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. 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: ● Putting all burden on the patient rather than sharing it between patient and clinician ● Framing the agreement in terms of punishments for possible future crimes or difficulties ● Using language that is stigmatizing, dominating, or pejorative
● Using coercion in any way ● Imposing limitations for the clinician’s convenience without clear and substantial benefit for the patient. ● Insisting on behaviors unrelated to actual use of medications ● Using the term “fired” to describe termination of treatment. ● Threatening abandonment or suggesting that patients will not have continued access to non- opioid pain-relieving treatments if opioids are terminated To be effective, written agreements must be clearly understood by the patient. This may require the provision of agreements in multiple languages. All agreements should be written at the sixth- to seventh- grade level or even lower. 129 Translators may need to be provided for speakers of other languages to ensure patient understanding and effective informed consent. A patient who does not fully understand the potential risks and benefits of a treatment cannot be truly “informed” as required by the legal and ethical guidelines for medical practice. Time must be allowed for patients to ask questions, and for prescribers to ensure patients understand what they are being told. Some, or all, of these tasks may be handled by trained personnel (or staff members) rather than clinicians. Although the term “agreement” is generally perceived as being more patient-friendly than the word “contract,” clinicians should understand that, from a legal standpoint, any written or oral agreement between a prescriber and a patient may be considered a binding “contract.” 130 Clinicians should ensure that the terms in any agreement are understood by the patient, and are acceptable, attainable, and consistent with high-quality practice.
Page 18
Book Code: MDAZ1124
Powered by FlippingBook