Patients Suffered First 100 Days After Hydrocodone Rescheduling
Ignoring the Law of Unintended Consequences—which dictates that undesired outcomes result from a well-meant action—appears to be human nature. In trying to do good, people create more problems, in part because they fail to consider all the moving parts in a complex world. Simple human stupidity is another reason, but much can be explained by self-deception. We want things to be all right, so we convince ourselves they are or will be.
The first 100 days following the Drug Enforcement Administration’s (DEA) decision to move hydrocodone from Schedule III to Schedule II (Fed Regist Volume 79, Number 163; 21 CFR Part 1308) is a lesson in unintended consequences. The actions taken by the DEA to more strictly regulate hydrocodone were aimed at reducing abuse, addiction and overdose deaths associated with prescription opioids. It is certain the agency did not intend to harm legitimate pain patients. Yet, the results of an online survey showed that patients on stable doses of hydrocodone-combination products had trouble getting prescriptions filled; were moved to less effective medications; and were subjected to higher costs, longer travel times and inconveniences that interrupted their medical care. These results were presented at the 2015 annual meeting of the American Academy of Pain Medicine (AAPM; poster LB002).
In the survey, spearheaded by the National Fibromyalgia & Chronic Pain Association, most of the more than 3,000 respondents reported multiple pain diagnoses; the most common complaints were fibromyalgia (91%), low back pain (62%) and neck pain (44%). About two-thirds of the participants reported being unable to access hydrocodone-combination prescriptions. More than 15% reported negative effects on doctor–patient relationships, some of them longstanding. It is not a pretty picture but one that, perhaps, could have been anticipated.
The AAPM did not take a position on rescheduling, but did enter a plea for the appropriate bodies to assess the possible impact of rescheduling on patients with chronic pain who have been prescribed hydrocodone-combination products for legitimate medical indications. The DEA’s rationale has been that the volume of hydrocodone prescriptions, with 130 million prescriptions written per year, has fed the prescription drug abuse problem. Unfortunately, the potential consequences to people in pain do not appear to have been sufficiently weighed. This change occurred despite evidence that hydrocodone, as a short-acting opioid, is less likely to be abused than a long-acting opioid (Butler et al. Harm Reduction J 2011;8:29).
Central to the public health problem associated with opioids is the way in which the problem of opioid addiction has been addressed in the United States. Since the 1914 Harrison Act was passed to tax opioids with the aim of discouraging their use, law enforcement has tried to address societal opioid abuse by criminalizing the disease of addiction and stigmatizing those who are trying to help people with their addictions. In 1914, knowledge about addiction was limited, and it was thought to be volitional and thus properly met with regulation and incarceration, not medical treatment. Because people with these afflictions were often thought to be weak, society allowed and even encouraged the criminalization of a medical disease rather than support a scientific and informed perspective.
Obviously, the problems of drug abuse and addiction were not solved by this approach. Although as much as 10% of the U.S. population was reported to have been addicted to opioids at the beginning of the 20th century, it wasn’t until the Harrison Act was passed that drug dealing appeared in the streets (Rhodin. J Pain Palliat Care Pharmacother 2006;20:31-32). This was certainly an unintended consequence, brought about by self-deception on a societal level. Yet, our society has been influenced by this early assessment that drug addiction was criminal and should be treated as such.
Consider that medical decisions today regarding addiction treatment are often made by nonmedical personnel. The use of buprenorphine for the treatment of opioid addiction is governed by the federal Drug Addiction Treatment Act of 2000, commonly referred to as DATA 2000. Physicians who wish to treat opioid addiction (but not pain) with buprenorphine in their medical offices must meet the requirements of DATA 2000 and get a waiver from the Substance Abuse and Mental Health Services Administration. But despite the overwhelming societal need for treatment, the number of addicted patients that a physician can treat is capped at 30 through the first year of certification and can be increased only to 100 thereafter. This nonmedical evaluation of a medical problem severely cripples the nation’s ability to fight addiction.
This mindset continues with the DEA’s action to crack down on the overall supply of hydrocodone rather than to treat addiction with compassion and care. Recently, I was asked to review a charge of inappropriate prescribing by a physician. The doctor was told by a nonmedical investigator to stop prescribing opioids to a particular patient because the person was abusing the drugs. In the viewpoint of the physician, that action would be throwing a patient to the street, forcing a patient to suffer more pain and possibly be moved to buying illegal drugs, including heroin. Heroin use stemming from policies to stop prescription drug abuse is truly an unintended consequence.
The AAPM and others, while acknowledging the major public health problem with opioids, were concerned that the consequences of rescheduling hydrocodone could adversely affect many people in pain. The data from this early report appear to support that concern.
We have two major public health problems: pain and substance abuse. They require informed and thoughtful approaches, but clearly are not going to be solved only through regulation. One approach that everyone should support is the search for safer and more effective therapies than opioids for pain. If the data from the first 100 days are not ignored but used to fuel better ways to solve these dual public health crises, that would be a very good consequence.