1. Methadone and Pain Prescribing
Cynthia Reilly, The Pew Charitable Trusts
Dr. Kim Wentz, Oregon Health Authority
Nancy Nesser, Oklahoma Health Care Authority
Medicaid National Meeting on Prescription Drug Abuse and Overdose
February 1, 2016

2. Director, Prescription Drug Abuse The Pew Charitable Trusts
Methadone for Pain
Cynthia Reilly
Director, Prescription Drug Abuse
The Pew Charitable Trusts

3. Methadone Use by State
Centers for Disease Control and Prevention, “Vital Signs: Prescription Painkiller Overdoses: Use and Abuse of Methadone as a Painkiller,”

4. Methadone-related Deaths
According to a CDC analysis of data from 13 states, methadone was implicated in 40 percent of deaths that involved only one opioid—more than double the deaths attributed to any other drug in its class and more than all the deaths attributed to these other drugs combined.
The Pew Charitable Trusts, “Prescription Drug Abuse Epidemic: Methadone,“ (2014),

5. Risks of Methadone Used for Pain
Verbatim text from our methadone fact sheet:
Methadone’s unique properties distinguish it from other opioid drugs. Pain relief from methadone lasts four to eight hours, but its effects on other organs, such as the lungs and heart, can continue for eight to 59 hours. As a result, patients may put themselves at risk by taking more of the drug before the original dose has been fully metabolized. When taken too often or at too high a dose, methadone can cause life-threatening respiratory depression and heart rhythm or heart rate abnormalities. Other commonly prescribed drugs, such as anxiety medications, can amplify these effects.
The Pew Charitable Trusts, “Prescription Drug Abuse Epidemic: Methadone,“ (2014),

6. Harms Associated with Methadone Use
Tennessee
46 percent increased risk of overdose death as compared to those who received an alternative therapy1
North Carolina
Almost a third of unintentional overdose deaths attributed to methadone2
Washington state
Methadone involved in 64 percent of prescription opioid overdose deaths between 2004 to 20073
1 Ray W, et al., “Out-of-Hospital Mortality Among Patients Receiving Methadone for Noncancer Pain.” JAMA Intern Med. 2015;175(3):420-7.
2 Whitmire JT and Adams GW, “Unintentional Overdose Deaths in the North Carolina Medicaid Population: Prevalence, Prescription Drug Use, and Medical Care Services,” State Center for Health Statistics Studies, no. 162 (2010),
3 Centers for Disease Control and Prevention, “Overdose Deaths Involving Prescription Opioids Among Medicaid Enrollees—Washington, ,” Morbidity and Mortality Weekly Report 58 no. 42 (2009): 1171–75,

7. Stakeholder Activities and Strategies

8. How Oregon Addressed Prevention of Methadone Overdose and Death
Oregon Health Authority
Kim Wentz, MD, MPH Medicaid Medical Director
Lisa Millet, MSH Injury and Violence Prevention Manager, Public Health

9. Introduction
How Oregon defined the problem, designed the intervention to address it, implemented the intervention, and evaluated the results of the intervention

10. Process
Epidemiology
Collaboration
Policy Change

11. Defining the Problem Our Medicaid population and program
Post expansion in 2013: 500,000 to over 900,000 members
25% of Oregonians are Oregon Health Plan members
115,000 FFS: 85, ,000 Duals
16 CCOs: over 800,000
25% of Oregonians received an Rx opioid painkiller 2013
20% of Oregonians live with chronic pain

12. Prioritized List Health Evidence Review Commission
Uses MED and CEBP, Cochrane, AHRQ, NICE, etc.
Prioritized List: conditions
#1 is pregnancy
Funding line dependent on revenue: 465 in 2016
Methodology
Covers conditions and certain treatments: e.g.backpain
Does not include drugs!

13. Pharmacy Program
Drug treatment is covered for all covered conditions on the Prioritized List
The Pharmacy and Therapeutics Committee (PnT) determines coverage for FFS
16 CCOs determine their own drug coverage, and are required to meet the needs of all the covered conditions
PnT sets the precedent for CCOs, but not binding, no state formulary
PnT has provider prevails language

14. Public Health Investigation
Epidemiology
Matt Laidler, MPH, Injury Prevention Epidemiologist created a special report for the OHA-wide Prescription Opioid Overdose Prevention work-group
Objectives:
Magnitude and Trends of sales, morbidity, and mortality
Relative Rates by drug and drug type

15. Data Deaths from death records – state vital statistics
Combined unintentional and undetermined deaths involving drugs
Excluded suicide and homicide
Used Drug Abuse Warning Network (DAWN): medical examiner component
Drug
PDMP: does NOT include methadone for MAT
Automation of Reports and Consolidated Orders System (ARCOS)
Not able to differentiate Methadone for pain from Methadone for Medication-Assisted Treatment (MAT)

16. Collaboration
OHA’s Public Health Division (PHD) with the Division of Medical Assistance Programs (DMAP) which administers Oregon Health Plan (OHP; Medicaid)
PHD thoroughly explored mortality data to find drivers of the epidemic (e.g. Methadone)
2010 Workgroup:
Addictions and Mental Health (AMH) + PH + Oregon Board of Pharmacy + DMAP
Examined data on overdose, diversion, and addiction
Made recommendations to DHS/ OHA leadership
Recommended to remove Methadone from the Preferred Drug List (PDL) for FFS

17. Oregon Opioid Initiative Partnership
Oregon Health Authority
Oregon Health Leadership Council
Health Systems
Oregon Coalition for the Responsible Use of Meds
State Policy Makers & Statues
OHSU & NW Addictions Technology Transfer Center
Coordinated Care Organizations
Opioid Use Disorder Treatment Programs
Local Public Health Departments
Public Safety
Emergency Departments
Pain Management Clinics
Substance Abuse & Mental Health Services Administration
Department of Justice
Center for Disease Control & Prevention
There is a broad partnership working in many sectors.
At present, community level and policy level efforts are coordinated through the Oregon Coalition for Responsible Use of Meds.
Local communities and regions are launching initiatives in partnership with health systems and CCOs
The efforts under consideration by the OHLC are considered key to statewide success in reducing overdose, and improving patient care and safety.

18. A Look Back…
In 2008, Oregon’s Injury Prevention Program began analyzing state vital records and medical examiner data to better understand the factors driving an increase in poisoning deaths
Unlike other injuries, poisonings seemed to be increasing considerably between 2000 and 2006.

19. A Look Back… 95% of poisoning deaths involved drugs/ medicines
Most of the increase was explained by deaths related to narcotics
Unlike other injuries, poisonings seemed to be increasing considerably between 2000 and 2006.
*Age-adjusted rates per 100,000
† Includes drugs such as aspirin, acetaminophen, and other antipyretic or antirheumatic drugs, prescription and OTC
‡Includes antiepileptic, sedative-hypnotic, antidepressant, antipsychotic, and other psychotherapeutic drugs
 Includes heroin, opioid analgesics (e.g oxycodone), and cocaine
  Drug deaths attributable to more than one of the above categories and deaths attributed to "drug overdose" on death certificates
‡‡ Includes corrosives, metals, plants, and detergents

20. Results
In 2006, 64% of all drug overdose deaths in Oregon involved Rx opioids
Of those, 58% involved Methadone
Prior to 2000, deaths associated with Methadone were uncommon in Oregon

21. Decedents in methadone overdose
30% were not prescribed methadone
77% misused or abused the methadone
75% history substance abuse
21% had received SUD treatment
52% history mental illness

22. Unintentional Overdose Mortality Rate Per 100,000 by Narcotic Type: Oregon, 1999-2006
Percent change in unintentional overdose rate:
Methadone: 531%
Other opioids (not heroin or Methadone): 434%
Heroin: -14%
Cocaine: 21%
Unlike other injuries, poisonings seemed to be increasing considerably between 2000 and 2006.
Some deaths involve multiple drugs; drug-specific rates may represent individuals counted in more than one drug category, where multiple drugs were associated with an overdose death.

23. In 1999, methadone represented 3% of all deaths due to poisoning by medications and drugs; in 2008, methadone represented 33% of all deaths due to poisoning by medications and drugs in Oregon (Figure 3) and 62% of all deaths involving prescription opioid analgesics. The rate of death associated with methadone poisoning has increased from 0.2 deaths per 100,000 in 1999 to 3.6 deaths per 100,000 in 2008—an increase of 1,700%. There were less than 10 methadone-associated poisoning deaths in 1999; in 2008, there were 134 (Figure 3).

24. Retail Distribution of Methadone and Methadone Overdose Mortality Rate: Oregon, 1999-2006
Unlike other injuries, poisonings seemed to be increasing considerably between 2000 and 2006.

25. Policy Change FFS Pharmacy: Prior authorizations: Preferred Drug List:
Dose threshold > 100 mg/d
Retro DUR letters to prescribers > 40 mg/d
New starts Methadone as pain killer > 20 mg/d
Deny if opioid naiive, allow transfer
Start low, increase only slowly
Preferred Drug List:
Made NonPreferred

26. The Decline of Methadone
Between 2006 and 2014, the rate of death associated with Methadone overdose declined 66%
Methadone overdose deaths:
140 in 2006
52 in 2014
Unlike other injuries, poisonings seemed to be increasing considerably between 2000 and 2006.

27. Other Possible Factors
Increased prescriber awareness of Methadone lethality and problematic combinations (benzodiazepine)
Prescribing guidelines
Better public information on Rx drug overdose epidemic
Research (e.g. Methadone and QTc prolongation)
FDA Alert 2006
CMS
Oregon Prescription Drug Monitoring Program (PDMP) 2011

28. Conclusions In-depth epidemiologic investigation was key
Find state-specific drivers
Collaboration within OHA: PH with HSD, was crucial
Do-able policy steps in OR: PDL, PAs
Evaluation late 2016 or 2017

29. Oklahoma’s Utilization Controls and Pain Management Program
Nancy Nesser
Pharmacy Director, Oklahoma Health Care Authority

30. Front-end Edits and Utilization Control Tools
Quantity limits
No more than 4 per day
Early refill limit
75% of the medication must be used before refill
Some states tighter on controlled substances (90%)
Cumulative early refill
Step therapy
Establish use with lower doses first

31. More Utilization Controls
Pharmacy and Prescriber Lock-in program
ProDUR edit on hydrocodone
Annual Rx limit on hydrocodone
Prescriber file clean up
Prefer abuse deterrent formulations

32. Step Therapy Opioid Analgesics
Tier 1 – generic immediate release – no PA needed
Tier 2 –
Short acting – Moderate priced brands
Long Acting – Generics and preferred brands
Tier 3 –
Short acting – Non preferred brands
Long acting – Non preferred brands
Oncology-only tier
Transmucosal Immediate Release Fentanyl

35. Results 12% Decrease in number of short-acting opioid claims
304,388 units of opioids unavailable for diversion or overdose per month
3.6 Million Units less per year

36. 35% of the state’s rx opioid-related deaths were Medicaid members

38. Further info on Pharmacy Edits
Keast S, Nesser N, Farmer K. Strategies aimed at controlling misuse and abuse of opioid prescription medications in a state Medicaid program: a policymaker’s perspective. Am J Drug Alcohol Abuse, 2015; 41(1): 1-6

39. SoonerCare Pain Management Program
Designed to equip SoonerCare providers with the knowledge and skills to appropriately treat members with chronic pain.
To accomplish this, the Oklahoma Health Care Authority (OHCA) has developed a prescriber’s toolkit.

40. SoonerCare Pain Management Program
Two practice facilitators will implement the components of the toolkit within selected SoonerCare practices.
Two behavioral health resource specialists will assist in linking members with substance use disorder or other behavioral health needs to the appropriate treatment.

41. Toolkit Contents Treatment protocols
Oklahoma Opioid Prescribing Guidelines
Office visit forms
Patient handouts
Monitoring recommendations
Screening tools
Journal articles

42. Treatment Protocols For new patient visit:
Obtain and review previous medical records
Initial history and physical
New patient pain assessment
Behavioral health screening
Substance use risk assessment
Prescription Monitoring Program
Patient-provider agreement
Patient education handouts
Non-opioid options
Initiate opioid therapy per the Oklahoma Opioid Prescribing Guidelines

43. Treatment Protocols For an established/subsequent patient visit:
Pain assessment documentation tool
Physical assessment
Prescription Monitoring Program
Random urine drug screen
Random pill counts
Non-opioid options
Initiate/Continue opioid therapy per the Oklahoma Opioid Prescribing Guidelines

44. Contact Info
SoonerCare Pain Management Program Contact: 
Jaclyn Mullen, RN BSN

45. Questions ?