Excerpted From: Melissa McPheeters and Mary K. Bratton, The Right Hammer for the Right Nail: Public Health Tools in the Struggle Between Pain and Addiction, 48 University of Memphis Law Review 1299 (Summer, 2018) (247 Footnotes) (Full Document)
The field of public health "is the science of protecting and improving health." It aims to create an environment in which populations have the greatest likelihood of achieving optimal health, largely through prevention activities, ranging from ensuring that water systems provide potable drinking water to providing vaccinations and responding to outbreaks of infectious diseases. Historically, public health arose in response to communicable disease threats, although many of the greatest public health accomplishments relate to the environment and chronic disease. For example, water fluoridation has led to dramatic decreases in oral disease in the community, with up to a 70% decrease in childhood tooth decay. Motor vehicle-related deaths have decreased substantially with improvements in safety features and changes to personal behavior including seat belt use. Although rates are still too high, infant and maternal mortality have both decreased more than 90% since 1990, with a combination of hygiene, nutrition, antibiotics and access to health care. Responses to these and other health threats have always included invoking medical science alongside law and policy, and the deployment of legal measures has always been a necessary part of public health.
The standard text for public health students defines "public health law" as:
the study of the legal powers and duties of the state to assure the conditions for people to be healthy (to identify, prevent, and ameliorate risks to health in the population) and the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals for the common good. The prime objective of public health law is to pursue the highest possible level of physical and mental health in the population, consistent with the values of social justice.
In public health and medicine, we use the terms "primary," "secondary," and "tertiary prevention" to describe actions that occur along the continuum of disease process, all of which are designed to prevent a particular poor health outcome. First, primary prevention aims to prevent disease from ever occurring. Primary prevention initiatives might include ensuring that individuals have adequate nutrition through population-level interventions such as nutritional information on menus and prepared food products or reducing food deserts. Secondary prevention takes place when biological changes have begun but a disease is not yet diagnosed. This phase in a disease process is also known as "subclinical" in that an underlying disease process is occurring but is not yet obvious. Secondary prevention measures address individuals whose blood sugar is elevated, for example, but for whom a diagnosis of diabetes is not yet warranted; such interventions include dietary changes and an exercise regimen. Lastly, tertiary prevention recognizes that, even when disease is present, intervention can still stave off poor outcomes, including an early death that could have been avoided by dietary management and insulin regulation. In this Article, we will place a series of laws passed in Tennessee in relation to the opioid epidemic in the public health framework of primary, secondary and tertiary prevention. Framing the opioid epidemic and public health's response in these constructs is not new, but this Article focuses specifically on placing the legal response in the public health framework in the State of Tennessee.
Laws intended to affect initial prescriptions and prescribing patterns are primary prevention. Those laws intended to address current and increasing opioid use among groups at risk of substance use disorder and other health outcomes can be classified as "secondary," and those intended to support the needs of individuals and groups with substance use disorder, with the goal of preventing further negative outcomes, can be classified as "tertiary." In an epidemic, the law responds to these prevention needs simultaneously because, at the same time, segments of the population exist in each state (pre-exposure, preclinical, and clinical). Primary, secondary, and tertiary interventions can be aimed at individual patients, healthcare providers, or the population as a whole. Traditionally, public health efforts have been population-focused, but in the opioid epidemic, a combined intervention strategy all levels--patient, provider, and population--is essential.
In addition to intervening at the appropriate time, laws seek to identify the best lever for action and to target that lever through mandates, restrictions, penalization, and sometimes even exceptions. Patient-focused legislation includes laws requiring patients to honestly describe their medication history to their prescribers. Provider-focused legislation includes mandates on provider continuing education. Population health laws would be those that emphasize community response, including broad provision of the anti-overdose drug, naloxone. This creates a population response by increasing the probability that, in the event of an overdose, reversal is more likely. Interestingly, the majority of the legal and policy response in public health, even when trying to effectuate population-health objectives, has focused on changing prescriber behavior, in large part through the implementation and use of prescription drug monitoring programs. To fully understand the public health response to the opioid epidemic, it is insightful to review the target of action for various laws that compose the public health levers used to find the right hammer for the right nail.
In reality, patients, prescribers, and the population are intertwined and act upon one another. The population is, in fact, made up of individual patients and of individual patient-prescriber relationships. Thus, changing the dynamic in that relationship has the potential to significantly affect the population. In this way, the effect of many individual "prescriber-patient interactions" improves the health of the population through the number of such interactions, but also by reducing the amount of drugs available in the community for use and misuse by non-patients.
For example, a primary-prevention initiative directed toward patients or the population would drive an educational program to alert them to the dangers of opioids. A primary-prevention activity directed to prescribers, however, alerts prescribers to a patient's prescription history so that they would take into account opioid naiveté in making a decision about an initial prescription. The idea is to prevent exposure to the "causative agent," in this case, the misuse of opioids. In secondary prevention, prescribers would be alerted to the potential for substance use disorder in their patients, potentially through a prescription history, and thus be able to manage their prescribing to prevent long term negative outcomes. Tertiary prevention would ensure access to treatment for people with substance use disorder to prevent longer term outcomes, including overdose. At the end of the day, public health treats the population, providers practice medicine, medicine treats the individual patients, and laws related to the opioid epidemic affect the population, provider, and patient. Each case balances control of individual behavior against a public good.
The tension between the appropriate limits of public health and the law go back well into the 17th century, when the mayor of London used a set of orders that included quarantine to fight the plague, which was rapidly taking over the city. Daniel Defoe, documenting the story at the time, noted that "[t]his shutting up of houses was at first counted a very cruel and unchristian method ... but it was a public good that justified the private mischief." This tension is apparent in public health historically, including, for example, in the decision to require vaccinations or to regulate access to tobacco. In the opioid crisis, there is the added aspect of regulation of healthcare practice, which introduces another level of careful balance, so as to carefully ensure that systems exist to support the best medical care without overly interfering with a clinician's ability to practice his or her art for the benefit of the patient.
In this Article, we focus on how laws related to patients, providers, and the population fit within a construct of primary, secondary, and tertiary prevention of an epidemic and how legal constructs that act upon issues amenable to primary, secondary, and tertiary prevention among patients, providers, and populations combine to form a network of interventions. We do not attempt to describe every law passed in Tennessee to address the epidemic; rather, we analyze a selection of laws that demonstrate the ability to characterize the policy response by primary, secondary, and tertiary, and with a focus on the patient, prescriber, or population. We will organize our description of a selection of opioid-related laws according the following construct:
• Primary Prevention: patient, population, prescriber
• Secondary Prevention: prescriber, population, patient
• Tertiary Prevention: patient, prescriber, population
We begin in Part II with background on opioids and the development of the epidemic, including an example of a patient-focused state law that had serious unintended consequences. In Parts III through VI, we survey a set of laws that we place within public health objectives of primary, secondary, and tertiary prevention and denote their focus on patients, prescribers, and the population. We demonstrate that these disparate elements of the law are all part of a complex network that provides levers at multiple levels and with multiple purposes to support an ultimate reduction in prescription drug overdose in the State of Tennessee. Though it is not a perfect rubric, it does provide one organizing principle that combines the emphasis of public health and the law.
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This Article has provided a survey of select laws related to the opioid epidemic in Tennessee as they pertain to efforts to induce primary, secondary, and tertiary prevention while focusing on patients, prescribers, and populations. Each of these levers is necessary to address a complex and evolving epidemic, and they combine proscriptive and protective elements to support the best opportunity for Tennessee to turn the tide on the epidemic. That said, although this Article placed these laws in a logical, structured framework, there is no indication in the legislative history that this or any other particular structure has guided the General Assembly in its determinations, and we do not know at this point which legal interventions have been most effective or why. Those studies are ongoing. The reality is that laws take time to settle in and have an effect, whether the intended effect or not. There is an educational process, as well as an implementation process, that becomes the responsibility of the assigned department, and the laws as written often do not account for that timeframe. Trying to introduce legal ramifications into the patient-provider relationship, where a fine line exists between laying appropriate guiding lines on the road and introducing too much protocol into clinical realities of complex and diverse patients, further complicates this dynamic.
It is furthermore true that legislating our way out of this problem is unlikely to be adequate. The mindset of both the patient and provider must shift to acknowledge the danger of opioids and the importance of exhausting other remedies before resigning to chronic drug use. Societal changes, including de-stigmatizing substance abuse, addiction, and mental health are essential to lay the ground work for communities to support their residents and to heal.
At this time, deaths due to drug overdose continue to rise, although the trajectory of those deaths that are specific to prescription drugs may be plateauing. That said, the majority of drug deaths continue to include an opioid, and most of those are a prescription opioid, whether obtained legally or illicitly. Some, however, are touting the rapid rise in illicit drug deaths, including fentanyl and heroin, as a direct and unintended consequence of a reduction in access to legal prescriptions, much like that seen in prohibition. This idea is in dispute. There is significant concern that the balance of laws may have focused too much on reducing use and spread of prescription opioids and not enough on ensuring treatment access to individuals with substance use disorders. Conversely, if patients did not seek, and providers did not so commonly prescribe opioids, there would arguably be fewer individuals in need of access to treatment.
In reality, patient, prescriber, and population are intertwined and act upon one another, and the laws in Tennessee relative to public health and the opioid crisis demonstrate recognition of that reality on some level. Public health objectives are population-health centered. As the population is made of individual patient-prescriber relationships, the laws must change that dynamic in many different, single patient-prescriber interactions to shift and improve population health. This shift in many small interactions can, in a multiplicative manner, reduce the prescriptions drugs available to a community and ultimately thereby reduce the number of individuals with substance use disorder.
Here in Tennessee, people continue to call for legislation as a response to the opioid epidemic. New legislation is under consideration this year, and it is unlikely that this trend will stop. The Governor has proposed an extensive set of changes to take advantage of our ability to affect the key actors--namely patients and providers--in the hope of achieving a healthier population. This set of proposed changes, much like the laws discussed here, have patient, provider, and population foci. Though we cannot legislate our way out of this problem, population health-level primary prevention in the form of guidelines and availability of tools such as the CSMD have proven insufficient in this culture when the law does not mandate its use. For a population that is already suffering, through mindset, overuse, and abuse at the primary, secondary, and tertiary levels--and although trends are slightly improved, continues to suffer--these public health laws, mandating lines on the road for all involved are necessary. Which ones will be effective at moving the societal needle to the point where they are no longer necessary-- and what the unintended consequences along the way may be--remains to be seen and studied.
Assistant Commissioner and Director of the Office of Analytics and Informatics, Tennessee Department of Health; Research Professor, Health Policy, Vanderbilt University Medical Center. Ph.D., Epidemiology, 2003, The University of North Carolina-Chapel Hill; M.P.H., Maternal and Child Health, 1996, The University of North Carolina-Chapel Hill; B.A., English, 1992, The University of Wisconsin.
Chief Deputy General Counsel, Office of General Counsel, Tennessee Department of Health. J.D., 2011, Regent University School of Law; B.A., Art History and English, 2006, The University of the South.
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