4 Steps Providers Must Take Before Prescribing Opioids

4 Steps Every Provider Must Take Before Prescribing an Opioid – Pain Medicine News – Nov 2018 – by Jeremy L. Belanger, Esq., CHC & Ronald W. Chapman II, Esq., LLM

Notice this is written by two lawyers, not doctors, to show what steps a are needed to avoid legal jeopardy.

Patients in pain who rely on opioids for analgesia and improved function deserve access to safe and effective medication; to deprive them of optimal pain relief certainly does them harm.

Regulatory and governmental agencies and private insurance companies are closely scrutinizing data related to the prescribing habits of medical practitioners, particularly with medications such as oxycodone, fentanyl, hydrocodone and carisoprodol, among others.  

The agencies look at a number of factors when reviewing the data to determine whether some amount of action against the practitioner is necessary.

These include

  • whether a practitioner is writing large numbers of opioid prescriptions;
  • whether there are groups of people who come in together to obtain prescriptions;
  • whether the patient is paying cash;
  • the morphine milligram equivalency of the medication being prescribed;
  • and many other data points

Based on these data alone, an agency may initiate an investigation or issue a complaint against a practitioner, his or her license, or Drug Enforcement Administration registration.

Agencies are increasingly taking the stance that there is a presumption that “if it wasn’t documented, it didn’t happen.” Although this is an invalid legal presumption to make, it is increasingly becoming the mantra among agencies and the premise for investigations and actions against practitioners

There is no standard of care mandated by federal law for medical professionals to follow when prescribing opioids.

The standard of care to apply is defined largely by state law; sometimes aspects are statutorily defined,5 and some are defined by case law.

To the extent federal law plays a part in developing guidance, it requires a prescription for a controlled substance, including opioids, to “be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

The guidelines in this article, if followed, can assist a medical practitioner in demonstrating that the minimum standard of care was satisfied. The recommendations described in this document are an amalgamation based on the various authoritative guidelines.

Ultimately, the decision to engage in treatment with opioids is appropriately left to the sound judgment of the practitioner. However, by following and documenting the information discussed below, a practitioner is better positioned to demonstrate that the course of treatment was appropriate and justified.

Initial Assessment

When beginning treatment for chronic pain, an evaluation needs to be conducted to document that the patient has one or more medical conditions indicating that the use of opioids is medically necessary.

Such an evaluation must include an assessment of the patient’s pain and should include documentation detailing

  • the onset of the pain,
  • the location of the pain,
  • the duration of the patient’s pain,
  • the character of the pain,
  • what aggravates the patient’s pain,
  • what relieves the patient’s pain, and
  • the timing of the pain (i.e., morning, afternoon, evening, etc.).

There should be a discussion as to past treatments and/or medications and the success rates of those medications. An opioid risk tool should be utilized to assess the patient’s personal and family history of alcohol or substance abuse and to evaluate the patient’s risk for substance abuse. The opioid risk tool should be included in the patient’s medical records.

Part of the evaluation must be the development of a treatment plan and treatment goals. Some examples of goals include decreasing pain and increasing function, improving pain-associated effects (e.g., sleeping issues, depression, anxiety, etc.), screen for treatment side effects, and avoiding unnecessary or excessive medication.

This plan needs to be updated throughout the course of treatment, so that it continues to be appropriate and realistic. A treatment plan may require the consultation of or referral to other providers, such as addiction specialists or mental health providers. Where appropriate, a treatment plan should include nondrug therapy, such as physical therapy or chiropractic treatment.

There is more skepticism surrounding when opioid therapy should be the sole mode of treatment. If there are justifiable reasons why opioid therapy is the only treatment (e.g., cost, other treatments have failed, or it is the best way to treat the pain), they should be documented in the record and supported with additional documentation.

If a patient reports that physical therapy has been attempted and was unsuccessful, a physician should obtain those records, review them, and include them in the patient’s medical file.

The treatment plan should include an end strategy for treatment.

An end strategy should consider

  • whether the underlying pain has improved or resolved,
  • whether intolerable side effects are present,
  • whether there has been inadequate pain relief,
  • whether the recommended treatment has failed to improve the patient’s quality of life,
  • whether the patient has failed to adhere to a treatment agreement, or
  • whether the patient has presented serious aberrant behavior.

Informed Consent and Treatment Agreement

Before prescribing opioids for the treatment of chronic pain, a practitioner should obtain an informed consent agreement and a treatment agreement.

An informed consent agreement should address the following:

A treatment agreement should cover:

Both documents should be updated regularly, at a minimum of once a year or if the treatment program were to change.

Initiating and Monitoring Treatment

Once a decision has been made to initiate opioid treatment, it should start as a therapeutic trial for a defined period of time, not to exceed 30 days. It should be clearly explained to the patient that the trial will be carefully monitored to assess the benefits and harm that may occur and to evaluate the level of and change in pain, function and quality of life.

The patient should be started on the lowest dosage possible, particularly those patients without an established tolerance.

Throughout treatment, practitioners need to regularly and proactively monitor the patient’s compliance with the treatment plan. Such compliance checks can include random pill counts, random drug screens and regular checks of the state prescription drug monitoring program (PDMP).

More frequent checks may be necessary for a variety of reasons: a patient also being prescribed a benzodiazepine and/or muscle relaxer concurrently with an opioid; the patient being assessed as having a high risk for substance abuse or misuse; or the patient exhibiting “red flags,” that is, aberrant or diversionary behavior. It is necessary to document that a compliance check was performed and the result of it.

A practitioner must monitor the patient’s progress in treatment and toward meeting the treatment goals. A practitioner should consider modifying a treatment plan if a patient is not making progress toward the treatment goals.

It’s clear that “treatment goals” cannot simply be “relieve pain” when opioids are prescribed. Instead, the treatment goal should be the activities enabled by pain relief, like going out more or visiting more, 

In this environment, higher order general goals like “feel more enthusiastic” or “be more patient” or  “feel a sense of accomplishment” aren’t sufficient in themselves; they have to be translated into specific behaviors that can be measured, like the ridiculous question: How far can you walk?

That’s like asking, “how long can you dance?” For me, there’s no answer to this without context:

  • When? (before I take an opioid pain pill or afterward, right now or some later time),
  • Where? (on a cement sidewalk or a forest trail),
  • How? (in “street shoes” or in specially padded athletic shoes with an orthotic)

If a practitioner determines that discontinuance of opioid therapy is required, the practitioner should design a safe tapering regimen and determine other appropriate treatment modalities.

“Other treatment modalities” do not include terminating the patient without usable referrals to doctors who are taking new patients.

Red Flags and Aberrant/Diversionary Behavior

There is no exhaustive list of behaviors that might be considered red flags. However, it is important for a practitioner to recognize such behaviors and to document them in the medical record as well as what actions have been taken, including discontinuance of opioid treatment or discharging the patient.

Examples of aberrant behaviors include, but are not limited to:

  • unauthorized self-escalation;
  • inconsistent or abnormal results from a urine drug screen;
  • obtaining opioids from more than one prescriber;
  • utilizing more than one pharmacy;
  • unauthorized or repeated ER visits;
    [How and why would your pain doctor “authorize” your ER visits?]
  • concurrent use of alcohol, illegal narcotics or other prescription medication;
  • resisting changes to a treatment plan; [some doctors may label even a questioning of their treatments to be “resistance”, so if you don’t do exactly as they say you can get kicked out of your pain management.]
  • resisting nonopioid treatment options;
    [I would absolutely resist many nonopioid treatments because either they don’t work for me or they are even damaging and painful]
  • requesting early refills or refills instead of an appointment;
  • prior discharge from another practice;
  • violating the treatment agreement;
  • arrest for drug-related crimes;
  • requesting refills due to lost or stolen prescriptions;
  • a history of overdoses; and
  • seeing a practitioner far from the patient’s home or receiving medication from a pharmacy that is far from a patient’s home or the practice.

That’s a darn long list and far from complete, making it a landmine for patients to navigate all the implications and limitations of these contracts even when they are trying to be compliant.

A clinician should document that he/she spoke with the patient regarding the behavior, and the essentials of that conversation should be documented

The presence of red flags does not necessarily require discontinuance of opioid therapy or discharging the patient. Urine drug screens, particularly point-of-care urine drug screens, often can be inaccurate or create false positives. However, by documenting, the practitioner demonstrates that he/she recognized the aberrant behavior and the reasoning for continuing treatment.


Proper documentation assists the practitioner in demonstrating that the minimum standard of care is satisfied and that the prescription was issued for a legitimate medical purpose in the ordinary course of professional practice.

I know how little time doctors have to spend on any one individual and I know I won’t be able to cover everything in a 15min appointment, so I do my own documentation. Before critical appointments with my pain doctor, I create a long document listing every single one of my latest pain symptoms, sensations, locations, and potential triggers, and ask to have it added to my medical record.

In this way, I have some control over what information is presented as a justification for my opioids.

Other thoughts?

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