Drug Diversion Christina Koehler, Pharm.D., RPh Survey and Certification

1. Drug Diversion Christina Koehler, Pharm.D., RPh Survey and Certification Judith M. Persichilli, R.N., B.S.N., M.A. Commissioner Department of Health

2. What is Drug Diversion? • Transfer of controlled dangerous substances from a lawful to an unlawful channel of distribution or use (Uniform Controlled Substances Act 1994) • Illegally obtaining, possessing or distributing drugs for personal or other use

3. FACTS

4. Drug Diversion How many tablets of Alprazolam and Hydrocodone will a 44 ounce soda cup hold?

5. Drug Diversion Methods • Drug Tampering • Improper wasting • Stealing Controlled Substances from patients • Removing excessive amount of Controlled Substances from AD machines

6. What is Drug Tampering? • The inappropriate or illegal alteration of a drug formulated under specified conditions • Harm to patients • Risk of infections

7. U.S. Outbreaks Associated with Drug Diversion by Healthcare Providers, 1983-2013

8. Licensed Facilities in New Jersey • All licensed healthcare facilities must be in compliance with N.J.A.C. 8:43 E • Ambulatory Surgery Centers N.J.A.C. 8:43 A 8.43 A Subchapter 9 • 42 CFR 416.48 Condition for Coverage: Pharmaceutical Services

9. Event #1 • The caps on Fentanyl vials were falling off • Facility sent vials of fallen caps back to the manufacturer • Findings came back with 2 puncture marks under microscopic examination • Assays of samples showed very minimal active ingredient • Unnecessary and excessive inventory transactions • Facility failed to report to the Department of Health

10. Event #1

11. Reportable Events Reporting of Drug Diversions: 8:43 E 10.11 (a) • A health care facility shall immediately report to the appropriate police authorities all criminal acts or potentially criminal acts that occur within a facility and pose a danger to the life or safety of patients or residents, employees, medical staff or members of the public present in the facility. 8:43 E 10.11 (b) • A facility licensed in accordance with N.J.S.A. 26:2H-1 et seq. shall notify the Department immediately of the types of reportable events described in (c) and (d) below.

12. Reportable Events Reporting of Drug Diversions: 8:43 E 10.11 (d) • Examples of reportable events in the nature of potentially criminal acts include, but are not limited to, the following: 8:43 E 10.11 (e) • A health care facility shall report incidents of infectious and communicable diseases to the Department pursuant to N.J.A.C. 8:57. • Reporting to the Professional Boards or The Health Care Professional Information Clearinghouse does not satisfy this regulatory requirement

13. Drug Diversion Reporting 1. Drug Enforcement Agency (DEA) • Within 24 hours of discovery and can amend submission within 30 days • Call Newark, NJ Field Division Office (973) 776-1100 • Online DEA 106 Form 2. New Jersey Drug Control Unit within 24 hours of discovery • Call (973) 504-6351 • Complete and fax form DDC-52 to (973) 504-6326 3. Contact Local Police Department • If local Police Department is contacted, the New Jersey Department of Health must be immediately contacted via Hippocrates • https://hippocrates.nj.gov/common/processLoginAuthentication.action. • If the Hippocrates report cannot be submitted electronically, call (800) 792-9770 4. If CDS loss involves a health care practitioner • Contact practitioner’s governing Board (Ex: Board of Nursing…) • Health Care Professional Responsibility and Reporting Enhancement Act Reporting (Clearinghouse aka Cullen’s Law) • Form must be filled out within 7 days of the event https://www.njconsumeraffairs.gov/pages/hcreporting.aspx • (973) 504-6310

14. Event #2 • Discovery of missing Percocet tablets • Staff member identified narcotic cabinet unlocked and opened • Closer examination of the facility’s CDS stock revealed tampered medications • Medications tampered and recapped with tape • Medications tampered and vial caps were falling off • Missing narcotic logbooks • Executed DEA 222 forms unaccounted for • Falsified records

15. Event #2

16. Event #2

17. Event #2

18. What is the common factor leading to Drug Diversion? ACCESS

19. Opportunities for Improvement 8:43 A 9.3 (b) • The facility’s P&Ps for the administration, control, and storage of medications shall include: 8:43 A 9.3 (b) 7 • The control of drugs subject to the Controlled Dangerous Substances Acts and amendments thereto, in compliance with the New Jersey State Board of Pharmacy Rules, N.J.A.C. 13:39, and all other Federal and State laws and regulations concerning procurement, storage, dispensing, administration, and disposition. Such policies and procedures shall include, but not be limited to, the following: 8:43 A 9.3 (b) 7 (i) • Provision for a verifiable record system for controlled drugs;

20. Opportunities for Improvement 8:43 A 9.3 (b) 7 (ii) • Policies and procedures to be followed in the event that the inventories of controlled drugs cannot be verified or drugs are lost, contaminated, unintentionally wasted, or destroyed. A report of any such incident shall be written and signed by the persons involved and any witnesses present; and 8:43 A 9.3 (b) 7 (iii) • In all areas of the facility where drugs are dispensed, administered, or stored, procedures for the intentional wasting of controlled drugs, including the disposition of partial doses, and for documentation, including the signature of a second person who shall witness the disposition; 8:43A 9.5 (e) • A declining inventory of all drugs in Schedules I through V of the CDS Acts and amendments thereto shall be made at the termination of each shift and shall be retained wherever these drugs are maintained.

21. Opportunities for Improvement 8:43A 9.5(e) • A declining inventory of all drugs in Schedules I through V of the CDS Acts and amendments thereto shall be made at the termination of each shift and shall be retained wherever these drugs are maintained.

22. Opportunities for Improvement • PREVENT Education Signs of Impairment • DETECT Policy Development Adequate Surveillance • RESPOND Proper Reporting Multidisciplinary Approach

23. THANK YOU! Christina Koehler Pharm.D., RPh Christina.Koehler@doh.nj.gov