chronic non-malignant pain management in primary...

Chronic Non-Malignant Pain Management in

Primary Care

Nancy Brim Kurtz, MD

No disclosures

Learning Objectives

• Develop an approach to chronic pain • Be familiar with treatments

– Non-pharmacologic interventions – Non-opioid medications – Opioid medications

Today’s Clinic Schedule…

1 PM 55 yo F with chronic low back pain 2 PM 68 yo M with spinal stenosis 3 PM 70 yo M on chronic opioids

Background

Chronic Non-Malignant Pain • Definition

– Pain lasting greater than three months – Present for at least 12 hours per day

• An estimated 100 million Americans suffer from chronic pain

– Low back pain most common complaint – IOM calls chronic pain a public health crisis

• An estimated 3-4% of adult Americans (9.6 to 11.5 million) take chronic opioids for chronic pain

Sources: IOM 2011; Narayana, AAPM 2009; Kelly, Pain 2008; Volkow 2016.

Chronic Pain Is Common…

Still, many providers do not feel fully equipped to treat it.

What are some difficult aspects of pain

management for you?

Treating Chronic Pain is Challenging • Chronic pain complaints are common

– 37.5% of adult visits in one primary care setting

• Patient factors make chronic pain treatment difficult – Subjective nature of pain – Lack of patient self management skills – Psychological comorbidities – Idea of a pill as a “quick fix”

• The Pain Score: Helpful or Harmful? – 2017: US Opioid Commission recommends against questions about pain in

hospital satisfaction surveys as it may pressure clinicians to treat pain too aggressively.

Sources: Upshur, 2006; Martell, 2007; Reid, 2002; Dunn, 2010.

Prescription Opioid Misuse: A growing public health problem

• 249 million opioid RX in 2013 – 4.3 million Americans had non-medical use of prescription opioids in the last

month

• Increasing number of overdoses – Overdose risk is proportional to opioid dose – 17,087 prescription opioid overdose deaths in 2016

• Chronic opioids for non-malignant pain associated with increased risk of all cause mortality – Includes deaths other than overdose, esp cardiovascular – Increased risk vs anticonvulsants or antidepressants

Sources: CDC, 2017; Ray, 2016 and Volkow, 2016.

Regional Variability in Prescribing

Non Medical Use of RX Opioids

Are RX Opioids a “Gateway” Drug

Turning the Tide with RX Opioids

Source: CDC, MMWR, 2017.

What to do for chronic pain?

Treat Chronic Pain

-Achieve functional goals

-Provide relief to improve quality of life

Risks of Treatment

-Side effects

-Misuse/addiction

-Diversion

Today’s Clinical Schedule…


Case 1: Chronic Low Back Pain & Non-Opioid Management

• 55 y.o. F with history of mild depression and obesity presents with low back pain.

• Pain began 3 years ago after a herniated disc at L4/L5. She underwent discectomy at that time.

• She continues to have dull, achy lumbar paraspinal pain. She rates it an 8/10.

• Occasional pins and needles radiating down her right leg, especially at night.

Image from the-good-doctor.net

Case: Chronic Low Back Pain & Non-Opioid Management

• She has seen a neurosurgeon and orthopedist who both felt that she would not benefit from another surgical procedure.

• She had a recent MRI of her spine s/p surgery and moderate DJD of the L-spine.

• She is taking ibuprofen 800 mg TID with no relief.


Case: Chronic Low Back Pain & Non-Opioid Management

• SH: On disability due to pain. No smoking, drinking or drugs. Sedentary due to the pain, gained 30 lbs in the past few years.

• ROS: Reports depressed mood, she is on citalopram prescribed by her psychiatrist with good effect.

• Exam shows BMI of 31 and is notable for bilateral paraspinal lumbar mild tenderness to palpation. Otherwise negative.


How would you characterize this patient’s

pain?

How would you begin to approach treating this patient’s chronic non-malignant pain?

Social

Biopsychosocial Model of Pain

Physical Psychological

Treating Chronic Pain • Identify location and characteristics of pain • Feel comfortable that dangerous or modifiable causes of

pain have been ruled out

• Clearly discuss functional limitations caused by pain

PEG Scale for Assessing Pain

• Over the past week, what number from 0-10 best describes: – your PAIN on average? – how pain has interfered with your ENJOYMENT of life? – How pain has interfered with your GENERAL ACTIVITY?

Krebs, 2009

Treating Chronic Pain • Establish realistic expectations for pain relief • Detailed history of prior interventions

– Prior medication regimens • What dosages? Any benefit or side effects?

– Prior non-pharmacologic interventions • How long did patient trial intervention? Any benefit or side effects?

• Discuss a comprehensive pain plan – May take multiple trials to find right plan – May include retrial of some prior interventions

• For medications, start LOW and titrate SLOWLY

What is “effective treatment” in pain? • Generally a 30-50% pain reduction is a considered a success • Areas of caution in evaluating pain treatments

– The placebo effect can be strong – Different patients may respond differently- there is no “one size fits all”

approach – Most studies do not have long term follow up – Lack of studies/data common- especially for many non-pharmacologic

therapies

Non-pharmacologic interventions

Non-pharmacologic interventions

• First line • Key to success of any pain management plan • Requires patient buy-in and participation

Non-pharmacologic interventions • MSK/Inflammatory Pain

– Superficial heat/cold – Physical therapy, exercise and tai chi – Massage/acupuncture/chiropractor/osteopath – Self care – Cognitive behavioral therapy – Sleep hygiene – TENs therapy – Steroid injections

• Neuropathic pain – Nerve blocks plus above

Self care • Weight loss • Supportive shoes • Firm mattress • Proper lifting techniques • Proper posture when standing and sitting

– Consider RX for ergonomics evaluation at work

Cognitive Behavioral Therapy

Beliefs, anticipation and expectation are better predictors of pain than any

physical pathology

Source: Turk and Theodore, 2011.

Cognitive Behavioral Therapy • Rationale:

– Behavior (decreased physical/social activity) – Cognitive habits (focusing on what you can’t do vs modifying activities or identifying what you

can do) – Attentional focus (focusing on pain and ignoring other aspects of identity/life)

• Training on pain coping strategies – Pacing – Physical activity – Pleasant activities – Progressive muscle relaxation – Distraction techniques – Cognitive restructuring

Source: Keefe, 1996. Thanks to Nora Keenan, Ph.D for help on this slide.

A conversation…

You think this patient would benefit from CBT for her pain. However, when you bring it up, she feels upset and states “My pain is real, it is not in my head. I am worried you don’t believe me” How would you discuss with her the role of CBT in chronic pain?

Tai Chi for Pain • Exercise routine emphasizing slow movements, breathing and

meditation • Review of 9 RCTs in BMJ of OA patients

– Reduced pain and decreased joint stiffness – Reduced physical disability

• Added benefit: improved balance in NEJM study of patients with Parkinson’s – Outperformed routine strength training – Improved functional capacity – Reduced falls

Sources: Kang, 2011 and Li, 2012.

Pain and Sleep Disturbances: A vicious cycle or a common cause?

• Pain commonly causes disrupted sleep and sleep deprivation may increase pain sensitivity

• May be related to altered function of dopamine and endogenous opioids

• Important to address in patients with chronic pain – Sleep hygiene/CBT – Sedating medications at night for pain and sleep – Evaluation for other sleep disturbances (OSA, RLS, etc)

Source:Finan PH; 2013.

Alternative Therapies = Reasonable Alternatives

• Massage – Cochrane 2015: short term benefit vs inactive controls

• Acupuncture – Lam in Spine 2013: reduced pain vs sham, improved function vs no

treatment

• Spinal manipulation – Cochrane 2011: short term benefit in pain and functional status.

Similar in efficacy to other interventions for chronic low back pain

Transcutaneous electrical nerve stimulation (TENs) therapy

• Low voltage electrical current for pain relief • Electrodes placed on the area of pain for relief

– May overwhelm pain signals – May stimulate endogenous endorphins

• Effectiveness not proven – Cochrane review inconclusive due to poor data

• Applied by clinician/physical therapist initially – Patient can repeat at home

Source: Nnoaham, 2008.

Epidural Steroid Injections • Annals review and meta-analysis, 2012

– Offers only short term relief of leg pain and disability for patients with sciatica

– “Small size of treatment effect raises questions about clinical utility of this procedure”

– Recent 2015 meta-analysis shows similar results for spinal stenosis/radiculopathy plus no effect on long term surgery risk

• Safety concerns-Fungal meningitis outbreak 2013 • Consider epidural steroid injections only after failure of non-

invasive treatments

Source: Chou, 2015 and Pinto, 2012.

“But the shot in the back didn’t work…” • There’s more than just epidural steroid injections:

– Nerve blocks – Facet blocks – Trigger point injections – Joint injections

• Cochrane 2008: Insufficient evidence of benefit. However, “it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy”

Pharmacologic Therapies

1st Line: Non-opioid analgesics • Neuropathic Pain

– Tricyclic antidepressants – SNRI antidepressants – Anticonvulsants – Topical anesthetics

• MSK/Inflammatory Pain (Nociceptive) – Acetaminophen – NSAIDs – Topical anesthetics – Muscle relaxers – SNRI antidepressants/ Tricyclics

Acetaminophen/NSAIDs • Acetaminophen

– Unclear data- negative study Lancet 2016 for OA pain, positive study in Pain Med 2017 – Relatively favorable side effect profile at low doses

• NSAIDs- are not all created equal – Variable pharmacodynamics amongst individuals

• Consider switching NSAIDs for non-response – 2017 study - diclofenac most effective for pain/function in knee OA patients

– Toxicities: drug interactions, GI, renal, cardiovascular – Topical NSAIDs?

• Short term relief if unable to tolerate oral NSAIDs

Source: Da Costa, 2016 and Yue, 2017.

NSAIDs: 2015 FDA Drug Safety Communication

• Increased risk heart attack/stroke – Risk increases as early as first weeks of use – Increased risk with longer use/higher dose – Can be in pts without risk factors but HIGHER likelihood in those with risk factors

• No risk factors: Less than 1 to 2 excess major vascular events per 1000 person-years • Risk for CV disease: More than 7 to 8 excess major vascular events per 1000 persons per year,

including 2 fatal events

– Pts who got NSAIDs in first year after first MI more likely to die – Increased risk of heart failure with NSAID use

NSAIDs and CV risk • Unclear if all NSAIDs have similar risk

– Previously naprosyn felt to be “heart healthy” NSAID? – Data from 2016 Precision study:

• Celebrex is non-inferior to ibuprofen and naprosyn – Is it superior? No worse CV outcomes but less GI bleeding. – Higher rates of kidney disease and hospitalization for HTN with ibuprofen at high doses

• Overall problems about 8% SEs with CV, GI, kidney problems • Flaws- loss to follow up, patient discontinuation and used higher doses of ibuprofen and naprosyn

• Nonselective NSAIDs and baby ASA – Caution with long term NSAIDs in people taking baby ASA for cardioprotective reasons

• NSAIDs may attenuate anti-platelet effect of ASA (ibuprofen less so)

Sources: Nissen, 2016 and FDA 2015.

NSAID Take Aways • Lowest dose for shortest duration

– Naprosyn vs ibuprofen vs celebrex?

• Avoid in patients with known cardiovascular disease • Caution in those with strong risk factors for CV disease

– In my practice this includes age especially when considering long term NSAID treatment

• Caution in patients taking baby aspirin for cardioprotective reasons • Watch blood pressure closely in patients on chronic NSAIDS

Tricyclics • Tricyclics often considered first line for neuropathic pain (unlabeled use) • Serotonin and norepinephrine inhibitory in pain pathway • Usual dose of amitriptyline is 25-100 mg/day; nortriptyline 10-75 mg/day. • Effective

– Pain decreased up to 51 to 58% • Side effects

– Anticholinergic – Sedation – Cardiac effects/QtC prolongation – Orthostatic hypotension – Many drug interactions

Source: Zin et al, 2008.

Pain Management Pearl

Nortriptyline (2nd generation TCA) has less anticholinergic side effects and sedation than amitriptyline (1st generation TCA)

Serotonin norepinephrine reuptake inhibitors (SNRIs)

• Duloxetine (Cymbalta) – Management of diabetic neuropathy as well as chronic MSK pain – Daily dosing up to 60 mg

• Cochrane 2014 suggests dosing somewhere between 60 to 120 mg daily for pain

– Side effects: nausea, fatigue, constipation – Generally better tolerated and fewer drug interactions versus TCAs

Sources: Quilici et al, 2009; Lunn et al.,2014 and Rowbotham et al, 2005.


Venlafaxine (Effexor) can be used off label for pain. It is generally less expensive. Often requires higher dosages

>150 mg/day for pain effect

Gabapentinoids • Gabapentinoids increasingly prescribed as opioid alternatives

– 2016: gabapentin 10th most common RX in USA – Pregabalin (Lyrica) ranked 8th in invoice drug spending 2016 ($4.4B)

• Many consider first line in neuropathic pain • Unclear data in chronic low back pain

– 2017 meta- analysis: gabapentinoids for chronic low back pain demonstrates significant risk of adverse effects without any demonstrated benefit

Sources: Goodman, 2017 and Shanthanna, 2017.

Gabapentin • Usual dose: 900-3600 mg/day • Unlabeled use for diabetic neuropathy

– High pain relief for 1/3 of participants – 66% experienced side effects – TID dosing- consider asymmetric dosing

• Common side effects: dizziness, sedation, weight gain, edema. • 2017 study with increased risk of opioid related death in patients

with concomitant gabapentin

Sources: Gomes, 2017; Moore 2014; Wallace, 2010; Toile,2008; Rosenstock, 2004;

Pregabalin – Better pharmacokinetics vs gabapentin

• Higher potency • More linear pharmacokinetics • Generally better tolerated

– Effective for diabetic neuropathy pain • 35 to 50% pain reduction for many • Up to 28% discontinued for dizziness/sedation • Usual dose of up to 300 mg/day

– Cost effectiveness – Abuse potential

Sources: Moore et al, 2009 and Tarride et al, 2006.


Both gabapentin and pregabalin have abuse/diversion potential, especially amongst current or past users of opioids and benzodiazepines. The abuse potential of

pregabalin is probably higher due to its pharmacodynamics with better bioavailability at higher

doses.

Sources: Goodman, 2017.

Topical Analgesics • Lidocaine -Analgesia established in post-herpetic neuralgia • Capsaicin- Depletes substance P in nerve fibers. FDA warning 2012-

association with chemical burns

– Poorly tolerated: Erythema in 63%, pain in 42% • 2017 Study: Topical analgesics effective and safe for the treatment of

chronic pain – Unmatched intervention group – Topicals included NSAIDs and non-NSAIDs (at clinician discretion) – Side effects reported <1%

Source: Giudin, 2017.

Skeletal Muscle Relaxers • Consider for muscular spasms • Side effects

– Sedation – Anticholinergic SEs (more with cyclobenzaprine)

• Avoid – Carisprodol (Soma)- metabolized to a barbituate – Chronic benzodiazepines


Cyclobenzaprine and tizanidine are more sedating (may help with insomnia), methocarbamol and metaxalone are less

sedating (but have less efficacy data)

?Medical Marijuana • Endocannabinoid system

– Broad range of neurologic & immunologic features

• Most data on effect on peripheral neuropathy, nausea and poor appetite – ? 3rd or 4th line agents for chronic neuropathic pain – ? 2nd line agent for central neuropathic pain in MS

• Many reports of utility for: – Anxiety, insomnia, MSK pain, inflammation, spasticity

Source: Ware, 2014

?Medical Marijuana • Safety profile: a barrier or a reason to use?

– Low risk of serious adverse drug reactions – Psychotropic effects – Dependency – Assoc with psychosis, MI, stroke, MVA, chronic bronchitis – 2014 study: Medical cannabis laws associated with lower state level opioid analgesic

overdoses – FEDERALLY ILLEGAL: NOT PRESCRIBED AT THE VA

• Method of delivery: cannabinoid extracts as the future? – Cannabinoid antiemetics as analgesics – Approval of herbal cannabis extract nabiximols in Canada

Sources: Ware, 2014 and Bachhuber, 2014.

Polypharmacy Can Be Beneficial

• Can target different symptoms • Can minimized doses of individual meds • Caution with serotonergic agents (SNRIs, TCAs, tramadol)

Source: Gilron, N Engl J Med 2005.

Chronic Pain is Complicated

Requires a multidisciplinary approach

Polypharmacy can be beneficial

Don’t forget non-pharmacologic interventions

Case 1 A potential regimen for her: • Switch to naproxen 500 mg BID PRN pain • Add acetaminophen 1000 mg BID PRN pain • Discuss with her psychiatrist change from citalopram to duloxetine

for pain management • Topical analgesic PRN • Can consider sedating muscle relaxer at night or low dose TCA at

night for neuropathic component

Non-pharmacologic RX

• Referral to the following specialties – PT – Structured program for weight loss – Acupuncture/ massage therapy or chiropractor – CBT for pain

Case 2: 68 yo M with spinal stenosis • 68 yo M with severe spinal stenosis on MRI. Symptoms are pain

with activity in low back radiating to legs. • Unable to take NSAIDs due to h/o GI bleed. Acetaminophen,

topicals, gabapentinoids, muscle relaxers all previously ineffective.

• PT, acupuncture and massage were ineffective. Has had multiple injections with no effect.

Case 2: 70 yo M with spinal stenosis • He has HTN and HL and h/o GI bleed on NSAIDs. • He the only caretaker for wife with Alzheimer’s and adult daughter with

TBI. Earns a living caring for large property plus pension. He denies alcohol or drugs.

• Pain is 7/10 at rest, up to 9/10 with activity – Increased difficulty with ADLs due to pain – He no longer enjoys working on his property due to pain – He refuses surgery as he must care for family.

• Exam shows pain on leg raise, limited ROM in back and mild hyperreflexia.

Case 2: 70 yo M with spinal stenosis • He recently went to urgent care with chronic back pain. • He was given tramadol with no effect and it caused blurred vision. • He was prescribed 3 days of oxycodone 5 mg which he has taken twice a

day. He reports pain is still 6/10 but he has good functional effect and is able to complete ADLs with less pain.

• He presents to you his PCP for pain management

Is he a candidate for a trial of opioid analgesics for her chronic non-malignant pain?

Image from terenceruffle.co.uk

Efficacy of Opioids for Chronic Pain? Controversial

• Shaheed et al in JAMA 2016 – Short term benefit (<3 months) of 10 pts from 100 pt pain scale in low back pain – Did not show clinically important pain relief in intermediate term – Discontinuation rates of 25-80% due to lack of efficacy/side effects

• Martel et al in Annals of Internal Medicine 2007 – No reduced pain scores with opioids versus non-opioid pain control – No trials longer than 16 weeks

• Cochrane Review 2007 – Opioids and tramadol help with pain relief and function – Concluded there are few high quality trials

• Kalso et al in Pain 2004 – Pain relief from opioids is modest: 2 to 3 points on a 0 to 10 scale – 80% experience at least one adverse event

Physiologic Effects of Chronic Morphine

• Tolerance to analgesic effects and increased pain sensitivities in animal models

• Changes in the nervous system similar to nerve injury causing hyperalgesia

• Management strategies: – Wean opioid – Opioid rotation

Sources: Ibuki, Pain 1997; Celerier, J Neurosci 2001.

Psychiatric Disease and Chronic Pain: Are we treating “Pain in the soul”

• Psychiatric disease is common in chronic pain – 30% to 54% prevalence of depression

• Substance abuse is common in chronic pain

– 36% to 56% prevalence of lifetime substance use

Sources: Martell, Ann Intern Med 2007; Banks, Psychol Bull 1996.

Are opioids a reasonable choice for my patient??

Are opioids a reasonable choice for my patient??

Consider opioids for chronic pain only for severe, refractory, disabling pain in patients who are:

1) Appropriately screened 2) Have failed other non-pharmacologic and pharmacologic therapies 3) Who show demonstrable functional improvement with opioids 4) Who do not have significant side effects

MOST PATIENTS WITH CHRONIC PAIN SHOULD NOT BE PRESCRIBED CHRONIC OPIOIDS

Medical Comorbidities to Consider

• Central sleep apnea and moderate to severe OSA • Dementia • Falls • Patients requiring other sedating drugs (eg chronic benzos) • Potential for pregnancy/breast feeding • Renal/hepatic impairment • Psychiatric disease/substance abuse hx

Opioid Risk Tool, © Lynn R Webster, MD

Reprinted with permission by author

FHx Substance Abuse Female Male Alcohol Illegal drugs Prescription drugs Personal Hx Substance Abuse Alcohol Illegal drugs Prescription drugs Age between 16 to 45 Hx preadolescent sexual abuse Psychiatric disease OCD, bipolar, schizophrena Depression Scores: 0-3= low risk, 4-8 moderate risk, >8 high risk

1 2 4 3 4 5 1 3 2 1

3 3 4 3 4 5 1 0 2 1

Risk of Misuse with Opioids • Generally do not prescribe in primary care for

– Untreated psychiatric disease – Active substance abuse

• High or moderate risk – EITHER, do not prescribe opioids without consultation from

pain clinic – OR prescribe with close monitoring

• Low risk – Opioid trial

Tramadol?

• Opioid-like analgesic • Controversy re: abuse potential • Consider trial for severe pain after other non-opioids fail • Recommend similar informed consent, contraindications and

monitoring as opioids • Side effects- especially seizures • 2014- Schedule IV Controlled Substance

If you consider an opioid trial… • Start with a low dose

– Eg oxycodone 2.5 to 5 mg BID PRN pain

• Avoid combination pills (Percocet, Vicodin) – 2013 FDA limitations on combination pills

• Vicodin (hydrocodone/acetaminophen) now schedule II • Limit of 325 mg acetaminophen per capsule in combined products

• Avoid Brand Names • Avoid mixture with other central acting drugs

Opioid Trial

• Informed Consent • Set Functional Expectations • Pain Agreement • Prescription Monitoring Program • Baseline Urine Toxicology Screening

Informed Consent

• Coombes vs. Florio, 2007 – Failure to warn

• Risks of – Sedation/confusion – Delayed reflexes/response – Tolerance/addiction – Endocrine concerns – Overdose

• Side Effects

Pain Medication Agreement • Prescriptions for opioids from only one provider • No sharing prescription opioids with others • Medications will be taken as prescribed (i.e. correct route, no unsanctioned

dose escalations) • Lost/stolen prescriptions will not be refilled • No early refills • No illegal substances, non-prescribed opioids/benzos • Regular follow up with physician (every 3-6 months) • Requirement to submit to random urine toxicology screening

Inappropriate Use of Opioids

• Inappropriate use of opioids or concurrent use of illicit substances is present in 3 to 43% by estimates

• Reid et al saw inappropriate use of opioids in ―31% in an urban hospital based primary care clinic ―24% in a Veterans Administration outpatient clinic

Sources: Reid, 2002; Edlund, 2010.

Diversion

• Pharmacy price of oxycontin 20 mg tablet – Approx. $2

• Street value of oxycontin 20 mg tablet – Approx. $10 to 20

• Oxycontin still slightly more valuable – New protection against crushing makes slightly less valuable – Still more euphoria – Methadone and MS contin less valuable

Prescription Monitoring Program

• MA Department of Public Health • Solicited reports on schedule II-V drugs • Limits include

– Data quality – Time lag – Patient tracking

Urine Toxicology

• Prior to initiation and at least one “random” test per year at a clinic visit – More if suspect diversion/abuse

• Document last dose, quantity, who is prescribing medication and other drug use

Inappropriate Urine Tox Results

• Refusal to submit to testing • Positive for the following:

– ? Marijuana – Cocaine – Amphetamines – Non-prescription benzodiazepines – Non-prescribed opioids (ie positive hydromorphone but prescribed

oxycodone) • Inappropriately negative for prescribed opioid if on long acting

daily opioids

Cheat Sheet for Urine Toxicology • Immunoassay (DAU urine test)

• “Screening Test” • Fast, cheap • Good for drugs of abuse • May not detect low level of oxycodone

– Make sure your lab has an oxycodone immunoassay! • More false positives/negatives

• GC/MS (must add on via VISTA email)

– “Confirmatory test” – Slower, much more expensive

• Most opioids present in urine 2-4 days

Reference Cheat Sheet for Urine Toxicology • Opium Alkaloids

– Positive for opioids on immunoassay – Includes morphine and codeine

• Semi-Synthetics – May be positive for opioids on immunoassay, often negative – Hydrocodone- derivative of codeine. Metabolized to hydromorphone – Oxycodone- major metabolite is oxymorphone – Heroin- metabolized to morphine so will be positive for opioids on immunoassay.

6-acetylmorphine is byproduct

• Synthetics – Negative for opioids on immunoassay – Fentanyl and methadone require special testing

Highlights of MA Substance Use Law 3/2016 • A new opioid prescription for an adult may not exceed 7 days

– Some exceptions including treatment of substance abuse, if the prescriber feels longer supply is necessary for treatment of an acute medical condition, chronic pain management, or pain associated with a cancer diagnoses or for palliative care (must document why and that non-opioid was not appropriate)

Highlights of MA Substance Use Law 3/2016 • Schedule II opioid prescription must include discussion of

the risks associated • Option for partial fill

– Requires that prescriptions for Schedule II narcotics should include a note that it may be filled at a lower amount

• More support for substance abuse treatment

Patient Follow up • Patient trial of oxycodone 2.5 to 5 mg BID for pain • Pain level still 6/10 but patient is able to achieve more ADLs,

starts aquatherapy and able to do more around the house • Denies side effect of medication

Case 3

• 70 yo M with chronic stable angina and PTSD presents for new patient visit and renewal of pain medications

• He has been followed in the clinic for years and has been on oxycontin 40 mg TID for his right knee osteoarthritis prescribed by a former colleague

• He reports good pain relief on this regimen. Pain is 3/10 and he feels opioids allow him to be active with grandkids. Denies adverse effects.

Case 3 • Chart review shows signed opioid agreement, appropriate urine

toxicology screens, no early refills or behavioral concerns. On a stable regimen the past 7 years.

• He is married and has children. Retired. Former alcohol use disorder 20 years ago, since sober. Non smoker and no illicits.

• He refuses a knee surgery due to his CAD. • Reports mood is good, works with psychiatry and takes

paroxetine.

Case 3 • Meds: CAD regimen, oxycontin, paroxetine • On exam he a normal BMI, right knee crepitus, walks with

cane. Otherwise exam unremarkable. • Knee imaging has been notable for mild OA. • Unable to use TCA/NSAIDs due to CAD. Skeletal muscle

relaxers/gabapentinoids too sedating.

Case 3 He is due for a refill of his oxycontin. He tells you this is the only medication that has ever helped him and you need to refill it so he can have a quality of life despite his pain. Do you refill his prescription today? 1. Yes, he is stable on this dose with no red flags 2. Yes, but I would make changes 3. Yes, but recommend complete taper 4. No and provide withdrawal medications

The 6As: Monitoring Patients with Chronic Non-malignant Pain on Opioids

• Analgesia: assess pain relief • Affect: evaluate mood • Activities: evaluate ADLs, function and QOL • Adjuncts: non-pharmacologic or non-opioid treatments • Adverse effects: side effects of treatment • Aberrant behavior: tolerance, dependence and addiction

Longer Acting Opioids vs Shorter Acting Opioids

• Previously, it was felt longer acting medications may provide better long term pain relief- this has not been shown – 2017 non-randomized study of OA patients on short vs long acting opioids

• No significant difference in pain scores • Lower average morphine equivalent daily dose with short acting

• Risks: increased risk of overdose with longer acting opioids • I try to avoid longer acting opioids

Source: Ghodke, Pain Med, 2017.

Long Acting/Extended Release Opioids

• Never use in opioid naieve patients • Consider starting with:

– Morphine Sulfate Extended Release – Oxycodone Controlled Release

• Generally reserve for opioid rotation: – Methadone – Fentanyl – Hydromorphone Extended Release (Exalgo) – Long acting buprenorphine (Butrans)

Abuse Deterrent Opioid Formulations • Abuse deterrent formulations stand up to common methods of

abuse – Crushing, heating, breaking and dissolving – Does NOT protect from overdose

• Only brand named opioid products have approved opioid deterrent labeling from FDA – Reformulated Oxycontin (oxycodone) – Targiniq (oxycodone/naloxone) – Embeda (morphine/naltrexone) – Hysingla (hydrocodone ER) – Xtampza ER (oxycodone)

What I recommended for this patient

• Discussed concern with him regarding high dose opioid and long term safety and recommendation for weaning opioids.

• How to discuss this?

What I did for this patient • Readdressed surgery- patient refused • Started lidocaine patch • Emailed psychiatrist re change for duloxetine (which patient

ultimately declined) • Referred for knee injection • Began a slow opioid taper (40/30/40) with hopes of decreasing

and getting to short acting

What I did for this patient

• Prescribed take home naloxone • Received multiple emails from patient with concern about

increasing pain, request for early refill due to a holiday • Will continue taper and increase monitor efforts

Pain Management Pearl: Consider take home Naloxone

• Consider for patients on chronic opioids – Esp for >50 MME/day and/or long acting opioids, h/o substance

abuse and/or concurrent benzo use

• Efficacy better established in heroin users Reduction overdose mortality – Studies ongoing in patients with chronic pain

• Opportunity to again discuss risks of opioids with patients

Source: Leavitt, 2010.

Intranasal Naloxone

• Intranasal formulation is off label • RX

– Two prefilled naloxone syringes – Mucosal Atomization Device – Sig: Spray 1 ml in each nostril. Repeat after 3 minutes if no or minimal

response. Include info sheet.

• Educate family and caregivers

Naloxone Information Sheet

Now what if we were to discontinue patient..

Case 3 Continued

• Let’s say patient begins requesting multiple early refills – Trip to ER for chronic pain requesting meds

• Confirmatory urine testing neg for rx opioids • Patient misses multiple appointments with providers, does not

engage in adjunctive care • Represents asking for early refill, pain 11/10, exam unchanged

Case 3 Continued

• Given multiple violations of pain agreement and inappropriate confirmatory urine toxicology screen, you recommend stopping chronic opioid therapy.

• How to discuss this?

How to Discontinue a Patient from Opioids

• Discuss with patient and document specific reasons for discontinuation

• If taper, document plan and provide to patient in writing • Discuss alternative pain regimen therapies

– Reassure patient you will continue to treat their pain in other ways

• For suspected substance abuse or psychiatric disease, provide appropriate referral

Opioid Taper?

Withdrawal symptoms

• Clonidine for withdrawal sxs. – Start with low dose, monitor for hypotension

• NSAIDs for achiness • Antiemetics • Antidiarrheals • Sleeping medication with low abuse potential (eg

trazodone) • Consider musle relaxer such as cyclobenzaprine for

spasms, avoid SOMA and benzos

“You have to prescribe these to me, they are the only thing that work!”

• There is NOT an obligation to prescribe opioids – If the risks outweigh the benefits, then provide the patient with an

alternative pain plan

• An opportunity to review with current patients on opioids the new data on risks and consider tapers

Pain Management Pearl: MA Voluntary Non-Opioid Directive Form

• Care provider must record in patient’s record if he/she receives a signed Directive

• Prior to prescribing opioid, a provider should check the medical records to see if a Directive has been recorded.

• Unless revoked by the patient verbally or in writing, a provider should consider a signed directive as the patient’s non-consent to opioid treatment.

http://www.mass.gov/eohhs/docs/dph/substance-abuse/non-opioid-directive.pdf

Can weaning chronic opioids help pain? • Murphy et al in Clin J Pain 2013

– VA hospital pain rehabilitation treatment program, retrospective – At start of program, patients RX’d opioids agreed to wean off, studied versus patients not RX’d

opioids – Improvement across all outcome for patients for participants (n=600) – Patients who weaned off opioids improved as much or more than the never opioid treated

group on all measures despite opioid cessation during treatment.

• Townsend et al in Pain 2008 – Longitudinal design (n=373) in a comprehensive pain rehabilitation program – 57.1% of patients RX’d opioids for pain at onset- this group had higher pain severity and

depression scores at onset. Opioids were weaned during the program – Significant improvement was found on all outcome variables after treatment and 6 months

post-treatment with NO differences between the initial opioid and non-opioid groups

Take Home Points

• Feel empowered to treat patients’ pain – Non-opioid therapy and non-pharmacologic

therapy are first line – Assess pain based on functional goals – Opioids should be considered a last resort

and prescribed only after careful patient screening

– Often requires a multi-modal approach

Image from mancrohns.wordpress.com

Questions?

Selected References • Banks S, Kerns R: Explaining high rates of depression in chronic pain: A diathesis-stress

framework.Psychol Bull 1996;119:95—110 • Centers for Disease Control and Prevention. National Vital Statistics System mortality

data. (2015) Available from URL: http://www.cdc.gov/nchs/deaths.htm. • Celerier et al. Progressive enhancement of delayed hyperalgesia induced by repeated

heroin administration: a sensitization process. J Neurosci 2001; 21:4074-80. • Chappel AS et al. A double-blind, randomized, placebo-controlled study of the efficacy

and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract 2011; 11(1): 33-41.

• Chou R et al. Epidural Corticosteroid Injections for Radiculopathy and Spinal Stenosis: A Systematic Review and Meta-analysis. Ann Int Med 2015; 163(5): 373-81.

• DaCosta et al. Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet 2016; 387:2093-2105.

• Deshpande A et al. Opioids for chronic low-back pain. Cochrane Database of Systematic Reviews 2007, Issue 3.

• Dunn KM et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med2010;152: 85-92.

• Finan PH et al. The association of sleep and pain: An update and path forward. Jpain 2013; 14(12): 1539-52.

• Gilron I et al. Morphine, Gabapentin, or Their Combination for Neuropathic Pain. N Engl J Med 2005; 352:1324-1334.

• Gomes et al. Gabapentin, opioids, and the risk of opioid-related death: A population-based nested case–control study. PLOS Medicine; https://doi.org/10.1371/journal.pmed.1002396

http://www.cdc.gov/nchs/deaths.htm

https://doi.org/10.1371/journal.pmed.1002396

Selected References • Ibuki et al. Effect of transient naloxone antagonism on tolerance development in rats

receiving continuous spinal morphine infusion. Pain 1997; 70:125-132. • Institute of Medicine of the National Academies Report. Relieving Pain in America: A

Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC. American Academy of Pain Medicine.

• Johnston LD et al.. Monitoring the Future: National Results on Adolescent Drug Use, Overview of Key Findings 2006. National Institute on Drug Abuse, Bethesda, MD, 2007.

• Kalso E et al. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 2004; 112: 372-380.

• Kang JW et al. T’ai chi for the treatment of osteoarthritis: a systematic review and meta-analysis. BMJ 2011 (1): e000035.

• Keefe FJ. Cognitive behavioral therapy for managing pain. The Clinical Psychologist, 49(3): 4-5.

• Kelly JP et al. Prevalence and characteristics of opioid use in the US adult population. Pain. 2008; 138(3): 507-13.

• Krebs EE et al. Development and Initial Validation of the PEG, a Three-item Scale Assessing Pain Intensity and Interference. J Gen Intern Med. 2009 Jun; 24(6): 733–738.

• Leavitt SB. Intranasal Naloxone for at home opioid rescue. Practical Pain Management 2010.

• Li F et al. Tai chi and postural stability in patients with Parkinson’s disease. NEJM 2012; 366: 511-9.

• Lunn et al. Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. Cochrane Database Syst Rev 2014; 1: CD007115.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2686775/

Selected References • Manchikanti et al. Evaluation of abuse of prescription and illicit drugs in chronic

pain patients receiving short-acting (hydrocodone) or long-acting (methadone) opioids. Pain Physician. 2005; 8(3): 257-61.

• Martell BA et al. Systemic review: opioid treatment for chronic back pain: prevalence, efficacy and association with addiction. Ann Intern Med 2007; 146(2): 116-127.

• Moore RA et al. Gabapentin for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2014 Apr 27;4:CD007938.

• Nissen et al. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med 2016 Nov 13.

• Nnoaham NE and Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD003222. doi: 10.1002/14651858.CD003222.pub2.

• Narayana A, et al., A healthcare claims database analysis to estimate the prevalence of chronic opioid use in adult patients in the United States. AAPM 2009; abstract 278.

• Pinto RZ, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Annals of Int Med 2012; 157 (12): 865-877.

• Ray WA et al. Prescription of Long-Acting Opioids and Mortality in Patients with non-cancer Pain. JAMA 2016; 315 (22): 2415-23.

• Shaheed et al. Efficacy, Tolerability, and Dose-Dependent Effects of Opioid Analgesics for Low Back Pain: A Systematic Review and Meta-analysis. JAMA Intern Med. 2016 Jul 1;176(7):958-68

http://www.ncbi.nlm.nih.gov/pubmed/24771480

https://www.ncbi.nlm.nih.gov/pubmed/27213267

https://www.ncbi.nlm.nih.gov/pubmed/27213267

Selected References • Trescot et al. Opioids in the management of chronic non-cancer pain: an update of

American Society of International Pain Physicians (ASIPP) Guidelines. Pain physician. 2008 11(2):L S5-62.

• Turk DC, Theodore BR. Epidemiology and economics of chronic and recurrent pain. In: Lynch ME ME, Craig KD, Peng PWH, editors. Clinical pain management: a practical guide. Hoboken: Blackwell; 2011. pp. 6–13.

• Upshur CC et al. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med 2006; 21(6): 652-655.

• US Food and Drug Administration. FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. Available at http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm. Accessed 9/14/2015

• Vital Signs: Overdoses of Prescription Opioid Pain Relievers --- United States, 1999--2008, Centers for Disease Control and Prevention Analysis: Morbidity and Mortality Weekly Report (MMWR), November 4, 2011 / 60(43); 1487-1492.

• Volkow ND and McLellan AT. Opioid Abuse in Chronic Pain- Misconceptions and Mitigation Strategies. N Engl J Med 2016; 374:1253-63.

• Ware MA and Desroches J. Medical Cannabis and Pain. Pain: Clinical Updates, October 2014.

• 2009 National Survey on Drug Use and Health (NSDUH): National Findings, SAMHSA (2010).

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

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