Pharmaceutical Industry Conference
October 14 & 15, 2009 — Portland, Oregon
Introduction and Conference Objectives
Ryan Haight Act
Panel – A Distributor's Perspective
Panel – A Manufacturer's Perspective
Panel – A Pharmacy's Perspective
How to keep (or Lose) Your DEA Registration
Paul Schmidt, Associate Special Agent in Charge, Portland District Office, opened the conference along with Chris Gibson, Director of the Oregon High Intensity Drug Trafficking Area. They welcomed the group and gave a brief summary on how federal and state agencies in Oregon are working together to combat the illegal trafficking of all drugs.
One Pill Can Kill
Denise Curry, Deputy Director, Office of Diversion Control, spoke about the ever-growing need for partnership between the pharmaceutical industry and DEA. She applauded the participants for their past efforts and current support in preventing drug and chemical diversion and provided many examples of how the diversion of pharmaceutical controlled substances is still a critical issue. – Presentation SlidesAttached
Introduction and Conference Objectives
Cathy Gallagher, Associate Section Chief of the Liaison and Policy Section, served as the master of ceremonies, made administrative announcements, and introduced the various speakers.
Liqun Wong, Chief of the Data Analysis Unit, gave a presentation on the latest drug scheduling actions. She discussed five different types of scheduling and explained the process of domestic and international scheduling. She summarized the Administrative Scheduling Review Process and the eight-factor analysis necessary to arrive at a scheduling recommendation. She also updated the most recent drug scheduling actions and on-going scheduling reviews.
Susan Carr, Associate Section Chief of the Drug and Chemical Evaluation Section, explained how DEA complies with international treaties. She also provided information and tips regarding the quota application process, adjustments, and calculations. She identified quota issues that are unique to bulk manufacturers. Finally, Ms. Carr explained how researching and manufacturing are designated as independent activities for which separate DEA registrations may be required. – Presentation SlidesAttached
Mark Via, Technical Information Specialist in the Regulatory Section, spoke on imports and exports. He provided DEA contact information as well as an import/export form guide for clarification. Mr. Via spoke about estimates and assessments, how they are established, and how they differ from quotas. He also addressed import and export approval requirements for clinical trial material and provided DEA contact information for questions on this issue. – Presentation SlidesAttached
Ryan Haight Act
Dan Dormont, DEA Legislative Counsel, presented an overview of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Mr. Dormont explained the existing restrictions and requirements regarding online pharmacies and what constitutes a violation of the act and the associated penalties.
Frank Moreno, Deputy Section Chief of the Diversion Technology Section, explained the Technology Section and presented information on two electronic reporting systems: the Controlled Substances Ordering System (CSOS), and the Drug Theft and Loss System (DTL). – Presentation SlidesAttached
Leonard Levin, Staff Coordinator in the Regulatory Section, gave an overview of the Regulatory Section which did not exist during the last Pharmaceutical Industry Conference. This section handles the following issues: scheduled investigations, security, drug theft and loss, 303 investigations, employment waivers, the Controlled Substance Ordering System (CSOS), Distributor Initiative, and quota reviews. Mr. Levin explained each issue and provided a point of contact. – Presentation SlidesAttached
Sandra Gunthrope of the ARCOS Unit and Melissa Buchheister of the Targeting and Analysis Unit spoke about ARCOS reporting. They explained the roles of each unit and how the ARCOS data is received, validated, and used to comply with reporting requirements. – Presentation SlidesAttached
The first day concluded with subject matter breakout sessions which gave attendees time to discuss specific topics with subject matter experts. The four topics available for discussion were: CSOS, ARCOS, quotas, and imports/exports.
The second day began with three separate panels providing insight as to how they comply with federal laws and regulations that apply to controlled substances.
The Distributor Panel consisted of a representative from the Healthcare Distribution Management Association, a representative from the National Coalition of Pharmaceutical Distributors, and a representative from AmerisourceBergen Corporation. The three representatives discussed the necessity to be cognizant of their customers' ordering habits, establish systems to identify the suspicious orders, and maintain procedures on handling and reporting the suspicious orders.
The Manufacturer Panel included representatives from Mylan, Abbott Laboratories, and Cephalon who discussed the controls used in their manufacturing facilities to prevent diversion. They primarily focused on compliance and security.
The Pharmacy Panel consisted of a National Community Pharmacists Association representative, a pharmacist representing the Association of Northwest Pharmacies, and the pharmacist/owner of Cammack's Pharmacies. The pharmacists discussed how DEA's actions against specific wholesale distributors had a negative impact on pharmacies. The pharmacists conveyed how better communication between DEA and pharmacies would have been appreciated. The pharmacists also raised the issue with drug disposal and that citizens should be able to bring controlled substances back to pharmacies for disposal.
Duane Stickles, Staff Coordinator of the Pharmaceutical Investigations Section, spoke of drug trends concerning the use of pharmaceutical controlled substances for non-medical purposes. He provided statistics that show a 44 percent increase of emergency room visits attributed to pharmaceuticals alone. Mr. Stickles discussed four trends in pharmaceutical diversion: doctor shopping, prescription fraud, theft, and internet-related distribution. He addressed the most commonly diverted drugs, places of interest where diversion appears to be on the rise, and some emerging trends to watch, such as Adderall abuse and steroids in dietary supplements. – Presentation Slides Attached
Cathy Gallagher, Associate Section Chief of the Liaison and Policy Section, provided policy updates on ultimate user drug disposal and electronic prescriptions for controlled substances. She also provided the status on the following proposed and finalized rules: DEA registration suffix, registration requirements for locum tenens practitioners, and agent of a practitioner in the Long Term Care setting. – Presentation Slides Attached
How to Keep (or Lose) Your DEA Registration
Linden Barber, Associate Chief Counsel in the Office of Chief Counsel, discussed registrant's due diligence responsibility of knowing their customers and to act responsibly when any suspicion of diversion arises. Mr. Barber cited effective controls against diversion as keeping good records, detecting and reporting suspicious orders, and reporting thefts and significant losses. He provided key questions for manufacturers, distributors, and pharmacies to help reveal diversion and identified emerging issues. – Presentation Slides Attached
The final speaker of the conference was Elton Malone, Assistant Special Agent in Charge from the Office of the Inspector General, Department of Health and Human Services. Mr. Malone spoke of diversion methods used to defraud the Medicare system. He advised the pharmaceutical industry members to be aware to avoid becoming the source of supply for this type of diversion. – Presentation Slides Attached
To conclude the conference, a question and answer session was held in which a panel of DEA presenters answered random questions from the audience.