[Pharmwaste] Bmps, controlled substances and hospitals?

Charlotte A. Smith csmith at pharmecology.com
Tue Feb 28 12:46:59 EST 2006


Hi Matt,

I couldn't agree more! I'd like to expand that model a bit and propose
that pharmaceutical reverse distributors are ideally suited for this
function. They have the systems and software to bring product back into
their warehouses and licenses and permits needed for security. DEA has
indicated a willingness to entertain a change in the controlled
substance regulations to enable this to happen, since under the current
regulations, controlled substances cannot be returned through the system
once they are dispensed to consumers.  Several reverse distributors are
working towards a letter to this effect requesting this type of change.
Once that regulatory hurdle is removed, a joint effort between
manufacturers, the retail drug community, and the reverse distributors
could make this happen. 

Kudos to Karin for a wonderful presentation and for raising interest in
this complex issue. 

Best regards, 

Charlotte A. Smith, R. Ph., M.S., HEM
President
PharmEcology Associates, LLC
200 S. Executive Drive, Suite 101
Brookfield, WI 53005
262-814-2635
Fax: 414-479-9941
csmith at pharmecology.com
www.pharmecology.com
H2E Champion for Change Award 2004

-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of McCarron,
Matthew
Sent: Tuesday, February 28, 2006 11:32 AM
To: Gilliam, Allen; pharmwaste at lists.dep.state.fl.us; H2E - Hospitals
for a Healthy Environment - Info Exchange Listserv
Subject: RE: [Pharmwaste] Bmps, controlled substances and hospitals?

Karin North from Palo Alto gave this presentation at the California HHW
conference last April, it has additional data to the last two notes:
http://www.ciwmb.ca.gov/HHW/Events/AnnualConf/2005/April28/Session2/Haza
rdDJour/ControlPharm.pdf

While Karen was explaining the value of partnerships for diversion of
Pharm. waste from waste water using HHW drop off, the same HHW drop off
facilities are woefully under funded as it is. The manufacturers have
discharge permits and/or NPDES permits at their production facilities.
The same mechanism that delivers the product to the Hospitals, retail
stores, and  Pharmacies can bring back to the production facilities
unused, out dated or recalled  products.  We just need that same relief
for "waste Pharm products".  The cost internalization for this process
should be part of the price.  It is much easier to put treatment
controls on a handful of production facilities than 10's of thousands of
Pretreatment programs.  The take back model is the only one that make
sense.

Matt McCarron 
California Integrated Waste Management Board  
1001 I Street, 13th Floor  39-G 
Sacramento, Ca. 95814 
916-341-6456 
916-319-7658 fax 
<mmccarro at ciwmb.ca.gov> 
www.ciwmb.ca.gov/
 
"Where is the knowledge that is lost in information?  Where is the
wisdom that is lost in knowledge?"   --T.S. Elliot


-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Gilliam,
Allen
Sent: Tuesday, February 28, 2006 6:53 AM
To: pharmwaste at lists.dep.state.fl.us; H2E - Hospitals for a Healthy
Environment - Info Exchange Listserv
Subject: [Pharmwaste] Bmps, controlled substances and hospitals?

observations tell me "most w.w. treatment facilities" aren't aware of
what's being flushed from their hospitals.  Here in arkie holler, I'd
guesstimate less than a third of our hospitals are permitted/sampled.
At the permitted ones, the focus is mainly their grease traps'
maintenance with a few being monitoring for silver and mercury.  What
percent of the entire plant's flow is "total toxics, controlled and/or
hazardous"?  My guess would be well below 10% and any exotics would have
been lost in the mix and non-detectable at the sampling point.
Non-detect = 0 toxics = no problem?  Maybe so...clapton says, "let it
rain, let it rain"...until we have species of fish that are all female
and become extinct. 

Repeating the "schtick" in the pretreatment regs (jump in here EPA HQ's
if I'm over generalizing again) in 40 CFR 403.12(p)(1),(2)&(4) @
http://www.adeq.state.ar.us/water/branch_npdes/pretreatment/pdfs/403.pdf
does require

(1) The [hospital] shall notify the [city]...etc...in writing of any
discharge into the POTW of a substance, which, if otherwise disposed of,
would be a hazardous waste under 40 CFR part 261.
(2) [hospitals] are exempt from the requirements of paragraph (p)(1) of
this section during a calendar month in which they discharge no more
than fifteen kilograms [~4 gallons] of hazardous wastes, unless the
wastes are acute hazardous wastes as specified in 40 CFR 261.30(d) and
261.33(e).  Discharge of more than fifteen kilograms of non-acute
hazardous wastes in a calendar month, or of any quantity of acute
hazardous wastes as specified in 40 CFR 261.30(d) and 261.33(e),
requires a one-time notification.  HAS THIS BEEN DONE AND THE CITY SAID
"OK, NO PROBLEM"?

THE BMP "SCHTICK"?  (4) In the case of any notification made under
paragraph (p) of this section, the [hospital] shall certify that it has
a program in place to reduce the volume and toxicity of hazardous wastes
generated to the degree it has determined to be economically practical.

Laurie?  It's in my optimistic mind that a lot of cities are finally
catching on to this federally required "program in place" (H2E's already
written it for them) and now specifically placed the language in their
permits.  These same requirements obviously, should also be placed  on
our long term health facilities, dentist offices (BMP already written
for this sector also), etc.

The above requirements and (on the surface) seemingly voluntary
practices have been shouted from every hill and vale here in this state
with no cities taking the bait.  I hope yours proves more fruitful to
help achieve the clean water act's objective of eliminating pollutant
discharges to waters of the U.S.  

"What do we do with the controlled substances?"  As Charlotte says
below, "there's not a good method yet".  the DEA is reading from their
book while EPA's reading from theirs.  And, the two don't seem to have
any overlapping chapters.  Hopefully, with the knowledge and energy of
some of the experts on this pharma listserve (Dr. Gressitt?), DEA
reg/policy changes (as we speak) can happen quickly to allow for the
most unencumbered, safe and economic means of handling/disposal.

The PSI group should be lauded in its attempts to bring this issue under
one roof as well as Charlotte for her one person "show on the go".

Hopefully Dr. Gressitt will keep us all informed on what's transpiring
"on the hill".

Allen Gilliam
ADEQ state pretreatment type guy

     



-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Charlotte
A. Smith
Sent: Monday, February 27, 2006 12:25 PM
To: Tenace, Laurie; pharmwaste at lists.dep.state.fl.us; H2E - Hospitals
for a Healthy Environment - Info Exchange Listserv
Subject: RE: [Pharmwaste] how do hospitals keep controlled substances
out ofthe sewer?


Most waste water treatment facilities I am aware of still allow flushing
of controlled substances since there are very limited options to meet
Drug Enforcement Administration disposal requirements. Hospitals can
give an estimate of how much would be involved based on a sample of
their witnessed destruction records. If it is an unused PCA morphine IV
or other relatively high volume, contained drug, it can go back through
reverse distribution through a transfer between registrants. When it's a
cc from a syringe, that's a problem. Some folks squirt it into the trash
or red sharps. 

Short answer - there is no really good method yet. 

Charlotte A. Smith, R. Ph., M.S., HEM
President
PharmEcology Associates, LLC
200 S. Executive Drive, Suite 101
Brookfield, WI 53005
262-814-2635
Fax: 414-479-9941
csmith at pharmecology.com
www.pharmecology.com
H2E Champion for Change Award 2004

-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Tenace,
Laurie
Sent: Monday, February 27, 2006 12:09 PM
To: pharmwaste at lists.dep.state.fl.us; H2E - Hospitals for a Healthy
Environment - Info Exchange Listserv
Subject: [Pharmwaste] how do hospitals keep controlled substances out of
the sewer?

I got a question today from one of our waste water treatment people. She
has tasked the hospitals in her district with developing BMPs for waste
water. They have asked her how they should manage controlled substances
that would have previously been flushed since she had told them that is
no longer acceptable.

How have other hospitals handled this issue? 

Sorry for cross posting - I know some of you are on both list serves.

Thanks,
Laurie 

Laurie J. Tenace
Environmental Specialist
Florida Department of Environmental Protection 2600 Blair Stone Road, MS
4555 Tallahassee, Florida 32399-2400
PH: (850) 245-8759
FAX: (850) 245-8811
Laurie.Tenace at dep.state.fl.us
 
view our mercury web pages at: 
http://www.dep.state.fl.us/waste/categories/mercury/default.htm
 
 

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