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Pharmaceutical Diversion Recent Trends and Updates

Pharmaceutical Diversion Recent Trends and Updates. Mark Rubbins, Diversion Group Supervisor Drug Enforcement Administration New England Field Division. Abuse Facts.

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Pharmaceutical Diversion Recent Trends and Updates

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  1. Pharmaceutical Diversion Recent Trends and Updates Mark Rubbins, Diversion Group Supervisor Drug Enforcement Administration New England Field Division

  2. Abuse Facts SOURCE: 2014 National Survey on Drug Use and Health (NSDUH) published September 2014 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) • In 2014, 27 million Americans aged 12 or older were current (past month) users of illicit drugs 1 in 10 Americans • 6.5 million used prescription-type psychotherapeutic drugs (any pain relievers, tranquilizers, stimulants or sedatives) for non-medical purposes in a one-month period (2011 data – 6.1 million) • 4.3 non-medical users of pain killers • Non medical use of prescription type drugs is second only to marijuana

  3. Abuse Facts The rate of non-medical use of prescription-type drugs among young adults (age 18-25) decreased to 5.0 % from a range of 5.5 -5.9% from 2002-2013. From 2002 to 2013, there was a significant increase among older adults (50 to 54) in the rate of illicit drug use (3.4 to 7.9%) – baby boomers aging – they like their drugs! Of the 4.8 million older adults who had used illicit drugs in the past year, 2.1 million were non-medical use of prescription-type drugs.

  4. Past Month Illicit Drug Use among Persons (Aged 12 or Older) - 2014 1 Numbers in Millions • Illicit Drugs include marijuana/hashish, cocaine (including crack), heroin, hallucinogens, inhalants, or prescription-type psychotherapeutics used non-medically. 4

  5. 2013 Partnership Attitude Tracking Study • Troubling data on misuse/abuse of prescription narcotics and stimulants • Every day 2,700 teens try a controlled medication to get high for the first time • Perception of teens toward this misuse/abuse very concerning • Misconception of the dangers of these substances • Parental attitudes are contributing to the problem – major disconnect!! 1SOURCE: 2013 PATS, Partnership for a Drug-Free America and MetLife Foundation, published September 2014

  6. 2013 Partnership Attitude Tracking Study • Many teens mistakenly believe that pharmaceuticals are safer than “street drugs” for a variety of reasons: • They’re “medicine” • Obtained from doctors, pharmacies, friends or family members – non threatening • It is not necessary to buy them from traditional “drug dealers” – after all, they came from a doctor, right? 1SOURCE: 2012 Parents and Teens Attitude Tracking Study Report, Partnership for a Drug-Free America and MetLife Foundation, published July 22, 2014

  7. 2013 Partnership Attitude Tracking Study One in four teens (23%) report misuse/abuse of a prescription drug at least once = 5 million teens 27 % of teens believe this abuse is safer than street drugs 23% feel parents don’t care as much if caught using Rx medications compared to street drugs 1SOURCE 2013 :PATS, Partnership for a Drug-Free America and MetLife Foundation, published July 22, 2014

  8. 2013 Partnership Attitude Tracking Study • Problematic, cavalier attitude regarding misuse/abuse of Rx drugs • One in eight teens (about 2.7 million) reports having abused or misused the stimulants Ritalin or Adderall • 31% of teens believe that prescription stimulants can be used as an effective study aid 1SOURCE: 2013 Parents and Teens Attitude Tracking Study Report, Partnership for a Drug-Free America and MetLife Foundation, published July 22, 2014

  9. 2013 Partnership Attitude Tracking Study • Parents attitude toward this issue even worse… • 21% of parents feel ADHD drugs can improve academic performance, even if child does not have ADHD • 16% feel a child abusing Rx drugs much safer than abusing illicit drugs • 13 % feel its ok if their teen were to take Rx drugs without a prescription…WHAT!!! 1SOURCE: 2013 Parents and Teens Attitude Tracking Study Report, Partnership for a Drug-Free America and MetLife Foundation, published July 22, 2014

  10. 2013 Partnership Attitude Tracking Study • 73% of teens say its easy to access Rx drugs from their parents medicine cabinet • 38% of teens who have misused Rx drugs obtained them from parents medicine cabinet • 23% said parents would not care as much if they were caught abusing Rx meds as compared to illicit drugs 1SOURCE: 2013 Parents and Teens Attitude Tracking Study Report, Partnership for a Drug-Free America and MetLife Foundation, published July 22, 2014

  11. Teen Attitudes

  12. The ‘OXY’ SUBCULTURE

  13. Pain Clinic “Clients”

  14. “No Florida Id Required” WHY? At least they also offer Detox too!

  15. DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

  16. Practitioners / Pharmacists Illegal distribution Self abuse Trading drugs for sex Employee pilferage Hospitals Practitioners’ offices Nursing homes Retail pharmacies Manufacturing / distribution facilities Pharmacy / Other Theft Armed robbery Burglary (Night Break-ins) In Transit Loss (Hijacking) Patients Individual and organized drug ring Doctor-shopping Feigning illness Forged / fraudulent / altered prescriptions How Controlled Substances are Diverted DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

  17. Registration • On-line application much faster than paper application – one week to get registration certificate vs. four-to-six weeks for paper • On-line application is approved same day it comes to Registration Unit in Boston if all certifications are included and valid • Applicant must have a valid MA Medical License and a valid MA Controlled Substance license before applying for a DEA Registration

  18. Registration • Renewals: Practitioner is sent a renewal reminder letter 60 days prior to expiration. Letter goes to registered address – if changed address and did not update or notify, may not receive letter. • Two more letters are sent before the registration is no longer valid on its expiration date. • Practitioner is no longer authorized to order, administer, dispense or store controlled substances. • 30 days after the expiration date, the registration is officially retired, and cannot be reactivated.

  19. Electronic Prescriptions for Controlled Substances(EPCS)

  20. EPCS • Interim Final Rule Published March 31, 2010 • Provides practitioners with the option of writing Rxs electronically. • Permits pharmacies to receive, dispense and archive these Rxs. • 2 factor authentication for practitioners • Something you know (password) • Something you have (hard token) • Something you are (biometric)

  21. EPCS • Third Party Reviews of Prescriber or Pharmacy Applications • Before any application may be used for electronic prescriptions for controlled substances, it must be reviewed, tested and determined by a third party to meet all of the requirements of 21 C.F.R.§ Part 1311.

  22. EPCS There are two alternative processes for review and certification of EPCS applications under the Interim Final Rule:

  23. EPCS (1) A third-party audit conducted by a person qualified to conduct a SysTrust, WebTrust or SAS 70 audit or a Certified Information System Auditor as stated in 21 CFR 1311.300(b), which comports with the requirements of paragraphs (c) and (d) of 21 CFR 1300.300, or

  24. EPCS (2) A certification by a certifying organization whose certification process has been approved by DEA as stated in 21 CFR 1311.300(e), which certification verifies that the application meets all of the requirements of 21 CFR Part 1311. Review of processing integrity is required under either type of review.

  25. EPCS Venders must have their systems certified by a third-party entity that it complies with the regulations. Practitioners and pharmacies should request a copy of the certificate. DEA Investigators should ask to see the certificate. Currently six companies approved – listed on our website.

  26. EPCS • Fax vs. Electronic Prescription • True electronic Rxs are transmitted as electronic data files to the pharmacy, whose application securely import the data file into its database – utilizing 2 factor authentication • A system the allows the prescriber to “sign” his/her name does not conform to EPCS regulations (hand held device, tablet) • A facsimile with a written signature is not an electronic Rxs.

  27. EPCS Final Rule is being drafted More info on the DEA Website www.DEAdiversion.gov

  28. Disposal of Controlled Substances

  29. Secure and Responsible Drug Disposal Act of 2010 • Public Law 111-273 • Enacted on October 12, 2010 • This Act amended the Controlled Substances Act to provide for disposal of controlled substances by certain persons. • Ultimate Users • Long Term Care Facilities • Survivor of decedent

  30. Disposal of Controlled Substances Final Rule Published September 9, 2014 in the Federal Register Patients now have expanded options to safely and responsibly dispose of unused/unwanted medications – through collection receptacles and mail-back packages Establishes “Authorized collectors”

  31. Disposal of Controlled Substances DEA –registered retail pharmacies, hospitals/clinics with an on-site pharmacy, narcotic treatment programs, manufacturers, distributors, and reverse distributors may become “authorized collectors” May apply to modify their registrations to reflect this status May also conduct mail-back programs

  32. Disposal of Controlled Substances Must be registered to handle schedule ll CDS – all collected substances treated as schedule ll Standard of destruction – “non-retrievable” “cannot be transformed to a physical or chemical condition or state as a controlled substance or CS analogue.”

  33. Disposal of Controlled Substances Authorized retail pharmacies and hospital/clinics with an on-site pharmacy may also place receptacles at LTCF’s

  34. Disposal of Controlled Substances Authorizes Police Departments to continue and expand current disposal programs Gives other entities access to becoming “collectors” (Manufactureres, Distributors, Reverse Distributors, Pharmacies)

  35. 10th National Take Back Day September 26, 2015 DRUG ENFORCEMENT ADMINISTRATION DIVERSION CONTROL PROGRAM

  36. 10th National Take Back Day: September 26, 2015 Total Collection Sites: 5,202 90 66VT 87 NH 167 24 44 19 44 176MA 58 27 22 258 35 RI 18 146 66CT 120 246 215 NJ 25 41 229 57 46 26 DE 219 348 139 123 178 101 19 DC 208 56 79 MD 81 125 18 79 188 63 93 85 96 26 33 296 9 17 PR & VI 150 21 HI & Guam Drug Enforcement Administration Diversion Control Program

  37. 10th National Take Back Day: September 26, 2015 Total Weight Collected (pounds): 742,771 (371 Tons) 19,320 5,800 VT 7,767 NH 19,760 2,746 1,495 24,396 MA 8,934 5,600 2,883RI 11,479 2,899 2,123 49,567 14,853 6,501CT 763 8,643 15,995 14,875NJ 2,547 6,360 27,192 47,233 4,625 7,227 DE 18,400 6,880 20,369 64,888 13,245 27,229 40,240 7,593MD 9,497 12,014 889 DC 17,427 1,139 10,601 37,890 5,320 6,285 10,167 1,800 6,402 62,277 897 PR & VI 3,489 2,766 3,291 HI & GU 30,193 Drug Enforcement Administration Diversion Control Program

  38. Questions????

  39. Thank You!

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