Examples of informed consent and treatment agreement documents are available online from the New Hampshire Medical Society at https://www. nhms.org/Resources/Opioid-Substance-Related- Resources/Examples-of-opioid-informed-consent- agreement. Both forms can help facilitate discussions with the patient about ongoing risks and benefits and also provide structure in case difficult conversations become necessary regarding adherence to the treatment regimen. It is advisable to have a strategy to manage opioid misuse by the patient should it occur and to know and discuss with the patient indications for which opioid therapy may be discontinued. Managing Side Effects HCPs should expect, prevent, and take steps to manage opioid-related adverse effects. Common opioid side effects with suggested management strategies are listed in Table 8. 77 Managing Comorbid Disorders Patients should have psychiatric disorders and psychological symptoms managed in the context of multidisciplinary care. Benzodiazepines may be helpful as second-line agents when used short term to treat the anxiety that arises with pain from injury or hospitalization; however, benzodiazepines are best avoided for long-term use because of their addictive potential, the increased risk for overdose, respiratory depression, and death when co- prescribed with opioids, and the blunting of cognitive and, therefore, coping skills in patients with chronic pain. 1 In 2016, the FDA announced the requirement of boxed warnings with information about serious risks of extreme sleepiness, respiratory depression, coma, and death associated with combining prescription opioids and benzodiazepines. 70 For chronic mental-health disorders, a combination of medications indicated for the specific condition plus evidence-based psychotherapy, such as CBT, are recommended. 1 SSRIs and SNRIs (and sometimes buspirone) are medications most frequently used for generalized anxiety disorder, which often accompanies chronic pain. 1 Tricyclic antidepressants are sometimes used for panic disorder, but SSRIs, because of their lower side effect profile, are generally considered safest and most effective. 1 Recommended medications for PTSD include venlafaxine ER and prazosin. 1 When comorbid anxiety disorders are severe, psychiatric consultation to establish medication regimen is recommended. 1 In milder cases, no medication may be necessary if adequate behavioral and other nonpharmacologic treatments are helpful. In general, opioid therapy in patients with untreated OUD is unlikely to achieve therapeutic aims, and initiating it is not recommended. 20 HCPs may consider or continue opioids for patients with chronic pain and histories of drug abuse and psychiatric issues only if they are able to implement more frequent and stringent monitoring parameters. 61
Table 7. Items to Perform and Document in the Patient Record When Prescribing Opioid Therapy for Chronic Pain 20,61,77,85,138,141 1. Signed informed consent 2. Signed opioid treatment agreement(s) 3. Pain and medical history Chief complaint Treatments tried and patient response Past laboratory, diagnostic, and imaging results
Comorbid conditions (e.g., medical, substance-use, psychiatric, mood, sleep) Social history (e.g., employment, marital, family status, substance use) Pregnancy status or intent, contraceptive use
4. Results of physical exam and new diagnostic and imaging tests Review of systems Pain intensity and level of functioning One or more indications for opioid treatment Objective disease/diagnostic markers 5. Results of opioid risk assessment prior to prescribing opioids
Clinical interview or any screening instruments Personal history of SUD, mental health disorder Family history of SUD, mental health disorder Co-management or treatment referral for patients at risk for SUD Treatment or referral for patients with active OUD Treatment or referral for patients with undiagnosed depression, anxiety, other mental health disorders 6. Treatment goals for pain relief, function, quality of life 7. Treatments provided With risk-benefit analysis after considering available nonpharmacologic and non-opioid pharmacologic op&ons All medications prescribed (including the date, type, dose, and quantity) All prescription orders for opioids and other controlled substances whether written or telephoned 8. Prescription of naloxone, if provided, and rationale 9. Results of ongoing monitoring toward pain management and functional goals SUD = substance-use disorder OUD = opioid-use disorder; PDMP = prescription drug-monitoring programs; UDT = urine drug testing
• A mention of nonpharmacologic and non- opioid therapeutic options for pain treatment • Potential short- and long-term side effects, such as cognitive impairment and constipation • The likelihood that tolerance and physical dependence will develop • Risks of drug interactions • Risks of impaired motor skills affecting driving, operating machinery, and other tasks • Signs and symptoms of overdose • Risks when combining opioids with other CNS- depressants, including benzodiazepines and alcohol • The importance of the patient disclosing all medications and supplements • How to handle missed doses • Any important product-specific risks, such as the dangers of chewing an ER formulation Opioid Treatment Agreements Opioid treatment agreements that spell out patient and HCP expectations and responsibilities are recommended by most opioid guidelines. 77,85 Consider including: 141 • Treatment goals in terms of pain management, restoration of function, and safety • Patient’s responsibility for safe medication use, such as agreement not to take more than
prescribed, alter pills, or combine with alcohol, unauthorized prescriptions, or illicitly-obtained drugs • Patient’s responsibility to obtain prescribed opioids from only one HCP or practice • Patient’s responsibility to fill prescriptions at only one pharmacy • Patient’s agreement to periodic UDT or other drug tests • Instructions for secure storage and safe disposal of prescribed opioids • HCP’s prescribing policies, including handling of early refills and replacing lost or stolen medications • Reasons for which opioid therapy may be changed or discontinued, including violation of the treatment agreement • Statement that treatment may be discontinued without the patient’s agreement • HCPs availability policy, including responsibility to provide care for unforeseen problems and to prescribe scheduled refills • Education that the patient should not expect complete elimination of pain • The patient’s signature The forms for informed consent and treatment agreements may be combined into one document and adapted to the HCP’s needs and preferences.
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