[Pharmwaste] FDA's proposed mail-back requirement for opioid prescriptions - comments due June 21st!

Fri Jun 3 18:57:02 EDT 2022

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Hi, from the explanations I have received during the many years that this
proposal was in the works, FDA has been working with both DEA and EPA on
this issue. The FDA convened a workshop last year, via Duke, that had both
FDA and EPA staff listening in to expert speakers.  

My understanding is that several different disposal facilities have the
correct permits and authorizations to dispose of controlled substances in
mailers or mixtures of drugs that may contain controlled substances. There
are many more options than in past years. I'm mostly aware of west coast
programs. MED-Project and Inmar are operating pharmaceutical stewardship
programs on behalf of drug manufacturers in WA, OR, and some CA counties in
compliance with state or local drug take-back laws. These programs offer
collection kiosks, collection events, and mail-back, collecting all
prescription and over-the-counter medicines including controlled substances
by each method. They have figured out how to properly dispose of returned
mailers per the DEA regulations. So the drug manufacturers participating in
those stewardship organizations have ready access to that information.

Hoping this is an idea whose time has finally come!

Margaret

From: Smith, Charlotte <csmith32 at wm.com> 
Sent: Friday, June 3, 2022 2:52 PM
To: Volkman, Jennifer (MPCA) <jennifer.volkman at state.mn.us>;
margaret.shield at cehstrategies.com; pharmwaste at lists.dep.state.fl.us
Subject: RE: Re: [Pharmwaste] FDA's proposed mail-back requirement for
opioid prescriptions - comments due June 21st!

Great idea but they will need to involve DEA as only a reverse distributor
with an on-site incinerator can currently receive a controlled substance by
mail from a consumer. Hopefully FDA is engaged with DEA on this issue. 

Best regards,

Charlotte A. Smith, RPh, MS

Senior Regulatory Advisor

PharmEcology Services

 <mailto:csmith32 at wm.com> csmith32 at wm.com

C: 713-725-6363

800 Capitol Street, Suite 3000

Houston, TX 77002

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From: Pharmwaste <pharmwaste-bounces at lists.dep.state.fl.us
<mailto:pharmwaste-bounces at lists.dep.state.fl.us> > On Behalf Of Volkman,
Jennifer (MPCA)
Sent: Friday, June 3, 2022 4:20 PM
To: margaret.shield at cehstrategies.com
<mailto:margaret.shield at cehstrategies.com> ;
pharmwaste at lists.dep.state.fl.us <mailto:pharmwaste at lists.dep.state.fl.us> 
Subject: [EXTERNAL] Re: [Pharmwaste] FDA's proposed mail-back requirement
for opioid prescriptions - comments due June 21st!

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This is excellent news! Manufacturer sponsored disposal as it should be!
Many people receive medications through the mail, so there's no reason they
can't be returned or sent for destruction via that same pathway. I plan to
comment. Mail back is much less work for the consumer, and a lower cost
option than the mix and toss products. Incineration = destruction!

Thank you for tracking this Margaret, I was unaware of the comment period. 

Happy Friday!

JV

From: Pharmwaste <pharmwaste-bounces at lists.dep.state.fl.us
<mailto:pharmwaste-bounces at lists.dep.state.fl.us> > On Behalf Of Margaret
Shield
Sent: Friday, June 3, 2022 3:50 PM
To: pharmwaste at lists.dep.state.fl.us
<mailto:pharmwaste at lists.dep.state.fl.us> 
Subject: [Pharmwaste] FDA's proposed mail-back requirement for opioid
prescriptions - comments due June 21st!

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Hello, I'm emailing about an important FDA comment period on safe and
environmental sound disposal of opioid medications that I hope you can
engage in. Comments are due June 21st!

FDA is proposing to use its Opioid Analgesic REMS authority to require that
all opioid drugs are dispensed with a prepaid mail-back envelope and
educational material. Drug manufacturers will be responsible for providing
this secure and safe medicine disposal method and FDA encourages them to
innovate in their design of the mailer, packaging, and service.

>From FDA's media release: 

"Mail-back envelopes have several favorable characteristics. They do not
require patients to mix medications with water, chemicals or other
substances nor use other common at-home disposal techniques. Opioid
analgesics sent back to Drug Enforcement Administration-registered
facilities in mail-back envelopes do not enter the water supply and
landfills (instead, they are incinerated). The nondescript mail-back
envelopes provided would be postage paid, offering patients a free disposal
option. Additionally, there are long-standing regulations and policies in
place to ensure that mail-back envelopes are fit for that purpose and can
safely and securely transport unused medicines from the patient's home to
the location where they will be destroyed."

Comments supporting FDA's proposed mail-back requirement are needed! 

This is a very positive step by FDA, and an action that many of us have
advocated for. Making it easy for patients and family members to dispose of
unwanted medication - especially potent opioid drugs - is a key prevention
strategy to reduce medicine misuse and help prevent poisonings. Mail-back
programs are regulated for security by the DEA and ensure non-retrievable
destruction that prevents release of APIs into the environment. FDA's mailer
requirement would be consistent with existing drug take-back programs -
using drop boxes, events, and mailers. This requirement would complement
widespread messaging promoting take-back and discouraging disposal of
leftover drugs in the household trash or down the sewer from local, state,
and federal agencies, and many allied organizations and community groups.

There is a dynamic back story to FDA's good, evidence-based decision. This
new requirement is not a certainty yet. For years, FDA has been receiving
pressure in many forms from manufacturers of medicine disposal products to
choose their disposal mixtures or pouches or this mandatory nationwide
requirement. Those companies are pressuring FDA's leaders and lobbying
Congress. Yet their products remain inadequately tested for consumer safety,
for effectiveness, or for environmental protection. It is not clear that any
of the medicine disposal products make drugs non-retrievable. Ultimately all
of those products are designed for trash disposal of a liquid or semi-solid
mixture of pharmaceuticals and other incompletely identified materials. In
the docket already, there is a comment from a medicine disposal product
manufacturer supporting their products over DEA-regulated mail-back. There
are other comments from entities with ties to those companies.

Your supportive comments, even brief ones, can make a significant
difference. Here is more information to assist you in commenting by June
21st.

"Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid
Analgesics Dispensed in an Outpatient Setting"

Comments are due by or on Tuesday June 21, 2022. 

https://secure-web.cisco.com/12mP29YqUVcgQiLvFjxaLA6pcLz2_JoimmUsGTqUrQIDGylT76IhZ5648cevdo8Sl_yU_J4Htxhl3YWHKr2JSoRW3fhDtmFRZ43e0dGvzokiEjJQBU48vLJelw3C0E7scPLC9S3e17DYzNZQWYcswucwy5cm5OMepPQx-qT8qBo0OArg0Mr65huMD5en_zHYo094w_UW8o62_a3_Ml08E0WMYaDYX4N3jY0LQwWmEP8pi2jMEKdvpfo5aVxUa6K0h7Pq6Mx-xPIr_Z1cOZwZd_coJ8Fqr6h5fHwJeFSVCX4Ym6lj87IPNs5dlLIDraNEzzUA3LABcNPkc-Y9heaeBCA/https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-considers-new-approa
ch-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary

Federal Register link for comments:
https://secure-web.cisco.com/1o7qD2VbH7idBzZvtcH44T89LdZ6w6QIIZnDURLvtinbxfP5wd9RvvPucsKmIDfFPz-IykWaODSxWBGIbhwz6wzNVja6054P5Tge39sG5SgSqvXv5inwLiCJkNrno-p3-7SkZe4RWj0-5GB-jp4LIZGhoF7JG3VlgqmqpD3L_AwK-_gz8bzn7BgtBh50wLvlgX8werYYKa_jw5uOgyxsh8_1rbwngR6X9xzfuM8pxy4IfrbH4CE0OxJkOBVOI-lVnMyULMyR-qZ87WMIIBId_lHhWnL1X35a2B9pjxGuH8Qy_kZauWpKvVGssqGTlXB9RBTAzLob8ZSzkGoJDNRiibw/https%3A%2F%2Fwww.regulations.gov%2Fdocket%2FFDA-2022-N-0165 

Some background resources that support of FDA's mail-back envelope
requirement:

*	2019 comment letter from San Francisco Department of the Environment
supporting using REMS authority to require mail-back envelopes with opioid
prescriptions. https://secure-web.cisco.com/1NgAo3BSIvgcb8z5OrrT5xRM33XtDbKYl5bCdQM6PAeyp-9NvIkuH5y9BShOno72CTHdHLoG4Kpi0xrA4IhCi9IWiVtttbBpSVhfG5eoZb6NY_3i-3dnAo0tuwHnc8B417hpH5pMPXx-OnAC5TfccyGKgrl6ALtAICxfH84G3AnvgzriXhtrgTV-zmdDtC1vNXfMupsKXT2G2YkeeucfjI8PdxQho3T4Oqu5KCj-CXplc25E1owpwrZOOjnTP1E0cULKS7aTLzGHNNWJqNFaSkQ3gDudOxQFHRzEvUbdVZdtQJekRzsTgaSDsy9IdBGsIMxzEF9gynea-SesxgACsxg/https%3A%2F%2Fwww.regulations.gov%2Fcomment%2FFDA-2019-N-1845-0126
Portions of this letter could be adapted for your comments. 
*	Link to my 2019 report for SF DOE "Medicine Disposal Products: an
overview of products & performance questions" describing the many unknowns
and concerns with these products:
https://secure-web.cisco.com/1pFMvdkJxYZhtqsdfEiNAcZnGVjgp7zPGo7EEUfAZIQOKhFDA2r1xPfXAKvyr60syzLCvQgsUOOR4Jel7Ir_FALiOXIpbOJSBkhSu6nXdzQT7GUX2DJ-eZ-1J6v0JAkFZtufXvWDlrxMPFelhkUzpbfsDUqNIR6bqWS3kps_HLJ01g3AyVTqFXr3vq2xmMy-F3bKjyreeRsVs2GyBtNOPeIwMzmcOI3SvD3L5Jl0PyCIA0qgTCwNT6A_DDozUxa_uPg1qe5C8xpEuoqKSEsPgF488CMoKCmeZcu_ZrFN3Jy-1HCD13Hkv0PoxnYp3bCVq/https%3A%2F%2Fsfenvironment.org%2Fsites%2Fdefault%2Ffiles%2Ffliers%2Ffiles%2Fmedicinedisposalp
roducts_march2019.pdf 
*	Link to my PowerPoint presentation with talking points for a June
2021 Duke University workshop sponsored by the FDA on Exploring Options for
Safe and Effective In-Home Opioid Disposal
https://secure-web.cisco.com/1U2Z1vWmfI2NzUZO58g9QX45s-bDPiIVf3hGeYsSPEHKvdzmsLxT5v3Fwj4_KpZQ6nFjM5FgT8yi3HkzjObJ8MWCSMAnuk4NLtWYySPC-jLrNc0IWnVlHIVgss3bNwAyQPaITFZV5V3V5P-nRo7XdfdlNOOMgFDIpN_xktL1s9vyM_fUAjpRQcbb-D6NUyFsi3lXOHEP4rkMqVbBAFRQrFNOx0SGx1-9X-w2rWtwBUL_aSmsdoz_O5ykCH_29zA06ix6v0Lb8FFGLk_3hFnuS5Tic9Qdm2SX22OVjS5j5Z7-C9y11EDI-6vw-Yg8dSpHLdNiTuOyXJapRtr_9U5QA1w/https%3A%2F%2Fdocs.google.com%2Fpresentation%2Fd%2F1ewyN33DGVwHJP4Te1MXPvTMmjifu_xUV%2Fedi
t?usp=sharing&ouid=115293893377595943300&rtpof=true&sd=true   (this is a
Google docs link, if you cannot access, please email me)

Thank you!

Margaret

Margaret Shield, PhD

(pronouns: she/her/hers)

Community Environmental Health Strategies, LLC

 <mailto:margaret.shield at CEHstrategies.com>
margaret.shield at CEHstrategies.com

mobile:  206-499-5452

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