Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the upcoming Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In the final post of the Promises and Perils of Emerging Health Innovations blog symposium, Leo Beletsky and the team from Health in Justice Action Lab provide a summary of an event held in conjunction with the Center for Health Policy and Law’s 2019 annual health law conference. The Promises and Perils of Prescription Drug Monitoring Programs (PDMPs) workshop was held on April 13, 2019 and convened experts, practitioners, experts, and other stakeholders to brainstorm strategies with the goal to “maximize the benefits of PDMPs, while minimizing harms.” Visit the Health in Justice Action Lab website (linked below) for information on this and other projects underway.

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

by Health in Justice Action Lab

In the wake of the opioid overdose crisis, all United States jurisdictions have rapidly adopted Prescription Drug Monitoring Programs (“PDMPs”). PDMPs electronically collect, monitor, and analyze controlled substance prescription information. Prescription Drug Monitoring Programs (PDMPs), CDC https://www.cdc.gov/drugoverdose/pdf/pdmp_factsheet-a.pdf (last visited October 30, 2019). According to the CDC, PDMPs “continue to be among the most promising state-level interventions to improve opioid prescribing, inform clinical practice, and protect patients at risk.” What States Need to Know about PDMPs, CDC (Oct. 3, 2017), https://www.cdc.gov/drugoverdose/pdmp/states.html. These purported benefits have been elusive, however, while various shortcomings and pitfalls have received little scrutiny.

On April 13, 2019, the Health in Justice Action Lab, in collaboration with the ACLU of Massachusetts, hosted a half-day workshop entitled Promises and Perils of Prescription Drug Monitoring Programs at Northeastern University. See Promises and Perils of Prescription Drug Monitoring Programs: A Workshop, Ne. Univ. Sch. L., https://www.northeastern.edu/law/academics/institutes/health-law/events/conference19/workshop.html (last visited Oct. 28, 2019). This interdisciplinary event convened researchers, health care providers, technologists, legal practitioners, and advocates, who applied clinical, public health, sociology, computer Science, and patients’ rights expertise to PDMP policy and practice. Id. In addition to those attending the meeting in Boston, MA, attendees also participated remotely via videolink. This event was part of the Northeastern School of Law Center for Health Policy and Law’s annual conference entitled The Promises and Perils of Emerging Health Innovations. See 2019 Health Law Conference Program, Ne. Univ. Sch. L., https://www.northeastern.edu/law/academics/institutes/health-law/events/conference19/program.html (last visited Oct. 28, 2019).

The focus of the workshop was to formulate strategies to maximize the benefits of PDMPs, while minimizing harms. Leo Beletsky, Professor of Law and Health Sciences and Faculty Director of the Health in Justice Action Lab, welcomed participants and provided a national overview of PDMPs. Professor Beletsky presented an in-depth background of PDMP implementation and provided a status update on legislative and legal status to PDMPs in the United States. Professor Beletsky and his research team also presented findings from their ethnographic and social listening project, which focused on provider and patient experiences with PDMP design, training, and data, as summarized on the Action Lab website. Prescription Drug Monitoring Programs, Health in J. Action Lab, https://www.healthinjustice.org/prescription-drug-monitoring (last visited Oct. 28, 2019).

The workshop consisted of “lightning talks” by participants on their research, as well as discussion of their legal, clinical, and patient perspectives See Promises and Perils of Prescription Drug Monitoring Programs: A Workshop, supra. Given the dearth of critical examinations of PDMPs, participants voiced concerns about a number of areas where PDMPs may cause unintended detriment. These drawbacks include harm to patients and providers as well as societal impacts related to privacy, such as the “unintended consequence of excessive regulatory enforcements, corresponding collateral damages particularly about inadequate prescribing for patients with genuine needs, and mandatory consultation requirements of PDMP.” M Mofizul Islam & Ian S McRae, An Inevitable Wave of Prescription Drug Monitoring Programs in the Context of Prescription Opioids: Pros, Cons and Tensions, 15(46) BMC Pharmacology and Toxicology 1, 4 (2014), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4138942/pdf/2050-6511-15-46.pdf.

Emergent Themes

Based on the diverse presentations and discussions, the following overarching themes emerged from the workshop:

The metrics of “success” for PDMP systems and policies have not been adequately defined.

Given its roots as a tracking tool, see CDC, supra, the role of PDMPs in improving health was never concretely articulated or operationalized beyond addressing the growing problem of prescription misuse and abuse. See Erin P. Finley et al., Evaluating The Impact of Prescription Drug Monitoring Program Implementation: A Scoping Review, 17:420 BMC Health Serv. Res. 1, 1 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477729/pdf/12913_2017_Article_2354.pdf.
PDMPs use quantitative measures as proxies, but these measures have not been critically assessed. See, e.g., Finley et al., supra, (“Thematic analysis revealed four domains of opioid-related outcomes frequently examined in original studies evaluating PDMP implementation: (1) opioid prescribing; (2) opioid diversion and supply; (3) opioid misuse; and (4) opioid-related morbidity and mortality. An evaluation framework incorporating these domains is presented that highlights significant gaps in empirical research across each of these domains.”).
Factors used in risk scoring by PDMPs and PDMP vendors are ironically structurally facilitated and perpetuated by use of PDMP (e.g. denial of a subscription at a pharmacy due to a patient’s PDMP score can lead to a higher PDMP score if they visit another prescriber or pharmacy). See, e.g., Improvements to Prescription Drug Monitoring Programs Can Inform Prescribing, Pew Charitable Trusts 1, 2 (2018), https://www.pewtrusts.org/-/media/assets/2018/05/supti_improvements_to_prescription_drug_monitoring_programs_can_inform_prescribing.pdf (“Prescribers must scan this list and, in states that lack enhancements, make their own assessment of risk factors, including… numbers of prescribers and pharmacies visited..”).
When it comes to opioid prescription, law enforcement exerts their influence in two steps: (1) discourage and shut down prescriptions and pharmacy sales, leaving entire towns and counties without access; and, (2) use PDMP surveillance to flag people for traveling an inordinate distance to get medications elsewhere. See Jacob Sullum, America’s War on Pain Pills Is Killing Addicts and Leaving Patients in Agony, Reason (2018), https://reason.com/2018/03/08/americas-war-on-pain-pills-is/ (“Doctors face ‘pressure from many directions’ includ[ing] ‘stories of some physicians losing their livelihoods and being shut down’”); Prescription Drug Monitoring Program And Medical Examiner/Coroner Meeting, Prescription Drug Monitoring Program Training and Tech. Assistance Ctr. 7 (2019), https://www.pdmpassist.org/pdf/Resources/PDMP_ME-C_Meeting_Summary_20190703_a.pdf (“Persons who abuse or misuse prescription-controlled substances may travel to other states to obtain prescriptions.”).
Adverse collateral harms of PDMP operations have not been well-defined or tracked. See generally Stephen P. Wood, Prescription Monitoring Programs: Helpful or Harmful?, Health Blog (June 08, 2018, 6:30 AM), https://www.health.harvard.edu/blog/prescription-monitoring-programs-helpful-or-harmful-2018060814001 (“Good intentions aside, there are some unintended and negative consequences of PMPs. The PMP can incorrectly target some patients. And for those people the system may actually do more harm than good, including taking away much needed medications. The results include poorly managed pain, inadequate palliative therapy, and in some cases driving patients to turn to illicitly obtained prescriptions or street drugs like heroin and fentanyl… The deep concerns among prescribers about misuse and diversion are completely justified, yet we must make sure that the pendulum doesn’t swing too far and cause harm to those patients who need these medications.”).
Defining and tracking harms is a necessary step to remedial and litigation efforts, which have been hampered by a lack of research into specific instances of detriment flowing from PDMP policies and practices. See Finley et al., supra, at 4 (“An additional finding of thematic analysis was that the impacts of PDMP implementation must be considered in terms of both potential benefits and potential harms… considerable concern has been expressed about the potential for a ‘chilling effect’ of PDMPs on providers’ opioid prescribing that might deprive patients of adequate pain control, and unclear long-term unintended consequences.”).
The absence of quality utilization metrics has impeded training and other efforts to change prescriber practices relating to PDMPs. See Jackie Rocheleau, How Helpful—Or Harmful—Are Prescription Drug Monitoring Programs?, Filter Mag. (Apr. 9, 2019), https://filtermag.org/how-helpful-or-harmful-are-prescription-drug-monitoring-programs/ (“While current PDMP requirements differ by state, no state trains physicians on what to do when they check the PDMP and find out that a patient has OUD. Doctors are free to reject patients without counseling them on addiction, prescribing naloxone, or sharing behavioral health resources. Only 13 states and Guam mandate training on PDMP use for physicians, but those trainings don’t cover how to address addiction with patients. According to training materials on state websites, most of the instruction only involves how to use the technology.”).

There are significant outstanding questions regarding law enforcement access to PDMPs and privacy concerns.

Law enforcement currently has broad access to highly sensitive PDMP data, which has led to some litigation. See, e.g., Andis Robeznieks, PDMP case pits patient privacy against law-enforcement intrusion, AMA (Aug. 16, 2017), https://www.ama-assn.org/delivering-care/patient-support-advocacy/pdmp-case-pits-patient-privacy-against-law-enforcement. Most systems have no clearly established systems of checks and balances. This lack of oversight is not widely known to the American public.
Warrantless access to PDMP data is widespread and is currently the subject of litigation filed by the ACLU. Nathan F. Wessler, The Government Needs to Get a Warrant if It Wants Access to Our Private Health Information, ACLU (May 29, 2019). It is also a target of state-by-state reform, supported by the American Medical Association and other organizations. Warrant requirements to access PDMP data are currently limited to about a dozen states. Whether it applies to federal law enforcement is an open question that is currently being litigated by the ACLU in the First Circuit’s Jonas Id.
In Kentucky, Wisconsin, and Maine, PDMP data is bundled with criminal drug offenses. Statutory restrictions requiring warrants to access PDMPs are associated with steep declines in law enforcement requests for PDMP data. See, e.g., Anne E. Boustead, Privacy Protections and Law Enforcement Use of Prescription Drug Monitoring Databases, OSF Preprints (2019).
There are many open questions about the dynamics of law enforcement access to PDMPs, which the Action Lab is currently trying to answer through a national Freedom of Information Act (“FOIA”) project.
In the context of the opioid overdose crisis, there has been a blurring of the roles between law enforcement, health care providers, and pharmacists. PDMPs have facilitated and operationalized this distortion. See Finley et al., supra, at 2 (“Because PDMPs have been adopted at the level of individual states, there is considerable variation in state policy regarding such elements as data reporting, how queries are generated, and the responsibilities of prescribers and law enforcement in prescription monitoring.”). Care must be taken to avoid widening the use of PDMPS which could lead to enforcement functions seeping into systems of care, which negatively impacts the provider-patient relationship; See Leo Beletsky, Deploying Prescription Drug Monitoring to Address the Overdose Crisis: Ideology Meets Reality, 15(2) Health L. Rev. 139, 167 (2018) (“Broad law enforcement access to some of the most private health information creates a number of problems, including blurring the line between healthcare and law enforcement.”).
Child protective services and other agencies are able to conduct investigations using PDMP data. Rosanna Smart et al., Office of the Assistant Secretary for Planning and Evaluation, Data Sources and Data-Linking Strategies to Support Research to Address the Opioid Crisis 48 (2018), https://aspe.hhs.gov/system/files/pdf/259641/OpioidDataLinkage.pdf (“There is also substantial interest in linking PDMP data with social services data (e.g., child welfare data) to better understand how opioid misuse affect child welfare outcomes.”); Rania Gihleb et al., IZA Institute of Labor Economics, The Effect of Mandatory Access Prescription Drug Monitoring Programs on Foster Care Admissions 5-9 (2018), http://conference.iza.org/conference_files/Gender_2019/giuntella_o7634.pdf (“The impact of mandatory PDMP is concentrated on first removals [of children], while we find no evidence of significant effects on repeated removals. Our results are largely driven by the reductions in cases of child neglect. However, we also find evidence of reductions in cases associated with child abuse. Consistent with previous evidence on the effects of mandatory PDMP on drug abuse, we find larger effects among children of younger caregivers…The Adoption and Foster Care Analysis and Reporting System (AFCARS) is a federally mandated data collection system providing case specific information on all children…The database aggregates individual information on each child in foster care and each child adopted under the authority of all state child welfare agencies… AFCARS data contain information on the reason behind child removal (e.g., neglect, physical abuse, parental drug use, parental incarceration etc.).”).

Some groups of patients are especially vulnerable.

PDMP disclosures and lack of robust privacy protections disproportionately impact marginalized groups. See Beletsky, supra, at 145-46 (“Confidential medical care is not equally distributed. There is a growing, global body of empirical data documenting the disparities in systemic violations to confidentiality and other rights of patients belonging to marginalized groups. This includes ethnic minorities; people living with HIV/AIDS; people who use drugs; and the poor. Reflecting the power imbalance that affects these groups in other domains, confidentiality violations disproportionately impact these patients because they are subject to increased state control, surveillance, and stigmatization…”).
Complex and rare disease patients are interpreted by the system as deviant and may face abandonment, as well as barriers to medication and care access, as a result. See at 177 (“Withholding prescriptions and abandoning or ‘firing’ complex or suspicious patients appear to be actions that may result from finding of unexpected information in PDMPs.”)
Treatment deserts in certain geographical areas force patients to travel greater distances, which is consequently interpreted by algorithms as aberrant behavior. This in turn leads to patients being denied treatment based on higher PDMP scores. See id. at 161 (“In addition, geographical barriers, inadequate health insurance coverage, and uneven distribution of medical resources may influence access to pain management services, preventative care, and substance use treatment.”).

Design flaws and systems limitations require greater decision support and care coordination.

Prescribers face time constraints and other barriers in understanding risk scores and information offered by PDMPs. Informational asymmetry and discrepancies among specialty-dependent activities generate unfairness. To remedy this, scoring calculations should be tailored to specialty areas of practice.
In a climate of increasing opioid austerity and misapplication of CDC Guidelines, PDMPs become tools for prescription suppression—especially when the state believes that few, if any patients should be on opioids, including cancer patients. See at 140 (“Since the dominant narrative pins the root cause of this crisis on over-prescription and diversion of prescription drugs, the response has focused on tracking and suppression of medication prescription and dispensation.”).
It is highly problematic for PDMP alarms (to the providers as well as to oversight actors) to override clinical judgment. See id. at 146 (“Effective flows of accurate information play a vital role in informing decisions on both the individual and community health. Given accurate information about the patient’s symptoms, risk factors, and medical history, providers can combine their clinical judgment with the latest available research to make diagnostic and treatment decisions.”). It is imperative to find ways to contextualize data with health status as a more accurate indicator of success.
Algorithmic transparency is critical to meeting health-based metrics. See id. at 168 (“These concerns are not unique to the deployment of PDMPs. Even elsewhere in the health care arena, observers have critiqued the advent of algorithms, artificial intelligence analytical tools and other ‘big data’ techniques whose cavalier adoption did not adequately consider the data quality, practical, or ethical implications of these systems.”).

Conclusions and Next Steps

Workshop participants concluded that efforts should be made to ensure that PDMPs are carefully and responsibly deployed to advance patient and public health. Further interdisciplinary research, implementation reform, and continued legislative and legal advocacy are needed to continually evaluate the interaction of PDMPs with other state-based laws and to measure the impact of PDMPs on health and other outcomes.

Recommendations

Establish clear metrics of success focused on patient well-being;
Create better functionality, including care coordination and integration with electronic medical records (EMRs), and provider training to align PDMP systems and policies with efforts to improve patient outcomes; and
Improve privacy through design, legislation, regulation, and impact litigation.

To facilitate next steps, the Health in Justice Action Lab has submitted FOIA requests to all United States jurisdictions, asking for all contracts, algorithms and risk scores, data aggregation and analysis, and law enforcement access and interactions related to PDMPs. This data will be used to better understand PDMP design, utilization, and impact across the states. The Lab is also working with state partners to facilitate improved privacy protections for PDMP data under state law. The Lab has created a listserv to enable further investigation and continued conversation following the workshop. Any interested persons may request access to the listserv by emailing admin@healthinjustice.org.

Bios and Handles:

Leo Beletsky is professor of law and health sciences at Northeastern University and faculty director of Health in Justice Action Lab. @LeoBeletsky

Health in Justice Action Lab is an interdisciplinary think tank based at Northeastern University. The Lab’s portfolio focuses on advancing data-driven solutions to address today’s overdose crisis. The statements expressed in this brief do not necessarily represent the views of any individuals or organizations affiliated with Health in Justice. @HiJAction