DEA Regulation Changes: Pharmaceutical Controlled Substances

Pharmaceutical

Controlled Substances

Regulation Changes:

What Do The New DEA Pharmaceutical

Regulations Mean For Your Organization?

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Sasha Laferte

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Meet Your PresenterMike AlbertOnsite Support Services Manager, New England

malbert@triumvirate.com

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 End 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

How often do you worry about

proper Controlled Substance

handling and disposal at you

institution?1) Never

2) 1-2 times a month

3) 1-2 times a week

4) Daily

5) All the time

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

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

We should continue to waste our un-used or partially used controlled

substances in to the sewer system –legal and cheap

What the Regulation States Now

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

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

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 End 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

“The DEA will not evaluate,

review or approve the processes

or methods utilized to render a

controlled substance non-

retrievable, as long as the desired

result is achieved.”

Disposal of Controlled

Substances; Final Rule

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)

Question

and

Answer?

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