states over generic substitution and therapeutic switching, a practice that allows health insurers to fill a prescription with drugs similar to brand-name drugs.

Read more: http://www.freep.com/article/20090608/BUSINESS06/906080329/Debate+over+generic+drug+use+heats+up

[boomerbust]

1. This is typical with Medicare D plans

My plan only allowed 3 months of coverage for a drug that has no generic. I was told I had to go back to my doctor to make sure this was the cheapest way to procede. I cancelled Medicare D.

[hobbit709]

2. There's a difference between generic and similar

Generic is just the nonbrand name equivalent. Similar is a drug that is not the same but USUALLY works the the same.

[WriteDown]

3. Exactly...

Generics are identical to their name brand counterparts which makes this article very weird.

[Psychic Consortium]

8. Ask people who take Prozac if generic and name brand are the same..... nt

[WriteDown]

15. The placebo affect is a powerful thing. nt

[Mojorabbit]

10. They are not identical

in all cases. There is latitude for the differences given in specs. I read a very good article about this in a medical journal a few years ago where components of some generics were analyzed. Some pain medicines were very deficient in active ingredients. Since so many of our drugs are made overseas I think a lot of fillers and short cuts may be being taken and there does not seem to be good oversight of the process.

on edit I found this
Psychobiology and Psychopharmacology

Borgheini, G. (2003) 'The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs', Clinical Therapeutics 25(6): 1578-92.
http://www.ncbi.nlm.nih.gov/pubmed/12860486?dopt=Abstract

This article suggests that present standards for determining bioequivalence between branded and generic medications may be inadequate; from the article's abstract, "Specifically, 1 study found that plasma levels of phenytoin were 31% lower after a switch from a brand-name to a generic product. Several controlled studies of carbamazepine showed a recurrence of convulsions after the shift to a generic formulation. After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations." The article concludes that "The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects".

[WriteDown]

14. Its an interesting article...

but I can find no peer review or funding info.

[enlightenment]

12. They're not identical.

If they were, they couldn't be sold because they would violate the patent the originator holds.

Usually, the difference is in the inert ingredients. Sometimes those inert ingredients can make a big difference. I was once given a generic equivalent of a prescription drug I had taken previously and had a violent allergic reaction to the generic. It wasn't the active ingredient; I was allergic to one of the inert ingredients that was in the generic version (but not the branded one).

I've never read any studies that suggest they perform differently. Apocryphally - and I know that's not scientific at all - I know that some store-brand OTC meds don't work as well as their branded counterparts for me (and friends have said the same). That could be for any number of reasons, including psychological, so I know I can't use it as proof of anything . . . and certainly can't lay the cause on the inert ingredients!

[WriteDown]

13. The reason that generics can be sold...

Is specifically because the patent on the original drug has expired.

[Karenina]

17. I have experienced a similar problem with BP meds.

A universal change was made in the computer which resulted in me getting a generic brand. Checked the boxes, same stuff, I didn't care...
BUT my stomach was having none of it. Before I got around to complaining about this new symptom, I got a refill of the original brand prescribed because the pharmacy was out of the generic. Presto Chango! The symptoms disappeared IMMEDIATELY. I reported that to my doctor who without a word or further inquiry changed my Rx back. He then explained that the INERT INGREDIENTS were likely the culprits.

[Psychic Consortium]

4. Generics are NOT identical to their name brand counterparts.

Another scam by Big Pharma.

[sharp_stick]

5. Your comment makes no sense

Big pharma doesn't care much for generics so if they could be proven to be different from the name-brand that would be great news for big pharma. That is unless you allege a massive conspiracy between the large pharmaceutical companies and the generic manufacterers in a plot to slowly undermine the production of generic drugs by providing shit instead of drug product.

[Psychic Consortium]

6. Follow the money trail.... who makes money on the manufacture of poor quality generics?

[sharp_stick]

9. That would be

companies like Dr. Reddy, Apotex etc. mostly privately held companies that aren't held in very high regard among those in the pharma industry. And the generics aren't usually that badly made, except for the scam crap you find on the internet.

[sharp_stick]

7. This isn't really a generic switch for name brand

This process is probably better called "therapeutic switching" which allows pharmacists to change the actual drug not simply switch to a generic form of the written prescription.

This allows a switch from something like Lipitor (no generic available) to something that is now available as a generic, like Coreg (carvedilol). The drug isn't identical in any respect to Lipitor, even functions in a different way physiologically, but some pharmacies and prescription plans encourage and demand it.

In most cases when the doc writes dispense as written the pharmacist is not supposed to fill with a different drug at least not without informing the patient and doc. They in no case should fill it with a different drug and not tell the patient.

For a lot of conditions and drugs it makes no real difference but docs can spend months working out a seizure med profile for a patient and a single therapeutic switch can screw it all up and put the patient at serious risk of seizure. Same goes for a lot of blood pressure drugs.

My advice (YMMMV) is keep a damned close eye on your prescriptions and know exactly what the brand name and generic name of all your medications are.

[Lone_Star_Dem]

11. In this case the prescription was originally DAW

It appears the doctor was told to change it from what I can tell.

The switch occurred even though Cheyenne's doctor had written "dispense as written," or "DAW," on the prescription. Cheyenne's Medicaid policy refused to fill the prescription until her doctor challenged it, said Pauley of Belleville.

I suppose where they wrote challenged it was supposed to be changed?

The article is poorly written and difficult to understand. It seems this is a case where there is not a generic that was an identical substitute for the drug at the current dosage level the patient was taking or else the doctor would not have written the original prescription as DAW in the first place.

[sharp_stick]

16. Exactly right, not the best article

It seems to imply that the prescription was a generic of the written prescription and I don't think that's the case.

When a doc writes DAW a pharmacy is not supposed to fill it with anything other than the written medication without informing the doc and the patient. The doc should then be allowed to challenge based on medical need but if I read the article properly they didn't even bother to tell this patient that they subbed the drug.

The insurance co's seem to make it difficult and time consuming for docs to challenge the substitions so they won't bother. This kind of showdown has been coming for awhile now.