CDC and FDA Add New Guidelines and Regulations Aimed at Curbing Overprescribing of Opioids

The Center for Disease Control and the Federal Drug Administration both recently released new guidelines, from the CDC, and new regulations, from the FDA, aimed at addressing the rising concern about the nationwide opioid epidemic. Not coincidentally, these guidelines and regulations were announced within a week of one another. I think this signals a strong message from the federal government to both state governments and health care providers: if you won’t fix this problem, we will.

CDC’s New Guidelines for Prescribing Opioids for Chronic Pain

Although many states have released their own guidelines for the management of chronic pain (Tennessee’s guidelines, released in 2014, are accessible here), this is the first set of guidelines available nationwide to healthcare providers. The CDC’s guidelines include 12 main recommendations, which include establishing treatment goals with patients prior to starting a patient on opioids, and avoiding concurrent opioids and benzodiazepines whenever possible.

The starting dosage recommendation of 50 mg morphine equivalent will likely result in some push back from providers, but I think this low number indicates how strongly the CDC feels about the riskiness of prescribing opioids at all for chronic pain in patients. Health care providers—physicians, nurse practitioners, and physician assistants—who have the ability to prescribe and who provide care for patients with chronic pain need to ensure that they are properly documenting justification for their medical diagnosis of patients with chronic pain, as well as their chosen treatment of each patient’s chronic pain.

Federal Drug Administration’s Safety Label Changes for Immediate-Release Opioid Pain Medications

The FDA released new regulations last week with required labels on immediate release (IR) opioid pain medication, including a box on IR opioid prescriptions warning about the risks for misuse, abuse, addiction, overdose and even death. These regulations are a follow up to the FDA’s 2013 prescription warnings on extended-release/long-acting (ER/LA) opioids resulting from the FDA’s concern of the risks associated with long acting opioids. Today, the FDA is acknowledging and clarifying that immediate release opioids are also dangerous, and play a persistent role in addiction, abuse, and overdose mortality related to opioid use.

What Do These Guidelines and Regulations Mean?

The CDC’s Guidelines for prescribing opioids and the FDA’s new labeling requirements for IR opioid pain medication indicate concern at the federal level regarding the prescribing of opioids. Healthcare providers who prescribe opioids should be cautious about their prescribing of these medications, and always document to demonstrate the provider’s decision-making in prescribing an opioid, and the patient’s clear medical need for the medication.