Conducting a Drug Diversion Investigation

1. Conducting a Drug Diversion Investigation Donna H. Mooney, RN, MBA North Carolina Board of Nursing

2. Investigating Drugs and Diversion – A Primer • The key to any investigation of drugs and diversion requires familiarity with the manner in which the drugs are properly handled and flow from the manufacturer to the ultimate consumer

3. Drug Production and Flow to Consumer https://www.nap.edu/read/18272/chapter/7#198-199, Figure 5.1 Source FDA 2011b (Last viewed 7.30.18 08:01)

5. Investigations of Drug Suppliers Who regulates? Common Questions: Sources of Information:

6. Investigation of Drug Manufacturers • Who regulates? • Common Questions: • Sources of Information:

7. Investigations of Wholesaler and Distributors • Who regulates? • Common Questions: • Sources of Information:

8. Wholesaler & Distributors • Facility Issues: • Hours of Operation • Type of Establishment • Adequate Lightning • Pest Free • Clean/orderly

9. Wholesaler & Distributors • Record Keeping Issues: • Computer based • Hard copy files • Manual records • On-site storage • Facilities shared

10. Wholesaler & Distributor • Security Issues: • Restricted Access • Alarm with monitoring • Controlled Substances Caged • CII in a vault

11. Wholesaler & Distributor • Storage Issues • Area for Quarantine • Air Conditioned • Monitoring methods • Refrigeration/Freezer • Monitoring Methods

12. Wholesaler & Distributor • Policies and Procedures • What are they • Prescription Drug Annual Examination • Recalls/emergencies • Natural Disaster • Receipt and distribution records • Transaction information including history, etc.

13. Wholesaler & Distributor • Inbound and outbound prescriptions • What business records do they receive • What records do they have on what is sent • Record content

14. Investigations of Pharmacies • Who regulates? • Common Questions: • Sources of Information

15. Pharmacies • Types of Pharmacies • Retail Establishments • Community Pharmacies (other than retail) • Compounding Pharmacies • Institutional Pharmacies • Nuclear Medicine • Special Class Pharmacies

16. Pharmacies • Facility Issues

17. Pharmacies • Record Keeping

18. Pharmacies • Security Issues

19. Pharmacies • Storage Issues

20. Pharmacies • Policies and Procedures

21. Investigations of Providers • Who regulates? • Common Questions: • Sources of Information:

22. Provider Issues • Dispensaries • Prescriptions • Recordkeeping

23. Specific Issues related to Drugs and Diversion • Controlled Substances • Over-the-Counter • Prescription Drug Monitoring Data Base

24. What is a Controlled substance? A substance that has been classified as having a potential for abuse/ addiction Controlled substances are classified in schedules ranging from Schedule I – Schedule VI

25. Drug Classifications 1. Schedule I – “street drugs” – they have no accepted federal medicinal purpose* (cocaine – PCP – methamphetamine – heroin) (*Medical Marijuana – States vs Federal) 2. Schedule II – high potential for abuse - Narcotics (Hydromorphone – Demerol – Morphine – Fentanyl) The new kid on the block - Nucynta

26. Drug Classifications 3. Schedule III – Opiates – Lesser potential for abuse than the II’s but also highly addictive (Oxycodone – Hydrodocone – T#3’s) 4. Schedule IV – Benzo’s, Tranqs and sleeping pills (Xanax – Valium – Dalmane – Lorazapam)

27. Drug Classifications 5. Schedule V – cough syrups with codeine; paragoeric containing compounds

28. Specific Issues related to Controlled Substances • Who regulates Controlled Substances? • Common Questions: • Sources of Information:

29. Jurisdictional Issues a. Federal controls b. Provincial Agencies c. Local law enforcement d. Regulatory Agencies

30. Understanding Accountability Systems • Manufacturer/ Distribution networks (lot numbers) • Pharmacy CV logs – CII files – Computerized records – CSRS records – Triplicate prescriptions - Drug Monitoring Data Bases

31. Understanding Accountability Systems c. Hospitals 1. Automated dispensing systems – SureMed Pyxis - Accudose 2. 24 hour count sheets 3. OR’s/Anesthesia/PACU’s/ER’s 4. Night Cabinet 5. Medication Audits

32. Understanding Accountability Systems d. Long Term Care Facilities 1. ordering meds/ log in 2. narcotic cabinet/box 3. shift count 4. Emergency box e. Methadone facilities f. MD offices - (samples) g. Residential Hospices/Home Care situations h. Pharmacies i. Treatment facilities (cancer care settings)

33. Understanding Accountability Systems • Prescription Drug Monitoring Databases • PDMP is a statewide electronic database which collects designated data on substances dispensed in the state. The PDMP is housed by a specified statewide regulatory, administrative or law enforcement agency. The housing agency distributes data from the database to individuals who are authorized under state law to receive the information for purposes of their profession. • Prescription monitoring programs in Canada vary province to province. There is no national database currently.

34. Understanding Accountability Systems • What are the benefits of having a PDMP? • Support access to legitimate medical use of controlled substances • Identify, Deter, and Prevent Drug Abuse and Diversion • Facilitate Identification, Intervention, and Treatment for Addiction and Drug Abuse

35. Detecting Diversion What is diversion? Unlawful channeling of regulated pharmaceuticals from legal sources to the illicit marketplace. It includes transferring drugs to people they were not prescribe for. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4657309/pdf/austprescr-38-164.pdf (last viewed 08:09 9/07/2018)

36. Detecting Diversion What is diversion? • “’Drug diversion’ is best defined as the diversion of licit drugs for illicit purposes. It involves the diversion of drugs from legal and medically necessary uses towards uses that are illegal and typically not medically authorized or necessary.” Source: “Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in Medicaid,” Centers for Medicare & Medicaid Services (Baltimore, MD: January 2012), p. 1 https://www.cms.gov/Medicare-Medicaid-Coordination/FraudPrevention/MedicaidIntegrityProgram/ downloads/drugdiversion.pdf

37. Detecting Diversion • By definition, diversion is a covert activity so statistics may not be accurate – it is likely underreported and under-detected. • U.S. Substance Abuse and Mental Health Services Administration estimated in 2007 that an average of 103,000 doctors, nurses, medical technicians and health care aides a year were abusing or dependent on illicit drugs. • Various studies suggest the number could be far higher; an estimated one in 10 practitioners will fall into drug or alcohol abuse at some point in their lives, mirroring the general population. • No doubt that drug diversion by healthcare providers is universal among healthcare institutions and is a pervasive problem.

38. Detecting Diversion • When does it happen? • At any time or point along the supply chain • Most common point is at or after the point of practitioner-patient interface including inpatient care • Deflection of prescription drugs from medical sources into the illegal market may occur at any point in the distribution process: • Manufacturers • Wholesale distributors • Doctors • Nurses • Ancillary staff • Patients • Pharmacists • Other healthcare professionals • Burglars

39. Detecting Diversion • Where does it occur? • Diversion can occur anywhere controlled substances are found. • Obvious locations are in the pharmacy, from the automated dispense system, or other medication management system. • The list also includes transportation carts, patient rooms during administration, in the hands of nursing staff before and after administration, and waste and sharps containers. • Controlled substances may also be found in receiving areas and mailrooms and in affiliated medical practices.

40. Detecting Diversion • What are the impacts? • The diverter • risk of morbidity and mortality to himself or herself • professional risks (felony criminal prosecution, civil malpractice) • Patients • substandard care • undue pain and/or anxiety • risk of adulterated or contaminated drug in place of the diverted drug

41. Detecting Diversion The most commonly diverted controlled prescription drugs are opioid pain relievers, including: • codeine • fentanyl • hydromorphone • meperidine • morphine • oxycodone • pentazocine • dextropropoxyphene • hydrocodone combinations (Vicodin, Lortab and Lorcet) • methadone • Source: http://www.oas.samhsa.gov/nhsda.htm

42. Detecting Diversion In addition to opioids, significant diversion is occurring with high cost antipsychotic and mental health drugs: • Abilify • Geodon • Risperdal • Seroquel • Zyprexa • Xanax • Klonopin • Ativan • According to the Center for Behavioral Health Statistics and Quality, in 2014, the estimate of 6.5 million Americans aged 12 or older who were current nonmedical users of psychotherapeutic drugs represents 2.5 percent of the population aged 12 or older.

43. Diversion • Reasons for Diversion • Impairment • Monetary • Control/Power/Abuse

44. Identifying a Narcotic Discrepancy A narcotic discrepancy will ALWAYS be a number and represents something not accounted for, or missing. Thereis a difference between a narcotic discrepancy and poor practice. Examples of poor practice will be things like illegible handwriting; time discrepancies, documentation of a controlled substance to a patient only when the suspect works, etc.

45. Identifying a Narcotic Discrepancy Drug theft by healthcare professionals/workers is accomplished by: • taking waste for personal use • stealing controlled substances (“CS”) from the patients • removing CS from automated dispensing machine (PRN) • tampering with patients’ CS medications • Prescription pad theft and forgery • Illicit prescribing

46. Tools for Determining Diversion a. The agency policy for documentation of controlled substances b. The physician’s orders c. The Controlled Substance sign out record d. The MAR e. Access f. Inventory logs - pharmacy

47. Other investigative tools a. Prior counseling records b. Body fluid specimens c. Background information • prior employment • NURSYS check • Prior regulatory discipline records/history • prior Board records • CSRS – CBC • Online verification systems

48. Performing an accountability audit • Anesthesia • Long term care • General Duty • Pharmacies

49. Methods of Diversion • Substitution/ Dilution • Manipulation of narcotic records • Prescription forgery/Illegally obtaining – calling in Rx’s • Failure to document • Inaccurate waste records

50. Diversion • Commonly Diverted Drugs • Prescription Drugs • Drugs in Institutions/facilities • Drugs on the Street