USP 797 and epinephrine

[ZakMeister]

http://wset.com/news/local/blacksburg-pharmacist-makes-epi-pen-alternative-for-20

It made me wonder how compliant the flu shots we make from the multi dose vials are compliant to USP 797 and also how viable it may be for pharmacists to start making prefilled epi injections for consumers?

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[zelman]

http://wset.com/news/local/blacksburg-pharmacist-makes-epi-pen-alternative-for-20

It made me wonder how compliant the flu shots we make from the multi dose vials are compliant to USP 797 and also how viable it may be for pharmacists to start making prefilled epi injections for consumers?

The flu shots we make are for immediate use, so they are compliant. This, however, is not. The FDA made a big deal last year about how syringes are not approved drug storage containers. Rather, they are drug administration devices. Hopefully this pharmacist has done stability/sterility testing and has an ISO class 5 environment to make these, but I'm not confident they have.

 

[Niosh]

Hopefully this pharmacist has done stability/sterility testing and has an ISO class 5 environment to make these, but I'm not confident they have.

This is the only way they could be compliant. They look like any typical retail pharmacy so I doubt they have the clean room and the sterility testing supplies. Trissel's only gives 24 hours for stability at best, so they would have had to have contacted the manufacturer for additional stability data or done their own stability testing.
What this pharmacy is doing is sketchy AF. Not to mention the picture of the no-longer-sterile syringe on an open counter next to a keyboard.

 

[BidingMyTime]

Hmmm, 24 hours for any multi-dose drug drawn up in a syringe is the rule. Pretty sure this guy is non-compliant by giving 3 months expiration.

 

[npage148]

Seriousl, just leave it in the vial and teach drawing it up.

 

[zelman]

Seriousl, just leave it in the vial and teach drawing it up.

You know there are young children out there with life-threatening allergies, right? My 7 year old cousin can use her Epipen Jr in an emergency, but I wouldn't expect her to be able to deal with a vial and syringe while she is dying.

 

[npage148]

Diabetics/caregivers do it with glucagon just fine and that involve reconstitution

I probably also wouldn't trust a 7 year old to admin an epipen properly while having an reaction.

 

[ldiot]

Do these patients even value their life? Just buy the damn pen

 

[zelman]

Diabetics/caregivers do it with glucagon just fine and that involve reconstitution

I probably also wouldn't trust a 7 year old to admin an epipen properly while having an reaction.

Glucagon dosing is the whole vial for everyone over 6 y/o (>25 kg). That increases simplicity by a huge amount. What sizes do epinephrine vials come in? Unless it's close to 0.3mg, you're gonna have panic-related dosing errors most of the time.

 

[Dred Pirate]

Glucagon dosing is the whole vial for everyone over 6 y/o (>25 kg). That increases simplicity by a huge amount. What sizes do epinephrine vials come in? Unless it's close to 0.3mg, you're gonna have panic-related dosing errors most of the time.

they do make a 0.3 mg vial - our local fire department uses it

 

[BidingMyTime]

You know there are young children out there with life-threatening allergies, right? My 7 year old cousin can use her Epipen Jr in an emergency, but I wouldn't expect her to be able to deal with a vial and syringe while she is dying.

Seriously, what do you think people did pre 1980's? It's not like life-threatening anaphylaxis attacks are anything new (although perhaps happening to a great number of people.) People in the old days used amps & syringes, they even knew how to change from a filter needle--yes, especially with young children, the people taking care of them need to be prepared to draw up and inject. Yes, it's stupid how much epipens cost, and the simplicity of epipens is very nice, but there is no reason for people to be at risk for death, amps & syringes aren't that difficult to learn how to use.

 

[zelman]

Seriously, what do you think people did pre 1980's? It's not like life-threatening anaphylaxis attacks are anything new (although perhaps happening to a great number of people.) People in the old days used amps & syringes, they even knew how to change from a filter needle--yes, especially with young children, the people taking care of them need to be prepared to draw up and inject. Yes, it's stupid how much epipens cost, and the simplicity of epipens is very nice, but there is no reason for people to be at risk for death, amps & syringes aren't that difficult to learn how to use.

Agreed. My previous post was based on my experience with epinephrine only in 1 mg and 30 mg vials. If @Dred Pirate is right, then a 0.3mg vial is a perfectly good option.