// October 19, 2017

Can changes to prescription labels and other public standards help tame the opioid crisis?


The opioid crisis in the U.S. seems to be part of nearly every news broadcast and news site today. And based on the number of people affected by this crisis, serious conversations about how to help are more important than ever. The CDC estimates that more than 100 Americans die every day from an opioid overdose. And nearly 12 million people – close to 4% of the U.S. population – misused opioids in 2016, according to a report published last month summarizing results of the 2016 National Survey on Drug Use and Health. 

The growing crisis is spurring new ways of thinking about how to reverse this national epidemic. All over the country, people from myriad disciplines and sectors, including healthcare providers, health policy makers, law enforcement officers, addiction experts, and government seek new and meaningful approaches to help the growing number of Americans addicted to opioids. As I write this today, the House Energy and Commerce Committee is preparing to hold a full committee hearing tomorrow about this epidemic.

USP is also doing our part.

How can a standard-setting body help in such a public health crisis?  USP has a long history of addressing public health crises – by developing or revising standards – and we are committed to doing the same to help with the opioid crisis.

Roundtable informs public standards in response to opioid crisis 

On October 23, USP convened a wide array of experts in different aspects of opioid addiction and misuse for a roundtable to explore strategies to protect the public’s health, as well as assist first-responders and healthcare providers.

Held in Washington, DC, and including experts from healthcare provider groups, research organizations, patient advocacy groups, government agencies, industry representatives, and others, the roundtable gathered additional input and feedback about these strategies. The four approaches being developed are:

  • Recommendations for effectively and safely storing and disposing of opioid prescriptions in order to help prevent misuse, including how this information should be communicated;
  • Clear prescription label information to ensure patients understand that a prescribed drug is an opioid and can be addictive;

  • Easy-to-follow instructions for using naloxone, so that first responders and others (including family, friends, and others who may not be trained healthcare providers) can quickly understand when and how to administer this life-saving antidote; and

  • New standards for healthcare providers to counsel patients about appropriate use of prescription opioids and how to avoid misuse.

Participants at the roundtable shared their diverse perspectives – many informed by in-the-field experiences – about practical considerations related to these potential standards, including how they could be best conceived, implemented and promoted to maximize adoption and impact. Input such as this from stakeholders who have expertise in different aspects of the opioid crisis is critical to developing impactful standards that can help save the most lives. We are grateful to the enthusiastic interest we’ve received from the many experts we’ve met with throughout this process, as well as the additional insights from participants of the roundtable. 

Next steps: Standards development to help opioid crisis

In the coming months, we will release a report based on these discussions which will inform the work of USP’s Healthcare Quality and Safety Expert Committee, whose members have been developing the concepts discussed at the roundtable. All proposed new or revised standards will be open to public comment for 90 days and we welcome additional discussions with a broad base of interested parties. 

Gaining early stakeholder feedback in our standards-development process helps optimize USP’s response to urgent public health needs. It is our deep hope that the resulting changes in USP standards can play an important role in mitigating this crisis that grips so many communities today.

Ronald T. Piervincenzi, Ph.D. is the Chief Executive Officer of USP.