[Pharmwaste] More on the DEA issue.

Charlotte A. Smith csmith at pharmecology.com
Wed Feb 1 10:49:10 EST 2006


Hi Ann,

I think it is a viable option for Maine, given your program. I don't
know how many other states have a comparable organization that would
drive this through. We do not have a Wisconsin DEA, for example. But it
can't hurt to ask to keep the discussion moving. Perhaps both scenarios
should be put forth at the same time. 

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 Pistell,
Ann E
Sent: Wednesday, February 01, 2006 8:15 AM
To: 'pharmwaste at lists.dep.state.fl.us'
Subject: [Pharmwaste] More on the DEA issue.

 At the conference referenced below, at the end of the day I posed a
question to Andy McFaul of DEA.  The question was this; if a state DEA
office contracted with a reverse distributor to act as their agent,
could
that RD then receive any and all waste drugs, (controlled included) from
either a collection event or a mailer.  

The answer was, much to our amazement, YES.  Andy did say that the state
DEA
would need to apply for some sort of license from them, but that it
would
not be an overwhelming hurdle.  What I took away from this was that no
rule
changes would be necessary as long as there was a contractual
arrangement.

I think Andy was leaving DEA soon after and I am sorry I did not have
time
to pursue this before he left. Others heard the same judgement and I
would
like to hear if you think there is some merit in directly asking federal
DEA
if this is a truly viable option.  It would sure make everything come
together.
Ann


Today's Topics:

   1. DEA regulatory change: some real traction? (Price, John L.)
   2. RE: DEA regulatory change: some real traction?
      (Charlotte A. Smith)


----------------------------------------------------------------------

Message: 1
Date: Tue, 31 Jan 2006 09:18:23 -0500
From: "Price, John L." <John.L.Price at dep.state.fl.us>
Subject: [Pharmwaste] DEA regulatory change: some real traction?
To: <pharmwaste at lists.dep.state.fl.us>
Cc: "Charlotte A. Smith" <csmith at pharmecology.com>,
	Scott at ProductStewardship.US,	Andria Ventura
<aventura at cleanwater.org>,
	Lucy Doroshko <doroshkl at michigan.gov>
Message-ID:
	
<1CF950D45B711640999E5736460286DDC2012D at tlhexsmb2.floridadep.net>
Content-Type: text/plain; charset="us-ascii"

Charlotte: Does "a movement afoot" mean that there is finally some
traction
at or within DEA for a regulatory change in response to ongoing requests
from collection programs? Or are you referring to the ongoing clatter
from
community programs continuing to request a regulatory change? From the
email
traffic that I've seen on this issue, so far it seems that everybody
except
DEA has the stomach for a regulatory change regarding take back of
controlled substances.  If DEA is getting on board, that's progress.

Thanks, Jack.

John L. (Jack) Price

Environmental Manager

Hazardous Waste Management MS 4555

Florida Department of Environmental Protection

2600 Blair Stone Road

Tallahassee, FL  32399-2400

Phone:850.245.8751

Fax: 850.245.8811

john.l.price at dep.state.fl.us

www.dep.state.fl.us/waste

Please Note:  Florida has a very broad public records law.  Most written
communications to or from state officials regarding state business are
public records available to the public and media upon request.  Your
e-mail
is communications and may therefore be subject to public disclosure.

  _____  

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, January 30, 2006 4:50 PM
To: Lucy Doroshko; Andria Ventura; pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] RE: Pharmwaste Digest, Vol 3, Issue 12

 

Hello! There is a movement afoot to get DEA to change the regulations to
enable reverse distributors to be able to accept controlled substances
from
consumer via the mail. This already happens to some extent with product
recalls. Some of the reverse distributors, such as Capital Returns, are
researching this approach. Consumers could receive mailback instructions
when they pick up their prescriptions at the pharmacy. Once the DEA
hurdle
is overcome, funding is the next challenge. Product stewardship would
seem a
logical choice, since reverse distributors could document which drug
company
manufactured the drug if it was in the original container and a
chargeback
could be issued. Original containment will not always be the case but
could
account for a majority of the returns. Otherwise we still haven't solved
the
issue of controlled substances being diverted, involved in poisonings,
and
entering the ecosystem. 

 

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

  _____  

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Lucy
Doroshko
Sent: Monday, January 30, 2006 3:44 PM
To: Andria Ventura; pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] RE: Pharmwaste Digest, Vol 3, Issue 12

 

I know that DEA is becoming more aware of this problem and the fact that
so
many community programs are being asked by residents to manage their
waste
pharmaceuticals.  I like your idea, Andria.  What about different
colored
containers (dayglo purple or some such) so that patients would remember
that
the drug is a controlled substance?  I already know the negative part of
that idea ... then the criminal element would more easily be able to
identify discarded medication in the trash.  But, has the idea of
different
colored containers for controlled substances been put forth?

 

Lucy Doroshko, Recycling Specialist
Pollution Prevention and Compliance Assistance Section MDEQ
Environmental
Science and Services Division
525 W. Allegan, One North
PO Box 30457
Lansing, MI  48909-7957
517/373-1322
FAX:  517/241-0858
doroshkl at michigan.gov

 

Check the DEQ Recycling Website at www.michigan.gov/deqrecycling


>>> "Andria Ventura" <aventura at cleanwater.org> 1/30/2006 4:40 PM >>>

Regarding the issue of controlled substances, would it be possible to
institute a policy requiring pharmacists to inform patients that a
prescription is controlled, and therefore, not acceptable for drop off
later
on when they dispense the drug?

Andria Ventura
Clean Water Action

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Message: 2
Date: Tue, 31 Jan 2006 08:51:46 -0600
From: "Charlotte A. Smith" <csmith at pharmecology.com>
Subject: [Pharmwaste] RE: DEA regulatory change: some real traction?
To: "Price, John L." <John.L.Price at dep.state.fl.us>,
	<pharmwaste at lists.dep.state.fl.us>
Cc: Scott at ProductStewardship.US, Andria Ventura
	<aventura at cleanwater.org>,	Lucy Doroshko
<doroshkl at michigan.gov>
Message-ID: <90996AD40E063143A4EF174D3B7A5A0D1B8E5F at localhost>
Content-Type: text/plain; charset="us-ascii"

Hi John,

At the Maine conference hosted by Dr. Gressitt I presented a model for
consumer take-back using reverse distributors. During the discussion
period,
several of us asked the DEA representative specifically if they would
consider a modification in the regulations to enable that process to
take
place. Andy McFaul from DEA said that a well drafted letter from
representatives of RDs to DEA describing the process and supported by
other
regulatory bodies, such as state boards of pharmacy and controlled
substances boards, would be considered. He encouraged actual draft
language.
I believe that process has begun although I am not involved with it at
this
time. I suspect the willingness to consider such a proposal is being
driven
by the incessant questions being received by DEA as to how best to bring
unused controlled substances back out of the market. 

 

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

  _____  

From: Price, John L. [mailto:John.L.Price at dep.state.fl.us]
Sent: Tuesday, January 31, 2006 8:18 AM
To: pharmwaste at lists.dep.state.fl.us
Cc: Charlotte A. Smith; Lucy Doroshko; Andria Ventura;
Scott at ProductStewardship.US
Subject: DEA regulatory change: some real traction?

 

Charlotte: Does "a movement afoot" mean that there is finally some
traction
at or within DEA for a regulatory change in response to ongoing requests
from collection programs? Or are you referring to the ongoing clatter
from
community programs continuing to request a regulatory change? From the
email
traffic that I've seen on this issue, so far it seems that everybody
except
DEA has the stomach for a regulatory change regarding take back of
controlled substances.  If DEA is getting on board, that's progress.

Thanks, Jack.

John L. (Jack) Price

Environmental Manager

Hazardous Waste Management MS 4555

Florida Department of Environmental Protection

2600 Blair Stone Road

Tallahassee, FL  32399-2400

Phone:850.245.8751

Fax: 850.245.8811

john.l.price at dep.state.fl.us

www.dep.state.fl.us/waste

Please Note:  Florida has a very broad public records law.  Most written
communications to or from state officials regarding state business are
public records available to the public and media upon request.  Your
e-mail
is communications and may therefore be subject to public disclosure.

  _____  

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, January 30, 2006 4:50 PM
To: Lucy Doroshko; Andria Ventura; pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] RE: Pharmwaste Digest, Vol 3, Issue 12

 

Hello! There is a movement afoot to get DEA to change the regulations to
enable reverse distributors to be able to accept controlled substances
from
consumer via the mail. This already happens to some extent with product
recalls. Some of the reverse distributors, such as Capital Returns, are
researching this approach. Consumers could receive mailback instructions
when they pick up their prescriptions at the pharmacy. Once the DEA
hurdle
is overcome, funding is the next challenge. Product stewardship would
seem a
logical choice, since reverse distributors could document which drug
company
manufactured the drug if it was in the original container and a
chargeback
could be issued. Original containment will not always be the case but
could
account for a majority of the returns. Otherwise we still haven't solved
the
issue of controlled substances being diverted, involved in poisonings,
and
entering the ecosystem. 

 

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

  _____  

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Lucy
Doroshko
Sent: Monday, January 30, 2006 3:44 PM
To: Andria Ventura; pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] RE: Pharmwaste Digest, Vol 3, Issue 12

 

I know that DEA is becoming more aware of this problem and the fact that
so
many community programs are being asked by residents to manage their
waste
pharmaceuticals.  I like your idea, Andria.  What about different
colored
containers (dayglo purple or some such) so that patients would remember
that
the drug is a controlled substance?  I already know the negative part of
that idea ... then the criminal element would more easily be able to
identify discarded medication in the trash.  But, has the idea of
different
colored containers for controlled substances been put forth?

 

Lucy Doroshko, Recycling Specialist
Pollution Prevention and Compliance Assistance Section MDEQ
Environmental
Science and Services Division
525 W. Allegan, One North
PO Box 30457
Lansing, MI  48909-7957
517/373-1322
FAX:  517/241-0858
doroshkl at michigan.gov

 

Check the DEQ Recycling Website at www.michigan.gov/deqrecycling


>>> "Andria Ventura" <aventura at cleanwater.org> 1/30/2006 4:40 PM >>>

Regarding the issue of controlled substances, would it be possible to
institute a policy requiring pharmacists to inform patients that a
prescription is controlled, and therefore, not acceptable for drop off
later
on when they dispense the drug?

Andria Ventura
Clean Water Action

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