Prescribing Opioids? Better Have This Chat With Your Patients

The FDA recommends that physicians and other clinicians consider prescribing naloxone for patients at increased risk of an opioid overdose.

This week, the FDA issued a Drug Safety Communication that recommends considerable changes to the current process of prescribing opioids to patients. The recommendations reflect the federal government’s ongoing efforts to combat the opioid epidemic, which continues to plague the country simultaneously being ravaged by the spread of COVID. Here are some of the changes and ways that practices and individual clinicians can remain current with compliance:

• If a patient is at an increased risk for an opioid addiction (called an opioid use disorder or OUD by the feds), physicians should consider a concurrent prescription for naloxone, an opioid-reversal medication (available under the brand names Narcan® and Evzio®). The patients about whom the FDA is specifically concerned here are also taking benzodiazepines or CNS depressants, have a history of OUD, or have previously suffered an overdose.
• Discussions with the patient about the availability of naloxone should occur when opioids are initially prescribed or renewed. It may also be appropriate to involve the patient’s caregiver or family— those who are joining the patient for appointments—in these discussions. They may be the person(s) administering the naloxone if the patient overdoses.
• Physicians should consider prescribing naloxone when the patient has household members at risk of an overdose or opioid misuse. Examples include young people with access to the medication, small children susceptible to accidental ingestion, or those with a history of disordered substance use or overdose. 
• Prescribers should consider the best form of naloxone for the patient and the situation. Clinicians should also familiarize themselves with the FDA’s efforts to diversify the types of naloxone treatments available, including nasal sprays, auto-injectors, and injections. 
• Medical practices should provide and post information about how to identify and reverse an opioid overdose. They should also post information about how to access medications like naloxone. 
• Even if a clinician is not prescribing opioids, they should consider prescribing naloxone to their patients at risk of an opioid overdose. These patients may be identified based upon their medication history, the clinician’s knowledge of the patient’s access to other medication sources, or an overdose history. 
• Federal and state governments regulate the availability of naloxone and other drugs that help combat opioid use disorder, such as buprenorphine and methadone. Practitioners should be familiar with their particular state’s requirements and the general availability of these medications to their patient population. For example, some states offer community health programs with opioid abuse services or non-prescription naloxone. Further, some communities have provided overdose medications to all law enforcement officers. Familiarity with these requirements can help clinicians appropriately advise their patients.
• Opioid labels will now contain information about naloxone and overdoses. 

How Do State Laws Address Naloxone Access and Use?

Many states have implemented specific rules and requirements to increase naloxone availability and allow billing to patients’ insurance companies. Illinois has issued an Illinois Naloxone Standing Order, which offers guidance to specific practitioners and the public. Under the Order:

• A pharmacist can obtain training on the use and administration of naloxone. Once they have completed the required training, they will be authorized to provide the medication even to a patient without a prescription. When they do so, they are required to report it to the Illinois Prescription Monitoring Program. (The State has provided a webinar for pharmacies online here.)
• Opioid overdose education and naloxone distribution programs (OENDs) can provide naloxone to individuals at risk of an overdose and to family or friends that may need to administer the medication in the event of an overdose. OENDs need to be registered with Illinois’ Department of Human Services Substance Use Prevention and Recovery Program.
• Illinois has created a patient-friendly handout explaining how to prevent opioid overdoses and how to use naloxone. Practitioners, clinics, and even non-prescribers should consider offering this information to their patients.

Other states have implemented similar programs. For example, Wisconsin’s NARCAN® Direct Program provides naloxone to dozens of state-approved community agencies to distribute to patients.

What it means:

• Informed consent remains an important conversation. A form signed by the patient without a thorough discussion of risks, benefits, and alternatives won’t suffice, especially for opioids. 
• Clinicians should understand how these changes impact their prescribing practices and the responsibilities that might impose on those under their supervision.
• Workplace handbooks for healthcare workers and employees should be updated to reflect this new guidance. Practices should train all practice members on the new recommendations and educate them on the common signs of opioid misuse.
• Clinicians need to collect comprehensive patient histories and gather information about the patient’s living environment to identify risk factors.
• Prescribers should carefully document their discussions about naloxone and opioid misuse in the patient record.
• Practitioners who prescribe opioids should evaluate the coverage offered by their malpractice insurance. Even if a clinician does nothing wrong, a patient’s overdose or abuse can lead to a claim against the clinician. Having proper insurance coverage can impact whether you pay out-of-pocket for an attorney to defend your license and actions, and whether high-dollar financial damages would be paid out by your carrier.

For additional guidance on the opioid prescribing laws in any of the states where we practice, or to establish compliant informed consent policies, reach out to one of our experienced healthcare attorneys.

This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader. It should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.