Transcript RxProperDisposalCompliance-2012 - MI-PTE

Welcome & Introductions

1LT Mindy Hughes, Civil Operations Program
Manager
Michigan National Guard Counterdrug Task Force
Training Objectives

 Learn Drug Enforcement Agency’s (DEA) requirements
and the steps to be completed to accept controlled
substance from end users
 How to dispose of controlled substances consistent with
federal and state laws
 Strategies for community engagement and promotion of
the use of disposal sites. Participants will be provided
resources to assist in development of legally compliant
disposal sites.
What Constitutes a Rx
Drug?

 Definition: A prescription drug is a medication that can
be purchased or given out only with written instructions
from a licensed healthcare provider, such as a doctor,
dentist, nurse practitioner or physician’s assistant, to a
pharmacist. These written instructions are known as a
prescription. Drugs that are available without a
prescription are know as over-the-counter drugs.
 4 of 5 US adults take Rx, OTC, or dietary supplement
every week
 33% take 5 or more medications weekly
2006 Institute of Medicine Report
The Differences…

What is the difference between prescription drugs and OTC drugs?
 A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Prescription drugs are:
 Prescribed by a doctor
 Bought at a pharmacy
 Prescribed for and intended to be used by one person
 Regulated by FDA through the New Drug Application (NDA) process. This is the formal step a drug sponsor
takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA
includes all animal and human data and analyses of the data, as well as information about how the drug
behaves in the body and how it is manufactured. For more information on the NDA process, please see "The
FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective."
OTC drugs are:
 Drugs that do NOT require a doctor's prescription
 Bought off-the-shelf in stores
 Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book"
covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated
adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed
without further FDA clearance, while those that do not, must undergo separate review and approval through
the "New Drug Approval System."
US Food and Drug Administration
Why We Care:
Abuse Concerns

 One-third of all new prescription drug users from 2006 to 2009 data were
12 to 17 year-olds
 Teens abuse prescription drugs more than any illicit drug except
marijuana—more than cocaine, heroin, and methamphetamine combined
 Violent Crime and Property crime associated with abuse and diversion of
Controlled Prescription Drugs (CPD) has increased in all regions of the US
over the past 5 years (S.3997, 2010)
 Unintentional overdose deaths involving prescription drugs increased
114% from 2002-2006
 Centers for Disease Control and Prevention has classified prescriptoin
drug abuse as an Epidemic
(S.3397, 2010 & ONDCP)
Take the American
Medicine Chest Challenge

5 Simple Steps:
1. Take inventory of your prescription and over-the-counter medicine.
2. Secure your medicine chest.
3. Safely dispose of your unused, unwanted, and expired medicine.
4. Take your medicine exactly as prescribed.
5. Talk to your children about the dangers of prescription drug abuse... they are listening.
American Medicine Chest Challenge
Home of the National Online Directory of Permanent Prescription Drug Collection Boxes
877-919-2622
Audience Poll

(Please use the icons on the left to answer accordingly)
Does your community have
prevention efforts in place for
Prescription Drug Abuse
Education for Youth?
Audience Poll

(Please use the icons on the left to answer accordingly)
Does your community have
prevention efforts in place for
Prescription Drug Abuse
Education for Pharmacists?
Why We Care:
Environmental Concerns

 Trace Pharmaceuticals in Drinking Water Supply
http://www.who.int/water_sanitation_health/publications/2011/pharmaceuticals/en/
 Take Backs provide alternate means of disposal such
as thermal (above 1200°C) destruction, or “witness
burn”, rather than flushing and are encouraged by
S.3397
World Health Organization & S.3397
Why We Care: Legal Authority
& Action Mandating Compliance

 S.3397 Secure and Responsible Drug Disposal Act of 2012
 Office of National Drug Control Policy (ONDCP)
 Drug Enforcement Agency (DEA) Guidelines, Office of
Diversion Control (Section 1307.21): Take Back of CPDs
must have permission of the DEA
 Food and Drug Administration (FDA) Guidelines
 Environmental Protection Agency (EPA) Guidelines
 State and Local Guidelines
FDA Guidelines for Drug Disposal

1. Follow instructions on the drug label for disposal, do not
flush unless label specifically instructs
2. Take advantage of community drug take-back programs
3. If no label instructions or local take back:
1.
2.
3.
4.
Take drug out of container and mix with undesirable
substance (kitty litter, used coffee grains) until
unrecognizable (Do not crush!)
Put them in a sealable bag prior to garbage disposal
Scratch out all personal information on container
When in doubt of proper disposal, talk to your pharmacist
Audience Poll

(Please use the icons on the left to answer accordingly)
Does your community have regular
Take Back events?
DEA Proper Disposal

Locate the DEA Special Agent in Charge of your area to complete
request (DEA Form 41). Special Agent will authorize:
1. Transfer to person registered under the Act and
authorized to possess the substance
2. Delivery to a DEA agent or nearest office
3. Destruction in the presence of an DEA agent or other
authorized person
4. Other means that the agent may assure substances do not
become available to unauthorized personnel
(Agent can arrange regular disposal approval)
Code of Federal Regulations: Section 1307.21 Procedure for disposing of controlled
substances (Office of Diversion Control, DEA)
Where to Start

 Gain support from your local Health Department,
Recycling Centers, Law Enforcement, Treatment
Centers, and community members
 Educate your community
 Gain approval from DEA to host a take back (or
regular take backs)
 Participate in the DEA National Take Backs
 Gain approval for a permanent collection site
Michigan Resources

 DETROIT DIVISION
211 W. Fort Street, Suite 610, Detroit, MI 48226
Diversion Number: (313) 226-7537
Diversion Fax: (313) 225-2163
Diversion Program Manager - James Geldhof
 Kent County Waste to Energy Company
950 Market Avenue Southwest, Grand Rapids, MI 49503
Kim Alexander, (616) 336-3965
 Operation Medicine Cabinet
http://www.operationmedicinecabinetmi.com/dropofflocations.html
Partner Programs

 Drug Free Communities
 Funding and Support for identifying needs / resources
 National Youth Anti-Drug Media Campaign
 Free online resources for teen prevention
 Media campaigns to increase teen exposure to prevention
 Community Substance Abuse Prevention Coalitions
 CADCA (Community Anti Drug Coalitions of America)
 SAMHSA (Substance Abuse and Mental Health Services
Administration)
 NIDA (National Institute on Drug Abuse)
 National Guard Civil Operations
National Initiatives

 DEA hosts regular National Take Back Event
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/
 The Drug Take Back Network
http://www.takebacknetwork.com/resources.html
More Resources

 http://www.fda.gov/ForConsumers/ConsumerUpdates
/ucm101653.htm#GuidelinesforDrugDisposal
 1-888-INFO-FDA (1-888-463-6332).
 www.justice.gov/dea
 Office of National Drug Control Policy, Proper Disposal of
Prescription Drugs, 2009.
Available at:
www.whitehousedrugpolicy.gov/publications/pdf/presc
rip_disposal.pdf
More Resources

 Find out the recommended disposal for your household drugs at
DailyMed:
http://dailymed.nlm.nih.gov/dailymed/about.cfm
 DEA Form 41
http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/41_form.pdf
 DEA Definitions:
http://www.deadiversion.usdoj.gov/21cfr/21usc/802.htm
 Code of Federal Regulations (e-CFR), Food & Drug
http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&rgn=div5&view=text&node=21:9.0.1.1.9&idno=21
 Government Printing Office: Official Printing of Regulations
(202) 589-0249
Questions?

Thank you!