Embed Size (px)
Citation preview
Pharmaceutical
Controlled Substances
Regulation Changes:
What Do the New DEA Pharmaceutical Regulations
Mean For You Organization?
Meet Your PresenterMike AlbertOnsite Support Services Manager, New England
www.linkedin.com/in/michaelalbert1
• Worked with Triumvirate for 6 ½ years
• Worked mostly in the HealthCare
Niche
• Managed Healthcare onsite teams at
large Healthcare Institutions
• Healthcare Environmental Manager
(HEM)
• Sat in on and worked with multiple
Environment of Care Committees
Drug Enforcement Administration (DEA)
New final rule went into affect September 9th, 2014
On Controlled Substances
(21 CFR Parts 1300, 1301, 1304 et al.)
Disposal of Controlled Substances; Final Rule
Our Key Message
Collection, Destruction and Removal
of Controlled Substances, is now
more protected, widespread and
sustainable
Who Is This For?
Ultimate Users
People who lawfully obtain Controlled Substances –Where and when can they dispose of unused/unwanted substances?
Registrants
Reverse Distribution the easiest way to
dispose of controlled substances?
Becoming a Collector for the
community – Safety, security and cost of
disposal.
Waste/Disposal
“No Dumping” Policies
Burdened time and risk with too much
documentation
What Will You Learn?
What is an ‘Ultimate User’ and ‘Non-Retrievable’?
Understanding what registrants are capable of providing to the public.
Required Paperwork and Documentation –New DEA Form 41
Knowing how to properly dispose of all controlled substances from your institution.
You Might Be Thinking...
• Can I really destroy any
controlled substance on my site?
• Do all DEA agencies have to
follow this regulation?
• Is this the safe and responsible
direction to go towards?
• Does the cost out-way the
benefit?
Benefits of CollectionWhat
Others Say
We should continue to waste our un-used or partially used controlled
substances “pharmaceutical wastage’ in to the sewer system – legal and
cheap
If we become a Collector, we will have much more unwanted attention at our
institution.
Letters still need to be sent into the Special Agent in Charge (SAC), for
authorization for destruction and disposal of controlled substances
What We Say Instead
If I were to collect and divert all controlled substances “pharmaceutical wastage” from the sewer system, we will be saving the environment and
helping future drinking water be clean
A collector could have more unwanted attention from the community but
controlled substances will be collected and taken out from illegal use.
Letters do not have to be written to the SAC for approval of destruction.
However, new practices will need to meet the new definition of Non-
Retrievable
Overview
What Changed?
Authorized Collector
Destruction and Disposal Options
Our Key Message
Collection, Destruction and Removal
of Controlled Substances, is now
more protected, widespread and
sustainable
What Changed?
What Changed?
Authorized Collector
Destruction and Disposal Options
Consolidation and
Implementation of the Secure
and Responsible Drug
Disposal Act of 2010
http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf
New Definitions
Ultimate End User
Non-Retrievable
Limited disposal
options leads to
improper
disposal
solutions
Where Do The Drugs Go?
www.whitehouse.gov/ondcp/disrupt-domestic-drug-trafficking-and-production
“the nonmedical use of
prescription drugs is a
growing problem in the
United States”
The Disposal Act
Options Before/After Changes
Ultimate User
(Normal Patient)Take Back Day
Take Back Day
Transfer to a
Authorized Collector
Practitioner/Non-Practitioner
Reverse Distribution
Reverse Distribution
“Sewering”
Collection to meet ‘Non-Retrievable’ Definition for
Disposal
“Sewering”
Need DEA Approval from
SACDo not need DEA approval
Authorized Collector
What Changed?
Authorized Collector
Destruction and Disposal Options
Registrants
can apply to
become an
Authorized
Collector
http://www.DEAdiversion.usdoj.gov.
Authorized Collector Need to Know
Safety and Security
In a Secure Area
Locked Container with Inner
Liner
No Inventory
Taken
Labeled for only
Schedule II - V
Prompt Disposal
Small Opening
Benefits of Collection?
Possible Solution/Resolution
Proper monitoring and a quick reference to the label on the
container is a must
Having the location of the container in an area where there is less traffic but more
employees is key to make sure eyes are tuned in.
The DEA have very ‘loose’ requirements to make sure that
each institution can come up with their own solution
What is Hard to Do
Keep Schedule I’s out of the container
Monitoring the Collection Container
Meet all requirements for the collection container and inner
liner
Disposal and Destruction Options
What Changed?
Authorized Collector
Destruction and Disposal Options
Options for
Disposal/Destruction
• Take Back Days
• Mail-Back Programs
• Collection Drop Offs
• Reverse Distribution
• Onsite Destruction
Our Key Message
Collection, Destruction and Removal
of Controlled Substances, is now
more protected, widespread and
sustainable
Onsite Destruction1) Don’t need special approval by the SAC. (Still
need Form 41)
2) Need to meet Non-Retrievable requirements
3) Pharmaceutical Wastage now defined
Controlled substance dispensed for immediate administration
pursuant to an order for medication in an institutional setting
remains under the custody and controlled of that registered
institutions even if the substance is not fully exhausted (“drug
wastage” & “pharmaceutical wastage”)
Container Ideas
New DEA Form 41
Sections:
A) Registrant
Information
B) Items Destroyed
1) Inventory
New DEA Form 41 (cont.)
Sections:
2) Collected
Substances
C) Method of
Destruction
D) Witnesses
Summary
What Changed?
Authorized Collector
Destruction and Disposal Options
Action Plan
Decide if you want to be collector and aide your community
Get a Policy or Procedure in place to more effectively adhere to new innovative options for controlled substance destruction disposal
Take advantage of the new regulations to get controlled substances out of our
drinking water and Environment (Pharmaceutical Wastage)
QUESTIONS?
