Navigating the Regulatory Waters in Pain Management

Primary care should know that the number of regulatory agencies that are getting involved in the management of chronic pain seems to be growing by the week. Since 2011, the Food and Drug Administration has become really involved with the post-marketing prescribing of opioids, with REMS being probably the most evident part of their movement towards influencing what prescribers do. But there is also the Drug Enforcement Administration, followed by the Center for Disease Control, the Joint Commission, the Center for Medicaid and Medicare Services, and the like and the number of regulators that are becoming involved in this arena just seems to be growing and growing. It can get very, very confusing for people in primary care. So the point that I try to drive home to healthcare providers is that with all of these different regulatory agencies being involved, the one that often doesn’t come to mind is the Federation of State Medical Boards. Primary care practitioners need to be aware of what their state level requirements are, and to not walk away from managing patients with chronic pain but to see what they can do to comply.

When I talk about staying on the rails in pain management and prescribing, I think it’s important to be following some set of guidelines that meet the requirements of the state you live in while also making sure that the patient doesn’t get lost in the shuffle. I think a lot of people think when I talk about staying on the rails it means having a pristine medical record to look at, so if somebody wants to come and look at it, they can say, “I pass all the tests. I had everything documented.” But to me, if the patient gets lost in the process, then it’s gone off the rails. Keeping a good medical record is one thing but making sure that you take the best possible care of a patient and are not abandoning the patient is just as important.