generic levothyroxine substitutions?

[swatchgirl]

Is the Sandoz generic levothyroxine 100 mcg AB rated? Is it interchangeable with Unithroid 100 mcg?

I did not see the Sandoz levothyroxine product listed in the orange book, and it doesn't say it's discontinued, so why isn't it in the orange book?

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[swatchgirl]

Oops, nevermind!!! The pill I was trying to identify was actually Levo-T (I hope), by Alara. And Levo-T is AB1, 2, 3 rated so it's all good.

 

[Caffeine QAM]

Oops, nevermind!!! The pill I was trying to identify was actually Levo-T (I hope), by Alara. And Levo-T is AB1, 2, 3 rated so it's all good.

Oh I see. I actually replied to you on the other thread you posted on. Apparently The Sandoz products are missing from Orange Book...because I found that it's rated AB2 from McKesson. So why is it missing from Orange Book?

 

[swatchgirl]

Oh I see. I actually replied to you on the other thread you posted on. Apparently The Sandoz products are missing from Orange Book...because I found that it's rated AB2 from McKesson. So why is it missing from Orange Book?

Have no idea. But thanks for checking! What is your opinion on generic-to-generic levothyroxine substitutions in general? I was surprised to learn (at least a few years ago don't know about right now) that levothyroxine is not even categorized as an NTI drug in Canada, Europe or Japan. I wonder why the US decided to include it.

 

[Caffeine QAM]

Have no idea. But thanks for checking! What is your opinion on generic-to-generic levothyroxine substitutions in general? I was surprised to learn (at least a few years ago don't know about right now) that levothyroxine is not even categorized as an NTI drug in Canada, Europe or Japan. I wonder why the US decided to include it.

My opinion doesn't really matter, as I'm not an expert on therapeutic equivalence. We can only go by what the FDA says, and their determinations are based off of the bioequivalence studies that the drug companies submit. If the studies show that the amount of active ingredient per 100mcg tab fall out of statistically acceptable range to be considered therapeuticall equivalent, who are we to say otherwise?

If there is variation between the different brands, then it would probably throw off prescribers or whoever is responsible for titrating the medications if non-equivalents were dispensed, because they'll never know what type the patients are getting (and even if they did, they wouldn't know how to act on that information). Even if the dose were being maintained the same, TSH levels can still fluctuate (studies have shown that the degree of TSH reductions vary depending on the brand) if each refill, patients were dispensed a different brand from before. If I bumped up a patient's dose from 100mcg to 125mcg, but the patient started getting a less potent brand, then I'd think it's not working, a higher dose is needed. Then I'll bump it up to 150mcg, and if a more potent brand get dispensed, all of a sudden I've over-titrated and the patient gets hyperthyroid, which can be pretty severe in the elderly.

 

[swatchgirl]

My opinion doesn't really matter, as I'm not an expert on therapeutic equivalence. We can only go by what the FDA says, and their determinations are based off of the bioequivalence studies that the drug companies submit. If the studies show that the amount of active ingredient per 100mcg tab fall out of statistically acceptable range to be considered therapeuticall equivalent, who are we to say otherwise?

If there is variation between the different brands, then it would probably throw off prescribers or whoever is responsible for titrating the medications if non-equivalents were dispensed, because they'll never know what type the patients are getting (and even if they did, they wouldn't know how to act on that information). Even if the dose were being maintained the same, TSH levels can still fluctuate (studies have shown that the degree of TSH reductions vary depending on the brand) if each refill, patients were dispensed a different brand from before. If I bumped up a patient's dose from 100mcg to 125mcg, but the patient started getting a less potent brand, then I'd think it's not working, a higher dose is needed. Then I'll bump it up to 150mcg, and if a more potent brand get dispensed, all of a sudden I've over-titrated and the patient gets hyperthyroid, which can be pretty severe in the elderly.

Having studies to reference while making a substitution decision would be ideal, I think it's the lack of data that makes it difficult for me. What is there to do when a product is not listed in the orange book? It becomes the pharmacist's personal call. That's a lot of personal calls. If businesses were really looking out for the interest of their customers, they'd have patients stay on the same drug if it is working well for them, rather than risking them going through the ups and downs from switching back and forth between different brands, just because their insurance plans said so. ...

 

[Caffeine QAM]

Having studies to reference while making a substitution decision would be ideal, I think it's the lack of data that makes it difficult for me. What is there to do when a product is not listed in the orange book? It becomes the pharmacist's personal call. That's a lot of personal calls.

Ideally, we don't want to reference studies... it's too tedious to look at a study and determine how one brand compares to another. The FDA does that for us. Furthermore, most pharmacists don't have the competency in statistics to interpret studies anyways. It shouldn't be a personal call...you should have a reference. If it's not in Orange Book, do as I did and reference your drug distributor (McKesson, Cardinal etc). Drug distributors have Orange Book Codes for the medications they sell because it helps the purchasers (us) determine if what we're getting is exactly what we need. Be resourceful. You already know how to reference Orange Book, which is more than I can say for some other pharmacists.

If businesses were really looking out for the interest of their customers, they'd have patients stay on the same drug if it is working well for them, rather than risking them going through the ups and downs from switching back and forth between different brands, just because their insurance plans said so. ...

For example? Kind of agree, kind of disagree...every payor has their formulary. It makes sense. After all, why pay for a $100 medication when there's another $50 medication in the same class that does the same thing? I'm all for discouraging prescribers from using the "newest and greatest" drugs that haven't been shown to be superior to cost-effective alternatives.

 

[Sine Cura]

Sandoz-labeled levothyroxine is actually Levo-T (same NDA). That is why you won't see it in the Orange Book or Drugs@FDA because the databases list unique NDAs or ANDAs, not distinct NDCs.

Re-labeled presentations of brand drugs are not "A" rated to themselves (that wouldn't make any sense), like Actavis methylphenidate ER OROS.

 

[Caffeine QAM]

Sandoz-labeled levothyroxine is actually Levo-T (same NDA). That is why you won't see it in the Orange Book or Drugs@FDA because the databases list unique NDAs or ANDAs, not distinct NDCs.

Re-labeled presentations of brand drugs are not "A" rated to themselves (that wouldn't make any sense), like Actavis methylphenidate ER OROS.

Ah thanks. Makes sense. I actually was wondering if that was the case, but found no information on it.

 

[swatchgirl]

For example? Kind of agree, kind of disagree...every payor has their formulary. It makes sense. After all, why pay for a $100 medication when there's another $50 medication in the same class that does the same thing? I'm all for discouraging prescribers from using the "newest and greatest" drugs that haven't been shown to be superior to cost-effective alternatives.

My mom. They switched her levothyroxine three times now without justification, notification or permission. I just don't like to see her suffer unnecessarily.

 

[swatchgirl]

Ideally, we don't want to reference studies... it's too tedious to look at a study and determine how one brand compares to another. The FDA does that for us. Furthermore, most pharmacists don't have the competency in statistics to interpret studies anyways. It shouldn't be a personal call...you should have a reference. If it's not in Orange Book, do as I did and reference your drug distributor (McKesson, Cardinal etc). Drug distributors have Orange Book Codes for the medications they sell because it helps the purchasers (us) determine if what we're getting is exactly what we need.

True! This is good advice.

 

[lane one]

My mom. They switched her levothyroxine three times now without justification, notification or permission. I just don't like to see her suffer unnecessarily.

The notification part is an issue, but the justification is that one manufacturer is 0.02 cents cheaper this week, and technically you don't need permission to dispense a different one every month. Assuming of course that the product they are substituting is appropriately rated. If its causing issues then then the prescriber needs to indicate brand medically necessary.

 

[zelman]

The notification part is an issue, but the justification is that one manufacturer is 0.02 cents cheaper this week, and technically you don't need permission to dispense a different one every month. Assuming of course that the product they are substituting is appropriately rated. If its causing issues then then the prescriber needs to indicate brand medically necessary.

You could just choose the cheaper option, but if you're making that decision based on two hundredths of a cent savings, you're probably a lousy healthcare practitioner. There needs to be a balance between cost-containment and consistency of therapy, not simple cost-minimization analyses.

 

[Caffeine QAM]

My mom. They switched her levothyroxine three times now without justification, notification or permission. I just don't like to see her suffer unnecessarily.

You mean insurance company changed which ones are covered 3 times?

 

[lane one]

You could just choose the cheaper option, but if you're making that decision based on two hundredths of a cent savings, you're probably a lousy healthcare practitioner. There needs to be a balance between cost-containment and consistency of therapy, not simple cost-minimization analyses.

Yes I agree. I didn't mean I would change it, I meant CVS changing preferred NDCs based on 0.2 cent difference. I don't like it either but that's the way a lot of companies operate.