Re: USP 797

[Lynn Hadaway]

Title: Re: USP 797

Here is my understanding of 797:

Because this is written by the US Pharmacopeia, it is applicable to all situations where drug compounding is done. The issue is oversight. State boards of pharmacy have control over all pharmacies and do inspect and accredit them. However the state pharmacy boards will not be involved with any situation that is not a pharmacy. So the doctors offices, ambulatory care centers, infusion centers, etc without a pharmacy will have no oversight to ensure that they are complying with 797. The only possible way could be the payers. If they demand compliance with 797, then these other places may have to become compliant. As I said before, nurses should refuse to work in these situations and we should be educating patients and families about these guidelines. But again, a patient may not be given a choice of pharmacy sources when the doctor is prescribing and providing the drugs. This is only going to get worse with the new Medicare Plan D, Prescription Drug Benefit plan. Our brilliant legislators only provided payment for the drug itself. That plan will not reimburse for any compounding services or supplies or for any administration services or supplies. How will a 75 year old with vision and motor coordination problems take a vial of lyophylized powder and properly prepare it for safe infusion? I think there will be lots of problems yet to come. Lynn

At 10:03 AM -0800 12/2/05, Nancy Bagnall-Trick RN, CRNI wrote:

Hello All -

 

You can find more info on USP 797 at the ASHP web site: www.ashp.org    Enter "USP 797" in the search space and you will get a long list of choices on the subject.

 

This is a very interesting topic and one that has created quite a stir in the pharmacy community.  My understanding (simplistic as it is) is that 797 addresses the process used to ensure a consistent quality outcome in the preparation any infusion therapy prepared in the pharmacy setting.  This may or may not include filtering, depending on your interpretation of quality measures or indicators used to define the outcome of preparation processes.   The best person I know to comment on this is Marc Stranz RPh.  Marc will know how it affects/doesn't affect preparation in MD offices. He has commented on this topic before...

 

Nancy

"KayBeth Weibel, CRNI" <[EMAIL PROTECTED]> wrote:

Sorry

KayBeth

----- Original Message -----
From: "Tim Talbert"
To: "CRNI KayBeth Weibel" ; "list serve"

Sent: Thursday, December 01, 2005 12:25 PM
Subject: Re: Codes for PICC in DR. OFFICE


There is no USP 797 requirement related to filtering after some period of
time, nor is such a requirement rational. It either needs to be filtered or
it does not.

Tim

>>> "KayBeth Weibel, CRNI" 11/30/05 >>>
RE: Codes for PICC in DR. OFFICEHi Shirley,

Your hospital may be getting it's information from the 797 guidelines. We
are a home infusion pharmacy that follows the 797 guidelines and we do not
need to filter our final products, unless it is TPN or the drug dictates
that it be filtered. We are not required to filter our antibiotics, because
our clean room meets the 797 guidelines, and we only dispense one week of
product at a time. Mostly, we are dictated by a drug's stability in
solution.

KayBeth Weibel, CRNI
Infusion Network
Falmouth, MA
----- Original Message -----
From: Lynn Hadaway
To: Venz, Shirley ; [EMAIL PROTECTED]
Sent: Wednesday, November 30, 2005 11:19 AM
Subject: RE: Codes for PICC in DR. OFFICE


I am not aware of any evidence stating that drugs for XX amount fo days
requires filtration. There are some meds that must be filtered for all doses
and your pharmacy should know which ones these are. Lynn


At 3:30 PM -0600 11/29/05, Venz, Shirley wrote:
Can anyone tell me requirements for filtering IV antibiotics
administered more than 5 days? Our hospital has had that policy for years

but I can't find evidence of why.
Thanks, Shirley

-----Original Message-----
From: [EMAIL PROTECTED]
[mailto:[EMAIL PROTECTED] Behalf Of Rakay Dance
Sent: Tuesday, November 29, 2005 2:39 PM
To: [EMAIL PROTECTED]; [EMAIL PROTECTED]
Subject: Codes for PICC in DR. OFFICE

Would anyone have codes for a PICC that is placed in a Dr.'s office?
Equipment, nursing time and all. I would appreciate the help. RaKay




--
Lynn Hadaway, M.Ed., RNC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861


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Lynn Hadaway, M.Ed., RNC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861