Jeffrey Summers, M.D. Director, Interventional Pain Division NewSouth NeuroSpine Flowood, MS

Transcription

1 Jeffrey Summers, M.D. Director, Interventional Pain Division NewSouth NeuroSpine Flowood, MS

2 Partial ownership in a medical service company that primarily sells DME, none of which has pain management applications. Includes compounding pharmaceutical services which produce topical analgesic creams.

3 WHO ladder Chronic Opiod therapy Non-Opiod pain management Pharmacological p.o. topical Injections Physical Medicine Surgical options Implantable devices

4

5 Scope of the Problem

6 Number of people with chronic pain exceeds that of diabetes, heart disease and cancer COMBINED Institute of Medicine million people with chronic pain in the US but only 4000 pain specialists

7 American Pain Foundation 50% of patients with severe pain are under treated American Academy of Pain Medicine 80% of people in nursing homes have under treated pain World Health Organization (WHO) Under treatment of pain is the #1 health problem in the US

8 But it s NOT because we aren t prescribing enough narcotics

9 United States has 4.6% of the world s population United States consumes over 80% of the world s opioid (narcotic) pain medication The milligram per person use of prescription narcotics in the United States increased 402%, between 1997 and 2007.

10 Average annual per capita consumption of morphine North America (US and Canada) 75mg 750x India (0.1 mg) 375x Nepal (0.2mg) 12x worldwide (6mg) India and Nepal are the major supplies of opium to the U.S.

11 Narcotics are now the most widely prescribed group of drugs in the USA (passing, antidepressants). 15% to 20% of the meetings between a doctor and a patient in the USA result in a prescription of narcotics.

12 aka Lorcet, Lortab, Vicoden, Norco Hydrocodone is the #1 prescribed pain medicine in the U.S. Hydrocodone is the #1 prescribed drug of any kind in the U.S. 99% of the hydrocodone produced in the world is consumed in the U.S.

13 81 medications in the U.S. contain hydrocodone The U.S. population in 2011 was 311 million In 2011, hydrocodone was Rx to 47 million different patients in the U.S.

14 40% Primary Care physicians 10% by Dentists 3% by Anesthesiologists specializing in treatment of pain

15 Musculoskeletal and connective tissue-26% Respiratory- 21% Fractures, sprains, contusions, injuries 19%

16 Fact: Good doctors prescribe narcotics What about the patients with chronic pain who need narcotics? Who does need chronic narcotics? What do narcotics do?

17 They do not treat the cause of the pain They attach to specific receptors in the brain, spinal cord and gastrointestinal tract Interfere with and prevent the transmission of pain signals to the brain Alter the brain s perception of pain But do they work???

18 Comprehensive literature review 2011 Evaluate the clinical effectiveness of narcotics in chronic non-cancer pain Manchikanti L, Pain Physician 2011;14;E133-E156

19 90% of patients who present to pain centers are taking opiods Paucity of literature for multiple drugs and multiple conditions of non-cancer pain Evidence weak for pain relief with improvement in functional status Only drug with high level evidence of effectiveness: Tramadol for arthritis Conclusion: There is a lack of literature on longterm therapy; thus, opioid therapy should be provided with great restraint and caution

20 Focused Review Chronic non-cancer pain treatment with narcotics Manchikanti et al, Pain Physician, 2011;14;E103-E117

21 Transient exacerbation of pain experienced by individuals who have relatively stable and adequately controlled baseline cancer pain Literature for breakthrough pain in chronic non-cancer pain including its terminology, prevalence, relevance, characteristics, and treatments, has been poorly described

22 There is no significant evidence for any type of breakthrough pain in chronic non-cancer pain based on available literature, methodology utilized, and response to opioids in chronic non-cancer pain.

23 Why has there been an explosion in the use and abuse of prescription pain medicine?

24 Changes by the medical community in the pharmacological approach to chronic pain resulted in increased acceptance of the use of controlled substances in the management of pain Changes in State law allowed improved freedom to prescribe controlled substances These same laws made it easier to prescribe controlled substances for illicit purposes

25 Previously rogue internet pharmacies were the prime source of improperly obtained prescription pill medicine. Abusers could contact a pharmacy who would connect them with an internet doctor who could diagnose and treat (with controlled substances) without ever seeing or examining the patient

26 The epidemic of rogue free standing pain clinics ( Pill Mills ) started after the Ryan Haight Act legislation in 2008 made it illegal for a doctor to prescribe medication to a patient without at least one face to face meeting.

27 WHEN IS A PAIN CLINIC PILL MILL?

28 Goal is functional restoration Treatment that is unsuccessful is discontinued Multiple consultations if goals not met The cause of the pain is treated Legit Clinics Goal is pain relief Treatment that is unsuccessful is increased No outside consultation The symptom of pain is treated Pill Mills

29 Multiple Specialists Anesthesiologists Neurologists Physical Medicine Psychology/psychiatry Multiple treatments Physical therapy Injection therapy Surgery Pharmacological Real Clinics Often one specialty or multiple specialties that have no specific training in the management of chronic pain Treatment is exclusively pharmacological Pill Mills

30 The physicians in your clinic are a pediatrician, radiologist, pathologist and two allergists that specialize in the treatment of chronic pain The cars in your parking lot have twice as many out-of-state tags as in state ones

31 the Hybrid Pill Mill

32 Pill Mill Hybrid Pill Mill All pills, all the time Cash only Gives pills to keep customers coming back for other treatment-injections, physical therapy etc. Will take insurance for treatments, but if you want pills, you better have your deductible and co-payments met

33 Pills not the primary form of treatment, but are used to keep patients coming back--and paying bills Often numerous, expensive treatments, such as injections-often dozens if not hundredsthat never help or never help for long. BUT--if you want pills, you have to be willing to participate with other treatments or you are refusing the physician s recommendations and may be drug seeking.

34 Starting a Sonic Drive-In or a fully operational pain clinic?

35 Building up to code Employer ID Number (EIN) Vendor s License Annual inspections by State Department of Health Franchise License Seller s Permit Food Service License Sign Permit Music License

36 The image part with relationship ID rid2 was not found in the file. : If operating out of a clinic: Building Permit: Yes EIN: Yes CON-None Facility credentialing-none

37 Pain Management Specialists

38 M.D. or D.O. degree Additional requirements NOTHING!!

39 M.D. or D.O. degree Victims!! BUT--Neurosurgeons can only operate in a hospital, which requires hospital privileges Pain clinics do not require a hospital or ASM, because in most states they can operate in a office setting.

40 ABMS has recognized an Added Qualifications in Pain Management certification since 1992 MUST have a primary Board certification in: Anesthesiology Physical Medicine and Rehabilitation Neurology Psychiatry Written exam, certification must be renewed every 10 years You DO NOT need a board certification in anything to call yourself a pain specialist

41 PAIN SPECIALTISTS

42 Your waiting room is so full, and you have a line of patients that snakes into the parking lot You have armed security personnel guarding your clinic.

43 Consider the Side effects

44 Overdose/death Addiction Dependence Endocrine dysfunction Immunosuppression Infectious disease Opioid-induced hyperalgesia

45 Acute Unresponsive to non-narcotics Progressive

46 Review of 45,432 patients (IARS) who underwent colon surgery, GB removal, hysterectomy, hip replacement Studied patients experiencing opiod-related side effects (nausea/vomiting, itching, urinary retention, constipation, respiratory depression) Are the side effects minor? Are there significant consequences?

47 Costs increased from $17,281 to $18,309 per stay Length of stay increased from 4.1 days to 5.2 days

48 Low Tes Loss of libido, infertility, erectile dysfunction, fatigue, depression, anxiety, loss of muscle strength/mass, osteoporosis, compression fractures More likely with continuous release preparations (OxyContin, Fentanyl patch, Oramorph, Exalgo, ER, XR, XL, CR, MR $$$) Katz. Clin J Pain 2008

49 The Risks A higher risk of the pain becoming chronic A higher risk of long-term disability Higher medical costs overall A greater risk of surgery being conducted on the patient A greater risk of narcotics being used later in the patient s life.

50 5 th Liver disease/cirrhosis 4 th COPD 3 rd Accidental injury (MVA) 2 nd Heart disease 1 st Cancer azdh.gov 2000

51 5 th COPD 4 rd Accidental injury (MVA) 3 nd Heart disease 2 st Cancer 1 st Accidental drug overdose (up 390%) CDC

52 Defined as a state of pain receptor sensitization caused by exposure to opiods Paradoxical response whereby a patient receiving opioids for the treatment of pain becomes more sensitive to certain painful stimuli Lee et al, A comprehensive review of opioid-induced hyperalgesia, Pain Physician 2011 Mar-Apr;14(2):145-61

53 Paradoxical effect of opiods causing a centralized increase in the level of pain experienced Higher doses of opioids may stimulate rather than inhibit the central nervous system Characterized by increasing pain causing doctors to escalating narcotic doses, which results in a worsening of the patients pain and condition Mercadante S Hyperalgesia: An Emerging Iatrogenic Syndrome, J Pain Symptom Manage 2003 Aug;26(2):769-75

54 Opioid treatment's effect seems to wane in the absence of disease progression Unexplained pain reports or diffuse allodynia (pain from a stimulus that normally does not cause pain) unassociated with the original pain Increased levels of pain with increasing dosages.

55 Detoxification Reduction of narcotic dose Narcotic rotation Treat with NMDA receptor antagonists (Meperidine, Methadone, Tramadol, Ketamine, Dextromethorphan, phencyclidine (PCP) Sublingual buprenorphine (Suboxone)

56 No consensus Most teaching centers consider the evidence to be strong that narcotics can be effective in the management of chronic pain.

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58 Research What is the goal/purpose? What are the inclusion and exclusion criteria? What are the methods? What are the results? Discussion

59 Goals Reduction of pain Improvement in function Inclusion/exclusion criteria Patient s baseline health, co-morbidities History of addiction, etc Methods What drugs did you use and in what amounts

60 Results Is the pain better? Can they do more? Discussion Does the patient know the risks? Does the patient know how you expect them to take the drugs (opiod maintenance agreement)? Is there an endpoint?

61 Is the patient having side effects? Is the patient reporting less pain? Does increasing the dose lower the pain? MOST IMPORTANTLY Can they do more when they take the drug?

62 Pharmacological Physical medicine Active PT (stretching, conditioning, strengthening, etc) Passive PT(heat/cold, ultrasound, TENS, massage, etc) Injections Spinal (epidural, caudal, facet) Joints Sympathetic (RSD, causalgia, CRPS)

63 NSAIDs Anti-Epileptic drugs (AEDs) Anti-Depressant drugs (ADs) Local Anesthetics Neuroleptics

64 Nociceptive pain due to tissue damage Intact nervous system is doing its job Neuropathic pain Pain propagated by damage or injury to the nervous system (radiculopathy, diabetic neuropathy, post herpetic neuralgia) Pain maintained by abnormal activity in the nervous system (CRPS aka RSD)

65 Narcotics are most effective for treatment of nociceptive pain Least effective (in typical therapeutic doses) for neuropathic pain

66 Adjuvant medications are indicated as front line drugs for the treatment of neuropathic pain Anti epileptic drugs Anti-depressant drugs Local anesthetics (injected, topical, p.o.)

67 Act via suppression of ectopic pain impulses at the spinal cord level Decreasing conductance in Na+ channels and inhibiting ectopic discharges Prevent neuroplastic changes Neuroplasticity- pathophysiological and biochemical changes in the nervous system to adapt morphologically and functionally to external stimuli as a result of an injury. Plays a crucial role in the onset and maintenance of pain symptoms. Tremont-Lukats Drugs Nov;60(5):

68 Carbamazepine (Tegretol) Gabapentin (Neurontin) Pregabalin (Lyrica) Topiramate (Topomax) Valproic Acid (Depakote) Lamotrigine (Lamictal) Levetiracetam (Keppra) Oxcarbazepine (Trileptal)

69 First anticonvulsant studied in clinical trials Probably alleviates pain by decreasing conductance in Na+ channels and inhibiting ectopic discharges. Results from clinical trials have been positive in the treatment of trigeminal neuralgia, painful diabetic neuropathy and postherpetic neuralgia

70 Haplotype testing recommended for Asians due to the risk of Stevens-Johnson Syndrome/toxic epidermal necrolysis. Aplastic anemia Leukopenia WBC monitoring recommended

71 Has the most clearly demonstrated analgesic effect for the treatment of neuropathic pain. Studies demonstrate efficacy in the treatment of painful diabetic neuropathy and postherpetic neuralgia. Based on the positive results of clinical studies and its favorable adverse effect profile, gabapentin should be considered the first choice of therapy for neuropathic pain.

72 Not metabolized, so no enzyme induction, or development of tolerance Minimal drug interactions Renal elimination Overdose potential limited by inability of gut to absorb more than 1200 mg per dose Side effects usually mild and reversible Sedation Nausea, diarrhea, constipation Loss of balance or coordination Blurred vision Peripheral edema

73 Do NOT affect GABA receptor nor GABA production Binds to alpha2delta receptor Decrease release of neurotransmitters Glutamate Norepinephrine Substance P Calcitonin GRP

74 Profile similar to gabapentin May have an earlier onset of analgesia (at lower blood levels) than gabapentin Negligible metabolism, enzyme induction or tolerance Drugs interactions potentiation of sedation with CNS depressants For neuropathic pain (not fibro) try gabapentin first due to cost considerations Schedule V

75 Studies showed it was ineffective for Tx of HIV associated peripheral neuropathy Pregabalin is also used off-label for the treatment of Perioperative pain Migraine Used in lieu of benzodiazepines for somatic anxiety symptoms

76 Studies have demonstrated effectiveness in the treatment of neuropathic pain related to diabetic peripheral neuropathy and postherpetic neuralgia June 2007 became the first drug approved by FDA for treatment of fibromyalgia

77 Update product labeling to include a warning about an increased risk of suicidal thoughts or actions Develop a Medication Guide to help patients understand this risk. These changes affect all approved AEDs except those indicated only for short-term use All patients who currently are taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

78 Studied extensively in the treatment of chronic pain, particularly neuropathic pain Have an analgesic effect independent of their anti-depressant properties Analgesic benefit earlier onset than anti depressant effect Effective analgesic dose is usually lower than the anti-depressant dose Analgesic effect related to inhibition of uptake of neurotranmitters (seritonin, norepinephrine, dopamine) in the descending (pain) inhibitory tracts of the brain and spinal cord

79 Tricyclic antidepressants SSRI (selective serotonin reuptake inhibitors) SNRI (serotonin norepinephrine reuptake inhibitors) SARIs (serotonin antagonist and reuptake inhibitors) NDRIs (norepineprine-dopamine reuptake inhibitors) MAOIs (monamine oxidase inhibitors) TeCAs (tetracyclic antidepressants)

80 Best studied of the ADs for the treatment of chronic pain Work on seritonin, norepinephrine and dopamine Significant anti-cholinergic effects Studies suggests effectiveness in multiple pain states Neuropathic pain (PHN, DPN) Fibromyalgia Headache

81 Amitriptyline, Nortriptyline, Desipramine Imipramine Affect DA, NE and serotonin levels

82 Multiple drug interactions Sedation Cardiac conduction abnormalities Orthostatic hypotension (falls) Tachycardia Weight gain amitriptyline 20 mg dose ave 3.6kg wt gain Amitriptyline contraindicated in elderly

83 The dirtier (DA, NE, 5 HT) the more analgesic benefit The dirtier the more side effects Tricyclics have good evidence of efficacy, but have high SA profiles SSRIs weak evidence of efficacy, low SA profiles SNRIs-better efficacy, lower SA, good starting point

84 Duloxetine (Cymbalta) Venlafaxine (Effexor) Desvenlafaxine (Pristiq) Milnacipran (Sevella) Tramadol (Ultram)

85 The only piece of medical equipment in your office is a scale. Your office is in a strip mall in which the largest building is your pharmacy.

86 Side effects: GI Renal CVA? MI? Route oral, IV, topical

87 Diclofenac-biochemical profile favorable for local absorption Available as: Gel (Voltaren, Selaraze) Drops (Pennsaid) Patch (Flector)

88 Bioavailability: 5-10% of oral route Plasma concentration: 15-25% of oral drug Oral NSAID: 15+% incidence of GI side effects Topical: <8% incidence of GI issues same as placebo

89 Carisoprodol (Soma) Cyclobenzaprine (Flexeril) Metaxalone (Skelaxin) Chlorzoxazone (Parafon Forte ) Methocarbamol (Robaxin) McIntosh G, Hall H (2008). Low back pain (acute), May BMJ Clinical Evidence

90 Half your patients spend the night before their appointment sleeping in their car in your parking lot. You ve prescribed for the Hydrocodone + Xanax + SOMA combination so much your pharmacy dispenses it as a Party Pack.

91 Local anesthetic Nerve blocks Sympathetic blocks Trigger point injections Steroid Epidural Joint Limbs Spine (Facets, Sacroiliac)

92 Generally poor evidence of long term efficacy with joint injections regardless of region injected (shoulder, hip, knee, spine) Paucity of studies investigating efficacy for intra-spinal (epidural) injections involving the cervical or thoracic spines. Generally low level evidence of long term benefit with intralaminar epidural injections Good evidence of efficacy with transforaminal epidural injections

93 Surgery sparing effect Analgesia often wanes with time requirement repeat procedures Frequency of repeat procedures ultimately defines if the procedures are indicated

94 You see 80 new patients on a slow day None of the doctors in your clinic are listed on the sign in front of the clinic

95 Neurodestructive procedures Rhizotomy Dorsal root entry zone lesions (DREZ) Cingulotomy Cordotomy Implantable Devices Continuous infusion pump Spinal cord/dorsal column stimulator

96 Indications Radiculopathy CRPS Peripheral neuropathy Phantom limb pain Post herpetic neuralgia Headaches Axial back/neck pain

97 Radiating leg (or arm) pain from nerve injury Vascular disease (RSD/CRPS), angina Ischemic peripheral vascular disease Neuropathy Phantom pain syndrome Failed back surgery syndrome Axial back pain (on the spine non radiating) Pelvic/visceral pain

98 North et al, SCS for neuropathic LBP 2.3 year follow up after device implanted Rigid exclusion criteria

99 Neurogenic back pain Constant No association with movement No association with position Not coming from pain sensors (nociceptors) but from the injured nerves themselves Not for mechanical low back pain (muscles, facets, sacroiliac joint, sprain/strain)

100 Physiologic contraindication (mechanical LBP) Abnormal Pain Behavior Unresolved psychiatric illness Unresolved issues of secondary gain Inappropriate medication use

101 Pain improvement- 53% had 50+% relief 12% increased pain Side effects Decreased sense of touch 47% Decreased strength/coordination 53% Bladder/bowel control problems 12%

102 Use of medicine 41% decreased pain medicine use 53% increased medicine use Return to work 40% working before SCS 35% working after SCS i.e., 15% of workers who received SCS did not RTW after implantation

103 HAVE Radiating leg pain from nerve injury Vascular disease (RSD/CRPS), Angina Ischemic peripheral vascular disease Neuropathy DON T HAVE Axial (non-radiating pain) Psyche issues Secondary gain

104 The contents in the 4 pockets of your white doctor s coat are a prescription pad, two Montblanc pens, 6 Powerball tickets and a Glock The delivery vehicle for your in office pharmacy is a Brinks Armored Car

105 Your patients take so much hydrocodone, they ask you if the pre-starch binder in the pills could be the reason they ve gained so much weight on their Low Carb diet Your business model for choosing analgesic drug therapies is based on Burger King s Have it your way campaign.

106 You practice in the South but there are twice as many vans or buses in the parking lot than pick-up trucks or SUVs Your follow-up appointment cards for existing patients say: First come, first served.

107 On your office s new patient intake forms the block for the accepted insurance plans lists only: Cash

108 THANK YOU!