By: Joan Cerniglia-Lowensen, Esquire and Kathryn D. Jackson, Law Clerk
When it comes to opioid use, the U.S. is in a league of its own. Roughly eighty percent of the world’s opioid supply is consumed within the United States. Drug overdose is the leading cause of accidental death in the United States. The likely source of these staggering numbers? Prescription painkillers, which currently outnumber heroin overdose deaths by almost sixty percent.[1] As a result of these overwhelming statistics, state legislatures have poured millions of dollars into combatting the epidemic.[2] Maryland Governor Larry Hogan has declared a “State of Emergency”, pledging billions of dollars to treatment programs and stricter regulations for healthcare providers. In the wake of this highly publicized crisis, state governments and individuals alike are desperate to recoup the resulting devastating losses. This increases the spotlight on healthcare professionals who handle these types of substances.
The worsening opioid crisis over the years has changed the way healthcare providers prescribe these substances dramatically. Not only have the actual standards changed, by way of state health departments, medical boards, and the Drug Enforcement Agency, but the sensitive climate has encouraged providers personally to be more conservative in prescribing these medications than ever before. In order to avoid liability when treating chronic or severe pain, it is important to understand the various evolving standards in regard to prescribers, pharmacies and licensing boards.
- Prescribers
Prescribers are probably the most obvious targets when it comes to liability for opioid prescription. As many providers know, the standard of care for medical malpractice requires that a physician act as a reasonably competent physician would under the circumstances. However, when it comes to prescribing dangerous and high-profile medications for patients, this can be a vague and wide range of activity that is not particularly helpful to prescribers. Generally, the recommendation of licensing boards or medical organizations alone cannot establish the standard of care. However, various professional standards and guidelines may evolve to become common practice and eventually dictate the standard of care. Under the CDC guidelines, prescribers should take precautions such as: getting an adequate patient history to rule out addiction, fully informing the patient about the risks associated with prescription opioid use, and following up regularly with the patient during treatment with the drug.
However, as of 2016, Maryland (and many other state governments) requires the use of the Prescription Drug Monitoring Program (PDMP) which can make these types of patient assessments more concrete and uniform across all prescribers.[3] All practitioners authorized to prescribe Controlled Dangerous Substances (including prescription opioids) must be registered. The system requires that the prescriber review the patient’s PDMP data before prescribing opioids and at least every 90 days during treatment. While the statute makes clear in § 21-2A-08 that a prescriber cannot be liable solely for retrieving/failing to retrieve information from the system or acting/failing to act based on that information, these types of standards are put in place in the hopes that they eventually become common practice—dictating the future standard of care. Additionally, the statute mandates certain statutory penalties (up to $500 for each violation) and delegates further disciplinary authority to the appropriate licensing board.
While a prescriber has not committed malpractice solely for breaching his or her duty under the PDMP, there are licensing implications for these improper actions. In addition to failing to abide by the PDMP requirements, there are various other “red flag” behaviors that can garner the attention of licensing boards. For example, not requiring regular follow-up visits, prescribing too many refills, or not referring a chronic pain patient to a specialist are all behaviors that generally attract the attention of licensing boards.
Perhaps emphasizing the importance of fighting this crisis, The Maryland Board of Physicians offers resources for physicians in addressing the epidemic on the front page of its website. Based on the CDC guidelines, the “Board Guidance” outlines the appropriate procedure before prescribing opioids, when prescribing, and during continued treatment. Additionally it offers a list of “red flags” to consider such as a patient history of substance abuse, reporting lost or stolen prescriptions, or paying cash for medications.
The CDC has also released information regarding alternatives for opioid prescription in an effort to combat the epidemic.[4] The literature suggests different types of non-opioid medication depending on the type of pain—ranging from migraines to fibromyalgia. Medications that the CDC suggests as alternative to opioids include: aspirin, acetaminophen, tricyclic antidepressants, and topical agents. While these medications also have a chance of causing degrees of harm, the CDC suggests that providers use non-opioid therapies to the extent possible to treat pain management, and to combat addiction and the worse long-term harms that opioid use entails.
- Pharmacists
Pharmacists who dispense opioids may also face liability when the drugs are misused or wrongly prescribed. In 1971, the Drug Enforcement Agency placed a “corresponding responsibility” squarely on the shoulders of pharmacies who dispense prescriptions. While the responsibility that the controlled substance be prescribed for a legitimate medical purpose is that of the practitioner, the pharmacist has a corresponding responsibility to verify that the substance is properly prescribed and dispensed. Pharmacists are also required to register with the PDMP—better enumerating the scope of their “corresponding responsibility” for the prescription of opioids. Under the PDMP, pharmacists must review patient data prior to dispensing any controlled dangerous substances if they have a reasonable belief that a patient is seeking the drug for any other purposes other than the treatment of an existing medical condition.
Under the PDMP, pharmacists may face monetary penalties and licensing action for failure to comply with the statute. While the Board of Pharmacists does not have the defined standards for opioid prescription as does the Board of Physicians, the organization does publish literature in regard to combatting the opioid crisis. Most notably, on June 1, 2017, it published the Maryland Department of Health and Mental Hygiene’s standing order allowing pharmacists to dispense naloxone to anyone who may be at risks of opioid overdose.
In conclusion, the approach that must be utilized by providers is a dynamic one in this climate. The burden is on the provider to minimize liability by remaining compliant with all state and federal guidelines for these prescriptions.
Joan Cerniglia-Lowensen is a Member with Pessin Katz Law, P.A. (PK Law). She has close to twenty five years of civil litigation experience throughout the State of Maryland in both state and federal courts. Prior to becoming an attorney, Ms. Cerniglia-Lowensen was a registered nurse achieving both a BSN and a MS with a major in nursing. As an attorney, she primarily practices in the health care defense field. She defends nurses, doctors, veterinarians, dentists, healthcare providers, healthcare facilities, mental healthcare workers, urgent care facilities and nursing homes in medical malpractice matters; professional liability and tort claims; and disciplinary actions before various regulatory boards. She provides risk management advice to a variety of healthcare entities, insurers and individuals and continuing education to healthcare workers and entities; and has been published in both journals and texts on issues of risk management and liability of healthcare professionals. She also defends individuals and entities in a variety of civil litigation matters. She can be reached at 410-339-6753 or jclowensen@pklaw.com.
Kathryn Jackson is a law clerk at PK Law. She is currently completing her third year of law school at the University of Maryland Carey School of Law and has accepted a position as an Associate at the firm upon her graduation.
[1] There were 20,101 deaths related to prescription painkillers and 12,990 related to heroin overdoes in 2015. Cite CDC article https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm. Of heroin addicts, four out of five indicate that their addiction started with the abuse of prescription painkillers.
[2] $78.5 Billion is spent annually in relation to opioid abuse in the United States. See About the Epidemic, Department of Health and Human Services, https://www.hhs.gov/opioids/about-the-epidemic/index.html
[3] See Md. Code Ann., Health–Gen. § 21-2A01.
[4] See Nonopioid Treatments for Chronic Pain, Center for Disease Control (Apr 27, 2016) https://www.cdc.gov/drugoverdose/pdf/nonopioid_treatments-a.pdf
