Legacy Patients From High-Dose Opioid Era
Modern pain management began to accelerate in the mid 1990’s when the fentanyl patch and extended-release oxycodone were developed and made commercially available. Many chronic pain patients who had been confined to home and bed for years were finally able to get some help. They were no longer the neighborhood “shut-in.” The excitement continued to build. Charismatic leaders advocated opioids as a “new way.” Pain was called the 5th vital sign and Congress declared the “Decade of Pain” in 2001.
There was one major problem. The long-running standard of opioid prescribing, the World Health Organization (WHO) Three-Step Analgesic Ladder of 1982 was all but forgotten.1 Only now is the wisdom of this ladder starting to re-emerge, be appreciated, and implemented.
The ladder is simple. Step 1: Use of non-pharmacologic measures and non-opioid pharmaceuticals. Only when these measures fail to control pain is a weak opioid (ie, tramadol, buprenorphine, and acetaminophen-opioid compounds) to be added (not substituted) to these therapies (Step 2). A potent opioid, including the long-acting preparations, are added (not substituted) when the non-opioid therapies and weak opioids fail to control pain (Step 3).
An unstated factor in the use of the WHO analgesic ladder is that progress through the first 2 steps to reach Step 3 requires at least several weeks and multiple clinical evaluations. Unfortunately, we may now have as many as 1 to 2 million persons in the country who are at Step 3 of the ladder, but were never given the trials of Steps 1 and 2.
The order of the day seems to be to find someone to blame. My answer is “get over it.” The situation we now confront has occurred due to multiple factors including encouragement to treat pain by our governments, private companies, and professional organizations. Most of all, the suffering “shut-ins” and their families desired pain treatment and have been grateful for the humanitarian help that opioids may bring.
Today, a major problem that is being swept under the carpet is the patient who has been on high-dose opioids for many years, greater than 20 years in some cases, and wants to remain on them. These patients were started on opioids in good faith and in step with FDA product labeling, state laws, and professional guidelines. In contrast to those who take opioids other than prescribed or for abuse purposes, these patients have improved their physiologic functions, carry on activities of daily living, and lead productive, decent lives. They show no toxic complications or physiologic impairments. No wonder they desire to continue their high-dose opioid regimen, which in many cases has been life-saving.
To make this point and help bring the issue into the light, my clinical associates and I just presented a poster at PAINWeek and the American Academy of Pain Management (AAPM) meetings entitled, “High Function and High Serum Levels in Ultra-High Dose Oxycodone Patients.”2,3 We described 17 patients who were referred to us taking daily oxycodone doses ranging from 875 to 3500 mg. All these patients function well. Over half hold a job and drive a car. Work ups for toxic complications have not shown anything significant. There is no hyperalgesia, respiratory impairment, or cardiac arrhythmias. By observing them, they look perfectly normal and happy. Thirteen patients (76.4%) have 1 cytochrome P (CYP) 450 defect and 6 (35.3%) have 2 CYP 450 defects. These patients and their families do not want to change regimens.
During the poster presentations at the meetings, essentially all the practicing physicians who stopped to visit had similar patients. Many had come to the same conclusion as me—there is no medical, objective reason to require these patients who began high-dose opioids years ago to now alter their regimen.
The rub of course is that insurance payors may not wish to pay for high opioid dosages and suppliers may not wish to see large stocks of opioids in a single pharmacy. For a multiplicity of reasons, some legitimate and others not so, some states and now the Centers for Disease Control and Prevention (CDC) want to restrict opioid dosages somewhere between 80 to 120 mg of morphine equivalents a day (MEQ).4 The CDC draft guidelines is aimed at primary care physicians (PCPs) who are treating chronic pain patients in an outpatient setting.The guidelines state that PCPs should start low and go slow and “should avoid increasing opioid doses over a certain level—90 milligrams MEQ.”4 Note, the draft is written for PCPs, and not pain specialists, but may be viewed as endorsing this practice for all patients, even those with chronic pain. The authors of the guidelines agreed that in general, “increasing dosages to 50 or more MEQ increases overdose risk without necessarily adding benefits for pain control or function.”
“If patients do not experience improvement in pain and function at ≥90 MEQ, or if there are escalating dosage requirements, providers should discuss other approaches to pain management with the patient and should consider working with patients to taper and discontinue opioids,” noted the CDC draft.3
The hostility of patients and their families that is being generated by the dosage restrictions is neither necessary nor appropriate. Frankly, it appears to me that most of the government agencies including the CDC are not being forthright about two issues. First, should not the legacy patients on high opioid dosages get a chance to testify and be heard? Most of the hostility that is related to me by patients and families is that the CDC and other agencies won’t consider listening to or appreciating the patients on high opioid doses. What happened to America as a Democracy? The second issue is which doctors should provide high-dose opioids to the few patients who have clearly benefited from these doses and who need them? We issue all kinds of special permits to doctors. Why not a certificate for the physicians who will take on these cases?
All said, isn’t it time that all stakeholders get an opportunity for input and compromise? What do they want to do about the high-dose opioid legacy patients who have functioned well for years? Going forward, most opioid guidelines seem appropriate as we now have a multitude of non-opioid measures and pharmaceuticals, so high opioid dosages are seldom required.
The last issue is simply denial. Some chronic pain patients will always need a high opioid dose just like a few diabetics need a lot of insulin. After all, some patients have genetic defects that interfere with opioid metabolism and others simply have severe pain and require a high opioid dose.
Practical Pain Management strives to keep clinicians informed about new developments in pain management. In that vein, this issue of PPM contains a number of articles that highlights the advances being made in electromedicine.