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.   References   1.  https://jamanetwork.com/journals/jamasurgery/article-abstract/2644905   2.  https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/why-we-need-bolder-action-to-combat-the-opioid-epidemic   3.  https://www.bmj.com/content/360/bmj.j5790   4.  https://www.aha.org/system/files/research/reports/tw/chartbook/2016/table3-4.pdf   5.  https://www.hhs.gov/opioids/sites/default/files/2018-01/opioids-infographic.pdf   6.  https://www.whitehouse.gov/sites/whitehouse.gov/files/images/The%20Underestimated%20Cost%20of%20the%20Opioid%20Crisis.pdf      Opioids      Addiction      Healthcare      Health      Health Technology        Sam Zamarripa   CEO at Intent Solutions  http://www.intentsolutions.com/

1 Comment

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.

References

1. https://jamanetwork.com/journals/jamasurgery/article-abstract/2644905

2. https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/why-we-need-bolder-action-to-combat-the-opioid-epidemic

3. https://www.bmj.com/content/360/bmj.j5790

4. https://www.aha.org/system/files/research/reports/tw/chartbook/2016/table3-4.pdf

5. https://www.hhs.gov/opioids/sites/default/files/2018-01/opioids-infographic.pdf

6. https://www.whitehouse.gov/sites/whitehouse.gov/files/images/The%20Underestimated%20Cost%20of%20the%20Opioid%20Crisis.pdf

  1. Sam Zamarripa

    CEO at Intent Solutions http://www.intentsolutions.com/

1 Comment

The Federal Focus on Packaging: Good News for Us

Comment

The Federal Focus on Packaging: Good News for Us

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.

###  


Comment

Getting Traction in Clinical Research

Comment

Getting Traction in Clinical Research

Sam Zamarripa

Traction in the clinical trials market: Our technology addresses more than the opioid crisis

Mention the term opioid crisis and you get attention. From members of the media, who don’t hesitate to devote space or air time to another story on the national epidemic. From lawmakers, who are under public pressure to do something about it. From healthcare professionals, teachers, employers—anyone who sees the epidemic’s ravaging effects on those they work with.

Helping solve the opioid crisis is something most people want to hear about. It’s the reason our company was founded, after all. The reason we developed our system for monitoring and managing prescription drugs. But helping people avoid the path to addiction is not the only use for our solution. We are gaining traction in other areas, too—especially in clinical trials, where a system like ours is sorely needed.

An end to the costs of adherence guesswork

Clinical trial administrators face a constant challenge with participant adherence—or the lack of it. Traditionally, trials have had no effective means of monitoring and managing in real time the way participants take their medication. Administrators must rely on participant notes or diaries submitted after the study is over—hardly a reliable way to trace adherence.

In fact, studies have shown that, even though medication adherence in clinical trials is generally reported as greater than 90% when based on subject self-reporting and pill count, the percentage is much lower when adherence is evaluated by periodic sampling of drugs in plasma or urine. While non-adherence can affect patient safety and ruin a trial, it is also costly. It has been estimated that it takes only 30% of participants who are less than fully adherent to require doubling the number of participants necessary to produce an equally significant study.

graph.png

 

Source: Shiovitz TM, Bain EE, McCann DJ, Skolnick P, Laughren T, Hanina A, Burch D. Mitigating the effects of nonadherence in clinical trials, Journal of Clinical Pharmacology, J Clin Pharmacol. 2016 Sep; 56(9): 1151–1164.

The costs are mind-boggling

The clinical trials patient recruitment firm Praxis has some eye-opening data about the cost of clinical trial delays. The company estimates the average cost of enrolling one patient in a trial is $15,700 for Phase 1, $19,300 for Phase 2, $26,000 for Phase 3 and $26,000 for Phase 4. These were the costs reported in July 2017. Other alarming stats from Praxis

The average dropout rate across all clinical trials is 30%.

The loss in revenue opportunity for niche drugs when a timeline is delayed is $600K per day.

The loss in revenue opportunity for blockbuster drugs when a timeline is delayed is $8M per day.

Almost 80% of all clinical trials fail to finish on time. 20% of those are delayed for six months or longer.

We deliver three key benefits to clinical trials

With stats like these, you can quickly see why pharmaceutical companies are showing strong interest in our solution. With tadTM collecting usage data from the moment the participants receive the drugs until they turn them in for reconciliation, clinical trial administrators get a precise accounting of adherence across the board.

Our system delivers:

·         Early detection of non-adherents. Administrators can quickly spot non-adherent participants and remove them from the trial before they have a chance to ruin the data and drive up the costs. With this early detection system, administrators are far less likely to reach a point where they need to expand the participant field.

·         Ongoing tracking of bona fide participants. For participants who stay in the trial, tad provides a clear picture of how well they are following the proper dosage pattern. It’s evidence that backs up administrators when they need to intervene or provide counseling to the participants about the importance of staying the course. No more notebooks. No more diaries. No more manual recording of dosage times and dates.

·         Accurate and speedy accounting. When a participant is kicked out for non-adherence, the drugs that were not taken must be returned and accounted for. The same goes for the conclusion of a trial—all the participants’ remaining drugs must be reconciled with the dosage diaries they kept. It’s a costly headache, and it can be eliminated with the tad system, which keeps a running real-time total of the pills that have been taken by each participant.

Many advantages over smart caps

There are many other advantages. Unlike smart pill bottle caps, another technology used in clinical trials, not just anyone can open the tad dispenser. tad’s biometric recognition system controls who has access to the drug and dispenses only the right dose at the right time to the right person. In addition, smart caps are easy to lose and, for patients with arthritis, difficult to remove and put back on. That’s not a problem with tad, which is the size of a smartphone and requires only the touch of a finger on the biometric keypad to dispense the correct dosage.

Our device can also be set up for windowed dispensation, meaning the pills will only dispense within a certain timeframe, as well as for dose titration, prescription tapering and remote prescription changes by the pharmacist per physician’s orders. Should there be an adverse event during the trial, the device can be locked so participants no longer have access to a drug. Smart caps offer no help in such a scenario.

A system “with legs”

There was a funny Business Insider article a few years back about products that were originally intended for a completely different purpose than the one they are known for today. The Slinky was developed to stabilize naval equipment on rough seas. Frisbees were pie containers. Play-Doh was a wallpaper cleaner. I’m certainly not putting tad in the same category as these products, but it is gratifying to see other uses for our system beyond the one that triggered the initial invention brainstorm.

To us at Intent Solutions, tad’s ability to solve many challenges in clinical trials is further proof that we have created a system that is going places. Helping patients. Helping companies. With the strength to bring significant change—and greater control—to any setting where people take prescription drugs.

Comment

Comment

Data makes the difference: Telling the life story of every prescription

Sam Zamarripa


Tangible objects are easy to talk about. “Do you like my new car?” “What kind of smartphone do you have?” “This tomato came from my own backyard.”

It’s the reason we usually lead with our device when we talk about what we do at Intent Solutions. It’s just easier to talk about tadTM and its abilities as a smart, automated prescription drug dispenser than it is to talk about our other solution: the data that tad generates.

Granted, it’s not as tangible as tad, but in the long run the data offers the real value to healthcare providers and clinical trial administrators. And it’s the reason I’m devoting this blog to describing its benefits.

tad can generate data and present it in a concise dashboard that provides every detail about what happens to a drug once it is prescribed to a patient. It tracks every time the drug is dispensed and by whom (through tad’s fingerprint recognition system), and it dispenses medication only as the prescription requires. It works like a Fitbit, tracking not footsteps but the minute-by-minute history of a prescription—all in a user-friendly app on a smartphone or computer.

 

In hospice care, tad’s data can solve diversion problems

In the case of hospice patients, for example, tad alerts hospice officials of any diversion attempt by unauthorized individuals to take or redistribute the drugs, or any attempt by anyone, authorized or unauthorized, to take more of the drugs and take them more frequently than the prescription requires. Problems are avoided quickly, with concrete evidence provided.

Should a prescription need to be changed or at the time of the patient’s death, tad provides a secure way for caregivers to return the remaining medications to the hospice organization for final accounting and disposal, and the data trail it provides is invaluable in helping the hospice reconcile the remaining medications with what was originally prescribed.

In hospice care, this is a very big deal. 

Whenever drug diversion is suspected in hospice care, it often boils down to a contest of wills or veracity between the professional caregivers and the family, and it’s left up to the hospice organization to decide if the drugs have been misused, abused or diverted to other uses. Not a good position to be in, especially with no precise record of how the drugs were administered after they were picked up or delivered from the pharmacy to the home. tad—and the data it generates—provides that record.

Current methods for preventing diversion—pill counts, lockboxes, limiting each prescription to only a few pills at a time, employee training—are costly and labor-intensive. No matter how carefully they are managed, they are only baby steps in the quest to solve a giant problem.

 

In clinical trials, tad makes adherence tracking an exact science

In another important market for Intent Solutions, clinical trials face a different challenge from hospice care. They struggle with accurately tracking whether participants in a clinical trial are taking their drugs as prescribed. 

Traditionally, trials have had no effective means of monitoring and managing in real time the way participants take their medication. Administrators must rely on participant notes or diaries submitted after the study is over, and then the number of participants may need to be expanded to account for uncertainties in adherence rates—increasing costs and slowing time to market.

tad reminds participants when it is time to take their medication, but it goes a step further. It also provides clinical trial administrators with a dashboard that keeps them up to date—in real time—with a clear view of usage data at every step of the trial’s progress. If adherence is a problem, administrators can spot it quickly and expand the field if necessary. If the trial is offering incentives to participants, administrators have solid documentation demonstrating the participants’ performance, and can intervene at any time to change the field.

Unlike smart pill bottle caps, tad controls who has access to the drug and dispenses only the right dose at the right time to the right person.

(While caps with a Medication Event Monitoring System were shown in a  to slightly improve compliance among patients with schizophrenia, lost caps were costly, and the study concluded that patient compliance with such monitors was only estimated, because they only recorded the number of bottle openings and the date and time of each opening. A more recent  published in 2017 in the JAMA Internal Medicine journal reported pill bottles with digital caps reminding clinical trial participants to take their meds had no effect whatsoever on adherence rates.) 

 

Removing the guesswork

At Intent Solutions, we think tad and the data it provides are far superior to these smart cap/smart bottle systems. While some of them do track the weight in the bottle as a measure of whether a dose was taken when it should have been, they provide zero control over who is taking the medication or who has access to the bottle. 

And while diversion isn’t the issue in clinical trials that it is in the hospice setting, isn’t it better to know precisely who triggered each dose of a medication, and when?

Knowing. That’s the difference Intent Solutions’ data makes. Whatever the environment, we’re removing a lot of the guesswork that—until now—has played a significant role in monitoring and managing prescription drugs. Sure, data might be intangible, but the results it delivers are real. 

We’ll be sharing some of those results when we report in a future post on a current pilot project with tad in hospice care. 

Comment

Setting the new standard for administering opioids and other prescription drugs

Sam Zamarripa


rawpixel-600792-unsplash.jpg

Every successful business or product starts by answering a fundamental human need. Granted, some needs are more urgent than others. Antibiotics? Pretty urgent. Refrigerator door ice dispensers? Not so much. Driverless cars? The jury is still out on that one.

What about a solution to the opioid crisis? Bingo. Everyone—from physicians to government leaders, from Boomers to Millennials, from employers to teachers, from EMTs to medical examiners overloaded by the sheer number of overdose victims requiring autopsy—all agree that something must be done. The numbers are old news by now: The CDC and National Center for Health Statistics (NCHS) report that more than 115 people die in the U.S. every day after overdosing on opioids. Research shows that roughly 21-29% of patients who are prescribed opioids for chronic pain misuse them. 

Something must be done, indeed. That’s the reason Intent Solutions was founded. 

It’s not just the numbers that moved us. Two of our founders have a friend who struggled and recovered from opioid addiction after hip surgery. I discussed a little more detail about it in a recent interview with Crain’s Atlanta Newsletter. In addition, we knew that Georgia, our home state, has one of the highest numbers of prescription opioid overdose deaths in the U.S. But our company’s goal is more far-reaching than tackling the opioid crisis in Georgia.

Putting the control back in controlled substances

Our platform includes an automated dispensing device—tadTMfor “take as directed.” It controls prescription drug dosage and collects usage data that up to now has been unavailable—data that can prevent the misuse, abuses and diversion of opioids and other prescription drugs. Current methods for tracking prescription drug adherence rely on pharmacy refill rates, which provide an inexact picture of prescription compliance or non-compliance by patients and caregivers. Our mission at Intent Solutions is to change all that—to set a new standard for administering opioid and other prescription drugs, and to render current methods obsolete.

If you think about the evolution of the pill bottle—from a little cup, a little glass, an open vial, to plastic—the first major innovations with the pill bottle came with the Poison Prevention Packaging Act and then later with the Tylenol scare in 1982, when people died after taking Tylenol laced with potassium cyanide. Within a matter of months, every pill bottle cap in America was then not only child-proof, but it was also sealed. Those innovations were two of the last big innovations in how we manage the vile itself.

At Intent Solutions, we believe that technologies like ours have a big role to play in improving adherence, and it is heartening to see the interest from the U.S. Congress, the Centers for Disease Control (CDC) and a range of statewide organizations in how we can be part of a broad-based solution to the problem. We’ll be reporting our progress in future blog posts. 

The good news about prescription opioids is that they work. They can relieve pain in people that are suffering with chronic pain. Our device gives them a level of safety that didn’t exist before, and it gives their doctors the ability to monitor them more carefully. That, in our view, is a combination destined for success.