Technologies to Reduce Diversion, Fraud and Abuse: Electronic Prescribing and Drug Deactivation

1. Technologies to Reduce Diversion, Fraud and Abuse:
Electronic Prescribing and Drug Deactivation
Presenters:
• Sean P. Kelly, MD, Emergency Physician, Beth Israel Deaconess
Medical Center
• Arthur F. Ream III, Chief Information Security Officer and Director
of Information Technology Applications, Cambridge Health Alliance
• Hooshang Shanehsaz, RPh, Director of Pharmacy, Cardinal Health,
and Vice President, Delaware Board of Pharmacy
Pharmacy Track
Moderator: Jinhee J. Lee, PharmD, Senior Public Health
Advisor, Division of Pharmacologic Therapies, SAMHSA, and
Member, Rx and Heroin Summit National Advisory Board

2. Disclosures
• Arthur F. Ream III; Hooshang Shanehsaz, RPh; and
Jinhee J. Lee, PharmD, have disclosed no relevant,
real, or apparent personal or professional financial
relationships with proprietary entities that produce
healthcare goods and services.
• Sean P. Kelly, MD – Employment: Imprivata, Inc.

3. Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– John J. Dreyzehner, MD, MPH, FACOEM – Ownership
interest: Starfish Health (spouse)
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center

4. Learning Objectives
1. Explain how electronic prescribing of controlled
substances reduces drug diversion and fraud
and improves patient satisfaction.
2. Outline DEA requirements for electronic
prescribing of controlled substances.
3. Describe the results of Delaware’s pilot program
with an at-home drug deactivation system.
4. Provide accurate and appropriate counsel as
part of the treatment team.

5. Technologies to Reduce Diversion, Fraud and
Abuse: Electronic Prescribing and Drug
Deactivation
Sean P. Kelly, MD and Arthur F. Ream III
March 29, 2016

6. Arthur F. Ream III, BS
CISO and Director of IT
Applications
Cambridge Health Alliance
Sean P. Kelly, MD
Emergency Physician
Beth Israel Deaconess Medical
Center

7. 1. Explain how electronic prescribing of controlled substances
reduces drug diversion and fraud and improves patient
satisfaction.
2. Outline DEA requirements for electronic prescribing of
controlled substances.
3. Describe the results of Delaware’s pilot program with an at-
home drug deactivation system.
4. Provide accurate and appropriate counsel as part of the
treatment team.
Learning Objectives

8. Agenda
Why EPCS matters & drivers of adoption
Regulatory overview
EPCS: A real-life rollout
Discussion/Q&A

9. Why EPCS matters
New York I-STOP enabling technology
and pharmacy readiness nationally
Paper-based prescriptions create
risk of fraud and DEA number theft
Combat a National Public Health Epidemic Improve Provider Workflows and Patient Safety
Dual workflows lead to provider
and patient dissatisfaction
More deaths from prescription drugs
than cocaine and heroin combined
0
5,000
10,000
15,000
20,000
25,000
1999 2001 2003 2005 2007 2009 2011 2013
Deaths Involving Drug Overdoses
Prescription Drugs Cocaine & Heroin
Source: CDC
eRx proposed as core objective for
hospitals in Meaningful Use Stage 2MU

10. The challenge of dual prescribing
workflows
• 38% of patient interactions in which
prescriptions are written include mix of
controlled & non-controlled substances
• What does this mean?
− Providers have to switch between
electronic and paper, creating inefficiency
and dissatisfaction
− Providers may revert to a single, paper-
based workflow, which could impact
Meaningful Use
41.4%
38.3%
20.3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Physician Prescription Mix
Just controlled
Mix of both
Just non-controlled

11. Impact of hydrocodone reclassification
• Hydrocodone combination drugs (i.e.,
Vicodin) now Schedule II, placing tighter
controls on prescribing:
− No refills
− No verbal/faxed orders
• Potential 68% increase in number of
prescriptions written for controlled
substances, exacerbating challenges of
dual workflows
15.6
26.3
0
5
10
15
20
25
30
Before Reclassification After Reclassification
Controlled Substance Prescriptions
(physician/week)

12. Overview of EPCSDEA requirements for EPCS
Pharmacy
certification
Adoption by state board
of pharmacy
CII-V Allowed (all schedules)
Two-factor
authentication
EMR
certification

13. EPCS Workflow

14. Consider the Clinician’s Workflows
Technology should:
• Integrate directly into the EHR’s
e-prescribing workflows
• Support DEA-approved 2FA
modalities, to deliver flexibility
for providers
• Present only the 2FA modalities
that are available and allowed

15. Two-factor authentication offerings
• Password
• Fingerprint biometrics
• Software and hardware OTP tokens
• Hands Free Authentication
– Automatically retrieves and verifies a one-time
password (OTP) from provider’s mobile device
– No need to carry, touch, or type a token code FIPS Compliant Readers
Something you are
Password
Something you know
FIPS Compliant
Token or Smart Card
Something you have

16. Two-factor authentication
considerations

17. Security AND Convenience
Imprivata ID
USB receiver
1. Provider places
EPCS order
3. Hands Free Authentication
automatically retrieves token code
from provider’s mobile phone
Second factor ✔
2. Provider scans
fingerprint*
First factor ✔
Automatically completes one factor of the
two-factor authentication
Provider simply enters order and scans
fingerprint
Hands-free
authentication runs
on provider’s locked
phone
4. EPCS order
complete ✔
* or enters password if biometric not available

18. EPCS: A real-life rollout

19. About Cambridge Health Alliance
• Three hospitals, 15 primary care
practices in Boston’s Metro North
region
• Serving about 140,000 patients
• 4,323 employees (691 physicians)
• HIMSS Stage 6 (pursuing
ambulatory Stage 7)
• NCQA Level 3 Medical Home
recognition for seven CHA
Primary Care Practices

20. Drivers for EPCS
• Increase patient safety and satisfaction
− Paper-based prescriptions inconvenient for patients
− Risk of fraud and drug diversion
• Improve provider satisfaction and efficiency
− Aim to give physicians the best tools available
− Eliminate dual prescribing workflows
• EPCS is part of a robust strategy for addressing
prescription drug abuse

21. EPCS team
• Project driven by IT in conjunction with
Clinical Informatics
• Implementation Team:
– EPIC application analysts
– Systems Engineer
– Server Engineer

22. Technology overview
• EHR: Epic 2014 IU1
• Two-factor authentication
o Hands Free Authentication (Imprivata)
o Mobile one-time password tokens
• Syncing providers with Surescripts

23. Why Imprivata Confirm ID?
• Comprehensive functionality to meet DEA
authentication requirements for EPCS
• Best solution for driving physician adoption
− Hands Free Authentication
− Seamless Epic integration

24. Hands Free Authentication at CHA
• Solid technology base
• Seamless integration with desktops
• Where to implement?
– Based on volume of prescriptions, particularly
for CII medications (i.e., ED)
– Primary care clinics with high CII volumes
• Feedback from clinicians
– Workflow streamlines patient visit
– Keeps providers focused on the patient

25. Results
• Since going live with EPCS and Imprivata Confirm ID, e-prescribing
rates have increased 40% for all medications
• Moving away from paper prescriptions has increased patient
satisfaction
• Feedback from physicians:
– Exceptionally easy workflow
– Able to service patients more effectively
– No need to travel to another location to physically sign a
prescription

26. EPCS with Epic: Tips for Success
• Surescripts: Start the process early and make sure you
specify if you are already e-prescribing non-controlled
substances
• Epic interfaces to Surescripts must be on latest's 10.6
version
• Epic turnaround time on build review is about two weeks
• Hold fairs to enroll providers into the system

27. Experience and Advice
• Simplify the EPCS process with a single, robust
solution (vs. using disparate technologies and
manual processes)
• EHR integration is essential!
• Think about multi-purpose solutions
EPCS

28. Questions/discussion

29. Appendix

30. Use Case/Workflow
Examples
Password
FIPS Compliant
Biometric
FIPS Compliant Token
Value/ Differentiation
Relative Speed &
ConvenienceHard/Soft Hands Free
Authentication
Physician prescribing in
patient exam room (shared
workstation)
or
Physician prescribing in
their office (dedicated
workstation)
X X
• Fastest authentication – touch and done
• No disruption to workflow
5
X X
• Fast – type password and done
• Minimal disruption to workflow
4
X X
• Fast – type password and touch finger
• Slower than Hands Free Authentication, but
fastest workflow when it is not available
3
X X
• Slow – type OTP code from token
and touch finger
2
X X
• Slowest– type password and type OTP code
from token
• Most disruptive to workflow 1
Physician prescribing in
hospital on Windows Tablet
(managed)
X
Typically not
available on
mobile devices
X
• Fast – type password and done
• Minimal disruption to workflow
4
X X
• Slowest– type password and type OTP code
from token
• Most disruptive to workflow 1
Two-factor authentication considerations

31. Identity proofing – institutional
Verifies practitioners are licensed and
allowed to prescribe controlled
substances
Medical Credentialing Office
Creates a list of practitioners that are
allowed to electronically prescribe
controlled substances
Creates a list of users that can approve
EPCS access in the EMR
Creates a list of supervisors that are
authorized to witness enrollment of
practitioners in Imprivata Confirm ID
Synchronizes Imprivata Confirm ID
with AD accounts of practitioners and
enrollment supervisors
Information Technology
Synchronizes Imprivata Confirm ID
with AD accounts of enrollment
supervisors and assigns enrollment
privileges
Supervisors do not have to be DEA
registrants and can be individuals from
IT, clinical or hospital administration
Enrollment Supervisors
Verifies photo IDs of practitioners match
those on the list from the Medical
Credentialing Office
Issues two-factor credentials to
practitioners and supervises enrollment
of credentials in Imprivata Confirm ID
Imprivata Confirm ID creates records
of IDs verified and enrollment of
credentials
EMR Administrators must be a different
entity/group than the Medical
Credentialing Office
EMR Administrator
Sets EPCS access for practitioners in
an EMR that has been certified for
EPCS
Approvers must be a different group
than the EMR Administrators and do
not have to be DEA registrants
EPCS Access Approvers
Approves EPCS access for practitioners
in the EMR (does not require two factor
authentication)

EPCS

32. Identity proofing – individual
Synchronizes Imprivata Confirm ID
with AD accounts of practitioners
Information Technology
AD accounts must include the full legal
name of practitioners and valid e-mail
addresses
Imprivata Confirm ID performs NIST
Level 3 identity-proofing of practitioners
using social security number, date of
birth, credit card information, valid e-
mail address and mobile or home
phone number
Credential Service Provider
Imprivata Confirm ID registers and
issues tokens to practitioners via two
channels
Practitioners can optionally self-enroll
fingerprints with Imprivata Confirm ID
Imprivata Confirm ID automatically
creates records of enrollment of
credentials
EMR Administrators must be a different
entity/group than the Credential Service
Provider
EMR Administrator
Sets EPCS access for practitioners in
an EMR that has been certified for
EPCS
Approvers must be a different group
than the EMR Administrators and are
required to be DEA registrants
EPCS Access Approvers
Approves EPCS access for practitioners
in the EMR using Imprivata Confirm ID
two factor authentication

EPCS

33. • Full auditing capabilities of user
and administrative activity
• User activity for signing
transactions, including
workflow, modality and device
• Administrative activity tracks
policy changes and overrides
• Configurable audit record
retention
Auditing and reporting

34. Technologies to Reduce Diversion, Fraud and Abuse:
Electronic Prescribing and Drug Deactivation
Delaware’s Initial Pilot Program with an
At-home Drug Deactivation System
March 29, 2016
Hooshang Shanehsaz, RPh

35. Presenter Information
Hooshang Shanehsaz, RPh
Director of Pharmacy, Cardinal Health,
Vice President, Delaware Board of Pharmacy
Prescription Drug Action Committee
Control Subcommittee, Chair
“Has disclosed no relevant, real or apparent personal or professional
financial relationships with proprietary entities that produce health
care goods and services.”
No Financial Disclosures for Verde Technologies

36. Learning Objectives:
1. Describe the results of Delaware’s pilot program with
an at-home drug deactivation system

37. The Urgent Problems

38. The USA consumes over 90% of the
world’s prescribed opioids-
yet we’re less than 7% of the
population

39. • Based on Delaware’s PDMP, 347,930 individuals filled
prescriptions for controlled substances in 2013
• Approximately 12% (n=42,364) filled prescriptions for
benzodiazepines and opioids in the same calendar quarter
• Most of those who filled prescriptions for both opioids and
benzodiazepines were aged between 51-75 years old (47%), and
more than two-thirds were male. Thus higher probability for
having children within the age ranges most prone to abuse
Why Delaware for a
Drug Deactivation Study?

41. • According to a 2012 CDC report, prescribing rates of opioids and
benzodiazepines were higher than average in Delaware compared to other
states:
• 90.8 opioid prescriptions per 100 persons (ranked 17th highest in the
US)
• 21.7 prescriptions per 100 persons for long-acting / extended-release
opioid pain relievers (ranked 2nd highest)
• 8.8 per 100 persons for high-dose opioid pain relievers (ranked highest)
• 41.5 prescriptions per 100 persons for benzodiazepines
Why Delaware for a
Drug Deactivation Study?

42. Six-month multiple-provider episode* rates† for state
residents, Schedule II, III, and IV Drugs— Prescription Behavior
Surveillance System, eight states, 2013
8.9
45
52.9
20.9
4.4
20.7
66.8
18.4
0
10
20
30
40
50
60
70
80
California Delaware Florida Idaho Louisiana Maine Ohio West
Virginia* Multiple-provider episode is defined as a resident filling a controlled substance prescription from five or more
prescribers at five or more pharmacies within 6 months.
† Per 100,000 state residents; annual rate is based on the average of the two half-year rates.
Source: MMWR. Controlled Substance Prescribing Patterns — Prescription Behavior Surveillance System, Eight States, 2013. Surveillance Summaries
October 16, 2015 / 64(SS09);1-14

43. Percent receiving >100 MMEs daily, 2013* - Prescription
Behavior Surveillance System, eight states, 2013
10.3
16
13.2
12
9.2
15
8.1
10.3
0
2
4
6
8
10
12
14
16
18
CaliforniaDelaware Florida Idaho Louisiana Maine Ohio West
Virginia*The percentage of patients receiving >100 MMEs per day for all opioids used by the patient calculated as an average
of four quarters
Source: MMWR. Controlled Substance Prescribing Patterns — Prescription Behavior Surveillance System, Eight States, 2013. Surveillance Summaries
October 16, 2015 / 64(SS09);1-14

44. The White House
• National Drug Control Strategy was revised in 2015
• Pillar 3: Disposal
1. Supports DEA Takeback
2. Drug Deactivation Systems
a) 2013 NIDA Research
b) “Exemplifies how the drug control interagency work
together with small business to address public health
and safety needs.”

45. Collaborative Delaware Pilot Program
Delaware Prescription Action Committee (PDAC)
The PDAC is a public-private partnership started by the State of Delaware’s
Division of Public Health and the Medical Society of Delaware to enable
multiple stakeholders to work collaboratively to address the prescription drug
abuse problem in Delaware.
Delaware Public Health (DPH)
DPH, a division of the Department of Health and Social Services, urges
Delawareans to make healthier choices.

46. Pilot Program Outline
Scope
1. To provide specific, pre-identified independent pharmacies with Deterra-SP
Drug Deactivation Systems in an effort to promote at-home drug
deactivation and collect end-user feedback; the pharmacies will provide the
Deterra-SP with each qualifying prescription
2. The end goal is to create awareness, educate communities/pharmacists and
provide a tangible solution for eliminating prescription medications from
the pool of available abusable drugs
Locations
a. 2 pharmacies in New Castle
b. 2 pharmacies in Kent
c. 2 pharmacies in Sussex
Metrics
Create and implement a web-based survey tool to collect end-user feedback
regarding ease-of-use and actual use.

47. Participating Delaware Pharmacies
PHARMACY NAME COUNTY
MARKET STREET PHARMACY
1914 N MARKET ST WILMINGTON, DE
19802 PHONE: (302) 421-9200
New Castle
FIRST STATE PHARMACY
1707 FOULK ROAD, WILMINGTON DE.
PHONE (302) 468-4300
New Castle
CAPE PHARMACY
17252 N VILLAGE MAIN BLVD.,UNIT 3 LEWES, DE 19558
PHONE: (302) 645-0090
Sussex
BAYARD PHARMACY
202 W. LOCKERMAN ST. DOVER, DE 19904
PHONE: (302) 724-4497
Kent
ATLANTIC APOTHECARY
100 S.MAIN ST SUIT 104 SMYRNA, DE 19977
PHONE: (302)653-9355
Kent
GEORGETOWN PHARMACY
432 E MARKET ST UNIT 101, GEORGETOWN, DE 19947
PHONE: (302) 856-2828
Sussex

49. Comparison of Disposal for Model Drugs
Presented at AAPS 2014:
-Oxycontin/APAP
-Hydrocodone/APAP
-Naproxen
-Ibuprofen
-Diphenhydramine
-Dexamethasone
-Amoxicillin
-Ketoprophen
-Venlafaxine%ofDrugDeactivated
(average)
Deterra
100
50
25
75
Coffee
15%
Cat Litter
21%
Sawdust
23%
98%
FDA Recommended
Ingredients SmartRX
Ingredient
Adsorption Technology
(deactivation)
Absorption Technology
(non-deactivation)

50. Challenges to Other Limited
Disposal Methods
Pharmacy Drop Boxes:
• Pharmacists are concerned and/or not interested in having the boxes
in stores, many cite the DEA data regarding increased robberies along
with the burden and added work it places on the employees
Take-Back Programs:
• The True Costs and Effectiveness are Unknown, According to a Recent
Study by Carnevale Associates (2014)
• Wake Forest and Eastern Tennessee Data presented at the National Rx
Drug Abuse Summit in April 2015:
Study Results:
• They found that 1%- 5% of available drugs are returned
• People won’t drive more than 5 miles to drop off
• Include PSA and marketing through radio, TC and ads

51. Prescription Drug Drop Box
1. Selbyville Police
Department
302-436-5085
68 W. Church St.
Selbyville, DE 19975
Directions
2. Greenwood Police
Department
302-349-4822
100 W. Market St.
Greenwood, DE 19950
3. Dover Police
Department
302-736-7111
400 S. Queen St., Dover,
DE 19904
Directions
4. Smyrna Police
Department
302-653-9217
325 W. Glenwood Ave.,
Smyrna, DE 19977
Directions
5. Camden Police
Department
Phone
1783 Friends Way
Camden, DE 19934
Directions
6. Harrington Police
Department
302-398-4493
20 Mechanic St.
Harrington, DE 19952
7. Newark Police
Department
302-366-7111
220 S. Main St., Newark,
DE 19711
Directions
8. New Castle County
Police Department
302-573-2800
3601 N. DuPont Hwy.,
New Castle, DE 19720

52. Related Pharmacy and Healthcare Examples
Over 4,000 independent
pharmacies, healthcare
organizations and law
enforcement partners

53. Survey Tool

54. • Total Responses: 1.5%
• Estimate 1,000 Deterra provided
Delaware Pilot Program
Initial Results

55. Q1: Which county do you live in?
Answered: 15 Skipped: 0

56. Q2: Where did you receive the Deterra
Drug Deactivation System?
Answered: 15 Skipped: 0

57. 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00%
within 24 hours
within 4 weeks
longer than 1 month
I will Not use it
Q3: Upon receipt of the product, how quickly did
you use it to destroy unwanted prescription drugs?
Answered: 15 Skipped: 0

58. Q4: Were the instructions clear and
easy to understand?
Answered: 15 Skipped: 0
All respondents answered “yes”

59. Q5: Did you have any trouble using the
product?
Answered: 14 Skipped: 1
All Respondents Answered “No”

60. Q6: Please check all that apply:
Answered: 15 Skipped: 0
0% 20% 40% 60% 80% 100% 120%
I would use this product again
I would recommend it to others

61. Q7: Why did you use the
product? Please check all that apply:
Answered: 15 Skipped: 0
0.00% 20.00% 40.00% 60.00% 80.00% 100.00%
To lower the risk of abuse and diversion
To lower the risk of accidental poisoning
To help the quality of the water supplu by not adding more drugs to the
environement
To remove presciption drugs from my home without causing
environmental damage
Other

62. Participating Pharmacists’ Comments
“This product is a no-brainer.” Everyone should use it.
Kevin, Rph Atlantic Pharmacy
“The customers that were asked, appreciated the product and did use it
to destroy old medications they had around the home. I believe with
heavy advertisement and really pushing the product it could be a
success.”
Sheila, Rph , Market Street Pharmacy
“I've used the product here in the pharmacy and it is so simple and
convenient to use. I truly believe this is an excellent product to get into the
hands of the general public to help protect our environment and water
supply.”
-Erik, Rph, Bayard Pharmacy

63. - Drug abuse is a multipronged problem which requires a multi faceted approach in resolving
- Education has to be the main pillar; educating the prescribers in more responsive diagnosing,
recognizing risk factors and prescribing
- Patients in being more educated consumers and guardians
- Creating tools to help consumer be more of an advocate; these tools have to be convenient,
easy to use, renewable, cost effective, environmentally friendly, and offer scientific solution
- Drug Drop Off Boxes offer an option however they are often being seen as inconvenient, carry
high risk and hard to maintain
Drug Deactivation Bags offer:
- Easy convenient way for medication disposal at home, in institution or in medical office
- A reliable, very cost effective solution for getting unused medications out of the medicine
cabinets and keeping them out of water supply
- No need for constant expensive monitoring, collection and destruction
- No hazardous waste by product
- Minimal training
Lessons Learned and Conclusions

64. Thank You

65. Technologies to Reduce Diversion, Fraud and Abuse:
Electronic Prescribing and Drug Deactivation
Presenters:
• Sean P. Kelly, MD, Emergency Physician, Beth Israel Deaconess
Medical Center
• Arthur F. Ream III, Chief Information Security Officer and Director
of Information Technology Applications, Cambridge Health Alliance
• Hooshang Shanehsaz, RPh, Director of Pharmacy, Cardinal Health,
and Vice President, Delaware Board of Pharmacy
Pharmacy Track
Moderator: Jinhee J. Lee, PharmD, Senior Public Health
Advisor, Division of Pharmacologic Therapies, SAMHSA, and
Member, Rx and Heroin Summit National Advisory Board