[Pharmwaste] Any laws to address medical samples proper disposal by sales reps?

Mon Jan 12 11:37:59 EST 2015

Dear Ms. Sanborn,

Medical offices could not legally dispose of unwanted (most likely outdated) pharmaceutical samples through the DEA Take Back Initiative.  These would normally be returned using a reverse distributor.

Some of the samples given to patients certainly showed up (legally) at DEA take back events.
The claim that this amounted to 40% of what was collected is outrageously false.

The inventory data my program collected didn't distinguish between medications packaged as samples and those in retail packaging.  Once the outer packaging is removed there is probably no way to tell one from the other.  I and one of the pharmacists that worked on our inventory, don't remember receiving any significant number of samples.

We did take in OTC, herbal medications, and vitamins.  If all of these are considered "non-target" then the percent could easily have been as high as 40.  Maybe these manufactures meant to say "non-target" rather than "samples"?

Further, I would be shocked if the national DEA office has any sort of inventory data for the medications collected during their take back program.  The national office doesn't even know the wight collected at each site!

I was told by the DEA that the only information that field offices were asked for by state DEA offices was the weight collected, the number of collection locations, and the number of law enforcement agencies participating.

The national DEA office only asked the state offices for the total weight collected, the number of collection locations, and the number of law enforcement agencies participating.  I know this because National totals are what they sent in response to my FOIL request for the weight collected at each location.  When I promptly appealed, stating they sent me the incorrect information, they first claimed I missed the appeal deadline.   After proving that I did not miss the deadline, they said that they didn't have the information I requested in the national office.  I didn't follow up with FOIL requests to each state office.

Some inventory work was done.  Someone from this listserv provided a one page chart summarizing Arkansas's Participation in DEA National Take Back Initative Results (seven events, through 10/26/13).  Along with AR totals for weight collected, number of collection locations and law enforcement agencies participating, there was an estimate, by the AR State Crime Lab, of the total number of pills collected in AR by event.  It is possible the crime lab actually looked at a random sample of what was collected to estimate the number of pills per pound.  It is also possible that at the same time they looked at other things as well.  If so, there are many things, such as what percent was controlled, that would have been looked at before samples were counted.  I just left a phone message with someone at the AR crime lab who may be able to shed light on what they did.  Other state crime labs, or other agencies, may have done some inventory work.  If so, no word of it has reached this listserv.

Finally, the DEA has publicly said the program was discontinued once the new rule, allowing pharmacies to take back controlled, was adopted, since the public now has other ways to dispose of their unwanted medications (despite the fact that it will take an unknown amount of time for this option to be widely available.)  Unless those manufactures produce some, there is no evidence to believe there are any other reasons.

Ed Gottlieb
Chair, Coalition for Safe Medication Disposal
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY  14850
(607) 273-8381
fax: (607) 273-8433
________________________________
From: pharmwaste-bounces at lists.dep.state.fl.us [pharmwaste-bounces at lists.dep.state.fl.us] on behalf of Heidi Sanborn [Heidi at calpsc.org]
Sent: Saturday, January 10, 2015 2:13 PM
To: Tenace, Laurie; 'pharmwaste at lists.dep.state.fl.us'
Subject: [Pharmwaste] Any laws to address medical samples proper disposal by sales reps?

Dear Pharma Listserv:

I was in a meeting yesterday where the lobbyists for Norvo Nordisk and Bay Bio were stating that the DEA wasn’t having any more med collections because 40% of what they were collecting was not targeted product and they were told it was medical samples.  I asked for names or anything in writing and didn’t get them.

1)      Has anyone confirmed that 40% of what comes in DEA events was medical samples or could you disprove that statement?

2)      Does anyone know of any local, state or federal law that requires management of medical samples outside of public medicine bin programs?

Thanks for your help!

Heidi

********************************************************************
Heidi Sanborn, Executive Director
(916) 706-3420  office  (916) 402-3911 cell  Heidi at CalPSC.org<mailto:Heidi at CalPSC.org>
[cpsc_logo_350_pix]
[cid:image001.png at 01CC57C5.8223CD60]<http://www.calpsc.org/>Web<http://www.calpsc.org/>   [cid:image002.png at 01CC57C5.8223CD60] <http://www.youtube.com/calpsc>  YouTube<http://www.youtube.com/calpsc>   [cid:image011.png at 01CC47A7.7F3D5C20] <http://www.facebook.com/pages/California-Product-Stewardship-Council/260410326394>  Facebook<http://www.facebook.com/pages/California-Product-Stewardship-Council/260410326394>   [cid:image012.png at 01CC47A7.7F3D5C20] <http://twitter.com/CalPSC>  Twitter<http://twitter.com/CalPSC>   [cid:image013.png at 01CC47A7.7F3D5C20] <http://linkedin.com/companies/275758/california+product+stewardship+council>  Linked In<http://linkedin.com/companies/275758/california+product+stewardship+council>
*********************************************************************

-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/attachment.html
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image003.jpg
Type: image/jpeg
Size: 757 bytes
Desc: image003.jpg
Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/image003.jpg
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image004.jpg
Type: image/jpeg
Size: 782 bytes
Desc: image004.jpg
Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/image004.jpg
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image005.jpg
Type: image/jpeg
Size: 760 bytes
Desc: image005.jpg
Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/image005.jpg
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image006.jpg
Type: image/jpeg
Size: 750 bytes
Desc: image006.jpg
Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/image006.jpg
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image007.jpg
Type: image/jpeg
Size: 778 bytes
Desc: image007.jpg
Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/image007.jpg
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image008.jpg
Type: image/jpeg
Size: 6660 bytes
Desc: image008.jpg
Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20150112/559a029a/image008.jpg