It seems that no amount of data-driven information can get policymakers to reconsider the hysteria-driven pain prescription policies they continue to put in place.
I can understand lay politicians and members of the press misconstruing addiction and dependency, but there is no excuse when doctors make that error. Yet National Public Radio reports that surgeons in 18 Upstate New York hospitals have agreed on an initiative to limit the amount of pain medicine they will prescribe to postoperative patients discharged from the hospital. The reporter says that researchers “now know” that patients prescribed opioids for postoperative pain “can become addicted” and that “the new prescription guidelines can prevent this particular gateway to abuse.”
But what does the research show? One recent study published in the BMJ of more than 568,000 “opioid naïve” postsurgical patients followed for 8 years found a total “misuse” rate of 0.6 percent. (“Misuse” includes a range of non-prescribed drug use, from self-medicating with leftover pills to treat an ankle sprain on one extreme to addiction on the other.) Broken down further, the researchers found the misuse rate was 0.15 percent in patients given just one prescription postoperatively and was 0.29 percent in patients who got a second prescription as a refill.
Multiple highly-respected Cochrane systematic analyses, the most rigorous reviews in the medical science literature, found the addiction rate in chronic noncancer pain patients on long-term opioid therapy to be around 1 percent.
Addiction and dependency/tolerance are two separate entities, but policymakers and many in the media equate the two. But the doctors in Upstate New York should know better. Physical dependence refers to the physiological adaptation to the drug such that abrupt cessation or tapering off too rapidly can precipitate a withdrawal syndrome, which in some cases can be life-threatening. Tolerance is an aspect of physiological adaptation, in which increasing dose of a medication become necessary to achieve the desired effect. Once a patient is properly tapered off of the drug on which they have become physically dependent, they do not feel a craving or compulsion to return to the drug. Dependence and tolerance are seen with numerous types of drugs, from anti-depressants and anti-epileptics to beta-blockers (used to treat hypertension and other cardiovascular conditions).
Addiction, on the other hand, is defined by the American Society of Addiction Medicine as a “chronic disease of brain reward, motivation, memory and related circuitry…characterized by the inability to consistently abstain, impairment in behavioral control, craving” that continues despite resulting destruction of relationships, economic conditions, and health. Addiction has a biopsychosocial basis with a genetic predisposition and involves neurotransmitters and interactions within reward centers of the brain. Some experts believe addiction is a learning disorder in which behavioral patterns are automatized as mechanisms for coping with stress or trauma. A major feature of addiction is compulsiveness. This compulsiveness is why alcoholics or other drug addicts will return to their substance of abuse even after they have been “detoxed” and despite the fact that they know it will further damage their lives.
Writing in the New England Journal of Medicine in 2016, Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse explained, “Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities.”
In 2016 the Centers for Disease Control and Prevention published guidelines regarding opioid prescribing for pain. Many scholars and clinicians specializing in pain management and addiction treatment criticized the guide as lacking a basis in evidence. Despite the fact that the CDC stated its guidelines were meant to be “voluntary rather than prescriptive standards, “ and that much of the guidelines were based on “Type 4 evidence” (defined as “based upon clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations”), policymakers on the federal and state level have been quick to adopt many of these guidelines as statutory limitations on opioid prescribing. The guidelines recognized that “clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.” But one-size-fits all limitations on prescription dosages and amounts implemented by policymakers are incompatible with that statement.
An outcry from chronic pain patients experiencing the rapid tapering or termination of their chronic opioid treatment that followed in the wake of statutory enactments of the CDC guidelines led former Food and Drug Administration Commissioner Scott Gottlieb to order a meeting on “Patient-Focused Drug Development for Chronic Pain” on July 9, 2018, stating in the meeting announcement: “In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriated needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. We will take the first steps toward developing this framework in the coming months, with the goal of providing standards that could inform the development of evidence based guidelines (emphasis added).” Thus, the Commissioner implied his sympathy with criticisms raised by academic and clinical physicians and their patients regarding the misinterpretation and misapplication of guidelines that lacked a solid basis on the evidence.
Complaints by academicians, clinicians, and the American Medical Association(Resolution 235) finally caused the CDC to issue a clarification in April 2019, noting, “Some policies, practices attributed to the Guideline are inconsistent with its recommendations.” Among the misapplications of the guidelines it noted were those that result in “hard limits or ‘cutting off’ opioids,” stating the “Guideline does not support abrupt tapering or sudden discontinuation of opioids.”
Yet the statutory and regulatory restrictions remain unchanged. To date 18 states have laws limiting the amount of opioids that can be prescribed for acute and chronic pain. Many have limits on the morphine milligram equivalent daily dose (MEDD) that may be prescribed, despite evidence in the peer-review science literature that MEDD is an inaccurate and inappropriate metric. And it appears that even many actively practicing physicians, such as the surgeons in the 18 upstate New York hospitals, ignore the science as well as pleas from patients.
So the march continues, undeterred by the facts, toward a pre-modern approach to the understanding and treatment of pain, and a pre-modern understanding of the risks and benefits of opioids, and the subtleties that differentiate dependency from addiction.