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Drug Diversion: Distractions, Dilemmas, Decisions, and Duties DEA Pharmacy Diversion Awareness Conference April 17 & 18, 2016 David H. Jones, RPh, FASCP Maryland Board of Pharmacy Commissioner and Secretary

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Page 1: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Drug Diversion: Distractions, Dilemmas, Decisions, and Duties

DEA

Pharmacy Diversion Awareness Conference April 17 & 18, 2016

David H. Jones, RPh, FASCP Maryland Board of Pharmacy Commissioner and Secretary

Page 2: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Objectives To understand Maryland Board of Pharmacy Composition and Committees To discuss compliance/disciplinary actions available to the Board. To describe relevant cases of drug diversion that have required Board action. To review options for avoidance/correction of drug diversion.

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Page 3: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

QUIZ: Drug Diversion Is

1. An epidemic 2. An assault on public safety 3. A war on legitimate prescription needs 4. A threat at all levels of healthcare 5. Not limited to opioids 6. All the above

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Page 4: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Diversion: When A Good Drug Goes Bad

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Page 5: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Definition

Drug diversion can be defined as the diverting of legal drugs for illicit purposes. It involves the diversion of drugs from legal and medically necessary uses toward uses that are illegal and typically not medically authorized or necessary.

Adapted from CMS statement, 2012

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Page 6: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Diversion From legitimate use to personal need

From legitimate use to allow illegal distribution Robbery Theft Burglary Creative accountability “Family and Friend Discount”

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Page 7: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Murphy’s Law Drug Diversion Variant

If it can happen it will; If it has not happened yet, it will; If it has not happened yet, are you sure?; If it cannot happen here, perhaps rethink that concept; and If it has happened, it may well happen again.

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Page 8: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

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Page 9: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Maryland Board of Pharmacy

Mission Statement “To protect Maryland consumers and to promote quality healthcare in the field of pharmacy through licensing pharmacists and registering pharmacy technicians, issuing permits to pharmacies and distributors, setting pharmacy practice standards and through developing and enforcing regulations and legislation, resolving complaints, and educating the public.”

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Page 10: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board of Pharmacy

Vision Statement “Setting a standard for pharmaceutical services, which ensure safety and quality health care for the citizens of Maryland.”

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Page 11: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Staff Executive Director Deputy Director(s) Units – Operations – Compliance – Regulatory/ Legislative – Licensing – MIS/Data Integrity – Public Information

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Page 12: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Commissioners Twelve commissioners – 10 are practicing pharmacists – 2 are public/consumer representatives

Pharmacists – 2 Community Practice – 2 Chain Drug Store – 2 Acute Care – 2 At Large – 1Home Infusion – 1 Long Term Care

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Page 13: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Committees

Disciplinary/Compliance Licensing Practice Public Relations Legislative/Regulatory Management Information Systems Others Ad Hoc

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Page 14: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Compliance/Licensing Monitor March 2016

Pharmacists: 10,909 Vaccinating Pharmacists: 4,166 Pharmacy Technicians: 9,195 Pharmacy Interns: 615 Pharmacies: 2,089 Distributors: 1,066

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Page 15: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Compliance Officer Statistics Month of February 2016

New Complaints: 38 Complaints Resolved: 21 Final disciplinary actions taken: 2 Reversals: 0 Summary Actions Taken: 2

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Page 16: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Disciplinary Actions Public Non-Public Initiated by complaint or findings by Board or Drug Control inspections Initial Board action at Disciplinary Committee Case Resolution Conference may be initiated Full Board reviews and validates all actions

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Page 17: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Case Resolution Conference (CRC) Pre-charge CRC Charge CRC CRC – 2 Board Commissioners – Board Counsel – Board Compliance Officer – Respondent – Defense counsel as needed

Consent Order determined Full Board reviews all Orders

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Page 18: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Disciplinary Actions Non-Public

Letter of Education Letter of Admonishment Relevant Continuing Education Credits may be attached – Separate from those required for renewal

Disciplinary Committee CRC

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Page 19: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Board Disciplinary Action Public

Summary Suspension Suspension Revocation Fine Probation Show Cause Hearing Full Evidentiary Hearing DEA Diversion Conference 2016 19

Page 20: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Examples of Disciplinary Actions

Practitioner/Licensee Information Protected

Page 21: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Pharmacist - 1 Diversion for own use Fraudulent prescriptions for personal needs Oxycodone, both sustained- and immediate- acting dosage forms Discovered during Division of Drug Control audit Terminated by employer Reviewed by Disciplinary Committee CRC requested – Demonstrated commitment to rehabilitation;

no drug or alcohol use x 12 months DEA Diversion Conference 2016 21

Page 22: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Action Suspension of license x 1 year – All but 6 months stayed

Fine: $5,000 Probation x 5 years – Cannot work alone – Cannot work more than 40 hours/week – Cannot “float” – Mandatory random drug screening weekly – Mandatory rehabilitation program – May appeal for modification after 2 years

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Page 23: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Pharmacist - 2

Fraudulent prescriptions filled for CDS – Oxycodone SR and IR – Hydrocodone with acetaminophen

Apparent diversion for street re-sale by patients Initially presented by representative of pain management office in next-door practice, including affected patients DEA Diversion Conference 2016 23

Page 24: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Pharmacist - 2 Requests for prescriptions ongoing over 11 months Facility person presented new prescriptions and drivers’ licenses Pharmacist “validated” prescriptions with physician’s office Discovered during BOP and DDC inspections DEA Diversion Conference 2016 24

Page 25: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Action Initial Summary Suspension implemented CRC Requested Resolution – Suspension maintained for 6 months, then

stayed – Probation x 3 years – CE to identify fraudulent Rx – Take and pass MPJE – Fine: $5,000

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Page 26: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Pharmacy Technician

Technician modified electronic “pill count” for hydrocodone 10mg/ APAP 650 mg & hydrocodone 5 mg/ 325 mg 1074 “lost” doses Diverted the “deleted” count to friends who resold on the street Received cash payment for diverted drugs Terminated and legal action initiated

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Page 27: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Action

Circuit Court – Nolle prossed for 3 counts – Technician pled guilty on 4th count

Board Action – Revocation – No appeal

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Page 28: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Pharmacy Fraudulent Prescriptions over 18 months C-II through C-IV – 30,000 units of oxycodone in various doses

and dosage forms – 24,000 dose of methadone – 20,000 doses of alprazolam

Summary Suspension Appealed to CRC DEA Diversion Conference 2016 28

Page 29: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Action Suspension for 1 year $10,000 fine Probation after suspension for 3 years – Assure all pharmacists are fully compliant with

CDS prescribing and dispensing – Discontinue association with Methadone

Clinic – Provide a Board Newsletter article about CDS

risk awareness and avoidance.

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Page 30: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Where Can We Go?

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Page 31: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

What to Do? Awareness of risk is an excellent defense against occurrence or recurrence. – Individual practitioner – System-related – Surprise!

The best defense is an aggressive offense – Act before you have to react – If it happened before, it can happen again

QA/QI Plan must address

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Page 32: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

It Is A Delicate Balance Benefits: – Meeting legitimate, defined patient needs

such as chronic or acute pain control – Provide needed access to medications

Risks: – Diversion, addiction, overdose – Legal and licensure action

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Page 33: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

What About Red Flags?

A Pharmacy Inspector Makes a Suggestion

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Page 34: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Red Flag Warnings Cash Payments – No Insurance – Out of Network

Pattern prescribing – Too many prescriptions for the same drugs, same

quantities, from the same prescriber or practice; Prescribing combinations of frequently abused controlled substances – Pre-printed prescription;

Scattered geography of patients; Shared addresses of patients on the same day;

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Page 35: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Red Flags II Overall volume of CDS Rx – Pattern out of the ordinary;

Quantity and strength of drugs prescribed; – High dose; large quantity

Patients with the same diagnosis code from the same prescriber or practice; Prescriptions written by prescribers not consistent with area of specialty – Dermatologist as Director of Pain Management – Improper Methadone Clinic

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Page 36: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Red Flags - III

Patient insisting on one specific brand; e.g., OxyContin®

– The generic just does not work; – I really need the OA not the OP version; – The only one that works is what I used to get; and – I’d rather pay cash because insurance will not cover.

– Red Flag Information Based on DEA Final Orders, 2013

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Page 37: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Always Know the patient or family member Contact the prescriber directly Obtain history and validating diagnosis Document all contacts Follow up fully on any incomplete information or calls Report, report! If in doubt, do not dispense

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Page 38: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

PDMP Please Don’t Mess Up My Prescription? Prescription Drug Monitoring Program! – Provide real-time electronic access to patients’ CDS

Rx history; – Identify aberrant drug using behavior; – Improve ability to identify possible substance use risk; – Improve ability to safely and effectively manage

patients’ clinical need for CDS; and – Increase confidence in all levels of prescribing and

dispensing decisions.

Based in part on Maryland Legislative Coalition statement 2015

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Page 39: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

Goals of PDMP Assist prescribing and dispensing professionals in identification and prevention of prescription drug abuse; Assist law enforcement and regulatory agencies in the identification and investigation of potential prescription drug diversion; and Promote a balanced use of prescription data that preserves the professional practice of healthcare providers and legitimate patient access to optimal pharmaceutical care

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Page 40: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

CRISP The Chesapeake Regional Information System for our Patients (CRISP) makes CDS prescription data collected by the PDMP available to healthcare providers.

The CRISP health information exchange (HIE) query portal is the authorized source for provider access to PDMP data.

CRISP provides user registration and technical support services for providers accessing medication history and other clinical information available using HIE.

Mandatory vs. Voluntary?

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Page 41: Drug Diversion: Distractions, Dilemmas, Decisions, and Duties · Distractions, Dilemmas, Decisions, and Duties DEA . Pharmacy Diversion Awareness Conference . April 17 & 18, 2016

DEA Diversion Conference 2016

Thank you! "Idiopathic from the Latin

meaning we are idiots because be can’t figure out the cause."

Gregory House; House, MD

Are there any questions?

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