1. How to Survive a DEA Inspection Series: DEA Pharmacy Inspection© Pennsylvania Pharmacists Association Hilton Double Tree Resort October 18, 2018

2. Carlos M. Aquino Compliance Consultant PharmaDiversion, LLC™ Individuals may not modify or use this presentation without the expressed written consent of PharmaDiversion, LLC.

3. PHARMADIVERSION DISCLAIMERS - We Do Not Represent DEA - We Do Not Speak on Behalf of DEA - We Suggest You Read the Mentioned Federal Laws and Regulations “There are No Financial Conflict”

4. My 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) 9 Years with PharmaDiversion LLC

5. LEARNING OBJECTIVES Role of DEA Office of Diversion Control - How to Prepare for a DEA Inspection - Required Records for a DEA Audit - Security Requirements for CS - Pharmacy Due Diligence Program

6. OUR CE PARTICIPANTS - Pharmacy Owners - Pharmacists-in-Charge - Staff Pharmacists - Pharmacy Technicians

7. PRE-TEST Question 1
When do you, as the PIC or owner of a pharmacy, report a theft or significant loss of controlled substances to the local DEA Office? 1. After an investigation of the theft or loss of controlled substances
2. Within one business day of discovering the theft or significant loss
3. When you submit the DEA Form 106 required by the DEA
4. After the local police department concluded their investigation

8. PRE-TEST Question 2
Who can be authorized by the registrant to order a Schedule II Controlled Substance through the use of a Power of Attorney (“POA”) letter?
1. The pharmacist
2. The pharmacy technician
3. The pharmacy owner’s spouse
4. Your grandmother
5. All of the above
6. All but number 4

9. PRE TEST Question 3
When do you report an individual POA revocation to the Certification Authority (DEA CSOS)?
1. When they leave their employment
2. When a registrant revokes their POA privileges
3. Within 6 hours of revocation to DEA CSOS
4. Only 1 & 2
5. All of the above

10. PRE TEST Question 4
A pharmacist, as part of their corresponding responsibility, should determine that a controlled substance prescription is written for a legitimate medical purpose by a practitioner acting in their usual professional practice.
True
False

11. PRE TEST Question 5
A stringent pharmacy DEA Due Diligence Program for C-II opioid prescriptions should include a review of the prescriber’s: (1) education in pain; (2) their field of medicine that covers pain management; (3) verification of their board certification in pain management and (4) a review of any state disciplinary board actions.
True
False

12. WHY PHARMACY TECHNICIANS
WHY PHARMACY TECHNICIANS? - Their Need to Know DEA Due Diligence Policy for Controlled Substance Prescriptions - Need to Understand the DEA Corresponding Responsibilities of a Pharmacist - Understanding the Need for Complete and Accurate DEA Records - Better Understand DEA Required Security for Handling and Storing Controlled Substances

13. www. deadiversion. usdoj
(Answer for Restless Night) INFO & LEGAL RESOURCES - Title 21 Regulations & Codified CSA - Questions & Answers - Significant Document Guidance - Pharmacist’s Manual 2010

14. DRUG ENFORCEMENT ADMINISTRATION (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 V Controlled Substances and Regulated Chemicals (Tactical Diversion Squad) - On-Site Audits and Inspections of Controlled Substances and Regulated Chemicals (Diversion Compliance Group)

15. ACTIONS BY DEA Criminal Investigation - Civil Action through USAO - Administrative Actions - Referral to State Regulatory Agency

16. DEA ADMINISTRATIVE ACTIONS - Letter of Admonition - Memorandum of Understanding - Voluntary Surrender of Registration (Never Surrender – Consult Attorney) - Order To Show Cause - Immediate Suspension - Revocation of Registration

17. DEA DRUGS OF INTEREST - Oxycodone 15mg & 30mg Tablets - Hydromorphone 4mg & 8mg Tablets - Morphine Sulfate IR 15mg & 30mg Tablets - Hydrocodone 10/325mg Tablets Methadone 10mg Tablets - Subsys Spray in All Strengths - Tramadol 50mg Tablets - Dispensing of Large Quantities of Benzos

18. Its Time to Scare Your Checkbook !!

19. CIVIL ACTIONS Title 21, United States Codes Section 842
CIVIL ACTIONS Title 21, United States Codes Section 842. Prohibited Acts B a) Unlawful Acts It shall be unlawful for any person –

20. (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

21. 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 $14,000 YES - $14,000 per Violation

22. CIVIL ACTIONS Title 21, United States Codes Section 842
CIVIL ACTIONS Title 21, United States Codes Section 842. Prohibited Acts B Prescriptions Without Required Information $63,000 per Violation

23. DEA RECORD-KEEPING COMPLIANCE

24. RECORDS FOR DEA INSPECTION Biennial Inventory Executed or Voided DEA Forms Invoices for C-III to C-V Drugs CMEA Certification (Annually) Power of Attorney Theft and Lost Reports Drug Destruction Reports Controlled Substance Prescriptions

25. Title 21 CFR – Maintenance of records and inventories “(a) 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.”

26. 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)

27. Biennial Inventory - Required every two year after the Initial Inventory - Physical Inventory of all C-II through C-V On-Hand including outdated Controlled Substances - Schedule II Report Separate from Schedules III to V - Cover Sheet with Required Information (Use a Clean Copy NOT the Work Copy) Title 21, Code of Federal Regulations Section (a) & (b)

28. ORDER FORMS (DEA Form 222) “Must be Available for Inspection” Electronic vs. Paper DEA Proper notation includes: -Date Drugs were Received -Quantity Received -Initials of Person Receiving the Drugs

29. PURPOSE OF CSOS - Eliminate the cost of mailing order requisitions - Reduce the time to get you the Schedule II orders - Not to make your life easier

30. Title 21 CFR – Procedure for filling electronic orders “(g) When a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record must be electronically linked to the original order and archived.”

31. Title 21 CFR – Preservation of electronic orders “(a) A purchaser must, for each order filled, retain the original signed order and all linked records for that order for two years.” “(c) If electronic order records are maintained on a central server, the records must be readily retrievable at the registered location”

32. Title 21 CFR – Canceling and voiding electronic orders “(b) The purchaser must retain an electronic copy of the voided order.”

33. Title 21 CFR – Procedure for filling electronic order “(e) If an order cannot be filled in its entirely, a supplier may fill it in part and supply the balance by additional shipments within 60 days following the date of the order.”

34. YOU RECEIVED THE DRUGS - Print out a copy of the order form - Verify the contents of the tote with the invoice - Staple the copy of the electronic order form to the invoice - Indicate the date received, the quantity received and who verified the order on the printed copy of the order form - Maintain them on a monthly basis

35. C-III THROUGH C-V INVOICES “Must be Available for Inspection” Proper notation includes: -Date Drugs were Received -Quantity Received -Initials of Person Receiving the Drugs Title 21, CFR Section & 22

36. POWER OF ATTORNEY “(a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records.” 21CFR Section Power of Attorney

37. THEFT & LOSS REPORT “Any Theft or Significant Loss Should be Reported” “What is a Significant Loss?” “Always Maintain a Copy of the DEA Form 106 with Your Inventory” Title 21, Code of Federal Regulations Section (b) DEA Pharmacist Manual April 2010

38. WHAT IS REQUIRED Notify your local DEA Office, in writing, within one business day of discovery - 21CFR (b) Submit a DEA Form 106 on DEA Diversion Website DEA FORM 106 INFORMATION Drug, Quantity, Strength, NDC Number Explanation of Theft/Loss Police Department You Reported the Theft/Loss Number of Previous Theft/Loss

39. DRUG DESTRUCTION - Use of Reverse Distributors - Required Records for DEA Inspection - Keep Each Destruction Folder - Copy 1 & 2 of DEA Form 222 (Copy 2 to DEA by End of Month) - Invoices for Schedules III to V

40. CMEA Requirements (Combat Methamphetamine Epidemic Act) - Valid Annual Certification (Certify that Employees are Trained on CMEA) - Employee Required CMEA Training - Limits Daily Sales to 3.6 Grams - Placement of Products - Sales (DEA 2 Years of Records) - Required Customer Information

41. SECURITY

42. SECURITY REQUIREMENTS All applicants and registrant shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective control against diversion, the Administration shall use the security requirements set forth in Sections – as standards for the physical security control and operating procedures necessary to prevent diversion. Title 21, Code of Federal Regulations Section (a)

43. Security Requirements Alarm Systems CCTV Systems Employee Background

44. ALARM SYSTEM - Include a Back-Up Cell System - Should be Tested Often - Limit Employee Access

45. USE OF CCTV SYSTEM Sufficient Cameras to Cover - Front of Store - Front Counter - Pharmacy Counter - Rear of Pharmacy - Dispensing Area - C-II Cabinet or Storage Room

46. EMPLOYEE BACKGROUND Every Five Years Verify the Last Two Employers Don’t Hire Anyone with a Controlled Substance Felony Conviction (21CFR ) Pre-Employment Agreement

47. PRESCRIPTIONS NOTE: No Federal or State Law or Regulation Requires You to Fill a Controlled Substance Prescription

48. DEFINITION OF A PRESCRIPTION “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. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner,

49. but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” Title 21, Code of Federal Regulations Section (a)

50. Title 21, CFR (a) Manner of Issuance of Prescriptions “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, directions for use, and the name, address and registration number of the practitioner.”

51. PHARMACIST IS NEVER PERMITTED TO CHANGE - Patient’s Name - Controlled Substance - Prescriber’s Signature Source: DEA Information & Legal Resources General Q&A

52. PRESCRIPTION ISSUES - Date Patient saw Physician - Verify with Physician or Office Manager - Write Name of Office Person Verifying the Prescription - Receptionist May Be Part of Diversion - Avoid Placing Pharmacy Label on Front of Prescription Title 21, Code of Federal Regulations Section 1306

53. PHARMACY AUDIT BY DEA & PBM - Make sure the required information is on the front of prescription (contact physician for concurrence) - Remember that the pharmacy label is a secondary record and that the front of the prescription is the primary record - You have the right to dispute their findings but they have the right to deny your claim for a prescription written without a legitimate medical purpose

54. MAILING OUT OF STATE - Need to be Registered with State as an “Out-of-State Pharmacy” - Pharmacy Must Comply with State PMP - Patient Signature on Mailed Rx (FedEx, UPS, etc.) - In-Transit Loss Must be Reported to DEA - Pharmacy Should Have a Written Policy

55. QUESTIONS WITH ANSWERS

56. PRE-TEST Question 1 When do you, as the PIC or owner of a pharmacy, report a theft or significant loss of controlled substances to the local DEA Office? 1. After an investigation of the theft or loss of controlled substances Within one business day of discovering the theft or significant loss When you submit the DEA Form 106 required by the DEA After the local police department concluded their investigation

57. PRE-TEST Question 2 Who can be authorized by the registrant to order a Schedule II Controlled Substance through the use of a Power of Attorney (“POA”) letter? 1. The pharmacist 2. The pharmacy technician 3. The pharmacy owner’s spouse 4. Your grandmother 5. All of the above 6. All but number 4

58. PRE TEST Question 3 When do you report an individual POA revocation to the Certification Authority (DEA CSOS)? 1. When they leave their employment 2. When a registrant revokes their POA privileges 3. Within 6 hours of revocation to DEA CSOS 4. Only 1 & All of the above

59. PRE TEST Question 4 A pharmacist, as part of their corresponding responsibility, should determine that a controlled substance prescription is written for a legitimate medical purpose by a practitioner acting in their usual professional practice. True False

60. PRE TEST Question 5 A stringent pharmacy DEA Due Diligence Program for C-II opioid prescriptions should include a review of the prescriber’s: (1) education in pain; (2) their field of medicine that covers pain management; (3) verification of their board certification in pain management and (4) a review of any state disciplinary board actions. True False

61. Carlos M. Aquino Compliance Consultant PharmaDiversion, LLC Media, PA Direct: