HONOLULU, HI—Legislation recently enacted in the State of Washington to moderate opioid dosing in light of a 240% increase in deaths between 2001 and 2009 is placing physicians in the position of negotiating with patients with chronic noncancer pain to taper doses, a panel of physicians noted during the American Pain Society’s 31st Annual Scientific Meeting.

The Washington State Opioid Treatment Regulations Rule 2876, which went into effect January 1, 2012, includes both a dosing guidance of 120mg/day as a consultation flag and the language, “shall obtain, evaluate and document in the health record prior to treating for chronic noncancer pain…” which some physicians have interpreted to mean patients on high doses of opioids should be tapered, said Jane C. Ballantyne, MD, FRCA, of the University of Washington, Seattle.

Dr. Ballantyne said the impetus for the rule was not just abuse and diversion; rather, that high death rates were found in high dose users associated with polypharmacy—particularly benzodiazepines—obesity and sleep apnea; and methadone.

Further, the rule was a response to rising deaths from prescription opioid overdose, physician opinion, and evidence that a daily 120 morphine equivalent dose (MED) was an inflexion point where death rates increased exponentially. In fact, one study found annual overdose rates by prescribed dose to be 1.8% for ≥100mg MED/day, a ninefold increased over the 0.2% rate for 1-20 MED/day. In Washington State, 63% of those who died were patients on Medicaid.

The Rule has not been without criticism from the pain field, including that the dose limit is arbitrary, with no basis in evidence or experience, and that patients will be denied opioids. Furthermore, the Rule has “damaged everything that has been gained in terms of fighting to make sure people suffering with pain have access to the medications they need,” she said.

James P. Robinson, MD, PhD, said the Rule places physicians squarely in the position of “power,” while patient responses may include a sense of threat, anger, ambivalence, humiliation, and the need to present with communications designed to persuade clinicians to continued prescribe opioids. He noted that negotiation is irrelevant if physicians either “do whatever the patient says to do” or they “just say no” and relevant if they are uncomfortable with infinite dosing and want to maintain rapport with patients and work collaboratively, if possible. Physicians also need to recognize both fear of uncontrolled pain and fear of withdrawal among patients and to expect challenges, including guilt provocation, anger, attacks, and threats, both explicit to the physician and to the patient; eg, a threat of suicide. Dr. Robinson emphasized that research is needed on both patient perception of opioids and whether bargaining/behavioral strategies work.

Early experience has found that supported and motivated patients can be weaned or tapered successfully, and do well; however, for others, a taper is difficult, “and we may have to consider that for some patients, tapering is not the best strategy,” Dr. Ballantyne said.

Teething problems identified to date with implementation of the Rule include that prescribers are refusing to prescribe (which predates the Rule); patients are being tapered even when they do no meet the Rule’s criteria; patients are being abandoned; there is no consensus on who should be tapered and who should be maintained; and a serious lack of appropriate treatment for those who are clearly dependent.

A clinical picture of someone stabilized on continuous opioid pain therapy includes high doses (>120 MED), reported good analgesia, good function, and satisfaction with treatment; however, their pain score remains high and no dose is enough. Suzanne E. Rapp, MD, pointed out that for patients on high doses (eg, >1,000 MED), it is more realistic to wean slowly, then plateau, as dose increases likely occurred over years.

A clinical picture of someone trying to taper reports worse pain, worse function, experiences dysphoria/anhedonia, is tearful and desperate to go back up on dose, is dissatisfied with treatment, cannot understand why opioids are being withdrawn, and are not concerned about safety; in fact, “they would rather die,” said Dr. Ballantyne.

The clinical picture of someone who successfully tapers off opioid pain treatment is that the pain is usually no worse, usually no better, occasionally worse, and occasionally better; function is usually better, and the patient feels “more like myself,” and “the fog lifted.” In addition, the family consistently reports they prefer the person off opioids, stating, “you’ve given me my wife/husband/daughter/son back,” she added.

“The fact that people who successfully taper off opioid pain treatment usually feel better without any diminution in pain relief suggests that the worsening pain and function seen during a taper have more to do with dependence and withdrawal than with needing high doses for pain relief,” Dr. Ballantyne said. “The difficulty we have achieving a taper in all but the most motivated and supported patients suggests that opioid dependence, whether or not this escalates into addiction, make a taper hard to achieve in all but the most motivated patients.”

David J. Clark, MD, PhD, said “hints” at the laboratory level suggest several factors bear on opioid dependence, including genetics, epigenetics, age, sex, and stress.