It is an increasingly rare day when patients, their physicians, and the pharmaceutical industry all agree on something. In this case, the something is the treatment of chronic pain, and they all agree that it is grossly undermanaged.
Why is pain so poorly managed in the United States? It’s not because the healthcare community has no access to potent analgesic medications. Actually, it is just the opposite. US physicians have a number of effective opioid analgesics at their disposal that work very well to control chronic pain. These medications are just waiting on pharmacy shelves to have their names called so they can do their job.
So, what’s the problem?
The problem is that they carry significant risks, which can be very serious if not proactively managed. These risks include misuse, abuse, addiction, diversion, and legal ramifications to the prescriber if their patient goes off program. Because of these risks, real or otherwise, thousands of patients are suffering unnecessarily from pain that could be controlled. In fact, many physicians have made the conscious decision not to treat, but to refer patients in pain to other practitioners. For some, it is just too much of a pain to treat patients in pain.
The answer to this problem has been to design a risk evaluation and mitigation strategy (REMS) to support the safe use of opioids. REMS programs have traditionally been the responsibility of the company marketing the opioid, with few ever really hitting the mark. Therefore, the FDA tasked itself to design comprehensive REMS to cover most long-acting opioids. On July 22, 2010, this plan was soundly rejected by the FDA’s own advisory committee as not being tough enough. However, the result was not all bad: what came out of this was better insight into the true problem, and in this case, it’s not just the drugs.
Medicine is a risky endeavor; has been from the beginning. All medications carry some risk, but with proper training and oversight, it can be managed. For pain, in prescribing opioids there is more fear of what might happen, rather than focus on what will happen. It is time to realize that effective treatment of chronic pain is everybody’s responsibility. Not mine, not yours, but ours. If you make it, take it, or prescribe it, you are part of solution. Patients need to be properly evaluated and educated before beginning treatment. Physicians need to be properly trained in anticipating and seeing the signs of trouble. Most importantly, pharma needs to champion both sides of this equation. It’s not just about building a better mousetrap; it’s also about showing everybody how to avoid getting their fingers caught.