Thursday, September 1, 2011

Rules Hurt Patients with Pain in Washington State

Legal Side of Pain Practice Imagine having such tight regulations on prescribing a class of medications, such as anti-hypertensives, that practitioners stop using them altogether for patients with high blood pressure. In effect, something similar may be happening with opioid analgesics in Washington state where aggressive new pain-management laws, meant to curb opioid overdose deaths, have some prescribers shunning these medications and leaving patients without adequate pain relief. Could this portend what might lie ahead elsewhere?

Writing in the Seattle Times [August 27, 2011], reporter Carol M. Ostrom examines early reactions to new regulations going into effect January 1, 2012 in Washington state that will restrain the prescribing of opioid analgesics. Overall, these rules, previously discussed in an UPDATE [here], require detailed evaluations and documentation for each patient with chronic pain; including a treatment plan, consent agreement, and drug testing. Prescribers also are mandated to complete special education on opioid prescribing, and to consult with a pain management specialist if a patient needs more than 120 mg/day of morphine or its equivalent, or if the patient has suspected risks of substance misuse or psychiatric complications.

Ostrom reports that the stern new regulations mark the end of a period of relatively liberal prescribing of opioids that began in the late 1980s. Before then, studies showed that pain was being seriously undertreated, even in dying patients with cancer. However, as opioid prescribing increased, so did the deaths — to allegedly alarming levels in Washington state.

In mandating the new rules, legislators were moved by ominous testimony from Alex Cahana, MD, head of the University of Washington's Division of Pain Medicine, and others, that portrayed a grim picture of patients addicted to opioids or dying from lax opioid prescribing, according to the news article. As a strong advocate of the regulations, Cahana, thinks practitioners have over-prescribed analgesics because they have little training in other modes of pain relief. “Since when does good pain management equal opioids? Since when has the whole practice been reduced to just prescribing a pill?" says Cahana in the article.

Now, well in advance of the regulations taking effect, a number of physicians and clinics have entirely stopped accepting new patients with chronic pain who are taking opioid pain relievers. In other cases, the supply of opioid analgesics is being discontinued for current patients, according Ostrom in the Seattle Times article. She asks, “Are doctors simply using the new law as an excuse to dump pain patients, who can be needy and demanding — and, in some cases, addicted?” Furthermore, “Will the new rules cut down on overdose deaths — or just make life unbearable for the many patients who are legitimately hurting?”

In one area of the state, a University of Washington neighborhood clinic stopped accepting new patients with chronic pain after there was an upsurge of patients coming in and saying their physicians had cut them off from opioid pain relievers. “A lot of it is because other providers have stopped [prescribing],” states Peter McGough, MD, chief medical officer for UW Medicine's Neighborhood Clinics quoted in the article. “I think there's been a fair amount of patient abandonment going on. … a lot of physicians are saying it's more trouble than it's worth, so I'm just going to send my patients away.”

Indeed, entire hospital systems, emergency departments, and clinics have reportedly adopted anti-opioid policies. Such a swift and sweeping prohibition surprised even critics of the new rules, who predicted there would be some negative fallout for patients but did not anticipate this sort of extreme reaction. In what might typify many concerns, a physician wrote the following in an online comment to the newspaper article:

“Our clinic reviewed the new rules and found them unworkable. They are so detailed and specific that following them 100% of the time would be impossible. This sets up a perfect legal case against any doctor whose patient should happen to accidentally overdose and die. It wouldn't be hard for a sharp lawyer to find some small part of the regulation that wasn't perfectly followed. I can't think of any other area of medicine that is so neatly handed over to a plaintiffs lawyer without having to lift a finger.”

According to Ostrom, “two large statewide physician groups have asked the state's medical-licensing board to amend the rules, saying they are so detailed that doctors could face discipline or legal liability if they don't dot every ‘i’ and cross every ‘t.’ The result, warned the Washington State Medical Association and the Washington Academy of Family Physicians, likely will be that many doctors simply refuse to see pain patients.” However, the medical-licensing board has declined to act.

Ostrom further observes that some statistics suggest a more targeted approach might be more fruitful. For example, “In King County, UW researcher Caleb Banta-Green has shown that the vast majority of prescription-overdose deaths aren't from single prescriptions but narcotics combined with other drugs or alcohol.” And, “Across the state, more than half of those who died were patients on Medicaid, according to state figures, and the most common pain drug was methadone, increasingly prescribed for Medicaid patients after the state restricted other medications.”

COMMENTARY: Many unresolved questions have been raised about these new regulations even before they have gone into effect. Will legitimate patients with chronic pain be held hostage due to a relatively tiny minority of individuals who misuse opioid medications? Will the regulations ultimately benefit patients, or will the Washington state model turn out to be another human experiment with unanticipated consequences of exacerbating, rather than resolving, public health problems?

In a video presentation [here (after the commercial message)] accompanying the news article, Cahana makes a case for approaching pain as a disease affecting the whole person, rather than merely as a symptom that needs amelioration via strong analgesics. Conceptually, he asserts that pain should be considered a verb rather than a noun; that is, a person does not “have pain” but, instead, “pains” or “is paining.” Traditionally, pain has been viewed as a symptom apart from the person rather than as being integral to who the person has become as a result of the disease of pain. “Treating pain as a symptom makes matters worse,” he states.

In this theoretical and somewhat academic perspective, Cahana suggests that opioid analgesics play only a relatively small role, if any, in helping patients to manage their chronic pain. While this argument may have some validity — ie, long-term opioids may not be the best or only solution for every type of chronic pain — the better solution Cahana seems to favor entails a multidisciplinary and multimodal approach to pain management, which would be excellent but is beyond the reach, in terms of cost and accessibility, of most patients in the state of Washington (or any other state).

Meanwhile, according to the Seattle Times article, even healthcare providers who are optimistic that the new rules will ultimately prove helpful worry that some patients may try risky alternatives in lieu of prescription opioids. For example, taking dangerous levels of acetaminophen or NSAIDs, or buying opioids on the street. As we reported last spring [UPDATE here], there already were reports in Washington state of a resurgence in heroin, along with inevitable overdoses and fatalities. Most of the problems stemmed from persons switching from prescribed opioid analgesics and misjudging the potency of illicit heroin. In her article, Ostrom quotes Kimber Rotchford, MD, a pain and addiction specialist, as bluntly saying: “The new law promotes the illicit traffic of opioids while doing nothing to increase access to mental-health help or alternative pain-relief treatments.”

Finally, the new regulations seem intended to strongly limit the supply of opioids without attacking the core problems at their source: ie, persons who accidentally or intentionally misuse the drugs and overdose. Nowhere in the regulations or in any discussions surrounding the issues has there been mention of take-home naloxone for averting fatal overdoses, along with necessary education of patients, their families, and others. We have previously noted the potential of this approach [here] and the success of community-based programs like Project Lazarus [UPDATE here] in addressing the problems without limiting access to vital pain medications for patients in need.

Note to readers (9/6/11) – please be sure to see the comment below from Dr. Bob Twillman that discusses certain clarifications of and concerns with the Washington State rules. – SBL