Enough Pain Regulations?
I’ve described the ongoing debate over the use of opioids to treat chronic pain. To catch new readers up to speed, the country is in the midst of an epidemic of deaths due to overdose on pain medications or heroin. The epidemic is evident to anyone who spends even a few minutes searching the internet using the keywords ‘overdose deaths.’ Another increasing phenomenon is the prosecution of physicians whose patients have died from overdose. Physicians have been found guilty of manslaughter, even when people used the prescribed medication inappropriately, far outside of prescribed guidelines. It is no surprise that in response, many doctors have stopped treating pain with opioids altogether.
I’ve described one group of physicians, Physicians for Responsible Opioid Prescribing or PROP, who have taken a position seen as extreme by some other physician groups, particularly groups involved in advocating for pain relief. The latest efforts by PROP have resulted in a direct conflict with pain advocacy groups. Readers of this blog who are interested in the issue can have a direct impact on the outcome of the situation.
Medications approved by the FDA have been shown through scientific study to be effective and safe enough to justify their use. At present, opioid pain medications are indicated for moderate or severe pain. There are no other restrictions on the use of pain medications from the FDA, but use of all medications, including opioids, must be within the ‘standard of care,’ a general pattern of practice in a given area that is sometimes difficult to pinpoint.
PROP has asked the FDA to change the indications to state that opioid pain medications are to be used only for severe pain. They also asked that opioids be recommended for use for a maximum of 90 days, and never in doses greater than the equivalent of 100 mg of morphine. They base their request on studies that have shown that some patients develop a condition of increased pain, when maintained on opioids for a prolonged period of time. They are also concerned about the large numbers of deaths from opioids, particularly among young people.
Details about their request can be found here.
The petition is opposed by a number of individuals and agencies, including the American Academy of Pain Medicine (AAPM) and the American Pain Society (APS). Their criticisms include the somewhat arbitrary limits of 100 mg morphine equivalents and 90 days of treatment. They also have concerns that more and more doctors are already ‘opting out’ of pain treatment for fear of liability, and the proposed changes will only worsen the shortage of doctors willing to treat pain patients by increasing their real or perceived vulnerability to lawsuits or prosecution.
I have tried to maintain a neutral position on this issue, but I will share some of my thoughts. As an anesthesiologist, I prescribed and administered medications ‘to effect,’ rather than to a certain dosage. Different people have profoundly different tolerances and responses to medication, so that a dose of ten milligrams in one person is as effective as fifty milligrams in another person. For that reason, I resist dose-based guidelines, as they leave some people with more ‘treatment’ than other people.
Likewise, while I agree that in general, opioid medications have been overprescribed over the years, I see real danger that in some parts of the country reasonable pain treatment will be hard to come by. I have been in enough painful situations to realize that pain is one thing when discussed theoretically, but something else entirely for the person who is suffering. I resist the idea that someone a thousand miles away, who has never met the patient, should tell the doctor in the room whether the prescription is or is not appropriate. I find it somewhat bizarre that just fifteen years ago, the Joint Commission for Accreditation of Hospitals was citing hospitals who were deemed insensitive to the needs of patients in pain. Hospitals preparing for site visits were told that they could lose accreditation if there was evidence that narcotics were not being offered frequently enough to suffering patients.
Of course, when I was growing up, Newsweek and Time had stories about the impending ice age that was already shortening growing seasons, and the need to take action to warm the planet, before we all became buried in ice. We know how that ended up.
The main problem that I have with the PROP petition is that for years, I’ve watched as doctors gave up more and more decisions about patient care. Right now, business majors working for insurance companies tell me which medications my patients should take. I don’t have to follow their ‘suggestions,’ but if I don’t, the patient may have to buy the medication out of pocket. Right now, hospitals CEOs decide how long patients are admitted after giving birth or having major surgery. Right now, we have government employees without medical degrees deciding which medical procedures are ‘cost effective’ for Medicare patients, a situation that will become commonplace for younger people in the near future.
I spent four years studying biology, another four studying medicine, another four studying anesthesiology, and yet four more studying psychiatry—not even counting the thousands of patients I’ve treated over the years, often consulting the literature to determine the best course of action. Does it make sense that some intern of a government agency, who has never struggled with treatment decisions, should write one-size-fits-all guidelines that I should follow?
Readers have a voice in the outcome of this debate, because the FDA is inviting opinions from the general population before making a decision. No matter your opinion, I encourage you to go to the FDA response site and be heard!
Back pain photo available from Shutterstock
Junig, J. (2012). Enough Pain Regulations?. Psych Central. Retrieved on February 12, 2016, from http://blogs.psychcentral.com/epidemic-addiction/2012/10/enough-pain-regulations/