August 3, 2021
PILL Designed to Help Patient Adherence to Prescribed Intervals
October 26, 2020
By Dave Andrews
Each day, more and more Americans become ensnared in the tight grasp of opioid use disorder. While increased awareness and additional support programs are helping those who are addicted overcome drug dependencies, the process is much easier said than done. Healthcare providers need to be increasingly familiar with treating both substance use disorders (SUD) and opioid use disorders (OUD). The PA Foundation has partnered with the National Institute on Drug Abuse (NIDA) to address this issue and enhance PA expertise through the NIDA Mentored Outreach Award in SUD Treatment Dissemination. This award provides funding for mentor-supervised projects that focus on adoption and/or dissemination of existing SUD treatment research and publication of results.
Stopping opioid use disorder before it starts is the best strategy. That’s the approach of PA Afton Heitzenrater, who works in the Adult Emergency Department at Rochester General Hospital in Rochester, New York, and her husband, Jeff.
Together, in an effort to help stem the tide of the opioid epidemic, the couple developed a simple idea into a meaningful product: PILL, which stands for Prescribed Interval Limit Lock. It’s described as a locked, tamper-resistant “smart” blister pack with a timer to limit a patient to the prescribed interval of medication.
Heitzenrater clearly recalls the day when the wheels started turning. Six years ago, while working at an orthopaedic surgery center, she received nine calls—in the span of just a few hours—from people seeking refills for their prescription pain medications they had prematurely exhausted.
“I remember telling my husband that night about how opioid abuse seemed to be getting worse,” said Heitzenrater, who was not only seeing the epidemic in her professional life, but also witnessing its impact in her personal life: Her cousin had recently passed away after an overdose—an ordeal that further fueled her desire for a solution.
“Jeff and I got to talking about how the delivery of pain meds to patients at the hospital is often controlled through PCA (patient-controlled analgesia) pumps, and then he simply asked, ‘Well, why can’t a similar approach be taken to modify a pill bottle?’”
It was one of those “lightbulb moments,” said Heitzenrater, who describes her husband as someone who has always been interested in mechanics, learning how things are built and finding ways to improve how they operate.
“It occurred to us in that moment how strange it was that, for as long as the pill bottle has been around, no one had yet created one that could help [regulate medication consumption],” said Jeff, who is a project manager for a large HVAC company in the Rochester area. “Ever since then, it’s been an exciting ride.”
The Right Connections
Though product development is a whole new frontier for his wife, Jeff had a bit of experience to lean on. He reached out to his uncle, with whom he had collaborated on several previous ideas for new products—predominantly golf and other sports-related innovations. But this was their first healthcare-related concept and the one they felt could have the biggest impact, by far.
They soon contacted a patent attorney who conducted a patent search to confirm no other similar products existed. Then, they asked for the help of some of their engineer acquaintances who helped them design their first prototype. They gradually modified and refined the prototype with the help of ROBRADY, a Florida-based product design and development firm.
Heitzenrater says the experience of developing a new product has enabled her to do things she never imagined herself doing as a PA.
“I’ve sat in front of a group of more than a dozen members of the FDA to discuss proposed legislation on opioid use and PILL’s applicability to the opioid crisis,” she said. “I’ve had discussions with Senate staff members, met with U.S. Department of Health and Human Services staff, been on countless conference calls, and held several meetings with major retailers and health insurers.”
The Heitzenraters acknowledge that their progress hinges largely on making the right connections. To do so, they have partnered with a lobbyist who is helping them as they try to facilitate collaboration among various groups.
Frequently, the Heitzenraters must clarify that PILL is not guaranteed to prevent someone who is already addicted to opioids—and therefore, highly motivated—from gaining access to more pills by breaking the device open. Rather, their objective is to help those who are not addicted control the potential urge to overconsume prescribed medications.
Investors are currently coming on board, which will help fund further refinement of the PILL prototype. With enough support and a good amount of luck, they anticipate the final product will go to market within the next 6-12 months.
“It’s extremely exciting and I also feel it’s been a good way to promote our profession,” Heitzenrater said. “Essentially, I’m the primary medical consultant for a product that we sincerely believe could make an impact on the industry and help save lives.”
Enhancing Patient Care
Making improvements and finding solutions is something that comes very naturally to Heitzenrater.
“She’s very passionate toward the PA profession and a very hard worker,” said PA Barb Esders, lead advanced practice provider for Rochester General Hospital’s ED and Heitzenrater’s supervisor for the past three years. “The product she’s involved with clearly stems from her inherent character and PA training of seeing an issue and striving to find a solution.”
For the past two years—when she isn’t in meetings with government officials or product developers—Heitzenrater has been splitting time between her clinical duties and her administrative role at Rochester General as the ED’s quality improvement clinician.
“I love what I do and can’t imagine doing anything else,” she said. “I’m either working to identify opportunities to enhance the level of care we provide, or I’m Interacting with a wide variety of patients and making a difference in someone’s life—often times supporting them through one of the most challenging times they’ll ever experience.”
The Heitzenraters are facing challenges of their own—though of a much different sort—as they experience the grueling process of developing a product, especially one for the healthcare market. But even though they could eventually be rewarded financially, both assert it isn’t their true motivation.
“[The PILL] will either go crazy, or it won’t go anywhere,” Jeff said. “But we’re in this for the long haul and will see it through no matter what because honestly, it’d all be worth it if it helped save even just one life.”
If you, like the Heitzenraters, have a passion for SUD education, knowledge, and treatment, consider applying today for the PA Foundation’s NIDA Mentored Outreach Award. Learn more about the eligibility requirements and submit your application by November 4, 2020.
Dave Andrews is a freelance writer and public relations professional based in Northern Virginia. Contact him at [email protected].
This article was originally published in August of 2018.