Chronic pain exacts an enormous physical, emotional and financial toll on society, with prevalence rates reported in different reviews ranging from 10% to 50%. In recent years, a paradigm shift has occurred in the approach to treating chronic nonmalignant pain. This shift has generated an unprecedented controversy reverberating throughout medical, judicial, health-policy and patient-advocate circles. Ironically, this philosophical change is not attributable to the advent of a new class of analgesics or an innovative procedure to relieve pain. The controversy revolves around opioids, the medicinal use of which possibly dates as far back as the 5th millennium BC by the ancient Sumerians and Egyptians.
In the 1980s, the role of opioids in the management of chronic noncancer pain was fervently debated. Opioids were considered inappropriate for chronic pain management owing to concerns about adverse effects, tolerance, dependence and addiction. In the subsequent decades, several circumstances shifted the scale in the opposite direction. First, controlled trials of opioids reported positive outcomes in chronic nonmalignant and neuropathic pain states, conditions previously thought to be resistant to opioids. Second, case reports indicated a low incidence of addiction in patients with no history of substance abuse who received opioids for chronic pain. Last, health-care professionals, including physicians, became subject to civil and professional action for failing to treat pain appropriately. In a highly publicized case in 2001, a California jury awarded a US$1.5 million verdict against a physician for failing to prescribe adequate pain medications.
In response to the increasing demands for optimal pain management, sustained-release opioids were developed and aggressively marketed. The rationale for these endeavors was that sustained-release opioids, when properly taken, were likely to be associated with more-consistent pain relief, slower development of tolerance, less euphoria and a more-favorable side-effect profile. US sales of sustained-release oxycodone--which has been marketed since 1995--exceeded US$1 billion in 2000 and peaked at US$2 billion in 2005 before the premature end to the drug's patent protection.
The darker side of this aggressive new approach to pain management soon surfaced. Accounts of rising rates of prescription drug abuse appearedinsidiously at first, then in an avalanche of negative reports in the news media. In 2004, 2.4 million people aged 12 years and over in the US used prescription pain relievers for nonmedical reasons; opioid analgesics were by far the most commonly abused drugs. In a recent survey, 21.5% of inner-city street drug users reported that they had used immediate and sustained-release oxycodone, methadone or hydrocodone within the past 30 days.
To thwart the growing problem of prescription narcotic abuse, the federal government launched an assault on the burgeoning trade in pharmaceutical opioids, targeting not only drug companies and patients who divert their opioids, but also physicians. In 2002, the Drug Enforcement Administration prosecuted 410 physicians for recklessly prescribing opioids--an 800% increase in physician prosecutions from 1999. Many physicians and addiction specialists believe that this concerted federal effort has fomented a profound sense of paranoia in primary-care physicians, placed patients and physicians in adversarial roles, and resurrected an old obstacle for the responsible treatment of chronic pain.
So what can physicians do to balance the needs of patients and the burdens enacted by federal regulatory agencies, without ignoring the alarming trend in prescription opioid diversion and abuse? We believe that opioids do hold a place in the treatment of nonmalignant pain, albeit with certain caveats. First, it is imperative that before considering an opioid trial, the patient be assessed for predictors of opioid abuse, such as a history of alcohol or substance abuse and drug-related convictions. The presence of one or more risk factors does not necessarily mean that the patient will use opioids inappropriately, but the added perils of opioid treatment need to be factored into the equation. Several risk assessment tools for predicting aberrant behaviors in patients treated with opioids have been developed. These tools need further validation--especially in the context of differentiating addiction from pseudoaddiction--before being incorporated as routine monitors. Second, the physician should weigh up the propensity for treatment success. For nonmalignant conditions such as herpes zoster and trauma-related pain, a growing body of literature supports at least the short-term use of opioids.[2,9,10] In other conditions, such as chronic pelvic pain, evidence supporting opioid therapy is lacking, although a subset of patients might benefit from treatment.
Social factors need to be considered when contemplating opioid therapy. Patients who frequently miss appointments, who reside with a friend or relative with a history of substance abuse or who are unable to safeguard their medications might be more likely to encounter problems with opioid therapy. The decision to implement opioid therapy often amounts to a decision to enter into a long-term, dependent relationship with a patient. For this reason, we rarely prescribe opioids to treatment-naive patients on the first visit without first communicating with the primary-care provider. The ideal candidate should be a responsible patient with a well-defined basis for pain in whom other interventions have failed despite compliance.
If opioid therapy is instituted, the patient needs to be aware that the use of these drugs is not an inalienable right or an irrevocable decision, but rather an ongoing trial whereby pain relief, functional improvement and mood enhancement are continuously balanced against side effects including but not limited to tolerance and addiction. Practical exit strategies, such as discontinuation of treatment, initiation of addiction treatment interventions, and discharge from the practice, must therefore be readily available. In our inner-city pain management practice, we use a signed opioid agreement to delineate the responsibilities of all parties involved, establish the framework in which opioids will be administered, and set grounds for termination of treatment.
Differentiating legitimate prescribing practices from misuse and diversion can be a challenge for federal investigators, and most patients cannot fathom the concerns of doctors that stem from ambiguous regulatory issues. Some physicians take the path of least resistance, inappropriately substituting nonregulated drugs when the use of opioids would be ideal, or not registering to prescribe controlled substances. Others prescribe high-dose opioids on first visits to patients from out of state, for questionable indications, without attempting other therapies or confirming previous treatment history. We believe that the appropriate approach to this dilemma is to adopt a middle way--akin to the teachings of Eastern philosophers--between the extremes of overindulgence and unnecessary deprivation. A middle way will best enable the frontline clinician to balance the seemingly paradoxical roles of an upstanding citizen seeking a society free of illicit drug use and a Hippocratic doctor looking out for their patients' best interests. As is true with all conflicts, this approach might be associated with some collateral damage in the form of a few patients who misuse opioids and others whose pain is inadequately controlled--at least in the beginning. Yet we believe that the middle-way treatment paradigm encompasses the best of both worlds, and that the astute clinician will eventually be able to discern good opioid candidates from those in whom the treatment is doing more harm than good. After all, isn't this part of the 'art' of medicine?
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Division of Pain Medicine, Department of ACCM, Johns Hopkins University, 292 Osler, 600 North Wolfe Street, Baltimore, MD 21287, USA. Email: firstname.lastname@example.org
Nat Clin Pract Neurol. 2006;2(11):580-581. © 2006
Nature Publishing Group
Cite this: The Middle Way: A Practical Approach to Prescribing Opioids for Chronic Pain - Medscape - Nov 01, 2006.