Federal Government Looks to Packaging Technology as New Path to Curb Opioid Crisis
by Sam Zamarripa
Modern dispensing, tracking, disposal tools gain attention for controlling access to pills
The federal government is launching an attack on the opioid crisis on a new front: improved technology for packaging and disposal of the drugs.
While it hasn’t received much media attention, many believe the technology is a stealth solution that can dramatically lower the numbers of Americans who develop a problem with opioids after they are prescribed the drugs for pain.
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 — have come under criticism for being too passive in dealing with the epidemic and for providing insufficient funding toward expanded treatment access.
Nonetheless, the bills — which are currently in conference committee working to produce a final bill in the next few weeks — 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 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.
In essence, that provision of the bill looks to change the method in which opioids and other prescription medications are dispensed from pharmacy to patient. For physicians, pharmacists, patients, lawmakers, federal agencies and anyone under public pressure to do something about the opioid crisis, it’s a step forward to change a system that should have been changed decades ago.
Packaging is ‘so very important’
The lack of security in current packaging was illustrated in sharp relief in 2015, when two teen-aged boys in Indiana died after they consumed a fatal mix of alcohol and oxycodone swiped by friends from their home medicine cabinets. The boys’ mother, Becky Savage, organized pill drops where local officials collected hundreds of pounds of prescription medications.
Photo: © BillionPhotos.com stock.adobe.com
It’s more than just an Indiana problem. 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 (1).
Recent estimates show as many as six million people in the U.S. are experiencing opioid use disorder (OUD), nearly three times higher than the federal government’s estimate of 2.1 million, according to global management consulting firm McKinsey and Co.(2)
“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,” said U.S. Rep. Buddy Carter, R-Ga. “That is why the packaging is so very important.”
As the only pharmacist currently serving in the U.S. Congress, Carter is keenly aware of the problem caused by unsecured pills. “We have heard of so many stories and I have witnessed personally so many situations where a family member got hold of unused pills, and that’s how the abuse got started,” he said. He has shown strong interest in the development of technologies that can stop the problem and encourages his fellow members of Congress to do likewise.
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 there is new packaging and dispensing technology that takes a broader swipe at preventing opioid misuse, and Carter believes the concept will help make a serious dent in the crisis. This type of technology is what’s referenced in the current bill.
One might think of blister packs and child-resistant caps at the mention of “drug packaging,” but the new legislation opens the door for fast-track development and approval of tools that are far more sophisticated than those approaches.
Dispensing one pill at a time
One young company, Atlanta-based Intent Solutions, heeded the call several years ago to apply technology innovation to curb the opioid crisis by developing a unique smartphone-size dispenser that releases one pill at a time when activated by a patient’s or caregiver’s fingerprint.
Called tadTM, an acronym for “take as directed,” the device works like a Fitbit, gathering data about patient usage. The device also gathers information via a mobile app to help physicians determine when a patient attempts to go beyond the prescription regimen or when an unauthorized user tries to access the supply of pills stored inside.
It’s a unique approach that Carter says is “headed in the right direction.”
There are currently smart caps on the market that alert patients when it is time to take their medication, but they do nothing to control access or to feed data to physicians on a patient’s adherence to a prescription. They were designed to tackle a different problem — patients forgetting to take their medications, not misusing, abusing or diverting them to others.
Blister packs might prevent or provide proof of tampering, but they don’t control dosage and restrict access to pills. And lockable bottles and lockboxes might restrict access, but don’t control dosage or track dispensing time and amounts.
Intent Solutions’ dispensing technology is the first of its kind — another reason it is gaining attention.
Carter compares the technology to seat belts. 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 the one by Intent Solutions makes sense, he says.
Founded by a former opioid addict
The company’s story is compelling. It was founded in 2013 by a recovering opioid addict who started down the road to addiction after a hip replacement, when his doctor prescribed opioids for acute pain. After four years of struggle in which he lost nearly everything, he searched for a way to help others avoid a similar crisis.
“The problem is not the medications, it’s the way they come to you,” said Sam Zamarripa, a former Georgia state senator who is now CEO and director of Intent Solutions. “One of the primary sources of opioids is the American medicine cabinet containing the classic unsecured pill bottle filled with current or unused medications.”
Zamarripa and his team believe that if tad were used only by patients who receive opioid prescriptions after outpatient surgery, it could significantly reduce the number of Americans who develop OUD. The company uses this formula:
Based on a retrospective study of just over one million surgical procedures performed between 2008 and 2016, it is estimated that 56% of those patients were prescribed opioids and of those, 0.6% were affected by OUD (3). How many of those procedures were outpatient? According to the American Hospital Association, there were approximately 17.3 million outpatient surgeries in the U.S. in 2014 (4). By applying the OUD rate of 0.6% to 56% of those surgeries, it could be argued that there were 57,000 new cases of OUD introduced from outpatient surgeries alone in 2014 — a $14.5B financial impact along with more drug-related deaths.
Previous approaches have made some headway, but not enough
More than 115 people die in the U.S. every day after overdosing on opioids (5). The drugs were prescribed heavily in the late 1990s before it became clear how addictive they are, and in less than two decades, opioid overdose rates had increased to alarming levels. The White House has estimated that OUD costs the U.S. approximately $504B annually or about $210K per year for each affected person (6).
Congress has taken a deep and broad look at what is causing the opioid crisis. In 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (CARA). It was the first major federal addiction legislation in decades, a comprehensive effort to address the opioid epidemic.
CARA took significant steps forward. It expanded the availability of naloxone to help in the reversal of overdoses. It increased the number of disposal sites for unwanted prescription medications. It allowed for Schedule II prescriptions like opioids to be partially filled if certain conditions and restrictions are met. And it strengthened PDMPs to help states monitor prescription drug diversion, especially by those individuals attempting to fill single prescriptions multiple times.
The 2016 law didn’t address the use of technology in packaging and dispensing to control access to the drug. The legislation currently in conference committee — sometimes referred to as CARA 2.0 — would do that, and it’s considered a positive sign by many.
Pharmacists would be receptive
Carter believes his fellow pharmacists — who would be the ones responsible for filling and programming the new dispensing devices — would embrace such a solution.
“I don’t think pharmacists would view this as a hurdle,” he said. “Pharmacists are over-trained and underutilized and it would give them an opportunity to use their skills.”
Meanwhile, tad™ is currently undergoing a clinical trial with a hospice facility in Florida, and Intent Solutions is starting non-clinical trials with local pharmacies to gauge patient satisfaction and usability.
CEO at Intent Solutions http://www.intentsolutions.com/