Prescribing opioids – Navigating the minefields

We continue with our series of general educational articles penned by one attorney, an MD, JD, giving you a view of the world through a malpractice plaintiff attorney’s eyes. This attorney is a seasoned veteran.  The series includes a number of pearls on how to stay out of harm’s way. While I do not necessarily agree with 100% of the details of every article, I think the messages are salient, on target, and fully relevant.  Please give us your feedback – and let us know if you find the series helpful.

Treating patients in pain with opioids creates serious legal quandaries for doctors.

A 2010 study (based on the American Society of Anesthesiologists Closed Claims Database) found that malpractice claims related to chronic non-cancer pain management primarily involved patients with a history of risk behaviors.

The study also found that death was the most common trigger of these claims.

Prescribing opioids causes a conflict. No doctor wants to undertreat the patient in pain. No doctor one wants the excess liability created by patients who are addicts, criminals, or a complex mishmash of unrelenting pain issues and co-morbidities.

On the other hand, that study also found that 59% of claims were grounded in physician mismanagement, either on its own or compounding a patient risk factor.

This means doctors still control the legal destiny of these cases. Steps can be taken to reduce the physician’s risk of being prosecuted as a “pill mill” or being held responsible for the dangerous or felonious use of the medication by the patient.

I. General principles and practices to avoid liability

The framework comes from the guidelines in the 2013 Federation of State Medical Boards Model Policy On The Use Of Opioid Analgesics In The Treatment Of Chronic Pain.

To avoid problems, think like your state board.

The Model Policy makes defines a stance an investigator will take to parse the issues. Chronic pain is acknowledged as a serious public health issue. Persistent pain is acknowledged as an indicator of under-treatment. Those preamble statements are then quickly followed by the statement that some pain just does not go away. The real focus will be on excessive and inappropriate treatment.

The Model Policy then segues into looking to physicians for their role in abuse, misuse and diversion of these drugs.

Persistent pain, in it of itself, will not be an adequate defense to a charge of over-prescribing.

The Model Policy then goes on to actually list pitfalls that lead to excessive prescribing, telling physicians what specific elements in their own practice they need to shore up to avoid running afoul of an official investigation.

These are:

• Lack of knowledge as to “best practices.”
• Inadequate research into the cause of the pain and treatments for it.
• Not understanding the causes and manifestations of addiction.

Actions more likely to manifest into a disciplinary situation are resorting too quickly too opioids and not monitoring for dependence.

The Model Policy then notes that state medical boards will consider the following to be inappropriate management:

• Inadequate assessment to determine if opioids are clinically indicated. The Model Policy specifically states that prescribers “should use opioid therapy for chronic non-cancer pain only when safer and reasonably effective options have failed.”

• Inadequate monitoring.
• Lack of patient education and informed consent.
• Dose escalation as a sole course of response to continued pain. The Model Policy specifically states that the prescriber should “maintain opioid dosage as low as possible and continue only if clear and objective outcomes are being met.”

The Model Policy then goes on to assure physicians that they will be considered to be using opioids legitimately (translation: will not be disciplined) if the investigation concludes that the use of opioids was for a legitimate medical purpose.

Indicia of legitimacy are:

• Was there a valid physician-patient relationship?
• Was the decision to use opioids based on sound clinical judgment and current best clinical practices, including consideration of alternatives?
• Was the treatment with opioids appropriately documented?
• Was the treatment with opioids appropriately monitored?
• Was the treatment with opioids of demonstrable benefit to the patient?

A practice should have a firm policy in place as to when and how it will prescribe these drugs – these are not decisions that should be safely made This is even more critical if you do not practice pain management as your specialty and only occasionally prescribe opioids.

This policy should encompass several features:

1. Alternatives

Prescribing opioids for chronic non-cancer condition should typically not be a first choice. Removing a patient from dependence on these drugs should always be the goal. Having a clearly stated office policy on this issue- distributed to patients- can distinguish your practice from those that prescribe for profit or out of negligence.

Discussing alternatives to opioid use is also intrinsic to the Model Policy’s informed consent. This means a discussion of the risks and benefits of options available to the patient, with a final settling on opioids as a shared decision.

2. A patient contract

A contract lists your office policies regarding appointments, prescriptions and patient conduct that the patient agrees to follow.

It will include the patient’s responsibility for safe medication use and storage and their consent to drug testing.

The contract will state grounds for termination from the practice, including lying about symptoms, lying about other medication sources, evidence of doctor-shopping as per the state’s prescription website (see below), stealing or dealing, refusal to be drug tested, or attempts to cheat when tested.

It is up to you to decide whether the penalty is immediate termination from the practice or a “strike” system. Whatever plan you use must be followed consistently between all patients.

3. Creating a proper record

The of a pill mill is an office moving patients through with little actual attention.

Your records should reflect the opposite.

A documented medical history and complete physical examination must precede the first issuance of a prescription. Subsequent prescriptions should be generally not be written without a physician visit, including a note that addresses alternatives.

An evaluating board will be looking at whether you assessed the nature and intensity of the pain, past and current treatments for the pain, any underlying or co-occurring disorders – including mental illness and addiction – and the effect of the pain on the patient’s physical and psychological functioning .

Each visit should also document that you warned the patient about limitations on activities such as driving and operating machinery and that you reinforced warnings about safe storage if there are children or other vulnerable people in the home.

A copy of all patient instructions should be maintained in the patient’s chart.

In determining if you are maintaining your records defensibly bear in mind the statement in the Model Policy that “The Board will judge the validity of the physician’s treatment of a patient on the basis of available documentation, rather than solely on the quantity and duration of medication administered. The goal is the management of the patient’s pain while effectively addressing other aspects of the patient’s functioning, including physical, psychological, social and work-related factors, and mitigating risk of misuse, abuse, diversion and overdose.”

In other words, if you can justify a higher dose for a longer period you will be defensible. But prescribing a lower dose for a shorter interval without a solid record can be problematic.

4. The addicted patient

Patients who already have an active substance abuse problem should not receive opioid therapy until they are established in a treatment/recovery program or alternatives are established such as co-management with an addiction professional.

5. Monitoring

(i) For effectiveness

Opioid therapy should start as a test trial of the lowest reasonable dose for up to 90 days, with periodic evaluation points within it to assess the patient’s progress using the “5 A’s”: analgesia, activity improvements, adverse effects, aberrant behaviors attributable to the opioid and the affect of the patient

Once an effective dose is settled, evaluation should continue at monthly intervals.

(ii) For abuse

You must check your state’s prescription monitoring program, both to detect doctor-shopping and to avoid liability arising from drug interactions.

This should be done at regular intervals because an initially legitimate patient may not stay so.

If required by state law, you may report the patient to law enforcement as a permissible act under HIPAA. However, do not contact another prescribing physician directly to report the patient’s activities, as this is not a valid disclosure exception under HIPAA.

You may, however, contact another physician without the patient’s permission to request their records if YOU require such to treat your patient. This would most likely come up when you mistrust what the patient told you about prior treatment and that information impacts your current choices. This WILL come under the treatment exception in HIPAA. This is a point that an evaluating board would note in analyzing whether you properly assessed your patient before prescribing opioids.

You should also drug test all chronic non-cancer opioid patients on a regular basis, the universality and regularity also being protective against charges of discrimination. This will identify additional drugs the patient may be taking (but not disclosing). It will also reveal if the patient is actually taking what you prescribed (rather than selling it).

. Pharmacy limits

Only one pharmacy should be designated. That pharmacy should also be informed to alert your office of inappropriate conduct by your patient on its premises, since that will be a violation of the patient contract and grounds for termination from your practice.

7. Replacement

Only one replacement, and only upon a verifiable loss or theft (the latter requiring a police report to have been filed), per patient should be your rule and the patient must be required to come to the office for the new prescription.

8. Termination

Terminating a patient for good cause does not relieve you from the requirement to avoid abandonment.

In addition to the usual requirement to cover emergency care (usually 30 days), you should offer appropriate referrals to addiction programs or specialists and should provide the patient with a one month’s prescription. It could be malpractice to force them into precipitous withdrawal.

II. Liability for undertreatment

With pain – of course actually a subjective issue – now oxymoronically deemed the “5^th vital sign”, are you at risk for treating pain?

The answer – unsatisfyingly – is “maybe”.

Proper alleviation of a patient’s pain is part of your duty of care. It is therefore potentially actionable.

On the other hand, absent something further such as a suicide due to unremitting pain it is not easily separable as a damage from the patient’s underlying condition.

Therefore, to date there is no clear indication as to whether undertreatment will be a significant malpractice or professional discipline concern.

A 2001 California case (actually brought under an elder endangerment statute) noted that the undertreatment would have to be egregious, such as administering far too low a dose to be expected to be effective or providing oral medication to a patient who cannot easily swallow.

By contrast, your documentation of appropriate dosages as per clinical guidelines and evaluation for other causes of the pain should be adequate for defensibility. You just need to demonstrate you didn’t simply dispense opioids on a request. You treated the patient’s complaints as presumptively valid and worked with them to achieve the maximum analgesia safely possible.

Summary: State medical board policies emphasize the facts that opioids should not be a first resort and must be prescribed at the lowest level and for the shortest time that is effective. A reviewing body will look to the physician’s records for proof of the consideration of alternatives and the clinical justification for opioid treatment. It will also look for appropriate monitoring. A patient contract is essential and sanctions should be enforced. Addicted patients should be referred for treatment. Under-treatment is unlikely to be a source of liability.

[Medical Justice notes: The ultimate Goldilocks conundrum. Not too many opioids. Not too few opioids. The issue rears its head with chronic non-cancer pain. Boards of Medicine, Attorney Generals, and the DEA are focused on avoiding substandard treatment and diversion. The stakes are high. They go beyond just Board discipline. There are potential criminal penalties, including jail time. Don’t blame me. I’m just the messenger.

Chronic pain is best managed by those practitioners who have extensive experience – understanding the issues vis a vis addiction, diversion, and pain control. They also understand the paper trail required for proper compliance. We know several doctors who had a handful of difficult patients – and continued prescribing opioids over the years. When these patients were arrested for drug diversion or hospitalized for overdose, their problem became the doctor’s problem. None of these doctors were running pill mills. They just had a few difficult patients – and it was easier to provide higher and higher doses of opioids than refer them elsewhere.]