In an effort to curb what many consider the worst public health drug crisis in decades, the federal government Tuesday published the first national standards for prescription painkillers, ending months of arguments with pain doctors and drug industry groups and beginning what officials contended would be more judicious prescribing of the highly addictive medicines.
The guidelines, issued by the Centers for Disease Control and Prevention, are nonbinding, and they come after numerous professional medical societies as well as some states have issued restrictions of their own. But they are the broadest measure now in place addressing the medications known as opioids, and they are likely to have sweeping effects on the practice of medicine.
"This is the first time the federal government is communicating clearly to the medical community that the risks outweigh the potential benefits of these drugs," said Dr. Andrew Kolodny, head of Physicians for Responsible Opioid Prescribing, which supports the guidelines. "It's one of the most significant interventions by the federal government."
Dr. Thomas R. Frieden, director of the disease centers, said, "It's become increasingly clear that opioids carry substantial risk but only uncertain benefits — especially compared with other treatments for chronic pain."
The guidelines recommend what many addiction experts have long called for — that doctors first try ibuprofen and aspirin to treat pain, and that opioid treatment for short-term pain last for three days, and rarely longer than seven. Under current practice, patients are often given two weeks or a month worth of pills.
The guidelines are meant for primary care doctors, who prescribe about half of all opioids but often have little training in how to use them. They call for patients to be urine tested before getting prescriptions and for doctors to check prescription drug tracking systems to make sure patients are not secretly getting medicine somewhere else. Currently, 49 states have such systems, but only 16 require that doctors use them, according to experts at Brandeis University.
The guidelines do not apply to prescriptions for patients who are receiving cancer or end-of-life treatment.
In the works for nearly two years, the standards have been bitterly opposed by the drug industry and pain doctors, who argue that rules would pose unfair hurdles for patients who legitimately have long-term pain. Opponents argued that the guidelines had been developed behind closed doors — disease centers officials dispute this — and that some of the limits were arbitrary. They also criticized the guidelines as an incursion into the role of doctors.
"The numbers are still arbitrary," said Robert Twillman, executive director of the American Academy of Pain Management.
Frieden said the guidelines were meant to be "a tool for doctors and for patients to chart a safer course," describing them as a benchmark for medical practice, not an unbending dictate. The idea, he said, is to balance the risks of addiction with the needs of patients.
"For the vast majority of patients with chronic pain," Frieden said, "the known, serious and far too often fatal risks far outweigh the transient benefits. We lose sight of the fact that the prescription opioids are just as addictive as heroin. Prescribing opioids really is a momentous decision, and I think that has been lost."
The guidelines represent a major shift from the 1990s, when the prescribing of opioids took off after claims by pharmaceutical companies and medical experts that they could be used to treat back pain and arthritis without fear of addiction.
But overdoses and deaths began to mount, and significant numbers of patients started turning to heroin to satisfy cravings. Still, for years, doctors, regulators and pain treatment advocates were deadlocked over how to address the crisis, arguing over whether tighter prescribing rules would penalize patients who need the drugs.
Now that logjam appears to be breaking amid frustration over the soaring death toll and data showing the dangers of opioids, particularly when used at high dosages. In 2014, the death toll from overdoses involving prescription painkillers or heroin reached 28,647, a 14 percent increase from the previous year.
"The urgency of the epidemic, its devastating consequences, demands interventions that, in some instances, may make it harder for some patients to get their medication," said Dr. Nora Volkow, director of the National Institute of Drug Abuse. "We need to set up a system to make sure they are covered. But we cannot continue the prescription practice of opioids the way we have been. We just can't."