Looking Beyond Red Flags

1. Looking Beyond Red Flags
Presenters:
• Nicholas Hagemeier, PharmD, PhD, Assistant Professor of Pharmacy
Practice, East Tennessee State University Gatton College of Pharmacy
• Marc Fleming, PhD, MPH, RPh, Assistant Professor, Pharmaceutical
Health Outcomes and Policy, University of Houston College of Pharmacy
• Kimberly Vernachio, PharmD, President, Vernachio Managed Care
Consulting
Pharmacy Track
Moderator: J. Kevin Massey, MS, Business and Program Development
Specialist, Weitzman Institute, Community Health Center, Inc., and
Member, Rx and Heroin Summit National Advisory Board

2. Disclosures
Marc Fleming, PhD, MPH, RPh; Nicholas
Hagemeier, PharmD, PhD; Kimberly Vernachio,
PharmD; and J. Kevin Massey, MS, have
disclosed no relevant, real, or apparent personal
or professional financial relationships with
proprietary entities that produce healthcare
goods and services.

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. Identify prescribers’ and pharmacists’
perceptions of Rx legitimacy and Rx drug abuse
communication behaviors.
2. Express the gaps and challenges related to drug
coverage of opioids and benzodiazepines.
3. Explain the benefit of early identification,
supportive benefit structures and intervention
training to empowering community pharmacists
to mitigate opioid addiction.
4. Provide accurate and appropriate counsel as
part of the treatment team.

5. Looking Beyond Red Flags
Nick Hagemeier, PharmD, PhD
Assistant Professor, Department of Pharmacy Practice
East Tennessee State University
Gatton College of Pharmacy
Johnson City, TN

6. Disclosures
Nicholas E Hagemeier, PharmD, PhD, has
disclosed no relevant, real or apparent personal
or professional financial relationships with
proprietary entities that produce health care
goods and services

7. Objectives
1. Identify prescribers’ and pharmacists’
perceptions of Rx legitimacy and Rx drug abuse
communication behaviors.
2. Express the gaps and challenges related to drug
coverage of opioids and benzodiazepines.
3. Explain the benefit of early identification,
supportive benefit structures and intervention
training to empowering community pharmacists
to mitigate opioid addiction.
4. Provide accurate and appropriate counsel as
part of the treatment team.

8. A CHIEF EVENT OF LIFE IS THE DAY IN
WHICH WE HAVE ENCOUNTERED A
MIND THAT STARTLED US
- Ralph Waldo Emerson

11. Red Flags
• Focus on identification
• Dispense vs. refuse to dispense
• Little emphasis on resolution

12. Role of the Community Pharmacist
• Relatively unexplored
– PDMP, perceptions, non-US studies
• Audience dependent
– AMA for example
– Draft CDC prescribing guidelines
• Intraprofessional dissonance

14. Tennessee community pharmacists said…
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
PDA a problem Perceived legitimate Addiction info in
pharmacy

15. Pharmacists who estimate low PO
legitimacy tended to be…
• Female (OR = 2.5; p<0.001)
• In chain or independent settings (OR = 1.9;
p<0.05)
• Fearful of disciplinary action (OR = 2.5; p<0.01)
• Confident in ability to detect PDA (OR = 2.5;
p<0.01)

16. Take home points
• Rxs perceived to be illegitimate are commonly
dispensed
• Modifiable and non-modifiable factors
influence legitimacy judgments
• Communication behaviors were not evaluated
in the study

17. NAS Prevention Behaviors
• Given 10 female
patients of childbearing
age dispensed a
prescription opioid for
greater than 7 days,
with how many of these
patients would you
expect to...

18. 0 2 4 6 8 10
Ask if questions
Counsel on indication
Discuss risks of PO use during
pregnancy
Discuss need to notify
prescriber if become pregnant
Ask patient if pregnant
Discuss LARC access
Behavioral Engagement (Mean)

19. Take home points
• Despite over 85% of pharmacists agreeing that
they have a responsibility to prevent NAS and
a similar percent agreeing that substance use
during pregnancy is a concern in their practice
settings, behavioral engagement in NAS
prevention is lacking
• Subjective norms matter

21. Influencers of Communication
• Subjective vs. objective patient information
• Practice setting barriers
• Patient relationships
• Level of HCP training and experience
• Pharmacists’ lack of patient information
• Fear of patient responses
• Individual and practice setting policies

22. Communication Behaviors
• Policies (pharmacy, pharmacist)
– Make conversations easier – “I won’t fill for out of
state patients”
– Make tough conversations more avoidable – “We
don’t dispense buprenorphine. It’s our store policy”
• Standard operating conversations
– “Do you have any questions for the pharmacist?”
– The Three Prime Questions
• Confrontational questioning
– “Why aren’t you taking this medicine the way you’re
supposed to?”
• Communication avoidance
– Red flag refusals

23. INFORMED LEGITIMACY JUDGMENTS
ROUTINELY NECESSITATE COMMUNICATION
Are legitimacy judgments legit?

24. BEST PRACTICES
Yet to be defined…

25. Next Steps
• Rethinking controlled substance dispensing
communication
– Establish expectations
• “We won’ts” vs. “We wills”
– SBIRT (Screening, Brief Intervention and Referral
to Treatment)
• Screening instruments
• Reimbursement
• Naloxone

26. Next steps
• Resources
– Develop comprehensive list of local resources for
patients
• Great learning opportunity for pharmacy students or
grad students
– Must-have expertise
• Abuse potential, storage, disposal, where to get help

27. Next Steps
• Documentation
– Pregnancy status
– 1 minute SOAP notes
– Risk assessment and pain scale score
– Treatment plan
• Team training
– Community and pharmacy
– Patient-centered technician

28. THE SINGLE BIGGEST PROBLEM IN
COMMUNICATION IS THE ILLUSION
THAT IT HAS TAKEN PLACE.
George Bernard Shaw

29. hagemeier@etsu.edu Nick Hagemeier
@NickHagemeier

30. Drug Coverage of Opioids and Benzodiazepines:
Gaps, Challenges and Opportunities to Empower
Pharmacists and Improve Outcomes

31. Benzodiazepines – the “other” epidemic.
• Benzodiazepines depress central nervous system (CNS) activity
and are used to relieve symptoms of anxiety, panic attacks, and
seizures
• When combined with other drugs that depress CNS activity,
such as alcohol or opioid pain relievers, benzodiazepines may
present serious or even life-threatening outcomes

32. Deaths from Prescription
Opioids
Opioids Other Drugs
75%
Death from Pharmaceuticals
Opioids Other Rx
58%
Do the Math
• Drug Overdose Death = leading causes of mortality from injury
in the United States.1
1) Paulozzi LJ. Prescription drug overdoses: a review. J Safety Res 2012;43:283-9.
Bohnert AS et. al. Risk of death from accidental overdose associated with psychiatric and substance use disorders. Am
J Psychiatry 2012;169:64-70.
30%
Involve Prescription Benzodiazepines
Patients with history of drug misuse or
other
psychiatric disorders.

33. Doing the Math: The Trend Over Time 1996 to
2013
Am J Public Health. Published online ahead of print February 18, 2016: e1–e3. doi:10.2105/AJPH.2016.303061
• Benzodiazepine overdose death
increased faster than the percentage of
patients filling and the quantity filled
• Rates of overdose death are 5 times
those at start of study EXCEPT: the Elderly
and minority groups

34. • 2006: Medicare Part D drug program there was no drug coverage for anti-anxiety
medications
• 2013 - Congress reversed the payment policy
• Generic benzodiazepines were
among the top 32 most-prescribed
medications
• Not new prescriptions!
Lessons Learned from Medicare
Reference Article: Medicare Part D and the Federal Employees Health Benefits Program: A Comparison of Prescription Drug Coverage
http://www.ahdbonline.com/issues/2013/january-february-2013-vol-6-no-1/1283-feature-1283
Medicare paid for nearly
40 million prescriptions

35. Lessons learned from the Veterans
Administration
Largest study of association between
benzodiazepine prescribing and fatal overdose
• A dose-dependent relation between
benzodiazepine dose and death from overdose.
• Increased risk for patients currently receiving
benzodiazepines and opioids on a regular basis.
• Risk is highest for those receiving higher doses
of either or both drugs.
• No association between PRN dosing and risk of
death from overdose.
Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics:
case-cohort study. BMJ 2015;350:h2698
Benzodiazepines should be conceptualized as a marker of risk

36. Prescription Opioids Deaths Among Women
Centers for Disease Control and Prevention. Prescription painkiller overdoses: A growing epidemic, especially among women. CDC
Vitalsigns July 2013; http://www.cdc.gov/vitalsigns/PrescriptionPainkillerOverdoses/

37. The Rising Tide
Washington Post – February 22, 2016
“Public Health Officials Petition FDA
To Add Boxed Warnings About
Concurrent Use Of Opioids,
Benzodiazepines.”
https://www.propublica.org/article/medicare-paid-for-nearly-40-million-tranquilizer-prescriptions-in-2013
Author: Charles Ornstein and Ryann Grochowski Jones. One Nation, Under Sedation: Medicare Paid for Nearly 40 Million Tranquilizer Prescriptions in 2013

38. The Pharmacist Role: Where to start?
Comprehensive Medication
Management

39. Health Literacy
Tracking American Health Literacy and Prescribing Improvement: Key findings from an independent survey
FEBRUARY 2015. https://about.itriagehealth.com/wp-content/uploads/2015/02/Health-Literacy-White-Paper_February-2015.pdf

40. Low Literacy increase the chances:
• Patients will choose more expensive treatment settings
• Choose more costly care
• Will Not understand cost implications of their healthcare choices
High School Graduate vs Advanced Degree
Private Insurance vs Medicaid
Health Literacy

41. No Judgement
The Pharmacist Role: Where to start?
Comprehensive Medication
Management

42. The Role of MTM
What is it? “Distinct service that optimizes therapeutic outcomes for individual
patients.”
Source: Bluml BM. J Am Pharm Assoc. 2005;45:566-72
How does the patient take it?
(Not the directions)
Why do they take it?
What is their goal of therapy?
Is it working?
Any side effects?
How many doses per day do they
feel they need and why?
Problem-Intervention
List problem with suggested
resolution
Encourage
Follow-up
Appointments
Know the available resources
Provide multiple
options
Communicate with Prescribers
Encourage use of
PDMP

43. Pharmacists Challenges in Intervention:
Making use of PDMPs
• Prescription Drug Monitoring Programs (PDMPs) - report
prescription drug distribution at the state level
• Health care entities and law enforcement are the primary
recipients of the information collected and stored through a
PDMP
• Currently, 49 states and Guam have operating PDMPs

44. A Case for Action
• 58 yo Male. Carpet Mill worker.
• Dx: T2DM, HBp, chronic abdominal pain
• Hx of multiple abdominal surgeries, small bowel resections
and peritonitis
• Presents to pharmacy with ER Rx for Oxycodone / APAP 10/325
• Prior Oxy/APAP fills at 4 different pharmacies from 6
prescribers, 3 ERs spanning 3 counties
Do you fill the prescription? What intervention do you recommend?

45. PDMPs and Pharmacists
• Research shows that pharmacists have a strong interest or
intention to use PDMPs1
• Green et al. reported that approx. 68% of CT pharmacists used
the PDMP - among nonusers 85% expressed interest2
• Doctor shopping detected by:
– insurance reject (76.6%), professional judgment (71.8%)
• Verify with prescriber (67%), PDMP (66.5%)
• Briefing on PDMP Effectiveness3
45
1Fleming ML, Barner JC, Brown CM, Shepherd MD, Strassels S, Novak S. Using the theory of planned behavior to examine pharmacists' intention to utilize a prescription drug
monitoring program database. Res Social Adm Pharm. Mar-Apr 2014;10(2):285-296.
2Green TC, Mann MR, Bowman SE, et al. How does use of a prescription monitoring program change pharmacy practice? J Am Pharm Assoc (2003). May-Jun 2013;53(3):273-
281.
3Prescription Montoring Programs Ctr of Excellence. Briefing on PDMP Effectiveness. 2013.

46. So What’s The Problem

47. Indiana Pharmacists
• Pharmacists were 6.4 times more likely to dispense fewer
controlled meds when frequently using the PDMP
• Pharmacists using the PDMP consistently refused to dispense
on average 18 more prescriptions
• Pharmacists that consistently use the PDMP were 3.3 times
more likely to refuse compared to PDMP nonusers.
Norwood CW, Wright ER. Integration of prescription drug monitoring programs (PDMP) in pharmacy practice: Improving clinical
decision-making and supporting a pharmacist's professional judgment. Res Social Adm Pharm. Mar-Apr 2016;12(2):257-266.

48. Pharmacists’ Actions When Suspected Abuse (n = 259)
Actions/Item
Frequency Distribution of Response Choices n (%)
Mean
(SD)
Strongly
disagree Disagree Neutral Agree
Strongly
agree
Notify law enforcement 2.9 (1.1) 37 (14.3) 42 (16.2)
114
(44.0)
41 (15.8) 25 (9.7)
Refuse to dispense the
prescription
4.4 (0.8) 4 (1.6) 1 (0.4) 21 (8.1) 99 (38.4)
133
(51.6)
Call the prescriber 4.5 (0.7) 1 (0.4) 5 (1.9) 14 (5.4) 89 (34.5)
149
(57.8)
Counsel patient about
addictions
3.0 (1.2) 35 (13.5) 47 (18.2) 91 (35.1) 50 (19.3) 36 (13.9)
Pharmacists should manage
opioid addiction
3.1 (1.3) 41 (16.0) 38 (14.8) 78 (30.4) 59 (23.0) 41 (16.0)
48
Fleming ML, Barner JC, Brown CM, Shepherd MD, Strassels SA, Novak S. Pharmacists' training, perceived roles, and actions associated with dispensing
controlled substance prescriptions. J Am Pharm Assoc. 2014;54(3):241-250.

49. Pharmacist-Patient Communication about Addiction and
Willingness to Counsel and Refer
• American Association of Colleges of Pharmacy New
Investigator Award
• To elicit the salient beliefs of Texas pharmacists regarding their
behavioral, normative and control beliefs concerning engaging
patients with aberrant prescription opioid use

50. Opioid/Pain Management Medication Therapy
Management
• Positive return on investment for many MTM initiatives1
• Pharmacist provider status
– Screening, Brief Intervention, and Referral to Treatment (SBIRT)
• Increased access to naloxone at pharmacies3
• Approximately 8 million prescriptions for
buprenorphine/naloxone dispensed from pharmacies4
– Pharmacists can play a key role in increasing access to medication-
assisted treatment (MAT)
50
1Dole EJ, Murawski MM, Adolphe AB, Aragon FD, Hochstadt B. Provision of pain management by a pharmacist with prescribing authority. Am J Health Syst Pharm. Jan 1 2007;64(1):85-89.
2Association AP. California provider status law effective January 1 2014; http://www.pharmacist.com/california-provider-status-law-effective-january-1. Accessed Jan. 6, 2014.
3Jones CM, Lurie PG, Compton WM. Increase in Naloxone Prescriptions Dispensed in US Retail Pharmacies Since 2013. Am J Public Health. Feb 18 2016:e1-e2.
4 Drugs.com. Suboxone Sales Data. Top 100 statistics 2013; http://www.drugs.com/support/citations.html. Accessed December 23, 2013.

51. Why is PDMP Use So Important?
• PDMP data analysis identified approximately 2,000 Medicaid
recipients with both cash paid and Medicaid paid prescriptions
on the same day
• 478 clients identified with both cash and Medicaid payments
less than 10 days apart for the same controlled drug
– 25% occurred on the same day
Prescription Drug Monitoring Program Center of Excellence at Brandeis. Using PDMPs to improve medical care: Washington state’s
data sharing initiative with medicaid and workers’ compensation. Walthan, MA: Brandeis University;2013

52. Conclusions
• PDMP use by pharmacists and patient intervention are
important factors toward mitigating abuse and diversion
• Lack of referral resources has been identified as a missing
component
• More training is need to move pharmacists from refusal to
opioid/pain management MTM (patient care)
• Private counseling areas and reimbursement may be key
components to progress
52

53. Looking Beyond Red Flags
Presenters:
• Nicholas Hagemeier, PharmD, PhD, Assistant Professor of Pharmacy
Practice, East Tennessee State University Gatton College of Pharmacy
• Marc Fleming, PhD, MPH, RPh, Assistant Professor, Pharmaceutical
Health Outcomes and Policy, University of Houston College of Pharmacy
• Kimberly Vernachio, PharmD, President, Vernachio Managed Care
Consulting
Pharmacy Track
Moderator: J. Kevin Massey, MS, Business and Program Development
Specialist, Weitzman Institute, Community Health Center, Inc., and
Member, Rx and Heroin Summit National Advisory Board