Oxycontin’s 12-Hour Problem: What NPs Need to Know about Prescribing
The L.A. Times Investigation
By Healthcare Attorney Alex Scarbrough Fisher
Earlier this summer, the L.A. Times reported on its investigation into Oxycontin, and the results aren’t pretty: the Times found that Oxycontin’s main selling point, that it lasts for 12 hours, is not supported by clinical research.
In spite of this, the Times found overwhelming evidence indicating that not only did Purdue Pharma (the marker of Oxycontin) have knowledge of Oxycontin wearing off well before the 12-hour mark, Purdue intentionally repressed this knowledge from doctors, patients, and the FDA for the past 20 years.
The L.A. Times investigation reports the following:
Purdue Pharma submitted falsified numbers to the FDA when they gained approval for Oxycontin in 1996, stating that the drug treats pain for 12 hours. The problem with Purdue's claim is that Oxycontin only treats pain for roughly half that time.
Purdue Pharma, despite continual feedback for the past 20 years from patients, doctors, and their own pharmaceutical reps that the drug wears off long before the 12 hour mark, has continued to market the drug as a “12 hour drug,” to give themselves a competitive advantage over other pain medications. The only problem with this, despite the obvious lying to consumers part, is that prescribing a strong narcotic for 12-hour cycles, when it only relieves pain for 6-8 hours, actually sets up patients for addiction due to dangerous pain relief/withdraw cycles.
Further, Pharma reps encouraged doctors to stick to the 12-hour prescription cycle, but simply prescribe higher doses. A study from Canada showed that this method of prescribing resulting in an overdose for 1 out of every 33 patients. It’s hard to imagine, but this study shows that Oxycontin prescribed in the method encouraged by Purdue Parma reps is more likely to kill a patient than anything else (really, anything else) in the world.
Why does this matter?
The prescription drug epidemic is HUGE in America. It’s a public health crisis, particularly so in the Southeast (where my practice as an attorney is based). It’s a difficult problem to understand, particularly the big question–who is at fault? People who simply like to abuse drugs? Doctors who are prescribing inappropriately? A culture as a whole that views “pain” as a problem to be eradicated by their healthcare provider? Now we have a small answer to this huge, multi-faceted question–who is at fault? A drug company–who has made billions for the past 20 years–that knowingly instructed doctors (WITH the FDA’s approval) to prescribe medication at a dangerously high dosage, and at intervals that all-but set up patients for addiction–at the low end of the spectrum–and death at the high end.
What can doctors and nurse practitioners do in response to this information?
- As always, monitor your patients, and realize that simply because a medication is approved for treatment by the FDA does not mean that it is the right treatment for YOUR patient.
- Despite the necessary and often beneficial role that pharmaceutical sales reps play in educating physicians and NPs about new technology and medication available, be mindful that these sales reps are in your office or at your hospital for their own financial gain. It is incumbent that healthcare providers not rely on sales reps as your sole source of information about medications that you may be prescribing.
- Finally, (and hopefully, most obviously), be mindful of your prescribing of Oxycontin. Monitor each patient individually for his or her feedback on when the drug wears off, and consider switching treatment based on your patient’s feedback. Do not rely on your sales reps, or even the FDA to know what is best for your patients. Regardless of what your opinion is on the role of prescription writers in the current opioid epidemic in America, we can all agree that doctors and nurse practitioners have a responsibility and an opportunity to be a part of the solution.
Comments or thoughts? Please feel free to comment below, or contact me directly at firstname.lastname@example.org.
Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex's administrative law practice's emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.