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Opioid Prescribing Guidelines & Requirements

Opioid Prescribing Guidelines & Requirements



This must be detailed and include current and past information. Physicians ought to “trust but verify” which should be done by reviewing old records, urine drug screening, and checking information from a prescription drug monitoring program. These will confirm or refute the story given by the patient. In light of the large amount of abuse and diversion, physicians must be on the alert for “red flags”.

Addiction risk screening is vital and should include personal and family history of alcohol, illegal and/or prescription drug substance abuse (including tobacco, age, history of sexual abuse), and a personal mental health history. Tools include the Opioid Risk Tool,24 Screener and Opioid Assessment for Patients with Pain (SOAPP),25 and others.

Analysis, Assessment, and Goals of Treatment

The physician should document an assessment as specific as possible (eg, lumbar radiculopathy rather than back pain) and goal setting (eg, maximizing function while minimizing risk, increasing the ability of the patient to work or perform specific activities, or tapering the medication dosages as tolerated).

Informed Consent

Risks reviewed should include dependence, addiction, overdose, and death. Driving risk while under the influence of opioids must be addressed.

Management Plan

The management plan must be individualized, multimodal, thorough, and consistent with the patient’s diagnosis, the current pain severity, and the functional ability or limitations. For new patients with chronic pain, obtaining prior records, testing, and consultations may be warranted. Until trust is built and additional information is obtained, a small prescription quantity may be justified.

Use the least risky medication or medications and treatments believed indicated on the basis of the evaluation. When the clinician determines that opioids are indicated, new short-acting, immediate-release opioid regimens should be started with as low a dose as possible, generally with a short treatment timeframe, and a plan for discontinuation. Written directions for the prescription should be specific, including how often to use the medication and the maximum number per 24-hour period. Low-quantity prescriptions reduce the risk of unintended diversion of leftover medications.

Patients using opioid medications long term should strongly be considered for dosage reduction if possible, especially for patients taking an MED of 50 mg/d or higher. This requires a therapeutic alliance between the physician and patient that supports the patient’s long-term well-being.

Documentation and Record Keeping

Thorough documentation is necessary for patient safety, legal requirement, and billing purposes.

Controlled Substance Agreement

Sample controlled substance agreements are readily available, including from the American Academy of Family Physicians/Family Practice Management26 and Kaiser Permanente.27

Periodic Review and Follow-up Visits

Follow-up visits may be much shorter than the initial evaluation, assuming there are no suspicions of aberrant behavior and the patient is stable or improving. An adaptation of the “4 As” of periodic review28 is analgesia, activity, adverse effects, affect, and aberrant behaviors. Always think about tapering opioid dosages if possible.


Urine drug screening initially and at least every six months; appointment visits every three months; and additional patient-specific laboratory testing may be indicated on the basis of the patient’s overall health (eg, kidney and liver testing). If problems or suspicions occur, the timeframes may be shortened. Pay special attention to red flags for abuse and diversion (see Sidebar: Red Flags for Drug Abuse, Addiction, or Diversion). Documented compliant patients with stable controlled pain may on occasion have timeframes briefly extended.

A review of the prescription drug monitoring program initially and at least every four to six months allows the prescribing physician to monitor the patient’s controlled substance profile. Physicians may use this information to identify likely adherence to the controlled substance agreement, as well as aberrant (ie, departure from the prescribed therapeutic plan) patient behavior, including “doctor shopping,” pharmacy shopping, and early refills.


Patients not improving as expected, or deteriorating, or those requiring escalating dosages require consultation by an appropriate subspecialist. Physicians should consider having patients who are receiving long-term opioid treatment see an appropriate subspecialist at least every one to two years to explore additional or new management strategies. Consultant availability (geographic, insurance, etc) may affect this decision and requires specific documentation if indicated but not obtained.

Morphine Equivalent Dosing

Patients receiving opioids should have their MED calculated (mg/d) using an opioid calculator29 and documented (Table 1). Overdose risk increases by 3.7% in patients taking an MED of 50 to 99 mg/d. This risk increases to 8.9%, with an annual overdose death rate of 1.8%, when the MED is 100 mg/d or greater.30 When higher dosages are necessary, documentation of specific informed consent by the patient, closer monitoring, and periodic comanagement by an appropriate subspecialist is required. Home naloxone rescue preparations may be warranted if the patient is at higher risk of overdose and death. Patients build tolerance to opioids over time and are at higher risk of overdose and death when there is a gap in opioid medication use (eg, incarceration, rehabilitation), especially if placed back on previous opioid dosages.