Joshua Lederberg, the Nobel Prize Laureate once observed that the failure of regulatory, legal and political institutions to integrate scientific advances into risk selection and assessment was the most important barrier to improved public health.
Lederberg noted that in the absence of such changes, "the precedents affecting the long-term rationale of social policy will be set, not on the basis of well-debated principles, but on the accidents of the first advertised examples."
Policies and regulations that seek to limit risk are often shaped by the immediate fear of sensational events. This perspective is commonly called "The Precautionary Principle" which in various forms asserts that unless innovators can demonstrate that a new technology is risk free, it should be not allowed into the marketplace. Moreover, any product that could possibly be dangerous at any level should be strictly and severely regulated.
Which brings us to yesterday’s announcement that the federal government (led by the DEA) is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.
The new rules mean that drugs like Vicodin, Lortab and other generic versions will be subject to the same prescribing rules as painkillers like codeine and oxycodone. Patients will be limited to one 90-day supply of medication and will have to see a health care professional to get a refill. Additionally, in many states prescribing authority will be limited to physicians, not nurses or physician assistants.
Will this limit abuse? That’s a theory. What's a fact is the negative impact it will have on the tens of millions of Americans who suffer from chronic pain.
Last September, CMPI held a conference on the issue of opioid pain medications. One of the panelists was Cindy Steinberg, the National Director of Policy and Advocacy for the US Pain Foundation. Here’s what she had to say about upscheduling:
That’s going to mean that people need to see their doctor at least four and sometimes 12 times a year just to obtain a script because of the very strict requirements on Schedule II medications. The hydrocodone combinations are now Schedule III and if they are upscheduled, in Massachusetts for example, where Schedule II scripts expire in 30 days and cannot be written for more than a 30 day supply, many people in my group are that are taking hydrocodone combinations medications would have to see their doctor every 30 days for a script.
They now see their doctor perhaps twice a year. So, they would have to go see their doctor 12 times per year. People have a hard time finding a pain doctor period, let alone getting an appointment.
Somebody in my group was referred to a pain specialist in January of 2012 and the first appointment she was able to get was in December of 2012. She had to wait almost an entire year to see a pain doctor. So how are we going to handle the number of people that are going to need appointments to get their medications? In Massachusetts, as I mentioned Schedule II scripts expire in 30 days and by federal law cannot be refilled. I have a person in my group that has osteonecrosis. He was an early heart transplant patient and the steroids he had to take to maintain his organ transplant resulted in osteonecrosis which has eroded every joint in his body. He’s had multiple joint replacements and lives with a very high degree of pain. His wife has to drive him to the doctor now every 30 days in order to get his Schedule II medication because he needs to get a physical script. And that’s going to happen to many people if these Schedule III medications are rescheduled. And as I mentioned, given all those extra appointments, think about what that is going to do to healthcare costs.
Upscheduling will result in tighter restrictions for patients who really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow regulations.
