[Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

Volkman, Jennifer (MPCA) jennifer.volkman at state.mn.us
Fri Jan 3 10:30:24 EST 2020 

These rules apply to business generated pharms, not pharms voluntarily collected from HH.

From: Hudak, David R <dhudak at co.pinellas.fl.us>
Sent: Thursday, January 02, 2020 8:03 PM
To: Scott Cassel <scott at productstewardship.us>; Margaret Shield <margaret.shield at cehstrategies.com>; 'Catherine Zimmer' <zenllc at usfamily.net>; Volkman, Jennifer (MPCA) <jennifer.volkman at state.mn.us>; 'Deborah DeBiasi' <deborah.debiasi at deq.virginia.gov>; 'Pharmwaste list' <pharmwaste at lists.dep.state.fl.us>
Subject: RE: [Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

Hi all,

I believe there is another twist to this issue with the recent EPA rule that went into effect August 21, 2019 that I believe negates anything from the FDA.

The EPA has not done a good job getting the message out.

https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.epa.gov%2Fhwgenerators%2Ffinal-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C1%7C637136137698616246&sdata=oajuGX9Lj5nvouIjj5n6Yxqcm%2FBysgG6ONlgVEImzVY%3D&reserved=0>

https://www.federalregister.gov/documents/2019/02/22/2019-01298/management-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.federalregister.gov%2Fdocuments%2F2019%2F02%2F22%2F2019-01298%2Fmanagement-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C1%7C637136137698616246&sdata=PpL3HFcHfNzN89S%2Fwh%2BH5hA71Ov1dtfUZRGyPHun4u8%3D&reserved=0>

https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.epa.gov%2Fhwgenerators%2Ffrequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C1%7C637136137698626242&sdata=cZ3FF%2B%2F42K58%2F5KlGYrkEr356gwKOFtzrVI6eeQY5qU%3D&reserved=0>

Just Google search Hazardous Waste Pharmaceuticals and you will see the impact of the new rule/law.

Compliance checks have already started within our County.

David R. Hudak, Paramedic
EMS Protocol & Equipment Coordinator
Pinellas County EMS and Fire Administration
12490 Ulmerton Road - Suite 134
Largo, Florida 33774

Phone (727) 582-5756
Fax (727) 582-5759
Cell (727) 336-9496
dhudak at pinellascounty.org<mailto:dhudak at pinellascounty.org>


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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 Scott Cassel
Sent: Thursday, January 2, 2020 5:09 PM
To: Margaret Shield <margaret.shield at cehstrategies.com<mailto:margaret.shield at cehstrategies.com>>; 'Catherine Zimmer' <zenllc at usfamily.net<mailto:zenllc at usfamily.net>>; 'Volkman, Jennifer (MPCA)' <jennifer.volkman at state.mn.us<mailto:jennifer.volkman at state.mn.us>>; 'Deborah DeBiasi' <deborah.debiasi at deq.virginia.gov<mailto:deborah.debiasi at deq.virginia.gov>>; 'Pharmwaste list' <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
Subject: Re: [Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

CAUTION:
This message has originated from Outside of the Organization. Do Not Click on links or open attachments unless you are expecting the correspondence from the sender and know the content is safe.
PSI developed a one-pager that eliminates the flushing option altogether, since our members thought it would be too confusing to the public. Here is the link to the document and you are free to use it if you like: https://cdn.ymaws.com/www.productstewardship.us/resource/resmgr/pharms_reports_factsheets/PSI_Pharms_Disposal_Info_She.pdf<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcdn.ymaws.com%2Fwww.productstewardship.us%2Fresource%2Fresmgr%2Fpharms_reports_factsheets%2FPSI_Pharms_Disposal_Info_She.pdf&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C1%7C637136137698656223&sdata=8FR3Le7A1eGdaA26hmE51nvsRvBXbW9%2B4kxE%2BO72OBQ%3D&reserved=0>

_______________________________________________________________
Scott Cassel ▪ Chief Executive Officer/Founder ▪ Product Stewardship Institute, Inc.
One Beacon Street, Suite 1500, Boston, MA 02108 ▪ 617-236-4822 (ph)
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Skype address: scott.cassel1

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: Thursday, January 2, 2020 1:18 PM
To: 'Catherine Zimmer' <zenllc at usfamily.net<mailto:zenllc at usfamily.net>>; 'Volkman, Jennifer (MPCA)' <jennifer.volkman at state.mn.us<mailto:jennifer.volkman at state.mn.us>>; 'Deborah DeBiasi' <deborah.debiasi at deq.virginia.gov<mailto:deborah.debiasi at deq.virginia.gov>>; 'Pharmwaste list' <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
Subject: Re: [Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

Hi all,  I think important to note that FDA’s guidance on flushing opioids has changed. The article’s statement that “FDA recommends flushing opioids” is only accurate when combined with the earlier statement “If a disposal program is not available”.

FDA now recommends use of medicine take-back programs as the first and best option, for opioids and all other drugs. The “flush list” is only if a drug take-back program is not readily available.
FDA’s messaging could be improved to be more clear and logical. Their new Remove the Risk campaign does a better job of this. However, the FDA needs to scrub all of its webpages and materials of older drug disposal messaging that is no longer consistent.

Here are examples of FDA’s current drug disposal messaging which is highlighted in FDA’s REMOVE THE RISK campaign:
·         Dispose of Unused Medicines: What You Should Know:   https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Fsafe-disposal-medicines%2Fdisposal-unused-medicines-what-you-should-know&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698686206&sdata=5j7zR2yXOK%2BfiSqggMVQ00ck4Eq87DAlPwRe%2FKM6LvA%3D&reserved=0>  (Tip: a short link to this page is www.fda.gov/DrugDisposal<https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.fda.gov%2FDrugDisposal&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698686206&sdata=gVksxcYbiPFE5js5j%2BFBwOCsoPcbUmNAVfG7ueAyFIE%3D&reserved=0> )
·         PDF fact sheet from the Remove the Risk campaign on safe opioid disposal: https://www.fda.gov/media/123330/download<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F123330%2Fdownload&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698696200&sdata=4BewLdkdUXWggQtbvpJtAhMeaG6Y02Qzvf4zskHXJ6w%3D&reserved=0>     (main resource page is: https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-opioid-disposal-remove-risk-outreach-toolkit<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Fensuring-safe-use-medicine%2Fsafe-opioid-disposal-remove-risk-outreach-toolkit&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698696200&sdata=jO9L58KgfNncM7Ewjl%2BtIa%2FUPmmhSdc%2FSVhKFN6yvvU%3D&reserved=0>)
Here’s a screen shot from part of the FDA fact sheet that is clear in flushing being the 2nd choice:
[cid:image005.jpg at 01D5C218.6BC1E310]

·         An image from another FDA webpage on drug disposal. It’s a great example of how FDA needs to match the right images with the text message. The text gets the disposal message correct, but in not the most straightforward right order. But from a quick glance at the toilet, pills, and WARNING! heading will a viewer think this recommends flushing or warns against flushing.
[cid:image006.jpg at 01D5C218.6BC1E310]


All of the FDA’s materials still suffer from the significant omission that some local jurisdictions do not allow any flushing of pharmaceuticals into the sewer system.

The UCSF survey results certainly show there is more work to do with the pharmacy community. My ongoing belief from experience is that consistency of messaging improves dramatically once a comprehensive drug take-back system is established, such as through the manufacturer responsibility laws in Washington and California.

Margaret Shield, PhD
(pronouns: she/her/hers)
Community Environmental Health Strategies, LLC
margaret.shield at CEHstrategies.com<mailto:margaret.shield at CEHstrategies.com>
mobile:  206-499-5452
www.CEHstrategies.com<https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.cehstrategies.com%2F&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698706193&sdata=1H6BRbq9Yprljjrow3UzoHmPCKE6571Ji%2BJaJnIUfL8%3D&reserved=0>

From: Pharmwaste <pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us>> On Behalf Of Catherine Zimmer
Sent: Thursday, January 2, 2020 9:10 AM
To: 'Volkman, Jennifer (MPCA)' <jennifer.volkman at state.mn.us<mailto:jennifer.volkman at state.mn.us>>; 'Deborah DeBiasi' <deborah.debiasi at deq.virginia.gov<mailto:deborah.debiasi at deq.virginia.gov>>; 'Pharmwaste list' <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
Subject: Re: [Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

And what FDA is still recommending is in conflict with what DEA calls “irretrievable”.

Seems it might be worth going back to FDA and getting them to update their recommendations.  Or go through the APhA—one would think they would be more concerned about complying with DEA.  I know most of my clients are.  And we send all opioids for incineration.

Very truly yours,

Catherine Zimmer, MS, BSMT
Executive Director, HEARRT Midwest<https://gcc01.safelinks.protection.outlook.com/?url=hearrtmidwest.org&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698706193&sdata=zs%2Blu8QDx19X3oJwTr6nES46W5FBRvUdzBtJqByrXME%3D&reserved=0>
Principal, Zimmer Environmental Improvement
Improving processes, minimizing waste and reducing costs.
zenllc at usfamily.net<mailto:zenllc at usfamily.net>
Ph:  651.645.7509



From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Volkman, Jennifer (MPCA)
Sent: Thursday, January 2, 2020 10:18 AM
To: 'Deborah DeBiasi'; Pharmwaste list
Subject: Re: [Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

If they read the FDA guidance, flushing is what they still recommend for opioids. So, that part is not surprising. I do know we’ve addressed the availability of collection in a couple of the newsletters that the Board of Pharmacy sends to pharmacies, and we’ve also done a webinar for them. But, I just ran into a pharmacist that didn’t know about our extensive collection network. At this point, a pharmacist almost has to be hiding under a rock to not be aware of collection, especially given that so many chains now collect, and that disposal question seems to be a common one from households. It doesn’t surprise me though that they don’t follow state’s recommendations and still defer to FDA’s “guidance”.

I was curious to see the difference in opioids and antibiotics. It could be that the author doesn’t understand that most jurisdictions that have invested in capturing opioids through collection do not, in fact, recommend flushing.

Last time I checked in with FDA, they said they might change their guidance when collection infrastructure is more developed. So, that decision is entirely subjective. If they could at least refer people to states and to follow their recommendations, that would help.

Disappointing article pushing flushing.

From: Pharmwaste <pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us>> On Behalf Of Deborah DeBiasi
Sent: Wednesday, January 01, 2020 7:28 AM
To: Pharmwaste list <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
Subject: [Pharmwaste] Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either

It’s surprising, and concerning that pharmacies are still giving out incorrect information.  We still have work to do.

Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either
By Shelby Lin Erdman, CNN
Updated 6:35 PM ET, Tue December 31, 2019
 (CNN)When it comes to getting rid of prescription drugs, fewer than half of the pharmacies surveyed for a new study gave accurate guidance that met US Food and Drug Administration standards for disposing of unused opioids and antibiotics.
Researchers from the University of California at San Francisco <https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ucsf.edu%2Fnews&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698716187&sdata=bpkXILXiG9IIjqi9pJGkJw%2BEDceEGBN9RmEzHB2t7Nw%3D&reserved=0> surveyed nearly 900 California pharmacies by phone over a two-month period in 2018 during the week and on weekends. For the study, published Monday in the journal Annals of Internal Medicine<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fannals.org%2Faim&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698716187&sdata=umZz50%2FK95NbbjZV24swRJmMbrxec62L8iAhxElqNPw%3D&reserved=0>, researchers posed as parents with leftover opioids and antibiotics from a child's surgery.
They were looking for correct drug disposal instructions based on US Food and Drug Administration guidelines<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fconsumers%2Fconsumer-updates%2Fwhere-and-how-dispose-unused-medicines&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698726181&sdata=CEfPoPhl4XoEMKlbgHpDoRrffNRZ3ao8f9dh5jiK%2Byc%3D&reserved=0>.
The agency recommends taking unused medications to drug disposal or takeback programs as the best way of getting rid of unused or unwanted drugs. If a disposal program is not available, the agency suggests mixing antibiotics with coffee grinds or kitty litter, sealing the mixture in a container and throwing it in the garbage. It recommends flushing opioids.

Researchers found only 47% of pharmacies gave correct instructions on how to dispose of antibiotics and 34% provided correct information about opioid disposal. On weekends, only 15% correctly directed customers about safe antibiotic disposal and 7% gave the correct information about disposing of opioids.

When asked about takeback programs at the 898 pharmacies, 91 said they had a program for antibiotic disposal and 82 said they had a program for opioid disposal.

"This clearly points to the need for better dissemination of information on proper medication disposal," Hillary Copp, senior study author and associate professor of urology at UCSF, said in a statement.

"The FDA has specific instructions<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Fsafe-disposal-medicines%2Fdisposal-unused-medicines-what-you-should-know&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698726181&sdata=958BZDg6wXaReZ70R4xL0ulXA2Xa34wKARuBU4dAZUs%3D&reserved=0> on how to dispose of these medications, and the American Pharmacists Association has adopted this as their standard. Yet it's not being given to the consumer correctly the majority of the time," Copp said.
The improper disposal of medication can result in antibiotic resistance, pollution, child and pet poisonings and drug misuse.


Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov<mailto:Deborah.DeBiasi at deq.virginia.gov>
WEB site address:  www.deq.virginia.gov<https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.deq.virginia.gov%2F&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698736176&sdata=doe9D4TuLTr%2FkDNxWd189merPySQB%2FYYlvxvUCNjLP4%3D&reserved=0>
Virginia Department of Environmental Quality, Office of Water Permits
State Coordinator for Industrial Pretreatment/Whole Effluent Toxicity (WET) Programs
PPCPs, EDCs, and Microconstituents
http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx<https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.deq.virginia.gov%2FPrograms%2FWater%2FPermittingCompliance%2FPollutionDischargeElimination%2FMicroconstituents.aspx&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698736176&sdata=Usno05IAgE8oua2Y3GswYmU5Pa40zjQww5bH1CHZh8Q%3D&reserved=0>
http://www.deq.virginia.gov/DentalRule.aspx<https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.deq.virginia.gov%2FDentalRule.aspx&data=02%7C01%7Cjennifer.volkman%40state.mn.us%7C253778515de940e6a56a08d78ff107b1%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637136137698746170&sdata=KYYhvJF7dUF4XTLaYs3wTn%2FG4Kb7twiu8lrzuK3jG1c%3D&reserved=0>
Mail:          P.O. Box 1105, Richmond, VA  23218
Location:  1111 E. Main Street, Suite 1400  Richmond, VA  23219
PH:         804-698-4028


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