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8/31/2016
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Opioid Misuse: The Evolution of an Epidemic
Carrie Vogler, Pharm.D. BCPS
Clinical Associate Professor
SIUE School of Pharmacy
• The speaker has no actual or potential conflict of interest in relation to this presentation.
Learning Objectives
• Explain the scope and impact of the U.S. opioid epidemic.
• Outline state and federal efforts to support safe and effective treatment of pain while reducing opioid use disorders.
• Describe how pharmacists and pharmacy technicians can be involved in curbing the opioid epidemic.
• List resources for pharmacists, technicians, and patients for pain management and opioid abuse.
Meet Cassy
Definitions
• Aberrant drug taking behavior
• Misuse
• Abuse
• Diversion
• Opioid use disorder
• Dependence
• Addiction1.Webster LR, Fine PG. Approaches to improve pain relief while minimizing abuse liability. J Pain 2010; 11(7):602‐611.2. Centers for Disease Control and Prevention. Injury Prevention & Control: Opioid Overdose. http://www.cdc.gov/drugoverdose/opioids/index.html
Definitions• Aberrant drug taking behavior
– Any drug‐related behaviors other than taking the medication exactly as prescribed
• Misuse
– The use of a medication for therapeutic intent, other than exactly as directed by the prescriber
• Abuse
– The use of a substance for a non‐medical purpose to alter one’s state of consciousness
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Definitions
• Diversion
– Knowingly transferring a controlled substance to a recipient other than for whom the substance is prescribed
• Opioid use disorder
– A problematic pattern of opioid use that causes clinically significant impairment or distress. A diagnosis is based on specific criteria such as unsuccessful efforts to cut down or control use, as well as use resulting in social problems and a failure to fulfill obligations at work, school, or home.
Definitions
• Dependence
– A physiologic receptor response to an exogenous substance and the result from removing that substance
• Addiction (substance abuse disorder)
– Impaired control over drug use, compulsive use, continued use despite harm, cravings
A 50 year old male patient is currently taking oxycodone ER 20mg PO Q 8 hours and oxycodone IR 5mg q 4 hour prn back pain. He fills his prescriptions a few days early each month. His physician has tried to decrease his dose but the pain is uncontrolled at lower doses. His wife states that he doesn’t seem like himself at home and is constantly talking about when his next dose of pain medication is due. He keeps missing work due to fatigue.
How would you best describe this patient’s condition?
a. opioid use disorder
b. diversion
c. abuse
d. withdrawal
The scope and impact of the U.S. opioid epidemic
Statistically Significant Drug Overdose Death Rates Increase from 2013 to 2014, US
Centers for Disease Control and Prevention. Injury Prevention & Control:
Opioid Overdose. “State Data.” www.cdc.gov/drugoverdose/data/statedeaths.html
Too close to home…
• Chicago ranked first in the nation for the number of ER mentions of heroin
• In 3 years, Illinois had 900 heroin overdose deaths
• In 2012, 400 Illinois residents died of prescription drug overdoses, 81% involving opioid pain killers like oxycontin and hydrocodone
Davis C., Carr D. The Network for Public Health Law. Drug Overdose Prevention Fact Sheet. Illinois Overdose Prevention Legislation. 1‐5.
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Which of the following medications most commonly
causes drug overdose?
A. alprazolam
B. morphine IR
C. methadone
D. sertraline
Overdose Deaths Involving Only a Single Drug Class, 2010
16651
1717
6497
296
3889
1351
24
0 2000 4000 6000 8000 10000 12000 14000 16000 18000
Opioid Analgesics
Antiepileptic, Antiparkinsonism
Benzodiazepines
Barbiturates
Antidepressants
Antipsychotic, Neuroleptic
Other Psychotropic
Deaths
Psychotherapeutic an
d CNS Pharmaceuticals
Jones, C. M., Mack, K. A., & Paulozzi, L. J. (2013). Pharmaceutical Overdose Deaths, United States, 2010. JAMA : The Journal of the American Medical Association, 309(7), 657–659.
Age-adjusted rate of drug overdose deaths and drug overdose deaths involving opioids, US, 2000-2014
National Vital Statistics Mortality File. CDC (2016). Increases in Drug and Opioid Overdose Deaths‐United States, 2000‐2014. CDC MMWR, Centers for Disease Control and Prevention. 64: 1378‐1382. www.cdc.gov/drugoverdose/prescribing/guideline.html
• 249 million prescriptions for opioids were written by healthcare providers in 2013
Centers for Disease Control and Prevention. Injury Prevention & Control: Opioid Overdose. Drug Overdose Fact Sheet
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Why Can’t We Stop this Epidemic?Why Can’t We Stop this Epidemic?• Lack of coordination of approaches and resources• Lack of effective implementation of promising practices
• Failure to engage with local communities and across multiple stakeholders
• Failure to spread promising practices• Direct and indirect counter‐forces by the pharmaceutical industry
• Lack of awareness among patients and consumers of the danger of prescription opioids
Martin L, Laderman M, Hyatt J, Krueger J. Addressing the Opioid Crisis in the United States. IHI Innovation Report. Cambridge, Massachusetts: Institute for Healthcare Improvement; April 2016.
State and federal efforts to support safe and effective
treatment of pain while reducing opioid use
disorders.
Federal Funding $1.1 Billion for Prescription Opioid Abuse and Heroin Use Epidemic
50%46%
2% 2%Treatment for Prescription Drugand heroin abuse
Support States to expand access tomedication‐assisted programs
National Health Service Corpsfunding to expand access tosubstance use treatment providers
Evaluate medication‐assistedtreatment
Botticelli, Michael. Addressing the Epidemic of Prescription Opioid Abuse and Heroin Use. 2/21/2016. https://www.whitehouse.gov/blog/2016/02/01
FDA Opioids Action Plan
Expand advisory committees
Develop warnings and safety information for immediate‐release (IR)
opioid labeling
Strengthen post‐market requirements
Update Risk Evaluation and Mitigation Strategy (REMS)
program
Expand access to abuse‐deterrent
formulations (ADF) to discourage abuse
Reassess the risk‐benefit approval
framework for opioid use
Support better treatment
Fact Sheet‐FDA Opioids Action Plan www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM484743.pdf
Guideline for Prescribing Opioids for Chronic Pain in the
US, 2016• Primary care clinicians
• Team‐based care
• Treatment for patients >18 with chronic non‐cancer pain
• Lack of long term studies using opioids > 1 year or longer
Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for ChronicPain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR‐1):1–49.
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Guideline for Prescribing Opioids for Chronic Pain Methods
• GRADE methodology
– Type 1‐4:
Does not imply the
strength of the
recommendation
‐Category A or B
4: Experience, OS,RCT
several limitations
3: OS or RCT with notable limitations
2: RCT with important limitations, or strong evidence
from OS
1 = RCT or overwhelming evidence from OS
RCT=randomized clinical trialsOS= observational studies
Guideline for Prescribing Opioids for Chronic Pain in the US, 2016
• 1‐3
Determining when to initiate or continue opioids for chronic pain
• 4‐7
Opioid selection, dosage, duration, follow‐up, and discontinuation
• 8‐12
Assessing risks and addressing harms of opioid use
Determining when to initiate or continue opioids for chronic pain
1. Use nonpharmacologic and nonopioid therapy first
2. Before starting opioids, discuss treatment goals with patients
– functional status
– pain control
3. Discuss risks and benefits with patients at start and periodically
Opioid selection, dosage, duration, follow-up, and discontinuation
4. Use immediate release opioids instead of ER/LA opioids
5. Prescribe lowest effective dosage.
–Caution when increasing dose to >50 morphine milligram equivalents (MME)/day
–Avoid increasing dosage to 90 MME/day
Opioid selection, dosage, duration, follow-up, and discontinuation
6. Prescribe 3 days of opioid therapy for acute pain, more than 7 days is rarely needed
7. Monitor benefits and harms within 1‐4 weeks and then every 3 months
Assessing risks and addressing harms of opioid use
8. Mitigate risk and consider offering naloxone:
–history of overdose
–history of substance use disorder
–higher opioid dosages (> 50MME/day)
–Concurrent benzodiazepine use
9. Review Prescription Drug Monitoring Program (PDMP)
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Assessing risks and addressing harms of opioid use
10. Urine drug testing prior to starting opioid therapy and at least annually*
11. Avoid concurrent benzodiazepines with chronic opioid therapy.
12. Offer and arrange medication‐assisted treatment for opioid use disorder
Based on the CDC Guidelines for Prescribing Opioids for Chronic
Pain, which of the following statements is true?
a. There are several long term studies that prove opioids can provide benefit for patients
b. Benzodiazepines are safe to use with high dose opioids
c. Reviewing the Prescription Monitoring Program is required before filling prescriptions
d. Patients taking morphine ER 50mg PO BID should be offered a prescription and training for naloxone
How can pharmacists and technicians help?
• 1‐3
Determining when to initiate or continue opioids for chronic pain
• 4‐7
Opioid selection, dosage, duration, follow‐up, and discontinuation
• 8‐12
Assessing risks and addressing harms of opioid use
U.S. Department of Health and Human Services
National Pain Strategy (NPS)Purpose: Build off Institute of Medicine 2011 Report to “increase recognition of pain as a significant health problem in the U.S.”
Develop a Federal Pain Research Strategy to complement the NPS
NINDS. (2015). National Pain Strategy: A Comprehensive Population Health‐Level Strategy for Pain, 1–72.
Key Areas Addressed in the National Pain Strategy
• Population research
• Prevention and care
• Disparities
• Service delivery and payment
• Professional education and training
• Public education and communication
Key Areas in the National Pain Strategy where Pharmacists can Help• Research • Develop nationwide team‐based pain self‐management programs
• Pharmacists can help educate:– Patients
• More clinician time with patients and less prescription opioid use
– Health care providers• Training on safe opioid prescribing practices• Risks associated with prescription analgesics• Tapering opioid therapy • Alternative options for pain control
– Students
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Working Groups
• Problem
• Objective
• Short term, medium term, and long‐term strategies and deliverables
• Federal stakeholders
• Collaborators
HCAHPS Pain Management Score• Proposed removal of pain from scoring formula used by Hospital Value‐Based Purchasing Program for FY 2018
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) CAHPS 2.0 Adult Core Questionnaire‐ HCAHPS.
www.hcahpsonline.org
Resources for pharmacists, technicians, and patients for
management and opioid abuse• Stop Overdose IL
www.stopoverdoseil.org
• ASHP Foundation Principles of Pain and Pain Management
http://www.ashpfoundation.org/painmanagement
• Prescribe to Prevent: Prescribe Naloxone, Save a lifewww.prescribetoprevent.org
• Medicare Part D Opioid Drug Mapping Toolhttps://www.cms.gov/Research‐Statistics‐Data‐and‐Systems/Statistics‐Trends‐and‐Reports/Medicare‐Provider‐Charge‐Data/OpioidMap.html
Lali’s Law: PA99-0480 Heroin and Opioid Overdose Prevention
• Dispensing of naloxone by pharmacists to first responders and other non‐health care providers
• Approved training programs must be established and conducted prior to naloxone being dispensed or acquired
• You and overdose victim are covered by the Good Samaritan Law
Illinois Department of Public Health Public Act 099‐0480.http://www.ilga.gov/legislation/publicacts/99/099‐0480.htm
Signs of an Opioid Overdose
Slow or shallow breathing
Gasping for air
Pale or bluish skin
Person is unresponsive
Dispensing Naloxone
Illinois Pharmacists Association. Illinois State Opioid Antagonist Training.http://www.ipha.org/isoatp‐registration
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A pharmacist completes an approved training program for dispensing naloxone. A patient that you dispensed naloxone for dies from a drug overdose. What happens to the pharmacist?
a. Criminal prosecution for dispensing naloxone to a layperson
b. License Termination
c. No prosecution due to the Good Samaritan Law and Pharmacy Practice Act
Screening Controlled Substances for Legitimacy:
The VIGIL SystemVerification Is this a responsible opioid user?
Identification Do I know for sure who this person is?
Generalization Do we agree on mutual responsibilities and expectations?
InterpretationDo I now feel comfortable allowing this person to have a
controlled substance?
Legalization How can I stay squeaky clean in meeting my legal requirements?
Brushwood, D. B. Screening Controlled Substance Prescriptions For Legitimacy : The VIGIL System.
Where can pharmacists review comprehensive controlled substance prescription information for a specific patient?
a. Primary care physicians’ office
b. Center for Medicare and Medicaid Services (CMS)
c. Illinois Prescription Monitoring Program (ILPMP)
d. Community Pharmacy
Illinois Prescription Monitoring Program
Illinois Prescription Monitoring Program. www.ilpmp.org
What can we do?• Retrain providers• Consider all providers• Identify alternative treatment options for pain management
• Create a role for pharmacists and retail pharmacy “corresponding responsibility”
• Engage in public messaging• “Flood the zone”• Recognize geography is important• Include law enforcement
Martin L, Laderman M, Hyatt J, Krueger J. Addressing the Opioid Crisis in the United States. IHI Innovation Report. Cambridge, Massachusetts: Institute for Healthcare Improvement; April 2016.
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Describe how pharmacists and pharmacy technicians can be involved
with curbing the opioid epidemic.
• Write down one thing that you can do to help prevent another opioid overdose.
Opioid Misuse: The Evolution of an EpidemicCarrie Vogler, Pharm.D. BCPSClinical Associate ProfessorSIUE School of Pharmacy
What questions can I answer for you?
