Learning objectives The Primary Care PA Role in the ......• M Szalavitz book “Unbroken Brain”...

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© American Academy of PAs. All rights reserved. These materials may not be duplicated without the express written permission of AAPA.

The Primary Care PA Role in the Treatment of Opioid

Use Disorder (OUD)

Alison Lynch, MD, MS, Clinical Professor of Psychiatry and Family Medicine, University of Iowa, Carver College of Medicine

andAdam Peer, BBA; AAPA Director of Constituent Organization Outreach and

AdvocacyOctober 8, 2018


Learning objectives

At the end of this session, participants should be able to:

• Review epidemiology, prevention, diagnosis, complications and evidence based guidelines for management of opioid use disorder (OUD)

• Review commonly used medications to assist with withdrawal and sobriety

• Demonstrate an increased awareness of the treatment of OUD• Identify barriers encountered in providing medication assisted

treatment (MAT) services• Identify compliance issues before engaging in efforts to increase

access to MAT


ARS Question: Who’s Here and Why

A. I already work to treat patients who have addiction issues

B. I want to work with patients who have addiction issues

C. I am here because of state CME requirements

D. I am trying to avoid patients who have addiction issues


A. Withdrawal

B. Tolerance

C. Craving

D. Recurrent Legal Trouble

ARS Question: According to DSM-5, in order to be diagnosed with OUD, you need all of the following EXCEPT:

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6. Continued use despite having problems7. Activities given up to use8. Use of substance when it is physically hazardous9. Use despite knowing it’s a problem10. Tolerance11. Withdrawal

DSM-5 (2013)1. Substance taken in larger

amounts than intended2. Persistent desire or can’t cut

down3. Time is spent obtaining,

using, recovering4. Craving5. Failure to fulfill obligations

http://www.samhsa.gov/disorders/substance-useDSM 5, 2013; pg 481-589 http://bit.ly/1U8FX04

Criteria for Diagnosis of SUD


Substance Use Disorders

• DSM IV to DSM 5

• No longer dependence & abuse à Substance Use Disorders (SUD)• Intoxication, Withdrawal, Substance induced disorders

• Elimination of recurrent legal problems

• Addition of craving or strong desire to use

• Only need 2 of the criteria• Mild (2-3 criteria), Moderate (4-5), Severe (6+)• Early Remission is 3-12 months of sobriety, Sustained Remission >12m

http://bit.ly/1U5b7VZ DSM 5 changes


What is Addiction?

• Reward Pathway• Ventral Tegmental Area (VTA)• Connected to the Nucleus Accumbens (NAc) and the Prefontal Cortex (PFA)• Communicates via Dopamine (DA)

• Psychological vs Physical Addiction• Vietnam War – 20% à 5% • “Outsourcing control of behavior to the environment” • Triggers, e.g. a place where a person has often used heroin stimulates cravings

• Some argue disease of human connection • Rat Park—social environment over morphine• J Hari book “Chasing the Scream”

• Others say developmental/learning disorder (and not “tough love”) • M Szalavitz book “Unbroken Brain”

http://bit.ly/29JUr7Dhttp://n.pr/2BFWgymhttp://bbc.in/1uDPRvNhttps://tinyurl.com/y7s9ghhdhttps://tinyurl.com/ybn7b44f


• At baseline, dopamine increases in response to natural rewards such as food, sex, video games, etc.

• When drugs that alter dopamine are used, the brain becomes less sensitive to the effects of dopamine (and more is needed to achieve pleasure or a high)

• Drug effects on dopamine activity• Increase release of dopamine (cocaine, stimulants, nicotine)• Mimic dopamine activity by activating receptors (opioids, marijuana,

nicotine)• Block inhibitory signals to dopamine-secreting neurons (opioids,

alcohol)• Reduce metabolism of dopamine (nicotine)• Block dopamine reuptake (cocaine, stimulants)

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How addiction works

http://www.samhsa.gov/disorders/substance-use

http://bit.ly/1U8FX04

http://bit.ly/1U8FX04

http://bit.ly/1U5b7VZ

http://bit.ly/29JUr7D

http://n.pr/2BFWgym

http://bbc.in/1uDPRvN

https://tinyurl.com/y7s9ghhd

https://tinyurl.com/ybn7b44f

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Risk Factors

• Family history (genetics, epigenetics)• 50% genetic risk • Intra-uterine stress exposure

• Age of first use• Includes tobacco• Method

• History of trauma• ACE Study

http://bit.ly/2aWFS07http://bit.ly/1SsllNahttps://www.cdc.gov/violenceprevention/acestudy/


A. Homicides

B. Suicides

C. Car Accidents

D. Breast Cancer

E. All of the above

ARS Question: In 2016 deaths related to drug overdoses exceeded


Opioid Deaths

• 2017: ALL drug overdose deaths 72,306 (63,600 in 2016)

• National overdose deaths in 2017• 49,068 involved an opioid (42,249 in 2016)• 29,406 deaths involving a non-methadone

synthetic opioid, predominantly fentanyl • 115 opioid overdose deaths/day (NIDA,

March 2018)

• 5 states with highest death rates (2016): WV, OH, NH, PA, KY (Iowa is #46)

2016 Data (previous question)

Homicides 17,793Suicides 44,193

Car Accidents 37,757

Breast Cancer 41,211

https://www.cdc.gov/drugoverdose/data/analysis.html

© American Academy of PAs. All rights reserved. These materials may not be duplicated without the express written permission of AAPA.12

https://www .drugabuse.gov/re lated -top ics/trends-statistics/overdose-death -rates

http://bit.ly/2aWFS07

http://bit.ly/1SsllNa

https://www.cdc.gov/violenceprevention/acestudy/

https://www.cdc.gov/drugoverdose/data/analysis.html

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But we’re working on it, right?

• 14 states saw a decline in opioid related deaths between July 2016-July 2017• Wyoming, Utah, Washington, Alaska, Montana, Mississippi, Kansas, Rhode Island,

Oregon, California, Tennessee, Massachusetts, Arizona and Hawaii• Probably due in part to increased availability of Naloxone

• But 5 states + Washington DC saw 30% spikes in deaths in same time period (and 70% increase in opioid overdoses in the midwest—IN, IL, MI, MN, OH, WI, IA, KA, MO, NE)

• As we cut down on prescribing, it ends up pushing people towards heroin

http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2018/02/22/overdose-deaths-fall-in-14-stateshttps://www.cdc.gov/mmwr/volumes/67/wr/mm6709e1.htm#T1_down


What can I do?


A. DAST

B. COWS

C. DSM-5 Level 1 or 2 Cross Cutting

D. SBIRT

E. I don’t regularly screen for SUD

ARS Question: Which of the following screening tools do you most often use?


Screening

• DAST, AUDIT• Substance specific screening tools available (e.g. CAGE)

• DSM 5 Level 1 à Level 2

• SAMHSA à SBIRT

• NIDA Screen à Ask, Advise, Assess, Assist, Arrange• Comparison of screening tools http://bit.ly/1MR43oA

• Especially recommend screening before initiating opioid treatment

• COWS- Clinical Opioid Withdrawal Scale• Used when initiating treatment

http://bit.ly/29H1cr3http://www.samhsa.gov/sbirthttp://bit.ly/29LD2dmhttps://www.ncbi.nlm.nih.gov/pubmed/28981581

http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2018/02/22/overdose-deaths-fall-in-14-states

http://bit.ly/1MR43oA

http://bit.ly/29H1cr3

http://www.samhsa.gov/sbirt

http://bit.ly/29LD2dm

https://www.ncbi.nlm.nih.gov/pubmed/28981581

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A. Clonidine

B. Varenicline

C. Gabapentin

D. Buprenorphine implant

ARS Question: Which of the following is FDA approved for opioid use disorder?


FDA Approved for Medication Assisted Treatment (MAT)

• Methadone• ONLY in OTP (opioid treatment program)

• Buprenorphine• Office-based treatment• Sublingual or buccal, pills or film, 2-24 mg daily• Combined with naloxone (Suboxone, Zubsolv, Bunavail)• Often used alone in pregnancy (Subutex)• Want patient in mild to moderate withdrawal before starting• Must have a waiver from the DEA to prescribe for treatment of OUD

• 8-24 hours of training required

• Naltrexone• Opiate free 7-10d before starting• Pill (ReVia)• Monthly injection (Vivitrol)


Buprenorphine Still Blocks Opioids as It Dissipates

C o u rte sy o f N A A B T , In c . (n aab t.o rg )

Imperfect Fit – Limited Euphoric Opioid Effect

BuprenorphineOpioid

Empty Receptor

Withdrawal Pain

Receptor Sends Pain Signal to the Brain

Perfect Fit - Maximum Opioid Effect

Euphoric Opioid EffectNo Withdrawal Pain


Buprenorphine Implant and Injection• Injection• FDA approved 2017• Once monthly depot injection• Need DEA X waiver to order

• Have to complete training program

• Equivalent to “8 to 24mg” of SL buprenorphine

• Monthly SC injection (in abdomen)

• Implant• FDA approved in 2016• DO NOT need DEA X waiver

to insert• Have to complete training

• Equivalent to 8mg of SL buprenorphine

• 4 rods in one arm x 6 months• May repeat in other arm• Can taper with PO meds

after removing rods permanently

https://probuphinerems.com/https://www.sublocaderems.com/

https://probuphinerems.com/

https://www.sublocaderems.com/

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Symptomatic Treatments for Withdrawal

Most often studied for withdrawal but theoretically may also be helpful for continued sobriety

• Clonidine• Lofexedine• Imodium• Tylenol • Zofran• Gabapentin• Topiramate • Tizanidine, hydroxyzine• Baclofen

Treat the underlying

issues

Detox is NOT a long term solution

Clonidine http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002021.pub4/full Lofexidine https://www.empr.com/drugs-in-the-pipeline/lofexidine-opioid-withdrawal-symptoms-management-priority-review-nda/article/708988/Tizanidine, hydroxyzine https://www.ncbi.nlm.nih.gov/pubmed/28795846 Baclofen http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007775.pub2/full Ketamine http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002022.pub3/full


Naloxone – Overdose Treatment

• Standing orders for Naloxone exist in all states as of July 2017

• Several different delivery routes (IV, IM, nasal)• May need to write Rx to get specific formulations for patients

• Recommended to write Rx for naloxone if prescribing opiates, benzodiazepines or you know your patient to take these meds

• Good Samaritan Laws (immunity or other legal protections for people who call for help in the event of an overdose) in 45 states (including Iowa)

http://pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139https://pharmacy.iowa.gov/sites/default/files/documents/2016/11/iowa_naloxone_brochure_final_0.pdf https://www.samhsa.gov/capt/sites/default/files/resources/good-samaritan-law-tool.pdf


What else do you need? • Wrap around services

• Housing, food, shelter, transportation, IPV/CPS, education, job, case management

• THERAPY• Counseling – individual or group• Recovery orientated services• Mutual support groups such as AA/NA

• Overdose Prevention• Patient/prescriber education, videos and additional

materials at Prescribe to Prevent

• Integrated care• SAMHSA Integrated Care www.integration.samhsa.gov


Maslow’s Hierarchy of Needs

https://www.flickr.com/photos/dullhunk/9730894552


What’s the law say?

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002021.pub4/full

https://www.empr.com/drugs-in-the-pipeline/lofexidine-opioid-withdrawal-symptoms-management-priority-review-nda/article/708988/




http://pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139

https://www.samhsa.gov/capt/sites/default/files/resources/good-samaritan-law-tool.pdf

http://www.prescribetoprevent.org/

http://www.integration.samhsa.gov/

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A. Comprehensive Addiction and Recovery Act (CARA) 2016

B. Title 42 of the Code of Federal Regulations Part 8 (42 CFR 8) 2007

C. Mental Health Parity and Addiction Equity Act (MHPAEA) 2008

D. Drug Addiction Treatment Act (DATA) 2000

ARS Question: The legislation that allowed PAs and NPs to prescribe buprenorphine is called:


Models of Care

Opioid Treatment Program (OTP)

• State and federally regulated program.

• Dispensing-based model.• Administrative barriers to PA-

practice.• However, it is possible for PAs to

order treatment in an OTP.

Buprenorphine Waiver• Office-based treatment.• Filled by pharmacy.• PA may practice in addiction

medicine, intended for primary care.

• Not necessarily equipped to provide additional services.

• Referral additional services.


Compliance


State requirements

• PA license• Additional prescriptive authority

requirements (e.g. MN, OH)• Prescription drug monitoring

program (PDMP)• State controlled substance

registration.• Special CME requirements.

PDM P http://www.nascsa.org/rxM onitoring.htm© DSAT Editor, DSAT for MSFT, GeoNames, MSFT, Navteq

Powered by Bing

State Prescription Drug Monitoring ProgramsSchedules II-IV Schedules II-V

MO – see state law.Source: Prescription Drug Monitoring Program Training and Technical Assistance Center

http://www.nascsa.org/rxMonitoring.htm

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State Legal Scope of Practice

• AAPA has asked state PA regulators to amplify this position in state law.• Medical board guidance• Administrative rule• State law

• Some state laws limit legal scope of practice to physician scope.

• SAMHSA clarified that PAs are waiver eligible if the physician is also waiver eligible.

• Physician not required to obtain waiver for PA to apply.

Visit AAPA.org for more information.Contact AAPA’s COOA team for additional resources.


Federal requirements

• Completed state requirements

• DEA registration

• In some cases, final state controlled substances registration

© DSAT Editor, DSAT for MSFT, GeoNames, MSFT, NavteqPowered by Bing

State Controlled Substance Registration (DEA)

1

3

License

Source: DEANV - pending


Waiver Requirements

• Separately submit training certificate (by email or fax).

• SAMHSA will submit application to DEA who will assign prescriber number.

• SAMHSA approval transmitted by email, includes prescriber number.

• Federal Comprehensive Addiction and Recovery Act (CARA) (effective until Oct. 1, 2021).

• Complete 24 hours of training (AAPA offers this training).

• Complete DATA 2000 Waiver Notification Form (electronic only) (SAMHSA)


Other considerations

Limitations

• PAs may treat up to 30 patients.

• PAs must use the unique prescriber number when issuing waiver prescriptions.

• Professional scope of practice and meeting standard of care

Documentation

• Ensure there is a system and process to:• Avoid non compliance; and• Document compliance

• Create compliance reminder systems.

• Mindful of Oct. 1, 2021 expiration date.

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Public Policy


States Address Opioid Addiction

• Nearly every state has an opioid-related taskforce.

• General consensus that more providers are necessary to address addiction.

• Achieve an increase in providers though moving aspects of addiction care into primary care.


Equipping primary care

• PAs must meet both legal scope requirements, but also professional scope – meeting the standard of care.

• States are creating resources to support addiction treatment in primary care.

• Important for PAs to review what resources are available in their state.


Examples of State Approaches

Expertise

• Provider access to addiction center (“spoke-and-hub”)

• Provider access to consults• Provider education

Access

• Reimbursement• Resources for those at high-risk• Comprehensive programs• Access and referral to other

providers • Rotations

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A. I plan to get my DEA X Waiver

B. I don’t plan on getting my DEA X waiver, but I will get the training for the buprenorphine implant

C. I don’t plan on getting my DEA X waiver, but I will start prescribing other medications to assist my patients with sobriety

D. I don’t plan on getting my DEA X waiver, but I will refer patients for MAT

E. I don’t plan to make any changes to my practice based on this talk

Final ARS Questions: What do you plan to do next?


More Resources

• American Society of Addiction Medicine (ASAM)• Providers Clinical Support System (PCSS) • Read “Denial: The greatest barrier to the opioid epidemic” by N.

Gastala https://www.ncbi.nlm.nih.gov/pubmed/28795846• Read “Medication-Assisted Treatment should be a part of every

family physician’s practice”• Yes: http://www.annfammed.org/content/15/4/309.long• No: http://www.annfammed.org/content/15/4/310.long


http://www.annfammed.org/content/15/4/309.long

http://www.annfammed.org/content/15/4/310.long

Learning objectives The Primary Care PA Role in the ......• M Szalavitz book “Unbroken Brain”...

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