What Every Prescriber and Pharmacist Needs to

Know About Addiction April 10-12, 2012

Walt Disney World Swan Resort

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.

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.

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

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%

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

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)

Prevalence of Addiction

•  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%

% of Persons ages 12 or older with Dependence or Abuse

Substance Abuse and Mental Health Services Administration (SAMHSA)

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

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)

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.

Pharmacy Trends In the past week, what percentage of prescriptions were identified as an early refill?

American Pharmacists Association. 2011 Early Refills Survey

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

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

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

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

Opioid Treatment Agreements

•  Describes Expectations and Obligations •  Sets Boundary Limits •  Allows for early identification and

intervention of aberrant behavior

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

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

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

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.

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

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

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

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

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

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

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

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

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.

Opioid Treatment: Changing Approach

Methadone Clinic Buprenorphine •  Criteria:

Withdrawal 12 months use

•  Criteria: DSM IV No time criteria

•  Dose regulated •  MD sets dose

•  Age > 18 •  Age > 16

•  Limited take homes •  Take homes (30 days)

•  Counseling services “required”

•  Counseling services must be “available”

Nicholls L, Bragaw L, Ruetsch C. Opioid dependence, treatment and guidelines. J Manag Care Pharm 2010;16:S14-S21

Use The SAMHSA Physician Locator Service To Find a Physician Authorized

To Prescribe Buprenorphine

www.buprenorphine.samhsa.gov.bwns_locator

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

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

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

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

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%

Key Points