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Title: | Disposal, Return of Patient Meds, and Options for Patients |
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Body: | Practitioner Diversion
Awareness Conference
Disposal and Returns of Patient Controlled
Substance Medications
Noreen Valentine, Group Supervisor
The following presentation was accompanied by an oral
presentation on December 17-18, 2018, and does not
purport to establish legal standards that are not
contained in statutes, regulations, or other competent
law. Statements contained in this presentation that are
not embodied in the law are not binding on DEA.
Summaries of statutory and regulatory provisions that
are summarized in this presentation do not purport to
state the full extent of the statutory and regulatory
requirements of the cited statutes and regulations. I
have no financial relationships to disclose.
LEGAL DISCLAIMER
U.S. Drug Enforcement Administration
Diversion Control Division
This presentation is for educational purposes only. This presentation may not be
further copied or used, with the embedded images and videos, without an
independent analysis of the application of the Fair Use doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use"
for purposes such as criticism, comment, news reporting, teaching, scholarship,
education and research.
Fair Use is a use permitted by the copyright statute that might otherwise be
infringing. Any potentially copyrighted material used in this presentation has
been reviewed and found to be used in a manner consistent with Fair Use. A
completed Fair Use checklist is attached.
Fair Use Act Disclaimer
U.S. Drug Enforcement Administration
Diversion Control Division
§
Discuss the Secure and Responsible Drug
Disposal Act of 2010, and the implementing
regulations of 2014.
§
Discuss how to properly dispose of
practitioner inventory.
§
Discuss how to properly dispose of
controlled substance waste.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
§
Discuss the disposal of controlled
substances by the patient "ultimate
user."
§
Discuss the disposal of patients'
controlled substances at long term
care facilities.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
At the completion of this block of instruction you
will be able to answer the following questions:
1.
Which method of destruction for controlled
substance practitioner inventory is not
allowed?
2.
Can a practitioner take back a controlled
substance that was already prescribed or
dispensed to a patient?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
3.
What is DEA's current recommended method of
disposal for practitioner inventory?
4.
When is a DEA Form 41 required for the
disposal of controlled substances.
5.
What disposal methods are available for
ultimate user's ?
U.S. Drug Enforcement Administration
Diversion Control Division
Doctor,
36%
Friend
or
Relative,
54%
Dealer
or
Stranger
Other,
5%
Where Do They Come From?
U.S. Drug Enforcement Administration
Office of Diversion Control
Source: Department of Health and Human Services
§
Authorized the DEA to promulgate regulations that
allow ultimate users to transfer pharmaceutical
controlled substances to authorized entities for
disposal.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
§
A person who has lawfully obtained, and
who possesses, a controlled substance for
their own use, or for the use of a member of
their household, or for an animal owned by
them or a member of their household.
21 USC § 802(27)
Ultimate User
U.S. Drug Enforcement Administration
Diversion Control Division
§
A registered manufacturer, distributor, reverse
distributor, narcotic treatment program,
hospital/clinic with an on site pharmacy, or retail
pharmacy that is authorized to so receive a
controlled substance for the purpose of destruction.
§
The registrant has a modified registration
authorizing the collection of controlled substances
from the "ultimate user."
What is a "Collector"
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1300.01(b)
§
This did not change existing methods of disposal
of controlled substances, for ultimate users but
expanded the options.
§
Ultimate users now have more locations where
they can securely, safely, responsibly, and
conveniently dispose of their unwanted
pharmaceutical controlled substances.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
§
The regulations continue to allow Federal, State,
tribal, and local law enforcement to maintain
collection receptacles at the law enforcement's
physical location;
§
And either independently or in partnership with
private entities or community groups, to
voluntarily hold take-back events and administer
mail-back programs.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
§
Created an exception for LTCFs to transfer
pharmaceutical controlled substances for disposal
on behalf of patients who reside or have resided at
that facility.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
Benefits to the public are:
§
Decrease the supply of pharmaceutical controlled
substances available for misuse, abuse, diversion,
and accidental ingestion; and
§
Protect the environment from potentially harmful
contaminants by providing alternate means of
disposal for ultimate users.
Disposal of Controlled
Substances Final Rule of 2014
U.S. Drug Enforcement Administration
Diversion Control Division
§
A controlled substance is considered "non-
retrievable" when it cannot be transformed
to a physical or chemical condition or state
as a controlled substance or controlled
substance analogue...
Non-Retrievable
U.S. Drug Enforcement Administration
Diversion Control Division
21 CFR § 1300.05
The purpose of this destruction standard is to:
§
Permanently render the controlled substance(s) to
a non-retrievable state and thus prevent diversion
of any such substance to illicit purposes.
Non-Retrievable
U.S. Drug Enforcement Administration
Diversion Control Division
These methods
do not meet the
standard
21 CFR § 1300.05
Disposal of Practitioner
Controlled Substance Inventory
and
Controlled Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
Practitioner options to dispose of inventory are:
§
Prompt on-site destruction if proper method.
§
Prompt delivery to a DEA registered reverse
distributor by common carrier or reverse
distributor pick-up.
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.05(a) and (b)
Returned or Recalled Controlled Substances
§
Prompt delivery by common or contract carrier or
pick-up at the registered location by:
§
Registrant from whom it was obtained.
§
Registered manufacturer of the substance.
§
Another registrant authorized by the
manufacturer to accept returns or recalls on
the manufacturers behalf.
21 C.F.R. § 1317.05(a) and (b)
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
§
A practitioner may also request
assistance from the Special Agent in
Charge.
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.05(a) and (b)
§
DEA is aware that there are companies that claim
that their products can render controlled
substance inventories non-retrievable, and have
DEA approval.
§
DEA has not approved any such products for the
disposal of practitioner inventory.
Products That Advertise
They are Non-Retrievable
U.S. Drug Enforcement Administration
Diversion Control Division
21 CFR § 1300.05
§
Controlled substance practitioner inventory
cannot go to a collector.
§
Collectors can only receive controlled
substances from the "ultimate users."
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.05(a) and (b) 21 C.F.R. § 1317.75(c)
DEA allows disposal of controlled
substance waste if:
§
It is authorized under your states
laws... and
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
§
It is the remaining portion of used needles,
syringes, or other injectable products in a
practitioner environment (hospital, clinic,
physicians office, etc.)
21 C.F.R. § 1304.21(e)
Recordkeeping for disposal of controlled substance
waste:
§
No DEA Form 41 required.
§
Recommended that two employees witness the
handling and the destruction of the controlled
substance waste.
21 C.F.R. § 1317.95(c) and (d)
21 C.F.R. § 1304.21(e)
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
Record of waste disposal must include:
§
Name of Substance
§
Form
§
Quantity
§
Date of Disposal
§
Manner of Disposal
21 CFR § 1304.22(c)
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
§
Records must be maintained at the
practitioner's registered location for a minimum
of two years.
§
Longer if required by state laws or regulations.
21 CFR § 1304.04(a)
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
§
A physician cannot take back
controlled substances that have
been administered, prescribed,
or dispensed to the "ultimate
user.
U.S. Drug Enforcement Administration
Diversion Control Division
Patient's Controlled
Substances
§
It is not authorized by Federal Laws and
Regulations.
§
Do not put yourself or your practice in harms way
by ignoring this.
Disposal of Ultimate
User's Controlled
Substances
U.S. Drug Enforcement Administration
Diversion Control Division
§
DEA recommends that "ultimate users" do
not flush their expired or unwanted
prescriptions and over-the-counter drugs
down the toilet or drain unless the label or
accompanying patient information
specifically instructs you to do so.
§
Be aware the FDA posted instructions to
flush certain types of controlled substances.
"Ultimate User" Destruction
U.S. Drug Enforcement Administration
Diversion Control Division
" Ultimate users" can now return unwanted or
expired prescription and over-the counter drugs to:
§
Law enforcement supported drug take-back
program or collection box.
§
DEA registered collector that has an on-site
collection receptacle.
§
DEA registered mail back program.
"Ultimate User" Destruction
U.S. Drug Enforcement Administration
Diversion Control Division
§
LTCFs may dispose of a current or
former resident's unwanted or unused
controlled substances in a collection
receptacle located at the LTCF.
Collection at LTCFs
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.80(a)
New Disposal Law Passed
§
On 10-23-2018 the SUPPORT for Patients and
Communities Act was signed into law
§
Under certain conditions, an employee of a
qualified hospice program may handle and dispose
of, without being registered by DEA, a controlled
substances lawfully dispensed to the person
receiving hospice care, as long as ...
§
The controlled substances are destroyed on-site
and
§
In compliance with all Federal, state, and local
laws.
New Disposal Law Passed
Summary of Destruction
Standards
Non-Retrievable
Standard
Not Required to
Comply with
Non-Retrievable
Standard
U.S. Drug Enforcement Administration
Diversion Control Division
Ultimate Users
Practitioner CS Waste Practitioner CS
Inventory
Summary of Disposal
Options
U.S. Drug Enforcement Administration
Diversion Control Division
Practitioner Inventory
DEA Reverse
Distributor
Ultimate User
Collection Box
Mail Back Programs
Commercial Products
Coffee Grounds
Kitty Litter
Etc.
Controlled Substance
Waste
§
Do not allow patients to bring their previously
prescribed or dispensed controlled substances to
your facility prevents diversion.
§
Timely proper disposal of inventory prevents
diversion.
§
Timely witnessing and documenting the disposal of
controlled substance waste prevents diversion.
Preventing Diversion
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
1. Which method of destruction of controlled
substance practitioner inventory is not
allowed?
a.
Return to whomever it was purchased from.
b.
Send the controlled substances to a reverse
distributor.
c.
Return to a DEA registered "collector" or a
take back location.
d.
Destroy the controlled substances on-site.
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
2. Can a practitioner take back a
controlled substance that was already
prescribed or dispensed to a patient?
a.
Yes
b.
No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
3. DEA's recommended way of
destruction is by incineration.
a.
True
b.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
4. Controlled substance waste must
always be reported on a DEA Form 41
(Destruction of Controlled Substances).
a.
True
b.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
5. A Practitioner can destroy controlled
substance inventory (expired) by placing
them into kitty litter or coffee grinds.
a.
True
b.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Thank-you for your time
and attention !
U.S. Drug Enforcement Administration
Diversion Control Division
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