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PRESCRIPTION DRUG MONITORING PROGRAMS

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The Issue:

 In line with other “epidemics” of grave public concern, the overdose crisis has spurred an expansion of public health surveillance. We focus on the principal element of this expansion—prescription drug monitoring programs (PDMPs). By collecting information on who is prescribing, dispensing, and receiving scheduled drugs, PDMPs are intended to detect—and deter—”problem patients”, rogue prescribers, and pharmacists who may be diverting potentially addictive and otherwise risky drugs. 


PDMPs are far from new, but the recent scale-up in the number, scope, funding, and legal mandates of these systems has occurred without sufficient scrutiny. The lens of public health law research has just begun to be trained on PDMPs. By integrating empirical and theoretical perspectives, our research adds to this nescient discourse. We argue that the zeal with which we have traditionally pursued supply reduction measures to address drug-related harms reflects the legal and system design of PDMPs, as well as the street-level implementation of these programs. This also explains why the success of PDMPs has been measured primarily by their impact on suppressing medication supply with little regard for truly meaningful metrics. But, when it comes to improving patient care and addressing drug-related harms, the evidence of PDMP benefit is far from clear.

 

Our Research:


Our research presents a narrative review of the 34 peer-reviewed studies evaluating PDMPs published since 2010. Only 11 (32%) considered any overdose outcomes. Of studies assessing overall mortality, three found PDMP deployment to be associated with reduced overdose rates, four reported a null result, and three reported PDMPs to be associated with an increase in overdoses. These findings stand to challenge the kind of unbridled enthusiasm, generous investment, and cavalier policy emphasis that has buoyed PDMPs since the onset of the overdose crisis.


We are currently undertaking research that examines the role of PDMPs in the post-Dobbs era.  PDMPs may be used to track reproductive health-related services, despite their mixed evidence for successfully improving other health outcomes such as substance use disorder and overdose. We propose expanding our PDMP research expertise and systems to now study the burgeoning potential public health consequences of tracking medications for reproductive health. 

Unintended Harms

Given mixed evidence of impact, the unintended harms of these systems warrant urgent examination. This includes deterring proper prescribing practices; chilling help-seeking among patients, especially those made vulnerable by a history of trauma in the healthcare settings and criminal legal involvement; and further fraying the fabric of provider-patient trust. Original qualitative data presented here give voice to stakeholder concerns about surveillance, privacy, and pervasive monitoring by law enforcement. A special focus on their privacy dimension is especially timely in view of recent appellate decisions allowing broad warrantless disclosure of PDMP data to law enforcement. Although the perils of expansive government monitoring and predictive technologies are recognized in national security, criminal justice, and other realms, a critique of PDMPs as dragnet electronic surveillance is long overdue. At the population level, these collateral impacts can hamper much-needed surveillance and control efforts, aggravating the very problems these policies and programs were intended to ameliorate.

Next Steps

Ultimately, however, our research is sober to the reality that PDMPs are here to stay. As we urge a more deliberate focus on privacy protections, we argue for PDMP integration with electronic health records; user-driven design that reimagines PDMPs as a care coordination, clinical decision-making, and public health prevention tool; and meaningful training on how to deploy PDMP functionality to improve individual and public health.

What We Are Doing
The Issue

KNOWLEDGE GENERATION

  • Social media scraping for stakeholder and patient perspectives

  • Analyzing law enforcement access to PDMP data

 TRANSLATION

  • Creating research briefs with policymakers, researchers and journalists

  • Articulating to policymakers and PDMP stakeholders opportunities to improve PDMP functionality as a public health prevention tool

 IMPLEMENTATION

  • Analyzing implementation and use of PDMPs by law enforcement, including tracking the use of MA PDMP

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what we are doing
Data Dashboard
Data Dashboard

Insights on Law Enforcement Engagement with the MA PDMP 

Methods:

These data were obtained pursuant to a Freedom of Information request by the ACLU of Massachusetts to the Massachusetts Department of Health in 2017. Data aggregation and graphic development was completed at The Action Lab.

 PDMP Proliferation Across All States
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 Narrative Review of PDMP Effectiveness
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Abortion Medication & Gender Affirming Care Timeline
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PDMP Fact Sheet
Current Research
More on PDMPs: Two Research Projects

A prescription drug monitoring program (PDMP) is an electronic database designed to track controlled substance prescriptions (CDC). More than a century after New York implemented the first PDMP, electronic public health surveillance has expanded to all 50 states. Practically, PDMPs track controlled substances (and some other) prescription and dispensing behaviors. These programs originally emerged as a response to the overdose crisis as tools to promote safe prescribing and limit practices like drug diversion, “doctor shopping,” and overprescription. However, their efficacy and ethical implications are contested. 

These datasets have become more widely used in response to the overdose crisis. They are also seen as important tools to limit overprescription, problematic use, and the illegal distribution of prescription drugs.

 

Despite these strengths, PDMPs create an unusual window for the criminal legal system to surveil sensitive prescription data. Specifically, laws criminalizing medication for abortion and gender-affirming care continue to pass, in conjunction with those allowing these very medications to be surveilled via PDMPs. 

 

Many states have very limited requirements restricting law enforcement access to this data, and where they do exist, policies vary widely. This lack of standardization and low-barrier access to highly personal data carries a number of risks. For one, law enforcement surveillance of health data can negatively impact the patient-provider relationship. This is due to real or perceived threats of criminal prosecution. Patient reluctance to seek care, or reveal aspects of one’s identity, and provider hesitancy to prescribe medications, may ultimately result in patient stigmatization, lower-quality care, and worsened health outcomes. This will only worsen as states continue to adopt laws criminalizing gender-affirming and abortion health care.

 

Another serious concern is privacy violations. The lack of restrictions governing law enforcement access to PDMP data implies access to patient health data and identity information. In the context of criminalization, laws that make it increasingly dangerous to be a person seeking abortion services or gender-affirming care, this lack of privacy can have huge implications for

patient safety. 

 

This can be seen in cases where prescription information about an individual’s gender-affirming care with testosterone outed individuals as transgender to their law enforcement colleagues without the individual’s consent. A previous study (summarized below) was done to identify state policies authorizing law enforcement access to PDMP data and the characteristics of those policies, particularly in states with laws banning gender-affirming pharmacotherapy.

State policies allowing law enforcement to access testosterone prescription data through PDMPs 

 

Aims

Testosterone replacement therapy is often prescribed for men with hypogonadism and transgender males. These treatments can be life-saving, as for youths, testosterone and other gender-affirming medical interventions are associated with lower odds of suicidality. However, more states are adopting policies restricting and criminalizing gender-affirming care, especially for minors. Testosterone is a Schedule III controlled substance based on concerns about its performance-enhancing use in sports. So, testosterone prescription and dispensation are trackable through state PDMPs.

Methods

Using the MonQcle software, state websites, and three research databases (LexisAcademic, Westlaw, HeinOnline), we identified and analyzed relevant state PDMP laws through January 2023. We extracted the following elements pertinent to law enforcement access restrictions: warrant/subpoena requirements; cross-state data exchange; unsolicited PDMP data reports to law enforcement; and PDMP query reporting requirements. States banning gender-affirming care were identified using the American Civil Liberty Union’s bill-tracking system (current as of December 2023). The number of states with bans allowing law enforcement access to PDMPs without a warrant or subpoena was also determined.

Findings

This study determined that all states, except for Missouri, allowed some form of law enforcement access to testosterone prescription data through PDMPs. 

 

Discussion

These results indicate that testosterone prescription data through PDMPs was accessible to law enforcement without basic safeguards, such as a warrant or subpoena, in nearly half of states. This ease of access to sensitive health information raises privacy, care quality, and civil liberties concerns, especially amid the increasing number of gender-affirming care bans. In addition, a majority of states allowed cross-state PDMP data sharing between law enforcement departments, which would allow states that ban gender-affirming care to track persons seeking out-of-state health services. 

Open Door: Law Enforcement Access to Prescription Drug Data Across the States

Aims

This study describes the legal landscape for law enforcement access to PDMPs and highlights areas of weakness for prescription data security. It lays the groundwork for future research evaluating the use of PDMPs in surveilling access to opioids, gender-affirming care, and abortion medications.

 

Methods

We used MonQcle, a digital software used for policy tracking and analysis to evaluate states’ PDMP laws. First, we created state profiles to organize laws related to PDMP access. Then we developed a number of questions to gather the following information: PDMP tracking of testosterone, a requirement for providers to query PDMP before prescribing, a requirement of warrants before law enforcement access, and ability for cross-state law enforcement access. 

Findings 

Our research found that despite national consensus on Schedule III-IV drug reporting requirements, regulations regarding access to PDMP data varied largely by state.

 

Law Enforcement Access by State

 

 

 

 

Unsolicited Reports

Dragnet Surveillance and Sharing Requirements

 

 

Training Requirements

 

Discussion

There is little standardization of reporting requirements across states. For example, most states impose reporting requirements for additional “drugs of concern” such as butalbital and gabapentin. Other states use more vague language, tracking additional “certain other select drugs that are not included in Schedule II, II, IV, or V” (Illinois) or “substances determined by the department to carry a bona fide potential for abuse” (Massachusetts). This lack of clear identification of which drugs are being tracked could be cause for concern for individuals seeking gender-affirming care or abortion services. These inconsistent access laws and allowance for warrantless PDMP searches by law enforcement opens the door to deploying electronic surveillance tools in the criminalization of gender-affirming care and medication abortion. 

 

This needs to be regulated by altering the class of gender-affirming care-related medications such as testosterone and by standardizing laws classifying drugs of concern. Further, ​​uniform access regulations across all states, including universal search warrant requirements, unsolicited report regulations, and transparent cross-state data-sharing pronouncements, are needed to protect vulnerable patient information and protect care-seeking behaviors.

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Resources
Resources

Mina Hong, Sarah Seymour, Leo Beletsky et al

Journal of Addiction Medicine, 2022

Leo Beletsky

Los Angeles Times, November 14, 2022

Leo Beletsky

Indiana Health Law Review, 2018

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