FDA approves new opioid safety measures for outpatients

The CDC also announced it has awarded $200 million to government agencies and organizations working to prevent opioid-related overdoses, deaths and other outcomes.

By Allen Cone
FDA approves new opioid safety measures for outpatients
The U.S. Food and Drug Administration announced ways to better communicate the serious risks associated with opioid drugs patients and healthcare professionals. Photo by qimono/pixabay

Sept. 20 (UPI) -- The U.S. Food and Drug Administration has taken steps for expanded and improved communication on the serious risk of opioids to patients and healthcare professionals.

The agency announced a more wide-ranging Opioid Analgesic Risk Evaluation and Mitigation Strategy in a press release Wednesday. For first time, the strategy applies to immediate-release opioid drugs intended for use in an outpatient setting. Extended-release and long-acting opioids have been subject to REMS since 2012.


The program expands its application from 62 opioid products to 347 opioid products intended for outpatient use.

In the REMS program, training must be made available to healthcare providers involved in the management of patients with pain. That includes nurses and pharmacists -- not just prescribers.

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The education is required to cover "broader information about appropriate pain management, including alternatives to opioids for the treatment of pain." In addition, the FDA is approving new product labeling containing information for the healthcare provider education through the new REMS.


"Opioid addiction is an immense public health crisis," Dr. Scott Gottlieb, commissioner of the FDA, said in a statement. "Addressing it is one of the FDA's highest priorities. As part of our comprehensive work in this area, we're taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction."

Gottlieb noted many people who become addicted to opioids are first exposed to them in the medical setting.

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"Providers have a critical role to play in making sure these products are appropriately prescribed to patients," he said. "Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use."

Immediate-release opioids, which are the most commonly prescribed form of opioids and account for about 90 percent of all opioid medications prescribed for outpatient use, include a more stringent set of requirements, Gottlieb said.

"Appropriate prescribing practices and education are important steps that we're prioritizing to help address the human and financial toll of this crisis," he said. "Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products."


By reducing overall dispensing, he said the goal is to prevent patients from becoming addicted to the drugs by decreasing the number of inappropriate prescriptions, while fostering more rational guidelines to keep them available to those who actually need them.

Also Wednesday, the Centers for Disease Control and Prevention announced it has awarded almost $200 million in new funding for government agencies and organizations working to prevent opioid-related overdoses, deaths and other outcomes.

The bulk of the awards -- about $155 million -- is new funding to states and four territories.

The CDC has also allotted $12 million to support 11 Tribal Epidemiology Centers and 15 tribal entities. Among American Indians and Alaska natives, the rate of drug overdose deaths is above the national average.

Additionally, the agency is distributing an additional $27 million to nine non-governmental organizations.

"This epidemic is the public health crisis of our time -- and we are losing far too many Americans each day from opioid overdoses," Dr. Robert R. Redfield, director of the CDC, said in a statement. "These funds will provide critically needed resources to those on the frontlines of the fight against the opioid overdose epidemic."

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