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Just to step back to the 797
question.. Chapter 797 is part of the
United States Pharmacopeia. That text is published by the United States
Pharmacopeial Convention, an organization that holds deemed status with the FDA
to create the rules that guide pharmaceutical manufacturers working under FDA
regulation. The Chapter addresses
the standards of practice for compounded sterile products, which are products
that are not manufactured by FDA regulated entities, usually meaning compounded
by pharmacies, but also applying to sterile products compounded anywhere. The FDA, and thus the USP,
has no jurisdiction in the practice of health care that falls under state
regulation, such as pharmacy, nursing, and physician practice. For that reason, USP Chapter 797 is a standard
of practice, but it is not a regulation unless the appropriate state authority
adopts the Chapter into regulations. As a standard of practice,
is can be and is employed in lawsuits that originate through a breach is
sterile drug preparation. The JCAHO integrated the 797
standards into their standards, with July 2005 as the “surveyable” date except
for facility remodeling, which has until 1/1/2008 to be completed. Chapter 797 requires that
all compounded sterile preparations be sterile at the time of administration. The Chapter does not address sterile
process once administration begins, considering that to be beyond its scope. The Chapter sets timeframes
for sterility of compounded products based on the risk of contamination for
those products. This is different
that stability, which is driven by data from resources such as Trissel’s text. For example, the Chapter
says that for low risk compounding, like reconstituting a vial to create a
single drug dose in a minibag, the product should be sterile for up to 14 days,
as long as all the proper aseptic techniques have been followed. It does not require filtration, but
indicates that filtration is one method to determine sterility. In fact, it says that if you filter
your product and the product remains sterile for 30 days (documented), then you
can use 30 days as your sterility dating. marc -----Original
Message----- That is a dangerous
situation indeed! Lynn At 1:15 PM -0700 12/2/05,
Rakay Dance wrote: This would be great if the Doc even had
nurses. He works with self trained "medical assistants" who are
hired to do what he says. He is the only infection control doc in this
side of the state. He receives referrals from all other docs.
RaKay From: Lynn Hadaway [mailto:[EMAIL PROTECTED] You are correct
that there is no oversight for rogue physicians doing things in their offices
that are outside of national standards. The only real control is for nurses not
to agree to work under these situations, but this means that the nurse must
know of these standards. We can also educate patients and families about the
credentials and accreditation to ensure safe practice. There also is a set of
practice guidelines for outpatient parenteral anti-infective therapy from the
Infectious Disease Society of America. Several years ago, Debbie Benvenuto
represented INS and I represented AVA, then NAVAN, on the committee that
updated these guidelines. There is a huge emphasis on a multidisciplinary
approach. Just don't give in to the economic pressure and lower your standards.
Lynn At 5:19 PM
-0700 12/1/05, Rakay Dance wrote: This may sound like sour
grapes but I don't understand why an infection control doc can mix antibiotics
on his desk or send them home with patients to mix and an infusion pharmacy has
such strict guidelines. We really strive for excellence and are proud of
our JCAHO status, but could be put out of business from doc's trying to boost
there income. They don't even have a pharmacist involved. Also what
can you do about an infection control doc that puts every patient on rocephin,
invanz or cubicin because of the once a day infusion that is more convient for
him. What about resistant organisms in our community. What can be
done. The doc laughs and says there are no 'pharmacy police'.
Rakay From:
[EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of KayBeth Weibel, CRNI Hi 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 |
Title: RE: Codes for PICC in DR. OFFICE
- RE: Codes for PICC in DR. OFFICE Lynn Hadaway
- RE: Codes for PICC in DR. OFFICE Stranz, Marc
