[Pharmwaste] Stakeholder Follow-up

Ed Gottlieb EGottlieb at cityofithaca.org
Mon Sep 8 16:08:00 EDT 2014


Dear Acting ONDCP Director Michael Botticelli & DEA Administrators,

Thank you for organizing today’s stakeholders conference call!

I have additional questions and comments below, including information regarding the applicability of the rules inner liner specifications that I mentioned during the call.

1.  In the Media conference call, were you able to stress that the public must know that it will be some time before pharmacies will be able take their medications, and some pharmacies may not take advantage of this opportunity at all?  For those living near a pharmacy that applies to participate, they may have a long wait.
A. The law does not take effect until Oct 9.
B. The DEA application process to accept controlled substances will take time (more or less depending on the speed of the application process)
C. Implementing a pharmacy program (purchasing/installing boxes & training staff) will also take time.  Though it is possible pharmacies have been privately preparing programs, it is likely they have been waiting to read the final rule so they don't need to redo anything that doesn't meet the requirements of the final Rule.
If this, possibly multi-month, delay is not stressed at every opportunity, I fear a flood of medications will go into the trash and down a toilet when people, excited by news reports of the new rule, finally bring their unwanted medications in, only to be turned away by their pharmacy.  I think a significant number of these frustrated people will get rid of their medications that day rather than store them, waiting for a local program to start.

2. The DEA's National Prescription Drug Take-Back Initiative is a tremendously successful program.  At the end of today’s call, I heard a speaker reminding us to participate in the “last” DEA Take Back event.
I think it would be a terrible mistake to discontinue the Take-Back program so soon.  Until it is shown that pharmacies, in all areas covered by the DEA Take Back, are acting on this unfunded opportunity, many communities will see a decrease in safe disposal options, possible to none.

Many local law enforcement agencies are only able to accept controlled substances because of the Take-Back Initiative.  Without it, some would not have room to securely store the collected medications until they can be properly destroyed.  Many have no funds to properly dispose of what they collect, other than the DEA pick-up following Take Back events.

3. Your efforts to increase the number of convenient, safe disposal options for unwanted household medications are very appreciated!

4. Inner Liner
Here are photos (w URL's or attachments in case they don't show up in the body of the email) of the two drop-box models law enforcement in our program are using.
[Front Access Locking Drop Box with Removable Tote]
[X]
The inner tote (used w/out lid) for the green, narrow-profile box can be seen at:

http://www.buschsystems.com/wp-content/uploads/2014/02/product-specs-waste-watcher-series-20-gallon-busch-systems.pdf

<http://www.buschsystems.com/wp-content/uploads/2014/02/product-specs-waste-watcher-series-20-gallon-busch-systems.pdf>
Note: The inner totes for these [and other models of collection boxes] are heavy duty, reusable plastic.  They are lined with heavy duty plastic bags, which are sealed before the bag is pulled out of the tote.
The bag is immediately put into a hinged lid transport container, pictured here:

http://www.globalindustrial.com/p/storage/bins-totes-containers/shipping-security/distribution-container-with-hinged-lid-22x15-1-4x17-1-4-blue

[Distribution Container With Hinged Lid 21-7/8x15-1/4x17-1/4 Blue]
This container is sealed with a tamper evident, numbered tag and the weight logged.  The tag is only removed when the contents are delivered for witnessed destruction or custody of the contents is transferred to the DEA.

My understanding, after reading the rule, is the tote, or possibly the plastic bag, needs to be labeled (with a unique number and the volume of the contents) and be disposed of with the medications.  I don’t see how either of those options are practical.  The rule seems to assume a disposable cardboard box is being used inside the secure box.  None of the many models of commercial boxes I have seen are designed to hold a cardboard box.

Even if a cardboard box is found that fits inside, that opens the possibility of a glass bottle breaking, puncturing the bag, soaking the box, and causing a spill and exposure risk.

Excerpt from our programs SOP (full SOP attached):

A.     Officers emptying the box must have had blood borne pathogen training.  Officers should request any necessary assistance to isolate and properly dispose of any hazardous material.

B.     Officers must wear disposable gloves when emptying the box, preferably ones that are resistant to punctures by sharps.

C.     Unlock the box and carefully remove the plastic collection tote.  Seal the liner bag (with a twist tie, tape, or a knot.  Holding the bag from the top and away from the body (to minimize the chance of a sharp puncturing the bag and sticking you) remove it from the tote and place it into a seal-able, hinged lid, storage bin (supplied by the Sheriff.)

D.     Once emptied, a new liner bag (supplied by the Sheriff.) is placed in the tote, which is then returned to the collection box and the box locked.

E.      The storage bin is then weighed (to an accuracy of at least 0.5 pounds) and sealed with a numbered security zip tie.  The officer shall fill out a two part chain of custody form.  The Sheriff will provide each participating agency with a batch of consecutively numbered security tags and chain of custody forms.

F.      The sealed bin can either be stored in the agencies’ evidence room (handling it as if it contained controlled substances) or it can be transferred to the Sheriff (by appointment) at the County Public Safety Building, 779 Warren Rd, Ithaca.

G.     When a bin is delivered to the Sheriff, the receiving Deputy and delivering Officer will weight the bin and record the transfer on the chain custody form.  The Deputy will also record the delivery in a log book kept in the storage trailer.  Each will retain a copy of the chain of custody form.

I hope there is a way that our SOP’s procedures can be approved as acceptable.  Please let me know if you have any questions about these points.
I look forward to receiving your response.  Thank you.

Regards,

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
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