mitigating risk when managing high dose, chronic pain patients

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Webinar November 1, 2017 Mitigating Risk When Managing High Dose, Chronic Pain Patients Ryan Thurber Polsinelli PC [email protected] Jeffrey Fitzgerald Polsinelli PC [email protected] Elizabeth S. Grace, MD, FAAFP Medical Director, CPEP [email protected]

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Page 1: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Webinar November 1, 2017

Mitigating Risk When Managing High Dose, Chronic Pain Patients

Ryan Thurber Polsinelli PC

[email protected]

Jeffrey Fitzgerald Polsinelli PC

[email protected]

Elizabeth S. Grace, MD, FAAFP

Medical Director, CPEP [email protected]

Page 2: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Blame and Enforcement

Rhetoric is high

– Top priority of Attorney General Jeff Sessions

– State AG and medical boards increasingly active

President declared public health emergency (10/26/17)

Health Affairs (10/8/2017)

– Blame hospitals (treat as hospital-acquired condition)

60 Minutes – Washington Post (10/15/2017)

– Blame manufacturers and distributors

But patients need treatment for pain

– Some People Still Need Opioids Slate (8/17/2017) 2

Page 3: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Blame and Enforcement

Tension exists between anti-opioid rhetoric and fact that treatment of pain is important

Some patients have chronic pain, and opioid analgesic treatment is appropriate

Physicians and supporting organizations can provide the appropriate clinical care, but structural safeguards are needed to reduce legal risk

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Page 4: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Beneficence

Non-Maleficence

Adequately address a patient’s chronic pain

While not harming the patient or putting him and undue risk

While not putting your career at risk

The Physician’s Challenge

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Page 5: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Strategies for Clinicians

Independently and objectively evaluate all patients, including patients who present with established diagnoses and treatment plans

Assess for risk of abuse before prescribing and periodically thereafter

Establish realistic goals regarding symptom improvement and establish measurable functional treatment goals

Check the prescription Drug Monitoring Program (PDMP)

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Page 6: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Strategies for Clinicians

Become familiar with screening for or identifying substance use disorder

– Be knowledgeable about addiction treatment resources in your area

Avoid prescribing opioids with benzodiazepines and/or other CNS sedating medications

Know your own vulnerabilities

Don’t ignore potentially important information

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Page 7: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Strategies for Clinicians

If you do prescribe higher dose opioids, or to patients at higher risk due to other factors, mitigate risk by:

– Assessing for adverse effects

– Prescribe Naloxone

– Document carefully

– Follow organizational policies and procedures

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Page 8: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Tapering Opioids: Who?

Inadequate improvement of pain and function >50 MED without benefit or co-prescribed with a

benzodiazepine Non-adherence with treatment plan Signs of SUD Significant adverse event (e.g., OD) Warning signs of OD (confusion, oversedation, slurred

speech) Condition is resolved https://www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf; Berna et al. Mayo Clin Proc. 2015;90(6):828-842

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Page 9: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Tapering Opioids: How?

Plans should be individualized General guidelines: decrease by 10% of the

original dose/week Slow down the taper, if necessary; don’t reverse Alpha 2 agonists can reduce withdrawal

symptoms Consult as needed: addiction, OB/Gyn (pregnant

patients), mental health Recognize risk of quickly resuming prior dose

after or during a taper (consider naloxone)

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Page 10: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Multiple benzodiazepines

Benzodiazepine combined with opioids and/or amphetamines

Active or history of substance use disorder

Patients with cognitive disorder

Benzos should be tapered for any patient taking a benzo for 2 weeks or more

Supratherapeutic doses

Tapering Benzodiazepines: Who?

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Page 11: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Tapering Benzodiazepines: How?

Carefully and slowly: watch for withdrawal

See references for potential tapering schedule

Scheduled rather than prn doses

Initiate alternative treatment , e.g., CBT

Suspend (or reverse) if severe anxiety or depression occur

http://nationalpaincentre.mcmaster.ca/opioid/cgop_b_app_b06.html https://www.va.gov/PAINMANAGEMENT/docs/OSI_6_Toolkit_Taper_Benzodiazepines_Clinicians.pdf

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Page 12: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Tapering Benzodiazepines: How?

Supratherapeutic doses (or other complicated patients)

– Consider referral to addictionologist

– Consider admission

– Consider anticonvulsants

http://nationalpaincentre.mcmaster.ca/opioid/cgop_b_app_b06.html https://www.va.gov/PAINMANAGEMENT/docs/OSI_6_Toolkit_Taper_Benzodiazepines_Clinicians.pdf

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Page 13: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Why Doctors Can’t Say No

Often it's easier to just say yes. But there are ways to say no that are better for both physician and patient

http://www.salon.com/2011/11/28/why_doctors_cant_say_no/

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Page 14: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Legal Risk Can Be Mitigated

Physician concerns about their personal exposure are real and appropriate – Encourage open dialogue

– Recognize that opinions can differ

Organizational support is essential – Assist physicians in providing quality care in a

changing environment

– Assist with documentation

– Assist with difficult cases

– Assist with education 14

Page 15: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Legal Risk Can Be Mitigated

Develop policy on use of opioid analgesics to treat chronic pain

Review and assess current patients with chronic pain and current prescription practices

Have a clear process to document basis for high dose prescriptions

Consider additional clinical education

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Page 16: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Chronic Pain Policy

Concise, practical and readable – Physician involvement is critical

Significant discretion on standards – Record basis for potentially controversial

standards

Issues to address – New patient intake

• Geographic limits; prior treatment; medical history

– Criteria for use of treatment agreement

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Page 17: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Chronic Pain Policy

Issues to address – Use of treatment plan, goals and schedule for re-

evaluation • Including assessment of non-opioid options

– Monitoring safeguards (set your own) • PDMP review

• Urine drug testing

• Evidence of diversion or dependence

• Documentation expectations and support process

– Response to suspected diversion

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Page 18: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Chronic Pain Policy

Issues to address – Objective clinical standards, such as

• Maximum dosages and combination of drugs

• Use of short acting and long acting drugs

• Marijuana and illicit drug use

• Evidence of injury or pain

– Standards for referral to pain specialist

– Standards for referral to substance abuse treatment

– Process for lost prescriptions

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Page 19: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Chronic Pain Policy

Issues to address

– Standards for tapering

• Expected timelines

• Standards for exceptions (if any)

– Issues/cases to be addressed by informal peer review

– Patient noncompliance and termination

• Consistency is important

Create policy and ensure it is followed

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Page 20: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Assess Current Practice

Review current high risk patients and prescribing patterns

Identify high risk patients – High dose opioids

– Co-prescribed other sedating medications

– Medical comorbidities that increase risk for adverse events

– Psychiatric comorbidities

– Vague and poorly defined conditions, or conditions for which opioids are not indicated or not typically used

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Page 21: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Assess Current Practice

Tools to review current high risk patients

– Prescriber PDMP self-query

– EHR diagnosis codes or e-prescribing query

– Ask prescribers about their comfort level and/or concerns

Analyze for potential diversion and clinical care (and documentation quality)

Develop plan to address issues or questions (if needed)

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Page 22: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Automate doing the “right thing”

– Process should ease burden on providers

– Process can add significant risk reduction

– Use a process that fits with your organizational culture

Consider documentation checklist

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Documentation for High Dose Prescriptions

Page 23: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Documentation for High Dose Prescriptions

Right Checks Right Chart Note Right Prescription

Patient chart reviewed and

contains:

Note from today’s encounter

contains statement:

Today’s prescription

reviewed:

☐ Current PDMP confirming

no unknown prescriptions

or other physician

prescribing opioids

☐ Urine drug testing dated

within __ days confirming

presence of prescribed

opioids and lack of others

or illicit drugs

☐ Treatment plan and

informed consent

☐ Current 5As of pain

management

☐ Discussed risk of abuse,

addiction or referral for

substance abuse

treatment

☐ About risk of diversion

☐ Addressing titration or

discontinuation of opioid

☐ About need for or

compliance with pain

contract

☐ Today’s prescription is no

higher morphine

equivalents than prior

prescription

☐ Prescription for no more

than __ day period

☐ No prescription for

benzodiazepines or

carisoprodol

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Page 24: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Clinical Education

Make resources available to providers

Develop process to keep up with clinical and regulatory changes

Be creative

– Attend CME

– Prescribing refresher courses

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Page 25: Mitigating Risk When Managing High Dose, Chronic Pain Patients

http://www.cdc.gov/drugoverdose/prescribing/resources.html

– CDC website that includes CDC prescribing guidelines, tools for your practice, and patient education resources.

http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf

– Washington Agency Medical Directors’ Group Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (3rd Ed., 2015)

https://professional.oregonpainguidance.org/wp-content/uploads/sites/2/2014/04/OPG_Guidelines_2016.pdf

– Oregon Pain Guidance Group Pain Treatment Guidelines

http://coacep.org/docs/COACEP_Opioid_Guidelines-Final.pdf

– Colorado ACEP 2017 Opioid Prescribing & Treatment Guidelines

Guidelines and Tools

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Page 26: Mitigating Risk When Managing High Dose, Chronic Pain Patients

https://www.cdc.gov/drugoverdose/pdf/Clinical_Pocket_Guide_Tapering-a.pdf

– CDC Pocket Guide: Tapering Opioids for Chronic Pain

https://www.va.gov/PAINMANAGEMENT/docs/OSI_6_Toolkit_Taper_Benzodiazepines_Clinicians.pdf

– Effective Treatments for PTSD: Helping Patients Taper from Benzodiazepines

https://www.colorado.gov/pacific/hcpf/pain-management-resources-and-opioid-use

– A list of resources from the Colorado Department of Healthcare Policy and Financing.

http://takemedsseriously.org/

– Colorado’s official online resources for information on the safe use, storage and disposal of prescription drugs.

Guidelines and Tools

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Page 27: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Your own state rules and regulations:

– Medical Practice Act

– Licensure board prescribing guidelines

– Prescription drug (controlled substance) monitoring program and related legislation

– Any additional state legislation specific to prescribing controlled substances

Guidelines And Tools

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Page 28: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. Nothing herein should be relied upon or used without consulting a lawyer to consider your specific circumstances, possible changes to applicable laws, rules and regulations and other legal issues. Receipt of this material does not establish an attorney-client relationship. Polsinelli is very proud of the results we obtain for our clients, but you should know that past results do not guarantee future results; that every case is different and must be judged on its own merits; and that the choice of a lawyer is an important decision and should not be based solely upon advertisements. © 2017 Polsinelli PC. In California, Polsinelli LLP. Polsinelli is a registered trademark of Polsinelli PC.

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Page 29: Mitigating Risk When Managing High Dose, Chronic Pain Patients

Webinar November 1, 2017

Mitigating Risk When Managing High Dose, Chronic Pain Patients

Ryan Thurber Polsinelli PC

[email protected]

Jeffrey Fitzgerald Polsinelli PC

[email protected]

Elizabeth S. Grace, MD, FAAFP

Medical Director, CPEP [email protected]