What Every Prescriber and Pharmacist Needs to Know About Addiction National Rx Drug Abuse Summit 4-10-12

1. What Every Prescriber and
Pharmacist Needs to
Know About Addiction
April 10-12, 2012
Walt Disney World Swan Resort

2. Learning Objectives:
1. Describe behavioral traits that can be used to
identify potential addicts and/or those engaged in
drug diversion.
2. Explain the role of prescribers and pharmacists in
opioid addiction intervention, support and
treatment.
3. Identify ways for prescribers and pharmacists to
differentiate between chronic pain patients
maintained on opioids and individuals addicted to
opioids.

3. Disclosure Statement
• All presenters for this session, Mr. Peter
Van Pelt and Dr. Elinore McCance-
Katz, have disclosed no relevant, real
or apparent personal or professional
financial relationships.

4. Thank You
Paul S. Harden, PharmD, CPE
Clinical Pharmacy Specialist, Pain Management
Philadelphia VA Medical Center
Kathryn L. Hahn PharmD, CPE, DAAPM
Affiliate Faculty, Oregon State University College of Pharmacy
Pharmacy Manager, BiMart Corp, Springfield, OR

5. Self-Assessment Questions
1. What percentage of opioid overdose deaths in 2007 had a
medical history of pain treatment?
a. 20% c. 40% b. 50% c. 75%
2. Admissions to substance-abuse treatment programs
increased by how much between 1998 and 2008?
a. 200% b. 300% c. 400% d. 500%
3. Pharmacists have access to the patients entire prescription
history.
a. True b. False
4. What percentage of pharmacists have point of care access
to addiction related resources?
a. 55% b. 35% c. 25% d. 15%

6. Addiction
• A primary, chronic, neurobiologic disease with
genetic, psychosocial and environmental factors
influencing its development and manifestions
The “4 Cs”
1. Loss of Control
2. Compulsion
3. Continued use despite adverse Consequences
4. Craving
Consensus Document: The American Academy of Pain Medicine,
The American Pain Society, The American Society of Addiction Medicine, 2001

7. Prevalence of Addiction
• General Population 3-16 %
(Zacny et al,2003)
• Chronic Pain Population 3.2%-18%
(Fishbain et al 1992)
• Hospitalized Population 19-25 %
(Savage,2003)
• Trauma Population 40-62%
(Doherty, 2000)

8. Prevalence of Addiction
% of Persons ages 12 or older with Dependence or Abuse
• ETOH 18.3 M 7.3%
• Marijuana 4.2 M 1.7%
• Illicit drugs 7.0 M 2.8%
• Pain Relievers 1.7 M 0.7%
• Cocaine 1.4 M 0.6%
• Cigarettes 59.8 M 23.9%
• All tobacco products 70.9 M 28.4%
Substance Abuse and Mental Health Services Administration (SAMHSA)

9. Scope of the Addiction Problem
• Prescription opioids caused 11,499 of the deaths in
2007 — more than heroin and cocaine combined
• Admissions to substance-abuse treatment programs
increased by 400% between 1998 and 2008
• Prescription painkillers are the second most
prevalent type of abused drug after marijuana
• In almost every age group, men have higher death
rates from drug overdoses than women
• About half of those who died had a medical history
of pain treatment
A Flood of Opioids, a Rising Tide of Deaths Susan Okie, M.D. N
Engl J Med 2010; 363:1981-1985

10. Trends in Emergency Department (ED) Visits
Involving the Nonmedical Use of Narcotic Pain
Relievers
• 2004 144,644
• 2005 168,376
• 2006 201,280
• 2007 237,143
• 2008 305,885
Substance Abuse and Mental Health Services Administration (SAMHSA)

11. Pharmacy Trends
According to the IMS report, the 10 most-prescribed drugs in the U.S. are:
1. hydrocodone/acetaminophen – 131.2 million Rx
2. simvastatin (Zocor), a cholesterol-lowering statin drug – 94.1 million Rx
3. lisinopril (Prinivil and Zestril), a blood pressure drug – 87.4 million Rx
4. levothyroxine sodium (Synthroid), synthetic thyroid hormone – 70.5
million Rx
5. amlodipine besylate (Norvasc), an angina/blood pressure drug – 57.2
million Rx
6. omeprazole (Prilosec), an antacid drug – 53.4 million Rx
7. azithromycin (Z-Pak and Zithromax), an antibiotic – 52.6 million Rx
8. amoxicillin, an antibiotic – 52.3 million Rx
9. metformin (Glucophage), a diabetes drug – 48.3 million Rx
10. hydrochlorothiazide, a water pill for blood pressure – 47.8 million Rx.
IMS Institute for Healthcare Informatics: “The Use of Medicines in the United
States: Review of 2010,” April 2011.

12. Pharmacy Trends
In the past week, what percentage of prescriptions were
identified as an early refill?
American Pharmacists Association. 2011 Early Refills Survey

13. Pharmacy Trends
For what type of products do you see early refills most
frequently? (Check up to three.)
American Pharmacists Association. 2011 Early Refills Survey

14. Behaviors Less Suggestive of
Addiction
• Aggressive complaining about the need for more drug
• Drug hoarding during periods of reduced symptoms
• Requesting specific drugs
• Openly acquiring similar drugs from other medical sources
• Unsanctioned dose escalation or other noncompliance with
therapy on one or two occasions
• Unapproved use of the drug to treat another symptom
• Reporting psychic effects not intended by the clinician
• Resistance to a change in therapy associated with “tolerable”
adverse effects with expressions of anxiety related to the
return of severe symptoms
Portenoy RK, Payne R. Acute and chronic pain. In Lowinson JH, Ruiz P, Millman
RB (eds): Comprehensive Textbook of Substance Abuse, 3rd Edition. Baltimore:
Williams and Wilkins; 1997

15. Behaviors More Suggestive of
Addiction
• Selling prescription drugs
• Prescription forgery
• Stealing or “borrowing” drugs from others
• Injecting oral formulations
• Obtaining prescription drugs from nonmedical
sources
• Concurrent abuse of alcohol or illicit drugs
• Multiple dose escalations or other noncompliance
with therapy despite warnings
Portenoy RK, Payne R. Acute and chronic pain. In Lowinson JH, Ruiz P, Millman
RB (eds): Comprehensive Textbook of Substance Abuse, 3rd Edition. Baltimore:
Williams and Wilkins; 1997

16. Behaviors More Suggestive of
Addiction (cont.)
• Multiple episodes of prescription “loss”
• Repeatedly seeking prescriptions from other
clinicians or from emergency rooms without
informing prescriber or after warnings to desist
• Evidence of deterioration in the ability to function at
work, in the family, or socially that appear to be
related to drug use
• Repeated resistance to changes in therapy despite
clear evidence of adverse physical or
psychological effects from the drug
Portenoy RK, Payne R. Acute and chronic pain. In Lowinson JH, Ruiz P, Millman
RB (eds): Comprehensive Textbook of Substance Abuse, 3rd Edition. Baltimore:
Williams and Wilkins; 1997

17. Opioid Treatment Agreements
• Describes Expectations and Obligations
• Sets Boundary Limits
• Allows for early identification and
intervention of aberrant behavior

18. Opioid Treatment Agreements
• Identifies one provider/team responsible for writing opioids
• All controlled substances must be obtained at the same pharmacy
• Patient is expected to inform provider of any new medications or medical
conditions, and of any adverse effects they experience from any of the
medications that you take.
• Medications may not be replaced if they are lost, get wet, are destroyed, left
on an airplane, etc.
• Early refills will generally not be given. Please do not phone for
prescriptions after hours or on weekends.
• Patient will not self-titrate the dose
• Agreement of urine drug testing
• Patient will safe guard medication from theft, loss, damage
• Parameters for which opioids will be discontinued
• Prohibits alcohol and illicit drug abuse
• Patient will keep scheduled appointments

19. Historical Background of
Treatment of Opioid Addiction
• Methadone treatment for opioid addiction approved in
1964
• Narcotic Treatment Act of 1974 limits methadone treatment
to specifically licensed Opioid Treatment Programs
• Drug Addiction Treatment Act (DATA) 2000-allows use of
approved Schedule III, IV or V medications for treatment of
opioid dependence
• Buprenorphine approved by FDA October 2002

20. Drug Abuse Treatment Act
(DATA) of 2000
• Allowed “Qualified” physicians to treat opioid dependence
outside methadone facilities
1. Addiction certification from approved organization, or
2. Physician in clinical trial of qualifying medication, or
3. Complete 8-hour course from approved organization
• DEA issues to qualifying physicians a new DEA number to use
medication for opioid dependence
• Can treat 30 patients at a time (100 after 1 year)
• As of today, only one medication formulation is approved for
this use...buprenorphine

21. Growing National Public Health Problem
Despite introduction of office-based treatment
for opioid addiction over a decade ago
(DATA 2000)
...the disease of addiction remains a
growing public health problem
...all health professionals have a role in
reducing problem and related harm
Alford DP, LaBelle CT, Kretsch N, et al. Collaborative care of
opioid-addicted patients in primary care using buprenorphine:
five-year experience. Arch Intern Med. 2011;171:425-31.

22. Growing National Public Health Problem
• White House Office of National Drug Control Policy 2011
National Drug Control Strategy:
- “seeks early intervention opportunities in healthcare”
- “integrate treatment for substance use disorders into
mainstream healthcare”
- “expand support for recovery”
• White House 2011 Interagency “Epidemic: Responding to
America’s Prescription Drug Abuse Crisis”
- education
- tracking and monitoring
- proper medication disposal
- enforcement
White House ONDCP 2011 National Drug Control Strategy

23. Prescription Drug Monitoring
Programs
• Opportunities
– Prescribers and pharmacists can access
data on prescription history
– Earlier detection of behaviors linked to
addiction, diversion, inadequate pain
control, etc.
– Transparency may offer access to better
pain control for legitimate persons with
pain

24. Prescription Drug Monitoring
Programs
• Challenges
– Not all states have them (yet)
– Not all state PDMP’s are interoperable
– Funding challenges
– Not in real time
– Low utilization by professionals
– May be limited access in the pharmacy

25. E-prescribing
• We are waiting for full implementation
for e-prescribing of controlled
substances
• There are efforts to better integrate Erx,
PDMP’s, and pharmacy operating
systems

26. REMS
• REMS are tied directly to prescriber
and patient education in the ONDCP
report
• REMS are in place to ensure continued
access to medications and to mitigate
risks
• The opioid REMS is focused on
education that focuses on
misuse, abuse, and addiction

27. What Role do Pharmacists Have in
National Public Health Problem?
APhA 2011 Needs Assessment Survey:
Pharmacists see
• 21 patients/wk avg regarding acute pain
• 19 patients/wk avg regarding chronic pain
• 7 patients/wk avg regarding addiction
American Pharmacists Association. 2011 Education Needs
Assessment Survey

28. Role of the Pharmacist in
Opioid Addiction Treatment
• Pharmacists are frequently faced with patients who are
seeking opioids for nonmedical purposes
• Pharmacists are challenged to differentiate among patients
who are seeking opioids
- for pain relief
- to misuse or abuse
- to divert
• Pharmacists are well positioned to identify patients whose pain
is undertreated, as well as those who have signs and
symptoms of opioid addiction.
Raisch DW, Fudala PJ, Saxon AJ, et al. Pharmacists' and technicians' perceptions and attitudes
toward dispensing buprenorphine/ naloxone to patients with opioid dependence. J Am Pharm
Assoc. 2005;45:23-32

29. Role of the Pharmacist in
Opioid Addiction Treatment
• Pharmacists can identify patients who may be
appropriate for treatment of opioid addiction and
make appropriate referrals
• Pharmacists have a role on the multidisciplinary
team supporting primary care practice
management of chronic opioids in complex
patients who are at risk for opioid abuse
• Pharmacists can play important roles in managing
opioid addiction

30. Treatment Options for
Opioid-Addicted Individuals
• Behavioral treatments educate patients about the
conditioning process and teach relapse prevention
strategies.
• Medications such as methadone and
buprenorphine operate on the opioid receptors to
relieve craving.
• Combining the two types of treatment enables
patients to stop using opioids and return to more
stable and productive lives.

31. Opioid Treatment: Changing Approach
Methadone Clinic Buprenorphine
• Criteria: • Criteria:
Withdrawal DSM IV
12 months use No time criteria
• Dose regulated • MD sets dose
• Age > 18 • Age > 16
• Limited take homes • Take homes (30 days)
• Counseling services • Counseling services must be
“required” “available”
Nicholls L, Bragaw L, Ruetsch C. Opioid dependence, treatment and guidelines. J Manag
Care Pharm 2010;16:S14-S21

32. Use The SAMHSA Physician Locator
Service To Find a Physician Authorized
To Prescribe Buprenorphine
www.buprenorphine.samhsa.gov.bwns_locator

33. Counseling Tips for Pharmacists with
Buprenorphine Patients
• Speak with the patient directly whenever possible
• Counsel patients about proper administration techniques,
adverse effects, and potential drug-drug interactions
• Ensure that the patient has an uninterrupted supply of
medication for opioid dependence
• Strongly encourage one pharmacy only
• Screen and refer patients with potential substance use
disorders to their primary care provider or local substance use
treatment program
DiPaula, B. Understanding Opioid Dependence: Therapeutic Options to Improve Patient Care. Found
at: https://secrue.pharmacytimes.com/lessons/201108-CS2.asp Accessed 2-11-12

34. Counseling Tips for Pharmacists with
Buprenorphine Patients
• Monitor refills for patients who have been prescribed
buprenorphine/naloxone. A suspicion of non-adherence might
be sufficient grounds for suggesting urine testing to the
prescriber
• Monitor for evidence of drug diversion
• Carefully monitor for potentially hazardous psychotropic co-
medications, such as benzodiazepines or carisprodol and other
muscle relaxants
• Signs of anxiety, depression, thought disorders or unusual
emotions, cognitions, or behaviors should be reported to
physician
DiPaula, B. Understanding Opioid Dependence: Therapeutic Options to Improve Patient Care.
Found at: https://secrue.pharmacytimes.com/lessons/201108-CS2.asp Accessed 2-11-12

35. Final Thought: Need vs. Utilization
Millions of
Users
MMT = Methadone Maintenance Treatment
OTP = Office-based Opioid Dependence Treatment
Buprenorphine Treatment: A Training for Multidisciplinary Addiction Professionals, ATTC.
Found at: http://www.nattc.org/explore/priorityareas/science/blendinginitiative/buptx/product_materials.asp, Accessed 2-11-12

36. Do you have point-of-care access to addiction-related
resources for patients who may need help with an
addiction issue?
American Pharmacists Association. 2011 Early Refills Survey

37. Self-Assessment Questions
1. What percentage of opioid overdose deaths in 2007 had a
medical history of pain treatment?
a. 20% c. 40% b. 50% c. 75%
2. Admissions to substance-abuse treatment programs
increased by how much between 1998 and 2008?
a. 200% b. 300% c. 400% d. 500%
3. Pharmacists have access to the patients entire prescription
history.
a. True b. False
4. What percentage of pharmacists have point of care access
to addiction related resources?
a. 55% b. 35% c. 25% d. 15%

38. Key Points