Opioid Regulations on Steroids: No Pun Intended 
[Posted on: Thursday, May 19, 2016]

In an unprecedented bipartisan move, last week the US Congress passed 18 bills to curb opioid abuse, most of which will have a direct impact on how physicians prescribe these drugs. Along with the CDC recommendations for training and prescribing rules for doctors and the Comprehensive Opioid Abuse Reduction Act (CARA) passed earlier in March, these new laws highlight the various aspects of the opioid abuse epidemic where better training and medical practice are needed. It has been widely interpreted that doctors will lead the way out of opioid epidemic with the help of these new rules. These new laws will create multi-dimensional measures to address addiction, abuse, monitoring, and prevention of over prescription of opioid painkillers. These rules update standards for doctors to manage their patients' pain and prescribe painkillers. These bills will create programs to increase availability of overdose reversal drugs or drugs intended to help wean people off addictive opioids, educating public about opioid abuse, minimizing the amount of opioid drugs dispensed at a given time, and asking FDA to be cautious before approving new opioid drugs. Provisions have been created for special populations such as veterans and infants born to opioid-addicted mothers. The breadth and depth of these new laws, along with the strong bipartisan support led several to coin the term “Opioid Week” at the Congress. Almost all these bills were introduced by one Republican and one Democratic congressman assuring that the bills will pass easily. This year has seen some of the most comprehensive rules to address opioid abuse. The CARA bill focused primarily on law enforcement but these new bills acknowledge that opioid abuse is a cultural and social issue fueled by rampant over prescription. The focus of the laws has been to move the responsibility from the addicts to doctors and healthcare systems. Why now? Perhaps in the extremely charged political environment in Washington DC, this is one of the few issues where both parties agree to work together. That said, it is estimated that implementing these laws will require more than a billion dollars; there is no agreement on the source of these funds. There are also practical concerns about reasonable implementation of these rules. First, it will require robust training programs for doctors across multiple specialties since pain killers are prescribed by practically all kinds of physicians. Public resources to mount such trainings are not available. Since doctors are expected to follow new “recommendations” from CDC, can patients sue the doctor in case their doctors fail to follow these? Liability issues for physicians and other healthcare providers are not clear but presumably increased under the new laws. These laws are in line with the belief that physicians need to play a more responsible role to curb the opioid epidemic. The funding issues have not been resolved so there is no time-line at this time, but physicians should be ready for training in the new rules.