[Pharmwaste] inconsistent message

Fri Nov 14 10:45:45 EST 2014

Hi all,

I stand corrected.  Apparently DEA sent out a clarification letter on Oct.
17 (http://www.deadiversion.usdoj.gov/drug_disposal/)  regarding the
disposal of dispensed CS intended to be wasted.  Recording of the waste is
still required, but the new irretrievable standard does not apply and the
"wastage" cannot be put in a collection container, although DEA states the
disposal must conform to all applicable local, state, federal and tribal
law.  

So, once again DEA doesn't provide for appropriate disposal of dispensed CS
and relies on other fuzzy laws.  And, this appears to allow healthcare
facilities to continue sewering controlled substances theoretically because
they are "small quantities".  University of Iowa Hospitals sewer 35 liters
of hydromorphone every year; multiply that amount by every hospital in the
US and every type of CS to be dispensed and that does not appear to be a
"small quantity".  

Very truly yours,

Catherine Zimmer, MS, BSMT

Zimmer Environmental Improvement, LLC

St. Paul, MN 

Ph:  651.645.7509

 <mailto:zenllc at usfamily.net> zenllc at usfamily.net

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Catherine
Zimmer
Sent: Friday, November 14, 2014 3:00 AM
To: 'Hauser, Deborah'; pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] inconsistent message

Hi Deb and all,

Unfortunately, FDA has a disconnect when it comes to pharmaceuticals in our
drinking water sources and exposure to wildlife living in that water.  Their
feeling is the potential for abuse, is of higher risk, hence pouring them
down the drain is ok.  Technically under EPA rules, any wastewater treatment
plant discharging to surface waters is prohibited from sending pollutants
that "pass through",e.g. pharmaceuticals and other chemicals.  However
pharmaceuticals are not explicitly prohibited.  

DEA in their new rules calls for "irretrievable" in their standard for
destruction of controlled substances.  They do not go so far as to define
irretrievable,  but suggest incineration and chemical digestion as examples.
Flushing CS to the sewer does not meet the irretrievable standard.  Also in
the new rules, hospital pharmacies and long term care facility pharmacies
are permitted to collect and dispose of controlled substances.  With the new
rules there is no legitimate reason for healthcare facilities to be sewering
drugs.  Waste pharmaceuticals can be legitimately and securely collected, no
inventorying is required (if the drugs have been dispensed), and the waste
incinerated.  Costs can be minimized by enacting waste reduction procedures.
Its not rocket science, just better management and attention to
environmental and public health impact.  

P.S. DEA only permits the flushing of the FDA list by "ultimate users", that
is, patients.  

Very truly yours,

Catherine Zimmer, MS, BSMT

Zimmer Environmental Improvement, LLC

St. Paul, MN 

Ph:  651.645.7509

zenllc at usfamily.net

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Hauser,
Deborah
Sent: Thursday, November 13, 2014 7:00 AM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] inconsistent message

Good morning,

I've gotten the occasional question from hospital workers here in Ohio about
policies to rinse Schedule IV drugs down the drain.  As I generally work
with the residential side of things, I'm not as well-versed on hospital
practices.  However, it seems to me there is a serious disconnect between
the message from the environmental folks (like my agency, Ohio EPA) and the
FDA.  The FDA's most recent guidance still suggests flushing a lengthy list
of pharms (see below).   Has anyone had any experience with hospitals making
it a policy to NOT flush pharmaceuticals?  As far as I know, it is still
legal to flush the pharmaceuticals that FDA advises.  But I guess I'd like
to see some sort of solution that involves incinerating ALL pharms, even the
ones that have historically been flushed.  Do any of you have any
suggestions I could pass on to Ohio hospitals?

Thanks,

Deb 

Medicine

Active Ingredient

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239930.pdf> Abstral (PDF
- 1M), tablets (sublingual)

Fentanyl

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM085817.pdf> Actiq (PDF -
251KB), oral transmucosal lozenge *

Fentanyl Citrate

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311346.pdf> Avinza (PDF -
51KB), capsules (extended release)

Morphine Sulfate

Buprenorphine Hydrochloride, tablets (sublingual) *

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride; Naloxone Hydrochloride, tablets (sublingual) *

Buprenorphine Hydrochloride; Naloxone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM219146.pdf> Butrans (PDF
- 388KB), transdermal patch system

Buprenorphine

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088581.pdf> Daytrana (PDF
- 281KB), transdermal patch system

Methylphenidate

Demerol, tablets *

Meperidine Hydrochloride

Demerol, oral solution *

Meperidine Hydrochloride

Diastat/Diastat AcuDial
<http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=
Search.Overview&DrugName=DIASTAT> , rectal gel [for disposal
instructions: click on link, then go to "Label information"
and view current label] 

Diazepam

Dilaudid, tablets *

Hydromorphone Hydrochloride

Dilaudid, oral liquid *

Hydromorphone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311370.pdf> Dolophine
Hydrochloride (PDF - 48KB), tablets *

Methadone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088584.pdf> Duragesic
(PDF - 179KB), patch (extended release) *

Fentanyl

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM179172.pdf> Embeda (PDF -
39KB), capsules (extended release)

Morphine Sulfate; Naltrexone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM204267.pdf> Exalgo (PDF -
83KB), tablets (extended release)

Hydromorphone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088597.pdf> Fentora (PDF
- 338KB), tablets (buccal)

Fentanyl Citrate

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311373.pdf> Kadian (PDF -
135KB), capsules (extended release)

Morphine Sulfate

Methadone Hydrochloride, oral solution *

Methadone Hydrochloride

Methadose, tablets *

Methadone Hydrochloride

Morphine Sulfate, tablets (immediate release) *

Morphine Sulfate

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM199333.pdf> Morphine
Sulfate (PDF - 282KB), oral solution *

Morphine Sulfate

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311374.pdf> MS Contin
(PDF - 433KB), tablets (extended release) *

Morphine Sulfate

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM270268.pdf> Nucynta ER
(PDF - 38KB), tablets (extended release)

Tapentadol

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM285397.pdf> Onsolis (PDF
- 297KB), soluble film (buccal)

Fentanyl Citrate

Opana, tablets (immediate release)

Oxymorphone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM283820.pdf> Opana ER (PDF
- 56KB), tablets (extended release)

Oxymorphone Hydrochloride

Oxecta, tablets (immediate release)

Oxycodone Hydrochloride

Oxycodone Hydrochloride, capsules

Oxycodone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM289880.pdf> Oxycodone
Hydrochloride (PDF - 100KB), oral solution

Oxycodone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM208530.pdf> Oxycontin
(PDF - 417KB), tablets (extended release)

Oxycodone Hydrochloride

Percocet, tablets *

Acetaminophen; Oxycodone Hydrochloride

Percodan, tablets *

Aspirin; Oxycodone Hydrochloride

Suboxone <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM225677.pdf>  (PDF
- 83KB <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM225677.pdf> )
<http://www.fda.gov/downloads/Drugs/DrugSafety/UCM225677.pdf> , film
(sublingual)

Buprenorphine Hydrochloride; Naloxone Hydrochloride

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM089830.pdf> Xyrem (PDF -
185KB), oral solution

Sodium Oxybate

 <http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362203.pdf> Zubsolv (PDF
- 354KB), tablets (sublingual)

Buprenorphine Hydrochloride; Naloxone Hydrochloride

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