[Sqg-program] RE: Unwanted Meds - DEA impediments to pharmacy based take back

Wed Nov 22 09:07:55 EST 2006

Right to the core of the problem as usual, Charles! And, indeed, that is the
model that has been in place in British Columbia for almost 10 years. And, it
is the model receiving a lot of play in the US because . . . well . . . it
makes sense. 

Major hurdle right now is US Drug Enforcement Agency regulations that do not
allow pharmacies to receive controlled substances.  It is very difficult for
pharmacies and nearly impossible for you-and-me-medication-taker to know
whether the medication is a controlled substance. You have to know that
oxycodone, for example, is a Schedule II controlled substance (see table in
21 CFR1308.12). There are 4 other Schedules of controlled substances 21 CFR
1308.11 & 13-15). This is not intuitive stuff, neither is it marked on the Rx
label.  In a collection, you only get maybe 5 or 10% controlled substances
but you never know when one will show up so you have to have authorized
personnel at the collection at all times. Only persons that are registered
with DEA to receive controlled substances once they have been dispensed
(e.g., reverse distribution facilities; very few if any pharmacies are
registered) or law enforcement personnel are authorized to receive controlled
substances from a consumer. And, that registrant or law enforcement officer
must witness the destruction of those controlled substances. That means
actually see them being flushed or being burned.  The intent of all this is,
of course, to prevent these controlled substances from being diverted to
intentional or unintentional illicit use. Many of the controlled substances
are opiates and stimulants so you get the idea about diversion potential.

Good news is that DEA is finally coming around to considering a rule change
that removes this impediment for collections of unused medications. Timetable
unknown. That will probably ease up the main impediment to pharmacy-based
take back. Well, it will if we can figure out the always tough question of
"who will pay."

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: sqg-program-bounces at lists.dep.state.fl.us
[mailto:sqg-program-bounces at lists.dep.state.fl.us] On Behalf Of Emery,
Charles
Sent: Tuesday, November 21, 2006 5:07 PM
To: Perrigan, Glen; Sqg-program at lists.dep.state.fl.us;
flhhw at lists.dep.state.fl.us
Subject: RE: [Sqg-program] FW: Unwanted Meds in the Landfill Questions -
foodfor thought

The sad thing about all of this is the easiest solution for individuals would
have been for people to have been allowed to take their waste pills back to
pharmacies and have the pharmacy add the waste pills to their normally
generated waste pills to be sent back to the redistributions centers for
disposal as a waste.

Charles Emery III 
Environmental Manager 
South District FDEP 
Box 2549 
Fort Myers, FL 33902-2549 
Phone (239) 332-6975 
FAX (239) 332-6969 
Charles.Emery at DEP.STATE.FL.US. 

	-----Original Message-----
	From: sqg-program-bounces at lists.dep.state.fl.us
[mailto:sqg-program-bounces at lists.dep.state.fl.us]On Behalf Of Perrigan, Glen
	Sent: Tuesday, November 21, 2006 4:39 PM
	To: Sqg-program at lists.dep.state.fl.us; flhhw at lists.dep.state.fl.us
	Subject: [Sqg-program] FW: Unwanted Meds in the Landfill Questions -
foodfor thought

	Farouk: Thanks for asking some important questions about this issue.
Some food for thought:

	1.	The idea is to prevent these medicines from getting into our
wastewater treatment plants, right? 

	I don't think at this point we can prevent medications from getting
into our wastewater treatment plants because unabsorbed medications and their
metabolites are excreted from humans no matter how we dispose with the unused
medications. However, we can reduce or delay the quantity that goes there by
reducing the amounts that are flushed in favor of disposal with the garbage. 

	2.	So, let us send them to landfills with the garbage, right? 
	3.	After landfilling them, they will come out with the leachate,
right or wrong? 

	       Not necessarily.  Recall that some of our garbage is bound for
waste to energy where the fate of organics (many pharms are organics) is
quite different than in a landfill.  Landfill fate: As I understand it, we do
not monitor leachate for pharmaceuticals or their metabolites at this time.
If that is the case, we do not know what fraction of pharmaceuticals report
to leachate v. are transformed v. are sequestered in a landfill environment.
There is research going on right now at U of F on fate of ~10 pharmaceuticals
in simulated landfill environment (results about 10 months out). 

	4.	The leachate goes to the wastewater treatment plants, right?

	Yes it does. If we do determine that we need to remove
pharmaceuticals from wastewater to certain maximum concentrations, it would
seem to me to be much easier and more cost effective to pretreat ~100
leachate sources (landfills) rather than every drop of wastewater from every
toilet, urinal and sink drain in the state.  Perhaps selected pretreatment
would even reduce wastewater pharmaceutical loadings such that treatment of
all wastewater would be unnecessary or at least cheaper. 

	5.	Finally, we are back to square one, right?  

	Not at all: we are taking a basic, reasoned and practical proactive
step to reduce or delay the environmental burden. That step is based upon
incomplete science that suggests that we have a problem but is not conclusive
about that.  The answer to "What is the solution?" is even more inconclusive
than the answer to "What is the problem? How serious is that problem?"  We
need to carefully consider whether expensive regulations, e.g., new and
tougher wastewater treatment standards and processes, are warranted given
suggestive but inconclusive knowledge about the problem we are trying to
solve. 

	As always, I welcome your thoughts and am open to discussing at any
time.  Please copy David and Victor as I do not have their email addresses.
Thanks again for your feedback. 

	Best, 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: Farouk M. El-Shamy [mailto:felshamy at pascocountyfl.net] 
	Sent: Friday, November 17, 2006 10:16 AM
	To: Perrigan, Glen
	Cc: David James; Victor Norka
	Subject: 

	Glen: I received a copy of your flyer on proper disposal of unneeded
medicine. I just have a thought to share with you.

	6.	The idea is to prevent these medicines from getting into our
wastewater treatment plants, right? 
	7.	So, let us send them to landfills with the garbage, right? 
	8.	After landfilling them, they will come out with the leachate,
right or wrong? 
	9.	The leachate goes to the wastewater treatment plants, right? 
	10.	Finally, we are back to square one, right? 

	How about that for a Friday morning?

	Sincerely,

	Farouk

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