Commonsense Opioid-Risk Management in Chronic Non-cancer Pain
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
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: