2015 Annual Convention

Transcription

1 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: Activity Type: Speaker: How to Be Prepared When the DEA Comes Knocking on Your Pharmacy Door ACPE # L04-P 0.15 CEUs ACPE # L04-T Application-based 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.

2

3 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 LLP New York, NY Carlos M. Aquino Compliance Consultant PharmaDiversion, 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. 1

4 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 Attorney James R. Schiffer Professional 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 Pharmacy Long Island University 43 Years as a Member of NCPA Carlos M. Aquino Professional 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 2

5 LEARNING OBJECTIVES 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. (Answer for a Restless Night) REGISTRATION & RESOURCES TAB - Title 21 Regulations & Codified CSA - Quick Links Tab - Pharmacist s Manual 2010 DEA OFFICE 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) 3

6 ACTIONS BY DEA - Criminal Investigation - Civil Action through USAO (United States Attorney s Office) - Administrative Actions - Referral to State Regulatory Agency DEA ADMINISTRATIVE 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!! 4

7 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) 5

8 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 (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 (38) 6

9 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 (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 7

10 ROLE OF A PHARMACIST & RED FLAGS KEY ELEMENT OF A REGISTRATION REVOCATION That the prescriber and/or pharmacist deliberately closed their eyes to the true nature of the Rx Willful Blindness Deliberate 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 8

11 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) 9

12 PRESCRIPTION MONITORING PROGRAM HOW 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 30mg Hydromorphone 8mg Hydrocodone 10mg Morphine Sulfate 30mg Methadone 10mg 10

13 QUESTIONS & ANSWERS James R. Schiffer, R.Ph., Esq. Associate Counsel Allegaert Berger & Vogel LLP New York, NY Main: Carlos M. Aquino Compliance Consultant PharmaDiversion, LLC Media, PA Direct:

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36