Background
Many states have used opioid-related legislation to address the burden of substance use disorder, overdose, and death. As of mid-2018, some 1,300 bills were under consideration across the U.S.1 Kentucky and West Virginia, which share the economically depressed central Appalachian region, have had some of the highest rates of overdose death in the nation.2 While provisional CDC data point to a possible modest decline in Kentucky's overdose death rate, it remains among the highest in the nation, and West Virginia, with increasing overdose deaths, is often the state with the highest overdose death rate in annual analyses.3 The gravity of substance use disorder problems in these states is reflected in state declines in life expectancy.Reference Dwyer-Lindgren4
Both Kentucky and West Virginia have enacted and implemented extensive opioid-related legislation in the six core areas identified by Parker and colleagues:
Encouraging appropriate prescribing
Educating the public and raising awareness
Expanding access to addiction treatment and harm-reduction services
Responding to overdoses
Providing penalties for traffickers and treatment for those who need it
Civil litigation and disciplinary action.Reference Parker, Strunk and Fiellin5
Harm reduction has been the most recent trend and has gained some ground in these socially conservative states, despite local opposition based on the perception that offering services to people who use opioids puts neighboring populations at risk of harm.Reference Katz6 Prior work by investigators in West Virginia and other states has suggested that legislative initiatives to address opioid-related problems were associated with both reductions in overdose deaths due to prescription opioids and increases in deaths from illicit opioid overdose.Reference Gurka, Hu, Linn, Thompson and Christy7
Types of Legislative Initiatives
We will set out examples of recent Kentucky and West Virginia enactments, then discuss early evidence regarding the impact of a recent Kentucky statutory innovation.
Following a taxonomy proposed by Beletsky, the “direct impact” group of these statutes authorizes actions specific to opioid burden mitigation, while the “indirect impact” group addresses initiatives that are intended to improve states' ability to respond to opioid issues. The “normative impact” approach includes legislation that (whether expressly or in effect) helps shift existing social or cultural norms that impede states' capacity to implement more effective approaches to opioid response.Reference Beletsky8 Some legislation has more than one type of impact.
Direct Impact:
Naloxone access (WV S 36, codified as W. Va. Code §18-5-22, expanding access to schools; WV S 272, first responder stocking and administration)
Pharmacist delivery of medication assisted treatment (KY HB 246, codified as KRS 194A.800)
Pharmacies required to sell or dispense safe opioid disposal kit (KY SB 6, codified as KRS 218A.170)
Indirect Impact:
Oversight of treatment programs (KY HB 124, codified as KRS 222.462; WV S 273, codified as W.Va. Code §16-5H-2)
Inter-jurisdictional sharing of Prescription Drug Monitoring Program data (KY HB 213, codified as KRS 218A.245)
School-based educational programming (WV H 2195, codified as W.Va. Code §18-2-7b)
Legislative initiatives may satisfy legislators' need to demonstrate active response to the opioid crisis, and have significant positive potential in some states, but they are clearly not the only route available. One area of increasing activity is shareholder demands for greater accountability from drug manufacturers and distributors, as well as from the systems and services that prescribe and dispense drugs. These shareholder actions take on growing urgency in the context of the massive multi-district litigation under way in the federal court for the Northern District of Illinois, which would, if successful, result in pharmaceutical firms paying states and municipalities fines on the scale of the 1998 tobacco companies' settlements. Initial “bellwether” trials among the hundreds of consolidated actions are anticipated in 2019.
Normative Impact:
Criminalization: Changes to controlled substances schedule (WV H 4336, codified as W. Va. Code §60-2-201 et seq.); increased criminal sanctions (KY HB 333, codified as KRS 218A.1412)
Public health harm reduction approaches: School-based use of opioid antagonist (WV S 36, codified as W. Va. Code §18-5-22d).
Early Evidence of Legislative Impact
One of Kentucky's more unusual 2018 enactments requires the state's Administrative Office of the Courts to transmit five years' worth of “data regarding any felony or Class A misdemeanor conviction that involves the trafficking or possession of a controlled substance” or other acts prohibited by applicable law to the state's prescription drug monitoring program (PDMP) (2018 HB 333, codified as KRS 218A.205). The statute further mandates that the PDMP establish a system that supports querying patient data for information regarding the targeted convictions (KRS 218A.202(19)Reference Bohnert, Guy and Losby9). With support from the U.S. Department of Justice, the Kentucky Injury Prevention & Research Center has partnered with the University of Kentucky's Institute for Pharmacy Outcomes and Policy to conduct interviews and surveys before and after implementation of the latter provision.
Survey questions were derived from interviews conducted between January and March 2018 that included representatives of licensing boards, professional associations, and state agencies. They were intended to assess prescriber and dispenser awareness and perception of the law as well as the law's likely impact on prescribing and dispensing behaviors. While there was some variation in responses, most (75-80%) respondents were unaware that drug conviction data would be available in the state's prescription drug monitoring program, and most (70-80%) agreed that having access to such data would be helpful in making controlled substance prescribing or dispensing decisions. A slightly smaller proportion, between 60-75% indicated their intent to request drug conviction data for use in treatment decisions.10 Assessment of the extent to which practitioners access drug conviction data and their use of the data in practice is in progress as of this writing.
Discussion
Legislative initiatives may satisfy legislators' need to demonstrate active response to the opioid crisis, and have significant positive potential in some states,Reference Hernandez, Meyers-Okhi and Farkas11 but they are clearly not the only route available. One area of increasing activity is shareholder demands for greater accountability from drug manufacturers and distributors, as well as from the systems and services that prescribe and dispense drugs.12 These shareholder actions take on growing urgency in the context of the massive multi-district litigation under way in the federal court for the Northern District of Illinois, which would, if successful, result in pharmaceutical firms paying states and municipalities fines on the scale of the 1998 tobacco companies' settlements.13 Initial “bellwether” trials among the hundreds of consolidated actions are anticipated in 2019.
Enforcement of existing laws can also take dramatic forms, such as the July 2017 U.S. Department of Justice action that led to 57 physicians' exclusion from Medicare participation.14 However, the ability of draconian enforcement actions to achieve positive effects is questionable because supply-reducing actions may drive patients to unsafe, illegal alternatives.Reference Pitt, Humphreys and Brandeau15 As the Kentucky data linkage initiative reviewed here demonstrates, time and resources are needed for nuanced assessment of evidence in the development of coherent, coordinated responses to the nation's multifaceted substance use issues. While this assessment continues, legislators are encouraged to give careful attention to the impact — whether intended or otherwise — of existing legislation as they continue to search for effective approaches.
Acknowledgements
Drs. Patricia Rippetoe Freeman and Jeffery Talbert at the UK College of Pharmacy, Institute for Pharmacy Outcomes and Policy conducted the survey research to which this report refers. Professor Jennifer Oliva of West Virginia University School of Law reviewed the authors' analysis of West Virginia's legislative initiatives.