Jason H. Ward Greensboro Resident Office U.S. DEPARTMENT OF JUSTICE DRUG ENFORCEMENT ADMINISTRATION

Prescription Drug Abuse Trends November 2011 report from the Centers for Disease Control (CDC) revealed: Prescription opiate abuse now causes more overdose deaths than heroin and cocaine combined. The number of babies born addicted to the class of drugs that includes prescription painkillers has nearly tripled in the past decade, according to the first national study of its kind. National Drug Intelligence Center (NDIC) data: Emergency room visits for non-medical use of pain relievers increased 39 % from 2004 to Treatment admissions for prescription opioids increased 74 % from 2002 to Nearly 1/3 of individuals who began abusing drugs in the past year reported their first drug was a prescription drug: 19 % indicated it was a prescription opioid. Thus, 1 in 5 new drug abusers are initiating use with potent narcotics (oxycodone, hydrocodone, and methadone).

$$$$$ Abuse and diversion of prescription controlled substances cost public and private medical insurers an estimated $72.5 billion per year. Source: National Drug Intelligence Center (NDIC)

Prescriptions Title 21 Code of Federal Regulations Section : Purpose of issuance of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. (b) The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

Illegal Distribution Established case law to support prosecution of practitioners who knowingly dispense/distribute controlled substances without legitimate medical purpose or outside the usual course of professional practice. 21 USC 841 (a) (1) (a) Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally -- (1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance..

PRACTITIONER PROSECUTION Phil Astin III, MD, age 54, of Carrollton, GA, pled guilty in U.S. District Court for the Northern District of Georgia to 175 counts of illegal distribution of controlled substances. According to the indictment, Astin distributed and dispensed a quantity of controlled substances for other than a legitimate medical purpose, and not in the usual course of professional practice. The controlled substances included Schedule II pharmaceuticals Percocet and Adderall; Schedule III pharmaceuticals Vicoprofen and Lorcet; and the Schedule IV pharmaceutical Xanax. In the plea agreement, Astin admitted that he knowingly violated federal law by illegally writing prescriptions for 19 patients. Astin was sentenced to 10 years imprisonment, followed by 3 years supervised release and 250 hours community service. He was ordered to pay a special assessment of $17,500. Source: DEA website;

Physician Prosecution Undercover buys where controlled substances were obtained (dosage units and prescriptions) without any medical justification; Prescriptions for Hydrocodone, Dosage Units of Phentermine, Diazepam, Alprazolam NO PHYSICAL EXAM OR MEDICAL QUESTIONS Federal Indictment: 6 counts of Illegal Distribution

Physician Assistant (PA) Provided prescriptions for cash to known prescription drug traffickers in Northwest NC and Southwest VA Provided prescriptions to friends without legitimate medical need (Fraudulent Insurance Claims filed) Federal Indictment for Illegal Distribution & Health Care Fraud Sentenced to 87 months / 5 Co-conspirators indicted

Other Options OTHER CRIMINAL VIOLATIONS: (a)(2): Utilizing DEA registration that is fictitious, revoked, suspended, expired, or issued to another person to acquire or obtain controlled substances (a)(3): To acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge; CIVIL PENALTIES: (a)(5): Failure to maintain records or file required reports ($10,000 per violation)

Prescriptions Title 21 Code of Federal Regulations Section : Purpose of issuance of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.

However…….. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

James Arnold King, R.Ph. Former Owner of Littleton Pharmacy, Littleton, NC James Arnold King  Provided controlled substances to female subjects in exchange for sexual favors  Utilized DEA #’s for providers who had not seen the patients in months, sometimes years, to create fraudulent prescriptions for controlled substances  3 females identified who obtained controlled substances in exchange for performing sex acts.  Took 1 of these females to a lake house where he provided both alcohol and controlled substances to her in exchange for her performing sex acts.  Surrendered license to practice pharmacy  Federal Indictment for Illegal Distribution 21 USC 841(a)(1)  Sentenced to 12 months in federal prison

Pharmacy Technician Inventory shortages noticed at pharmacy Responsible for ordering of controlled substances; over- ordering to account for diversion (MOST TRUSTED EMPLOYEE-COMMON STORY!!!) Confessed to providing Alprazolam to boyfriend for his subsequent illegal distribution Federal Indictment for Illegal Distribution of Alprazolam 3 months active sentence followed by probation

Other Penalties: Order to Show Cause Surrender of DEA Registration Civil Fines (minimum $10,000 per violation) Letter of Admonition (Warning Letter)

“Doctor Shopping” The most popular form of diversion is known as "doctor shopping," where individuals, who may or may not have legitimate illnesses requiring a doctor's prescription for controlled substances, visit many doctors to acquire large amounts of controlled substances.

Employee Diversion / Theft Diversion is often committed by employees of DEA registrants: Pharmacy employees Physician support staff Employees of manufacturers, distributors, etc.

CLAMP DOWN ON Rx PADS Common diversion method is theft of prescription pads by patients, staff, and/or colleagues _____________________________________ Serialized/Numbered prescriptions help in detection and investigation of such diversion

Report ALL Thefts (DEA-106) 21 CFR (b) (b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within 1 business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.

INTERNET PHARMACIES In January 2007, DEA Greensboro, Wilmington, San Francisco and San Jose culminated an 18-month-long investigation into the illegal distribution of thousands of dosage units of controlled pharmaceuticals nationwide each week by a North Carolina Internet pharmacy. 4 suspects were arrested and $4.2 million in assets seized.

Ryan Haight Online Pharmacy Consumer Protection Act Effective April 13, 2009 Now a FELONY offense to distribute controlled substances via the internet without an “in-person” medical evaluation by the prescribing practitioner! 21 USC 841(h)(1)

QUESTIONS ?

Drug Enforcement Administration Greensboro Resident Office Diversion Group (336) CONTACT INFO: