Changing Outdated Methadone Regulations That Harm Pregnant Patients

Methadone regulations have changed minimally since 1974, despite advances in the understanding of the nature of opioid use disorder (OUD) and the role of medications in its treatment. At that time, most patients with OUD were considered to have anti-social personality disorders and the regulations aimed to exert maximal control over medication access. Six- or seven-day clinic attendance is required for months, regardless of distance, or childcare and other social responsibilities. Take home medications are not allowed unless rigid and formulaic conditions are met. Although addiction medicine has rejected the "criminal" paradigm in favor of OUD as a treatable medical disorder, methadone regulations have not kept pace with the science. Pregnancy is characterized by an ultra-rapid metabolic state, but regulations prevent the use of daily divided doses of methadone to maintain stability. This results in repeated episodes of maternal/fetal opioid withdrawal, as well as other fetal physiologic abnormalities. Interference with dose regimen adjustments prevents optimal outcomes. Further, methadone clinics are mostly urban, leaving patients in rural areas without access. This led to excessive morbidity and mortality when the opioid crisis hit. The response of merely expanding capacity in overcrowded urban clinics created a contagion menace when Covid-19 arrived. Pregnant women (and parents with children) were forced to negotiate dosing in dangerous conditions. A revised methadone system must provide treatment that is local, flexible, and limited in size to manage viral contagion risks. This regulatory change can most easily be started by changing regulations that adversely affect pregnant women.