[Pharmwaste] FW: FDA's website guidance conflicts with ONDCP's new program

Wed Sep 10 19:40:34 EDT 2014

I read it to mean that non-registrants don't have to comply with the non-retrievable standard and that they can follow Federal or State guidance. I'm asking them for more consistency in their guidance. In MN, we've never followed the FDA's "recommendation". What they could and should do, since this was only ever a recommendation, is to refer people to local collection at law enforcement and to pharmacies that register as collectors with DEA, with a caveat that pharmacies may not be on line until 2015. For those who don't feel comfortable waiting for that option, they can still choose to sewer, but that should no longer be the only recommended option. 

Another issue is labeling and instructions for controlled substances. I believe the instructions recommend sewering. I don't know who decides what goes on those (FDA or State Board of Pharmacy), but that should also be consistent. it makes no sense for a pharmacy that collects all pharms to continue to put sewering language on the instructions. So I think we can still push for something better than what FDA has now in both those areas.

________________________________________
From: pharmwaste-bounces at lists.dep.state.fl.us [pharmwaste-bounces at lists.dep.state.fl.us] on behalf of Lotzer Donna M [DLotzer at uwhealth.org]
Sent: Wednesday, September 10, 2014 10:12 AM
To: 'pharmwaste at lists.dep.state.fl.us'
Subject: RE: [Pharmwaste] FW: FDA's website guidance conflicts with ONDCP's     new     program

This is taken directly from the new rule…sadly. Donna Lotzer

Issue: A commenter asked the DEA to clarify whether or not the non-retrievable standard of destruction applies to substances disposed from households, and this commenter stated that the DEA should develop and endorse a practical solution for in-home disposal.

Response: Ultimate users may continue to dispose of their own pharmaceutical controlled substances in the manner recommended by other Federal and State agencies, such as the FDA, Office of National Drug Control Policy (ONDCP), and EPA. The non-retrievable standard is only applicable to inventoried controlled substances (i.e., a registrant’s stock) and collected controlled substances (i.e., substances collected from ultimate users by authorized collectors) to be disposed of by registrants, pursuant to § 1317.90. The non-retrievable standard does not apply to non-registrants.

It does appear to conflict with this statement from the rule…until you realize the limitation above.

Non-Retrievable Destruction Standard
Issue: Forty commenters asked the DEA to outline performance standards and parameters
for the “non-retrievable” destruction standard. Although many commenters applauded the DEA for proposing a standard that will permit future innovation, many commenters felt that innovation may be hindered by the uncertain terms. Commenters asked the DEA to list currently-approved methods, and to outline how the DEA will evaluate new technology intended to render controlled substances “non-retrievable.”

Response: In the NPRM, the DEA indicated that incineration and chemical digestion are some examples of current technology that may be utilized to achieve the non-retrievable standard. The preamble of the NPRM states that sewering (disposal by flushing down a toilet or sink) and landfill disposal (mixing controlled substances with undesirable items such as kitty litter or coffee grounds and depositing in a garbage collection) are examples of current methods of disposal that do not meet the non-retrievable standard.

From: Volkman, Jennifer (MPCA) [mailto:jennifer.volkman at state.mn.us]
Sent: Tuesday, September 09, 2014 11:28 AM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] FW: FDA's website guidance conflicts with ONDCP's new program
These aren't the best messages I've written and I didn't take time to look up the best address for FDA (I took it from the source view of their web page), but I think more of us need to tell/ask ONDCP and FDA to get rid of FDA's guidance that emphasizes flushing of certain medications. There is consistency between ONDCP's and EPA's guidance, but FDA must still not be convinced that collection is favorable over flushing? Maybe they are working on it? Seems silly for ONDCP to launch this big media event to promote collection when their disposal guidance links to flushing.
________________________________
From: Volkman, Jennifer (MPCA)
Sent: Monday, September 08, 2014 7:34 PM
To: oipl at ondcp.eop.gov<mailto:oipl at ondcp.eop.gov>; druginfo at fda.hhs.gov<mailto:druginfo at fda.hhs.gov>
Subject: RE: FDA's website guidance conflicts with ONDCP's new program
Hello again,
I missed this link! It shows consistency between EPA and ONDCP, but still points to the FDA’s confusing flush disposal recommendations for certain prescription medications.
http://www.deadiversion.usdoj.gov/drug_disposal/index.html
I come at this from the perspective of trying (for 20 years) to get simple information out to families so they can do their part to reduce poisoning, abuse and environmental impacts. Telling people to put all of their medications in a bag and bring them to a collection box is the simplest way to get them to take action. If they find conflicting information on the label, websites or in the instructions that come with prescriptions, they are likely to put off trying to figure out how to do the right thing. The very best result of all of this is to raise awareness and get people to act.
Thanks for all of your hard work!
JV

From: Volkman, Jennifer (MPCA)
Sent: Monday, September 08, 2014 5:57 PM
To: 'oipl at ondcp.eop.gov'; 'druginfo at fda.hhs.gov'
Subject: FDA's website guidance conflicts with ONDCP's new program
Good afternoon,
I listened in on the stakeholder Q and A today and someone asked whether ONDCP was going to update its information on flushing drugs. The ONDCP’s website actually points to the FDA’s website for disposal instructions. It is the information on the FDA’s website that needs updating:
Here is where FDA instructs people to flush certain drugs:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES
I understand the original impetus for the wording of the information back in 2009. It is just something that needs to be made consistent if at all possible.
The ONDCP site at this link http://www.whitehouse.gov/ondcp/prescription-drug-abuse still refers people to the FDA website link above. If you scroll down below the graphs, it is in this paragraph, highlighted:

“What You Can Do
•        Follow disposal guidelines: No matter who you are, you can help address this issue in your home. By following the guidelines, you reduce the risk of unintentional diversion or harm. Learn how to dispose of unused medicines<http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm>, read the frequently asked questions<http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm> about safe drug disposal, and get information on drug poisoning<http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief_full_page.htm>.”
The simplest thing might be for you to delete that paragraph because the one you have below it works just fine:
“Take advantage of community take-back programs: Call your city or county government's household trash and recycling service hazardous waste program, or your local police or sheriff's department to see if a take-back program is available in your community.”
You could update it with a note that you’ve revised rules so that pharmacies may be able to collect medications in the future, once state and local laws are sorted out. Don’t send people to pharmacies yet!!!
The FAQs posted by FDA are also in need of updating:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm
This is what the MPCA’s website tells people to do:
http://www.pca.state.mn.us/index.php/living-green/living-green-citizen/household-hazardous-waste/disposing-of-unwanted-medications.html
Please let me know what the plan is for an update.
Thank you!
Jennifer Volkman
Statewide HHW Program Coordinator
Minnesota Pollution Control Agency
651-757-2801