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Opioids – The Grand Debate

January 08, 2015 (20 min read)

An examination of ACOEM’s newly revised opioid practice guidelines for treatment of pain

By Robert G. Rassp, Esq.

We hate statistics but policymakers can’t live without them. For example, 100 million residents of the United States have chronic pain according to a 2011 report from the Institute of Medicine. Pain is considered by some physicians as the fifth vital sign (blood pressure, respiration, temperature, heart rate are the other four). There are four categories of pain duration that a medical physician is obligated to treat—acute (one month), sub-acute (two to three months), chronic (more than three months), and post-operative.

The widespread use of opioid medications for treatment of pain did not begin until the late 1980s when long-acting opioids were found to be effective for non-cancer pain, with less than 1% of patients becoming addicted to them. Pharmaceutical companies conducted “research” showing the efficacy of long acting opioids in studies that lasted no longer than three months. This opened up Pandora’s box and by 2010, there were 16,000 deaths nationwide from opioid related overdoses according to the Centers for Disease Control and Prevention.

In response to the epidemic of opioid use and misuse, policymakers are demanding action—not by the FDA—but by state regulators and the payer community who are imposing medical treatment guidelines on prescribing physicians. There is no national consensus of what those guidelines should be. In fact, Medicare has a “Y” symbol by just about every known opioid medication including fentanyl lollipops, oxycontin (oxycodone), dilaudid (hydromorphone), and MS Contin. In Medicare parlance, a “Y” means the medication, device, or procedure is a “yes” and is reimbursed under the Medicare program.

Despite the deaths due to opioid overdoses, many chronic pain patients are able to live normal lives, including having the ability to work, while on dosages of opioid medication that would kill someone who is “opioid naïve” who has never taken any opioid based drug. In fact, many elderly patients are on long acting opioid medication for chronic severe arthritis and other pain generators and are able to function with very active lifestyles.

California Workers’ Compensation System Response

How does all of this play out in the California workers’ compensation system? There is a movement afoot to specifically reduce the use of opioid medication in work related injury cases. “Dueling” medical treatment guidelines exist that are based on so-called “evidence based medicine” but whose terms defy any logic since all are based on different standards of medical care. If you have an opinion, you can find a study that supports your position. Curiously, Medicare itself does not have any clear cut medical treatment guidelines for prescribing opioid medications. That decision making is left to each prescribing physician and community standards of medical care, which means that treatment is individualized to each patient’s needs and is not subject to anyone’s guidelines.

More specifically, state workers’ compensation systems, including California, Washington, Utah, and Texas, as well as the Veterans Administration, use ACOEM, ODG, or their own guidelines for the authorization of opioid use in acute, sub-acute, chronic, and post-operative durations of treatment. Those guidelines are evolving as we enter 2015. In March 2014, the Administrative Director of the California Division of Workers’ Compensation proposed new opioid prescribing guidelines that incorporated some of the guidelines reflected in all of the resources mentioned above. In December 2014, the Journal of Occupational and Environmental Medicine, ACOEM’s publication, issued its newly revised opioid prescription guidelines in a white paper that ACOEM claims is based on evidence based medicine with an emphasis on weighted studies found in medical literature. (See Hegmann et al., “ACOEM Practice Guidelines: Opioids for Treatment of Acute, Subacute, Chronic and Post-Operative Pain”, JOEM Vol. 56, No. 12 (Dec. 2014))

Understanding Morphine Equivalent Dose

The centerpiece of each separate guideline mentioned above revolves around what “morphine equivalent dose (MED)” is acceptable on a daily basis for treatment of acute, sub-acute, chronic, and post-operative pain. For the purpose of this article, a typical morphine equivalent daily dose is 30 mg morphine oral medication every 4-6 hours, which is equal to 120 mg to 180 mg per day of morphine or its equivalent. For example, the morphine equivalent dose of dilaudid is 7.5 mg for every 30 mg of morphine so the MED of dilaudid would be 30-45 mg per day.

Many treatment guidelines in conventional medicine allow for up to 120 mg MED per day before a “red flag” appears and a specialist is required to be involved in the prescribing process. There is no consensus in medicine exactly what the MED should be for any given patient since there is so much variability between patients, the precipitating pain condition, and how each patient reacts to different formulations of opioid-based pain medication.

The California Medical Board proposed in 2014 that the maximum MED dosage should not exceed 80 mg per day without a red flag. The ODG Guidelines recommend no more than 80 mg per day MED. The DWC Medical Director is leaning towards an MED ceiling of 50 mg per day, which is currently recommended under the ACOEM guidelines discussed below. In addition, ACOEM, ODG, and the DWC proposed guidelines include an annual attempt to completely wean patients off opioids all together. The weaning attempts have become compulsory and are part and parcel of the utilization review process that is mandated in Calif. Labor Code Section 4610.

These guidelines contrast with the typical scenario in a physician’s office which treats injured workers under the California workers’ compensation system. Up until the time utilization reviews were mandated in 2004 under Calif. Labor Code Section 4610, everyone would “win” with prescriptions for opioid medications. A 90-day supply of Vicodin ES (hydrocodone with acetaminophen) provides a patient with four tablets a day for 90 days at a cost of about $68.00. A doctor visit to obtain a prescription for the 90 days is about $98.32 for a specialist under the OMFS. Parenthetically, Medicare has a new requirement that a prescription for all Schedule II narcotics be issued by the prescribing physician every 30 days via office visits since the FDA in 2014 changed opioids from a Schedule III to a Schedule II narcotic.

So for under $200.00 every three months, everyone “wins.” The injured worker gets pain relief from opioid therapy to the tune of 120 mg to 180 mg MED per day, the doctor can see hundreds of patients at $98.32 per ten minute office visit for each patient, and each employer’s claims administrator pays $800.00 a year per injured worker for “pain management.” Everyone is happy until the injured worker becomes dependent on the opioids or suffers from the side effects of long term opioid use. So now in 2015, the pendulum is swinging the other way, big time.


ACOEM Practice Guidelines for Opioids

The ACOEM white paper pre-amble states: “All treatment recommendations are guidance based on synthesis of the evidence plus expert consensus. These are recommendations for practitioners, and decisions to adopt a particular course of action must be made by trained practitioners on the basis of available resources and the particular circumstances presented by the individual patient.” (Hegmann, p. e144) This quote should be part of the actual ACOEM or DWC regulatory guideline since so many times, opioid treatment is denied, delayed, or ended based on utilization reviews that take the average patient into account and do not account for individual variation.

In fairness to ACOEM, its 2015 opioid treatment guidelines are based on a review of 264,617 articles on pain studies, with 263 actual studies with 157 deemed of high or moderate quality. (Hegmann, p. e144) The white paper does not identify how many of the articles or studies were conducted at the university level (usually of higher quality), how many were supported by the payer community (such as workers’ compensation payers, of questionable research quality), or how many were industry supported (usually by pharmaceutical companies, also of questionable quality).

The medical director of the California DWC has not formally adopted the March 2014 proposed Opioid Treatment Guidelines, probably because she was expecting the ACOEM white paper to be issued by the end of 2014. It stands to reason, though, that since the California MTUS adopts ACOEM guidelines for most treatment modalities, California would also be able to simply adopt the new ACOEM opioid treatment guidelines.

Here is a synopsis of the ACOEM opioid guidelines:

Acute pain (up to 4 weeks) (see Hegmann, Table 1, p. e145):

> There must be a comprehensive history and physical exam
> Acute, severe pain from trauma uncontrolled by other agents and/or functional deficits caused by pain
> Schedule IV opioid is ok if allergy to NSAID or Tylenol; or if nothing else works
> Recommend to taper off opioid after 2 weeks
> More detailed screening of patient if opioids are prescribed over 2 weeks, especially in cases of severe pain with no objective findings
> Maximum daily oral dose for opioid-naïve patients who have severe acute pain is 50 mg MED; use lowest possible dose
> Discontinue opioids for patient who have “meaningful functional recovery”
> Opioid naïve patients with functional recovery do not need to be tapered off|
> Patients with acute pain who are on greater than 50 mg per day MED for over 3 weeks need to be tapered over 3 to 7 days
> Transition patients to NSAID or Tylenol, or nothing at all after ending opioids
> Opioids are not recommended for patients who perform safety sensitive jobs
> Routine opioid use for “nonsevere acute pain” such as low back sprains or injuries with no tissue damage are not recommended

Post-Operative Pain (up to 4 weeks) (see Hegmann, Table 1, p. e145):

> Same as for acute pain, plus:
> Limited use of opioids as adjunctive (“along with something else”) therapy to more effective treatments
> Closely screen patients who need opioids more than two weeks post surgically

Sub-Acute (1 to 3 months) and Chronic Pain (greater than 3 months) (see Hegmann, Table 1, pp. e145-e146):

> Have the same guidelines
> Comprehensive history and physical
> Screening of patients before initiating a trial of opioids
> Use of an opioid trial if other evidence-based approaches for functional restorative pain therapy have been used with inadequate improvement in function
> Opioids are then recommended for treatment of function impaired by sub-acute or chronic severe pain (e.g. inability to work because of any of the following: chronic severe radiculopathy, chronic severe peripheral neuropathies, complex regional pain syndrome, and severe arthroses)
> Maximum daily oral dose recommended based on risk of overdose/death is 50 mg MED
> Use of opioid agreement with family participation
> Baseline and random UDT (urine drug testing); in certain situations, other studies such as hair for remote use or blood for acute toxicity) may be appropriate
> Opioid treatment for patients who are in safety sensitive jobs is not recommended
> Opioid treatment for non-malignant pain is not recommended unless the opioid prescription is patient-specific and limited to cases in which other treatments are insufficient and above criteria for opioid use are met
> Opioid treatment is not recommended for routine treatment of breakthrough pain superimposed on chronic pain in the absence of overt trauma or acute nociceptive pathology (e.g. fracture, heart attack, tooth abscess)
> Opioid treatment is not recommended with an intrathecal drug delivery system for chronic non-malignant pain conditions
> Discontinue opioid treatment for sub-acute or chronic pain patients who have any one of the following:

o  Have no functional gain
o  Non-compliance
o  Aberrant drug screening results and/or diversion
o  Adverse effects such as cognitive impairment, falls, poor judgment, untreated sleep apnea, psychological disorders, concurrent use of depressant medications like benzodiazepines (Xanax, Ativan, Valium, etc.) and diphenhydramine (Benadryl)

> Tapering is recommended if opioids are moderate to high level (50-100 mg MED) on a long-term basis
> Consultation with an addiction specialist or psychiatrist is recommended for complex patients (high dose patients, prior withdrawal problems, complex psychosocial confounders)
> Transitioning to only an NSAID or Tylenol or complete cessation of analgesics is/are generally indicated

In chronic pain patients, ACOEM guidelines recommend an opioid trial if (see Hegmann, Table 3, p. e148):

> Severe disorders warranting opioid treatment for conditions like complex regional pain disorders, severe radiculopathy, severe degenerative joint disease
> Other evidence based approaches for functional restorative pain therapy have failed in functional improvement including the use of:

o  Physical restorative approaches (physical therapy, pool therapy)
o  Behavioral interventions
o  Self-applied modalities (e.g. home exercises)
o  Non-opioid drugs such as NSAIDs, acetaminophen, topical agents, SSRI anti-depressants, anti-epileptic drugs (Lyrica, Neurontin) for nerve pain
o  “For patient with back pain, this includes [previous trial of muscle relaxants (but not concurrently with opioids)], fear avoidant belief training and ongoing progressive aerobic exercise and strengthening exercises. For CRPS patients, this includes progressive strengthening exercises. For degenerative joint disease patients, this includes [NSAIDs], weight loss, aerobic, and strengthening exercises.”
o  Function is impaired by sub-acute or chronic severe pain; patient cannot work or exercise
o  Pain scales should not be relied upon
o  Make sure the patient is not getting opioids elsewhere (use a prescription monitoring data base like CURES)
o  Review risk factors for overdose or death including concurrent use of benzodiazepines, illicit substances including marijuana, unemployment status, but may use opioids if objective evidence of significant trauma, or moderate to severe injuries

If an opioid trial is instituted, then follow the following instructions (see Hegmann, Table 3, p. e148):

> Have a functional restoration plan with specific targets
> Active exercise program that is verified
> Use non-opioid prescriptions including ones listed above
> Informed consent with signed opioid treatment agreement
> Lowest effective opioid dose; use weaker types first; do not prescribe Demerol
> Only prescribe one opioid
> Prescribe on a regular basis, not as needed, consider at night, not while at work
> For trial period, one week supply; if it works then up to 90 day supply
> Frequent (i.e. once a week) follow up to track progress towards functional restoration goals, adverse effects, compliance, surreptitious medication use
> Discontinuation of opioid prescription if there is no functional gain, resolution of pain, improvement to the point not requiring opioids, intolerance or too many side effects, noncompliance, misuse, aberrant drug screening results, diversion, or concurrent use of alcohol, benzodiazepine, or sedating medications

Maintenance of opioid medication treatment can occur if the trial criteria above is met, plus (see Hegmann, Table 3, p. e148):

> Less frequent follow up (three to six months) for patients who are stabilized
> Convert to long-acting opioid on a scheduled basis and not “as needed”
> As needed opioids not recommended for long term treatment of chronic pain unless there is an acute severe injury
> Do not use sub-lingual Fentanyl for sub-acute or chronic pain patients
> Fentanyl patches require caution due to unpredictable absorption
> Contact prescription drug monitoring agents such as CURES
> Confirm on-going compliance with opioid agreement and informed consent
> Recommend Tramadol for chronic pain patients as first level opioid option [see Hegmann, p. e147: “Tramadol seems to be a better initial option than more potent opioids. Nevertheless, with the long-term use, especially higher dose, it may be considered equivalent to other opioids for the purposes of this guideline. It has also been associated with motor vehicle crashes [citation omitted].”]

Commentary and Analysis

Some commentary on the ACOEM opioid treatment guidelines is important at this point since it seems likely that the guidelines announced in the ACOEM December 2014 white paper will be adopted in whole by the California DWC Administrative Director. In fact, as this article is written, a proposed new Chronic Pain Treatment MTUS is being proposed by the DWC with a separate Opioid Treatment MTUS to be announced soon.

Maximum daily dose of 50 mg MED

What are missing from the actual guidelines quoted above are explanations and clarifications of nuances of some of them. For example, in the guideline for a maximum daily dose of 50 mg MED, the authors of the ACOEM white paper state: “The maximum daily dose recommended based on risk of overdose/death is 50 mg MED [citation omitted]. Exceeding that dose should be based on documented need, and incremental functional gain increased surveillance for adverse effects and frequent reconsideration of benefit versus risk.” (Hegmann, p. e146) This implies that ACOEM will permit physicians to prescribe greater than 50 mg per day MED dosing for patients with chronic pain who are dosage stabilized, highly functional, with minimal side effects, and who have not changed types or dosing of opioid medications.

The reason this nuance is buried in the text and is not cited as a guideline is because the authors of the ACOEM white paper admit that there are no studies of patients who are on long-term opioid medication for nonmalignant chronic pain. The 67 chronic pain studies that the ACOEM panel reviewed involved patients who were on at most 3 to 6 months of opioid medication treatment. Only one study was over 3 months—at 16 weeks. (Hegmann, p. e147) There were no long term studies greater than 16 weeks reviewed by the ACOEM or any other group. So how can utilization review physicians systematically deny long term opioid therapy when the sacred cow evidence-based medicine does not exist for or against it? The ACOEM guidelines imply allowing for long term use provided that the patient meets the criteria of dose stabilization, functional activities of daily living, minimal side effects, and unchanged dose and type of opioid used. Physicians who treat chronic pain patients must use this language in their requests for authorizations for these patients to continue receiving long term opioid treatment.

Opioids that contain acetaminophen or ibuprofen

Also, use of NSAID or acetaminophen (Tylenol) at the same time as a short-acting opioid is encouraged for acute pain. The authors of the ACOEM white paper state: “Based on expert opinion, NSAIDs or acetaminophen should generally accompany an opioid prescription. Lower potency opioids are recommended when sufficient for pain relief. As-needed dosing rather than scheduled is generally indicated.” (Hegmann, p. e146) What is interesting about the ACOEM guidelines is the absence of current research that cautions over-prescribing of opioids that contain acetaminophen or ibuprofen. Many patients combine over the counter acetaminophen (Tylenol) or ibuprofen (Motrin) with their opioid medication, not knowing that the opioid medication also contains acetaminophen or ibuprofen. High dosages of acetaminophen or ibuprofen are known to be toxic to the liver for the former, and can affect kidney function or aggravate hypertension for the latter. The threshold safety level of acetaminophen or ibuprofen is less than 3000 mg per day but the ACOEM white paper does not mention this risk.

Post-operative pain from major surgery

For post-operative pain from major surgery, use of “scheduled opioid medication is usually required. Opioids sufficient to participate in therapeutic exercises (eg, progressive ambulation [after a total joint replacement]) and allow sleep may be needed.” (Hegmann, p. e146 (bracketed information inserted by this author)) Implied in this text is the additional guideline that allows use of opioids in post-operative cases for injured workers to participate in post-surgical physical therapy and for sleep.

Lower pain threshold

Another issue that is briefly mentioned in the ACOEM white paper is the fact that patients who currently take opioids or have done so in the past have hyperalgesia (a lower pain threshold) than people who have never taken an opioid medication. This is why ACOEM recommends trying non-opioid medications as a first line treatment for pain. Disclosure: This author was the chairman of an Institutional Review Board (IRB) [see 45 C.F.R. 46] in some of the studies cited in the ACOEM white paper that established these findings using what is called a “cold-presser” test. The actual research was funded by the National Institute of Drug Abuse (NIDA). The research cited by ACOEM was actually intended to determine what emergency room physicians are supposed to do with severe trauma patients who were already on opioid therapy for a separate medical condition. The problem becomes the lower the pain threshold, the higher the dose or strength of the opioid is needed to provide the same pain relief. This is why we have a national problem with tolerance and dependency on opioid treatment.

Intrathecal pain pumps

Another controversy has been created in the ACOEM white paper by its recommendations against using intrathecal pain pumps. This recommendation is contrary to the ODG guidelines, which do allow for the use of implanted pain pumps that use opioid medications for chronic pain patients. In addition, pain pumps are used routinely in general medicine as a last resort end point for treatment of chronic, severe, intractable pain and are reimbursed under Medicare and other health plans. In many patients, intrathecal pumps are safe and effective, and allow them to engage in activities of daily living. At least the authors of the ACOEM white paper concede that if a patient already has a pain pump, don’t use these guidelines to force discontinuation and removal of them. (Hegmann, p. e149)

The end justifies the means?

Policymakers in California are telling us by adopting these types of guidelines that employers should not be required to pay for long-term opioid prescriptions. Perhaps in the future, medical treatment for injured workers will be integrated into group or individual health plans and these guidelines will not be necessary because community standards of medical care will prevail. Community standards of care require individualized, patient-centered treatment protocols without the constraints of generalized evidence-based guidelines.

However, the debate also exists in generalized medicine, outside the purview of medical treatment for injured workers. In general medicine, the use of opioids for chronic pain is being discussed:

“It is much less clear when to consider decreasing or stopping opioids in the setting of difficult to measure subjective clinical outcomes such as pain, function, and quality of life. Opioid prescribing guidelines emphasize consideration of discontinuation of opioids in the setting of opioid-associated harm (e.g. intolerable adverse effects, aberrant medication-related behaviors, lack of progress towards therapeutic goals) [citation omitted], or both. However, little attention has been given to reassessing the need for continued opioid therapy in patients prescribed opioids for years, who show evidence of persistent benefit and no harm. It is difficult to measure an individual patient’s psychological changes associated with pain over time, which may alter the need for continued opioid therapy. This question of the appropriate duration of opioid therapy has been listed as a key research gap in the use of opioids for chronic pain by national pain societies [citation omitted].

“Moreover, in the setting of busy outpatient practices, it takes less time to continue opioid therapy than to discuss tapering or discontinuing opioids with patients who may be concerned that changes in opioid doses will worsen their pain. Discussing opioid discontinuation is not only time consuming but can also be emotion laden and uncomfortable with patients who are concerned about maintaining access to opioids [citation omitted]. Another important barrier preventing clinicians from discontinuing opioids is the lack of knowledge, confidence, and skill in how to taper opioids safely in patients who are physically dependent. Although other analgesics [e.g. NSAIDs] can be discontinued easily and without a taper, chronic opioid therapy often requires a gradual taper to prevent pain hypersensitivity during opioid withdrawal [citation omitted]. Complicating this lack of knowledge and skill is a lack of readily available evidence-based guidance about how to effectively and safely taper opioids in patients with chronic pain.” See Alford, “Weighing In on Opioids for Chronic Pain: The Barriers to Change,” Journal of the American Medical Association, Vol. 310, No. 13 pp. 1351-1352, October 2, 2013.

This quotation remains in effect today and the ACOEM opioid treatment guidelines fail to describe the reality of the treatment of chronic pain patients in the general medical population. There is no evidence-based research to indicate how these patients should be treated and the role long term use of opioids may benefit or harm them. How can ACOEM with no research tell us that chronic pain patients all need to be weaned from the opioids? The debate will continue but the likely decision to adopt the ACOEM opioid guidelines in California will cement the policymaker’s desire not to have employers and their claims administrators pay for long term opioid therapies.

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