2015 Annual Convention

Date: Tuesday, October 13, 2015 Time: 9:45 am – 11:15 am Location: Gaylord National Harbor Resort and Convention Center, National Harbor 10 Title: How to Be Prepared When the DEA Comes Knocking on Your Pharmacy Door

ACPE # 207-000-15-128-L04-P 0.15 CEUs ACPE # 207-000-15-128-L04-T Activity Type: Application-based Speaker: James Schiffer, Associate, Allegaert Berger & Vogel, LLC Carlos Aquino, Founder and President, PharmaDiversion, LLC Pharmacist and Pharmacy Technician Learning Objectives: Upon completion of this activity, participants will be able to: 1. Discuss the role of the DEA pertaining to controlled substances and DEA requirements for handling

controlled substances. 2. Discuss the Red Flag Indicators for prescriptions and safeguards the independent practice should put in

place to avoid issues with controlled substance prescriptions. 3. Review DEA Regulations for the purchase of Schedule II drugs and best practices the pharmacy should

operate under to avoid violations. 4. Review DEA administrative penalties, sanctions and procedures which DEA may follow when a

pharmacy registrant is found to be out of compliance with DEA regulations/federal statutes. Disclosures: James Schiffer is an Associate with Allegaert Berger & Vogel, LLC. The conflict of interest was resolved by peer review of the slide content. Carlos Aquino is the Founder and President of PharmaDiversions, LLC. The conflict of interest was resolved by peer review of the slide content. NCPA’s education staff declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

NCPA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is accredited by NCPA for 0.15 CEUs (1.5 contact hours) of continuing education credit.

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How to Survive a DEA Inspection Series:

“How to be Prepared When the DEA Comes

Knocking on Your Pharmacy Door”

NCPA 2015 Annual Convention

October 13, 2015

James R. Schiffer, R.Ph., Esq.Associate Counsel

Allegaert Berger & Vogel LLPNew York, NY

Carlos M. AquinoCompliance ConsultantPharmaDiversion, LLC

Media, PA

Individuals may not modify or use this presentation without the expressed written consent of PharmaDiversion, LLC

FINANCIAL DISCLAIMERS

“Neither Counsel Schiffer or Consultant Aquino have any

affiliation or financial relationship with NCPA or any

convention exhibitor.”

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PHARMADIVERSION LLC DISCLAIMERS

- We Do Not Represent DEA- We Do Not Speak on Behalf of DEA- We Suggest You Read the Mentioned

Federal Laws and Regulations

www.deadiversion.usdoj.gov

Attorney James R. SchifferProfessional Experience

42 Years as a Pharmacist(28 years as Pharmacy Owner in Brooklyn, NY)

11 Years as an Attorney with Allegaert Berger & Vogel LLP

28 years as an Adjunct Professor of Pharmacy Administration

Arnold & Marie Schwartz College of PharmacyLong Island University

43 Years as a Member of NCPA

Carlos M. AquinoProfessional Experience

24 Years with Philadelphia Police(Last 10 years assigned to DEA Task Force)

12 Years with PFD DEA Diversion(8 as an Investigator & 4 as a Supervisor)

6 Years with PharmaDiversion LLC as a DEA Compliance Consultant & Founder

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LEARNING OBJECTIVES1. Discuss the role of the DEA pertaining to controlled 

substances and DEA requirements for handling controlled substances.

2. Discuss the Red Flag Indicators for prescriptions and safeguards the independent practice should put in place to avoid issues with controlled substance prescriptions.

3. Review DEA Regulations for the purchase of Schedule II drugs and best practices the pharmacy should operate under to avoid violations.

4. Review DEA administrative penalties, sanctions and procedures which DEA may follow when a pharmacy registrant is found to be out of compliance with DEA regulations/federal statutes.

www.deadiversion.usdoj.gov(Answer for a Restless Night)

REGISTRATION & RESOURCES TAB

- Title 21 Regulations & Codified CSA- “Quick Links” Tab

- Pharmacist’s Manual 2010

DEAOFFICE OF DIVERSION CONTROL

Responsible to Prevent, Detect, and Investigate Diversion of Pharmaceutical Controlled Substances & Regulated Chemicals While Ensuring an Adequate Supply for Legitimate Medical and Scientific

Purposes

- Enforcing the Federal Laws & Regulations relating to Schedules I to Schedule V Controlled Substances (Tactical Diversion Squad)

- On-Site Audits and Inspections of Controlled Substances and Regulated Chemicals (Diversion Compliance Group)

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ACTIONS BY DEA

- Criminal Investigation

- Civil Action through USAO(United States Attorney’s Office)

- Administrative Actions

- Referral to State Regulatory Agency

DEAADMINISTRATIVE ACTIONS

- Letter of Admonition- Memorandum of Understanding

- Voluntary Surrender of Registration(Never Surrender a Registration – Consult Attorney)

- Order To Show Cause- Immediate Suspension

- Revocation of Registration

It’s Time to Scare

Your Checkbook !!

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CIVIL ACTIONS

Title 21, United States Codes

Section 842. Prohibited Acts B

a) Unlawful Acts

It shall be unlawful for any person –

(5) To refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II of this chapter;

(10) Negligently to fail to keep a record or make a report under Section 830 of this title

c) Penalties

(B) In the case of a violation of paragraph (5) or (10) of subsection (a) of this section, the civil penalty shall not exceed $10,000

YES - $10,000 per Violation(SAMPLE: 3 DEA Forms 222, 7 invoices for Schedules IV without required

information, no biennial inventory, power of attorney not readily retrievable, 10 prescriptions lacked patient address on front of the prescription can result in an

exposure of up to a $220,000 civil fine)

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DEA INSPECTION RECORDS

Initial/Biennial Inventory

Executed or Voided DEA Forms 222

Invoices for C-III to C-V Drugs

CMEA Certification (Annually)

Power of Attorney

Theft and Significant Lost Reports

Drug Destruction Reports

Prescription Information

Accountability for Controlled Substances

Title 21 CFR 1304.04 (a)Maintenance of records and inventories

“Every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of

such inventory or records, for inspection and copying by authorized employees of the

Administration.”

(Check with your DOH/BOP state regulations)

READILY RETRIEVABLE

“The term readily retrievable means that certain records are kept by automatic data processing systems or other

electronic or mechanized record-keeping systems in such a manner that they can be separated out from all other

records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some

other manner visually identifiable apart from other items appearing on the records.”

Title 21, Code of Federal Regulations Section 1300.01(38)

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PRESCRIPTION ISSUES

“All prescriptions for controlled substances shall be dated as of, and signed on, the day

when issued and shall bear the full name and address of the patient, the drug name,

strength, dosage form, quantity prescribed, direction for use, and the name, address and

registration number of the practitioner.”

Title 21, CFR 1306.05 (a) Manner of Issuance of Prescription

ACCOUNTABILITY OF CONTROLLED SUBSTANCES(Needed to Prevent and Detect Potential Employee Theft)

Perpetual Inventory of All Controlled Substances

Electronic or Paper Format for All Controlled Substances

Periodic Physical Inventory

Perpetual Inventory is Used by DEA for Audit

Account for All Expired Drugs Awaiting Destruction

Account for All Non-Significant Shortage/Overage

POTENTIAL ALLEGATION BY DEA FROM A DEA AUDIT AND INSPECTION

Failure to Maintain Complete and Accurate DEA Required Records

Failure to Maintain Complete and Accurate Inventory of Controlled Substances

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ROLE OF A

PHARMACIST&

RED FLAGS

KEY ELEMENT OF A REGISTRATION REVOCATION

That the prescriber and/or pharmacist deliberatelyclosed their eyes to the true nature of the Rx

Willful BlindnessDeliberate Ignorance

A Famous Quote, “I’ll fill anything as long as you got paper. After all, who am I to tell you, you are not in pain”

CORRESPONDING RESPONSIBILITY – best defined as the need to determine that there is a legitimate medical purpose for the prescription

COMPONENTS OF YOUR DUE DILIGENCE

Prescriber

Patient

Controlled Substance

Prescription Monitoring Program

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WHAT YOU NEED TO KNOW ABOUT PRESCRIBER

Medical Education

Field of Medicine

Board Certification

Board Discipline for Controlled Substances

Valid DEA & State License

(Dr. Marcus Welby vs. Dr. Gregory House)

WHAT YOU NEED TO KNOW ABOUT THE PATIENT

Establish Who is the Patient

Know the Medical Purpose for Patient Prescription(s)

Determine Patient is NOT a Drug Seeker or Doctor-Shopper

Obtain Identification & Insurance Information

Perform a Patient PMP Profile for All Controlled Substance

(Florida Pharmacist Filling C-V Prescriptions)

WHAT TO KNOW ABOUT THE PRESCRIBED DRUG

Method of Payment for Prescription

Cocktail Prescriptions

Drug Prescribed Exceeded Daily Acceptable Dosage(Story: RX for 1,200 Methadone 10mg in Philly)

Off Label Use of Prescribed Drug

Similar Opioids Prescribed for Pain

Prescriptions with Same Drug & Same Quantity

(Story of the Arrest of New York Prescriber)

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PRESCRIPTION MONITORING PROGRAMHOW TO USE PMP

Done for Every C-II Prescription

Initially Done for a C-III to C-V Prescriptions(Afterward Every 90 Days)

Note Information on the Back of Prescription

Document & Report Bogus Prescription

PHARMACIST’S RESPONSIBILITIES

Corresponding Responsibilities

PHARMACY’S RESPONSIBILITIES

Due Diligence

DRUGS OF DEA INTEREST ESPECIALLY CASH PRESCRIPTIONS

Oxycodone 30mgHydromorphone 8mgHydrocodone 10mg

Morphine Sulfate 30mgMethadone 10mg

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QUESTIONS &

ANSWERS

James R. Schiffer, R.Ph., Esq.Associate Counsel

Allegaert Berger & Vogel LLPNew York, NY

Main: 212-571-0550Email: jschiffer@abv.com

Carlos M. AquinoCompliance ConsultantPharmaDiversion, LLC

Media, PADirect: 610-487-4663

Email: carlos@pharmadiversion.com