Showing results for 
Search instead for 
Do you mean 

Reply
Highlighted
Administrator
Posts: 578
Registered: ‎02-22-2010
0

Single Dose Vials Webinar

[ Edited ]

Thanks for joining our webinar with Eric Kastango on "Maximizing the Use of Single Dose Vials."

 
View the on-demand recording or download the slides.

 

Have a question for Eric? Post it here and he will do his best to answer.

Administrator
Posts: 578
Registered: ‎02-22-2010
0

Re: Single Dose Vials Webinar

Here are some questions from today's live presentation:

 

Q: If a SDV can only be kept for 6 hr in a LAFW after opening, can we use the 30 hour (room temp) or 9 days if refrigerated BUD for medium risk products if drawn up in single dose syringes or vials?

 

 

Q: All repacked doses must be assigned and labeled with a BUD based on appropriate determination of contamination risk level. What would be the risk level on single use vials, undergoing multiple entries to make multiple smaller doses?

 

If this is “assigned a BUD” then does that mean that NO end product testing is required even though this is very similar to “batching” items?

 

 

Q: If information on storage, stability, and beyond use dating is not available in the manufacturer’s directions, CMS and The Joint Commission defer to recommendations available through nationally recognized sources, what does CMS say about independent stability testing when no published data in nationally recognized sources are available?

 

In other words, if manufacturer says their product has been tested and is stable for 24hrs in a certain solution. If I have an independent lab test the same ingredients and their tests show stability data for 7days. If I follow this stability data and assign a BUD based on the risk level of this admixture and it is within the 797 guidelines, does CMS approve?

 

 

Q: What do we do with stability data that does not include microbial data? Example, recent Velcade study showing up to 5 days stability for the reconstituted single-dose vial.

Occasional Advisor
Posts: 7
Registered: ‎05-19-2011

Re: Single Dose Vials Webinar

  Even better~why are companies packaging (Velcade) in 3.5mg vials when the dose is so much smaller?

Expert
Posts: 1,167
Registered: ‎02-23-2010

Re: Single Dose Vials Webinar

That is a great question and one the FDA has started to ask the manufacturers!

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,167
Registered: ‎02-23-2010

Re: Single Dose Vials Webinar

To everyone who attended the webinar on Wednesday, as you know, we experience some significant technical issues.  Sorry for the inconvenience.   The webinar will be repeated on August 30th @ 1pm EDT.  Stay tuned for more information from Pharmacy OneSource. Thanks.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Anonymous
Posts: 0

maximizing the use of Single dose vials webinar

Eric

I posted earlier in another area but then attended your webinar.  I guess I'm a little confused on SDV BUD.... In the pharmacy, we mix the bupivacaine (with preservatives) for pain pumps and give a 9 day exp (medium risk).  However with the shortage of the bupivacaine with preservatives, we are considering using the SDV without preservative.  My initial thought is that must be used within 6 hr due to SDV requirement but listening to the webinar, it sounds like we can give it a medium risk BUD.

 

Can you clarify for me -- what is the BUD for medications mixed under aseptic technique in the pharmacy if there are no preservatives in the vial (SDV)

 

Thanks

Nancy

Administrator
Posts: 578
Registered: ‎02-22-2010
0

Re: Single Dose Vials Webinar

Here are some questions from our live rebroadcase on August 29, 2012:

 

Q: Does the  FDA require that the rationale for how much overfill is included in a vial and why be submitted with the original NDA?  ­

 

Q: ­Can you recommend a sterile glove appropriate for hazardous drug compounding?­

 

Q: If you have to discard a SDV after 6 hours or according to the manufacturer's PI, don't you theoretically have to give the BUD of the drawn up product (into multiple doses/packages) 6 hours or less, and nothing longer than 6 hours?

Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: maximizing the use of Single dose vials webinar

Nancy,

 

Using your compounding personnel is trained and has passed their media fill testing, uses good aseptic technique (sterile gloves and sterile alcohol), you can treat any CSP made from a SDV as a medium-risk level CSPs and can use the default BUDs (30 hours room temp, 9 days refrigerator and 45 days frozen) in the chapter.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,167
Registered: ‎02-23-2010

Re: Single Dose Vials Webinar

Q: Does the  FDA require that the rationale for how much overfill is included in a vial and why be submitted with the original NDA? 

 

A­: I don't know.  I will try to find out.

 

Q: ­Can you recommend a sterile glove appropriate for hazardous drug compounding?­

 

A: I know Covidien makes a sterile glove that is appropriate for hazardous drug compounding.

 

Q: If you have to discard a SDV after 6 hours or according to the manufacturer's PI, don't you theoretically have to give the BUD of the drawn up product (into multiple doses/packages) 6 hours or less, and nothing longer than 6 hours?

 

A:  BUD is about both microbial sterility (which USP 797 risk levels are based on) and chemical stability.  If the drug is chemically stable and all elements of the chapter are adhered to, then you can treat all CSPs made from a SDV as a medium-risk level CSP using the default BUDs from the chapter. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Anonymous
Posts: 0

Re: maximizing the use of Single dose vials webinar

Thanks Eric... that helps alot!

 

Nancy