Rx Summit: Collaboration remains the key ingredient

The 2016 National Rx Drug Abuse & Heroin Summit opened today in Atlanta with a general session teeming with leaders. Some 2,000 stakeholders from 49 states, Canada and three foreign countries attended.

Rep. Hal Rogers (R-Ky.) said the success of the summit isn’t judged by how many people attend. “It’s also about how many lives we save,” he said. Rogers created Operation UNITE, a not-for-profit organization, in 2003, which hosts the summit.

In 2014, there were more than 47,000 overdose deaths, 28,000 of which were opioid-involved, or 78 deaths a day, according to the Centers for Disease Control and Prevention (CDC). At the general session, the “CDC Life Counts Clock” was turned on, visually representing the number of people who died from an opioid-related overdose, and it ticked away over the course of the two-hour session as reminder to stakeholders that lives are being lost and there is no time to waste.

At next year’s summit, the numbers need to be lower, said Rogers. “If the number isn’t declining, let’s agree that we will change what we’re doing,” he said. “We aren’t just here to talk about saving lives. We’re here to commit to make it happen.”

There have been successes recently: prescription drug monitoring programs (PDMPs) are a noted example.

“Each year we add pressure on the FDA for abuse deterrents and better labeling,” said Rogers. He pointed out that last week the FDA released black-box requirements to warn patients about addiction to short-acting opioids.

“I want to applaud [FDA Commissioner Robert] Califf for taking the lead on this effort,” he said. “He’s only been on the job for a few weeks, and we’re pleased to have him with us.”

FDA’s culture

Califf opened with a direct acknowledgement of some of the hits the FDA has been taking with regard to opioids.

“Other people have made allusions to the culture at the FDA,” he said. “In almost every instance, we will disappoint some and please others.”

Achieving the balance between providing appropriate pain relief and reducing addiction and abuse is difficult. Clearly there are advocates on both sides of the issue with compelling positions.

“I’m not asking for your sympathy,” he said. “I’m asking that you work with us as we adjust decisions that are so fluid in an evolving epidemic.”

Certain questions should become routine when physicians treat someone with pain, according to Califf: “Is there a non-opioid option? How many pills does my patient really need? Does my patient understand the risk of addiction and the risk of making pills accessible to family members and others?”

And the responsibility needs to go beyond the physicians to the integrated health systems that monitor the prescribers, he said, noting that the FDA fully supports the opioid prescribing guideline from CDC released this month.

FDA is also supporting potential over-the-counter versions of naloxone, according to Califf.

SAMHSA offers up grants

Kana Enomoto, acting administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), told attendees about one of several initiatives announced by her agency this week: $11 million in funding now available to states for the purchase of naloxone. In another initiative, $10 million in grants will go to 20 states for using PDMP data to connect with prevention efforts.

Enomoto also announced the federal proposed rule that was released today, which would increase the cap on the number of patients that could be treated by one buprenorphine prescriber from 100 to 200. “The goal is to expand access to this important treatment,” she said. SAMHSA is in charge of the waiver process under which physicians can be trained to provide buprenorphine treatment.

“This is an opportunity to stop the clock” of overdoses, she said.

ONDCP notes heroin link

Michael Botticelli, director of the Office of National Drug Control Policy (ONDCP), who is in long-term recovery himself, focused on the need to treat substance use disorders as a brain disease. And he noted that while most people who misuse prescription opioids don’t turn to heroin, four ot of five people who use heroin started with prescription opioids.

“Leadership matters,” said Botticelli, noting that since the inception of the first national drug control strategy of this administration, the focus has been on evidence-based treatment. “We also need the support of Congress, governors, local leaders and the medical community,” he said.

The message of collaboration across stakeholders was a recurring theme at the summit.

In addition, Botticelli said the SUD treatment system needs to be truly integrated into healthcare. In 2013 only a minority of substance use disorder referrals came from a healthcare provider.

“There’s a misconception that treatment can’t work until you hit bottom or face jail. We don’t wait that long for any other health condition,” he said.

NIH emphasizes research

Frances Collins, director of the National Institutes of Health (NIH), discussed the importance of research, talking about the potential for utilizing non-opioids in the treatment of pain. While research is still in the early phases, there are promising new areas to explore.

“We need a coordinated strategy for reducing pain,” said Collins.

He noted that a new buprenorphine implant is promising, and forthcoming research is showing that Vivitrol can work to reduce overdose risk. The treatment worked better than intense medication-assisted treatment with methadone or buprenorphine in maintaining abstinence in a new study: there were 0 overdoses in the Vivitrol group, and 7 in the control group, at 78 weeks. He noted that Vivitrol isn’t for everyone, but that the study “deserves a lot of attention.”