The good news: the tech boom has not overlooked us. The bad news: we can look forward to even closer scrutiny and deeper intrusions into our privacy when technology is used to invade and monitor our bodies from the inside.
The Emergence of Trackable Pill Technology: Hype or Hope?– By Mark A. Young, MD, MBA, FACP and Lauren DiMartino – June 8, 2018
Technological advances in the domain of wearable medical technology have optimized delivery and efficiency of healthcare throughout the medical spectrum.
This is such typical MBA jargon, the kind found in every cliché about finance nerds, that I find it jarring here.
This isn’t a medical article, it’s a marketing brochure to attract financial investors to profitable businesses. All the businesses that have sprung up to monitor pain patients have been very profitable (like drug-testing labs and PDMP database software).
The combination of wearable technology with a Digital Ingestion Tracking Program (DITP) embedded within a pill has further enhanced functionality. Within the field of pain management, there is an emerging application for the use of this dynamic combination.
So now we’re supposed to swallow a tiny computer in every pill to make sure when and how it actually traveled through our bodies. This is a whole new level of intrusive monitoring developed for us.
They claim it’s for diseases like high blood pressure that require regular medication. Top many patients forget to take, don’t take, or don’t even purchase their expensive meds these days and then they end up in the emergency room with a stroke.
However, by now I’ve learned how much effort is being directed at arbitrarily limiting opioid use that I’m certain this technology will be used on us. Isn’t high tech amazing?
(Of course, any additional cost incurred by putting a tiny computer in every single capsule will be borne by the patient, just like we’ve had to absorb the higher cost of abuse-deterrent opioids)
Heralding a new era in pharmacotherapeutics, the US Food and Drug Administration (FDA) has recently approved the first-ever medication equipped with DITP.
This revolutionary advance has created huge potential for further expansion of the technology to other pharmacological agents, including pain medication.
It’ looks like this company will try to position itself as another cure for “opioid use disorder” and only use its applicability in other health conditions as window dressing to seem more equitable (see, you ALL benefit!).
How it Works
Digital Ingestion Tracking Program functions through a closed loop program in which the patient has full control.
Yes, the patient can decide not to use the data gathered, but good luck getting more medication if you refuse to go along with this invasive monitoring.
As with our “opioid contracts,” we are being coerced at every turn. They have us over a barrel and they know it so they can ask us to do pretty much anything. Is this really a choice?
What other medical scenario involves telling a patient: you can either give me total control over every dose of this medication you take (and when and how) and not deviate the slightest bit from the “as prescribed” schedule or I won’t give you this quality-of-life-saving medication (and make sure no other doctors do either by writing about your “non-compliance” in your medical chart).
Embedded within each pill is an ingestible event marker (IEM), which is a unique sensor designed to track drug ingestion. The IEM is made of a copper, magnesium, and silicon assembly that allows the patient’s stomach acid to function as an organic battery.
The IEM offers a safe option for transmitting secure information to a wearable patch worn by the patient. The signal is transmitted from the wearable patch to a mobile application on the patient’s smartphone. An additional signal is sent from the smartphone application through the cloud to a secured web portal that the physician is able to access.
This process allows patients, caregivers, and healthcare providers [and law enforcement, like with PDMPs -zyp] to conveniently monitor ingestion of medications.
The advantages of DITP are multiple, including improved patient compliance and enhanced adherence.
By equipping a patient with DITP, physicians are able to corroborate whether the patient has taken the prescribed pill and at precisely what time.
For patients on pain medication, this information is immensely important as compliance is a cornerstone of proper pain management.
The word “compliance” bothers me more and more. Only prisoners are expected to be “compliant”, versus other groups we belong to, like students, co-workers, and neighbors, are expected to be “cooperative”.
“Compliant” implies absolute control over a submissive victim, and it’s often not benevolent.
Parents and teachers have roles of benevolent control, while dictators and tyrants (and jailers) exercise demeaning and destructive control, demanding complete submission from their subjects, compliance at any cost.
That’s what is demanded of us: submissive compliance.
The anti-opioid activists don’t give a hoot about the outcomes of their edicts: pain, depression, suicide. But if we don’t “comply” with their exact instructions for whatever minuscule amounts of opioid they might deign to prescribe us, we face losing access to all opioid pain relief now and in the future.
As a pain patient who takes opioids, this is an endless nightmare. My life depends on a healthcare industry, specifically pain management, to approve my continued use of opioids. I need that medication to survive this life.
Knowing that a patient has consumed his or her prescribed medication, as directed, may enforce and support statutory safeguards and prevent improper diversion of pills or overdose.
Why in the world would they describe “safeguards” as “statutory”?
I looked it up and statutory means: “(Law) prescribed or authorized by statute – subject to a punishment or penalty prescribed by statute”.
I thought “safeguards” were there to reduce medical errors and assure good outcomes for the patients, but this shows that their aim is to “enforce and support” legislated (unscientific and arbitrary) dose limits.
In the event that a patient chooses to deviate from his or her original dosing schedule, the DITP updates the portal, allowing the physician virtual access to patient information.
This is almost funny, it’s so obnoxious.
So, this pill you’re taking at the “wrong time”, while it’s slithering through your intestines, is going to “rat you out” (update) to your doctor/cop (the portal) who’s monitoring your digestion via tiny sensors in the pill you took.
Despite the benefits, there are several salient limitations of the DITP including:
- potential for a “false-negative” response,
- increased cost,
- passive notifications to providers, and
- possible[?] privacy concerns.
Well, if it’s either that or not get any opioids anymore, possibly be branded with OUD (Opioid Use Disorder) and never again being prescribed opioids…
As they say, BOHICA – bend over, here it comes again.
While DITP helps to positively identify whether a patient has ingested a prescribed narcotic embedded with an IEM sensor, it does not necessarily ensure that the patient has not simultaneously ingested a non-IEM pill in an effort to overmedicate.
The wording here sounds like it’s coming straight from the DEA: they still refer to opioids as “narcotics” to stigmatize them as much as possible.
The current era of opioid hypervigilance and public focus on the ill effects of narcotic medications (ie, opioids) has led to a heightened realization of the importance of optimized tracking methods.
…and this is the service they are selling. Now they’re not even pretending to talk about anything other than opioids anymore.
Technological solutions such as DITP offer a novel opportunity in this arena.
This same boilerplate text could appear in glossy marketing materials for just about any industry. These are the usual generic statements from financial companies, focused on the money-making opportunity and with little interest in the specific product.
One recent study explored the clinical utility of DITP in emergency room pain patients. The Harvard findings demonstrated that a digital pill is a reasonable method to measure opioid consumption patterns in patients with acute pain.
“Reasonable method?” Reasonable for who? Now the opioid-police are not only in the examining room with your doctor or over the counter at the pharmacy, but in your own guts too…
Use of DITP further allowed intervention when opioid abuse was detected. This study revealed a 90% medication adherence to ingestion of prescribed opioids.
DITP may provide an innovative strategy for enforcing the proper use of opioid drugs.
Medicolegally, there are distinct advantages for pain practitioners to vigilantly monitor opioid use, adherence, and compliance among patients.
Medico-legally? What has happened to the “medical visit”? Now we have not only the DEA with our doctor in the “private” exam room, but lawyers as well.
With non-compliance or non-adherence to physician-prescribed regimens growing, and estimated at 100 billion dollars per year[?], the use of DITP may help ameliorate the issue.
The sentence above doesn’t even make sense. And how can non-compliance and non-adherence be growing when opioids are prescribed so much less? This is clearly a fabricated statement of convenience – the truth hardly matters anymore.
It sounds like a garbled text from some standard marketing/sales materials used for all the other companies this company might be promoting to investors.
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And another article about insidious monitoring of pain patients:
Sampling of Available Smart Bottles – by Michael Crowe, PharmD, MBA, CSP, FMPA – July 2018
There are many smart bottle companies competing today. In a prior article, the most common features of smart bottles were covered. In this article, a glimpse into 4 specific products (GlowCap, AdhereTech, CleverCap, and SMRxT) is given.
These 4 aren’t the only ones available, but they do represent the varied means by which smart bottles record medication adherence and are some of the most well-known products in the space.
Glowcap is probably better defined as a smart cap than a smart bottle. The cap provides visual and auditory reminders when it is time for the patient to take his or her dose. The action of removing the cap at the dosing time is equated to a taken dose.
GlowCap has a companion mobile app, as well as an adherence portal. The patient can decide with whom to share their adherence record, whether it be prescribers, pharmacies, or caregivers.
Compared to GlowCap, the Adheretech bottle moves the technology from the cap to the actual container. Cellular functionality is incorporated into each of its bottles, meaning patients don’t have to pair the bottle with a wifi hub, or app on a mobile device. However, there is a portal where healthcare providers can view their patients’ adherence levels.
Like GlowCap, Adheretech equates a dose to removal of the cap at dose time; however, it also incorporates something called capacitance, which is similar to how your smartphone’s screen registers touch. In the same way that your phone can detect two fingers on the screen, the AdhereTech bottle can sense an approximate number of doses remaining based on the capacitance at the floor of the bottle’s interior.
With CleverCap, the technology is all in the cap, as it was with GlowCap. However, rather than cap removal equating to a dose, the CleverCapdevice has a door on the device, and internal mechanics that can be calibrated to track precisely how many dosage units were removed and when. This is helpful as we know that patients don’t solely open their bottles to take a dose; they might remove the cap to determine if they need a refill or to confirm the color or imprint on the dosage unit.
Like AdhereTech and CleverCap, SMRxT incorporates cellular connectivity into its bottles so patients are not required to connect the bottle with wifi or pair the bottle with a hub or device. It can also communicate with the patient, caregivers, or healthcare providers.
What is unique about the SMRxT system is the ‘way’—no pun intended—in which it measures a dose taken. Each bottle sent to a patient is precalibrated with the weight of each unit (tablet or capsule) and the patient’s dosing schedule. Each time the patient sets the bottle down on a level surface, the bottle weighs the contents. If it detects a weight reduction, it will record that as a dose
Depending on the time and amount, it may be categorized as an on time dose, a partial dose, an extra dose, or a late dose. Missed doses are also recorded. These dosing trends can be monitored over time and, if helpful to the patient, the dosing window can be adjusted remotely by the pharmacy.
The smart bottle space is certainly one with many potential benefits and choices.
Again, who are the intended beneficiaries of all these “many potential benefits and choices”?
Perhaps these tools might be useful in the relatively rare circumstances when people who are addicted to opioids must also take them for pain or for patients with the beginnings of dementia.
But for the average pain patient, these are just a reminder that we are simply not trustworthy, a judgment based solely on the fact that we use this type of medication for our chronic pain.
Michael Crowe earned his Doctor of Pharmacy from Ferris State University and completed a PGY-1 community pharmacy residency.
He founded the Genesee County Pharmacists Association in 2011 and earned an MBA from The University of Michigan in 2013. He has served on the Michigan Pharmacists Association Executive Board for over four years, currently serving as Speaker of the House of Delegates.