Presentations

Welcome by, Steve Comer, Associate SAC, DEA, Atlanta Field Division and Howard Davis, Diversion Program Manager, DEA, Atlanta Field Division

Introduction and Conference Objectives, Mark Caverly, Section Chief, DEA, Liaison and Policy Section

Regulatory Updates, Mark Caverly

Physician Education Programs, Ralph Orr, Program Manager, Virginia Department of Health Professions

Pseudoephedrine Tracking – Chemical Investigations – Logbook Enforcement, Thomas Farmer, Tennessee Meth Task Force; Jeanette Gravis, Assistant US Attorney, St. Louis; Nicholas Winton, Australian Attorney General’s Department

Opioid Treatment Issues, Denise Curry, Deputy Director, DEA, Office of Diversion Control and Nick Reuter, Senior Public Health Advisor, Department of Health and Human Services, SAMHSA

ONDCP Rx Policy Issues, John Walters, Director, White House Office of National Drug Control Policy

Strategic National Stockpile, Heidi Pfeiffer, Centers for Disease Control and Prevention; Jason Stear, Centers for Disease Control and Prevention, and Mark Caverly, Section Chief, DEA

Registration Update, Mary Thompson-Holder, Unit Chief, DEA, Registration Customer Response Unit

Scheduling Actions, Susan Carr, Deputy Section Chief, DEA, Drug & Chemical Evaluation Section

DEA Regulatory Section, Barbara Boockholdt, Section Chief, DEA, Regulatory Section

Distributor Initiative, Maureen O’Keefe, Acting Section Chief, DEA Pharmaceutical Investigations Section

DEA Chemical Operations Overview Investigative Techniques, Scott Masumoto, Acting Section Chief, DEA, Synthetic Drugs and Chemicals Section

The Drug Enforcement Administration’s (DEA) Office of Diversion Control sponsored the 17th National Conference on Drug and Chemical Diversion June 17 - 19, 2008 in Charleston, South Carolina. Participants included individuals from approximately 32 states responsible for policy-level regulatory drug control and operational law enforcement affecting the diversion of licitly manufactured controlled substances, DEA Diversion Program Managers (DPMs), 4 federal agencies, and 3 representatives from Australia involved in policy making from around the world..

This conference is held on a yearly basis and is one of the mechanisms used by the Office of Diversion Control to illuminate communication and cooperation with state and local counterparts. Through activities like the Annual Conference and the initiatives it engenders, the Office of Diversion Control hopes to build and encourage participants to take full advantage of the opportunity for exhilarating exchange and knowledge sharing.

The conference was constructed around various presentations and break-out sessions scheduled over three days. Each session began with multiple presentations, followed by vigorous discussion on the growing trend of prescription drug abuse and strategies being taken by federal and state authorities. The afternoon allowed participants to select from a number of breakout sessions, with topics including: Emergency Plans/SES; Opioid Treatment Issues, Drug Disposal Issues and Internet Investigations.

The conference opened with a welcome by Steve Comer, Associate Special Agent in Charge, Atlanta Division and Howard Davis, Diversion Program Manager (DPM), Atlanta Division. Associate SAC Comer continued with a brief overview of the drug and chemical situations within the Atlanta Division and what the division is doing to attack drug threats.

Mark Caverly, Section Chief, DEA, Liaison and Policy Section, presented introductory comments and outlined the objectives for the 17^th Annual Conference noting specifically that drug diversion issues have been magnified and will continue to be a matter of public health and safety. The presentations provided an update on initiatives that the Office of Diversion Control considers to be vital for the success of the Diversion Program within the DEA. The presentations are briefly summarized below.

Mark Caverly, Section Chief, DEA, Liaison and Policy Section, informed the audience of the regulatory updates since the last conference held in June 2007. The update contained a brief summary of the proposed and final rules from the DEA published in the last calendar year to include:

1. The Combat Methamphetamine Epidemic Act of 2005
2. Finalized Rules

• Iodine
• Multiple CII Prescription Rule
• Controlled Substances Re-export Rule
• Authorized Sources of Narcotic Raw Materials
• Changes to Patient Limits for OBOT Practitioners

3. Pending Rules

• Single Sheet DEA Form 222
• Electronic Prescriptions for Controlled Substances (EPCS)

After the Regulatory Update Session, attendees participated in regional breakout groups to discuss matters pertaining to diversion in their respective areas of the country.

Ralph Orr, Program Director, Prescription Monitoring Program, Virginia Department of Health Professions, gave a 30 minute presentation on the cooperative initiatives of the implementation of a Prescription Monitoring Program (PMP) combined with the need for education among practitioners treating patients for pain.  The VA Department of Health Professions partnered with the Virginia Commonwealth University (VCU) School of Medicine to develop an online pain management curriculum called VCU Chronic Non-malignant Pain Management. The curriculum emphasizes current issues in the management of pain through a case-based modular format and offers ongoing access to practice resources in pain management. Mr. Orr encouraged more states to participate in PMPs and emphasized the need for more users of the programs currently in place.

Linden Barber, Associate Chief Counsel, DEA, gave a detailed talk entitled A Team Approach to Fighting Internet Diversion. DEA is actively investigating unscrupulous entrepreneurs who use the Internet to solicit orders for controlled substances, and find doctors and pharmacists who are willing to give drug distributions the appearance of legitimacy by issuing "prescriptions." DEA is working together with other agencies and law enforcement to fight the growing problem of controlled substances that have a legitimate medical use being diverted into illegitimate channels, with particular emphasis on fighting Internet diversion.

Day two of the conference began with a panel presentation by Nicholas Winton, Project Officer, Australian Attorney General’s Department; Jeannette Graviss, Assistant United States Attorney, St. Louis; and Thomas Farmer, Director, Tennessee Meth Task Force on efforts related to methamphetamine precursor chemicals.

• Nicholas Winton reported on Project STOP. Project STOP is aimed at attacking the methamphetamine problem in Australia. Project STOP has been a national program in Australia since August 2007 and is part of an integrated approach to address pseudoephedrine controls including rescheduling, awareness raising and the introduction and promotion of therapeutic alternatives.
• Jeannette Graviss presented information regarding prosecuting violations of the Combat Methamphetamine Act. Specifically, Ms. Gravis discussed an investigation in which acquisition of pseudoephedrine through the use of logbook purchase records established the intent to manufacture methamphetamine.
• Thomas Farmer reported on the work of the Tennessee Methamphetamine Task Force in response to the meth epidemic. The task force is a unique organization that partners different law enforcement agencies, legislators, first responders, social workers and health professionals to identify methamphetamine labs through electronic tracking of pseudoephedrine (PSE) purchases.

Denise Curry, Deputy Director, Office of Diversion Control and Nicholas Reuter, Senior Public Health Advisor, Substance Abuse and Mental Health Services Administration, discussed opioid treatment issues. Ms. Curry gave an overview of the Drug Addiction Treatment Act of 2000 (DATA), which authorizes qualified physicians to prescribe, administer and dispense buprenorphine (Suboxone and Subutex) for the maintenance and detoxification treatment of narcotic addiction. She outlined pertinent regulations and described the outcome of scheduled regulatory investigations conducted by DEA to determine compliance with DATA’s established patient limits of no more than 30 patients during the first year of approval or 100 patients thereafter. Ms. Curry reported that of the physicians inspected during 2007 and 2008 a majority or 52% were found to be in compliance and 34% were not in compliance. The major infraction(s) involved recordkeeping. Buprenorphine prescribing and distribution trends were discussed. Ms. Curry also discussed the legal requirements pursuant to 42 CFR 2.67 which require law enforcement to ascertain a court order prior to initiating a criminal complaint investigation against a DATA qualified physician or narcotic treatment program.

An overview was provided on the public health crisis involving an alarming increase in methadone associated mortality across the United States. A report released June 2008 by the Florida Department of Law Enforcement (FDLE) and the Florida Medical Examiners states that the drugs most associated with lethal drug occurrences in Florida from July 2006 through December 2007 were cocaine, methadone and benzodiazepines. The report contains information compiled from autopsies performed by medical examiners across the state in 2007. A 2006 Center for Disease Control (CDC) study conducted in West Virginia with state Medical Examiner data revealed that 34% of unintentional drug overdose deaths in 2006 involved methadone. And of that number 30% had prescriptions identified in the state Prescription Monitoring Program and 21% had a prescription issued within 30 days of their death.

Ms. Curry also highlighted the significant potential associated with methadone (relative to its clinical use) to cause fatalities which is greater than that of other commonly used opioid analgesics such as hydrocodone, oxycodone, and fentanyl. She concluded with a discussion of the voluntary initiative undertaken in response to the methadone associated mortalities by the pharmaceutical industry, DEA and other federal agencies to restrict distribution of the 40 mg methadone diskettes to authorized narcotic treatment programs and hospital pharmacies.

Mr. Reuter discussed opioid abuse, diversion, morbidity, and mortality from the perspective of the Substance Abuse and Mental Health Services Administration (SAMHSA) perspective.  According to SAMHSA’s National Survey on Drug Use and Health, prescription opioid drug products used for pain treatment and opioid dependence are serious public health concerns.  Approximately 7 million people in the U.S. currently abuse prescription controlled substances, mostly pain relievers.  This is more than cocaine and less than marijuana.  In 2006, more people initiated abuse of these prescription drugs than marijuana.  Accidental deaths from drug overdoses have increased steadily over the last several years, and are the leading cause of accidental deaths in some age groups.  Methadone, a drug product used in both addiction treatment and pain relief, is associated with considerable levels of morbidly and mortality.

SAMHSA’s approach to reducing the abuse of opioids includes consumer education and awareness, provider (prescriber) education and training, provider screening, and intervention, and substance abuse treatment.  The agency is sponsoring education in states with the highest levels of prescription opioid abuse.  A new system will permit physicians to contact experienced pain treatment specialists for guidance on specific cases. The use of buprenorphine for opioid dependence continues to expand, and SAMHSA continues to closely monitor buprenorphine abuse.

ONDCP Director John P. Walters encouraged the audience to continue their work on prescription drug diversion. Director Walters emphasized the upward trend in prescription drug abuse, and the role law enforcement can play in helping to thwart this problem. Director Walters thanked the conference participants for their service and encouraged them to work with treatment providers to identify the sources of prescription drug diversion. He noted that prescription drug diversion investigators are on the front lines of this emerging threat.

Heidi Pfeiffer, Emergency Response Specialist, Center for Disease Control, and Jason Stear, Emergency Response Specialist, Center for Disease Control, presented the CDC’s Strategic National Stockpile (SNS) and CHEMPACK programs. The SNS is a national repository of antibiotics, chemical antidotes, antitoxins, life support medications, IV administration, airway maintenance supplies, and medical/surgical items designed to supplement and re-supply state and local public health agencies in the event of a national emergency anywhere and at anytime with the US or its territories. The first line of response is the 12 hour push package containing pharmaceuticals, antidotes, and medical supplies designed to provide rapid delivery of a broad spectrum of assets for an ill defined threat. The CHEMPACK program is a component of the SNS which places containers throughout 4 designated regions for use in the event of a chemical attack.

Mary Thompson-Holder, Unit Chief, DEA, Registration and Program Support Section, provided a registration update to the participants. Some of the important aspects are as follows:

• As of June 2008, the total controlled substances registration population is in excess of 1.2 million, which represents an increase in the registrant population at a rate of 2-3 percent a year. The largest registrant population is the practitioner, followed by mid-level practitioner. The total number of chemical handler registrants is 1,400.
• Interactive forms - There are a number of application forms/reports required by DEA that are available online. As of June 2008, 80-85% of registrants renew online; 95% of new applicants apply online; and the remaining 5% continue to write to DEA to request forms.
• DEA Interactive Web Based Change forms, implemented in 2007, enable registrants to submit name, address, schedule and or drug code changes online. Registrants no longer print paper forms and mail changes to DEA. This process has resulted in the reduction of 700,000 pieces of paper a month being received and handled by the Registration Section.
• Other functions available via the website:

1. DEA number validation allows active DEA registrants to research the validity of other DEA registrations and
2. CMEA certifications are only available online. As of June 2008, 65,000 retail stores have certified with DEA. Concern expressed that some retail stores are not reporting as required.

Susan Carr, Deputy Section Chief, DEA, Drug and Chemical Evaluation Section (ODE), presented information on evaluations currently being conducted or recently completed by ODE staff on drugs and chemicals that have a potential to pose a public health and safety problem. Data was presented on the non-controlled drugs carisoprodol; tramadol; dextromethorphan; indiplon; salvinorin A; and several phenethylamine and tryptamine compounds that have similar structures to schedule I hallucinogens. These evaluations are conducted to determine whether a drug or chemical should be considered for addition to, transfer between, or removal from the schedules or listed chemicals in the Federal Controlled Substances Act (CSA).

Since the passage of the Anabolic Steroid Control Act of 2004, ODE has reviewed additional steroids found in dietary supplements or used by professional athletes. ODE for the first time has used the administrative process to propose to control three additional anabolic steroids: boldione, desoxymethytestosterone, and 19-nor-4,9(10)-androstadienedione.

Information was presented on current chemical evaluations being conducted, recently completed or implemented by the ODE staff. Controls and proposed controls have been completed on NPP and ANPP (fentanyl precursor chemicals) and iodine.

Information was presented on ODE’s responsibility for implementation of quotas as mandated by the Combat Methamphetamine Epidemic Act of 2005. These quotas are to provide for the annual need for the list 1 chemicals ephedrine, pseudoephedrine and phenylpropanolamine. Based on the 2008 Assessment of Annual Needs published in the Federal Register on December 27, 2007, ODE issued manufacturing, procurement and import quotas for ephedrine, pseudoephedrine and phenylpropanolamine for the calendar year 2008.

Maureen O’Keefe, DEA, Acting Section Chief, Pharmaceutical Investigations Section, informed the participants as to the background, accomplishments and continuing efforts of the DEA Distributor Initiative, explaining that the focus of the initiative is to provide guidance to DEA-registered distributors on the issues surrounding illegal Internet sales; the registrant’s obligations under the CSA as well as the regulations to report suspicious orders before they occur, excessive purchases; and the need for registrants to perform due diligence in knowing their customers.

Barbara Boockholdt, Section Chief, Regulatory Section, DEA, presented an overview of the DEA headquarters regulatory section. During the presentation Ms. Boockholdt discussed both the regulatory and import/export units within the section: their structure; their purpose within the DEA; their relationship with the states; and their various duties and responsibilities. Of note is the new 100 patient rule for data waived physicians; DEA inspections; pre-registration and scheduled investigations; special DEA investigative emphasis on the abuse of hydrocodone; DEA registrant responsibilities under the Code of Federal Register for suspicious orders; and the current DEA distributor initiative.

Scott Masumoto, Acting Section Chief, Synthetic Drugs and Chemicals Section, DEA, provided a brief overview of domestic and international efforts to combat methamphetamine production and the controls placed on related chemicals.

The purpose of the conference was to disseminate and present the various initiatives the Office of Diversion Control has been working on and facilitate communication and support of these initiatives in order to accomplish DEA’s mission.