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Abstract
Prescription drug monitoring program (PDMP) predictivesurveillance platforms were designed for—and funded by—lawenforcement agencies. PDMPs use proprietary algorithms todetermine a patient’s risk for prescription drug misuse, diversion, andoverdose. The proxies that PDMPs utilize to calculate patient riskscores likely produce artificially inflated scores for marginalizedpatients, including women and racial minorities with complex, painrelated conditions; poor, uninsured, under-insured, and ruralindividuals; and patients with co-morbid disabilities or diseases,including substance use disorder and mental health conditions.
Law enforcement conducts dragnet sweeps of PDMP data totarget providers that the platform characterizes as “overprescribers”and patients that it deems as high risk of drug diversion, misuse, andoverdose. Research demonstrates that PDMP risk scoring coercesclinicians to force medication tapering, discontinue prescriptions, andeven abandon patients without regard for the catastrophic collateralconsequences that attend to those treatment decisions. PDMPs,therefore, have the potential to exacerbate discrimination againstpatients with complex and stigmatized medical conditions bygenerating flawed, short-cut assessment tools that incentivizeproviders to deny these patients indicated treatment.
The Federal Food and Drug Administration (FDA) is authorizedto regulate PDMP predictive diagnostic software platforms as medicaldevices, and the agency recently issued guidance that provides aframework for such oversight. Thus far, however, the FDA has failedto regulate PDMP platforms. This Article contends that the FDAshould exercise its regulatory authority over PDMP risk scoringsoftware to ensure that such predictive diagnostic tools are safe andeffective for patients.