[Pharmwaste] Drug collection information
Charlotte A. Smith
csmith at pharmecology.com
Wed Nov 16 23:04:23 EST 2005
Yes, Steve, it took about 9 years for the RD regulations to get
finalized. We did have a Memorandum of Understanding to work under,
though, very early in the game.
Charlotte A. Smith, R. Ph., M.S., HEM
President
PharmEcology Associates, LLC
200 S. Executive Drive, Suite 101
Brookfield, WI 53005
Phone: 262-814-2635
Fax: 414-479-9941
csmith at pharmecology.com
-----Original Message-----
From: Stevan Gressitt [mailto:gressitt at uninets.net]
Sent: Wednesday, November 16, 2005 7:45 PM
To: Charlotte A. Smith; grace.welham at deancare.com; 'Bickford, Barbara
J.'
Cc: pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Drug collection information
Charlotte, As I was sitting besides Andy when the statement you make was
made I would like to vouch for your accuracy. There is frequently a gap
between the district office and central headquarters. I would also like
to reiterate, I heard clearly that no rules or regulations have been
changed.
If there is reference to any rule change it was that the DEA has indeed
issued final regulations on automatic dispensing units for long term
care facilities. I thank Andy for educating me this past week that these
are not table top fit-in-the-back-of-a-pickup-truck units. These are
sophisticated computerized heavy units that aren't akin to fancy
buckets, modified mail boxes, or sharps containers. They outsize ATM
machines as I understand it.
Part of the problem is that there are multiple DEA district/regional
offices with varying contact points in an agency that is woefully
undermanned. Within the context of increasing demand on their services
we are bringing up a whole new area that takes sober consideration on
their part. As I recall it was many years in the making, not weeks or
months, for the LTCF to have final regs published in the Register. I
have been told (Charlotte please add history here?) that it was actually
many years from inception to when the Reverse Distribution Industry
obtained their licensure regulations.
In my simple opinion there has been increased call from press, some
areas of the public, and the waste world and the public health community
to try and resolve this obstacle and the DEA is responding. I think we
will have to keep making efforts to provide reasonable proposals to
them, consolidate as many as possible into replicable processes, and in
time with no untoward events the process will evolve. In the meantime,
untoward events, diversion, loss, theft are the villains we should be
trying to keep at bay or our efforts will be soundly discredited, and
rightfully so.
More recently information is becoming available from the area of the
world hit by the tsunami and the volume of unusable donated medicine
with expiration dates back to 1987 among other problems such as labels
in languages unfamiliar to the staff in the region will lead to ore
pressure to resolve this problem. I believe discussions are ongoing as I
type. This unfortunate and embarrassing situation for many countries and
agencies will lead to more focus on good donation practices and
avoidance of bad donation practices and perhaps even removal of tax
advantages for donating what is essentially trash under the guise of
"humanitarianism."
More concretely, it is my understanding that several of the reverse
distributors were by now to have had a conference call at the very least
to see how their industry could step up to the plate. It may well be
that for those of us who do not belong to that "club," we may need to
ask when they will move beyond competitiveness into the world of
collaboration. I hope that is taken constructively given that the former
Reverse Distribution Industry web page appears now to be down ( There
was a trade association I dealt with a couple years ago that has simply
disappeared after neglect by the various companies and failure of it to
represent all of them beyond a few of the major players.) It may be time
to call on the Reverse Distributors to recreate an industry
organization.
Stevan Gressitt, M.D.
-----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: Wednesday, November 16, 2005 5:27 PM
To: grace.welham at deancare.com; Bickford, Barbara J.
Cc: pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Drug collection information
Hi all,
Our understanding of the DEA's position is that the law enforcement
agent must take it back to their facility and dispose of it as they do
confiscated items. It does not go back into the DEA loop. You might want
to confirm that with your agent in Milwaukee. Andy McFaul from DEA in
Wash was quite clear that the rules had not been changed to allow the
drugs back into the system at this 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
grace.welham at deancare.com
Sent: Wednesday, November 16, 2005 3:18 PM
To: Bickford, Barbara J.
Cc: pharmwaste at lists.dep.state.fl.us
Subject: Re: [Pharmwaste] Drug collection information
Hello,
Regarding the DEA rule changes, I believe they have already changed the
rule. Or, perhaps they simply made an existing rule apply. The only
thing that really changed is that if law enforcement accepts medications
for disposal, they can hand it over to a DEA licensed waste hauler,
where the controlled substances re-enter the controlled substance system
(meaning it must be documented where the controlleds go and who handles
them), but they DO NOT need to be destroyed immediately. This is in
accordance with CFR 1307.12 I believe. I am uncertain how the
regulation read before, but I don't believe it's going to get easier for
us to collect controlled substances.
I'm not sure my message to Donna got posted, so I've copied it here:
Hi Donna,
I'm working on the Madison, WI project, which is scheduled for Spring
2006. If you have contacts at the CDC, I am happy to speak with them
regarding the collection.
To answer some of your questions, the containers we are using are from
the hazardous waste hauler. The meds are going directly into the drums
used for transport. I am uncertain of Michigan pharmacy law, however in
Wisconsin, the only meds that can be accepted are ones that are
dispensed in error. One of my concerns in doing a collection at the
pharmacy is that pharmacy staff would have to log each and every drug
that is collected to document the meds collected are not re-dispensed to
patients. That would cause a considerable amount of paperwork. If
Michigan proceeds with the collection at pharmacies, I strongly
recommend speaking with the Michigan Board of Pharmacy to ensure
compliance with their rules and regulations. I've copied Dianne Miller
at Michigan Pharmacists Association. She will have more information
regarding Michigan pharmacy specifics.
As for the DEA, if it is possible to ensure controlled substances aren't
collected, I don't think they would care too much. However, you bring
up a good point that many patients may not be aware their medication is
controlled. DEA wants all controlled substances (Schedule II-V) to be
documented, and many patients don't realize their sleeping pill or
prescription cough syrup is controlled. If controlled substances are
collected, law enforcement must be present at the collection under USC
Section 844 and 21 CFR Section 1301.24. It would be difficult for the
pharmacist to tell a patient they can't take the medication back because
a police officer isn't present. To the patient, it's all the same
thing; to pharmacists and DEA it is not. If you want to do a continuous
collection, I would recommend asking the police department to hold the
collection as they are able to accept all medications and from there the
DEA licensed haz waste hauler can take the meds for disposal.
I have been in contact with Investigator Tom Hill at the Milwaukee DEA.
If he not able to help you, he can probably direct you to the right
person. His phone number is (414) 297-3395.
----------------------------------------------------------
Grace Welham, Pharm.D.
Drug Information Pharmacist
Dean Health System
(608) 250-1198
----------------------------------------------------------
"Bickford, Barbara J."
<Barbara.Bickford at dnr.state.w To:
<pharmwaste at lists.dep.state.fl.us>
i.us> cc:
Sent by: Subject:
[Pharmwaste] Drug collection information
pharmwaste-bounces at lists.dep.
state.fl.us
11/16/2005 02:16 PM
On 11/14, Wendi Shafir forwarded to this list serv a request from Donna
Twickler, EPA Region 5, in the form of Donna's email to me. Here is
what I sent to Donna with one small addition (Donna, that is EPA's
website on pharmaceuticals and the environment). If anyone else
responded to Donna, I invite you to post your response here also.
Barb Bickford, Medical Waste Coordinator
WI Dept. of Natural Resources, Bureau of Waste Management
101 S. Webster St., P.O. Box 7921, Madison, WI 53707-7921
Phone: 608-267-3548 FAX: 608-267-2768
barbara.bickford at dnr.state.wi.us OR medical.waste at dnr.state.wi.us DNR
medical waste information: www.dnr.wi.gov/org/aw/wm/medinf/
Hospitals for a Healthy Environment: www.h2e-online.org
______________________________________________
From: Bickford, Barbara J.
Sent: Thursday, November 10, 2005 4:33 PM
To: 'Twickler.Donna at epamail.epa.gov'
Subject: Drug collection information
Donna, my answers are indented below.
Hi Barb,
USEPA Region 5 was approached by CDC to participate in a
pharmaceutical collection program with them (and FDA) in Michigan.
The focus of their collection is antibiotics, however they will
accept other solid pharmaceuticals that are not considered
controlled
substances.
Apparently this is the first time CDC has done this, so they are
looking for information and support. I mentioned Wisconsin has a
pharmaceutical collection in Madison scheduled this Fall. CDC has
contacts in Madison, so they are very interested in the specifics
of
the Madison collection event. I was wondering whether you could
provide me with some specific information on the collection, which
I
can share with CDC?
The collection will be April 29, 2006, not this fall.
Contact:
Grace Welham, Pharm.D.
Drug Information Pharmacist
Dean Health System
(608) 250-1198
grace.welham at deancare.com
The proposed Michigan collections would involve secure drop off
containers/totes located at Meijer stores throughout Michigan, for
a
3 month period. It's unclear whether these containers would be
situated in the customer area near the pharmacy or behind the
counter. They will be somehow monitored by the pharmacy staff.
The first question CDC asked is whether USEPA has any containers
for
depositing the pharmaceutical bottles in the container, but would
prevent access to the drugs after they had been deposited. An
example is a mailbox type container, either attached to a wall or
free standing that is secured. USEPA Region 5 does not have this
type of container
nor the ability to purchase them. Along these lines I was
wondering
what type of containers Wisconsin used/will use for their one day
collection. Are you aware of containers that meet the above
description in the healthcare setting that could possibly be
borrowed
for the duration of the project? I saw a medical waste contaier
in
the Federal Occupational Health office today, when I received a
flu
shot. It was designed like a mailbox, however it was smaller
than
would be needed for pharmaceutical collections. The nurse
thought
there were larger containers of the same design available for
purchase.
I don't know what containers Dean Health Systems intends to
use. I suppose they will receive them, sort out the
controlled
substances, sharps, mercury thermometers, and aerosals and
put
the remainder directly into DOT compliant shipping
containers.
The question I have is whether theMichigan project group had
coordinated with U.S. Drug Enforcement Agency to date. I know you
have received guidance from their DC HQ DEA office. I am not sure
that the only thing that the project team has to do is say "no
controlled substances will be collected". Do individuals always
know
whether their perscription is a controlled substance? Does it
matter
whether or not the individual deposits the drug directly into the
container or the pharmacy staff deposits it. How are containers
typically secured? I know that the DEA issues drive most
programs
to have 1 day pharm collection events, due to the fact that a law
enforcement official has to be present during the collection.
I don't know if prescriptions must be labelled as controlled
substances. Even if they are, you cannot guarantee that CSs
won't be brought in. Charlotte Smith told us last week that
about 10% of prescriptions are CS's, which is a lot, and for
painkillers (as are used after oral surgery) there are often
unused Rx's out there in medicine cabinets.
I haven't heard anything to suggest that the person must
deposit the drug vs the collector. I have heard of that for
sharps, if the collector touches the container, they must
have
bloodborne pathogen training and have been offered the
shots.
This is really more of an OSHA issue, and maybe you should
ask
them.
Again, I don't know much about the containers or how they
are
secured.
Also, could you provide me with the name of the person at DEA you
with whom you have been coordinating? I would like to contact
them
directly, to ask them if they would like to or feel they need to
participate on the work group. I would also like to ask whether
they
have secure containers that could be borrowed for the 3 month
duration of the project. It is estimated that approximately 190
containers would be needed.
I'll try to forward the letter Grace got from DEA. [I did,
and
Grace had posted it to this listserve in mid-September]
Charlotte Smith was at a meeting sometime recently where a
DEA
person said DEA may have to change its rules to accommodate
drug collections. DEA is aware that their rules present a
road
block and force people to flush/landfill contrulled
substances,
and that that is not good for the environment.
CDC decided to use Phamlink (sp) for disposal. I don't know
anything
about this company, but according to CDC they meet all applicable
disposal regulations (including EPAs). What company are you
using
for
disposal?
I am not sure but I think they are using Onyx.
The last question I have is whether Wisconsin has information on
the
environmental hazards associated with the improper disposal of
pharmaceuticals. We are checking with our headquarters office to
determine if there is any EPA information on this available for
distibution.
Nothing specific from us. USGS has done some studies
linking
the presence of some compounds with problems in aquatic
life.
EPA information on the environmental hazards associated with
the improper disposal of pharmaceuticals is available at
www.epa.gov/nerlesd1/chemistry/pharma/index.htm.
Any information you could provide would be greatly appreciated.
Thanks!
Donna
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