Prescribers must be able to answer with confidence four key questions when obtaining informed consent in the context of treatment with opioids: 122 1. Does the patient understand the various options for treatment? 2. Has the patient been reasonably informed of the potential benefits and risks associated with each of those options? 3. Is the patient free to choose among those options, free from coercion by the healthcare professional, the patient’s family, or others? 4. Does the patient have the capacity to communicate his or her preferences— verbally or in other ways (e.g., if the patient is deaf or mute)? 5. Is there a proxy available if the patient cannot provide consent due to cognitive impairment? Documentation related to these key areas can be accomplished by creating a separate paper or electronic informed consent form or by incorporating informed consent language into a larger treatment plan or patient/provider agreement. Patient-Provider Agreements A written agreement between a clinician and a patient about the specifics of their pain treatment with opioids can help clarify the plan with the patient, the patient’s family, and other clinicians who may become involved in the patient’s care. 104 Such agreements can also reinforce expectations about the appropriate and safe use of opioids. Caution must be exercised, however, to ensure that patient/provider agreements are not used in a coercive way to unethically place patients in the position of having to agree to its terms or else lose an important component of their treatment (or even lose all treatment). 128 Although evidence is lacking about the most effective methods to convey the information included in most patient-provider agreements, such agreements have been widely used and are recommended by regulators and many experts on treatment guidelines for long-term opioid therapy. 28 The Veterans Administration and U.S. Department of Defense chartered an expert panel to undertake a systematic review of existing medical literature on this subject. In the clinical practice guidelines resulting from that work, the panel concluded that opioid treatment agreements are a standard of care when prescribing long-term opioid therapy. 128 Clinicians should strive to craft agreements that serve their patients’ best interests and avoid coercive or punitive language. Thus, agreements should avoid: 1. Putting all burden on the patient rather than sharing it between patient and clinician 2. Framing the agreement in terms of punishments for possible future crimes or difficulties
Table 3. Opioid dose recommendations for post-procedural pain 126
Procedure
Number of oxycodone 5 mg tablets (or equivalent)
Dental extraction Thyroidectomy
0 5 5 5
Breast biopsy or lumpectomy
Lumpectomy plus sentinel lymph node biopsy
Hernia repair (minor or major)
10 10 10 15 15 15 15 20 20 30 50
Sleeve gastrectomy
Prostatectomy
Open cholecystectomy
Cesarean delivery
Hysterectomy (all types)
Cardiac surgery via median sternotomy
Open small bowel resection
Simple mastectomy with or without sentinel lymph node biopsy
Total hip arthroplasty Total knee arthroplasty
Establishing a written treatment agreement Written documentation of all aspects of a patient’s care, including assessments, informed consent, treatment plans, and provider/patient agreements, are a vital part of opioid prescription “best practices.” Such documentation provides a transparent and enduring record of a clinician’s rationale for a particular treatment and provides a basis for ongoing monitoring and, if needed, modifications of a treatment plan. 104 Many computerized systems are now available for the acquisition, storage, integration, and presentation of medical information. Most offer advantages that will benefit both patients and prescribers, such as maintaining up-to-date records, and providing instant availability of information relevant to prescribing or treatment. Although automation can help, clear documentation is not dependent on electronic record-keeping; it merely requires a commitment to creating clear and enduring communication in a systematic fashion. Good documentation can be achieved with the most elaborate electronic medical record systems, with paper and pen, or with dictated notes. Clinicians must decide for themselves how thoroughly, and how frequently, their documentation of a patient’s treatment should be. Informed Consent Informed consent is a fundamental part of planning for any treatment, but it is particularly important in long-term opioid therapy, given the potential risks of such therapy. At its best, consent also fortifies the clinician/patient relationship.
Managing chronic non-cancer pain Management of chronic non-cancer pain begins by establishing individualized treatment goals, exploring non-opioid treatment options, and addressing comorbid depression and anxiety, if present. Pain management goals may include both pain and functional targets, with the understanding that being 100% pain free is not realistic. Functional goals should focus on activities that are meaningful to the patient and attainable based on the severity of the painful condition. Multi-modal approaches that include non-drug (procedures, integrative treatments) and drug interventions are recommended. 28 Be aware that comorbid conditions such as depression and anxiety can impact pain management. (In a study of 250 patients with chronic pain and moderate depression, using antidepressant therapy reduced pain levels before analgesic interventions were added. 127 ) For patients with intractable, moderate-to- severe chronic noncancer pain unresponsive to non-opioid treatment options, a trial of opioids may be indicated guided by the following principles (each detailed below): • Discuss risks and benefits of opioid use • Establish a written treatment agreement • Check or monitor opioid use with the prescription drug monitoring program • Use caution with dose escalation • Prescribe naloxone if at risk for overdose • Screen for opioid misuse or abuse using history and, ideally, a validated questionnaire, as well as urine drug testing • Taper or discontinue opioids when possible
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