[Pharmwaste] Atten: William Fowler

Ed Gottlieb EGottlieb at cityofithaca.org
Thu Aug 18 14:57:58 EDT 2016


Dear Mr. Stanchina,

Thank you for providing responses to my questions and copying the pharmwaste list.
My intention has been, and remains, to locate and disseminate as much information about safe medication disposal as possible with the goal of seeing the convenience and overall use of safe disposal grow.
I was interested to learn that you sell such a wide range of sizes and that the DEA is one of your customers.

Regarding question 10, I was wondering if a range of solvents had been tested to see if they could extract medications from activated carbon.
Commonly used solvents include: tetrachloroethylene, toluene, acetone, methyl acetate, ethyl acetate, hexane, petrol ether, and ethanol.  I may not recall correctly but I think the testing results you sent used ethanol.

Regarding question 11, I was not asking about tests done at the upper temperature range.  At some point the activated carbon, and the medications it adsorbed, will burn.  The description Verde sent of the carbon reactivation process seems to indicate that if a drug becomes volatile when heated to 100-649 degrees C, it could be extracted.  The question is, do any controlled substances become volatile between 100-649 degrees C?

Thanks again for your assistance in helping me understand these details.

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: Sean Stanchina [sstanchina at Verdeenvirotech.com]
Sent: Thursday, August 18, 2016 2:10 PM
To: Ed Gottlieb
Cc: pharmwaste at lists.dep.state.fl.us; John Mulcahy
Subject: RE: Atten: William Fowler

Good afternoon Mr. Gottlieb,

Please find our responses below, in italicized red font.  Your recent post in reaction to the Mallinckrodt UB press release eluded to us acting non responsive.  While that was not our intention, as you can imagine, this is a quite exciting and busy time for Verde.  We make every effort to respond to all inquiries in a timely manner.  While we believe your overall efforts are in line with our cause and we share common goals, we would like to confirm your intentions prior to any further publicity you choose to volunteer on our behalf.

Sean Stanchina
National Account Manager
Verde Technologies
O:  612.568.1128 x.703
C:   612.386.8468
E:   sstanchina at verdeenvirotech.com<mailto:sstanchina at verdeenvirotech.com>
W:  http://deterrasystem.com<http://t.sidekickopen30.com/e1t/c/5/f18dQhb0S7lC8dDMPbW2n0x6l2B9nMJN7t5XX4QZn7HW5vwq6F5v_YXjW5vw6HK56dP00dJsm9z02?t=http%3A%2F%2Fdeterrasystem.com%2F&si=4821792309116928&pi=f80d9f72-2a3d-4696-a13c-28dc009b2ad5>

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From: Ed Gottlieb [mailto:EGottlieb at cityofithaca.org]
Sent: Thursday, June 30, 2016 1:00 PM
To: Sales <sales at Verdeenvirotech.com<mailto:sales at Verdeenvirotech.com>>
Cc: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: Atten: William Fowler

Dear Mr. Fowler,

Thank you for providing documentation regarding the effectiveness of the Medsaway® product.  No other medication disposal product that I've seen provides nearly as much.  It is my opinion that having multiple, effective disposal methods is a very good thing!  I have a number of questions regarding the research done on Medsaway®, and activated carbon in general, that I hope you can answer:

1.  You report deactivation results, for a number of medications, from 94.3-100% after seven days.  For Oxycontin, you report 99% within four days, with the majority within one day.  Is day-by-day deactivation information for the full range of tested medications available?  This relates to questions 2, 3, & 5 below.  All of our research is 3rd party verified and published by Mercer University School of Pharmacy as per our NIDA Contract.  All data has also been reviewed by the American Association of Pharmaceutical Scientists (AAPS).
2. Do the directions for Medsaway® instruct the user to place it in the trash after it is sealed or do they suggest storing it securely for a period of time before disposal?  No specific storage instructions are provided on the Deterra products.
3. Do you know of any ANSI, or similar, standard that applies to products trying to meet the DEA definition of non-recoverable?  If a Medsaway® package is diverted from the trash soon after it is filled, at least some drugs will be recoverable.  Without an accepted standard, and with DEA being on record as not willing to evaluate products, how can compliance with the DEA standard be determined in such a situation?     This is a standard that is too vague – “Non-Recoverable for all practical purposes.”  Our patented technology renders the drug inert and non retrievable for all practical purposes.  We hold a DEA license and share our research with our DEA contacts.  The DEA has purchased Deterra and handed it out during take back events, as a method for individuals to bridge the gaps between Take Back Days.
If the contents of our product was to be consumed by an addict shortly after the product was used, the immediate reaction would be, the user would reject the contents and vomit.  Likewise, the carbon consumed would adsorb chemicals in their stomach, similar to how the medical community may charcoal a person after a poisoning.
4. Is the once per day mixing methodology used in your experiments representative what would be expected from the actual use of the product (mixed when: first used, placed and transported in a garbage truck, dumped at the land fill, and during trash compaction)?  We calculate several steps in the process that would generate sufficient agitation.
5. If the Medsaway® bag is torn before deactivation is complete, wouldn't the medication containing liquid drain away from the activated carbon?  And, in a landfill, wouldn't medication dissolved by rainfall flow downward, away from the activated carbon?  In other words, is it reasonable to conclude that in real world conditions, the product is not likely to deactivate a significant amount of any remaining medication once the bag is broken and the liquid drained?  Sufficient adsorption is highly likely in most any scenario.  Deactivation begins immediately.  The volume and type of drug plays a role in the deactivation period.  For instance, a transdermal patch designed to release medication over a 72 hour period will be deactivated much sooner than 72 hours, yet not be entirely deactivated in the first hour.  That technology is designed to be a slow release.  The scenario you describe, however so rare, would still be better than the most common means of disposal currently – sinking or flushing.
6. Do the tested medications include examples of all pill/capsule types or might there be some untested varieties that are slower to dissolve in water?  While it is nearly impossible to test every drug on the market, our research is vast and makes every attempt to test how different pills and capsules dissolve or open.
7. You report that "little of the original drug [Fentanyl] content was recovered from activated carbon using water and alcohol.  Can you please tell me what percent is a "little"?  I don’t know where “a little” is mentioned.  Standby for our most recent research to be released by Mercer University indicating zero.
8. Would pulverizing the activated carbon effect the amount of drug recovered?  Smaller particle sizes would accelerate adsorption.
9. Did you try to extract drugs other than Fentanyl and, if so, what were the results?  Yes, please review our published washout and TCLP extraction data.
10. Is it possible that other solvents would be more effective at extraction?  It is unclear on what other solvents you infer.
11. Has it been established that there are no drugs that can be extracted from activated carbon by heating?  Your description of the carbon reactivation process seems to indicate that if a drug becomes volatile when heated to 100-649 degrees C, it could be extracted.  Our goal is to make the drug non available for all practical purposes.  Although we have tested against heat, we have not ran tests to 649 degrees C.
12. The amount of activated carbon provided has obviously been calculated to be more than enough to deactivate 30 pills, the number tested.  Apparently [http://www.mallinckrodt.com/corporate-responsibility/safe-drug-disposal], the directions say it is designed to inactivate 10-15 pills.  If usage directions are not followed, have you determined the percent deactivation for a worst case scenario, where the Medsaway® bag is totally filled with more than 30 pills?  Like any product, directions are intended and expected to be followed.  However, throughout our product suite, more Activated Carbon is supplied than what would be necessary to deactivate and dispose of the specified capacity.
13. Do you know why Medsaway® was scaled to this capacity?  It is my experience, from running take back events, that even regular take back users bring, on average, more that one pound of drugs for disposal.  This is clearly many times the capacity of a Medsaway® bag. Deterra is offered in a wide variety of sizes ranging from our Deterra SP, which Deactivates 15 pills, 2 oz. of liquid, or 2 transdermal patches, all the way up to a Deterra 5.0 which Deactivates 2,600 pills, 14 liters of liquid, or 345 transdermal patches.  Many law enforcement agencies are using the Deterra 3.5 and 5.0 for Take Back events to collect the medications while also handing out Deterra LP for each household to bridge the gap until the next Take Back event.  We acknowledge that while Take Back programs are effective at gathering a portion of unused medications and preventing possible diversions, they are just one of the many tools or tactics exercised to battle the prescription drug abuse epidemic and help prevent the harmful disposal of pharmaceuticals negatively affecting our environment.

Aside from my responses to your questions, please review the attached documents:

1.  An excerpt from the 2015 US Drug Control Strategy, written by the ONDCP.  The highlighted portion refers to Verde Technologies.

2.  A press release from the US Department of Justice announcing the DEA would be handing out Deterra at their Drug Take Back Day.

Thank you for your interest and support of Deterra.

Verde Technologies
612.568.1128
Deterrasystem.com

Thank you very much for your assistance!

Sincerely,
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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