Strategies for Selecting Treatment and Mitigating Risk in Patients With Chronic Pain
Scott M. Fishman, MD
Division of Pain Medicine and the Department of Anesthesiology and Pain Medicine, University of California, Davis
Chronic pain is a significant health problem in the United States; back pain alone affects roughly as many patients as diabetes, heart disease, and cancer combined.1 Unfortunately, due to factors that range from cultural and social barriers to governmental regulations, too often pain is undertreated.
Although opioid analgesics treat more types of pain and are usually more potent than other classes of analgesics, opioids are ineffective for some patients and can cause adverse physiologic or psychiatric effects in others. However, opioids should not be disregarded because of their complexity, particularly when few other options are available. If a physician determines that opioid treatment is appropriate for a patient, opioid medications can be used chronically with both effectiveness and safety.
Safety and Risk Management
The public health crisis of undertreated pain is clashing with the crisis of prescription drug abuse. According to the US Department of Health and Human Services,2 in 2008 more than 6 million Americans used prescription drugs (eg, pain relievers, tranquilizers, stimulants, and sedatives) nonmedically in the month preceding the survey, a figure that exceeded the number of people who abused cocaine, heroin, hallucinogens, and inhalants combined. Prescription drugs were also the drugs of choice among new drug users, with 2.5 million initiate users, and opioid pain relievers represented three-quarters of the overall problem of prescription drug abuse. In 2006, opioids caused more deaths due to overdose than cocaine and heroin combined
(AV 1).3,4 By 2008, the number of emergency department visits caused by the misuse of legal drugs was comparable to that for illicit drugs.
The methods for acquiring these prescription drugs are wide ranging and include “doctor-shopping,” illicitly acquiring prescription drugs via the Internet, and obtaining them from friends and relatives. When surveyed,5 more than 50% of teens in grades 7 through 12 agreed that prescription drugs were easier to get than illegal drugs. Nearly 20% reported having abused prescription drugs that were not prescribed for them, and 40% believed that prescription drugs, even when used without a prescription, were much safer than illegal drugs. Almost one-third saw nothing wrong with occasional use of prescription drugs without a doctor’s prescription, and about 30% believed that prescription pain relievers are not addictive.
These alarming statistics have created pressure on clinicians to focus on risk management during pain treatment. For example, the White House National Drug Control Strategy6 stated that physicians must assess patients’ risk factors for drug abuse, particularly when patients are beginning therapy for chronic pain. The document further advised that physician licensing boards should insist on more effective education for both existing and future doctors regarding risk management and that state licensing boards should maintain oversight and take action against physicians who incorrectly prescribe pain medications. The DEA7 has also issued a strong statement emphasizing that physicians have a responsibility to prevent diversion and abuse when prescribing a controlled substance for a legitimate medical purpose in the usual course of professional practice.
To abide by these recommendations, physicians must understand what constitutes addiction to a controlled substance. A consensus document8 on pain treatment defined dependence, tolerance, and addiction as separate, unrelated phenomena that are often confused with each other. Tolerance means that exposure to the medication over time reduces the drug’s effects, so that more of the drug is needed to obtain the same effect. Dependence refers to a physical need for the drug that can have negative consequences upon abrupt termination of the medication. For example, clonidine is an antihypertensive agent that produces physical dependence, and withdrawal can be life threatening, but clonidine does not produce addiction. Cocaine, on the other hand, produces psychological addiction but rarely produces physical dependence. Addiction is characterized by the compulsive use of a drug that produces dysfunction and the continued use of the drug despite that dysfunction (whereas patients treated for pain should have increased function because their pain improves). While patients with addiction will take unmodulated amounts of abusable drugs, patients treated for pain should be able to modulate the amount of their analgesic medication that they take to balance the greatest amount of pain relief while retaining the most function. Pseudoaddiction is an iatrogenic syndrome in which aberrant behavior results from inadequate pain control and resolves with effective treatment of the pain.
FSMB Model Policy for Controlled Substances
The Federation of State Medical Boards developed a model policy for physicians on the use of controlled substances for the treatment of pain.9 The basic tenets of this policy are that pain management is integral to the practice of medicine, the use of opioids may be necessary for pain relief, and the use of opioids for other than a legitimate medical purpose poses a threat to the individual and to society. The policy acknowledges the physician’s responsibility to minimize the potential for the abuse and diversion of controlled substances but is not meant to restrict or dictate medical decisions made by the physician.
The policy’s guidelines for the treatment of pain recommend that physicians should:
- Perform a complete patient evaluation, including a medical history and physical examination
- Produce a written treatment plan with stated objectives
- Obtain informed consent for and agreement to use the treatment from the patient after discussing the risks and benefits of the use of controlled substances
- Perform a periodic review of the patient’s treatment plan
- Be willing to refer the patient when the patient’s problem is outside the physician’s area of expertise
- Maintain accurate and complete medical records
- Be licensed in the state and comply with state and federal regulations.
Practice Recommendations for Opioid Treatment
Patients’ adherence to medication prescribing instructions—ie, taking the prescribed amount of medication and not abusing or diverting medications—is key to successful pain management. Tools to increase compliance with prescribing instructions include patient medication diaries and opioid agreements. Questionnaires designed to help screen patients for substance abuse risk prior to initiating treatment include the ORT10 and SOAPP,11 while the COMM12 screens for aberrant behaviors that may be predictive of abuse or addiction in patients currently on long-term opioid therapy (AV 2).13 Drug screening and, if available, the state’s prescription drug monitoring program—which makes data available to physicians regarding their patients’ prescription drug use—should also be a part of a balanced opioid risk management plan.
The CDC has made practice recommendations3 intended to help prevent unintentional opioid overdoses, some of which might be considered controversial. For example, the CDC suggests prescribing opioid medication for acute and chronic pain only after determining that alternatives do not deliver adequate relief, but opioids should possibly be used before other medications because of their known benefits versus risks. The CDC also advocates using the lowest effective dose of opioids and consulting a pain specialist for any patient whose dosage has increased to ≥120 morphine mg equivalents per day without substantial improvement in pain and function. However, arranging this consultation may be problematic if physicians cannot locate a pain specialist. The CDC further recommends not prescribing long-acting or controlled-release opioids for acute pain and periodically requesting a report from the state prescription drug monitoring program to be aware of patients’ prescriptions from other physicians. Finally, the CDC recommends performing urine testing for opioids and other drugs only in patients < 65 years old with noncancer pain. Nonetheless, older patients and those with cancer can have abuse problems, and these patients should not be excluded from a risk management program associated with responsible chronic opioid prescribing.
Clinical experience supports using the lowest effective dose of opioids and, if possible, limiting patients to a single prescriber and a single pharmacy. Using a formal opioid agreement can make treatment both easier for the practice and fairer for the patient, but care must be used to ensure that the agreement is fully collaborative and does not stigmatize or otherwise disadvantage the patient. Clinicians should use caution with opioids in patients with medical conditions such as congestive heart failure, COPD, sleep apnea, or excretion problems, or with metabolic difficulties such as renal or hepatic dysfunction, which may be affected by opioid-related adverse effects. Use caution when combining opioids with other sedative drugs like benzodiazepines or barbiturates.
The treatment goals of opioid therapy are to reduce pain and increase function. Objectively identify the expected outcomes of pain treatment by asking the patient what functioning they have lost that they want to recover, and then, during the course of treatment, follow functional outcomes closely rather than relying on subjective responses. Assess the function and pain status of patients routinely, and make treatment adjustments as necessary. Finally, establish a risk management program that includes evaluating patients for risk factors for medication abuse, monitoring for aberrant behaviors indicating misuse of medications, performing urine drug screens, and using data from prescription drug monitoring programs when available.
For Clinical Use
- Be aware that chronic pain is a common but undertreated health problem in the United States
- Prescribe opioids when necessary for treating chronic pain, but recognize that they carry the risk of serious adverse effects and the potential for abuse
- Establish functional outcome goals and effective and transparent risk management for patients when prescribing opioid treatment
CDC = Centers for Disease Control and Prevention, COMM = Current Opioid Misuse Measure, COPD = chronic obstructive pulmonary disease, DEA = Drug Enforcement Administration, ORT = Opioid Risk Tool, SOAPP = Screener and Opioid Assessment for Patients with Pain
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- Pleis JR, Lucas JW, Ward BW, for the National Center for Health Statistics. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. Vital Health Stat 10. 2009(242):1–167.
- Substance Abuse and Mental Health Services Administration. Results from the 2008 National Survey on Drug Use and Health: National Findings. Rockville, MD: US Dept of Health and Human Services; 2009. NSDUH Series H-36, HHS Publication No. SMA 09-4434.
- Centers for Disease Control and Prevention. Unintentional drug poisoning in the United States. http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief.htm. Published March 18, 2010. Accessed May 27, 2010.
- Warner M, Chen LH, Makuc DM. Increase in fatal poisonings involving opioid analgesics in the United States, 1999–2006. Hyattsville, MD: National Center for Health Statistics; 2009. NCHS Data Brief, No. 22.
- Partnership for a Drug-Free America. The Partnership Attitude Tracking Study (PATS): teens in grades 7 through 12, 2005. www.drugfree.org/Files/full_Teen_Report. Published May 16, 2006. Accessed May 27, 2010.
- Office of National Drug Control Policy, The White House. National Drug Control Strategy. Washington, DC: The White House; 2004. http://www.policyarchive.org/handle/10207/bitstreams/20716.pdf. Accessed May 27, 2010.
- Drug Enforcement Administration, US Department of Justice. Dispensing controlled substances for the treatment of pain. http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm. Published August 28, 2006. Accessed June 1, 2010.
- Savage S, Covington EC, Heit HA, et al. Definitions Related to the Use of Opioids for the Treatment of Pain. Glenview, IL: American Academy of Pain Medicine, American Pain Society, American Society of Addiction Medicine; 2001. www.painmed.org/pdf/definition.pdf. Accessed June 1, 2010.
- Fishman SM. Responsible Opioid Prescribing: A Physician’s Guide. Washington, DC: Waterford Life Sciences; 2007.
- Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6(6):432–442.
- Butler SF, Budman SH, Fernandez K, et al. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004;112(1–2):65–75.
- Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1–2)144–156.
- Højsted J, Sjøgren P. Addiction to opioids in chronic pain patients: a literature review. Eur J Pain. 2007;11(5):490–518.