Informed Consent

Securing a patient's informed consent for the use of chronic opioid therapy for pain management is a crucial step in therapy. Informed consent gives the patient the opportunity to be an informed participant in health care decisions and provides a way to document full disclosure of the benefits and risks of opioid therapy. Not only does informed consent foster an open dialogue between provider and patient, it also protects the clinician and the clinic should a legal disagreement occur in the future. For more discussion about informed consent, visit the IHS risk management site.

Written informed consent should address:

1. Realistic and often limited benefits of opioid therapy
2. Potential risks of opioid use disorder, misuse, tolerable and physical dependence, and overdose
3. Potential side effects (e.g., constipation, cognitive impairment/over-sedation, etc.)
4. Potential risk of drug interactions and impaired motor skills that may affect the ability to drive and complete other tasks
5. Release of information to coordinate care with other treatment providers

Patient-Provider Agreement

In addition to informed consent, a patient-provider agreement should be established and documented for opioid therapy that builds mutual understanding and provides a roadmap for treatment. The agreement should provide a clear understanding of clinic, provider, and patient expectations, such as:

• The goals of treatment, in terms of pain management, restoration of function, and safety
• The patient's responsibility for safe medication use, including not using more medication than prescribed or using the opioid in combination with alcohol or other substances; storing medication in a secure location; and safe disposal of any unused medication
• The patient's responsibility to obtain his or her prescribed opioids from only one provider, clinic, or pharmacy
• The patient's agreement to periodic drug testing (such as blood, urine, hair, or saliva, etc.)
• The provider's responsibility to be available or designate a covering provider to address unforeseen concerns and to prescribe scheduled refills
• The provider's prescribing policies and expectations, including the number and frequency of prescription refills, as well as the provider’s practices on early refills and replacement of lost or stolen medication
• Specific reasons for which drug therapy may be changed or discontinued (including the violation of the policies, practices, and agreement)

Continuation or modification of therapy is dependent on the provider's evaluation of a patient's progress toward the stated treatment objectives and goals, such as improvement in pain associated symptoms, improved physical and psychosocial function including ability to work, need for healthcare resources, participation in activities of daily living, and quality of social life. The treatment plan and goals should be established as early as possible in the treatment process and revisited regularly.

Sample Agreement Templates

Download the following sample agreements and amend them to suit your practice or clinic:

• Sample Patient-Provider Pain Medicine Agreement [PDF - 133 KB]
• Sample Medication Safety Agreement and Informed Consent for Treatment [PDF - 121 KB]

References

IHM Part 3, Chapter 30, Chronic Non-Cancer Pain Management.