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7 Articles in Volume 8, Issue #3
CES in the Treatment of Pain-Related Disorders
Commonsense Opioid-Risk Management in Chronic Non-cancer Pain
Injection Needle Injury of Oral Sensory Nerves
Maximizing Safety with Methadone and Other Opioids
Personality Disorders and the Bipolar Spectrum
Protecting Pain Physicians from Legal Challenges: Part 2
Technology in Pain Medicine

Commonsense Opioid-Risk Management in Chronic Non-cancer Pain

A Clinician's Perspective

This article is reprinted with permission from Pain Treatment Topics, Pain-Topics.org.

Chronic non-cancer pain (CNP) is a serious and likely undertreated public health problem. In a 2005 survey, 19% of US adults reported chronic pain and 34% reported recurrent pain.1 The annual costs of pain-related healthcare, litigation, and compensation are estimated at $100 billion in the United States alone.2 While opioids have been a mainstay in the treatment of acute pain, the role of opioids in treating chronic pain is less well defined and overshadowed by persistent concerns of misuse, abuse, and addiction. Fortunately, during the past 20 years, there have been major advances in clarifying these issues.

Publication of the World Health Organization (WHO) Analgesic Stepladder in 1986 provided a tool for guiding nonspecialists in the logical use of opioids for cancer pain.3 In the early 1990s, clinicians began to acknowledge that opioids also had a genuine role in the treatment of CNP.4 The Joint Commission for the accreditation of Healthcare Organizations (JCAHO) placed additional emphasis on the appropriate treatment of pain through its publication of pain management standards in 1999.5 Since then, key organizations have developed consensus statements to guide providers in prescribing opioids for CNP.6-8 Many states also have responded by adopting “Intractable Pain Treatment Acts” that specifically allow opioids to be prescribed for CNP and reduce the fear of Board actions against practitioners who prescribe them.9

The emphasis on improving treatment of CNP has produced a dramatic increase in the prescription of opioid analgesics. From 1999-2002, the sales of opioids reported through the DEA’s Automation of Reports and Consolidated Orders System (ARCOS) database increased by an astounding 76%.10 While opioids can be a powerful option in treating chronic pain, their use comes with some potential side effects and risks of serious medical complications including misuse, abuse, addiction, overdose, and death.

Through the same period (1999-2002), the increase in deaths from opioids roughly matched the increase in sales for each type of opioid. During this timeframe, there was a 95% increase in deaths related to opioids, and by 2002, prescription opioids replaced illicit drugs as the most common cause of fatal drug poisoning.10 While misuse, abuse, and addiction are thought to be relatively infrequent, recent work examining chronic pain patients in primary-care settings found a point prevalence for any DSM-IV-defined substance-use disorder of 9.7%.11 Other studies have noted higher rates in certain subpopulations of patients.12

There is a substantial risk to providers who prescribe opioids for CNP. While a particular state’s Intractable Pain Treatment Act may help protect providers against Board action, the Act often prohibits opioid prescriptions in cases where the provider “knows or should know” that the opioids are going to be misused.9 Furthermore, physicians may face criminal charges for inappropriate prescribing, especially when opioids may be involved in a patient’s death.13,14 Complicating this issue, malpractice suits have been brought against physicians for the undertreatment of pain.15

Commonsense Approach

Short of not prescribing them at all, there is no way to completely eliminate the risks of opioids. There are, however, certain commonsense steps to take that can help manage the risks to both patients and providers. In 2004, there was a Model Policy for the Use of Controlled Substances for the Treatment of Pain developed by the Federation of State Medical Boards of the United States.16 A stated aim was to promote “adequate pain management and education of the medical community about treating pain within the bounds of professional practice and without fear of regulatory scrutiny.”

In brief, the Model Policy requires:

  • Evaluation of the Patient. A medical history and physical examination must be obtained, assessed, and documented in the medical record.
  • Treatment Plan. A written plan should state treatment objectives that will be used to determine therapeutic success.
  • Informed Consent and Agreement for Treatment. The physician should discuss with the patient the risks and benefits of using controlled substances.
  • Periodic Review. The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health.
  • Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives.
  • Medical Records. The physician should keep accurate and complete records.
  • Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations.

While the Model Policy was not intended to be a clinical practice guideline, at its core is a framework for commonsense opioid prescribing and risk management. The items listed above reflect necessary steps, including the due diligence required to protect both the patient and the provider, and their universal application can help manage risks when prescribing opioids. In the following sections, these seven requisites are addressed with a particular focus on opioid risk management.

Evaluation of the Patient

A thorough evaluation involves taking a complete medical history. For patients with chronic pain, this is frequently the lengthiest part of the visit. Unfortunately, with regard to medication doses and previous therapies, patients’ memories are sometimes inaccurate and often incomplete. In addition to the history provided by the patient, it is advisable to review medical records from current providers, previous providers, and pharmacies. This provides independent source verification of the patient’s treatment history and is done prior to contemplating any therapy, including opioid prescriptions. Objectives of this step include:

  • Confirm current therapies;
  • Verify present opioid use;
  • Identify failed medication therapies;
  • Validate previous medication reactions; and
  • Expose undisclosed substance misuse, abuse, or addiction.
While opioids can be a powerful option, their use comes with some potential side-effects and risks of serious medical complications. Commonsense steps can help to manage opioid risks to both patient and healthcare provider.

There is a clear need to verify current opioid use as this translates directly to opioid tolerance and equianalgesic dose conversion. Patients may overstate their current opioid doses in an effort to increase their new dose to a desired level. Other patients may report current opioid use, but upon records review it may become apparent that the medication was discontinued. The historical dose, which was discontinued, may now be a lethal one. Records may reveal other comorbid conditions (eg, sleep apnea) that are absolute or relative contraindications to opioid therapy or unreported drugs that may interact with opioids (eg, benzodiazepines) and pose overdose risks.

While patients often bring in piecemeal medical records or old pill bottles, information should be obtained directly from the sources. It may take some time to collect these records; however, there are steps to reduce this wait to only days and sometimes even hours. A HIPAA-compliant request for medical records can be prepared during the office visit and then faxed to each of the previous providers and pharmacies. At times, additional providers are discovered during the initial records review, and these providers can be faxed requests as well.

In brief, patients currently using opioid pain medications should be able to name their present provider and pharmacy. Those who are unable or unwilling to provide this information should not be prescribed opioids. Physicians should be concerned about being duped by “professional patients.” Knowing that old records will be requested and reviewed tends to filter out some patients who are simply “doctor shopping.”

If there is concern about continuity of care (ie, running out of opioid medication) the records request can be completed in advance of the first visit. Patients can be made aware of this requirement when scheduling an appointment or through a “New Patient Letter,” which includes a section similar to the following:

“For patients with chronic pain we will need to review your medical and pharmacy records before prescribing any pain medications. We cannot accept your personal copies; they must come directly from your previous providers. To ensure we have an opportunity to review these prior to your appointment, you may stop by the clinic in advance and complete a Request for Medical Records form. Otherwise, we will not be able to obtain your records until after your first visit.”

Treatment Plan

A treatment plan involving opioids does not have to be complex to be complete. It should state simply and clearly how one can recognize if the treatment is successful. That is, the treatment plan often begins with the question: “How will we know if the therapy is working?” While an overall reduction in pain is a primary goal of most therapy, pain scores may not change appreciably during the course of treatment.

For example, one study of age-dependent dose escalation saw no change in Visual Analog Scale (VAS) pain scores for younger patients treated with opioids over a two year period.17 However, successful treatment for chronic pain also may be reflected by verbally reported pain relief as well as improvements in mood, ability to cope with pain, and sleep.18 Other criteria for success may include functional goals, such as participating in physical therapy sessions or returning to work or school. The treatment plan should also list any further investigations (eg, MRI), nonopioid medications, and referrals to other specialty treatment providers.

If opioids are to be prescribed, the treatment plan should also include the criteria of failure and how the practitioner will know if/when opioids should be tapered, changed, or discontinued. It must be clear early in the discussion process that opioids are being prescribed as a trial and that the initial opioid prescription does not constitute a lifelong contract to continue the therapy indefinitely. If it is unambiguous from the beginning that opioids are being prescribed as a trial, eliminating them and moving on to other therapies will be an easier step. It should also be clear that the goal of treatment with opioids is pain reduction, not pain elimination. In a review of opioid efficacy involving more than 1000 patients with a variety of pain conditions, the mean decrease in pain intensity was 30%.19 While this is a significant reduction, it is less than the complete relief expected by many patients.

There is justified concern regarding the prescription of opioid pain medications for patients with a history of substance abuse or who are suspected of opioid misuse. For these patients, a rigidly structured trial involving frequent office visits, regular urine drug tests (UDTs), and day-by-day or week-to-week dispensing may be necessary. This trial should be time limited, and the appearance of aberrant behavior should prompt referral to an integrated pain and addiction treatment program.20

There are three phases to an opioid trial: Initiation, Titration, and Maintenance…

  1. Initiation. During initiation, patients not currently using opioids are started at suitable naïve-level doses. Opioid-tolerant patients are continued on appropriate equianalgesic doses, adjusted for incomplete cross-tolerance if the current opioid is to be changed to another product.
  2. Titration. In this process, the dose of the medication is progressively increased in meaningful steps. For outpatients, dosing might be increased week by week after each assessment. Even a modest 25%-per-week step-up affords nearly a 600% cumulative dose increase over 8 weeks. Proper titration in an opioid trial can address concerns of pseudoaddiction. That is, some patients with undertreated chronic pain may exhibit “drug-seeking behaviors,” even though their motivation is pain relief and not the rewarding effects of the drugs. Their behavior may falsely resemble addiction, and this pseudoaddiction” may be difficult to distinguish from true addiction. However, with proper titration during an opioid trial, aberrant behaviors disappear once adequate pain relief is achieved.
  3. Maintenance. Once an effective dose has been reached, patients enter a maintenance phase. There is some concern that opioid tolerance will build over time; however, for CNP, regular dose escalation has been shown to be uncommon during long-term treatment.21

Recognizing Failure

Most providers would recognize a failed opioid trial if a patient’s function worsened or if the patient developed an intolerable side effect. Other forms of failure may be more subtle.

Data analysis for the nineteen patients (61%) in the “no other treatment options available” subgroup or the “surgery was their only option” subgroups showed notable improvements in pain, stiffness, and exercise ability with Hackett-Hemwall dextrose prolotherapy.

Opioids typically have a dose-response curve, with larger doses providing greater relief than smaller doses. Clearly, if a patient does not gain at least partial relief at low doses and titration fails to produce further relief, elimination of the opioid or rotation to another opioid is appropriate.

Another pattern of failure is rapid and intractable opioid tolerance manifested by the constant need for dose escalation.18 A patient may report good relief at low to moderate opioid doses but this is short-lived. Each incremental dose increase restores the relief but, again, only for a short period. This stair-step pattern is doomed and elimination of the opioid or rotation to another opioid is appropriate.

Failure of an opioid trial may also become evident as a pattern of persistent noncompliance; that is, the patient’s inability to use the medication safely and comply with the treatment plan. Some typical examples include: failing to follow a prescribed dosing schedule, reporting loss of prescriptions, neglecting other recommended therapies, or missing follow-up visits.22

Maximum Doses

For pure opioids there are no upper limits to titration. The literature describes patients who have been prescribed morphine in doses as high as 2000 mg per day for CNP.23 Practically, however, the useful range of opioids for CNP appears to be much lower. There is concern that daily doses of morphine (or a morphine equivalent) greater than 180 mg have not been validated adequately by clinical trials.24 Typical opioid doses from controlled trials are shown in Table 1.

There is absolutely no suggestion in the literature that there should be a fixed maximum dose for any particular opioid. When prescribing opioids, a provider should recognize when to re-evaluate chronic opioid therapy, and reaching a predetermined, self-imposed limit is an occasion to do so. The College of Physicians and Surgeons of Ontario reviewed opioid dosing practices and indicated that it was unusual for patients to require more than 300 mg/day of oral morphine for CNP.7

Table 1. Typical Opioid Doses from Controlled Trials
  Typical Dose Range (mg/day)
Opioid Nociceptive Pain Neuropathic Pain
Morphine 20-120 70-300
Oxycodone 20-40 20-80
Adapted from Kahan et al 2006.20

Informed Consent and Agreement for Treatment

With any medical therapy, a treatment plan and informed consent are necessary before initiation. With respect to opioid therapy, the Federation of State Medical Boards recommends the use of a written agreement when a patient is at high risk for medication abuse.

Unfortunately, there is very little evidence regarding the efficacy of these treatment agreements.22 It is not clear that outcomes or compliance are improved through the use of a written agreement for treatment; yet, some studies report positive outcomes for nearly all patients who sign a written treatment agreement.25 In another study of opioid “contracts,” the most common reason for physician cancellation was positive urine drug testing (50%), followed by prescription drug abuse (26%).26 Some experts believe that patient consent in the form of a written treatment agreement should be universally applied and obtained from all patients before initiation of opioid therapy.8 A written Agreement for Treatment with Opioids affords an explicit opportunity to discuss opioid risks, benefits, and common side effects. This is essential information, prompting the patient to weigh the benefits against the risks and costs and to make an informed decision concerning opioids.

The opioid agreement also provides both an entrance and exit strategy for the patient and provider as well as defining criteria for both events.27 It may specify boundaries of the opioid trial and when opioids may be discontinued. In addition, it can be used to outline requirements for follow-up visits, additional therapies, drug testing, and the process for medication refills, so there is a clear delineation of patient and practitioner responsibilities. A sample opioid agreement is shown in the Appendix.

Periodic Review

Managing opioid therapy requires regular clinic visits to monitor progress toward the predetermined treatment goals. Failure to do so may result in the prescription of large doses of opioids in the absence of improvement in pain levels or function. At each visit, the patient’s status should be reassessed with regard to the 4 A’s:18

  • Analgesia— Is the patient receiving tolerable pain relief? VAS pain scores may not change appreciably during treatment, but patients may still report their pain is “much better.”
  • Activities of daily living— Has the patient improved functionally? What goals has the patient achieved from the treatment plan?
  • Adverse effects— Have any side effects (eg, constipation, somnolence) developed? Can the side effect be treated, or should the opioid be decreased, changed, or discontinued?
  • Aberrant drug-taking behaviors— Is the patient using the medication as prescribed? While aberrant drug-related behavior may well indicate substance misuse or abuse, it might also signify poorly treated pain (pseudoaddiction) or worsening mental health.28,29

The frequency of visits is both phase and patient-dependent. During the titration phase, visits may be necessary every 1 to 4 weeks. During maintenance, visit intervals may be extended, with a comprehensive follow-up visit completed, optimally, every 3 months.24 Some experts recommend that dosing adjustments only be made during clinic visits;8 whereas, others will prescribe adjustments during the titration phase after a brief telephone assessment. Once a patient has entered the maintenance phase, a loss of analgesia should prompt re-evaluation before contemplating dose escalation.

As a risk-management measure, periodic review also entails routine urine drug testing. The Agreement for Treatment should include consent to regular and random drug testing. This is done to help ensure a patient is taking the prescribed medications as directed and refraining from using illicit substances. Since there are no consistent indicators of opioid misuse, as a safety measure all chronic pain patients should be required to submit a urine sample prior to receiving their first opioid prescription.

While it appears straightforward, the interpretation of urine drug test (UDT) results should be made cautiously and in complete view of the patient’s medical history. False positives and false negatives can and do occur. Certain synthetic (eg, methadone) and semi-synthetic opioids (eg, oxycodone) may not reliably appear on immunoassays. Additional and more specific testing with individual blood serum tests or GC/MS is often necessary. Ideally, providers should become familiar with their particular laboratory, understanding which assays they use and what limitations those have.29

Consultation

Pain is rarely simple. In addition to physical features there may also be psychological, social, and behavioral factors. During the course of therapy, providers must be able to recognize the limits of their training and experience and should be willing to refer the patient for additional evaluations.

Consultation can be a call for assistance or a request for confirmation. A second opinion from a subject-matter expert may be in order when the working diagnosis remains in question after a complete evaluation. Consultation is also appropriate when progress toward treatment goals is inexplicably stalled. As noted above, reaching certain triggering doses of opioids may prompt consideration of referral. At times, frustrated patients might ask for referrals, and in most cases, their requests should be granted.

Psychiatric and personality disorders may manifest during therapy, and affected patients should be referred to appropriate mental health professionals. Suicidal ideation requires immediate referral. Behaviors suggesting substance misuse or addiction should be addressed by an addiction specialist experienced in treating pain.

Medical Records

The Federation of State Medical Boards Model Policy recommends that patients’ medical records include a number of items:

  • The medical history and physical examination;
  • Diagnostic, therapeutic, and laboratory results;
  • Evaluation and consultations;
  • Treatments recommended;
  • Treatment objectives;
  • Medications (including date, type, dosage, and quantity prescribed);
  • Discussion of risks and benefits;
  • Informed consent;
  • Instructions and agreements, and;
  • Periodic reviews.

Not every patient visit requires addressing each of the above elements. Beyond these, the medical record should document the thought process of the provider regarding the decision to trial, continue, or discontinue opioid therapy. There should be a clear identification of the risks and the steps taken to mitigate those risks, such as a structured opioid trial for a patient with a history of substance abuse. Additional documentation would include: the interpretation of drug testing, equianalgesic dose conversions, compliance regarding refill requests, lost medications, and missed appointments.

Compliance with Controlled Substances Laws and Regulations

Opioid medications are regulated at both federal and state levels to ensure that efforts to control drug abuse are balanced against the need for maintaining drug availability for legitimate medical purposes.30 Clearly, to prescribe controlled substances, the pro-vider must be appropriately licensed. Complying with controlled substances directives involves reading the laws, guidelines, and regulations. Fortunately, in the United States, nearly half of the states have adopted the Federation of State Medical Boards Model Policy. While a State Medical Board is the best source of information, this website may provide links directly to a state’s pain policies: www.medsch.wisc.edu/painpolicy/matrix.htm.

Discussion

Substance Misuse, Abuse, and Addiction

While there are a number of questionnaires available to help predict a patient’s risk of abuse or addiction, we do not use them routinely. Some patients will lie and honest patients may be unfairly penalized. When taking a patient’s medical history, we routinely ask about substance abuse. If a patient does admit to past problems with opioids, this becomes an opportunity to reflect on the past utility of opioids and how they might be used in the current care plan. Certainly, we want to know about a patient’s history of substance abuse. Unfortunately, this information is often unavailable from the patient or the medical record. Regardless, it is not our clinic’s practice to deny access to opioid pain medications because of a history of substance abuse. When a history of substance abuse is admitted or discovered, the treatment plan will likely be more tightly constructed and involve a team approach.

Opioid Agreements

In our clinic, opioid agreements are used for all patients beginning chronic opioid therapy, and the standard form is part of our electronic medical record system. The agreement is completed electronically and printed to review with the patient. Once there is informed consent and understanding of patient and provider responsibilities, it is signed electronically by the patient and physician using a signature pad. The paper copy is kept by the patient.

Opioid Doses

In our practice, doses higher than 300 mg/day of oral morphine for CNP are unusual but not unheard of. There is a significant inter-individual variability in the response to opioids. Regardless of the milligram strength, if a patient is receiving pain reduction with improved function, and not suffering any intolerable side effects or exhibiting any opioid abuse behavior, then that is considered the proper dose for the patient.

Pain Specialist Shortage

Unfortunately, there is a national shortage of pain specialists, with only an estimated six of them per 100,000 persons with chronic pain in the United States.31 For many areas of the United States, there may not be local referral options. In such cases, patients may be required to travel to larger metropolitan areas or tertiary care centers to receive a pain or other specialist consultation.

A more rigidly structured trial of opioids is necessary for patients with a history of substance abuse or who are suspected of opioid misuse.

Summary

Opioids have a legitimate role in treating chronic non-cancer pain. While there are risks to their use, these medications should be available to patients who gain benefit from them and are able to use them safely. The risks can be managed by using a well-planned opioid treatment program for all patients. The Federation of State Medical Boards Model Policy, adopted by nearly half of the states, provides a suitable program framework, and its universal application can help to minimize risks when prescribing opioids. In particular, providers should:

  1. Request and review patient medical records prior to prescribing.
  2. Prescribe opioids as a trial, with criteria for both treatment success and failure specified.
  3. Use an Agreement for Treatment with Opioids to obtain informed consent.
  4. Monitor progress with regular visits and adherence with periodic urine drug testing.
  5. Involve consulting physicians as necessary to help clarify or confirm.
  6. Document the decision process to trial, continue, or discontinue opioid therapy.
  7. Learn and follow federal and state laws regarding controlled substances.

Application of the Model Policy should help standardize the process of opioid management but not dictate the individual therapy. Pain management is not a “one-size-fits-all” proposition. Treatment decisions regarding the use of opioids should only be made after a comprehensive evaluation of patients and in view of their complete medical history. Due consideration should be given to factors such as past or potential substance misuse. Opioid selection, doses, and treatment monitoring will need to be tailored to the patient.

Providers must also recognize the evolving risks to their patients. Regular visits are a necessary component of pain management, and chronic pain patients often require more frequent visits than non-pain patients. Changes in health status—as well as increases in medication use—should prompt re-evaluation of the diagnosis and treatment plan.

Acknowledgements

Medical Editor: Stewart B. Leavitt, MA, PhD, is the Publisher/Editor-in-Chief of Pain Treatment Topics and was the founding editor of Addiction Treatment Forum in 1992. He has served as a consultant to the US Center for Substance Abuse Treatment and as an officer in the US Public Health Service, stationed at the National Institutes of Health. He has more than 25 years experience as a medical researcher/ writer.

Medical Reviewers: Paul Jones, DO, is a Staff Physician at the Harry S. Truman Memorial Veterans’ Hospital and an adjunct Assistant Professor of Physical Medicine and Rehabilitation at the University of Missouri-Columbia School of Medicine in Columbia, Missouri. He is Board Certified in physical medicine and rehabilitation (ACGME and AOBPM&R); family practice (AOBFP); and by the American Board of Electrodiagnostic Medicine. Credentials of other reviewers Lee A. Kral, PharmD, BCPS and Paul W. Lofholm, PharmD, FACA, are available at: www.pain-topics.org/contacts_aboutus/in dex.php#MedAdvisors.

Last updated on: January 28, 2012
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