EPs Face Some Significant Legal Risks with Opioid Prescriptions
August 1, 2015
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Several cases of well-intentioned EPs prescribing long-acting opioids have led to poor outcomes, including death and malpractice lawsuits, says Lewis Nelson, MD, professor and vice chair for academic affairs in the Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine. Nelson is director of the New York City Poison Control Center’s Fellowship in Medical Toxicology.
“Some lawsuits involved EPs prescribing fentanyl patches to patients without the correct indications — such as chronic pain patients already on high-dose opioids,” Nelson says. In one case, a patient who had recent orthopedic surgery who returned to the ED for persistent pain was given a fentanyl patch, only to be found dead the following day.
“All prescription opioid users have a story with a beginning and an end. You don’t want to be the EP that started the problem by prescribing acetaminophen and hydrocodone for an ankle sprain, or the one that prescribed right before the deadly overdose,” says Tom Scaletta, MD, FAAEM, chair of the ED at Edward Hospital in Naperville, IL “Both scenarios are very high-risk.”
Follow Strict Policy
Prescribing opioids for patients with drug-seeking behavior is a high-risk practice, warns D. Richelle Heldwein, MPH, CPHRM, assistant vice president of clinical risk management in the Pocatello, ID, office of Western Litigation. “This presents a risk for overdose, driving while impaired, drug diversion, and can promote criminal behavior within this patient population,” she warns. Heldwein recommends EPs:
- Follow a strict policy of only ordering opioid medications for acute pain, and refusing to prescribe or administer them for non-cancer, chronic pain.
- Follow strict prescribing guidelines, such as just enough medication to get the patient through the night or the weekend until the primary or specialist care provider’s office is open.
- Make sure the patient has good discharge instructions, including the name and phone number for the outpatient physician for follow-up care.
- Follow a strict policy of not re-filling pain medications for patients.
- Here are some possible legal repercussions for EPs involving opioid prescriptions:
- The EP can potentially be held criminally liable.
Prescribing controlled substances to someone known to be using the drug for nonmedical purposes “is the basis for many of the recent ‘pill mill’ prosecutions,” Nelson warns. “Many such doctors are going to jail now because of this practice.” EPs are generally limited in their ability to determine the patient’s intent, he notes.
While criminal liability is possible if EPs prescribe opioids in a manner outside the norms of recognized medical practice, only in a rare case would a prosecutor want to risk taking on the issue of medical necessity and medical judgment in the context of an ED visit, according to Michael E. Clark, JD, LL.M. (Health Law), special counsel at Duane Morris in Houston. The exception is when there is a demonstrable pattern of the EP providing such prescriptions for improper purposes.
“The core question is whether, under the circumstances and based on a physician’s training and experience, he or she can justify the medical necessity of prescribing opioids to an individual who presents at an ER,” Clark says.
- The EP could be held liable for a patient’s illegal acts of selling legitimate prescription drugs into the illicit market.
Clark says this depends on whether it was foreseeable, in light of what the EP knew about the patient, his or her medical history, and other relevant information.
“Many states have tightened their ‘pill mill’ regulations, making prescribing to a patient you reasonably believe is using them for illegitimate purposes a crime,” Nelson says. A quick Internet search for physicians who have gone to jail for inappropriately prescribing will yield hundreds of examples. “The majority are acting beyond the normal scope of practice of a healthcare provider,” Nelson adds.
- The EP could be sued for contributing to a patient’s opioid addiction.
Seventeen percent of discharged ED patients were prescribed opioid pain relievers, according to a recent study of patients treated in EDs during a single week across the country.1
Opioid-naïve ED patients who were prescribed opioids for acute pain are at increased risk for additional opioid use a year later, according to a study of all patients discharged from an urban academic ED with an acute painful condition during a five-month period.2
Scaletta developed a program called SmartControl as a means of electronically tracking drug-seeking patients.
“The largest group of frequent ED users are prescription narcotic seekers,” he says. “They are also the easiest to effect behavior modification, by just saying no.”
Although it is difficult to prove who prescribed the pill that led to an addiction, “there is increasing evidence EDs represent the initiating source in a significant proportion of patients who have opioid addiction,” Nelson says.
In May 2015, the Supreme Court of West Virginia ruled patients who become addicted to prescription medications can sue doctors and pharmacies for addiction-related damages.
“This invokes the concept of comparative negligence, and opens the door for prescriber liability,” Nelson says.
EPs can protect themselves legally with cautious prescribing; following prescribing guidelines that limit the duration and intensity of prescribing; contacting patients’ primary care providers; seeking risk factors for unsafe use, such as sleep apnea or benzodiazepine use; and reviewing medical and pharmacy records, Nelson says.
“Using sound clinical judgement will reduce the likelihood of prescribing for fraudulent or dangerous reasons,” he adds.
Clark says while he is not aware of an EP being sued for contributing to a patient’s opioid addiction, “under the right set of facts, it could happen.” These factors would become important, he says:
- the number of pills and refills in the prescription;
- the EP’s knowledge about the patient’s medical history and efforts made to determine its validity;
- the appropriateness of the warnings provided about the addictive nature of the pain medication and the need for follow up with a pain management specialist for assistance in managing pain conditions with less dangerous medications.
Scott G. Weiner, MD, MPH, an attending physician in the Department of Emergency Medicine at Brigham and Women’s Hospital in Boston, sees legal risks for EPs who prescribe opioids to patients as “relatively low — as long as the physician does due diligence.”
Weiner says EPs should carefully weigh the risks and benefits of opioids; ensure other pain options, such as topical analgesics, have been exhausted; and carefully counsel patients about the risks and benefits, including the fact medications can be highly addictive.
“A handout can be created for this purpose, and would probably be a good idea for departments to implement,” he advises.
- The EP could be sued for overprescribing of opioid analgesics, resulting in an unintentional overdose.
“The therapeutic range is narrow for these medications, meaning the difference between a safe dose and a toxic one is small,” Nelson says. “There are several risk factors, such as sleep apnea, that further narrow the window.”
- The EP could be sued for prescribing a medication that is subsequently used for intentional self-harm.
The legal risk for EPs of such a suit is “likely small, assuming it cannot be shown the physician knew the patient’s intent,” Nelson adds.
Database Can Be Protective
Documentation that the state’s Prescription Drug Monitoring Program (PDMP) report was checked is “an extra level of protection for an EP,” Weiner says. This demonstrates the EP screened the patient and thought about the decision to prescribe prior to giving the opioid.
“A PDMP profile is just one part of this decision, but it is an important piece of information,” he says. Weiner is unaware of any cases in which an EP was held liable for failure to check the database. However, there are an increasing number of states that have some form of prescriber mandate, in which the physician must look up the PDMP prior to prescribing opioids in certain situations. (A list of states that require prescribers and/or dispensers to access PDMP databases in certain circumstance can be found at http://bit.ly/1GF3t90.)
“In those states, I think it is only a matter of time before a physician is sued for failure to check the database when there is an adverse outcome,” Weiner warns.
Checking the PDMP can help to defend an EP’s decision to deny narcotics to a patient.
“However, it does not work in reverse and allow protection for prescribing if there is no noted drug abuse pattern in the database,” Heldwein cautions.
Being able to show an EP checked the database helps establish the EP acted reasonably under the circumstances, Clark says.
“The failure to do so is highly probative on the same issue, and may demonstrate a failure to meet an objective standard of care,” he warns.
REFERENCES
- Hoppe JA, et al. Opioid prescribing in a cross section of U.S. emergency departments. Presented at the American College for Medical Toxicology Annual Scientific Meeting, March 2015, Clearwater Beach, FL.
- Hoppe JA, et al. Association of emergency department opioid initiation with recurrent opioid use. Ann Emerg Med 2015; 65:493-499.
SOURCES
- Michael E. Clark, JD, Special Counsel, Duane Morris, Houston, TX. Phone: (713) 402-3905. Fax: (713) 583-9182. E-mail: [email protected].
- D. Richelle Heldwein, MPH, CPHRM, Assistant Vice President, Clinical Risk Management, Western Litigation, Pocatello, ID. Phone: (208) 237-9575. Fax: (208) 637-2806. E-mail: [email protected].
- Lewis Nelson, MD, Professor and Vice Chair for Academic Affairs, Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine/Director, Fellowship in Medical Toxicology, New York City Poison Control Center, New York, NY. Phone: (212) 447-8150. E-mail: [email protected].
- Tom Scaletta, MD, FAAEM, Chair, Emergency Department, Edward Hospital, Naperville, IL. Phone: (630) 527-5025. E-mail: [email protected].
- Scott G. Weiner, MD, MPH, Department of Emergency Medicine, Brigham and Women’s Hospital, Boston, MA. E-mail: [email protected].
Several cases of well-intentioned EPs prescribing long-acting opioids have led to poor outcomes, including death and malpractice lawsuits.
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