Approximately 50% of patients do not take their medication as prescribed, according to World Health Organization estimates. In addition to causing hundreds of thousands of avoidable deaths, this is very costly, with roughly $105bn in the US and €125bn in the European Union being spent on easily preventable emergency care.
Importantly, medication non-adherence is purely an issue in real-world settings, it also occurs in clinical trials, adding an unknown element when it comes to the accuracy of study results, according to Dr James Burnstone, CEO of Manchester-based health tech company Elucid. This is why the pharma industry recruits more people than necessary into trials, and non-adherence is also a contributing factor in the 90% failure of rate of clinical trials.
Burnstone and his team at Elucid believe they may have found a technological solution to the issue of medication non-adherence – a smart pill bottle linked with a mobile app called Pill Connect, which is currently being studied in clinical trials. “People don’t trick an app as much as they might want to, unfortunately, deceive a doctor,” Burnstone notes.
How can Pill Connect improve adherence?
As Elucid’s Pill Connect bottle and app combines the medicine itself with its dosing schedule, at a pre-determined time the patient is reminded through the app to take their pill. They respond to the reminder with the press of a button and the correct dose of medication is dispensed digitally from the bottle, which Burnstone hopes will “reduce some of the difficulties people find with [regular] medicine use”.
The data showing the patient has dispensed the medication is sent to a control centre, which can be accessed by the clinician or trial investigator, depending on the setting the bottle is being used in.
When a patient does not respond to the reminder, the pills remain inside the bottle and the relevant users are alerted. “[The app] can tell the trial investigator, ‘James did not dispense Tuesday to Thursday, so do not use that data to expect to see what happened inside of his body,’” says Burnstone.
The patient can choose to use the app to explain why they did not adhere, meaning Elucid’s product does more than just say whether or not a patient has dispensed their medication, it improves understanding of reasons behind the non-adherence – perhaps side effects or an inconvenient dosing schedule – and encourages action by the clinician or trial investigator.
Outside of the scheduled dosing times the Pill Connect bottle is locked, preventing double dosing, reducing waste and bolstering safety. Burnstone notes this is useful for Alzheimer’s disease patients, for example, who may not remember if they have already taken their medication for the day.
“There are other solutions where [technology] takes the cap off [the pill bottle], but that does not provide information on whether the patient has taken one or two pills, or whether they just put the cap back on,” says Burnstone. “We wanted to make it so our product actually [means] a single pill has been dispensed and gone into the patients’ hands.”
Not quite so smart pill bottles
Unfortunately, Elucid cannot be “100% sure that the patient has administered the drug” using Pill Connect, Burnstone admits; all the system can measure is “intent to dispense”.
However, he notes that “in our clinical trials to date, we found that people who go through the steps to dispense will take the drug. If they don’t want to take the drug, they won’t dispense.” He also hopes that since patients have an easy method to explain their reasoning behind non-adherence, this will reduce the “need for a [so-called] ‘fake dispense’.”.
Looking to the future, Burnstone discusses the possibility of combining a smart pill bottle with smart pills, which are currently in development. “We can control dispensing, access and reporting, and then the smart pill can tell us it [whether it] has gone in the body,” he says.
From R&D to market
Elucid is currently focused on collecting as much data as possible about the Pill Connect’s ability to improve medication adherence through clinical trials.
In addition to a recently- completed trial with the University of Groningen’s Medication Adherence Expertise Centre in the Netherlands, Elucid is on the verge of initiating a study in the UK with a consultant at the Manchester NHS Foundation Trust. This trial will be twice as long as the Groningen study, which only ran for two weeks, to test the “technical robustness” of Pill Connect, and lay the groundwork for larger studies.
Looking forward to a commercial launch for which there has been significant interest from pharma companies, Elucid will have an international focus because the product’s use in the clinical trial space requires this.
However, this global focus will bring a challenge to the company’s use of a pill bottle. Burnstone acknowledges that blister packs are the industry standard in many places, including the UK, and that “some drugs cannot be [stored] in bottles…for stability reasons”.
“There is a market where [Pill Connect] can fit, and there is market where it does not,” Burnstone says. However, he remains hopeful that the success of the product will make it the go-to adherence system where there is a choice of pharma packaging.