Opioid Usage, Pain Opioid Usage, Pain Management and MoreManagement and More

Lessons Learned from the Lessons Learned from the MMA/BOLIM Chronic Pain ProjectMMA/BOLIM Chronic Pain Project

January, 2010January, 2010Noel J. Genova, MA, PA-CNoel J. Genova, MA, PA-C

Learning ObjectivesLearning Objectives

Efficacy of chronic opioid therapy—Efficacy of chronic opioid therapy—evidence , lack of evidence, opioid-evidence , lack of evidence, opioid-responsive conditions.responsive conditions.

Documentation—the “6 A’s”Documentation—the “6 A’s” Screening for misuse and addiction, Screening for misuse and addiction,

and referring for treatment if and referring for treatment if appropriate.appropriate.

Recognition of medication diversion.Recognition of medication diversion.

““Table of Contents”Table of Contents”

Description of the MMA/BOLIM Description of the MMA/BOLIM Chronic Pain ProjectChronic Pain Project

Initial objectives of the Project, and Initial objectives of the Project, and qualitative information found during qualitative information found during chart review (~200 participants, chart review (~200 participants, ~1000 charts reviewed).~1000 charts reviewed).

Emerging issues (from chart reviews Emerging issues (from chart reviews and Integrated Pain Mgt Conference and Integrated Pain Mgt Conference Group).Group).

Something for Surgical PAsSomething for Surgical PAs

Comments on pts receiving high-dose Comments on pts receiving high-dose chronic opioid therapy.chronic opioid therapy.

Comments regarding pts on Comments regarding pts on buprenorphine and methadone.buprenorphine and methadone.

Comments on pre-surgery screening for Comments on pre-surgery screening for opioid use, and histories of addiction.opioid use, and histories of addiction.

D/C’ing opioids after surgical D/C’ing opioids after surgical intervention and resolution of painful intervention and resolution of painful condition.condition.

MMA/BOLIM Chronic Pain MMA/BOLIM Chronic Pain ProjectProject

Started in March, 2008. Funded by Started in March, 2008. Funded by Maine’s Board of Medicine, Maine’s Board of Medicine, administered through Maine Medical administered through Maine Medical Association.Association.

Intended as a service to licensees Intended as a service to licensees and all Maine prescribers.and all Maine prescribers.

All visits confidential, and free of All visits confidential, and free of charge to the practices.charge to the practices.

Initial ObjectivesInitial Objectives

Raise awareness of drug-related Raise awareness of drug-related deaths, particularly from methadone.deaths, particularly from methadone.

Help prescribers prevent diversion.Help prescribers prevent diversion. Teach prescribers to recognize and Teach prescribers to recognize and

treat addiction.treat addiction. Review records for appropriate Review records for appropriate

documentation of initial evaluation documentation of initial evaluation and on-going monitoring of pts on and on-going monitoring of pts on opioids.opioids.

Initial Objectives, cont’dInitial Objectives, cont’d

Assist prescribers in use of the Assist prescribers in use of the Prescription Monitoring Program.Prescription Monitoring Program.

Discuss methods for urine drug Discuss methods for urine drug screening.screening.

Offer sample treatment agreements.Offer sample treatment agreements. Review Maine’s Chapter 11 Rules for Review Maine’s Chapter 11 Rules for

Use of Controlled Substances for Use of Controlled Substances for Treatment of Pain (in other states, the Treatment of Pain (in other states, the FSMB model rules).FSMB model rules).

Last Year’s NewsLast Year’s News

Treatment of chronic, non-terminal pain Treatment of chronic, non-terminal pain with opioid medications has had the with opioid medications has had the unintended consequence of increased unintended consequence of increased diversion of medications, increased non-diversion of medications, increased non-medical use of prescription medications medical use of prescription medications by young people, an increase in drug-by young people, an increase in drug-related deaths nationally, and possibly related deaths nationally, and possibly an increase in opioid misuse or addiction an increase in opioid misuse or addiction among patients treated for chronic pain.among patients treated for chronic pain.

Last Year’s News, Cont’d.Last Year’s News, Cont’d.

Risks of chronic opioid therapy (COT) Risks of chronic opioid therapy (COT) include endocrine abnormalities, include endocrine abnormalities, aggravation of pain, worsening aggravation of pain, worsening depression, sleep disturbances depression, sleep disturbances (including sleep apnea) and worsening (including sleep apnea) and worsening function. This is especially concerning, function. This is especially concerning, because the indications for the use of because the indications for the use of the therapy is increased pain relief, the therapy is increased pain relief, increased function, and overall increased function, and overall improvement in well-being.improvement in well-being.

The Problems are On-GoingThe Problems are On-Going

Drug-related deaths in Maine were again Drug-related deaths in Maine were again higher than MVA-related deaths in 2008.higher than MVA-related deaths in 2008.

Prescribers are generally well-aware of Prescribers are generally well-aware of these issues, and are looking for how to these issues, and are looking for how to reduce risks, while continuing to treat reduce risks, while continuing to treat pain effectively.pain effectively.

Non-medical use of prescription Non-medical use of prescription analgesics remains a serious problem analgesics remains a serious problem among youth.among youth.

Maine Drug Related vs. MVA deathsMaine Drug Related vs. MVA deaths90% caused by at least one prescription drug90% caused by at least one prescription drug

78% had narcotics present78% had narcotics present Office of Medical ExaminerOffice of Medical Examiner

19971997 20002000 20052005 20062006 20072007

MVA MVA relaterelatedd

192192 169169 169169 188188 183183

Drug Drug relaterelatedd

3434 6060 176176 167167 154154

Deaths per 100,000 related to Deaths per 100,000 related to unintentionalunintentional overdose and annual sales of overdose and annual sales of prescription opioids by year, 1990 - 2006 prescription opioids by year, 1990 - 2006

Source: Paulozzi, CDC, Congressional testimony, 2007Source: Paulozzi, CDC, Congressional testimony, 2007

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1

2

3

4

5

6

7

8

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Deaths per 100,000

Opioid sales (mg perperson)

Methadone Related Deaths Methadone Related Deaths 20052005

Larger Circle indicate higher rates NYTLarger Circle indicate higher rates NYT 8.17.08 8.17.08

Where Pain Relievers Were ObtainedWhere Pain Relievers Were Obtained Non-medical Use among Past Year Users Aged 12 or Older 2006Non-medical Use among Past Year Users Aged 12 or Older 2006

1 The Other category includes the sources: “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.”

Bought/Took from Friend/Relative

14.8%

Drug Dealer/Stranger

3.9%

Bought on Internet

0.1% Other 1

4.9%

Free from Friend/Relative

7.3%

Bought/Took fromFriend/Relative

4.9%

OneDoctor80.7%

Drug Dealer/Stranger

1.6%Other 1

2.2%

Source Where Respondent Obtained

Source Where Friend/Relative Obtained

One Doctor19.1%

More than One Doctor

1.6%

Free from Friend/Relative

55.7%

More than One Doctor3.3%

Learning from the ProjectLearning from the Project

Use of drug screens—”I’m a doctor, not a Use of drug screens—”I’m a doctor, not a cop”. Must screen for addiction—a cop”. Must screen for addiction—a treatable, potentially fatal medical treatable, potentially fatal medical condition.condition.

Alcohol abuse is often missed or ignored.Alcohol abuse is often missed or ignored. Polypharmacy with controlled substances Polypharmacy with controlled substances

starts insidiously, and is difficult to stop. starts insidiously, and is difficult to stop. Benzos and butalbital often used w/COT.Benzos and butalbital often used w/COT.

Urine Drug TestingUrine Drug Testing

History of substance use and abuse History of substance use and abuse very important, but not entirely very important, but not entirely accurateaccurate

Studies from pain treatment centers Studies from pain treatment centers consistently show ~40% of urines consistently show ~40% of urines with unexpected results.with unexpected results.

Interpretation of results can be trickyInterpretation of results can be tricky—develop a relationship with your lab.—develop a relationship with your lab.

Learning from the Project, Learning from the Project, Cont’dCont’d

We are not trained to obtain the elements We are not trained to obtain the elements of the history, particularly in monitoring of of the history, particularly in monitoring of opioid analgesics (the “6 A’s”).opioid analgesics (the “6 A’s”).

Prescribers want to learn to use the PMP.Prescribers want to learn to use the PMP. Many prescribers find confrontation of Many prescribers find confrontation of

patients with aberrant behaviors to be patients with aberrant behaviors to be very difficult, time-consuming, and very difficult, time-consuming, and draining. Training is needed on this issue.draining. Training is needed on this issue.

The “6 A’s”The “6 A’s”

AnalgesiaAnalgesia Activity (function)Activity (function) Aberrant BehaviorsAberrant Behaviors Adverse AffectsAdverse Affects Affective Aspects (mood, sleep. Affective Aspects (mood, sleep.

Remember usefulness of CBT)Remember usefulness of CBT) Adjuncts (pharmacologic and non-Adjuncts (pharmacologic and non-

pharmacologic)pharmacologic)

Barriers to Best PracticesBarriers to Best Practices

Lack of strong evidence-based studies.Lack of strong evidence-based studies. Lack of access to a full range of Lack of access to a full range of

adjuncts, esp in rural areas. Lack of adjuncts, esp in rural areas. Lack of reimbursement for intensive reimbursement for intensive interdisciplinary therapies.interdisciplinary therapies.

Local culture which equates treatment Local culture which equates treatment of pain with use of opioid medication.of pain with use of opioid medication.

Lack of reimbursement for the time Lack of reimbursement for the time needed to treat pts comprehensively.needed to treat pts comprehensively.

2009 Guideline2009 Guideline

Chou, R, Fanciullo GJ, Fine PG, et al; Chou, R, Fanciullo GJ, Fine PG, et al; Clinical Guidelines for the Use of Chronic Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Opioid Therapy in Chronic Noncancer Pain; Pain; The Journal of PainThe Journal of Pain; Vol 10, #2; ; Vol 10, #2; February, 2009; pp. 113-130.February, 2009; pp. 113-130.

Appendices regarding Screening and Appendices regarding Screening and Brief Intervention for Addiction are Brief Intervention for Addiction are especially useful and important.especially useful and important.

2009 Guideline (cont’d)2009 Guideline (cont’d)

Addresses Efficacy and Risk AssessmentAddresses Efficacy and Risk Assessment ““Sparse” evidence for use in chronic back Sparse” evidence for use in chronic back

pain, daily headache, and fibromyalgia.pain, daily headache, and fibromyalgia. Good appendices with tools for screening Good appendices with tools for screening

for risk of misuse or addiction, consent for risk of misuse or addiction, consent forms, and documentation tools.forms, and documentation tools.

Monitoring process not evidence-based, Monitoring process not evidence-based, but may reveal a community standard.but may reveal a community standard.

Emerging ObjectivesEmerging Objectives

Management of patients on high-dose Management of patients on high-dose opioids who are not responding well.opioids who are not responding well.

Discontinuing chronic opioid therapy.Discontinuing chronic opioid therapy. Treatment of acute pain (e.g. Treatment of acute pain (e.g.

associated with surgery) in patients who associated with surgery) in patients who are on buprenorphine or methadone.are on buprenorphine or methadone.

Use of medical marijuana for chronic Use of medical marijuana for chronic pain.pain.

Emerging Objectives Emerging Objectives (Cont’d)(Cont’d)

Substituting evidence-based Substituting evidence-based treatments for COT in patients with treatments for COT in patients with fibromyalgia, chronic headaches and fibromyalgia, chronic headaches and migraine, and chronic low back pain migraine, and chronic low back pain for which there is no structural cause for which there is no structural cause identified (in pts who are not doing identified (in pts who are not doing well on COT).well on COT).

Maine PAs and Schedule II Maine PAs and Schedule II MedsMeds

Maine PAs licensed by the BOLIM must apply Maine PAs licensed by the BOLIM must apply for Schedule II prescribing authorityfor Schedule II prescribing authority

Maine PAs licensed by the Board of Maine PAs licensed by the Board of Osteopathic Licensure cannot prescribe Osteopathic Licensure cannot prescribe Schedule II medications.Schedule II medications.

Some of the recommendations in this lecture Some of the recommendations in this lecture may pertain more to physician and NP may pertain more to physician and NP practice than to PA practice, but will inform practice than to PA practice, but will inform the practice of PAs caring for pts with chronic the practice of PAs caring for pts with chronic pain. pain.

Pts on High-Dose OpioidsPts on High-Dose Opioids

No real definition of high-dose opioids, but No real definition of high-dose opioids, but general agreement on ~200 mg/day general agreement on ~200 mg/day equivalent of morphine.equivalent of morphine.

~160 mg/day of oxycodone.~160 mg/day of oxycodone. ~60-120 mg/day of methadone (~60-120 mg/day of methadone (extreme extreme

care must be used in dosing methadone).care must be used in dosing methadone). ~100 microgram q 3 days fentanyl patch.~100 microgram q 3 days fentanyl patch.

High-Dose Opioids--High-Dose Opioids--ReferencesReferences

Ballantyne JC and Mao J; Opioid Ballantyne JC and Mao J; Opioid Therapy for Chronic Pain; Therapy for Chronic Pain; NEJM;NEJM; 349:20; Nov 13, 2003; 1943-53.349:20; Nov 13, 2003; 1943-53.

Chang G, Chen L, and Mao J; Opioid Chang G, Chen L, and Mao J; Opioid Tolerance and Hyperalgesia; Tolerance and Hyperalgesia; The The Medical Clinics of North America;Medical Clinics of North America; 91 91 (2007) 199-211.(2007) 199-211.

RecommendationsRecommendations

Be sure to document efficacy of high-Be sure to document efficacy of high-dose opioids.dose opioids.

Screen for misuse and/or addiction.Screen for misuse and/or addiction. Be aware of the possibility of opioid-Be aware of the possibility of opioid-

induced hyperalgesia.induced hyperalgesia. Strongly consider consultation with a Strongly consider consultation with a

pain specialist.pain specialist.

Discontinuing Opioid MedsDiscontinuing Opioid Meds

May be indicated if med not effective.May be indicated if med not effective. Consider possibility of opioid-induced Consider possibility of opioid-induced

hyperalgesia, which may indicate need hyperalgesia, which may indicate need to taper and/or D/C COT.to taper and/or D/C COT.

May be necessary if pt misusing the May be necessary if pt misusing the med.med.

Some pts want to D/C med.Some pts want to D/C med. Condition may have improved or Condition may have improved or

resolved (e.g. after surgery).resolved (e.g. after surgery).

Case ExampleCase Example

A 40 yo man with chronic pain after A 40 yo man with chronic pain after extensive injuries sustained 15 yrs extensive injuries sustained 15 yrs ago when he fell off a roof. He is on ago when he fell off a roof. He is on 480 mg of oxycodone daily, has 8/10 480 mg of oxycodone daily, has 8/10 pain, cannot work, and his wife has pain, cannot work, and his wife has asked him to leave, as he is unable asked him to leave, as he is unable to participate in family activities.to participate in family activities.

Discontinuing Opioid MedsDiscontinuing Opioid Meds

Taper can be slow (~10%/week), or Taper can be slow (~10%/week), or rapid. See rapid. See www.Pain-Topics.comwww.Pain-Topics.com, , March, 2006; Kral, Lee A.March, 2006; Kral, Lee A.

Buprenorphine can be used if the pt Buprenorphine can be used if the pt does not tolerate discontinuation of COT. does not tolerate discontinuation of COT. Check with DEA, supervising physician, Check with DEA, supervising physician, licensing board, and local pain specialist licensing board, and local pain specialist before initiating. Special training before initiating. Special training needed.needed.

BuprenorphineBuprenorphine

Cannot be prescribed by PAs for Cannot be prescribed by PAs for addiction. An act of Congress addiction. An act of Congress required to change the restriction. required to change the restriction.

If used for pain, Dx must be clearly If used for pain, Dx must be clearly indicated on Rx.indicated on Rx.

Efficacy for pain relief controversial.Efficacy for pain relief controversial. In Maine, has “street value”.In Maine, has “street value”.

Buprenorphine (cont’d)Buprenorphine (cont’d)

Is an opioid agonist. Competes with Is an opioid agonist. Competes with other opioids for binding sites. Can other opioids for binding sites. Can induce withdrawal, and prevent induce withdrawal, and prevent efficacy of other opioids.efficacy of other opioids.

Get HelpGet Help

Work with someone experienced in Work with someone experienced in its use before discussing with a pt.its use before discussing with a pt.

In any surgical setting, recommend In any surgical setting, recommend working with an anesthesiologist working with an anesthesiologist familiar with the med.familiar with the med.

RecommendationsRecommendations

If treating pts for non-terminal If treating pts for non-terminal chronic pain, always have an exit chronic pain, always have an exit strategy.strategy.

Be prepared to discontinue COT, if Be prepared to discontinue COT, if indicated.indicated.

Have a back-up plan for pts who do Have a back-up plan for pts who do not do well with a standard taper.not do well with a standard taper.

Acute Pain in Pts on Opioid Acute Pain in Pts on Opioid Agonist Therapy (OAT)Agonist Therapy (OAT)

Why is the pt on OAT?Why is the pt on OAT? Technical expertise required to avoid risk Technical expertise required to avoid risk

of drug interactions.of drug interactions. Buprenorphine may precipitate Buprenorphine may precipitate

withdrawal if combined with other withdrawal if combined with other opioids.opioids.

Methadone maintenance may predispose Methadone maintenance may predispose pts to opioid-induced hyperalgesia.pts to opioid-induced hyperalgesia.

OAT (cont’d)OAT (cont’d)

Reference—Alford D, Compton P, Reference—Alford D, Compton P, Samet J; Acute Pain Management for Samet J; Acute Pain Management for Patients Receiving Maintenance Patients Receiving Maintenance Methadone or Buprenorphine Methadone or Buprenorphine Therapy; Therapy; Annals of Internal Medicine;Annals of Internal Medicine; 17 Jan. 2006; 144:127-134.17 Jan. 2006; 144:127-134.

Case ExampleCase Example

35 yo man presents for day surgery. 35 yo man presents for day surgery. He had not revealed that he was on He had not revealed that he was on methadone maintenance, and methadone maintenance, and standard questionnaires in the surgical standard questionnaires in the surgical intake process did not include this intake process did not include this piece of medical history. The pt’s post-piece of medical history. The pt’s post-procedure pain was difficult to control, procedure pain was difficult to control, and the pt became combative.and the pt became combative.

RecommendationsRecommendations

Review definitions of addiction, Review definitions of addiction, dependence, and tolerance.dependence, and tolerance.

Work with someone who is Work with someone who is experienced in this situation.experienced in this situation.

Incorporate elements of the history Incorporate elements of the history that allow the pt to reveal history of that allow the pt to reveal history of addiction without feeling judged, or addiction without feeling judged, or scared that pain control will be scared that pain control will be withheld.withheld.

Medical MarijuanaMedical Marijuana

Legal in some states, including Maine.Legal in some states, including Maine. May be useful for chronic, non-terminal May be useful for chronic, non-terminal

pain.pain. Proponents note its safety, esp. Proponents note its safety, esp.

compared to COT.compared to COT. It can be a drug of abuse.It can be a drug of abuse. Little research on this Schedule I drug.Little research on this Schedule I drug.

ReferenceReference

Ben Amar, Mohamed; Cannabinoids Ben Amar, Mohamed; Cannabinoids in Medicine: A Review of their in Medicine: A Review of their Therapeutic Potential; Therapeutic Potential; Journal of Journal of Ethnopharmacology;Ethnopharmacology; 105 (2006) 1- 105 (2006) 1-25.25.

Recommendations for Recommendations for PhysiciansPhysicians

Only physicians can certify pts for use of mj.Only physicians can certify pts for use of mj. Document indication for use, efficacy, dose, Document indication for use, efficacy, dose,

and its place in overall therapeutic plan.and its place in overall therapeutic plan. Physicians should follow any advice available Physicians should follow any advice available

for certifying use. (In Maine, Maine Medical for certifying use. (In Maine, Maine Medical Association.)Association.)

Physicians should not certify pt for use if not Physicians should not certify pt for use if not comfortable in doing so.comfortable in doing so.

““Soft” indications for COTSoft” indications for COT

Many dx’es for use non-specific, such as Many dx’es for use non-specific, such as “chronic pain”, chronic back pain.“chronic pain”, chronic back pain.

Multiple fibromyalgia-related websites Multiple fibromyalgia-related websites browsed (Arthritis Foundation, NIH, browsed (Arthritis Foundation, NIH, Mayo Clinic, National Fibromyalgia Mayo Clinic, National Fibromyalgia Foundation). None advised use of Foundation). None advised use of “strong” opioid medication.“strong” opioid medication.

No place for COT for tx of chronic H/A. No place for COT for tx of chronic H/A.

ReferencesReferences

Chou R, Qaseem A, Snow V, et al; Chou R, Qaseem A, Snow V, et al; Diagnosis and Treatment of Low Back Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Pain: A Joint Clinical Practice Guideline from the ACP and the Am Guideline from the ACP and the Am Pain Soc; Pain Soc; Annals of Internal Medicine;Annals of Internal Medicine; 2 Oct, 2007; Vol 147, #7; 478-91.2 Oct, 2007; Vol 147, #7; 478-91.

Chou R and Huffman L; Meds for Acute Chou R and Huffman L; Meds for Acute and Chronic LBP; same issue; 505-14.and Chronic LBP; same issue; 505-14.

RecommendationsRecommendations

Review your diagnoses and Review your diagnoses and treatment plans for pts with chronic treatment plans for pts with chronic pain. pain.

Discuss latest treatment options with Discuss latest treatment options with pts. They may have changed since pts. They may have changed since the current plan was put in place.the current plan was put in place.

Consider tapering and/or D/C’ing COT Consider tapering and/or D/C’ing COT if pt not doing well.if pt not doing well.

Summary Summary RecommendationsRecommendations

Keep up with medical literature if you Keep up with medical literature if you prescribe COT. It is rapidly changing.prescribe COT. It is rapidly changing.

Pay close attention to documentation.Pay close attention to documentation. Be aware of community standard of Be aware of community standard of

care.care. Identify resources for treatment of Identify resources for treatment of

chronic pain and addiction.chronic pain and addiction. Be vigilant for risk of diversion.Be vigilant for risk of diversion.

Questions? Comments?Questions? Comments?

Thank you for your attention.Thank you for your attention. Noel J. Genova, MA, PA-CNoel J. Genova, MA, PA-C

MMA/BOLIM Chronic Pain ProjectMMA/BOLIM Chronic Pain Project

tel: 671-9076tel: 671-9076

e-mail NoelPAC@aol.com.e-mail NoelPAC@aol.com.