U.S. senators are taking another crack at tackling the national opioid epidemic with a bill that would establish a dramatic new limit on initial opioid prescriptions for acute pain.
That proposed limit — a three-day supply — is drawing strong skepticism from pain management physicians.
The legislation is an encore initiative for U.S. Sens. Sheldon Whitehouse (D-R.I.) and Rob Portman (R-Ohio), who in 2016 sponsored the Comprehensive Addiction and Recovery Act (CARA). That measure supported expanded access to the opioid antagonist naloxone, as well as expanded access to diversion programs and medication-assisted treatment such as methadone. Then-President Barack Obama signed the measure that summer.
The pair are teaming up again on Senate Bill 2456, also known as CARA 2.0, introduced in the Senate in February. The bill would authorize $1 billion in “dedicated resources to evidence-based prevention, enforcement, treatment, and recovery programs,” according to a release from Senator Portman’s office, which also called the measure “part of the necessary response to the urgent call for adequate and sustained resources that appropriately reflect the magnitude of the crisis.”
The proposed three-day limit on opioid prescriptions for acute pain would be one of the more impactful provisions for pain doctors and their patients. Exceptions would include prescriptions for chronic pain, cancer care, hospice or end-of-life care, and pain treatment that’s part of palliative care.
The sponsoring senators cite Centers for Disease Control and Prevention (CDC) guidelines to bolster their case. CDC guidelines for prescribing opioids for acute pain recommend “no greater quantity than needed for the expected duration of pain severe enough to require opioids,” according to an agency fact sheet, available at tma.tips/cdcpainguidelines. “Three days or less will often be sufficient; more than seven days will rarely be needed,” CDC says.
Ignoring the clinical picture
Three days is an arbitrary duration that would be totally inadequate for any major operation that causes severe pain, says Gatesville pain physician Richard Hurley, MD, president of the Texas Pain Society.
“If they had said a three-day limit on initial opioid treatment for acute pain by primary care, I think everybody could support that, because primary care [doctors] aren’t going to operate on a ruptured aortic aneurysm,” Dr. Hurley said. He says it’s easy to see that the three-day limit “was developed by those who have never been in the trenches and have never experienced severe pain before.”
The limit, Dr. Hurley added, “does not take into account the patients themselves, and it doesn’t take into account the diagnosis, etiology of pain, and the overall time it takes for the body to heal. It basically takes the clinical picture out, and that’s absurd. You can’t do that, and not everybody is the same. Not everybody heals the same.”
Austin addiction psychiatrist Carlos Tirado, MD, president of the Texas Society of Addiction Medicine, says he understands the logic behind limiting the initial prescription for acute pain.
“There’s evidence to show that individuals who become chronically addicted to prescribed opioids initially acquired those prescriptions for the treatment of uncomplicated acute pain,” Dr. Tirado said. “So, treatment of acute pain basically lapsed into continuation of opioids for chronic pain. The spirit of it certainly is appropriate in regard to creating more of a block to patients receiving excessive doses and amounts of opioid analgesics in response to an uncomplicated acute pain condition, like a sprained ankle, back strain, or a minor surgical procedure.”
But the language in the bill could be interpreted narrowly and put physicians in a bind, he adds.
“Any time regulations like this are [proposed], as we can see with the CDC guidelines, they very quickly are perceived as limits on physician practice. Physicians legitimately have clinical practices, realities that don’t neatly fit within a prescribed guideline,” he said. “There’s always that kind of balance that needs to happen between physicians’ practice of medicine and any attempts to implement more of a public health strategy and risk mitigation for opioid prescribing.”
The senators filed their bill one month after the governor of Arizona signed a new law that generally limits first-time Schedule II opioid prescriptions to a five-day supply.
While the opioid limit may be one of the most contentious pieces of the federal bill, it’s not the only policy change it would bring. According to press releases from the bill sponsors, CARA 2.0 would also:
- Require prescribers to use their state’s prescription drug program (PMP) before prescribing Schedule II, III, or IV drugs;
- Make permanent a section of the original CARA that allows physician assistants and nurse practitioners to prescribe buprenorphine under the direction of a qualified physician;
- Allow states to waive the current limit of 100 patients that each physician can treat with buprenorphine, if they follow evidence-based guidelines; and
- Increase criminal and civil penalties for opioid manufacturers that fail to report suspicious opioid orders or fail to maintain effective opioid diversion controls.
The Texas Medical Association is monitoring the bill.
The PMP issue has been hotly debated in Texas. TMA fought attempts to impose burdensome mandates on physicians to check the state PMP before writing prescriptions for controlled substances. During the 2017 legislative session, TMA won a delay on a mandate for physicians to check the state PMP before issuing prescriptions for four drug classes: opioids, barbiturates, benzodiazepines, and carisoprodol. The delay until Sept. 1, 2019, gives stakeholders more time to study the issue.
As a physician who mostly handles patients with chronic pain, Dr. Tirado of the Texas Society of Addiction Medicine says he finds CARA 2.0 encouraging overall. The bill authorizes $300 million to expand evidence-based medication-assisted treatment — such as methadone — and $10 million for funding of a national campaign on the dangers of prescription opioid misuse.
“I think one of the things that has really limited practitioners, and allowed the epidemic to reach the proportions it has, has been the lack of opportunity for individuals to engage medication-assisted treatment in the case of opioid addiction, and not having the national infrastructure for recovery support services,” he said. “Those factors, which are covered in the legislation, are very helpful to practitioners in the community who are trying to manage these illnesses long-term.”
Tex Med. 2018;114(6):42-44
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