Dispensing Effient in its original container

Hey guys, just curious if any of you knew of any additional reasoning behind the requirement to dispense effient in its original container other than simple storage issues (ie it has a dessicant and is light protected). I typically don't work much retail, but I know when we send up unit doses at the hospital it comes in foil blister packs (somewhat like Micardis), thus it may be that it degrades in the presence of moisture and this is a precaution by the manufacturer (to ensure it is always stored in the presece of a dessicant) as any decrease in efficacy could adversely affect ACS/post-stent patients. What is the consensus?

tongiecc said:

Hey guys, just curious if any of you knew of any additional reasoning behind the requirement to dispense effient in its original container other than simple storage issues (ie it has a dessicant and is light protected). I typically don't work much retail, but I know when we send up unit doses at the hospital it comes in foil blister packs (somewhat like Micardis), thus it may be that it degrades in the presence of moisture and this is a precaution by the manufacturer (to ensure it is always stored in the presece of a dessicant) as any decrease in efficacy could adversely affect ACS/post-stent patients. What is the consensus?

Click to expand...

moolman said:

Read the PI, do what it says hence you dispense it in the original bottle due to stability.

Click to expand...

Asking for clinical knowledge here, please refrain from replying if all you can do is refer me to the PI, which I have already read. Thanks!

**i.e. why is it not acceptable to dispense in a similar dessicant containing light protected container? What is unique about their storage device? (I would assume nothing, and that this is merely the only way for the manufacturer to ensure that a low moisture environment is maintained)

moolman said:

Your asking a circular question in that you already answered it, that's why I'm referring you to the PI. There isn't some sophisticated magic answer.

Drug not stable
Store in original bottle
Drug can be stored in another bottle if you can seal it as well as the original bottle but why, that's just a bit ******ed and extra work and cost.

Do you want a more sophisticated answer like the drug has been shown to degrade over time resulting in less bioavailability and a decrease in Cmax blah, blah, blah... all that or we can say Drug not stable, keep it on original bottle, that sounds pretty clinical to me.

Click to expand...

Soooo.....where in the PI does it say that the reason for storing it in the original container is due to stability? And, what reasoning does it give you? The answer of course is nowhere/none. So we are just making the assumption that this is the reason. Thus, I can unfortunately draw no credible answer from this, as it is merely presumption.

No worries, I do know of an rph that knows, he was just stuck at jury duty today so I obviously couldn't ask him, and I was just taking a stab in the dark that someone on here might know. Not a big deal guys, I appreciate your efforts.

moolman said:

He's a clinical hospital pharmacist, you must answer with a sophisticated clinical answer, if the terms Cmax, Vd are not in the response or you are only a retail pharmacist, you can STFU.

Click to expand...

Hey be nice bro! I never told u to "stfu", I just wanted a more detailed answer. I dont think any more or less of anyone regardless of the setting they work in. That's the problem w/the Internet/a forum, you can't read the tone someone is communicating in. I'm glad u replied moolman, you did well before anyone else, so totally not trying to knock u.

All4MyDaughter said:

What similar dessicant containing light protected containers do you have in your pharmacy? We don't have any...

Click to expand...

Haha, you don't have desiccant containing black vials at your pharmacy?! I was more just thinking out loud. and was just trying to discern more info

Ackj said:

How many packages do you think the manufacturer ran stability studies on? Do you think they can guarantee that whatever container you rig up to be "similar" is actually keeping the drug adequately dry and dark? THAT is what's unique about it. They tested that fancy bottle with the shiny foil stickers on it, and it got approval in that way.

Click to expand...

True, or maybe they figure if it isn't kept in the original bottle at all times it may be dispensed incorrectly (think partial fills, etc). Also, this would help to limit their liability come lawsuit time (ie they blame Johnny Rph if they can't recall it being dispensed correctly, or if they can conjure up an amber vial with effluent in it that your pharm dispensed)

moolman said:

My apologies:

Here's the source:
http://www.lmgtfy.com/?q=why+does+dabigatran+need+to+be+stored+in+the+original+bottle?

First link:

Although the original label states that dabigatran should be stored in its original packaging to protect it from moisture, that information isn't emphasized or displayed prominently in the package insert. Despite this relative lack of information in the labeling, the FDA has taken steps to prevent exposure of the product to moisture. Dabigatran comes in blister packs or a 60-pill bottle (a month's supply) with a desiccant cap to minimize product breakdown from moisture, an unusual and expensive packaging option. (The United States is the only country where a bottle is used to dispense dabigatran. In all other markets, dabigatran comes only in blister packs.) The related FDA Drug Safety Communication (http://1.usa.gov/hGJG0z) provides some information on the effect of moisture on the drug's efficacy: "Pradaxa capsules will hydrolyze [decompose] over time when exposed to humidity, causing a breakdown of active ingredient, and rendering the medication less effective." And dabigatran's label states that once the bottle is opened, the product must be used within 30 days (unlike most medications, which don't lose any efficacy until after a year).

Click to expand...

I appreciate the effort here (although I'm pretty sure you're just trying to diss me w/the "let me google that for you"). But the link/search is for pradaxa bro.

moolman said:

You're right, fail on my part. I'm replying on a iPhone, just replace the dabigatran with prasugrel and you pretty much get the same reason as dabigatran and needing to protect against moisture, Cmax.

Click to expand...

Don't you just hate it when you are really trying to stick it to someone and then you screw something up? It's happened to me too buddy. We've both been on these forums for a while man, so how bout u drop the Cmax and we be friends on here? I'm not in the business of making enemies, so hope u take me up on that bro!

And on another humorous note, I actually tried googling it when I gave up on worthless efacts, lexi, etc. and I wasn't gonna call the company/MSL today on this, and I couldn't get the patent result u got on the first link (I didn't type it in ? form and had resorted to using "prasugrel" AND "original bottle", and many searches along those lines (sad, I know), but in the patent page it has this which is gold:

[0032]Studies have shown that the hydrochloride and maleate salt forms provide improved efficacy and stability profiles compared to other salts and also compared to the free base molecule (see U.S. Pat. No. 6,693,115). Another study revealed that stored tablets containing prasugrel degrade by both hydrolytic and oxidative pathways. There are crossovers between these degradation pathways wherein intermediates or products of certain steps in one pathway may interconvert or be kinetically accelerated or hindered by the concentration of product (or intermediate), air or moisture from the environment or the other pathway (see International Application Publication No. WO 2006/135605). This study involved a formulation comprising a therapeutically effective amount of prasugrel hydrochloride packaged in an air and moisture impervious gas-inerted blister package to improve the stability and shelf life of prasugrel. Despite the improvements associated with these studies, there remains a need for alternate approaches to prepare stable pharmaceutical formulations comprising prasugrel.

So NE way thanks for that for realz, hope u have a good eve bro, even if u gotta "cmax" me again, that did seriously help

moolman said:

It's because you're asking a pharmacy question but a semi-lazy one at that. On top of that we only like to discuss things like who's hawt or Craigslist rentals, etc. Cmax.

Click to expand...

Wow, very kind of you. I informed you I didn't work in retail often, allowed you to post a simpleton reply and didn't poke fun at you, apollogized multiple times to you for no reason but to spare your fragile ego, and then didn't call you out in a rude manner when you couldn't tell the variation between effient and pradaxa, and then I proceeded to scour out an answer from your google search link to attempt to save face from you, and you call me lazy?? You're a class act. FYI, the metabolism section of the PI states the mechanism of degradation. Call me when you're dosing tacrolimus drips for ventilated transplant patients. I'm logging off of SDN now, and won't return for some time due to the excessing bullying and lack of clinical/professional knowledge found here.