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Corrections & Clarifications: An earlier version of this story misspelled the first name of Afton Heitzenrater.
ROCHESTER, N.Y. — A physician's assistant and her husband have developed a pill bottle that controls when and how much medication is dispensed.
And  Afton Heitzenrater, 30, of the Rochester suburb of Spencerport, N.Y., and her husband, Jeff, now think they have a way to stop opioid misuse before it has the chance to start.
“It allows for responsible prescribing, dispensing, use and tracking of controlled substances,” said Heitzenrater, a 30-year-old physician assistant in the emergency department at Rochester General Hospital.
Afton Heitzenrater's fiancé inspired her six years ago when she was telling him about her day at an orthopedic practice where she worked: Before noon, she had taken nine calls from patients who said they were out of their pain pills.
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Then around the same time, a young, healthy cousin died from a prescription overdose.
Jeff Heitzenrater wondered why a pill bottle couldn't control how much a person was taking, like pain pumps that patients use in a hospital. With the help of Jeff’s uncle, Joseph Bujalski of Boynton Beach, Fla., and Robrady Design in Sarasota, Fla., the couple developed PILL, an electronically metered dispensing system for opioids.
The circular dispenser uses software that makes one pill available from a blister pack at predetermined intervals. Once that pill is used, the person has to manually rotate a dial on the back of the package and wait for the prescribed time to get another pill.
The electronics are self-contained and do not use wireless or cellphone signals.
“It allows for responsible prescribing, dispensing, use and tracking of controlled substances,” said  Afton Heitzenrater, who as a new physician assistant in an orthopedic practice wrote her share of prescriptions for pain medication.
“I think back pain was something that was notoriously controlled with opioid medication,” she said.
Because of what she said was her concern about the prescriptions, she helped institute an office policy that called for patients to sign an agreement for controlled substances and to participate in drug screening.
Her husband's uncle, her husband and two others in the Rochester area have patented PILL, an acronym that may end up being shorthand for one of these three phrases:
• Prescriber's Intended Limit Lock
• Prescription Intelligence Limiting Losses
• Prescribed Interval Limit Lock
She and her team are seeking feedback through an Internet poll.
The invention comes as federal regulators consider requiring blister packs for opioids.
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But in some ways, a blister pack is little better than a bottle — patients can take multiple tablets at once or someone else can take them to use or sell. By encasing the blister pack in tamper-resistant plastic and adding a timer,  Afton Heitzenrater said their invention makes a blister pack smart.
“This was an intervention early on, when they get that first prescription, to help prevent a person from taking this medication too often or more than prescribed,” she said.
Afton Heitzenrater and her partners are seeking money to develop a prototype that can be tested and put into pharmacies if it works as anticipated.
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“It means I made a difference,” she said. “I get emotional because of the loss of the family member.
"I have seen overdoses on a near-daily basis when I’m in the emergency department. I see what this does to the patient, their families,"  Afton Heitzenrater said. "And if we can intervene early on, if I can save one life, that’s worth it for me.”
How does PILL work?
PILL is a thin, hard orange plastic container holding a blister pack, a dial that is rotated from the underside of the casing and a computer chip set to release a pill when the prescription says so — every six hours, for example.
When the countdown display hits zero, a user can rotate the dial to expose the pill. The person doesn’t have to take the pill right away.
Once the pill is removed and the person turns the dial, the timer resets and the device is locked until the predetermined interval lapses.
A Robrady Design's mock-up of the PILL dispenser shows an outer case, electronics and locking mechanism on a timer, the pill pack and a dial that can be rotated when the timer counts down to 0:00.
The chip can be set to different intervals — shorter when a patient first gets the medication and longer after a few days as the individual's need diminishes.
When the medication is finished or the device times out after the length of the prescription, the patient returns the dispenser to the pharmacy.
Data then could be downloaded and a doctor could use the information or combine it  with data from other people with the same condition to study appropriate dosing. Some data might be specific to the patient.
How would this reduce the risk of addiction?
Not long ago, pain was considered a vital sign, right up there with a patient’s blood pressure, heart rate, temperature and breathing. Satisfaction surveys asked patients to rate how well their pain was controlled, and that could have been a factor in overprescribing opioids.
But more than 1 in 10 patients who receive an initial 10-day prescription for opioids are still using the drugs after a year, according to a nearly decade-long study from researchers at the College of Pharmacy at the University of Arkansas.
"It will flip a switch in them and cause the addiction,"  Afton Heitzenrater said. "There are others that think if one pill helps, … how much will two pills help? I think increased use and decreased time frame between your medications can cause some of that.”
Their electronic dispenser should serve as a safety check and help patients understand their treatment — similar to patients signing consent forms for procedures and surgeons initialing surgical sites, she said.
Some people she treats in the emergency room are afraid to use opioids, but the physician's assistant said the metered and timed dosage of the PILL would show patients that providers take potential risks of the medication seriously.
Colin Geer, a patient care technician who works with Heitzenrater, said college-age or elderly patients may benefit the most. Geer, 27, said PILL might have prevented him from becoming addicted when he was a college wrestler recovering from surgeries.
“A schedule will help,” he said. “It decreases the ability to take more. If I had this dispenser that said, ‘This is when you’re supposed to take it,’ it’s more difficult to abuse.”
Why does PILL look like a birth control case?
Heitzenrater said she and her husband initially thought about using a plunger or hopper to re-engineer a pill bottle. That's the design you see on the patent application.
But the team at Robrady wanted something less like a Rube Goldberg machine.
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“In this day and age with all the digital technology, you’ve got to embrace that,” said Rob Brady, chief executive officer and design director.
The team adapted the idea of a birth control disc because the packaging sends the message of being on a schedule. The color is the same as a pill bottle, so people would know they are dealing with a prescription.
“We are big into brand recognition,” he said.
How close is this to actually being used?
That depends on how quickly the Heitzenraters and Robrady can get money to make prototypes, persuade a drug maker to use the technology and start a clinical trial.
Jeff Heitzenrater's uncle, Joseph Bujalski, has been the force behind the patent and was its first financier, but more money is needed. The inventors are looking for angel investors — a lender to help them take their first steps — or other types of financing.
If things go well, a conservative estimate to start a clinical trial is a year.
The Heitzenraters’ timing is good. The Senate is considering a bill to allow the federal Food and Drug Administration to require blister packs for opioids.
She and the design team showed the mockup to congressional representatives and the FDA.
“This a fantastic idea,” said Dr. Bryan Gargano, associate chief medical officer at Rochester General Hospital. “I love the idea there’s a timer in it.”
He said PILL’s success likely hinges on laws about opioid packaging.
“If there’s not legislation, it will come down to doctors choosing this type of dispenser for particularly high-risk patients," he said. "And you’re going to have to get some kind of insurance prior authorization, most likely, and it will have less of a benefit than if there was broader implementation.”
Follow Patti Singer on Twitter: @PattiSingerRoc
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