My office is being flooded by patients who take Toprol XL (metoprolol succinate - generic form - marketed as Toprol Succinate ER - "extended release") because of a supply shortfall. Reportedly there's another generic kid in town, but for some reason they can't keep enough of the drug on the shelves. Anyone else have more info on this?
Seems doctors are the last to know about such things...
-Wes
The problem stems from multiple factors:
ReplyDelete1. One generic manufacturer had their products seized (by the FDA, I think), but I can't remember the reason why.
2. Another manufacturer has stopped making the drug. Again, I'm not sure why.
3. The only generic supplier left, Par, actually distributes an authorized generic. An authorized generic is actually made by the brand name company, but distributed by a generic firm. This allows the brand name company to still make some profit after patent protection runs out. As you can imagine, AstraZeneca (the manufacturer of brand name Toprol XL) is a bit reluctant to supply a large amount of the drug to Par, when the only other choice their brand name product.
Supposedly, another generic manufacturer, Watson, is supposed to begin releasing product around the end of this month, but only in two strengths . . . 50mg and 100mg I think. Don't forget, you can always switch your patients to immediate-release metoprolol (generic Lopressor). Oh, and if you think this shortage is bad, there's also potentially going to be a shortage of hydrocodone/acetaminophen products and amoxicillin/cephalexin soon. Imagine that . . .
Jacob Milbradt, PharmD
Jacob-
ReplyDeleteThanks so much for the info.
From an older pharmacist - Sandoz recalled all its lots of metoprolol ER in September due to documentation & in process controls. The recall was with the knowledge of the FDA.
ReplyDeleteIn November, Ethex, another generic supplier of many products had a widespread recall due to oversized products. This affected not only metoprolod, but also MS IR & ER, isosorbide mononitrate (generic Imdur), propafenone, buspirone & doxasosin.
PAR, the only other generic manufacturer is not able to keep up with production. Likewise, the branded Toprol XL cannot keep up since they only manufactur what then can sell, which normally is a fraction of the market.
I have been dispensing 30 day supply of brand, but charging the insurance for generic & taking the loss. But, now that the brand is in short supply, you will need to switch to the shorter acting metoprolol.
There are far more recalls recently than in years past. Most are drugs are not prescribed my the majority of prescribers (perphenazine, thioridazine). The recent shortage of hydrocodone products is due to a problem with manufacturers underestimating the need for raw materials. They are limited to purchasing a certain amount every quarter & the raw material supply they've been allowed to purchase has been limited in the fourth quarter of the last year. This shortage will readily be corrected now the new quarter has begun.
Get a good realtionship with a pharmacist you trust has the knowledge & you'll know if you really need to switch drugs or temporarily prescribe or allow to be filled less than a 90 day supply.
Anony 11:10PM-
ReplyDeleteBut, now that the brand is in short supply, you will need to switch to the shorter acting metoprolol.
We've had to resort to switching patients off toprol entirely because the supply short-fall has depleted the supply of short-acting metoprolol (metoprolol tartrate), too.
I found the notice from Pharmacy Industry News regarding the Sandoz issue. (pdf) Thanks for the tips and info.
This poses an interesting question: in the interest of "protecting public safety" (a la, the FDA), could regulatory efforts actually backfire and render patient's at greater risk as a result of complications from regulatory heavy-handedness when supply is cut short and doctors left ill-prepared to cope with the consequences?
Maybe it had peanut butter in it.
ReplyDeleteITs nothing but a ploy to rake in more money....supply and demand....gees those guys will stop at nothing.
ReplyDelete