FDA, data analytics and the opioid crisis

A relative recently had knee replacement surgery. Doctors prescribed Oxycontin for pain management afterwards. She only took one or two pills before switching to acetaminophen.

That’s not the norm. To the contrary, a two-pronged opioid addition epidemic grips the nation. The national response hasn’t really gelled, but it might be starting. The Kaiser Foundation reports opioid overdoses killed more than 42,000 people in the U.S. in 2016.  That’s two-thirds of all drug overdoses. Gun deaths per 100,000 people were half those of drug overdoses, according to the Centers for Disease Control and Prevention.

One piece of evidence: An extraordinary speech given by FDA Commissioner Dr. Scott Gottlieb yesterday to a prescription drug abuse summit. He outlined a multi-pronged approach the agency will take to help tamp down opioid abuse. It gets complicated because the opioid crisis really has two components. One is over-prescription by doctors who aren’t familiar enough with the drug and its effects. The other is a flood of illegal, recreational opioids, mostly sold through the internet.

Data analytics is the vogue now for many federal agencies. Analytics and the systems that they run on are often called mission enablers. The mission to tamp down the opioid crisis is a good case in point.

Gottlieb described FDA’s expanding data analytics program to better understand prescription patterns. People who study opioids believe sloppy prescribing and followup contribute to addiction. FDA has been running analysis on its Sentinel database. Now it will look through Medicare databases and available pediatric medical databases.  Analysts are looking at initial prescriptions and refill rates versus the types of illnesses and surgeries. He said investigators already analyzed retroactive prescriptions for a million surgeries.

The goal is what he calls “policies that rationalize prescribing.” Right now, it seems like everyone routinely receives a prescription for 30 pills. Often people only need a couple. Others on long-term opioid treatment end up addicted for lack of careful management. For some classes of surgery, prescription levels are all over the map.

This apparently standardless way of prescribing potent drugs leads Gottlieb to muse whether doctors should have mandatory training, to coincide with registration with the Drug Enforcement Administration.

Gottlieb proposed another information technology tool. Namely, a “robust e-prescribing system.” It would incorporate “evidence-based prescribing guidelines” alerting doctors to a “rational” prescription for a given condition. It might be two pills, it might be 30. Much more data is needed to understand the right prescription not only for each surgery or illness, but also each patient’s mental makeup, history and tolerance to pain.

FDA is getting in on the battle against illegal opioids, too. Gottlieb said FDA sleuths have been prowling the dark web. They’ve scored some “notable takedowns.”

Next, Gottlieb said FDA will host a summit that includes social media companies and internet service providers. He wants them to apply their know-how to stemming the illegal opioid flow. One idea: Search engines rigged  to send those looking for fentanyl to pages with treatment programs or information on the dangers.

He chided the internet industry for lack of “meaningful, voluntary actions” while acknowledging the danger in having it “cross a threshold” taking ISPs and social media outlets into policing. Gottlieb is correct in that this is dangerous territory from legal and privacy standpoints.

Ultimately, FDA is not a law enforcement agency in the sense that DEA is. It can aid in stopping illegal trafficking, and it can have a lot of leverage on legal prescriptions. Medical practitioners complain about federal reporting requirements concerning drugs like opioids. But now it’s a good thing FDA has that big data.

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