FDA New Guidance on Opioids Drawing Response

www.nationalpainreport.com/fda-new-guidance-on-opioids-drawing-response-8839531.html

The FDA’s safety announcement this week that says it has identified harm reported from sudden discontinuation of opioid pain medicines and is requiring label changes to guide prescribers on gradual, individualized tapering was generally praised.

Stanford Psychologist Beth Darnall—who was in Australia speaking to the 2019 Australian Pain Society speaking on the topic—indicated that the guidance was appropriate.

“It is wonderful to see national agencies issuing dedicated communications to correct the misapplication of CDC guidelines, and to assure patient protections from iatrogenic harms caused by rapid and forced tapering,” she said.

She also said that communicating this message to pharmacies is important.

“The FDA recommends labeling and guidance to clinicians. Who will guide the recommendations and policies to *pharmacies* to assure that clinicians have the *autonomy to implement best practices for their patients* and prevent rapid and forced tapering caused by opioid prescription fills being denied?

For “Richard A Lawhern, PhD, Director of Research for the Alliance for the Treatment of Intractable Pain, this is a long overdue “baby step” the FDA has taken.

“How much longer can FDA, CDC and other Federal and State agencies ignore the even larger reality? he asked. “As several past presidents of the American Academy of Pain Medicine and other prominent medical professionals have pointed out in a December 2018 letter to the Governor of Oregon, there are no published trials data that establish benefit to legacy patients from mandated tapering of opioid therapy. To the contrary, as FDA points out, there is a risk of medical collapse when such measures are imposed.”

A dentist who had to retire due to CRPS nearly two decades ago, was even less enthusiastic.

“I cannot believe that these “findings” were a surprise to anyone that deals with opioids,” wrote Dr. Mark Helfand to the National Pain Report. “I graduated dental school in 1984 and even back then it was known that you should never stop or greatly reduce the dosage of opioids quickly. It must be done slowly and gradually over time. If not, the effects on the patient are at least serious pain and illness. At most, death.”

Gary lives in Virginia and wrote to the National Pain Report that the FDA word getting out needs to happen fast.

“Virginia must not have received the memorandum from the FDA. As of yesterday, April 9 2019, I was told by 5 pain management clinics in Charlottesville, Lynchburg, and Roanoke that they will not prescribe new – or continue to prescribe from other doctors – any narcotic analgesic.”

Filed under: General Problems