By Pat Anson, Editor

Although generally supportive of the CDC’s new opioid prescribing guidelines, some doctors are worried that patients who need opioid pain medications may lose access to them.

The voluntary guidelines, which discourage the prescribing of opioids for chronic pain, are intended for primary care physicians, but are widely expected to have a ripple effect throughout the healthcare system and on anyone who prescribes opioids.

"If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable. If they produce unintended consequences, we will need to mitigate them. They are not the final word," said Patrice Harris, MD, the board chair-elect of the American Medical Association, the nation’s largest medical group.

Like many other medical organizations that submitted public comments on the CDC guidelines, the AMA said it had concerns about the poor quality of scientific evidence supporting several of the recommendations. But the dozen guidelines are largely unchanged from a draft version that was released last September.

“We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” said Harris, who chairs the AMA Task Force to Reduce Opioid Abuse.

The lack of clinical evidence was also pointed out by other physicians.

 “There are few well-controlled clinical studies on opioid-prescribing methods for chronic pain. While the guidelines will be updated as new data become available, concerns may be raised that appropriate access to opioids could be negatively affected by federal guidelines based on admittedly weak data,”  wrote William Renthal, MD, of the Department of Neurology at Brigham and Women’s Hospital in an editorial in JAMA Neurology.

The head of the American College of Obstetricians and Gynecologists (ACOG) said he was concerned the guidelines overstate the risks of opioids for women during pregnancy and after labor.

“ACOG agrees with the CDC that opioid should only be used for treatment of pain when alternatives are not appropriate or effective, but we also know that there are times, including during pregnancy and the postpartum period, when such use is both appropriate and safer than the alternative,” wrote ACOG president Mark DeFrancesco, MD. “Opioids may be needed to treat acute pain such as from cesarean delivery, kidney stones, sickle cell crisis or trauma in pregnancy, or as part of an established plan to treat problems associated with substance use disorders.”

DeFrancesco said the risk of birth defects and other problems caused by opioids was low and research demonstrating a connection was lacking.

“We are concerned that some of the CDC's patient education communications regarding use of opioids during pregnancy could discourage women from needed, appropriate care by overstating the risk of rare complications associated with opioid use during pregnancy and by understating the potential risk associated with opioid discontinuation, “ he said.

Two pediatric physicians are concerned the guidelines are only intended for patients 18 and older and do not address pain or opioid use by children.

“Unfortunately, the exclusion of children from the national discussion on pain is not new,” wrote Neil Schechter, MD, of Boston Children’s Hospital and Gary Walco, PhD, of Seattle Children’s Hospital in an editorial in JAMA Pediatrics. “Data clearly show that poorly treated pain in the young has deleterious long-term consequences on the development of pain systems and related responses, as well as psychological well-being. Furthermore, the long-term impact of pain on a developing organism may be quite different than on an adult and may suggest more aggressive, or at least different, interventions.”

Schechter and Walco urged the CDC to provide ”an explicit and definitive statement that this guideline should not be applied to those younger than 18 years of age for fear of untoward consequences.”

The Alliance for Balanced Pain Management (AfBPM), a coalition of patient groups and professional societies, said it was concerned about opioid dosing limits and the CDC recommendation that three days or less supply of opioids “often will be sufficient” to treat acute pain from surgery or trauma.

“When the CDC suggests the exact number of days and the precise dosing limit, the agency may be inserting itself too far, interfering with physician care of patients who live day to day with serious pain,” said Brian Kennedy, Alliance for Patient Access and a member of the AfBPM Steering Committee. “These guidelines mark a milestone in the national conversation about how we treat pain, both chronic and acute. Multimodal approaches to pain treatment make use of non-opioid treatments and have tremendous value for patients, but we shouldn’t tie physicians’ hands when it comes to treatment options.”

 “The data will never be perfect. The measures will never be perfect. The guidelines will never be perfect. And neither will clinicians and their performance,” wrote Thomas Lee, MD, of Press Ganey and Harvard Medical School in a JAMA editorial. “But by acknowledging these imperfections and trying to get better with the tools available, physicians can more effectively reduce the suffering of patients.”