Last week’s announcement that the FDA is considering requiring physicians’ to obtain additional training in order to prescribe certain Schedule II narcotics is welcome news – for payers and patients. Physicians aren’t so welcoming.
The list of drugs includes several varieties of morphine (e.g. Avinza, MS Contin), fentanyl (including Duragesic patches), methadone, and that old favorite, OxyContin. As a group, the listed drugs accounted for 21 million prescriptions written for 3.7 million patients in 2007.
The rationale behind the FDA’s move is concern over the adverse consequences suffered by many patients on the medications – consequences the FDA – and others – believe could be reduced by more thorough training of prescribing physicians. The FDA’s move came as a result of a law passed in 2007 enabling the agency to selectively address certain medication issues utilizing ‘Risk Evaluation and Mitigation Strategies’. In the past, the FDA’s powers were sort of all-or-nothing; they could either require warnings or pull a drug off the market.
According to the NYTimes, the head of the FDA’s initiative, Dr. John K. Jenkins, said:
“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products…”
This is good news for many payers, who have expressed concern over physicians’ apparent willingness to prescribe very powerful drugs for conditions that didn’t appear to merit them. Workers comp payers have long held that prescribing patterns are a major driver of extended disability as well as high costs. I’d cite the use of OxyContin as a major issue for comp payers. Purdue Pharmaceuticals, OxyContin’s manufacturer, has been hammered by the FDA and others for its egregious, and illegal, marketing activities. While Purdue was fined $600 million, reports indicate the manufacturer’s OxyContin revenues totaled almost $3 billion during the time it was illegally marketing the drug.
What does this mean for you?
Unfortunately, it looks like in some instances, crime does pay. The good news is the FDA’s new initiative will likely help reduce not only costs, but more importantly adverse outcomes.
Insight, analysis & opinion from Joe Paduda
I never object to more training as long as it is not too heinous. If we are able to access it on line and do it on our own time table, there should be no issue. If the training is lengthy and requires travel, the only thing this law will do is to deprive legitimate pain patients of their medications and cause misery for them.
It had better include all prescribers, not just physicians as NP’s can practice independently in our state of WA. Also, I see ‘big’ brother’s hand in all this. I personally see it going to be more and more difficult to prescribe to patients with intractable pain in dosages that are individualized versus, MS 200 mg equivalents and that’s it garbage. I hardly have anyone on that in my pain practice. I run a tight ship and the last thing I need to more government oversite and bossing around by physicians that write for no more than Vicodin #28 and consider that ‘good pain management.’
I JUST EXPERIENCED MY FIRST SHORTAGE OF rOXICODONE. MY PHARMACY SAID THEY DIDN’T KNOW WHEN THEY WOULD BE ABLE TO GET A SHIPMENT. i WENT ON THE INTERNET AND WAS SHOCKED TO FIND THAT THIS SHORTAGE WAS REAL AND THE PROBLEM IS ABUSE AND “SHOCK OF ALL SHOCKS” THI INDUSTRIAL COMISSION. THIS IS ANOTHER EXAMPLE OF THIS ORGANIZATION DOING WHAT IT DOES BEST, AND THAT IS TO TRY AND GET OUT OF DOING ANYTHING FOR THE WORKER THAT THEY CHOSE TO INSURE. IT’S FUNNY, THAT YOU CAN’T SUE AN EMPLOYER FOR MAKING YOU UNABLE TO WORK OR TAKING AWAY YOUR ABILITY TO PROVIDE FOR YOURSELF OR FAMILY. BUT,,,,IT’S NOT FUNNY WHEN THEY TRY AND GET OUT OF A COURT ORDERED REQUIREMENT FOR RELIEF AND MEDICATIONS. SOMEBODY NEEDS TO EXAMINE THE ACTIONS OF THE INDUSTRIAL COMISSION AND THEIR ILLEGAL WAYS OF CORUPTION AND BEING IN THE POCKET OF BUSINESS. i’M SHOCKED THAT THE ONLY THING THAT MAKES THE PAIN BEARABLE (SORTA) IS BECOMING DIFFICULT TO OBTAIN. i DON’T ABUSE AND HAVE ONLY ASKED FOR AN INCREASE IN DOSAGE ONCE IN 9 YEARS. THIS IS A SHAM AND i GOING TO CALL MY SENATOR TOMORROW AND ASK HIM WHY I HAVE TO SUFFER FOR SOMEBODYS ABUSE PROBLEMS.