[Pharmwaste] Drug collection information

grace.welham at deancare.com grace.welham at deancare.com
Wed Nov 16 16:17:46 EST 2005


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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