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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Ed, you are awesome! Your dedication to getting the word out may be above and beyond your duty as a pretreatment coordinator, but is in line with your position
as Chair of the Coalition for Safe Medicine Disposal. I’m glad you sent the letter to DEA and there is no reason you can’t give programs in your state a heads up. We may have one situation like you describe and I have contact information for the sites, so
I might check up vs. send info to DEA for follow up. It isn’t my place to do that, but my coworker and I prepared the guidance and provided training to law enforcement when they began establishing sites. We register sites and receive annual reporting on the
quantity collected. So…I think we all balance our interest in preserving programs by passing along knowledge vs. passing along a non-compliant situation for a potential hammer response. Especially in the case where it is more of an awareness issue than a blatant
attempt to avoid regulation. <o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Cheers,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">JV<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">From:</span></b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif""> pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us]
<b>On Behalf Of </b>Ed Gottlieb<br>
<b>Sent:</b> Thursday, February 26, 2015 1:59 PM<br>
<b>To:</b> pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> [Pharmwaste] DEA needs to do outreach<o:p></o:p></span></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black">FYI,
<br>
<br>
I just sent this letter to DEA Division Director Arnold. He supervised the writing of the new take back rule.<br>
<br>
Ed<br>
<br>
<br>
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Dear Director Arnold,<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">After seeing yet another news story about a new drop box being installed
<u>outside</u> a law enforcement building, I wrote a letter to the editor (see below), with the intention of sending it to some widely read law enforcement publications.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">I realized that this sort of outreach really should come from the DEA. Please consider how you can effectively communicate the basic requirements of the
new Controlled Take Back Rule to law enforcement agencies. If that includes the use of letters to the editor, you are welcome to copy any, or all, of my letter.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Regarding a previously submitted question, I still hope for your response regarding the acceptability of a small, frosted Plexiglas view port to detect
the fill level of a drop box without unlocking it. If personal information can't be read through the view port, is such a feature acceptable?<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Thanks for your consideration of both these issues! I look forward to your response.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Sincerely,<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Ed Gottlieb<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Chair, Coalition for Safe Medication Disposal<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Industrial Pretreatment Coordinator<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Ithaca Area Wastewater Treatment Facility<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">525 3rd Street<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Ithaca, NY 14850<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">(607) 273-8381<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">fax: (607) 273-8433<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><span style="color:black">Pharmaceutical Drop Box Programs Need Review</span></b><span style="color:black"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Providing the public with convenient ways to dispose of unwanted medications, especially controlled substances, is an important public service. Removing
unwanted pharmaceuticals from homes decreases the likelihood of illegal diversion, accidental overdose, and environmental contamination.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">After the US Drug Enforcement Agency (DEA) established the Take Back Initiative in 2010, what had been a small number of existing law enforcement collection
events quickly multiplied. The ninth and final DEA event, on September 27, 2014, included 4,076 agencies collecting 309 tons of unwanted medications at 5,495 sites in just four hours!
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">To increase disposal convenience, a steadily growing number of law enforcement agencies (and pharmacies, mainly for non-controlled collection[JPL1] ) have
installed permanent drop boxes at their locations. Thanks to wide community support, and some limited funding from state agencies and others, new drop boxes continue to be installed.
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Kudos to all of you that have taken the lead on this important issue!
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">But, are you aware that your drop box program may need to be modified to be compliant with recent changes to federal take back rules? This letter was
inspired by reading multiple stories of new drop boxes being installed that are in violation of a new federal rule.
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Late in 2014, the DEA issued a rule regulating the take back of controlled substances. [http://www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_public.pdf]<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">The big change is that pharmacies can now apply to take back controlled pharmaceuticals. Since the rule does not require participation, and provides no
funding, it may be quite some time before a pharmacy near you participates. Law enforcement programs remain the primary method for safe disposal.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">I want to mention that once the new rule was in place, the DEA announced the end of the hugely successful Take Back Initiative. That decision has left
many law enforcement agencies struggling to find funding to keep their one day and/or drop box collection programs going. It is going to be a tough transition time.
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Back to my main point...the rule also specifies how law enforcement collects controlled substances. Please take the time to make sure your program is
in compliance with the new rule. To find the references below, the full rule is located at:
<a href="http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf">http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf</a><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Here are a few details, specific to law enforcement, which should be part of your review check list.
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">1. Boxes must be inside buildings. The DEA is looking for active monitoring.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">§ 1317.35 Collection by law enforcement. (3) Collection receptacles located inside law enforcement's physical address. Also:<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">§ 1317.75 Collection receptacles (d) (1) Inside a collector's registered location, inside law enforcement's physical location, or at an authorized long-term
care facility;<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">2. Signage must indicate that Schedule II-V controlled and non-controlled substances are acceptable and that Schedule I controlled is not. [§ 1317.75 (e)
(4)]. (I had to add this wording to my programs signage using stickers.)<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">3. Collected medications must be “stored in a manner that prevents the diversion of controlled substances and is consistent with that agency's standard
procedures…” [§ 1317.35 (c)] (We wrote an SOP specifying that inventory of the contents was not necessary. Identifying and counting so many controlled substances isn’t practical. This also cleared to way to be in compliance with our state accreditation
rules.)<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">4. The box must contain an opaque inner liner that, upon removal, must be labeled as specified in your departments SOP. If custody is to be transferred
to a reverse distributor, a specific list of labeling requirements must be followed. [§ 1317.35]<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">For those of you holding take back events, you can authorize non-law enforcement personnel to assist with required, and voluntary, activities including:
receiving, weighing, separating controlled from non-controlled, removing unacceptable items (sharps, mercury), inventorying, etc. [Executive Summary: J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and Mail-Back Package Contents;
Response to Issues 2 & 3,] <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">If you have any questions about the rule, you should contact your DEA field office. I’d also be happy to try and answer your questions. Please let me
know if your DEA field office says something in conflict with your reading of the rule. Thank you.
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="color:black">Keep up the good work!<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black"><br>
<br>
<o:p></o:p></span></p>
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