“Ohio’s Approach to Combating the Rx Drug Epidemic”

Indianapolis, IndianaDecember 13, 2011

WARREN COUNTY DRUG TASK FORCE

JOHN BURKE, COMMANDER

P.O. BOX 898LEBANON, OHIO 45036

PHONE: (513) 336-0070CELL: (513)-623-3278

FAX: (513) 336-9097

E MAIL:

Burke@wcdtf.org

PHARMACEUTICAL DIVERSION

• Commander, Warren County, Ohio, Drug Task Force & Criminal Investigations

• Commander- Southwestern Ohio HIDTA Major Case & Interdiction Initiatives

• President-National Association of Drug Diversion Investigators (NADDI)

• 32 years Cincinnati Police Division

• Commander Pharmaceutical Diversion Squad

• Six investigators, one secretary

PHARMACEUTICAL DIVERSION

• DEFINITION?

“Any criminal act involving a prescription drug”

PHARMACEUTICAL DIVERSION

• Best drugs for pain are the best drugs to obtain a “high”

• Successful pain drugs= increased prescribing=more drugs available=more abuse

• Increases demand and street values • Extended Release (ER) products contain

concentrated amounts of medication• Successful compromise of ER Rx=euphoria!

SOURCE OF DIVERTED DRUGS

• Forged and Altered Prescriptions • “Doctor Shoppers”• Prescribers/Dispensers of Rx Drugs • Theft (Health Facility and Other)• Package theft/diversion (UPS, DHL, Fed X)• Internet • Pharmacy Robbery & Burglary • International Smuggling

Rx Counterfeiting

• Huge problem in the United States• NCS high $$ targeted usually• Appearance of pills and packaging almost

identical• Requires testing from the manufacturer• Can be integrated into the retail drug supply• Terrorism (Financing and Creating)• RFID &/or Serialized pills possible solution

INTERNET PHARMACIES

• National Association of Boards of Pharmacy (2011)

• NABP lists 7,234 Internet Drug Websites as NOT Recommended

• 6,018 (83%) do not require valid Rx, consultation with an Rph or take insurance

• Only 3.4% of those reviewed appeared to be “potentially legitimate”

TOP Rx DRUGS OF ABUSE

• HYDROCODONE (Vicodin) $6- $8

• OXYCODONE (Percocet, Percodan) $6 - $8

(OxyContin-?) (Oxycodone IR- $1 mg.)

• ALPRAZOLAM (Xanax) $3

Prescription Reformulations

• OxyContin® - Manufactured by Purdue Pharma

• In retail market August 2010• “OC” indicia replaced by “ OP”• 80mg. Tablets slightly larger• Street preliminary indications- OxyContin

much less desirable- heroin use exploding• Oxycodone IR has become new Rx abused

OxyContin® Abuse

• All indications are that the reformulation of OxyContin® is working

• Lowering of street price and demand • Continued surge of oxycodone IR (30mg.) AKA:

“Perc 30’s) • Surge in abuse of heroin• Some signs of oxymorphone (Opana) abuse

Oxycodone Express

• Hundreds of “Pain Management” practices in Florida & southern Georgia

• Long lines obtaining oxycodone IR (Roxicodone®) at clinics

• Van loads of folks from Midwest going to these clinics

• Filling Rx’s in Florida or other states• PMP now in place in Florida

ILLEGAL PRESCRIBERS

• Affect hundreds of addicts either directly or by feeding traffickers

• Collaborative damage is immense • Become “legal” drug trafficker in a white coat• Cash only practices or• Significant health care fraud • Dispensing CS out of office-huge red flag!!

Agency cooperation is the key to MAXIMUM success

• Law enforcement/Prosecutor• Regulatory agencies• Health care fraud investigators • Consult with experienced investigators• Take your time DEVELOP AND USE ALL RESOURCES POSSIBLE!

ILLEGAL PRESCRIBER INVESTIGATIONS

HB 93

• Introduced in the House on 2/8/11• Passed by both the House and Senate

unanimously.• Passed w/ an emergency clause.• Signed into law by the Governor on 5/20/2011

HB 93

Also known as: the “Pill Mill” bill or “Pill Mill” legislation

HB 93

EMERGENCY CLAUSE• Passed as an emergency bill – meaning the bill

went into effect the day it was signed into law by the governor (5/20/2011).

• Also, public health/safety required the bill to be enacted immediately.

HB 93

WHAT PROMPTED THE LEGISLATION?

HB 93• 4 people die everyday in Ohio from unintentional

prescription drug overdoses.

Ohio Department of Health, citing Ohio Hospital Association. “Hospital discharge data, 2002-2007.”

• Fatal and non-fatal poisonings cost Ohioans $3.6 billion annually.

Ohio Department of Health, citing Ohio Hospital Association. “Hospital discharge data, 2002-2007.”

HB 93

• Ohio’s overdose death rate tripled from 1999-2006. In the same time frame, the U.S. death rate (only) doubled.

Ohio Department of Alcohol and Drug Addiction Services, citing Ohio Department of Health, “Burden of Poisoning in Ohio, 1999-2008.”

HB 93

• In 2010 in Scioto County, 9.7 million doses were dispensed for a population of 78,000. That is equal to 123 doses for every man, woman and child that lives in the county.

HB 93

• In 1997, Ohio’s per capita dosage averaged 7 pills. Ohio State Board of Pharmacy

• In 2010, Ohio’s per capita dosage averaged 67 pills. Ohio State Board Pharmacy

• Increase over 900% in less than 15 years.

HB 93

• In 2009, Southern Ohio Medical Center (SOMC) reported 64 infants (5%) being born with prescription opiates in their system.

• That number increased to 77 (7%) in 2010.• Real number closer to 25%.• Consistent throughout Ohio.

HB 93

PAIN MANAGEMENT CLINICS

HB 93

• A pain management clinic is defined by the bill as:– A primary component of practice is treatment of pain or

chronic pain;– The majority (50.1%) of patients for the facility are treated

for pain or chronic pain through the use of controlled substances, tramadol (treat) and Carisoprodol (relieve), and any other substances specified by the medical board.

– Any other identifying criteria est. by Medical Board.

HB 93

• The Bill specifically excludes:– Hospitals or hospital owned facilities– Educational institutions or programs• Facilities affiliated with such institutions/programs

– Hospice facility licensed w/Ohio– Ambulatory Surgical Facility

HB 93

• If not a legitimate pain management clinic more commonly known as a “pill mill.”

• Many pills were getting on the street because of these “pill mills” or “bad prescribers.”

• This bill was designed to help take regulatory action against both.

HB 93

• Requires the State Board of Pharmacy to license pain management clinics.– Provides for pain management clinics to be licensed as

terminal distributors of dangerous drugs with a pain management clinic classification – even if operated by a business entity not otherwise required to be licensed as such a distributor.

-- Not licensed prior to this bill by anyone.• Must operate under rules to be adopted by the State

Medical Board.

HB 93

• To qualify for a license, the pain management clinic must establish to the OSPB:– Facility must be owned and operated by 1 or more

physicians licensed by the OSMB; and– Employee compliance w/OSMB rules; and– Any person with ownership interest must submit to

criminal background check; and– Employees must submit to criminal background checks;

and• Employees not allowed to have a felony record

– Maintain an accurate record of ownership and notify OSPB of any changes.

HB 93

• Requires the State Medical Board (the Medical Board) to adopt rules establishing standards for physician operation of pain management clinics and standards to be followed by physicians who provide care at pain management clinics.

HB 93

• Rules Est. by the OSMB must meet the following:– Standards and procedures for doctors to follow in

operating a pain clinic; and– Standards and procedures to be followed by physicians

working at the clinic; and– Identify any other non scheduled drugs that identify a

facility as a pain clinic for purposes of requiring a licensure as a pain clinic; and

– Other criteria identifying a pain clinic;– Standards or procedures for other people working at the

clinic.

HB 93

• Authorizes the Pharmacy Board to impose a fine of up to $5,000 per day, and the Medical Board to impose a fine of up to $20,000, for failure to follow the rules of operation or standards for pain management clinics including violations by others working at the clinic.

• Failure to obtain a license or violate provisions is a M1, a subsequent conviction is a F5.

• OSPB in consultation w/ OSMB has summary suspension authority of clinic license.

HB 93

• OSPB required to prepare and submit annual report on pain clinics est. under this bill including the following:– Total # applications received;– # of licenses granted or denied;– Disciplinary action taken against license holders;– Total revenue generated from licenses and fines

and penalties paid by holders, or other disciplinary action taken against holders

HB 93Since January 2011, the State Medical Boardrepresented by The Office of the AttorneyGeneral, has sanctioned more than 30physicians for inappropriate prescribing. Thatnumber exceeds the number of sanctions issuedby the Medical Board in all of 2010 for similarconduct.

On Wednesday October 12th The medical board permanently revoked Dr. Daniel Brumfield license

“I, along with management, came up with a way to increase the number of non-pain patients by asking patients to bring a friend. In hindsight that was a terrible idea,”

This was done to get around House Bill 93, or

HB 93

• Limits the amount of controlled substances that a prescriber, other than a veterinarian, may personally furnish to a patient and provides for a $5,000 per instance fine for surpassing those limits.

HB 93

• Personally furnish is not defined by the bill.– Safe definition is: action of a prescriber who provides in

whole or part a supply of drugs to a patient for the patient’s personal use.• Does not have to directly furnish to a patient.

– Monthly = 30 day period cannot exceed 2,500 dosage units of all combined controlled substances;

– 72 hour period = cannot exceed amount necessary for a patient’s necessary use.

– Does not include methadone being prescribed for addiction