pathophysiology of injury acute pain...5/4/19 5 pain is a public health problem chronic pain is a...
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TAPERING OPIOIDS, BUPRENORPHINE and the ROLE of the PATIENT’S PHARMACIST
Ann LaPolla, DNP, JD, MPH , Legal Counsel NADDI Opioid Task ForceDean Healey, RN DOPL Investigator
Co-chairs Utah NADDI Opioid Task Force
What is pain?
In 1968, McCaffery defined pain as “whatever the experiencing person says it is, existing whenever s/he says it does”.
Pain is a subjective experience with no objective measures.
The patient, not clinician, is the authority on the pain and that his or her self-report is the most reliable indicator of pain.
In 1979, the International Association for the Study of Pain (IASP) definition of pain: an “unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.’’
Pain is a complex experience with multiple dimensions.
Pathophysiology of injury
Injury to tissue causes cells to break down and release various tissue byproducts and mediators of inflammation (e.g., prostaglandins, substance P, bradykinin, histamine, serotonin, cytokines).
Acute Pain
Complex, unpleasant experience with emotional and cognitive, as well as sensory, features that occur in response to tissue trauma
Associated with pathology
Usually resolves with healing of the underlying injury
Usually nociceptive, but may be neuropathic
Examples: trauma, surgery, labor, medical procedures, and acute disease states
Chronic Pain
Pain that extends beyond the period of healing
Levels of identified pathology are often low and insufficient to explain the presence and/or extent of the pain
Disrupts sleep and normal living
Ceases to serve a protective function
Degrades health and functional capability
Chronic pain serves no adaptive purpose
Chronic pain
May be nociceptive, neuropathic, or both
Caused by injury (trauma or surgery), malignant conditions, or chronic non-life-threatening conditions (arthritis, fibromyalgia, neuropathy)
May exist de novo with no apparent cause
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Neuropathic pain
Caused by aberrant signal processing in the peripheral or central nervous system
May be peripheral or central
Reflects nervous system injury or impairment
Pathologic pain because it serves no purpose
Pathophysiology of chronic NP Occurs when pathophysiologic changes become
independent of the inciting event
Sensitization plays an important role in this process
Nerve injury triggers changes in the CNS that can persist indefinitely
Central sensitization explains why NP is often disproportionate to the stimulus or occurs when no identifiable stimulus exists
Central Sensitization
State of spinal neuron hyperexcitability (may be caused by opioids)
May be caused by tissue injury, nerve injury or both
Ongoing nociceptive input from the periphery is needed to maintain it
“Wind-up”: repeated stimulation of C- nociceptors initially causes a gradual increase in the frequency of DH neuron firing
Activation of N-methyl D-aspartate (NMDA) receptors
Importance of peripheral sensitization
Role in central sensitization
Role in clinical pain states:
Hyperalgesia: increased response to a painful stimulus (may be caused by opioids)
Allodynia: pain caused by a normally innocuous stimulus (air, clothing in Complex Regional Pain Syndrome “CRPS”)
Characteristics of NP
Continuous or episodic
Burning, tingling, prickling, shooting, electric shock-like, jabbing, squeezing, deep aching, spasm, or cold
Categories of neuropathic pain
Painful peripheral mononeuropathy and polyneuropathy (diabetic neuropathy, carpal tunnel)
Deafferentation pain (postmastectomy pain, phantom limb pain)
Sympathetically maintained pain (CRPS, postherpetic neuralgia)
Central pain (post-stroke pain, cancer pain, MS pain)
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Causes
Metabolic disorders (e.g., diabetes)
Toxins (e.g., alcohol chemotherapy agents)
Infection (e.g., HIV, herpes zoster)
Trauma
Compressive (nerve entrapment)
Autoimmune and hereditary diseases
Clinical states
Diabetic neuropathy
Alcoholic neuropathy
Post-herpetic neuralgia
Carpal tunnel syndrome
Deafferentation Pain
Pain that is due to a loss of afferent input
Quality: burning, cramping, crushing, aching, stabbing or shooting
Hyperpathia/Hyperalgesia : exaggerated response to painful stimuli
Dysesthesia: MS, altered, uncomfortable sensation that may not be painful
Other abnormal sensations
Causes
Damage to a peripheral nerve, ganglion, or plexus
CNS disease or injury (occasional)
Clinical states
Phantom limb pain
Post-mastectomy pain
Sympathetically Maintained Pain
Quality: burning, throbbing, pressing, or shooting
Allodynia
Hyperalgesia
Associated ANS (automatic nervous system) dysregulation and trophic changes (changes in skin, tissue, muscles, bones, i.e. wasting, thinning, thickening)
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Causes
Peripheral nerve damage: CRPS
Sympathetic efferent (motor) innervation
Stimulation of nerves by circulating catecholamines
Clinical states
CRPS
Phantom limb pain
Post herpetic neuralgia
Some metabolic neuropathies
Central Pain
Quality: burning, numbing, tingling, shooting
Spontaneous and steady or evoked
+/- sensory loss
Allodynia
Hyperalgesia
Causes
Ischemia (e.g., stroke)
Tumors
Trauma: spinal cord injury
Demyelination
Clinical states
Post-stroke pain
Some cancer pain
Pain associated with multiple sclerosis
Prevalence of pain
Pain is the most common reason why patients seek medical care
An estimated 100 million Americans suffer from chronic pain
Most common types of chronic pain are neck and low back pain, myofascial/FM pain, HA, arthritis and neuropathic pain
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Pain is a public health problem
Chronic pain is a chronic illness
Affects at least 100 million American adults
Costs society $560–$635 billion annually
Federal and state costs almost $100 billion annually
Consequences of untreated pain
Endocrine/metabolic: altered release of multiple hormones leading to metabolic disturbances as evidenced by weight loss, fever, shock, increased RR and HR
CV: increased HR, vascular resistance, BP, myocardial oxygen demand, hyper coagulation leading to CP, MI and DVT
Respiratory: decreased air flow 2/2 reflex muscle spasm and splinting that limit respiratory efforts leading to atelectasis and PNA
Consequence of untreated pain
GI: decreased gastric motility leading to delayed gastric emptying, constipation, anorexia, ileus
Musculoskeletal: muscle spasms, impaired muscle mobility and function leading to immobility, weakness and fatigue
Immune: impaired immune system leading to infection
GU: abnormal release of hormones that affect UO, fluid volume and electrolyte balance leading to decreased UO, HTN and electrolyte imbalances
Prevention of chronic pain
Poorly controlled acute pain may lead to chronic pain
Chronic neuropathic pain (post-mastectomy pain, post-thoracotomy pain, phantom limb pain) may be caused by lack of appropriate pain management and/or failure of early rehabilitation
The risk of post herpetic neuralgia may be increased with inadequate pain control of acute herpes zoster
Importance of prevention of chronic pain
Patient: quality of life 2/2 decreased risk of a chronic disease
Society: decreased lost dollars in productivity
Health care system: decreased cost
Insurance companies: decreased expenditures
Inadequate control of pain interferes with quality of life
Ability to carry out activities of daily living, i.e. work, relationships, hobbies
Adverse psychological consequences, i.e. anxiety, fear, anger, depression, or cognitive dysfunction
Suicidal ideation
Family members report varying levels of helplessness, frustration, fatigue
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Financial consequences of under treated pain
Patients, families, health care organizations, and society bear the financial burden
Patients with chronic pain are five times as likely as those without chronic pain to use health care services
Lost productivity and income; patients are often unemployed or underemployed
Leading cause of medically related work absenteeism; results in more than 50 million lost work days per year in the United States
Misconceptions about pain
Physical or behavioral signs of pain (e.g., abnormal vital signs, grimacing, limping) are more reliable indicators of pain than patient self-report.
Elderly or cognitively impaired patients cannot use pain intensity rating scales.
Pain does not exist in the absence of physical or behavioral signs or detectable tissue damage.
Pain without an obvious physical cause, or that is more severe than expected based on findings, is usually psychogenic.
Comparable stimuli produce the same level of pain in all individuals (i.e., a uniform pain threshold exists).
Prior experience with pain teaches a person to be more tolerant of pain.
Misconceptions about pain II
Analgesics should be withheld until the cause of the pain is established.
Non-cancer pain is not as severe as cancer pain.
Patients who are knowledgeable about pain medications, are frequent emergency department patrons, or have been taking opioids for a long time are necessarily addicts or “drug seekers.”
Use of opioids in patients with pain will cause them to become addicted.
Patients who respond to a placebo drug are malingering.
Neonates, infants, and young children have decreased pain sensation.
2019 HHS DRAFT REPORT
“Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations” hhs.gov
Comments closed 04/2019
Pain Management Best Practices Inter-Agency Task Force: 29 experts
Comprehensive Addiction and Recovery Act (CARA) 2016
HHS Task Force: Concepts
Balanced pain management: biopsychosocial model of care
Individualized patient-centered care
Appropriate risk assessment
Multidisciplinary
Stigma
Education
HHS Best Clinical Practices
Medications
Buprenorphine
FDA approved for pain
partial agonist at mu opioid receptor
decreased risk for respiratory depression
safer than full agonists
antagonist at the kappa receptor decreasing anxiety and depression
problems with insurance prior-auth
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Chronic Pain Assessment
Use Non-pharmacologic and Non-opioid Pharmacologic Therapies as Alternative Treatments to Opioids
Opioid medications are not the appropriate first line of treatment for most patients with chronic pain
Other non-pharmacologic and non-opioid pharmacologic therapies, should be tried and the outcomes of those therapies documented first
Opioid therapy should be considered only when other potentially safer and more effective therapies are proven inadequate
Combination therapies with opioids
Assure that use of opioid pain treatment does not interfere with early implementation of functional restoration programs, such as exercise and physical therapy
Identify if Benefits Outweigh the Risks
Consider initial and ongoing risks associated with opioid exposure based on:
age of the patient
history of substance use disorder
psychiatric, physical, or medical co-morbidities.
Only consider opioid therapy when expected benefits of pain improvement, function, and quality of life are anticipated to outweigh the risks
Definitions
Tolerance: a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time
Physical dependence: a state of adaptation that often includes tolerance and is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist
Addiction (SUD)
A primary, chronic, neurobiological disease, with genetic (40-60%), psychosocial, and environmental factors influencing its development and manifestations
Characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving
Triaging patients
Is the patient taking opioids?
No: use other modalities, avoid starting opioids, assess and treat co-morbidities: obesity, diabetes, PVD, PAD, heart failure, HTN
Yes: assess for underlying qualifying medical conditions, calculate MME, assess for hyperalgesia, assess for addiction, assess for risk (ORT), assess for misuse, assess for sleep apnea, OIC, adverse effects of opioids, review and verify medical records and imaging, talk to treating physicians
Triaging patients: medical conditions
Low back pain, headaches/migraines, FM: opioids are not recommended, not effective and may increase pain, multiple modalities
Acute pain: assess dose, fix what can be fixed, multiple treatment modalities, establish taper plan or plan to transition to buprenorphine, opioids should be used only 3-10 days depending on surgical procedure, SLVAMC discharges all surgical patients on BUP
Chronic pain: identify type (s) (NP, AP, CS, PS), fix what can be fixed, re-image and re-evaluate, taper plan, transition to buprenorphine, multiple modalities, chronic pain patients can taper off opioids
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Palliative Care and Hospice
Palliative Care: life-limiting condition, goals are comfort and maintenance of function, establish taper plan, lowest effective dose to maintain function and quality of life, buprenorphine trial-well tolerated
Hospice: < 6 months to live, only a 6 month benefit, patients transition to palliative care to requalify for hospice benefit, patients are now graduating from hospice, taper plan, buprenorphine is well-tolerated
Education and Counseling
Crucial at every interaction
Assess reading level of individual patient
Identify barriers to learning
Individualized learning plans
Mandatory classes:
Opioid overdose recognition and Narcan administration class 2 x year
Opioid class 2 x year: safety, medications, adverse effects, choices
Healthy Lifestyles Class: nutrition, physical activity, motivation, pain management skills
Substance Use Disorder Class every month
Support Groups
Opioid Taper Support Group
Buprenorphine Support Group
SUD Support Group
Patient Shaming (Stigma)
Don’t do it: vulnerable fragile patients with co-existing psychiatric issues
risk of self harm (abandonment of Suboxone Rx and return to heroin) and suicide
patients feel worthless, embarrassed, loss of motivation to continue taper and/or treatment
Risk to HCP, patients and 3rd parties
Use techniques to de-escalate the situation
Call the prescriber, if prescriber won’t cooperate call DOPL or DEA
Refuse the prescription
don’t personalize it
safety reasons
call for help
Tapering Opioids
Dignity and Respect
Identify underlying medical, psychological and social issues
Fix what can be fixed: use multi-modal approach
Rapid tapers do not work
Slow process, may take 2-4 years for LTHD opioids
Must develop trust
Listen to the patient
Reasons to Taper Opioids
Patient safety issues: aberrant behaviors, SUD, OD, self harm, harm to others
Opioids no longer control patient’s pain
Patient desires to stop opioid therapy
Opioids were never medically necessary
Opioids are no longer medically necessary
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The conundrum of opioid tapering in long-term opioid therapy for chronic pain: A commentary Ajay Manhapra, MD, Albert J. Arias, MD and Jane C. Ballantyne, MD
https://doi.org/10.1080/08897077.2017.1381663
Complex Persistent Dependence in LTOT: grey area between dependence and addictionManifested by desire to continue or increase opioids despite provider’s recommendations to taper and discontinueSigns and symptoms: worsening pain, worsening function, sleep disturbances, protracted withdrawals with taperBuprenorphine recommended: long half-life, ceiling on adverse effects, breaks reward cycle, allows safer and more comfortable taper
Rapid tapers
Inpatient detox: OD, self harm, harm to others, aberrant behaviors, physician abandonment of practice
Buprenorphine transition stops withdrawals and provides pain relief
Must evaluate continued treatment with MAT for long term success
Must continue therapy and psychological support for best outcome
Tapering Opioids
Part of tapering is holding the taper
Encourage alternative modalities and skills for pain control
Therapy and counseling are crucial
Written Taper Plan
Continual reassessment of patient’s tolerance of taper
Realistic goals
Example Opioid Taper PlanInsurance: University of Utah MedicaidRestricted Medicaid: YCase Worker: XXXXRestricted pharmacies: Y University of Utah UNIPalliative Care: consult completed with U PalliativeTransfer from hospice: NDiagnoses: 60% 3rd degree burn, necrotic LLE, failed fem-fem bypassAffiliated providers: vascular surgery, PCP, U of U psychiatry, OP Burn Clinic, U of Utah anesthesiaFailed therapies: PT, fem-fem bypass, multiple failed graftsFuture therapy: skin grafting scheduled in one weekCurrent therapies: Xarelto, high dose oxycodone and methadoneEstimated length of opioid therapy: unknownCurrent MME: patient stopped opioids 40 hours agoTaper plan: transition to buprenorphine for pain management, Buprenorphine Induction today: tolerated fair; notified patient that I will not prescribe high dose >90 MME to patient; he should be through withdrawals; if he returns to high dose opioids, he is at risk for overdose and deathGoal MME: 0Patient has been counseled regarding the need to taper for health and safety reasons. CDC and American Pain Academy Guidelines reviewed with patient. Risks of long term opioid therapy discussed with patient. Please do not fill opioids, benzodiazepines or Soma for patient written by other providers. Patient is restricted to: Ann E. LaPolla, APRNOpioid Therapy Contract Requested by Pharmacy: YOpioid Therapy Contract faxed to pharmacy: Y
Benefits of multi-disciplinary teams
Members: multiple providers (PCP and specialists), pharmacist, psych, social worker, chaplain
Essential in complex patients with co-morbidities
Effective and efficient care for patients, rapid response to patient needs
Continuity of care
Ease of transition between levels of care: acute inpatient to palliative to hospice to palliative
Multidisciplinary Teams: Managing and tapering opioids
Risk-benefit analysis of opioids
Probable length of opioid therapy
Lowest effective dose
Alternatives to opioid therapy
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NADDI OPIOID TASK FORCE
Multidisciplinary Teams
Composed of members from DOPL, DEA, FBI, AG Office, local law enforcement, case management teams from insurance providers and hospitals, ED physicians, Pain Management physicians, Addiction and Recovery HCP, Psychiatrists, Pharmacists
Non-disciplinary approach, prevention
Team 1: intervention, triage and placement of patients when providers are removed from practice or abandon practice
Team 2: support for providers caring for LTHD patients
Benefit: Regulatory support for taper and transition plans, health and safety of patients, health and safety of providers
Acute on chronic pain case study
38-year-old female s/p pancreatic transplant, end-stage renal disease on HD, heart failure, pulmonary HTN, osteoporosis, tube feeds for low albumin, recent MVC cervical spine pain, MRI confirms severe central stenosis 2/2 multiple herniated discs and vertebral displacement, scheduled for immediate cervical fusion
Chronic pain issues: severe pain during and following HD 2/2 noncompliance with fluid restriction
Current opioid therapy: Oxycodone 5 mg po bid following HD, #24 for 30 days
Goal of current opioid therapy: increase compliance with HD, hx of missing HD 2/2 pain
Case study
Team members: PCP, pain management, nephrology, cardiology, pulmonology, GI, transplant, neurosurgery, anesthesiology psych, nutrition, pharmacy, social work
Medication issues: on transplant meds, immunosuppressed, no steroids, no NSAIDs
Allergies: NKMA
Current issue: post-operative pain management for multi-level fusion
Case study
Desired outcome: effective intra- and post-operative pain management, taper back to baseline MME of < 10
Effective pain management: allows appropriate progress in rehabilitation and return to prior level of functioning
Remember goal: compliance with HD
Communication between team members
Notes faxed to all team members
One pharmacist for all medications
Opioid and taper plan faxed to all team members for comments
Who will manage immediate post-operative pain? pain at discharge? Communicate with pharmacist
Phone calls between team members for rapid changes
Specific issues with HD patients
AKF: all patients on HD are palliative
Patients can choose not to go to HD and die quickly
Patients require close surveillance for early interventions
Patients on HD become frustrated and fatigued; more likely to give up
Not enough evidence to support safety of buprenorphine in HD patients
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BRAVO METHOD OF TAPERING Anna Lembke, MD Stanford University 2018
Broaching the subject: empathy, time and addressing fears
Risk-benefit calculator: function, safety, risks of continuing on opioid therapy
Addiction happens: difference between dependence and addiction
Velocity and validation: go slow, engage patients, never go backwards
Other strategies for controlling pain
Long term high dose opioid taper case study
2016: 37-year-old male with low back pain presented to clinic on the following medications: Oxycontin 80 mg po qid, Oxycontin 20 mg po qid, Oxycodone 30 mg (11 per day, # 330 per 30 days), Soma 350 mg po qid, clonazepam 1 mg po tid
No imaging, No PT, No records, MD arrested and clinic closed, patient had been on this dose since age 18, paid cash $300.00 per visit
MME 1095
Concerns
No underlying qualifying medical condition, no evaluation
BZO, Soma, and High MME
Assessment: accompanied by wife who describes him as a “zombie”, awake, O x 4 occasionally falls asleep during visit, speech is not clear, unable to participate and engage in conversation
Plan
Lumbar spine films ordered
MRI ordered + SLR LLE, Strength 3/5 LLE, decreased sensation
PT
Interventional Pain
Surgical evaluation post-MRI
Taper Plan
Is patient willing to taper?
Is the patient medically stable to taper? Co-morbidities? IP or OP?
Family support
Soma: taper over 2 months
Clonazepam: psychiatry consult; start taper when off Soma, plan 4-6 month taper
Discontinue Oxycontin 20 mg qid on first visit MME 120 decrease
Oxycodone: weekly prescriptions
COWS every week, clonidine prn
2017 One year assessment
Oxycodone: 20 mg po 5 x day MME 150
Oxycontin: 60 mg po bid MME 180
Dropped 765 MME in one year
Clonazepam: managed by psychiatry, current dose 0.5 mg po bid and tapering
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2018 Two year assessment
Oxycodone 15 mg po bid prn MME 45
Oxycontin 60 mg po bid MME 180
Decrease of 870 MME over 2 years
Clonazepam 0.5 (#15 tabs per month)
10/2018 Assessment
Tapered to Oxycontin 40 mg po bid MME 120
Unable to taper further, increased pain, anxiety
Transitioned to buprenorphine 8 mg sl tid; 7 day prescriptions until stable
2016 MRI large disc herniation with nerve root impingement
2016 He declined surgery and injections, terrified of needles
2019 Current Assessment
Buprenorphine 8 mg sl tid, wants to taper after surgery
Currently receiving injections in preparation for surgery
Goal is to taper off everything
What role did his pharmacists play?
Did not fill prescriptions on many occasions 2/2 to safety concerns
Contacted his previous provider on many occasions
Counseled him to taper at every encounter
During the tapering process, supported him with every decrease
Willing and available to contribute and consult on taper plan
Entire pharmacy congratulated him when he tapered off opioids
Pharmacists have been instrumental in tapering 3 additional LTHD to off over the past 2 years
Buprenorphine for Pain
Use in chronic pain management in US is fairly recent (FDA approved 02/2002); Europe has a 25 year history
CPG are being developed
Frequent review of the literature
HHS support for use for chronic pain
Be aware of dosing in chronic pain; many patients need microdosing (Butrans patch; Belbuca)
In office induction; RTC in 2-7 days
Methadone dose needs to be 40 mg or less, need to bridge with Butrans or microdose buprenorphine
May use as LA, while tapering SA opioids
May experience nausea and slight withdrawals (anti-emetic and clonidine for 3-5 days)
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Benefits
Better long acting control of chronic pain
Do not wake up with pain
Eliminates “pill anxiety”
Improved sleep
Improved clarity
Improves anxiety and depression
Improved quality of life for patients
Issues
Med review for serotonin syndrome issues
Partial mu agonist: avoid BZO, Soma; No alcohol
Still has a street value, be aware of diversion
Many heroin addicts first use of buprenorphine products is on the street
Georgia, former USSR, buprenorphine crisis because heroin was inaccessible, IV use
Recent buprenorphine MD case SLC
Higher safety profile than full mu agonists but may be lethal in opiate naive patients, children, pets
May require multiple naloxone doses to reverse 2/2 to high affinity to receptor
Questions
Questions???