Receiving an opioid at just one encounter, such as in the ED setting, is linked to future adverse outcomes, including addiction, according to a recent study.1
“We were surprised by the magnitude of variability in opioid prescribing, even within the same ED, as well as how persistent the effect of one exposure to a high opioid-prescribing physician was,” says lead author Michael L. Barnett, MD, MS, an assistant professor of health policy and management at Harvard T.H. Chan School of Public Health in Boston.
The ED patients had not used prescription opioids in the six months before the ED visit, yet the intensity of the EP’s opioid prescribing was linked to the patient’s likelihood of becoming a long-term opioid user during the subsequent 12 months.
“Acute treatment of pain, either postoperatively or in the setting of acute injury, is now felt to represent one of the primary gateways to chronic use of pain medications, opioid use disorder, and addiction and/or overdose,” says Michael D. Anderson, a risk specialist and supervisor of patient safety and risk management at Medical Insurance Exchange of California (MIEC) in Oakland, CA.
Malpractice litigation against EPs is likely to rise commensurately. “We expect EPs to be increasingly included as potential targets of claims in which it is alleged that opioids were prescribed acutely either without adequate indication, or in excessive amounts,” Anderson says.
False Marketing Alleged
In May, Ohio’s attorney general filed a lawsuit alleging opioid manufacturers engaged in fraudulent marketing.2 This could trigger increased opioid-related litigation for all prescribers, including EPs, says Renée Bernard, JD, vice president of patient safety at The Mutual Risk Retention Group in Walnut Creek, CA. However, it’s unlikely EPs could point to alleged fraudulent marketing practices as a defense for inappropriate prescribing practices.
“I can’t see how any medical malpractice defendant prescriber could successfully argue false marketing practices at this point in time, when we have so much more knowledge about this issue,” Bernard says.
When litigation commences against a product, manufacturers typically defend the product unless and until test cases result in large losses, says Mollie K. O’Brien, Esq., director of claims at Coverys, a Boston-based provider of medical professional liability insurance.
“In these matters, the treating physicians, those using the allegedly dangerous or defective products, are called upon as witnesses in litigation, as opposed to being named as party defendants,” O’Brien explains. Typically, this is the case because treating physicians could not be said to have foreseen the danger to the patient.
“In the case of opioid addiction, however, the tide may change,” O’Brien notes, adding that advocates for addicted patients may allege that addiction was foreseeable to the prescribing physician. “EPs don’t want to be the guinea pigs for such a case. Many are erring on the side of caution — not prescribing — to avoid that possibility.”
Reduce Likelihood of Lawsuit
There has been a consistent rise in costs from opioid-related litigation since 2005, according to the PIAA Data Sharing Project.3 Emergency medicine notched the second-highest “paid to close” ratio, after psychiatry.
Bernard warns, “It’s imperative for EPs to educate themselves on new drug monitoring regulations and best prescribing practices to reduce their likelihood of being involved in litigation.”
John Burton, MD, chair of Carilion Clinic’s department of emergency medicine in Roanoke, VA, says, “The big picture here is the growing sensitivity of the public to the dangers of prescribed opiates.” He sees these two groups as highest risk for EPs legally:
- Patients prescribed long, multi-week courses of opioids;
- Patients co-prescribed opioids and benzodiazepines.
Although prescribing of opioids during the ED visit always carried the potential for legal risks, such cases were uncommon.
“However, the game changer is the potential for suits by discharged ED patients who receive prescribed opiates for therapy following the emergency encounter,” Burton explains. Here are some possible allegations involving ED prescribing of opioids:
- The EP’s prescribing practices are not consistent with either institutional policies or state statutes.
EPs must be “hypervigilant” in this regard. Burton warns: “Follow local policies and state statutes very closely to assure your practice remains aligned with these practice changes.” A recently passed statute in Virginia requires all physicians to offer a prescription of naloxone to any patient for whom benzodiazepines and opioids are co-prescribed in any encounter. “The statute brings up an entirely long list of unintended consequences,” Burton laments. Two obvious questions: What specific instructions must the EP give to the patient regarding the use of naloxone, and what counseling should the EP give to the patient regarding risk of addiction and risk of respiratory depression with the co-prescribed medications?
“In one recent conversation in our ED, a patient in whom we were counseling for this specific circumstance was very confused as to the proper use of naloxone,” Burton says. The patient asked if she should use it daily when she takes the other medications, how she could afford the drug, and whether she should receive an intranasal or injection form of the drug. “The conversation prompted us to reflect on the complexities of prescribing this drug for patients who we encounter in a single visit to the ED,” Burton says.
This is just one example of a state statute in response to the opiate crisis that has direct implications for emergency medicine practice. “As state legislators derive their own statutes, there are a number of possible legislative efforts that could similarly impact emergency medicine practice,” Burton adds.
- The ED prescription caused long-term substance addiction.
“Sooner or later, a plaintiff attorney or family will desire to pursue such an allegation,” Burton warns.
Anderson says the primary liability concern around opioid treatment is the risk of overdose and death due to respiratory suppression. However, MIEC has seen, and paid indemnity on, cases in which a patient’s opioid addiction is the claimed injury. “As focus on the potential liability associated with opioids continues to increase, we expect to see more of these types of cases,” Anderson predicts.
One way EPs can mitigate liability risks is by acknowledging and discussing the risks of opioids with patients. Barnett says, “Some patients may decline opioids if they are more informed about the risks of addiction or overdose. This conversation could be documented in high-risk situations.”
In Burton’s view, EPs should be “very hesitant” to prescribe opiates in volume or duration that would exceed brief, acute pain management periods.
“To be very blunt, now is not the time to be prescribing one-month refill for patients who allege they have lost their monthly supply of opiates for chronic pain,” Burton says. For instance, the plan for an acute fracture patient should be a multi-day prescribed course of pain medication as opposed to a multi-week prescription. Many state statutes now limit the days of prescribed therapy for opiates, particularly in the ED setting. “Law enforcement has specifically focused on ‘pill mill’ physicians,” Burton notes. Thus far, the focus has been on chronic pain management clinics or primary care physicians prescribing multi-month, large-dose opioids to patients.
“To date, I have not seen suits or law enforcement focused on ED prescribing, unless there is some allegation of an unusual pattern or circumstances for prescribing,” Burton says.
Many more cases brought against physicians are expected. “The courts and public have certainly lost their patience with excessive opiate prescribing by physicians,” Burton adds. “We have seen very aggressive penalties for physicians convicted of malfeasance, including jail time.”
- Opiates prescribed in the acute care setting harmed the patient.
“As the public becomes more sensitive to the potential for these events, one would expect to see an increase in these types of suits,” Burton says. Typically, the patient suffers a stroke, cardiovascular event, or respiratory arrest after discharge from the ED.
“These tend to be uncommon cases and are frequently challenged with proving causation between the prescription action in the acute care setting and the patient event,” Burton says.
- The patient drove while under the influence of controlled substances received on discharge from the ED.
California law requires physicians to report patients with disorders characterized by lapses of consciousness to the Department of Motor Vehicles. Generally, this is interpreted to refer to seizure disorders. “But recently, we’ve noted plaintiff claims alleging negligence where an opioid use disorder was not timely reported by a physician per these regulations,” Bernard says.
EPs should seek clarification on their state reporting requirements, says Bernard, including whether the EP can delegate the report to be performed by another member of the care team.
- The EP failed to conduct a thorough history, including checking the state’s prescription drug monitoring database.
“EPs frequently encounter patients who are attempting to access opioids through more than one provider and pharmacy,” Bernard notes.
EPs write 5% of all opioid prescriptions, typically providing about a five-day supply, according to researchers who analyzed medical examiner reports of prescription drug-related deaths in San Diego County during 2013.4
Although EPs appear to provide fewer prescriptions to patients who die because of prescription drugs, EPs accounted for a high proportion of total providers, according to the study. These results highlight the need to use prescription drug monitoring program data to monitor prescription patterns closely, the authors argued. Eleven states currently have such programs in place. “These programs are one useful resource to help guide EPs in determining how to manage pain in the time between an ED visit and the referred outpatient appointment,” Bernard says.
Failure to take a full history, including checking the prescription drug monitoring program database, could lead to an ED patient receiving a dangerous cumulative opioid dose. Anderson says, “It is also important to perform morphine-equivalent dosing calculations to determine the cumulative effects of concurrent opioids being prescribed to a given patient.”
Opioid abusers often arrive at an ED after experiencing a suspected overdose. These patients subsequently may return to the same ED for acute opioid medications.
“EPs may increasingly face liability for failing to recognize opioid use disorder or addiction based on previous ER visits and prescribing additional opioids to addicted patients,” Anderson cautions.
Potential Addicts
O’Brien says, “EDs have been plagued for years by addicts and chronic pain patients seeking opioid medication.” As a result, EPs have long been savvy at identifying these high-risk individuals, even before the more recent onslaught of media attention to the opioid epidemic.
“Recently, there have been a number of studies published about a new at-risk population: potential addicts,” O’Brien says. These are patients who are prescribed a course of treatment with opioid medication and develop a dependency as a result.
“Although the media hasn’t targeted only EDs, the discussion regards all opioid prescribing, and, as such, applies to the EP directly,” O’Brien explains. “The result is that the EP must be circumspect about any opioid prescribing.” This is true even for the legitimate patient suffering from moderate pain, O’Brien adds.
“Previously relied-upon practices of prescribing only enough medication to bridge the time between the ED visit and an appointment with the patient’s primary or consulting physician is now deemed dangerous,” O’Brien explains. If one of those patients should develop an addiction, she warns, “the EP could, under the current landscape, certainly become a target in litigation.”
Whether EPs ultimately will end up as defendants in litigation alleging that improperly prescribed opioids led to addiction remains to be seen. “But the risk-averse EP won’t, and shouldn’t, wait to find out,” O’Brien notes. “Smart practice will include significant safety measures and conservatism in the prescription of opioids.”
REFERENCES
- Barnett ML, Olenski AR, Jena AB. Opioid-prescribing patterns of emergency physicians and risk of long-term use. N Engl J Med 2017;376:663-673.
- Mike DeWine, Ohio Attorney General. Attorney General DeWine Files Lawsuit Against Opioid Manufacturers for Fraudulent Marketing; Fueling Opioid Epidemic, May 31, 2017. Available at: http://bit.ly/2ty1vtE. Accessed July 7, 2017.
- PIAA Research Notes Vol. 2(2), PIAA 2016.
- Lev R, Lee O, Petro S, et al. Who is prescribing controlled medications to patients who die from prescription drug abuse? Am J Emerg Med 2016;34:30-35.
SOURCES
- Michael D. Anderson, Risk Specialist/Supervisor, Patient Safety & Risk Management, Medical Insurance Exchange of California, Oakland, CA. Phone: (510) 596-4930. Fax: (510) 318-6755. Email: [email protected].
- Michael L. Barnett, MD, MS, Assistant Professor, Health Policy and Management, Harvard T.H. Chan School of Public Health, Boston. Email: [email protected].
- Renée Bernard, JD, Vice President, Patient Safety, The Mutual Risk Retention Group, Walnut Creek, CA. Phone: (925) 949-0109. Email: [email protected].
- John Burton, MD, Chair, Department of Emergency Medicine, Carilion Clinic, Roanoke, VA. Phone: (540) 526-2500. Fax: (540) 581-0741. Email: [email protected].
Experts say that as time passes, EPs should increasingly expect to be included as potential targets of malpractice claims alleging that opioids were prescribed without adequate indication or in excessive amounts.
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