10 tips to mitigate legal risks of opioid prescribing



Opioid-related lawsuits against physicians are on the rise. Common allegations include unnecessary prescribing, failing to heed contraindications, and missing warning signs of a likely overdose, said Ericka L. Adler, a Chicago-based health law attorney. To mitigate your risk of getting sued, legal and clinical experts offer the following advice.

Erica L. Adler

Erica L. Adler

1. Identify at-risk patients

Consider the full range of patient risk factors before prescribing or continuing opioids, said Ilene R. Robeck, MD, director of virtual pain education at Richmond VA Medical Center in St. Petersburg, Fla., and cochair of the National VA PACT Pain Champions Initiative.

“When we look at the overdose data, there used to be a perception that people who overdosed were not taking their medication as prescribed, and that’s not true all the time,” she said. “In fact, in some [studies], half the people who overdose take their medication exactly as prescribed. The problems are related to dose, mixing the opioids with other medications, [patient] age, and underlying medical problems.”

Ensure that therapy considerations related to opioids address the full patient picture, Dr. Robeck advised. For example, patients with liver disease, sleep apnea, chronic obstructive pulmonary disease (COPD), asthma, and kidney disease are more prone to overdose. In addition, while nonmedical use of prescription drugs is highest in patients aged 18-25 years, opioid overdose rates are highest among patients aged 25-54 years, according to the Centers for Disease Control and Prevention.

Dr. Ilene R. Robeck

Dr. Ilene R. Robeck

2. Monitor midlevel providers

Closely monitor and limit opioid prescribing by the midlevel providers you supervise, said pharmacologist and consultant James T. O’Donnell, PharmD. A fair share of medical malpractice lawsuits result from failing to supervise a physician assistant (PA) or nurse practitioner (NP) prescribing or treating pain patients.

“Excessive or inappropriate opiate prescribing will result in legal actions against the supervising physician,” Dr. O’Donnell said. “Close monitoring of midlevel providers requires establishing guidelines for opiate prescribing.”

Develop practice protocols that track and regulate midlevel prescribing and regularly discuss prescribing dangers with staff. Know your state law; the extent to which an NP or PA can prescribe varies widely.

Dr. James T. O'Donnell

Dr. James T. O'Donnell

3. Document

Keep detailed records of patient encounters that include specifics of what the patient tells you, said Ms. Adler.

Clear documentation about prior conditions, interactions with other health care providers, and past and current treatments help protect the doctor should liability later arise. In the case of a dishonest patient, clear record keeping could help show that a patient lied or omitted facts if the notes later become evidence in a lawsuit, she said.

“I also think [doctors] should document their policies, so there is clarity and understanding in the relationship,” Ms. Adler said. “Showing a policy where national standards/recommendations are followed will help protect the practice.”

4. Restrict refills

Require prescriber review before patients can obtain refills or new prescriptions for patients who run out of medicine before their next appointment, Dr. O’Donnell said.

“Excessive or early refills for opiate prescriptions are signs of abuse,” he said. “This creates risk to the patient and malpractice risk to the physician.”

It’s also helpful to limit the number of pharmacies used for opioid prescriptions, Ms. Adler said. This makes it easier track medications and narrows the pathway between prescription and drug obtainment.

5. Partner with pharmacists

Work closely with other health providers, such as psychiatrists, therapists, and pharmacists to ensure safe prescribing decisions. Pharmacists have a corresponding responsibility in dispensing opiates, Dr. O’Donnell said.

“Take the pharmacists’ calls regarding your opiates prescriptions,” he advised. “The pharmacist will know what other medicines the patient is taking and may advise of dangerous dosage or interactions.”

6. Require patient agreements

Opioid treatment agreements aid in patient accountability and promote education of drug risks, Dr. Robeck noted. In such contracts, patients agree to fully comply with all aspects of the treatment program and acknowledge that they will not use medication with harmful substances. Other terms can include that patients:

• Only obtain opioid prescriptions from one provider.

• Agree to keep all scheduled medical appointments.

• Promise to undergo urine drug screens as indicated.

• Agree not to share or sell medication.

• Agree not to drive or operate heavy machinery until medication-related drowsiness clears.

Contracts can help patients remain informed about the dangers and benefits of medications, while protecting the physician’s right to terminate treatment if the patient violates the agreement, Ms. Adler said. One sample agreement can be found here.

7. Involve family members

Family members and caregivers are critical to a patient’s opioid therapy plan, Dr. Robeck said. Discuss with patients ahead of time the potential for family member involvement. Family or the patient’s support system should be educated about the patient’s medications, the risks, and how to respond in an emergency.


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