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At a Glance:
Title:
15037-nnr
Date:
April 7, 2015

15037-nnr

April 7, 2015

DECISION AND ORDER

This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and the Rules of the Texas Department of Insurance, Division of Workers’ Compensation. For the reasons discussed herein, the Hearing Officer determines that the preponderance of the evidence is not contrary to the decision of the Independent Review Organization (IRO) that Claimant is not entitled to Oxycodone 15mg #360, Nabumetone 500mg #180, and Zanaflex 4mg #90 for the compensable injury of (Date of Injury)

STATEMENT OF THE CASE

A contested case hearing was held on April 1, 2015 to decide the following disputed issue:

Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IRO) that Claimant is not entitled to Oxycodone 15mg #360, Nabumetone 500mg #180, and Zanaflex 4mg #90 for the compensable injury of (Date of Injury)?

PARTIES PRESENT

Petitioner/Claimant appeared and was assisted by CR, ombudsman.

Respondent/Carrier was represented by DG, attorney.

EVIDENCE PRESENTED

The following witnesses testified:

For Claimant: Claimant.

For Carrier: None.

The following exhibits were admitted into evidence:

Hearing Officer’s Exhibits: HO-1 and HO-2.

Claimant’s Exhibits: C-1 through C-5.

Carrier’s Exhibits: CR-A through CR-M.

DISCUSSION

On (Date of Injury) , Claimant was working as a ramp agent when he picked up mail and felt pain to his lower back. As a result of the compensable injury, the Carrier has accepted a lumbar sprain.

It is undisputed that Claimant had back problems prior to sustaining the compensable injury of (Date of Injury). Claimant testified that in 2000, he had problems with his back and was referred to a neurologist because of those problems. Claimant had been taking medication prior to sustaining the compensable injury, and surgery was recommended; however, the medication was controlling Claimant’s pain-level and allowing him to remain active.

Claimant maintains that the denied prescription medications are necessary for the compensable injury sustained on (Date of Injury). The various medications were prescribed by his treating physician and the requested medications were denied by the Carrier’s utilization review agents and referred to an IRO who upheld the Carrier's denial.

The IRO reviewer, a physician board certified in physical medicine, rehabilitation and pain medicine, opined that there was a lack of documentation of functional improvement, muscle spasms, and pain relief.

Texas Labor Code Section 408.021 provides that an employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed. Health care reasonably required is further defined in Texas Labor Code Section 401.011 (22a) as health care that is clinically appropriate and considered effective for the injured employee's injury and provided in accordance with best practices consistent with evidence based medicine or, if evidence based medicine is not available, then generally accepted standards of medical practice recognized in the medical community. Health care under the Texas Workers' Compensation system must be consistent with evidence based medicine if that evidence is available. Evidence based medicine is further defined in Texas Labor Code Section 401.011 (18a) to be the use of the current best quality scientific and medical evidence formulated from credible scientific studies, including peer-reviewed medical literature and other current scientifically based texts and treatment and practice guidelines. The Commissioner of the Division of Workers' Compensation is required to adopt treatment guidelines that are evidence-based, scientifically valid, outcome-focused, and designed to reduce excessive or inappropriate medical care while safeguarding necessary medical care. Texas Labor Code Section 413.011(e). Medical services consistent with the medical policies and fee guidelines adopted by the commissioner are presumed reasonable in accordance with Texas Labor Code Section 413.017(1).

In accordance with the above statutory guidance, the Division of Workers' Compensation has adopted treatment guidelines by Division Rule 137.100. This rule directs health care providers to provide treatment in accordance with the current edition of the Official Disability Guidelines (ODG), and such treatment is presumed to be health care reasonably required as defined in the Texas Labor Code. Thus, the focus of any health care dispute starts with the health care set out in the ODG. Also, in accordance with Division Rule 133.308(s), "A decision issued by an IRO is not considered an agency decision and neither the Department nor the Division are considered parties to an appeal. In a Contested Case Hearing (CCH), the party appealing the IRO decision has the burden of overcoming the decision issued by an IRO by a preponderance of evidence-based medical evidence."

Regarding the use of oxycodone, the ODG refers to this medication as an opioid and refers to the opioid section for guidance and states as follows:

Therapeutic Trial of Opioids

  1. Establish a Treatment Plan. The use of opioids should be part of a treatment plan that is tailored to the patient. Questions to ask prior to starting therapy:
  2. (b)Are there reasonable alternatives to treatment, and have these been tried?
  3. (c)Is the patient likely to improve? Examples: Was there improvement on opioid treatment in the acute and subacute phases? Were there trials of other treatment, including non-opioid medications?
  4. (d)Has the patient received a screen for the risk of addiction? Is there likelihood of abuse or an adverse outcome? Specific questions about current use of alcohol, illegal drugs, other prescription drugs, and over-the counter drugs should be asked. Obtaining a history of personal and/or family substance abuse issues is important. See Substance abuse (tolerance, dependence, addiction). See Opioids, screening for risk of addiction. (Webster, 2008) (Ballyantyne, 2007)
  5. (e)Ask about Red Flags indicating that opioids may not be helpful in the chronic phase: (1) Little or no relief with opioid therapy in the acute and subacute phases. (2) The patient has been given a diagnosis in one of the particular diagnostic categories that have not been shown to have good success with opioid therapy: conversion disorder; somatization disorder; pain disorder associated with psychological factors (such as anxiety or depression, or a previous history of substance abuse). Patients may misuse opioids prescribed for pain to obtain relief from depressed feelings, anxiety, insomnia, or discomforting memories. There are better treatments for this type of pathology. (Sullivan, 2006) (Sullivan, 2005) (Wilsey, 2008) (Savage, 2008)
  6. (f)When the patient is requesting opioid medications for their pain and inconsistencies are identified in the history, presentation, behaviors or physical findings, physicians and surgeons who make a clinical decision to withhold opioid medications should document the basis for their decision.
  7. Steps to Take Before a Therapeutic Trial of Opioids:
  8. (h)Attempt to determine if the pain is nociceptive or neuropathic. Also attempt to determine if there are underlying contributing psychological issues. Neuropathic pain may require higher doses of opioids, and opioids are not generally recommended as a first-line therapy for some neuropathic pain.
  9. (i)A therapeutic trial of opioids should not be employed until the patient has failed a trial of non-opioid analgesics.
  10. (j)Before initiating therapy, the patient should set goals, and the continued use of opioids should be contingent on meeting these goals.
  11. (k)Baseline pain and functional assessments should be made. Function should include social, physical, psychological, daily and work activities, and should be performed using a validated instrument or numerical rating scale. See Function Measures.
  12. (l)Pain related assessment should include history of pain treatment and effect of pain and function.
  13. (m)Assess the likelihood that the patient could be weaned from opioids if there is no improvement in pain and function.
  14. (n)The patient should have at least one physical and psychosocial assessment by the treating doctor (and a possible second opinion by a specialist) to assess whether a trial of opioids should occur. When subjective complaints do not correlate with imaging studies and/or physical findings and/or when psychosocial issue concerns exist, a second opinion with a pain specialist and a psychological assessment should be obtained. (Sullivan, 2006) (Sullivan, 2005) (Wilsey, 2008) (Savage, 2008) (Ballyantyne, 2007)
  15. (o)The physician and surgeon should discuss the risks and benefits of the use of controlled substances and other treatment modalities with the patient, caregiver or guardian.
  16. (p)A written consent or pain agreement for chronic use is not required but may make it easier for the physician and surgeon to document patient education, the treatment plan, and the informed consent. Patient, guardian, and caregiver attitudes about medicines may influence the patient's use of medications for relief from pain. See Guidelines for Pain Treatment Agreement. This should include the consequences of non-adherence.
  17. (q)Consider the use of a urine drug screen to assess for the use or the presence of illegal drugs.
  18. Initiating Therapy
  19. (s)Intermittent pain: Start with a short-acting opioid trying one medication at a time.
  20. (t)Continuous pain: extended-release opioids are recommended. Patients on this modality may require a dose of “rescue” opioids. The need for extra opioid can be a guide to determine the sustained release dose required.
  21. (u)Only change 1 drug at a time.
  22. (v)Prophylactic treatment of constipation should be initiated.
  23. (w)If partial analgesia is not obtained, opioids should be discontinued.
  24. On-Going Management. Actions Should Include:
  25. (y)Prescriptions from a single practitioner taken as directed, and all prescriptions from a single pharmacy.
  26. (z)The lowest possible dose should be prescribed to improve pain and function.
  27. (a)Office: Ongoing review and documentation of pain relief, functional status, appropriate medication use, and side effects. Pain assessment should include: current pain; the least reported pain over the period since last assessment; average pain; intensity of pain after taking the opioid; how long it takes for pain relief; and how long pain relief lasts. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life. Information from family members or other caregivers should be considered in determining the patient's response to treatment. The 4 A's for Ongoing Monitoring: Four domains have been proposed as most relevant for ongoing monitoring of chronic pain patients on opioids: pain relief, side effects, physical and psychosocial functioning, and the occurrence of any potentially aberrant (or nonadherent) drug-related behaviors. These domains have been summarized as the "4 A's" (analgesia, activities of daily living, adverse side effects, and aberrant drug-taking behaviors). The monitoring of these outcomes over time should affect therapeutic decisions and provide a framework for documentation of the clinical use of these controlled drugs. (Passik, 2000)
  28. (b)Home: To aid in pain and functioning assessment, the patient should be requested to keep a pain dairy that includes entries such as pain triggers, and incidence of end-of-dose pain. It should be emphasized that using this diary will help in tailoring the opioid dose. This should not be a requirement for pain management.
  29. (c)Use of drug screening or inpatient treatment with issues of abuse, addiction, or poor pain control. (Webster, 2008)
  30. (d)Documentation of misuse of medications (doctor-shopping, uncontrolled drug escalation, drug diversion).
  31. (e)Continuing review of overall situation with regard to nonopioid means of pain control.
  32. (f)Consideration of a consultation with a multidisciplinary pain clinic if doses of opioids are required beyond what is usually required for the condition or pain does not improve on opioids in 3 months. Consider a psych consult if there is evidence of depression, anxiety or irritability. Consider an addiction medicine consult if there is evidence of substance misuse. (Sullivan, 2006) (Sullivan, 2005) (Wilsey, 2008) (Savage, 2008) (Ballyantyne, 2007)
  33. Recommended Frequency of Visits While in the Trial Phase (first 6 months):
  34. (h)Every 2 weeks for the first 2 to 4 months
  35. (i)Then at approximate 1 ½ to 2-month intervals
  36. Note: According to the California Medical Board Guidelines for Prescribing Controlled Substances for Pain, patients with pain who are managed with controlled substances should be seen monthly, quarterly, or semiannually as required by the standard of care. (California, 1994)
  37. When to Discontinue Opioids: See Opioid hyperalgesia. Also see Weaning of Medications. Prior to discontinuing, it should be determined that the patient has not had treatment failure due to causes that can be corrected such as under-dosing or inappropriate dosing schedule. Weaning should occur under direct ongoing medical supervision as a slow taper except for the below mentioned possible indications for immediate discontinuation. The patient should not be abandoned.
  38. (k)If there is no overall improvement in function, unless there are extenuating circumstances
  39. (l)Continuing pain with the evidence of intolerable adverse effects; lack of significant benefit (persistent pain and lack of improved function despite high doses of opiates- e.g. > 120 mg/day morphine equivalents)
  40. (m)Decrease in functioning
  41. (n)Resolution of pain
  42. (o)If serious non-adherence is occurring
  43. (p)The patient requests discontinuing
  44. (q)Immediate discontinuation has been suggested for: evidence of illegal activity including diversion, prescription forgery, or stealing; the patient is involved in a motor vehicle accident and/or arrest related to opioids, illicit drugs and/or alcohol; intentional suicide attempt; aggressive or threatening behavior in the clinic. It is suggested that a patient be given a 30-day supply of medications (to facilitate finding other treatment) or be started on a slow weaning schedule if a decision is made by the physician to terminate prescribing of opioids/controlled substances.
  45. (r)Many physicians will allow one “slip” from a medication contract without immediate termination of opioids/controlled substances, with the consequences being a re-discussion of the clinic policy on controlled substances, including the consequences of repeat violations.
  46. (s)If there are repeated violations from the medication contract or any other evidence of abuse, addiction, or possible diversion it has been suggested that a patient show evidence of a consult with a physician that is trained in addiction to assess the ongoing situation and recommend possible detoxification. (Weaver, 2002)
  47. (t)When the patient is requesting opioid medications for their pain and inconsistencies are identified in the history, presentation, behaviors or physical findings, physicians and surgeons who make a clinical decision to withhold opioid medications should document the basis for their decision.
  48. (u)Routine long-term opioid therapy is not recommended, and ODG recommends consideration of a one-month limit on opioids for new chronic non-malignant pain patients in most cases, as there is little research to support use. The research available does not support overall general effectiveness and indicates numerous adverse effects with long-term use. The latter includes the risk of ongoing psychological dependence with difficultly weaning. See Opioids for chronic pain.
  49. When to Continue Opioids
  50. (w)If the patient has returned to work
  51. (x)If the patient has improved functioning and pain (Washington, 2002) (Colorado, 2002) (Ontario, 2000) (VA/DoD, 2003) (Maddox-AAPM/APS, 1997) (Wisconsin, 2004) (Warfield, 2004)

The Nabumetone is addressed under NSAIDS and states the following:

Specific recommendations:

Osteoarthritis (including knee and hip):Recommended at the lowest dose for the shortest period in patients with moderate to severe pain. Acetaminophen may be considered for initial therapy for patients with mild to moderate pain, and in particular, for those with gastrointestinal, cardiovascular or renovascular risk factors. NSAIDs appear to be superior to acetaminophen, particularly for patients with moderate to severe pain. There is no evidence to recommend one drug in this class over another based on efficacy. In particular, there appears to be no difference between traditional NSAIDs and COX-2 NSAIDs in terms of pain relief. The main concern of selection is based on adverse effects. COX-2 NSAIDs have fewer GI side effects at the risk of increased cardiovascular side effects, although the FDA has concluded that long-term clinical trials are best interpreted to suggest that cardiovascular risk occurs with all NSAIDs and is a class effect (with naproxyn being the safest drug). There is no evidence of long-term effectiveness for pain or function. (Chen, 2008) (Laine, 2008)

Back Pain - Acute low back pain & acute exacerbations of chronic pain:Recommended as a second-line treatment after acetaminophen. In general, there is conflicting to negative evidence that NSAIDs are more effective than acetaminophen for acute LBP. (van Tulder, 2006) (Hancock, 2007) For patients with acute low back pain with sciatica a recent Cochrane review (including three heterogeneous randomized controlled trials) found no differences in treatment with NSAIDs vs. placebo. In patients with axial low back pain this same review found that NSAIDs were not more effective than acetaminophen for acute low-back pain, and that acetaminophen had fewer side effects. (Roelofs-Cochrane, 2008) The addition of NSAIDs or spinal manipulative therapy does not appear to increase recovery in patients with acute low back pain over that received with acetaminophen treatment and advice from their physician. (Hancock, 2007)

Back Pain - Chronic low back pain:Recommended as an option for short-term symptomatic relief. A Cochrane review of the literature on drug relief for low back pain (LBP) suggested that NSAIDs were no more effective than other drugs such as acetaminophen, narcotic analgesics, and muscle relaxants. The review also found that NSAIDs had more adverse effects than placebo and acetaminophen but fewer effects than muscle relaxants and narcotic analgesics. In addition, evidence from the review suggested that no one NSAID, including COX-2 inhibitors, was clearly more effective than another. (Roel Recommend non-sedating muscle relaxants with caution as a second-line option for short-term (less than two weeks) treatment of acute LBP and for short-term treatment of acute exacerbations in patients with chronic LBP. (Chou, 2007) (Mens, 2005) (Van Tulder, 1998) (van Tulder, 2003) (van Tulder, 2006) (Schnitzer, 2004) (See, 2008) See the Low Back Chapter. Muscle relaxants may be effective in reducing pain and muscle tension, and increasing mobility. However, in most LBP cases, they show no benefit beyond NSAIDs in pain and overall improvement. Also there is no additional benefit shown in combination with NSAIDs. Efficacy appears to diminish over time, and prolonged use of some medications in this class may lead to dependence. (Schnitzer, 2004) (Van Tulder, 2004) (Airaksinen, 2006) Sedation is the most commonly reported adverse effect of muscle relaxant medications. These drugs should be used with caution in patients driving motor vehicles or operating heavy machinery. Drugs with the most limited published evidence in terms of clinical effectiveness include chlorzoxazone, methocarbamol, dantrolene and baclofen. (Chou, 2004) According to a recent review in American Family Physician, skeletal muscle relaxants are the most widely prescribed drug class for musculoskeletal conditions (18.5% of prescriptions), and the most commonly prescribed antispasmodic agents are carisoprodol, cyclobenzaprine, metaxalone, and methocarbamol, but despite their popularity, skeletal muscle relaxants should not be the primary drug class of choice for musculoskeletal conditions. (See2, 2008)

Classifications:Muscle relaxants are a broad range of medications that are generally divided into antispasmodics, antispasticity drugs, and drugs with both actions. (See, 2008) (van Tulder, 2006)

ANTISPASTICITY DRUGS: Used to decrease spasticity in conditions such as cerebral palsy, MS, and spinal cord injuries (upper motor neuron syndromes). Associated symptoms include exaggerated reflexes, autonomic hyperreflexia, dystonia, contractures, paresis, lack of dexterity and fatigability. (Chou, 2004)

Baclofen (Lioresal®, generic available): The mechanism of action is blockade of the pre- and post-synaptic GABAB receptors. It is recommended orally for the treatment of spasticity and muscle spasm related to multiple sclerosis and spinal cord injuries. Baclofen has been noted to have benefits for treating lancinating, paroxysmal neuropathic pain (trigeminal neuralgia, non-FDA approved). (ICSI, 2007)

Side Effects:Sedation, dizziness, weakness, hypotension, nausea, respiratory depression and constipation. This drug should not be discontinued abruptly (withdrawal includes the risk of hallucinations and seizures). Use with caution in patients with renal and liver impairment.

Dosing:Oral: 5 mg three times a day. Upward titration can be made every 3 days up to a maximum dose of 80 mg a day. (See, 2008)

Dantrolene (Dantrium®, generic available): Not recommended. The mechanism of action is a direct inhibition of muscle contraction by decreasing the release of calcium from the sarcoplasmic reticulum.

Side Effects:A black-box warning has been issued about symptomatic fatal or nonfatal hepatitis.

Dosing:25 mg a day for 7 days, 25 mg three times a day for 7 days, 50 mg three times a day for 7 days and then 100 mg three times a day. (See, 2008)

ANTISPASMODICS:Used to decrease muscle spasm in conditions such as LBP although it appears that these medications are often used for the treatment of musculoskeletal conditions whether spasm is present or not. The mechanism of action for most of these agents is not known. (Chou, 2004)

Cyclobenzaprine (Flexeril®, Fexmid™, generic available, ER as Amrix®): Recommended for a short course of therapy. Immediate release (eg, Flexeril, generic) recommended over extended release (Amrix) due to recommended short course of therapy (also note substantial increase in cost for extended release without corresponding benefit for short course of therapy). Limited, mixed-evidence does not allow for a recommendation for chronic use. Cyclobenzaprine is a skeletal muscle relaxant and a central nervous system depressant with similar effects to tricyclic antidepressants (e.g. amitriptyline). Cyclobenzaprine is more effective than placebo in the management of back pain, although the effect is modest and comes at the price of adverse effects. It has a central mechanism of action, but it is not effective in treating spasticity from cerebral palsy or spinal cord disease. Cyclobenzaprine is associated with a number needed to treat of 3 at 2 weeks for symptom improvement. The greatest effect appears to be in the first 4 days of treatment. (Browning, 2001) (Kinkade, 2007) (Toth, 2004) See Cyclobenzaprine. Cyclobenzaprine has been shown to produce a modest benefit in treatment of fibromyalgia. Cyclobenzaprine-treated patients with fibromyalgia were 3 times more likely to report overall improvement and to report moderate reductions in individual symptoms (particularly sleep). A meta-analysis concluded that the number needed to treat for patients with fibromyalgia was 4.8. (ICSI, 2007) (Tofferi, 2004) A recent RCT found that time to relief was better with immediate release compared to extended release cyclobenzaprine. (Landy, 2011)

Side Effects:Include anticholinergic effects (drowsiness, urinary retention and dry mouth). Sedative effects may limit use. Headache has been noted. This medication should be avoided in patients with arrhythmias, heart block, heart failure and recent myocardial infarction. Side effects limit use in the elderly. (See, 2008) (Toth, 2004)

Dosing:5 mg three times a day. Can be increased to 10 mg three times a day. This medication is not recommended to be used for longer than 2-3 weeks. (See, 2008)

Methocarbamol (Robaxin®, Relaxin™, generic available):The mechanism of action is unknown, but appears to be related to central nervous system depressant effects with related sedative properties. This drug was approved by the FDA in 1957.

Side Effects:Drowsiness, dizziness and lightheadedness.

Dosing:1500 mg four times a day for the first 2-3 days, then decreased to 750 mg four times a day. (See, 2008)

Metaxalone (Skelaxin®, generic available) is reported to be a relatively non-sedating muscle relaxant. The exact mechanism of action is unknown, but the effect is presumed to be due to general depression of the central nervous system. Metaxalone was approved by the FDA in 1964 and data to support approval were published in the mid-1960s. (Toth, 2004)

Side Effects:Dizziness and drowsiness, although less than that compared to other skeletal muscle relaxants. Other side effects include headache, nervousness, nausea, vomiting, and GI upset. A hypersensitivity reaction (rash) has been reported. Use with caution in patients with renal and/or hepatic failure.

Dosing:800 mg three to four times a day (See, 2008)

Chlorzoxazone (Parafon Forte®, Paraflex®, Relax™DS, Remular S™, generic available): this drug works primarily in the spinal cord and the subcortical areas of the brain. The mechanism of action is unknown but the effect is thought to be due to general depression of the central nervous system. Advantages over other muscle relaxants include reduced sedation and less evidence for abuse. (See, 2008)

Side Effects:Drowsiness and dizziness. Urine discoloration may occur. Avoid use in patients with hepatic impairment.

Dosing:250-750 mg three times a day to four times a day.

Carisoprodol (Soma®, Soprodal 350™, Vanadom®, generic available): Not recommended in ODG. Suggested by the manufacturer for use as an adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. (AHFS, 2008) A 250 mg formulation was FDA approved in 9/07 for treatment of acute, painful musculoskeletal conditions such as backache. Neither of these formulations is recommended for longer than a 2 to 3 week period. Carisoprodol is metabolized to meprobamate an anixolytic that is a schedule IV controlled substance. Carisoprodol is classified as a schedule IV drug in several states but not on a federal level. It is suggested that its main effect is due to generalized sedation as well as treatment of anxiety. This drug was approved for marketing before the FDA required clinical studies to prove safety and efficacy. Withdrawal symptoms may occur with abrupt discontinuation. (See, 2008) (Reeves, 2003) For more details, see Carisoprodol, where it is “Not recommended.” See also Weaning, carisoprodol (Soma®).

Side Effects:drowsiness, psychological and physical dependence, & withdrawal with acute discontinuation.

Dosing:250 mg-350 mg four times a day. (See, 2008)

Orphenadrine (Norflex®, Banflex®, Antiflex™, Mio-Rel™, Orphenate™, generic available):This drug is similar to diphenhydramine, but has greater anticholinergic effects. The mode of action is not clearly understood. Effects are thought to be secondary to analgesic and anticholinergic properties. This drug was approved by the FDA in 1959.

Side Effects:Anticholinergic effects (drowsiness, urinary retention, dry mouth). Side effects may limit use in the elderly. This medication has been reported in case studies to be abused for euphoria and to have mood elevating effects. (Shariatmadari, 1975)

Dosing:100 mg twice a day; combination products are given three to four times a day. (See, 2008)

ANTISPASTICITY/ANTISPASMODIC DRUGS:

Tizanidine (Zanaflex®, generic available) is a centrally acting alpha2-adrenergic agonist that is FDA approved for management of spasticity; unlabeled use for low back pain. (Malanga, 2008) Eight studies have demonstrated efficacy for low back pain. (Chou, 2007) One study (conducted only in females) demonstrated a significant decrease in pain associated with subacute and chronic myofascial pain syndrome and the authors recommended its use as a first line option to treat myofascial pain. (Malanga, 2002) May also provide benefit as an adjunct treatment for fibromyalgia. (ICSI, 2007)

Side effects: somnolence, dizziness, dry mouth, hypotension, weakness, hepatotoxicity (LFTs should be monitored baseline, 1, 3, and 6 months). (See, 2008)

Dosing: 4 mg initial dose; titrate gradually by 2 – 4 mg every 6 – 8 hours until therapeutic effect with tolerable side-effects; maximum 36 mg per day. (See, 2008) Use with caution in renal impairment; should be avoided in hepatic impairment. Tizanidine use has been associated with hepatic aminotransaminase elevations that are usually asymptomatic and reversible with discontinuation. This medication is related to clonidine and should not be discontinued abruptly. Weaning should occur gradually, particularly in patients that have had prolonged use. (Zanaflex-FDA, 2008)

Benzodiazepines:Not recommended due to rapid development of tolerance and dependence. There appears to be little benefit for the use of this class of drugs over nonbenzodiazepines for the treatment of spasm. (See, 2008) See Benzodiazepines.

ofs-Cochrane, 2008) See also Anti-inflammatory medications.

Neuropathic pain: There is inconsistent evidence for the use of these medications to treat long-term neuropathic pain, but they may be useful to treat breakthrough pain and mixed pain conditions such as osteoarthritis (and other nociceptive pain) in patients with neuropathic pain. (Namaka, 2004) (Gore, 2006)

See NSAIDs, GI symptoms & cardiovascular risk; NSAIDs, hypertension and renal function; & Medications for acute pain (analgesics). Besides the above well-documented side effects of NSAIDs, there are other less well-known effects of NSAIDs, and the use of NSAIDs has been shown to possibly delay and hamper healing in all the soft tissues, including muscles, ligaments, tendons, and cartilage. (Maroon, 2006) The risks of NSAIDs in older patients, which include increased cardiovascular risk and gastrointestinal toxicity, may outweigh the benefits of these medications. (AGS, 2009)

Lastly, the Zanaflex is addressed under the muscle relaxant section of the ODG and states the following:

Recommend non-sedating muscle relaxants with caution as a second-line option for short-term (less than two weeks) treatment of acute LBP and for short-term treatment of acute exacerbations in patients with chronic LBP. (Chou, 2007) (Mens, 2005) (Van Tulder, 1998) (van Tulder, 2003) (van Tulder, 2006) (Schnitzer, 2004) (See, 2008) See the Low Back Chapter. Muscle relaxants may be effective in reducing pain and muscle tension, and increasing mobility. However, in most LBP cases, they show no benefit beyond NSAIDs in pain and overall improvement. Also there is no additional benefit shown in combination with NSAIDs. Efficacy appears to diminish over time, and prolonged use of some medications in this class may lead to dependence. (Schnitzer, 2004) (Van Tulder, 2004) (Airaksinen, 2006) Sedation is the most commonly reported adverse effect of muscle relaxant medications. These drugs should be used with caution in patients driving motor vehicles or operating heavy machinery. Drugs with the most limited published evidence in terms of clinical effectiveness include chlorzoxazone, methocarbamol, dantrolene and baclofen. (Chou, 2004) According to a recent review in American Family Physician, skeletal muscle relaxants are the most widely prescribed drug class for musculoskeletal conditions (18.5% of prescriptions), and the most commonly prescribed antispasmodic agents are carisoprodol, cyclobenzaprine, metaxalone, and methocarbamol, but despite their popularity, skeletal muscle relaxants should not be the primary drug class of choice for musculoskeletal conditions. (See2, 2008)

Classifications:Muscle relaxants are a broad range of medications that are generally divided into antispasmodics, antispasticity drugs, and drugs with both actions. (See, 2008) (van Tulder, 2006)

ANTISPASTICITY DRUGS: Used to decrease spasticity in conditions such as cerebral palsy, MS, and spinal cord injuries (upper motor neuron syndromes). Associated symptoms include exaggerated reflexes, autonomic hyperreflexia, dystonia, contractures, paresis, lack of dexterity and fatigability. (Chou, 2004)

Baclofen (Lioresal®, generic available): The mechanism of action is blockade of the pre- and post-synaptic GABAB receptors. It is recommended orally for the treatment of spasticity and muscle spasm related to multiple sclerosis and spinal cord injuries. Baclofen has been noted to have benefits for treating lancinating, paroxysmal neuropathic pain (trigeminal neuralgia, non-FDA approved). (ICSI, 2007)

Side Effects:Sedation, dizziness, weakness, hypotension, nausea, respiratory depression and constipation. This drug should not be discontinued abruptly (withdrawal includes the risk of hallucinations and seizures). Use with caution in patients with renal and liver impairment.

Dosing:Oral: 5 mg three times a day. Upward titration can be made every 3 days up to a maximum dose of 80 mg a day. (See, 2008)

Dantrolene (Dantrium®, generic available): Not recommended. The mechanism of action is a direct inhibition of muscle contraction by decreasing the release of calcium from the sarcoplasmic reticulum.

Side Effects:A black-box warning has been issued about symptomatic fatal or nonfatal hepatitis.

Dosing:25 mg a day for 7 days, 25 mg three times a day for 7 days, 50 mg three times a day for 7 days and then 100 mg three times a day. (See, 2008)

ANTISPASMODICS:Used to decrease muscle spasm in conditions such as LBP although it appears that these medications are often used for the treatment of musculoskeletal conditions whether spasm is present or not. The mechanism of action for most of these agents is not known. (Chou, 2004)

Cyclobenzaprine (Flexeril®, Fexmid™, generic available, ER as Amrix®): Recommended for a short course of therapy. Immediate release (eg, Flexeril, generic) recommended over extended release (Amrix) due to recommended short course of therapy (also note substantial increase in cost for extended release without corresponding benefit for short course of therapy). Limited, mixed-evidence does not allow for a recommendation for chronic use. Cyclobenzaprine is a skeletal muscle relaxant and a central nervous system depressant with similar effects to tricyclic antidepressants (e.g. amitriptyline). Cyclobenzaprine is more effective than placebo in the management of back pain, although the effect is modest and comes at the price of adverse effects. It has a central mechanism of action, but it is not effective in treating spasticity from cerebral palsy or spinal cord disease. Cyclobenzaprine is associated with a number needed to treat of 3 at 2 weeks for symptom improvement. The greatest effect appears to be in the first 4 days of treatment. (Browning, 2001) (Kinkade, 2007) (Toth, 2004) See Cyclobenzaprine. Cyclobenzaprine has been shown to produce a modest benefit in treatment of fibromyalgia. Cyclobenzaprine-treated patients with fibromyalgia were 3 times more likely to report overall improvement and to report moderate reductions in individual symptoms (particularly sleep). A meta-analysis concluded that the number needed to treat for patients with fibromyalgia was 4.8. (ICSI, 2007) (Tofferi, 2004) A recent RCT found that time to relief was better with immediate release compared to extended release cyclobenzaprine. (Landy, 2011)

Side Effects:Include anticholinergic effects (drowsiness, urinary retention and dry mouth). Sedative effects may limit use. Headache has been noted. This medication should be avoided in patients with arrhythmias, heart block, heart failure and recent myocardial infarction. Side effects limit use in the elderly. (See, 2008) (Toth, 2004)

Dosing:5 mg three times a day. Can be increased to 10 mg three times a day. This medication is not recommended to be used for longer than 2-3 weeks. (See, 2008)

Methocarbamol (Robaxin®, Relaxin™, generic available):The mechanism of action is unknown, but appears to be related to central nervous system depressant effects with related sedative properties. This drug was approved by the FDA in 1957.

Side Effects:Drowsiness, dizziness and lightheadedness.

Dosing:1500 mg four times a day for the first 2-3 days, then decreased to 750 mg four times a day. (See, 2008)

Metaxalone (Skelaxin®, generic available) is reported to be a relatively non-sedating muscle relaxant. The exact mechanism of action is unknown, but the effect is presumed to be due to general depression of the central nervous system. Metaxalone was approved by the FDA in 1964 and data to support approval were published in the mid-1960s. (Toth, 2004)

Side Effects:Dizziness and drowsiness, although less than that compared to other skeletal muscle relaxants. Other side effects include headache, nervousness, nausea, vomiting, and GI upset. A hypersensitivity reaction (rash) has been reported. Use with caution in patients with renal and/or hepatic failure.

Dosing:800 mg three to four times a day (See, 2008)

Chlorzoxazone (Parafon Forte®, Paraflex®, Relax™DS, Remular S™, generic available):this drug works primarily in the spinal cord and the subcortical areas of the brain. The mechanism of action is unknown but the effect is thought to be due to general depression of the central nervous system. Advantages over other muscle relaxants include reduced sedation and less evidence for abuse. (See, 2008)

Side Effects:Drowsiness and dizziness. Urine discoloration may occur. Avoid use in patients with hepatic impairment.

Dosing:250-750 mg three times a day to four times a day.

Carisoprodol (Soma®, Soprodal 350™, Vanadom®, generic available): Not recommended in ODG. Suggested by the manufacturer for use as an adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. (AHFS, 2008) A 250 mg formulation was FDA approved in 9/07 for treatment of acute, painful musculoskeletal conditions such as backache. Neither of these formulations is recommended for longer than a 2 to 3 week period. Carisoprodol is metabolized to meprobamate an anixolytic that is a schedule IV controlled substance. Carisoprodol is classified as a schedule IV drug in several states but not on a federal level. It is suggested that its main effect is due to generalized sedation as well as treatment of anxiety. This drug was approved for marketing before the FDA required clinical studies to prove safety and efficacy. Withdrawal symptoms may occur with abrupt discontinuation. (See, 2008) (Reeves, 2003) For more details, see Carisoprodol, where it is “Not recommended.” See also Weaning, carisoprodol (Soma®).

Side Effects:drowsiness, psychological and physical dependence, & withdrawal with acute discontinuation.

Dosing:250 mg-350 mg four times a day. (See, 2008)

Orphenadrine (Norflex®, Banflex®, Antiflex™, Mio-Rel™, Orphenate™, generic available):This drug is similar to diphenhydramine, but has greater anticholinergic effects. The mode of action is not clearly understood. Effects are thought to be secondary to analgesic and anticholinergic properties. This drug was approved by the FDA in 1959.

Side Effects:Anticholinergic effects (drowsiness, urinary retention, dry mouth). Side effects may limit use in the elderly. This medication has been reported in case studies to be abused for euphoria and to have mood elevating effects. (Shariatmadari, 1975)

Dosing:100 mg twice a day; combination products are given three to four times a day. (See, 2008)

ANTISPASTICITY/ANTISPASMODIC DRUGS:

Tizanidine (Zanaflex®, generic available) is a centrally acting alpha2-adrenergic agonist that is FDA approved for management of spasticity; unlabeled use for low back pain. (Malanga, 2008) Eight studies have demonstrated efficacy for low back pain. (Chou, 2007) One study (conducted only in females) demonstrated a significant decrease in pain associated with subacute and chronic myofascial pain syndrome and the authors recommended its use as a first line option to treat myofascial pain. (Malanga, 2002) May also provide benefit as an adjunct treatment for fibromyalgia. (ICSI, 2007)

Side effects: somnolence, dizziness, dry mouth, hypotension, weakness, hepatotoxicity (LFTs should be monitored baseline, 1, 3, and 6 months). (See, 2008)

Dosing: 4 mg initial dose; titrate gradually by 2 – 4 mg every 6 – 8 hours until therapeutic effect with tolerable side-effects; maximum 36 mg per day. (See, 2008) Use with caution in renal impairment; should be avoided in hepatic impairment. Tizanidine use has been associated with hepatic aminotransaminase elevations that are usually asymptomatic and reversible with discontinuation. This medication is related to clonidine and should not be discontinued abruptly. Weaning should occur gradually, particularly in patients that have had prolonged use. (Zanaflex-FDA, 2008)

Benzodiazepines:Not recommended due to rapid development of tolerance and dependence. There appears to be little benefit for the use of this class of drugs over nonbenzodiazepines for the treatment of spasm. (See, 2008) See Benzodiazepines.

Claimant relies on the office notes and reports from his treating physician in order to establish that the ODG have been met. However, the treating physician does not address the ODG and does not explain why Claimant’s compensable injury of a lumbar sprain would require the prescribed medications. Although the treating physician notes numerous times in his medical records that the Claimant’s complaints began in December of 2005, it does not appear that the treating physician was aware that Claimant had problems with his lumbar back prior to 2005. As noted above, prior to sustaining the (Date of Injury) compensable injury, Claimant had already been referred to a neurosurgeon because of problems to his lumbar spine.

The medical evidence presented in support of the necessity of the proposed procedure is insufficient and is not supported by evidence-based medicine. Therefore, the preponderance of the evidence is not contrary to the decision of the IRO that Claimant is not entitled to the prescribed medication for the compensable injury of (Date of Injury).

The Hearing Officer considered all of the evidence admitted. The Findings of Fact and Conclusions of Law are based on an assessment of all of the evidence whether or not the evidence is specifically discussed in this Decision and Order.

FINDINGS OF FACT

  1. The parties stipulated to the following facts:
    1. Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
    2. On (Date of Injury), Claimant was the employee of (Employer), Employer.
    3. On (Date of Injury), Employer provided workers’ compensation insurance with Ace American Insurance Company, Carrier.
    4. On (Date of Injury), Claimant sustained a compensable injury.
  2. Carrier delivered to Claimant a single document stating the true corporate name of Carrier, and the name and street address of Carrier’s registered agent, which document was admitted into evidence as Hearing Officer’s Exhibit Number 2.
  3. The IRO determined that the requested medication was not health care reasonably required for the compensable injury of (Date of Injury).
  4. Claimant did not present evidence-based medical evidence contrary to the IRO decision.
  5. Oxycodone 15mg #360, Nabumetone 500 mg #180, Zanaflex 4mg #90 is not health care reasonably required for the compensable injury of (Date of Injury).
  6. CONCLUSIONS OF LAW
  7. The Texas Department of Insurance, Division of Workers’ Compensation, has jurisdiction to hear this case.
  8. Venue is proper in the (City) Field Office.
  9. The preponderance of the evidence is not contrary to the decision of the IRO that Oxycodone 15mg #360, Nabumetone 500 mg #180, Zanaflex 4mg #90 is not health care reasonably required for the compensable injury of (Date of Injury).
  10. DECISION

Claimant is not entitled to Oxycodone 15mg #360, Nabumetone 500mg #180, and Zanaflex 4mg #90 for the compensable injury of (Date of Injury).

ORDER

Carrier is not liable for the benefits at issue in this hearing. Claimant remains entitled to medical benefits for the compensable injury in accordance with §408.021.

The true corporate name of the insurance carrier is ACE AMERICAN INSURANCE COMPANY,and the name and address of its registered agent for service of process is

CT CORPORATION SYSTEM

1999 BRYAN STREET, SUITE 900

DALLAS, TEXAS 75201-3136

Signed this 7th day of April, 2015.

Teresa G. Hartley
Hearing Officer

End of Document
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