How to Survive a DEA Inspection – Compliance by
Prescribers and Pharmacists
James R. Schiffer RPh, Esq. & Carlos Aquino
9:15-10:15 am
Overview
Prescribers of controlled substances and the pharmacists who fill such prescriptions will familiarize themselves with the federal laws and regulations pertaining to Schedules II though V controlled substances that are prescribed, administered, or dispensed for legitimate medical purposes.
Learning Objectives
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Review recent administrative and civil actions by the Drug Enforcement Administration (“DEA”) through their Diversion Control Division (“Diversion”) personnel on prescribers and pharmacists who prescribes, administers or dispense a controlled substance.
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Review the responsibility of a prescribing practitioner, who prescribes a controlled substance, and a pharmacist who fills such prescription that is required to comply with federal laws and regulations enforced by DEA Diversion personnel.
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Review the actions of DEA Diversion personnel when they proceed with an Order to Show Cause against a DEA registration based on allegations that controlled substance prescriptions were prescribed or dispensed without a legitimate medical purpose.
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Discuss the severity of DEA administrative actions when evaluating if a practitioner or a pharmacy has been maintaining complete and accurate DEA required records and inventories of controlled substances prescribed, administered or dispensed as a part of a patient treatment plan.
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Recognize the steps to be taken by a practitioner or a pharmacist to follow federal laws and regulations enforced by DEA pertaining to the prescribing and or dispensing of controlled substance for a legitimate medical purpose.
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Explain the necessity of a prescriber or a pharmacist to maintain complete and accurate records, especially electronic medical records with a full written explanation of a patient treatment plan requiring the prescribing of a controlled substance.
Biographies
James R. Schiffer RPh, Esq.
Jim Schiffer’s law practice draws on his many years of pharmacy and business experience. Jim has been named by American Druggist trade magazine as one of the nation’s most influential pharmacy leaders for his work concerning the activities of Pharmacy Benefit Managers in the pharmacy marketplace, and he has received several national awards from pharmacy organizations for his work on behalf of the pharmacy profession.
Some 25 years after he became a pharmacist, Jim enrolled in law school; having completed his law degree in 2003, his practice has focused on representing businesses, trade associations and individuals (many of which are health care providers) in a variety of health care related matters, including government administrative investigations, professional disciplinary matters and administrative law proceedings, contract and business negotiations, and litigation matters.
Jim’s experience includes representing clients in audits, investigations and proceedings before the U.S. Food and Drug Administration; the Drug Enforcement Administration; the Centers for Medicare and Medicaid Services; the New York State Attorney General’s Office Medicaid Fraud Control Unit; various agencies within the New York State Department of Health, including the Office of Health Insurance Programs, the Bureau of Narcotic Enforcement, and the New York Office of the Medicaid Inspector General; the New York Board of Pharmacy’s Office of Professional Discipline; the New Jersey Board of Pharmacy; the New Jersey Department of Banking and Insurance; and the New Jersey Office of the Medicaid Fraud Control Unit. Jim similarly represents pharmacy clients with respect to audits and investigations conducted by and on behalf of commercial insurers and their associated pharmacy benefit managers. Jim is frequently called upon to serve as adjunct counsel in criminal health care matters for those parties so charged. He also regularly advises clients in connection with negotiating and drafting stockholders’ agreements, stock purchase agreements, and asset purchase agreements.
Since 1987, Jim has served and continues to serve as an Adjunct Professor of Pharmacy Administration at Long Island University’s Arnold & Marie Schwartz College of Pharmacy and Health Sciences. He regularly presents pharmacy continuing education programs through the Arnold & Marie Schwartz College of Pharmacy, the Pharmacists Society of the State of New York, New York City Pharmacists Society and the National Community Pharmacists Association.
Jim was awarded the 2022 John W. Dargavel Medal by the National Community Pharmacists Association Foundation for his leadership and accomplishment on behalf of independent pharmacies, and he is the recipient of the 2013 Bowl of Hygeia Award in New York, in recognition of his outstanding civic leadership as a pharmacist and has received awards from the National Community Pharmacists Association for his efforts on behalf of the community pharmacy profession.
Carlos Aquino
In January 2009, Carlos Aquino retired from DEA Diversion and founded PharmaDiversion, LLC as a pharmaceutical consultant specializing in DEA controlled substance issues. He has 12 years with the Philadelphia Office of DEA and assigned to their Diversion Group (eight years a diversion investigator and four years as a group supervisor) and 24 years with the Philadelphia Police Department He retired with the rank of Police Sergeant. The last ten years he was assigned to the Philadelphia DEA Task Force as a street supervisor and an undercover agent conducting illicit and pharmaceutical drug investigations.
Carlos graduated from Temple University with a BA in Criminal Justice. He also completed the instructor’s Development Course, DEA Training Center in Quantico, VA.
Presentation Slides
Coming soon.