Washington’s New State Law for Prescribing Opioids
Washington State recently enacted a law that limits the daily amount of opioids a physician can give a chronic pain patient. The limit is 120 mgs of morphine or a comparable dose of a morphine-like drug per day. In order for a non-pain specialist to prescribe a higher dose, he/she must first get authorization to do so from a pain specialist.
Fortunately for my patients, I am a pain specialist and I don’t need to get authorization for doses above 120 mgs of MED (morphine equivalent dose) per day. The new law requires urine drug testing, screening for drug abuse risk, the use of informed consent and opioid agreements, and tells physicians when they must refer patients for specialty consultations. The new law emphasizes the use of functional assessment tools to measure the effectiveness of pain management plans. I am in the process of incorporating such a tool on this website. It will soon be part of the painclinics.com site. I have been practicing in compliance with these new rules for years since they have long been recommended for providing a safe and sound basis for a pain management practice.
The impetus for this extraordinary intervention in the practice of medicine by the legislature was an increase in the last ten years of accidental overdose deaths of chronic pain patients who took opioid medications for their chronic pain. Statistics presented in support of this law showed a correlation between the increased number of prescriptions of opioids written per year, and both the increased risk of death at higher doses and the increased number of accidental deaths attributed to the use of opioids. There was a significantly greater risk of overdose deaths among welfare patients. The reason for this disproportionate risk among welfare recipients was not explained.
The study had shortcomings in that it failed to conclusively show that opioids were the sole cause of accidental deaths, since most of those who died had other medications in their bodies at the time of death. These other medications included amphetamines, benzodiazepines (Valium, Xanax, Klonopin, Ativan), anti-psychotic and anti-depressant medications, alcohol, and others. Nor did the findings clearly implicate any specific opioid as being more dangerous than another. The new law presumes that all opioids are equally dangerous based on the MEDs alone as the predictor of lethal outcomes.
However, further inquiry has revealed that the use of methadone by physicians lacking the training in how to prescribe it safely may help to account for a portion of the increased incidence of accidental deaths among welfare patients. Methadone is very cheap and is one of the few long-acting opioid medications on the DSHS (welfare) drug formulary. Other medications like OxyContin are too expensive and their use is limited in DSHS patients.
The use of inaccurate drug conversion tables and administration schedules that ramp up the doses of methadone too rapidly probably contributed to these deaths. The same lethal outcomes occurred in Oregon years ago when their state welfare program made a similar transition to methadone from other long-acting opioids. Methadone can be administered safely if a physician is trained, as I am, in its proper use. Sadly, most medical schools and residency programs still provide inadequate training in chronic pain management despite the urgently growing demand for such training.
History of Opioid Prescribing Regulations in US
The history of the role of opioids in pain management is quite interesting. For decades in the 19th and early 20th centuries, there were no laws restricting the use of opioids or of other psychoactive substances. Morphine, heroin, and cocaine were used commonly for pain and were easily available in apothecaries and in the offices of physicians and dentists. Opioids were commonly prescribed to women for menstrual pain, which resulted in the claim that most “addicts” were women. In 1914, due to the increasing incidences of addiction and mortalities associated with opioid use, the Harrison Act made it illegal to acquire opioids without a physician’s prescription. It became illegal for physicians to treat opioid addiction unless they were first licensed by the federal government, since addiction was not considered to be a disease requiring medical care. The restrictions on the medical use of opioids coincided with the institution of Prohibition in 1920 against alcohol manufacture and sales. The simultaneous prohibition of alcohol sales and the significant restrictions on access to “narcotics” gave rise to organized crime’s ascendency in the black market sales of these substances to the public.
To gain compliance from the general population, the government and media spread inaccurate information about the pharmacological nature and behavioral effects of opioids. Opioids were purported to create sex-crazed Chinamen who tried to seduce white women. The use of opioids was alleged to be associated with wanton sex and violence in non-white users, which was stated with blatantly racist bombast. In addition, it was commonly stated that opioids always caused addiction in whoever used them. These scary warnings were commonly presented not only in newspapers, but also in schools, churches, and other civic groups.
State medical boards prohibited the use of opioids for chronic pain management as late as the 1980’s. In Washington State in the 1980’s, the first commandment of pain management was “thou shalt never use opioids to treat chronic pain”. Medical boards sanctioned doctors who gave as little as a single tablet per day of Vicodin (hydrocodone) for a patient with severe low back pain. Complicating this was the false belief that everyone who took opioids became addicted. This was the primary reason given for its prohibition for chronic pain management.
New Thoughts about Opioids
When I was in medical school, addiction was defined as the presence of physical dependence (as evidenced by tolerance, and withdrawal symptoms upon cessation of the drug) along with cravings, out-of-control and compulsive abuse despite obvious adverse consequences to self and to others. Subsequent research however made an important distinction between physical dependence and true addiction (cravings, out-of-control, compulsive abuse despite obvious adverse consequences to self and others). What had been called “addiction” was actually “physical dependence” in most instances. [See Definitions in the Patient Education section] Unfortunately, most lay people and many physicians today still don’t know about this important distinction and continue to use the term ”addiction” to mean physical dependence.
The percentage of those in the general population who have true addictions based on this revised definition is lower than previously thought…about 10-12%. Among those in the chronic pain community, the percentage is higher…estimated to be from 15 to 30% by some studies. This disproportionately higher percentage in the chronic pain population may be due to the greater exposure of chronic pain patients to opioids, thus uncovering a higher vulnerability to addiction in the general population than the first epidemiological studies had surmised. It may also mean that there are common genetic factors among chronic pain patients and those vulnerable to developing addictions. This correlation needs to be studied more.
From One Extreme to the Other
In the 1990’s, the pendulum swung to the other extreme when research by Russell Portnoy, MD at Sloan Kettering Cancer Center in New York City showed that cancer patients were able to tolerate very high doses of opioids without becoming addicted. New state guidelines for the use of opioids were written that encouraged the liberal use of opioids for chronic non-malignant pain patients even though Portnoy’s studies were limited to cancer patients only. Pain gained the status of becoming the “fifth vital sign” (the first four being weight, pulse, blood pressure, and temperature). Physicians and nurses were instructed to inquire about pain and to rate it on a “0 to 10” scale at each patient encounter. Medical practitioners became more aware of the need to address the problem of pain.
At about the same time, Purdue Pharmaceutical released OxyContin for use in the chronic pain population. Purdue unfortunately downplayed the risk of addiction among users, and engaged in an over-zealous marketing campaign. Purdue has since been fined for failing to adequately warn physicians and the public of the risks of OxyContin as a potentially abusable drug. During the 1990s, the treatment of chronic pain with opioids accelerated with improved pain management for many patients, but accompanied by increased occurrences of addiction and accidental overdose deaths.
At the same time, the abuse of OxyContin by growing numbers of young people along with the increasing abuse of other prescription opioids resulted in dramatic increases in addictions and overdose deaths. An underground market for opioids and other illicit drugs fueled a major increase in drug-related crime by gangs. Something had to be done to stop this alarming trend.
A Balanced Approach
As a result, it became clear that DEA and law enforcement concerns had to be integrated with legitimate chronic pain management concerns to create a “balanced” policy capable of addressing the needs of pain patients while acknowledging the dangers and risks to addiction-prone individuals of opioid use. The current law is an attempt to create such a “balanced” policy. I concur with most of the stipulations of the law that I described earlier.
The law, as it pertains to osteopathic physicians non-pain specialists, allows for a waiver of the 120 mgs MED limitation provided an osteopathic physician can document that he/she has received a threshold number of hours of chronic pain management training. To be considered as a pain specialist, DOs, like myself, need additional hours of training, years of pain management practice completed, a significant percentage of the practice devoted to pain management, and recognition of pain management proficiency by a national pain organization. I qualify as a pain specialist according to the new law’s requirements.
Pain management physicians are in an excellent position to diagnose patients with addictions since addiction risk assessment and urine drug screening are required as part of a “best practice” in pain management. Through the coordination of pain management with addiction management and law enforcement, patients will get the best care, and society will benefit by pain specialists’ ability to identify and treat chronic pain and addiction. Such coordination also will make it easier to identify those malingering “patients” who are posing as chronic pain patients in order to obtain opioids for sale. The State is also about to create an internet data base for physicians to access information about who is getting what opioids from which physicians. This will be a very valuable tool to help identify the “doctor shoppers” and to reduce the amount of prescription opioids they would sell on the streets.
Concerns About the Law’s Unintended Effects
It remains to be seen what the unintended consequences of the dosage limit of this law will be. My concern is that many primary care physicians will stop treating chronic pain patients for fear of getting into trouble with medical boards and/or law enforcement. This is already happening at Swedish Hospitals where they refuse to provide opioids in the ERs unless there is obvious trauma. Many community health centers are refusing to see new chronic pain patients who are already on opioids. I am already receiving reports from new patients that their physicians, who had previously treated their pain with opioids, have now decided to stop the use of opioids altogether. Some patients have been cut off of opioids without a tapering schedule putting them into withdrawal, and have been told not to return for more opioids. The Seattle Times just published an article (August 24, 2011) addressing this rapidly growing problem of increasingly limited access to pain management, generated by physicians’ fearful reactions to the new law’s implementation.
Another adverse consequence is that, given the diminishing numbers of physicians willing or able to prescribe opioids for chronic pain, it will take months and possibly years for some patients to get the pain management consultations that the State requires. What will these pain patients do in the meantime? Some patients will turn to over-the-counter medications like ibuprofen (Advil, Motrin) and acetamenophen (Tylenol). These carry the dangers of causing gastrointestinal bleeding and kidney failure in the case of ibuprofen, and liver failure in the case of acetamenophen. Each year, about 16,000 Americans die of GI bleeding alone due to overdosing on ibuprofen, naproxen (Aleve), and other anti-inflammatory medications. This number will probably increase. Liver transplantations are likely to increase to save those whose livers have been destroyed by the continued toxicity from too much acetamenophen use.
Another fear is that some will go to the streets to obtain opioids. This will expose them to other illicit drugs, such as heroin, methamphetamine, marijuana, as well as to prescription medications that will be taken without physician supervision. Some will turn to alcohol, tobacco, and to whatever new gimmicks and supplements are being touted on TV or on the internet for controlling pain.
How many of these patients will die of accidental drug overdoses, or acquire Hepatitis B or C, or HIV from dirty needles if they try heroin? How many patients will commit suicide because they feel the despair of untreated chronic pain, with feelings of abandonment by the medical establishment, and the loss of function that attends untreated pain. Many will suffer unnecessarily from undertreated pain. Ironically, the State’s attempt to gain control over how much medication patients can take for pain, may result in physicians losing control over what their patients do to get their pain under control.
A Work in Progress
As far as I know, no one is studying the potentially adverse outcomes of Washington’s new opioid law that was pushed through the legislature without the pain management community being adequately consulted. In order to fairly assess the consequences of this law on public health, all these outcomes must be monitored over the next few years to determine whether it was a wise choice to make.
I suspect there will be a mix of good and bad outcomes. There probably will be fewer accidental overdose deaths from opioids prescribed by physicians as the number of such written prescriptions plummets. On the other hand, there probably will be a sharp rise in heroin and illicitly obtained opioid addictions and accidental overdose deaths in those who can’t get adequate pain management through legitimate means. The black market sales of opioids may soar along with more gang violence and drug related crime.
The development of competent and safe chronic pain management is a very important new area of medicine, especially as Baby Boomers age and demand safe and effective means of pain control. Ours is a “work in progress” as more scientific and level headed thinking is needed to formulate and fine tune balanced policies that will seriously address the growing chronic pain problem, while minimizing the potential adverse outcomes of controversial policy decisions. This will require the coordinated efforts of pain management experts, law enforcement, government officials and agencies, and policy makers. This is a task that must be done to safeguard members of society and treat those who suffer. More to come…