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Practitioner Diversion Awareness Conference Training and Resources Kathy Federico Acting Section Chief Regulatory Drafting and Support Section

Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

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Page 1: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Practitioner Diversion Awareness Conference

Training and Resources Kathy Federico

Acting Section Chief Regulatory Drafting and Support Section

Page 2: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

LEGAL DISCLAIMER The following presentation was accompanied by an

oral presentation on November 18-19, 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.

U.S. Drug Enforcement Administration Diversion Control Division

Page 3: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

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

Page 4: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

§ Introduce practitioners to key federal resources involving controlled substances. § Inform practitioners on key state

resources involving controlled substances.

Course Objectives

U.S. Drug Enforcement Administration Diversion Control Division

Page 5: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

§ Provide practitioners with information on how to assist patients and their family members with overcoming controlled substance addiction.

Course Objectives

U.S. Drug Enforcement Administration Diversion Control Division

Page 6: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

§ Provide practitioners with information concerning resources specific to their communities. § Provide resources for practitioners

related to the prescribing and dispensing of controlled substances.

Course Objectives

U.S. Drug Enforcement Administration Diversion Control Division

Page 7: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Questions to Discuss

U.S. Drug Enforcement Administration Diversion Control Division

At the completion of this block of instruction you will be able to answer the following questions: 1. Which website can you access in order to obtain

information about DEA laws and regulations?

2. Does the DEA provide a guidance manual for practitioners on the DEA website?

Page 8: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Questions to Discuss

U.S. Drug Enforcement Administration Diversion Control Division

3. Which website provides a list of treatment centers for individuals seeking addiction treatment?

4. Which websites would you go to in order to locate a controlled substance collection site?

5. Who can submit a tip to the DEA online?

Page 9: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Federal and State Resources

U.S. Drug Enforcement Administration Diversion Control Division

Page 10: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

U.S. Drug Enforcement Administration Diversion Control Division

Diversion Control Division Website Contains: § Significant Guidance

Documents

§ Registration Information

§ DEA Laws and Regulations https://www.deadiversion.usdoj.gov/

Federal and State Resources Drug Enforcement Administration

Page 11: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Federal and State Resources Drug Enforcement Administration

U.S. Drug Enforcement Administration Diversion Control Division

Diversion Control Division Website Contains: § Electronic Prescribing

(EPCS) § Electronic Ordering

(CSOS) § Practitioner Manual § Mid-Level Practitioners

Manual § Questions and Answers § Drug Disposal

https://www.deadiversion.usdoj.gov/

Page 12: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

https://www.dea.gov/druginfo/fentanyl.shtml

U.S. Drug Enforcement Administration Diversion Control Division

Fentanyl Resources: § Fentanyl Fact Sheets and

abuse information § First Responder's Guide

§ Recommendations for

First Responders https://www.whitehouse.gov/ondcp/key-issues/fentanyl/

Federal and State Resources Drug Enforcement Administration

Page 13: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Locate the nearest DEA Office on the Diversion Control Divisions web-site. You can search by zip code, city, county, or state.

U.S. Drug Enforcement Administration Diversion Control Division

Federal and State Resources Drug Enforcement Administration

37203

Page 14: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

U.S. Drug Enforcement Administration Diversion Control Division

§ Illegal pharmaceutical tips can be submitted online.

§ These tips will be forwarded to the field office in your area.

Federal and State Resources Drug Enforcement Administration

Page 15: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

U.S. Drug Enforcement Administration Diversion Control Division

§ Sign up for emails from the DEA.

§ Emails include:

significant guidance documents, regulation clarifications, training opportunities, etc.

Federal and State Resources Drug Enforcement Administration

Page 16: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Federal and State Resources Centers for Disease Control

U.S. Drug Enforcement Administration Diversion Control Division

CDC – Opioid Overdose Page provides:

§ Basic Opioid Information § Data and Statistics § Overdose Prevention § Information for Patients § Information for

Providers § State Information § Large number of

publications https://www.cdc.gov/drugoverdose/index.html

Page 17: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

https://www.cdc.gov/vitalsigns/opioids/index.html

Federal and State Resources Centers for Disease Control

U.S. Drug Enforcement Administration Diversion Control Division

CDC Vital Signs is: § A Monthly Publication.

§ That Highlights Important

Health Threats.

§ Provides Appropriate Responses to Those Threats.

Page 18: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

https://www.cdc.gov/rxawareness/

Federal and State Resources Centers for Disease Control

U.S. Drug Enforcement Administration Diversion Control Division

The CDC RX Awareness site:

§ The goals are to increase awareness of the dangers of opioid addiction.

§ And to decrease the number of individuals who abuse opioids.

§ Highlights real stories of drug addiction.

Page 19: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

HHS’s Five Point Strategy:

§ Better Addiction Prevention, Treatment, and Recovery Services.

§ Better Data. § Better Pain Management. § Better Targeting of

Overdose Reversing Drugs. § Better Research.

Federal and State Resources Department of Health and Human Resources

U.S. Drug Enforcement Administration Diversion Control Division

https://www.hhs.gov/opioids/

Page 20: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

It is SAMHSA's Mission to reduce the impact of substance abuse and mental illness on America's communities.

Federal and State Resources Substance Abuse and Mental Health Services Administration

U.S. Drug Enforcement Administration Diversion Control Division

www.samhsa.gov

Page 21: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

In an effort to meet their mission, SAMHSA provides leadership and devotes its resources, including programs, policies, information and data, contracts and grants.

Federal and State Resources Substance Abuse and Mental Health Services Administration

U.S. Drug Enforcement Administration Diversion Control Division

www.samhsa.gov

Page 22: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

Federal and State Resources Food & Drug Administration

U.S. Drug Enforcement Administration Diversion Control Division

https://www.fda.gov/

Page 23: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Resources For Patients and Family Members

U.S. Drug Enforcement Administration Diversion Control Division

Page 24: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Resources For Patients Center for Disease Control

U.S. Drug Enforcement Administration Diversion Control Division

CDC Page Provides:

§ Opioid Overdose tip Card

§ Opioids and Chronic Pain factsheet

§ What you need to Know

§ Guidelines at a Glance

§ Pregnancy and Opioids

Information for Patients | Drug Overdose | CDC Injury Center

Page 25: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Resources For Patients Center for Disease Control

U.S. Drug Enforcement Administration Diversion Control Division

CDC Page Provides: § Infographics

§ Patient Poster

§ Guideline Presentation

§ Podcast

Information for Patients | Drug Overdose | CDC Injury Center

Page 26: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Resources for Patients Drug Treatment Locator

U.S. Drug Enforcement Administration Diversion Control Division

§ Run by SAMHSA. § Secure resource for

patients that are looking for drug treatment. § Patient enters their zip

code and the web-site will provide locations near them.

https://www.findtreatment.samhsa.gov/

Nashville, TN

Page 27: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

www.getsmartaboutdrugs.com

Resources for Patients Parents

U.S. Drug Enforcement Administration Diversion Control Division

Get Smart About Drugs provides:

§ Resources for parents, educators, and caregivers.

§ Current news items.

§ Trending topics.

§ DEA publications.

§ Drug abuse websites for youth.

Page 28: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

www.justthinktwice.com

Resources for Patients Teens

U.S. Drug Enforcement Administration Diversion Control Division

Just Think Twice provides teens with:

§ News and Media reports.

§ Real life addiction stories.

§ Consequences of drug addiction.

§ Facts and stats relating to drug addiction.

Page 29: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Resources for the Community

U.S. Drug Enforcement Administration Diversion Control Division

Page 30: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

DEA 360 Strategy

U.S. Drug Enforcement Administration Diversion Control Division

Page 31: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Law Enforcement actions against drug cartels and heroin traffickers in specific communities; Diversion Control enforcement actions against DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies, and practitioners; and

DEA 360 Strategy

U.S. Drug Enforcement Administration Diversion Control Division

Page 32: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Community Outreach through local partnerships that empower communities to take back affected neighborhoods after enforcement actions and prevent the same problems from cropping up again.

DEA 360 Strategy

U.S. Drug Enforcement Administration Diversion Control Division

Page 33: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Community Outreach Partners

Community Based

Solution

DEA & Federal Partners

Community Leaders

Community Based

Organizations

Substance Abuse

Professionals

Schools

Faith –Based Organizations

State & Local Law

Enforcement Partners

Social Service Organizations

U.S. Drug Enforcement Administration Diversion Control Division

Page 34: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

DEA 360 Strategy

U.S. Drug Enforcement Administration Diversion Control Division

Page 35: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

DEA 360 Strategy

U.S. Drug Enforcement Administration Diversion Control Division

www.wakeup-knoxville.gov

Page 36: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

DEA 360 Strategy

U.S. Drug Enforcement Administration Diversion Control Division

www.getsmartaboutdrugs.gov/knoxville

www.justthinktwicewv.gov/knoxville

Page 37: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Community Resources Higher Education

U.S. Drug Enforcement Administration Diversion Control Division

www.campusdrugprevention.gov

Campus Drug Prevention provides: § Institutions of higher education

and their surrounding communities with these resources to prevent drug abuse among college students. § Promotes the importance of

prevention and its role in helping ensure the health and safety of our nation’s colleges and universities.

Page 38: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Community Resources National Drug Take Back Sites

U.S. Drug Enforcement Administration Diversion Control Division

Search for a take back location by zip to locate a site a near you.

https://www.deadiversion.usdoj.gov/drug_disposal/takeback/

Page 39: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Community Resources Collection Sites

U.S. Drug Enforcement Administration Diversion Control Division

Search by zip code to locate a permanent collection site near you.

https://www.deadiversion.usdoj.gov/drug_disposal/index.html

37203

Page 40: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

www.operationprevention.com

Community Resources Teachers – Operation Prevention

U.S. Drug Enforcement Administration Diversion Control Division

The DEA has joined forces with Discovery Education to create a comprehensive and innovative program to combat opioid misuse through integration in the classroom.

Page 41: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

www.operationprevention.com

Community Resources Teachers – Operation Prevention

U.S. Drug Enforcement Administration Diversion Control Division

The Operation Prevention site provides: § Virtual classrooms § Virtual field trips § Parent tool kit § Video challenges § Student learning modules

Page 42: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Resources For Practitioners

U.S. Drug Enforcement Administration Diversion Control Division

Page 43: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

The CDC Guidelines for Prescribing provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

Resources For Practitioners CDC Guidelines For Prescribing

U.S. Drug Enforcement Administration Diversion Control Division

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

Page 44: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

The NASCSA offers a list of all state prescription monitoring programs along with contact information.

Resources For Practitioners National Association of State Controlled Substances Authorities

U.S. Drug Enforcement Administration Diversion Control Division

www.nascsa.org

Page 45: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

NIDAMED’s mission is to disseminate science-based resources to health professionals on the causes and consequences of drug use and addiction, and advances in pain management.

Resources For Practitioners National Institute On Drug Abuse

U.S. Drug Enforcement Administration Diversion Control Division

https://www.drugabuse.gov/nidamed-medical-health-professionals

Page 46: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

§ The FSMB provides educational tools and resources that enhance the quality of medical regulations and raise public awareness of the vital role of state medical boards.

§ Provides a list and contact information for each state medical board.

Resources For Practitioners Federation of State Medical Boards

U.S. Drug Enforcement Administration Diversion Control Division

https://www.fsmb.org

Page 47: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

§ NABP is the independent, international, and impartial association that assists its member boards and jurisdictions for the purpose of protecting the public health.

§ Provides a list of links to all state pharmacy boards.

U.S. Drug Enforcement Administration Diversion Control Division

Resources For Practitioners National Association of Boards of Pharmacy

https://nabp.pharmacy/

Page 48: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Post Questions

U.S. Drug Enforcement Administration Diversion Control Division

1. Which website can you access in order to obtain information about DEA laws and regulations?

A. www.deadiversion.usdoj.gov B. www.fbi.gov C. www.floridapharmacyboard.gov D. www.whitehouse.gov

Page 49: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Post Questions

U.S. Drug Enforcement Administration Diversion Control Division

2.Does the DEA provide a guidance manual for practitioners on the DEA website?

A. Yes B. No

Page 50: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Post Questions

U.S. Drug Enforcement Administration Diversion Control Division

3. Which website provides a list of treatment centers for individuals seeking addiction treatment.

A. www.dea.gov B. www.hhs.gov C. www.samhsa.gov D. www.deadiversion.usdoj.gov

Page 51: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Post Questions

U.S. Drug Enforcement Administration Diversion Control Division

4. Which websites would you go to in order to locate a controlled substance collection site?

A. www.deadiversion.usdoj.gov B. www.epa.gov C. www.hhs.gov D. www.samhsa.gov

Page 52: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Post Questions

U.S. Drug Enforcement Administration Diversion Control Division

5. Who can submit a tip to the DEA online?

A. Pharmacists B. Patients C. Practitioners D. General Public E. All of The Above

Page 53: Practitioner Diversion Awareness Conference · DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies,

Thank-you for your time and attention!

U.S. Drug Enforcement Administration Diversion Control Division