In her SpineLine commentary of May/June 2015, NASS President, Dr. Heidi Prather, addressed the difficult issue of opioid use in spine care. After an elegant, succinct summary of the problem and its many dimensions, Dr. Prather emphasized the consequences and sequelae of untreated pain, and asked a very thorny question. While recognizing the epidemic of opioid use, which, in my opinion has been incorrectly equated with opioid abuse, she wrote, “What do we have to offer these patients? If we withhold opioids, we do not have many alternatives. We would not think of withholding a treatment for hypertension or diabetes.”
The crisis in opioid misuse is obviously a tremendous health care concern on many levels. Aside from issues of basic patient welfare, the rise in morbidity and mortality from opioids raises multiple ethical and social issues. The primary concern of the provider is to diagnose and treat patients, a concern embedded in responsibility. Not only is the physician obligated to practice and prescribe based on reputable efficacy data, but also to First, do no harm (Primum non nocere). We all took an oath to do this. How can pain be treated without harm?
If the data on opioid deaths due to overdose are any indication, this duty may be impossibly hard to do, as both physicians and the general public get bombarded with alarming statistics. The annual rate of drug overdose deaths (all causes, not just opioids) in the United States is approaching the total number of deaths from the Vietnam War (the entire war), 58,220. In 2015, deaths attributed to opioid overuse accounted for 38% of all lethal drug overdoses (20,101 of 52,404). In contrast, deaths attributed to heroin abuse accounted for 24% of all deaths.
In Pennsylvania, the Physician General convened the Philadelphia Opioid Task Force which met periodically between January and March 2017. Opioid overdose death rates were found to have been higher in 2016 than in 2015 with white males, ages 45-54 being the highest-risk demographic subgroup. The Task Force also released data on emergency department visits, noting a greater than 50% increase in opioid related complaints since 2007. The Task Force subsequently issued 18 recommendations in four areas: Prevention and Education, Treatment, Overdose Prevention and Involvement of the Criminal Justice System.4 I found two of the recommendations to be of particular interest.
In the Prevention and Education section, recommendation 3 is “Destigmatize addiction and its treatment.” I agree. I would also, however, expand the recommendation to include not only addiction—the overuse of opioids for a purpose distinct from that for which they were initially prescribed—but also habituation, a physiologic phenomenon, and dependence. Perhaps this is semantics, but I feel rather strongly that there are certain patients with chronic benign pain for whom the optimum long-term management strategy may involve chronic opioids. As anyone who has been involved with the management of chronic pain knows, this is not a static situation and the fact that periodic dosage adjustment for increased activity and a resultant increase in pain, or simple habituation may be required. Scenarios such as these should not be misconstrued.
Recommendation 5 is also of interest: “Establish insurance policies that support safer opioid prescribing.” While the educational spirit of this is commendable, the practical consequences are worrisome. In Pennsylvania, a statewide database must be queried prior to any opioid prescription. Opioid prescribing history and providers are available. This is extremely valuable in direct patient education and management. Also in Pennsylvania, several third-party payers are routinely limiting the size of an opioid prescription (fine) as well as the frequency (problematic). In essence, this latter development is taking the strategic aspect of management out of the hands of the physician and has, anecdotally, resulted in some well-publicized incidents of nonprescription drug use with fatal consequences. This is distressing in the extreme. I would submit that such constraints, while not necessarily causing disastrous outcomes, are nonetheless contributory. I am certainly not advocating carte blanche prescribing behavior but, as Dr. Prather1 has reminded us, pain has a profound emotional component and, citing the work of Schofferman et al,5 severe and untreated (to which I would add undertreated) pain can “cause psychological disorders and even suicide.”
Professional medical associations have weighed in as well. Arguably the most visible of these is the American Medical Association Task Force to Reduce Opioid Abuse. This Task Force currently has 27 member societies. One, the American Association of Orthopaedic Surgeons (AAOS), published a comprehensive statement produced by the AAOS Patient Safety Committee outlining 11 areas of attention required as Strategies for Success. When discussing opioid culture change, the committee notes that “Patients with similar injuries and surgeries experience varying amounts of pain…Peace of mind is the strongest pain reliever.”6 While the intuitive logic of this view is unassailable, I would submit that peace of mind is more readily achievable in the setting of reasonable pain control.
At the highest regulatory level, the US Food and Drug Administration (FDA) is “strongly committed” to take action to address the opioid crisis.7 Recognizing that opioids have “significant benefits when used as prescribed,” the FDA has committed to approach the crisis from a benefit-risk perspective. This approach, which has long been the modus operandi of the FDA, is well illustrated in reviewing the process by which the agency requested that a particular oxymorphone, Opana ER (Endo Pharmaceuticals), be removed from the market. After a comprehensive review of post marketing data, an FDA advisory committee determined that Opana ER was associated with a shift in the route of abuse from nasal snorting to injection, compounding the problems of addiction with increases in the incidence of HIV and hepatitis C.
The overall assessment of the drug efficacy did not, in the view of the agency, sufficiently offset the negatives from either a qualitative or quantitative point of view. In this instance, the recommendation to call for a withdrawal of the drug from the market was extremely reasonable. While this may be viewed as the removal of a potentially valuable drug from the list of treatment options, in this case, a comprehensive review of data not readily available to the individual prescriber more than justifies the seeming loss.*This is an excerpt from the September/October 2017 issue of SpineLine. To read the full column, click here.