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By Diana Nordlund, DO, JD, FACEP, Deputy Compliance Officer, Emergency Care Specialists, PC, Grand Rapids, MI
Opiate overdose deaths have quadrupled in the past 18 years. The CDC reports a daily death toll of 91 in the United States alone.1 This issue has become not only a public health crisis, but also a political one. Thus, legislative activity at the state and federal levels of government has reached a fever pitch, the ramifications of which certainly will affect the practice of emergency medicine.
For some time, the DEA and Office of the Inspector General have been increasing enforcement actions against so-called “pill mills” and racketeering rings.2 Case law decisions have permitted plaintiffs to sue for opiate-related injuries despite plaintiffs’ participation in criminal drug-diversion activity.3 More recently, criminal prosecution of prescribers has extended beyond profit-based drug diversion. In February 2016, a California physician was convicted of second-degree murder for the opiate-related deaths of three patients and sentenced to 30 years to life in prison.4 The following month, a family physician in Nevada pleaded guilty to involuntary manslaughter for the overdose death of a patient to whom he had prescribed oxycodone. Subsequent to the plea, the physician was sentenced to 10 years in prison followed by three years of supervised release and a $25,000 fine.5 It is in this context that one examines legislative responses to opiate prescribing practices and their effect on the daily practice of emergency medicine.
Six major categories are targeted across the nation: prescription drug monitoring programs, prescribing guidelines and limits, provider training and education, rescue drugs and Good Samaritan laws, regulation of pain management centers, and other measures, such as public school education, mandatory disclosures to patients, parental consent for minors, and formal informed consent/signed treatment agreements for patients. A discussion of the key points that are most germane to emergency care follows.
A prescription drug monitoring program (PDMP) is a statewide database for monitoring controlled substance prescriptions. Requirements vary from state to state, but the CDC recommends providers consider checking the PDMP prior to every prescription for opioids.6
As of mid-2017, the only states that do not require checking the PDMP in at least some circumstances and/or provide for disciplinary action if the prescriber fails to query the database are Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Michigan, Missouri, Montana, Nebraska, Oregon, South Dakota, and Wyoming.7 Lawmakers in some of these states, including Michigan, are considering legislation pending that, if passed, would mandate a PDMP query.
State laws vary as to exceptions, the degree of documentation required, and associated penalties. Existing penalties include lost reimbursement, fines, and state licensing board sanctions that may include licensure suspension or revocation.8
The CDC has set forth prescribing guidelines for opiate-based treatment of chronic pain. At first blush, one might think these guidelines do not apply to emergency medicine, particularly because the guidelines refer to a “focus” on primary care clinicians.
However, the CDC defines chronic pain as pain that “typically lasts > 3 months or past the time of normal tissue healing.”9 Further, the CDC guidelines cite a 2012 study showing that 43% of U.S. adults experience common pain complaints such as arthritis, back or neck pain, and recurrent headaches, all of which are seen frequently in the ED.
Finally, the same guidelines state that their purpose is “to inform clinicians who are considering prescribing opioid pain medication for painful conditions that can or have become chronic.”9 When the possibility of a chronic condition is added to their application, it is clear that EPs must take note of these guidelines.
In broad strokes, the guidelines suggest that before prescribing opioids, clinicians should:
Although these are only guidelines, several states have enacted legislation based on these tips, including statutory limits on prescription duration for acute pain, ranging from as few as three days to as high as 10 days.10
By mid-July 2017, naloxone accessibility laws had been passed nationwide. Although details vary, these laws include some degree of immunity for prescribers, dispensers, and laypersons and provide for third-party prescriptions or allow laypersons to obtain reversal agents without a prescription. Additionally, Good Samaritan laws were passed in 40 states (and Washington, DC) to provide legal protection to persons reporting an overdose.11
In addition to states mandating training for prescribers, some medical schools are initiating opioid training for medical students.12 Further, providers may be required to provide certain information to patients prior to prescribing, develop a treatment plan, and complete formal informed consent.13 Lastly, some states require documentation of certain elements of these discussions in the medical record.14
Given the above, it seems highly likely that every state will regulate at least some aspects of opiate prescribing by EPs. States that have not passed PDMP laws are in the process of creating such legislation. Further, both civil and criminal case law is amassing rapidly. One needs only to conduct an online search using the keywords “narcotic lawsuits” to be besieged with a plethora of solicitations for litigation representation related to addiction- and/or overdose-related injury. Successful lawsuits to date include a high-profile case in St. Louis in which a jury awarded $17.6 million to a 45-year-old municipal employee who ultimately entered addiction treatment.15
In addition to lawsuits levied against individual prescribers and clinics, there is a growing number of actions brought against drug manufacturers. At least two states (Mississippi and Ohio) have filed lawsuits directly against manufacturers, and at least 40 states have joined an investigation of manufacturers headed by a coalition of state attorneys general.16,17
As more plaintiffs litigate successfully and as more states pass laws regulating prescribing practices, there is a significant increase in provider risk. Practice groups that respond with prescribing policies and guidelines will find that those documents are discoverable and may be used as evidence of malpractice if a provider does not adhere to them. Practice groups that do not implement such measures will find that failure to do so can be held up as evidence of negligence as well. Furthermore, deviation from state law can carry significant civil and criminal penalties, including license censure or revocation, fines, and imprisonment. Thus, prioritizing responsible prescribing and patient safety in a manner that adheres to state law and respects national guidelines is important for patients and providers alike.
EPs would be well-served to become familiar with their relevant governing state law and develop compliant opiate-prescribing practice patterns. Regardless of the requirements of state law, a responsible prescribing practice likely includes the following: perform and document informed consent, prescribe the lowest effective dose in the smallest effective quantity of an immediate-release formulation, avoid co-prescribing benzodiazepines whenever possible, consider naloxone, and review (and document such a review) the PDMP.
Prescribing opiates is now an extremely high-risk aspect of the practice of emergency medicine. National public service messages and state-based efforts will produce lasting effects. Individual providers are well-served by familiarizing themselves with existing state law as well as pending legislation. From a proactive perspective, if pending legislation can be improved by provider input, it behooves EPs to advocate at the state level of government before the bill becomes law.
At the individual practice level, ensuring adequate provider education and facilitating uniformly responsible prescribing practices improves safety for both patients and providers. As always, EPs are on the front lines of patient care and uniquely poised to effect positive change approximately 356,000 times per day.18 This crisis presents another opportunity to improve the quality of life for patients and the quality of care delivered in the United States.
Financial Disclosure: The following individuals disclose that they have no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study: Arthur R. Derse, MD, JD, FACEP (Physician Editor), Stacey Kusterbeck (Author), Diana Nordlund, DO, JD, FACEP (Author), Jonathan Springston (Editor), Shelly Morrow Mark (Executive Editor), and Terrey L. Hatcher (Editorial Group Manager).