1.  1LT Mindy Hughes, Civil Operations Program Manager Michigan National Guard Counterdrug Task Force Welcome & Introductions

3.   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. Training Objectives

4.   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 What Constitutes a Rx Drug? 2006 Institute of Medicine Report

5.  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."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." The Differences… US Food and Drug Administration

6.  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)

7.  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 Take the American Medicine Chest Challenge

8.  (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

9.  (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? Audience Poll

10.   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 Why We Care: Environmental Concerns World Health Organization & S.3397

11.   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 Why We Care: Legal Authority & Action Mandating Compliance

12.  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.Take drug out of container and mix with undesirable substance (kitty litter, used coffee grains) until unrecognizable (Do not crush!) 2.Put them in a sealable bag prior to garbage disposal 3.Scratch out all personal information on container 4.When in doubt of proper disposal, talk to your pharmacist FDA Guidelines for Drug Disposal

13.  (Please use the icons on the left to answer accordingly) Does your community have regular Take Back events? Audience Poll

14.  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) DEA Proper Disposal Code of Federal Regulations: Section 1307.21 Procedure for disposing of controlled substances (Office of Diversion Control, DEA)

15.   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 Where to Start

16.   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 Michigan Resources

17.   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 Partner Programs

18.  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

19.   http://www.fda.gov/ForConsumers/ConsumerUpdates /ucm101653.htm#GuidelinesforDrugDisposal http://www.fda.gov/ForConsumers/ConsumerUpdates /ucm101653.htm#GuidelinesforDrugDisposal  1-888-INFO-FDA (1-888-463-6332).  www.justice.gov/dea 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 www.whitehousedrugpolicy.gov/publications/pdf/presc rip_disposal.pdf More Resources

20.   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/text- idx?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 More Resources

21.  Questions? Thank you!