Author: Novarum DX
Late last year the FDA cleared a pill with an inbuilt ingestion tracking system. Remarkably, the tablets have an inbuilt sensor that is aware when the medication has been taken and data is transmitted to a patch worn outside the body. This lets clinicians know whether patients have been taking the prescribed dose of medication needed to treat their mental health condition.
Only a few years ago, such technology would have seemed like science fiction and the idea that the FDA would have embraced it would have seemed just as far-fetched.
Does this herald a new era for pharmaceuticals where every drug will need to be augmented with an ingestible pill and proprietary monitoring system? Probably not. There will, however, be digital technologies that can complement a far wider range of treatments.
While patient compliance is a challenge across the pharmaceutical industry, some areas of healthcare are more vulnerable than others. Management of conditions like cholesterol present circumstances where patients don’t see or feel rapid symptomatic benefit. In these cases, compliance can be more problematic than for patients who can directly link the medication to a physical improvement in their condition and are therefore motivated to continue treatment.
Likewise, the timing, mode of administration and frequency have an impact on patient compliance — taking one tablet first thing in the morning is an easy routine to adhere to, compared to having an injection on every three days, for example. However, only the most complex situations would benefit from having ingestible pills (or similar tracking technologies for other drug formats). Most patients aren’t aiming to deceive, they simply forget or lose motivation to maintain their treatment regime.
The digital revolution means that most patients already have technology in their pocket loaded with an array of sensors and communication technology. By comparison, the patient information leaflets that are supplied with drugs, lack user-friendliness and interactivity.
Even the most routine over the counter medicines could build both brand loyalty and provide meaningful, accessible, useful patient information with the introduction of interactive mobile apps.
How many of us have taken paracetamol (acetaminophen) for a headache, for the symptoms to recur shortly after, only to be uncertain when we took the original dose? Imagine a QR code on the packaging which seamlessly helped you track your usage, perhaps also providing warnings about incompatible medications and alerting the user about the risk of prolonged usage patterns.
What if your prescription dosage was automatically uploaded to your phone and prompted you with reminders? Perhaps you could confirm you had taken the dose or ‘snooze’ the alert till later? You could also log some simple symptomatic observations, all of which might be easily summarised to help prompt discussion with your doctor and optimise future treatment.
Of course, we are already starting to see sophisticated usage trackers getting added to inhaler technology. Meanwhile, as insulin pumps become ever more sophisticated, they can provide a wealth of information back to clinicians and patients alike.
They may become swamped with data and we will need intelligent decision support tools to help extract the pertinent data. This could provide an opportunity for pharmaceutical manufacturers to differentiate products in competitive spaces.
However, none of these technologies provide any real-time information on the effectiveness of the dose — if what you really want to track is the concentration of the drug in serum, it may be better to do exactly that. Indeed, there is growing interest in the pharma world towards adding complementary diagnostics to their therapeutics, these would be able to track a condition specific biomarker, the drug itself, or in the case of biologic drugs — antibodies to the drug.
Patient convenience means that if the therapy is being administered at home, it’s likely this monitoring would be performed by the patient themselves using simple point-of-care style diagnostics. Once again, the patient’s own phone becomes a useful tool to help provide instructions, record and share the result and even to measure the response on the test itself.
In my mind, the question is no longer whether regulators will support clearance of such technology-supported-therapeutics, but rather which manufacturer is going to be at the forefront of the new era? As the tech giants like Apple, Google and Amazon increasingly join the mHealth (mobile health) space, the pharma giants will benefit from investing more in digital healthcare to ensure their value proposition remains strong and that they are not left behind.