Epi-Pen generic confusion

[rxboy1996]

Mylan Pharmaceuticals recently released an Epinephrine Auto-Injector (EAI) as the authorized generic to EpiPen 0.3 mg and EpiPen Jr 0.15 mg. However, Mylan's EAIs are "BX" rated to brand EpiPen and EpiPen Jr. meaning that according to the FDA, the FDA considers them not to be therapeutically equivalent to other pharmceutically equivalent products. The message that went out at Walgreens states pharmacists must follow their state's drug product selection laws and that there are only certain states (10 states) where there must be prescriber approval to substitute brand EpiPen for Mylan's generic.

What i want yalls thoughts and discussion on is: Isn't there already a generic Adrenaclick on the market, which is also referred to as an "epinephrine auto-injector?" An article by Consumer Reports http://www.consumerreports.org/drugs/how-to-get-cheaper-epipen-alternative/ ..states that pharmacists in more than a dozen states, including California, Colorado, Connecticut, Florida, Vermont, and Washington can fill an EpiPen prescription with generic Adrenaclick—without returning to their physician for a new prescription. The Adrenaclick generic is made by Impax Laboratories. This EAI has its own website and all but I have no idea if it is available on the market?

So my question: is the EAI generic for both Adrenaclick and EpiPen interchangable or the same thing? I have never processed a prescription for a generic Epinephrine Auto-Injector before because I've always done brand EpiPen.

Anyone have any thoughts or has gone through processing an rx for a generic? I guess in the states that can substitute an EpiPen for generic Adrenaclick, do you just fill whatever is cheaper between generic EpiPen and generic Adrenaclick?

---

Members don't see this ad.

 

[sosoo]

i have not yet seen the Mylan generic version. make sure what you have really is from Mylan. currently at CVS there is no generic equivalent.

 

[Sine Cura]

The authorized generic is not BX rated to "brand" EpiPen. It is relabeled brand EpiPen. It's on the same NDA.

The BX rating on EpiPen is indicating that this product is not therapeutically equivalent to otherwise pharmaceutically equivalent epipephrine auto-injectors (on a different NDA/ANDA) and vice versa. It's the same deal with ProAir/Ventolin/Proventil.

 

[rxboy1996]

i have not yet seen the Mylan generic version. make sure what you have really is from Mylan. currently at CVS there is no generic equivalent.

Supposedly, there is a generic out. Walgreens said they wouldn't automatically send them out to stores but we could order them for next day if we needed one. And I even found a manufacturer savings card on the Mylan website for it https://www.my-generic-epinephrine-auto-injector.com/

 

[nasacort24hr]

The authorized generic is not BX rated to "brand" EpiPen. It is relabeled brand EpiPen. It's on the same NDA.

The BX rating on EpiPen is indicating that this product is not therapeutically equivalent to otherwise pharmaceutically equivalent epipephrine auto-injectors (on a different NDA/ANDA) and vice versa. It's the same deal with ProAir/Ventolin/Proventil.

So you mean that we can or can not substitute the product of BX rating without calling the prescriber?
Say if Rx written for Ventolin, and for whatever reason you need to substitute to pro air, can you do so without calling md? (What if pt needs it and unable to contact md?)
What about this EpiPen? Pt need that for anaphylaxis, what if we can't get a hold to md? Can we just substitute the product and call /fax md later to ask okay to substitute?

 

[npage148]

Imo bx rated=\= generic

 

[rxboy1996]

So you mean that we can or can not substitute the product of BX rating without calling the prescriber?
Say if Rx written for Ventolin, and for whatever reason you need to substitute to pro air, can you do so without calling md? (What if pt needs it and unable to contact md?)
What about this EpiPen? Pt need that for anaphylaxis, what if we can't get a hold to md? Can we just substitute the product and call /fax md later to ask okay to substitute?

Prescriber approval to substitute an EpiPen with an EAI is required in the following states: Alaska, Arkansas, Hawaii, Idaho, Maine, Mass., NH, Tennessee, West Virginia, and Wyoming.

I am in North Carolina so we can switch without approval. We dispensed our first the other day. Rx sent over for EpiPen, but NC Medicaid only covers generic EAI so we switched it.

As far as Ventolin/ProAir/Proventil, we've always switched at our professional discretion.

 

[Sine Cura]

So you mean that we can or can not substitute the product of BX rating without calling the prescriber?
Say if Rx written for Ventolin, and for whatever reason you need to substitute to pro air, can you do so without calling md? (What if pt needs it and unable to contact md?)
What about this EpiPen? Pt need that for anaphylaxis, what if we can't get a hold to md? Can we just substitute the product and call /fax md later to ask okay to substitute?

https://www.mylan.com/-/media/mylan...auto-injectors-ag-to-epipen-auto-injector.pdf

According to the U.S. Food and Drug Administration (FDA), generic drugs are equivalent to brand drugs in terms of dosage, safety, strength, quality, the way they work and the way they are administered. An [authorized generic] is a brand-name prescription drug – already approved by FDA – and marketed as a generic under a private label. The AG is sold and distributed as a generic product. Unlike a standard generic, an AG has identical inactive ingredients to the branded product. The FDA approval of the branded product as safe and effective applies to the AG, as well.

The Mylan "generic" is the authorized generic, or relabeled Epipen. The BX rating relates to Epipen vs. Adrenaclick vs. Auvi-Q, NOT to the Mylan authorized generic versus Epipen. How can something be BX-rated to itself?

 

[Lnsean]

We substitute Epipen Brand for Mylan generic of epinephrine all the time now. I will not sub out epipen with an adrenaclick generic though (a lot of techs/pharmacists will do this eventhough Walgreens system does not allow them to...they will rescan the rx and type in the generic NDC for adrenaclick...I refused to do this because if something were to happen when your pt needed the epipen...you could be held liable).

 

[CetiAlphaFive]

So they can dispense the generic mylan epipen if the RX says epipen, correct?

What he is saying is that the Mylan "generic" is literally an Epi Pen that has a different piece of paper glued to the front, making it a generic.

It is literally, LITERALLY, the same thing.