While it hasn’t received much media attention, the federal government is launching an attack on the opioid crisis on a new front: improved technology for packaging and disposal of the drugs.
That’s good news for Intent Solutions.
Two recent bills—the Support for Patients and Communities Act passed by the House in June and The Opioid Response Act of 2018 passed September 17 by the Senate—include a new tactic that strikes at the heart of what many believe to be the major culprit in the epidemic’s explosion: the sheer number of unsecured opioids readily available in American medicine cabinets.
The bills are currently in conference committee working to produce a final bill in the next few weeks.
The Senate bill gives the Food and Drug Administration (FDA) the authority to create limited-amount packaging—such as supplies of pills for three or seven days—and requires opioid manufacturers to provide patients a safe way to dispose of leftover drugs as part of the packaging.
What hasn’t been extensively reported is that the bill also sets up rules and guidelines for the FDA to accelerate the development of more secure packaging of opioid prescriptions and gives direction on how the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) can reimburse for the use of those technologies.
That portion of the bill is pointed directly at us, and companies like us.
Packaging is ‘so very important’
Because U.S. Rep. Buddy Carter, R-Ga, is also a pharmacist, he understands the problem—and how technology like ours can help solve it.
“We all know what a problem the opioid epidemic is in America, with 115 people dying every day, and we know a lot of them get started by the number of prescriptions being written and the number of pills dispensed that end up just sitting in the medicine cabinet,” Rep. Carter said recently. “That is why the packaging is so very important.”
Carter introduced a provision in the final version of the House bill that would require a coating to prevent opioids from being crushed so they can’t be ground and snorted or mixed with a liquid and injected. But new packaging and dispensing technology like ours takes a broader swipe at preventing opioid misuse, and Carter believes the concept will help make a serious dent in the crisis.
He says our approach is “headed in the right direction.”
Like us, he compares new dispensing technology to seatbelts. America didn’t ban cars to reduce deaths on its highways; it adopted common sense solutions to make them safer. Until the pharmaceutical industry can develop better drugs to treat pain without the addictive qualities of opioids, the smart dispensing device like tadTM from Intent Solutions makes sense, he says.
We wholeheartedly agree, and we greatly appreciate the fact that Rep. Carter is our ally in Congress on this matter.
An August 2017 JAMA Surgery review found more than two-thirds of patients reported unused prescription opioids following surgery, and safe storage and disposal rarely occurred, suggesting an important source of diversion of the drugs to others for sale or recreational use. The research underscores the problem—yet again—and gives us added impetus to work for widespread acceptance of the solution our company has to offer.
We will keep our readers updated on the final bill once it comes out of conference committee.
FDA Innovation Challenge
In other encouraging news from government, the Food and Drug Administration (FDA) has launched an Innovation Challenge to recognize medical devices that lead to the prevention and treatment of opioid use disorder (OUD). Applicants selected for the Challenge will work directly with the FDA to accelerate the development of and eventual review of marketing applications for their products, and will be granted Breakthrough Device designation based on certain statutory criteria.
The call for applications is another clear signal from government on the importance it is placing on devices and technology that can help curb OUD. We have submitted our application and will keep you posted on its progress, as well.