America consumes 80% of the world opioid supply (99% of the world hydrocodone supply), but has about 5% of the world’s population. If you don’t think America has some kind of opioid problem, then move along because this rational, evidence-based, experience-laden way in which I’m going to discuss opioid use and misuse will not interest you.
To combat our opioidification the Food and Drug Administration has recommended prescribing restrictions on hydrocodone (remember, we consume 99% of the global hydrocodone supply). These obstacles do not appear derived from evidence-based guidelines and probably won’t do much to reduce the vast majority of inappropriate prescribing, although they may slightly curtail physicians that run pill mills and may also help with diversion (lying to get opioids to sell them on the street).
But I want you to consider these following pain scenarios, because this is how the majority of opioids are prescribed in the United States. In each scenario there is a patient with chronic low back pain who started taking a Norco (acetaminophen and hydrocodone) every day or two for her pain, but now four years later is taking 8 Norco a day.
- Patient A was never referred to physical therapy, never prescribed an adjuvant medication for chronic pain (adjuvant medications treat the way chronic pain is produced in the nervous system), never given a graduated exercise program, never had her anxiety or depression discussed never mind treated, and never given the option of a long-acting opioid. In short, she was only ever offered one therapy, the wrong one. Over time, her pain worsened (a natural consequence of untreated depression, anxiety, and immobility) and she needed more Norco a day.
- Patient B was offered all the above therapies and they were well-covered by her insurance, but she found reasons to cancel physical therapy at the last minute, was intolerant of every medication except the Norco, and refused to speak with a pain psychologist despite being profoundly depressed (PHQ-9 of 24) and suffering from an anxiety disorder. Over time her pain worsened and she needed more Norco a day.
- Patient C wants to go to physical therapy, but the co-pay is $80 so even twice a month isn’t possible (a month of Norco costs $5). She is dutifully doing her home exercises, but often does too much and pays for it in pain the next day because learning pacing from a pain psychologist isn’t a covered benefit. She is open to addressing her depression and anxiety, but don’t have mental health coverage. She tried nortriptyline (the only truly low-cost adjuvant medication for chronic pain, $4 a month via WalMart), but it was ineffective. Generic gabapentin, the next generic that is offered (because brand name drugs are prohibitively expensive under her health plan) is $1 a pill and that will be about $180 a month. She would love to do Tai-Chi or restorative Yoga to get moving, but can’t afford it. Over time her pain worsened and she now needs 8 Norco a day.
- Patient D had an MRI when she complained of back pain. A bulged disc was identified. After 2 epidurals that didn’t work (no PT or other multidisciplinary approach was offered), she had back surgery. When, after a brief 4 month post surgery respite, the pain worsened she had more epidurals and another surgery with a multi level fusion. And then another one. Over time her pain worsened (she now has failed back syndrome) and she takes 8 Norco a day
Despite the fact that opioid monotherapy is sub-optimal care, it happens all the time. I’m not sure how the FDA restrictions will help a doctor, who has less than 15 minutes and may not fully understand the multidisciplinary approach required to address chronic pain, delve into anxiety, depression, physical therapy, cognitive behavioral therapy, weight loss, pacing, adjuvant medications, nerve blocks, dietary modifications, and the appropriate use of opioids (just to name a few therapies).
Non compliance is a challenge in all aspects of medicine, and chronic pain is no different. However, the availability of opioids as a potential therapy certainly confuses things. A beta-blocker for high blood pressure has no component of secondary gain. How do we approach non compliance in chronic pain when opioids are on the table? We know that exercise and physical therapy reduces both pain and work disability for many patients with back pain and are the standard of care, but what if a patient is less than compliant with physical therapy or flat-out refuses yet shows up on time for her opioid prescriptions? Non compliance isn’t limited to physical therapy or exercise either. How will the FDA restrictions guide clinicians in these scenarios?
In almost every single health plan in the United States it is easier to get an MRI and back surgery than it is to get physical therapy. FDA restrictions will not solve this problem.
In the United States there is a reluctance to accept that the mind-body connection is a huge part of the pain equation. The neurochemical changes of depression and anxiety increase pain, because the same chemicals released by an anxious or depressed nervous system are the very same chemicals that produce pain. Basically, depression and anxiety fuel the fire of pain. How will the FDA regulations fix this mind-body disconnect (among both patients and providers ), solve mental health parity, and break down the stigma of mental health?
What if the patient actually has access to and wants to go to a cognitive behavioral therapy program, but she works two jobs and can’t afford to take the time off to go? After all, most of these programs are offered during the day. How will the FDA restrictions help in this scenario?
There are only a few generics for the medications that can actually treat chronic pain, so most of these drugs are very expensive. Many opioids are as cheap as M & Ms. A few extra hoops for hydrocodone won’t solve this issue.
Some docs have admitted to essentially giving Vicodin goody bags to improve Press Ganey scores. Yes, you read that correctly. Check out that link at the peril of your sanity. There is a push to give the patient what they want, which may not always be the standard of care. And yes, many people want opioids. How will the FDA restrictions put the brakes on this trend?
And finally, we practice medicine in a world where some chronic pain conditions respond suboptimally to evidence-based therapies and appropriate, responsible opioid prescribing may be a necessary component.
I practice in chronic pain Nirvana. Everyone of my patients has access to skilled physical therapy, adjuvant medications, a pain psychologist, and a psychiatrist, although rising co-payments are eroding away at the way people can practically access these services. We have intensive cognitive behavioral therapy programs designed to get the immobile moving (immobility is the nemesis of chronic pain, a self-fulfilling prophecy). We even have Tai Chi and Feldenkrais. And yet, sometimes even when we harness all these treatments we still need opioids (although almost always we are able to lower the dose). And sometimes, patients decline all these therapies and only want opioids.
Proposing restrictions helps us think about opioid misuse and abuse, which is good. New York City’s decision to limit opioids prescriptions from the emergency room to a three-day supply is a more thoughtful approach, although not perfect. Chronic pain shouldn’t be managed in the emergency department, although what happens to the patient without insurance who goes to the emergency room for her pain because she knows she won’t be turned away? Should this patient be treated differently than the patient who is going to the emergency room to get Dilaudid (hydromorphone) hoping that her doctor, with whom she has a pain contract, won’t find out?
Requiring a new written prescription for hydrocodone every 30 days probably won’t change too much. Some doctors, to avoid the hassle, might refer a little sooner to pain programs (which will be good, if such a program is available) or to a surgeon (in general less good for chronic pain, but always available). Some doctors may refuse to start opioids (good for some patients and bad for others), but many doctors will probably just leave written prescriptions with their receptionists for their patients to pick up. In summary, the American problem with opioids and chronic pain will remain unchanged.