As pain management practice evolves and the number of patients with chronic pain increases, it is important to determine what evidence supports current practice related to the use of opioids for chronic, noncancer pain. Using opioids to treat this pain has been common but controversial. Fears of addiction and legal intervention permeate the prescribing of long-term opioid therapy.
Some of these fears are very real. Prescription drug abuse rates increased by 542% in teens (ages 12 to 17) and 124% among adults between 1992 to 2002.1 Of the 1.5 million drug-related ED visits in 2005, 27% involved pharmaceuticals alone and 10% involved alcohol with pharmaceuticals.1 For prescribers of opioid medications, the risk of having their prescriptions misused is very alarming. Thankfully, a new guideline has been developed to help practitioners assess patients being considered for chronic opioid therapy (COT), prescribe opioid medications, and monitor patients for compliance and medication efficacy. This article will address the need for the guidelines, provide information on the elements of the guidelines, and offer an overview of some of the techniques.
Risk evaluation and mitigation strategy
Recently, the FDA informed manufacturers of designated opioid products that require risk evaluation and mitigation strategy (REMS) sheets to ensure that the benefits outweigh the risks.2 The FDA has the authority to require these sheets under the FDA Amendments Act of 2007. The medications that will be affected by these REMS sheets include most opioids: fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.2 It is hoped that by developing these sheets the manufacturers will be able to provide information that will help decrease misuse while supporting the appropriate use of opioid medications to treat pain.
Chronic opioid therapy
Chronic pain is defined by the International Association for the Study of Pain as pain lasting beyond the normal healing period, which is assumed to be 3 months.3 For many patients, chronic pain robs them of quality of life, independence, and the ability to earn a living. In the United States, chronic noncancer pain is a leading cause of disability.3 The cost of one type of chronic noncancer pain, low back pain, was estimated to be between $85 to $100 billion in 2004 and 2005.3 The cost to a patient's quality of life and loss of self-esteem is immeasurable.
In primary care, one of the most common reasons patients visit their healthcare provider is for the treatment of chronic noncancer pain. For most patients, the expectation is that they will receive a prescription for pain medication. For most prescribers, the fear is that the patient will become addicted to the opioid medication, divert it, or misuse it.
One of the mainstays of treating chronic noncancer pain is COT. How comfortable are practitioners with prescribing long-term opioids? In a recent survey of NP prescribing patterns conducted by the editors of The Nurse Practitioner, about 400 NPs responded with information on how they felt about prescribing opioids. The study identified barriers and biases that have a direct effect on opioid prescribing. Approximately 50% of NPs felt that their education had not prepared them to treat or prescribe opioids for chronic pain.4 Additionally, the NPs who felt comfortable prescribing opioids for short-term pain relief (73%) had a decreased comfort level (32%) when asked about prescribing long-term opioids for chronic pain.4 This change in attitude may have been related to fear of addicting patients (61%) and regulatory oversight (71%), which was reported by a large number of respondents.4 Although opioids can be an effective means of controlling chronic, persistent noncancer pain, these prescriber fears and biases against opioids can lead to undertreatment of pain in patients with chronic, persistent pain as opioids are passed over in favor of lower level medications.
Clinical guidelines
As a response, to offer support for prescribers and evidence-based information, the American Pain Society and the American Academy of Pain Medicine recently developed a clinical guideline to examine the evidentiary support for safe opioid prescribing and to make treatment recommendations. The guideline was developed by a panel of national experts from a variety of disciplines who reviewed the current literature and developed practice recommendations. These recommendations include the following:
* Prior to starting COT, there should be a full history and physical, appropriate diagnostic testing, assessment of risk of substance abuse and misuse, or addiction.
* Using a benefit-to-harm analysis, a trial of COT for moderate-to-severe pain, or if pain is affecting function of quality of life, is an appropriate approach if the benefits outweigh the risks.
* Before COT is started, informed consent should be obtained. A COT management plan should also be developed, and a discussion initiated with the patient on treatment goals, expectations, potential risks, and alternatives.
* When conducting the trial of COT, the medication dose and titration should be individualized.
* Methadone should be prescribed carefully, with initiation and titration being done by clinicians familiar with its use and risks.
* Reassessment of patients on COT should occur at regular intervals and include random urine screens, pain intensity rating, functionality, progress to therapeutic goals, adverse events, and compliance with the prescribed regimen. A urine screen should be obtained more frequently for patients who exhibit high-risk or aberrant drug-related behaviors. For the purposes of the guidelines, aberrant behaviors are defined as a "behavior outside the boundaries of the agreed on treatment plan which is established early in the healthcare provider-patient relationship."3 (See Behaviors predictive of drug addiction or misuse).
* For high-risk patients such as those with aberrant behaviors, history of drug use, or psychiatric issues, COT should be used only if strong monitoring parameters are able to be maintained and help from "addictionologists" or a mental health specialists is available.
* When dose escalation, high-dose prescriptions, and aberrant behaviors occur, the prescribing clinician should perform a full assessment to address the cause. Consider opioid rotation if adverse reactions are intolerable or if there is inadequate pain relief after medication doses have been increased. Consider tapering or weaning opioid therapy in patients with repeated abuse or failure to progress with therapeutic goals.
* The approach to COT should be multidisciplinary and include functional restoration, psychotherapeutic interventions, and other adjunct nonopioid therapies.
* Clinicians should counsel patients on COT to avoid driving when impaired.
* Clinicians should encourage minimal or no use of opioids in pregnant women unless potential benefits outweigh risks.3
The comprehensive nature of these guidelines provides good frontline support for NPs. The strong base of complete history and physical exam coupled with the use of screening tools to measure risk for opioid misuse or aberrant behaviors is a clear recommendation that will benefit a prescriber considering COT for a patient.
Screening tools
The guidelines recommend two screening tools for clinicians to use to assess risk for opioid misuse including the Screener and Opioid Assessment for Patients with Pain (SOAPP)5,6 and Opioid Risk Tool (ORT).6 These tools are both simple sets of questions, easy to use, and take very little time to complete. Copies of these tools and the supporting reliability and validity studies can be obtained at http://www.painedu.org . With both the ORT and SOAPP, the higher the score the higher the risk of the patient when COT is started. The Diagnosis, Intractability, Risk, and Efficacy6 screening tool is an additional tool that can be used to screen COT candidates for suitability to opioid misuse. With this screening tool, the higher the score the better the patient is as a candidate for COT therapy.
The use of these tools can help determine if a patient considered for COT would have difficulty with the process. This does not mean the patient cannot have COT, but only that if the risk scores are higher on the tools, extra monitoring and more frequent office visits are indicated. Using the opioid screening tools to develop a baseline risk assessment will help determine which patients are good candidates for COT and which will require more time, monitoring, and follow-up.
Using the risk-benefit approach to institute COT is also a good process to use for patient selection. For some patients, the use of other clinical specialties such as mental health or psychology will clarify the less objective risks for patients being considered for COT. Discussing these issues with patients can help clarify the goals of treatment and ensure that patients understand the expectations and goals of treatment. Formalizing these discussions and evaluations in a treatment agreement can be reassuring for the patient and provide a record for the practitioner. Examples of opioid treatment agreements are also included in the guidelines. In some organizations, all patients who are on opioid therapy are required to sign a treatment agreement so there is a formal record of the risk and benefit assessment.
The monitoring recommendation in the guidelines is important for several reasons. The majority of patients can do very well on stable pain medication doses if the pain is stable. Adjustments and titration for medication can be expected over the course of COT for some patients in whom pain levels are variable. Other patients may demonstrate aberrant behaviors such as unauthorized dose escalations, recurrent prescription loses, or using illicit drugs. For these patients closer monitoring, urine screening, and compliance with the plan of care can allow the COT to continue. For other patients on COT who fail to progress with their plan of care and therapies, discontinuing COT and weaning the patients to other nonopioid treatment options should be the course of action. Using the opioid treatment agreement to delineate when these actions will be taken is instrumental to safe COT practice.
To assist the practitioner in tracking changes, alterations to the plan of care, and monitoring for opioid misuse, there are some additional tools that can be used. The Current Opioid Misuse Measure7can be used to screen for aberrant behaviors in patients who are on COT. The behaviors that this tool identifies are
* signs and symptoms of intoxication
* emotional volatility
* evidence of poor medication response
* addiction
* healthcare use patterns
* problematic medication behavior.3
Additionally, the Pain Assessment and Documentation Tool (PADT)8 can help the clinician document important elements of the COT process. The tool is based on the four "As"—analgesia, activities of daily living, adverse events, and potential aberrant drug-related behavior—and they are used for reassessing pain management on return visits. The PADT is available as an appendix on the COT guidelines.
Helping your patients
Clinicians are always looking for better and easier ways to provide care and relieve pain. The new COT guidelines provides some relevant and useful tools and recommendations to make prescribing COT for patients a better and safer option for both the patient and the prescriber.
Behaviors predictive of drug addiction or misuse
REFERENCES
1. Stanos SP, Fishbain DA, Fishman SM. Pain management with opioid analgesics: balancing risk and benefit. Am J Phys Med Rehabil. 2009;88(suppl 2):S69–S99. [Context Link]
2. FDA. Opioid drugs and risk evaluation and mitigation strategies: FDA to meet with drug companies about REMS for certain opioid drugs. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm . [Context Link]
3. Chou R, Fanciullo G, Fine P, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113–130. [Context Link]
4. D'Arcy Y. Be in the know about pain management. Nurs Pract. 2009;34(4):43–47. [Context Link]
5. Butler SF, Budman SH, Fernandez K, Jamison R. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004;112:65–75. [Context Link]
6. Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools and pain management instruments for a screening, treatment planning, and monitoring compliance. Pain Med. 2008;9(S2):S145–S166. [Context Link]
7. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the current opioid misuse measure. Pain. 2007;130:144–156. [Context Link]
8. Fine P, Portnoy R. A Clinical Guide to Opioid Analgesia. Vendome Group Healthcare Division LLC; 2007. [Context Link]
