FDA Takes New Action

The Food and Drug Administration (FDA) recently released a revised Blueprint which contains content that drug companies will be required to make available to prescribers of opioid painkillers for training purposes.

The FDA said the following in a statement:

“The revised Blueprint broadens content to include information on acute and chronic pain management, safe use of opioids or other non-opioid or non-drug treatments, as well as material on addiction medicine and opioid use disorders.”

To be finalized later in 2018, the Blueprint will apply to the makers of both immediate-release and extended-release formulas. In a first-ever move, the FDA is requiring that the guidance will be provided to healthcare providers who are involved in pain management, including prescribers, pharmacists, and nurses.

FDA Commissioner Scott Gottlieb said the following in a statement:

“With millions of Americans misusing prescription opioids and more than 40 people dying every day from overdoses involving opioid medications, it has become abundantly clear that we need to do everything we can, along with our partners, to get ahead of this crisis.”

“Appropriate prescribing practices and education are important steps…to help address the human and financial toll of this crisis. We can and must do more to arm physicians…with the most current and comprehensive guidance on the appropriate management of pain.”

According to the US Centers for Disease Control and Prevention, more than 42,000 people died in 2016 from overdoses related to prescription painkillers (40%) or illicit opioids.

According to the news release, the agency’s Opioid Policy Steering Committee (OPSC) is also “considering ways…to augment existing prescribing and dispensing practices, such as utilizing electronic prescribing systems and interfacing with state prescription drug monitoring programs, while [continuing to maintain] appropriate prescribing for patients in medical need.”