Digital pills

Later this year microchip-embedded pills that monitor medication adherence, physical activity and haemodynamics will be released through a UK pharmacy chain. Catherine Hanrahan investigates whether it’s a pill Australian doctors are ready to swallow.

A man wakes up and swallows a routine handful of medications for controlling his diabetes and cardiovascular disease. He clicks on his smartphone, boots up a screen showing he only had four of his five medication sets yesterday, took 4302 steps, had a resting heart rate of 65 and slept for 7.5 hours. 

Hidden in one of the pills is an ingestible sensor transmitting this information to his smartphone via a small bandaid-like patch on his shoulder.

It sounds like science fiction but it is exactly how some British patients will be managing their medication regimens by the end of this year, and the implications look to be far reaching. 

Or are they?

Lloydspharmacy, a British high street pharmacy chain, and Proteus Biomedical, a US company specialising in digital ‘intelligent medicine’, signed an agreement in January to commercialise Helius, a digital health system designed to help patients and their carers manage their medications.

The Helius system (see box) will be incorporated into Lloyds­pharmacy’s existing blister packaging service that is intended to improve patient adherence.

“The Helius system is an exciting development which takes our current medication adherence offering to a whole new level,” Steve Gray, director of Lloydspharmacy healthcare services, said in January.

The program will be piloted in selected Lloydspharmacy pharmacies in September, although the cost to patients is yet to be finalised, a Lloyds­pharmacy spokesperson told MO. Media reports earlier this year suggested Helius would cost about £50 ($75) per month.

With the WHO estimating that half of patients do not take their medication correctly,1 and the Australian federal health department estimating non-adherence costs the public hospital system around $660 million annually,2 non-adherence remains one the biggest challenges facing healthcare. 

A technology-based solution such as Helius could offer patients a novel way to improve adherence to their prescribed medicines, but it opens up a host of questions – privacy concerns over transmission of personal health data, regulatory hurdles for such a device, and whether there is evidence that high tech monitoring adherence really does help bridge the adherence gap. 

Associate Professor Chris Pearce, director of research at the Inner East Melbourne Medicare Local and a GP with an interest in e-health, says the Helius system is a very interesting idea with lots of potential, but it won’t improve adherence.

“What it will improve is the monitoring of compliance,” he says. Existing ways of measuring adherence, such as monitoring scripts and pill jar opening, are “clumsy or imprecise”, according to Professor Pearce. 

“I’m not sure that, if people really don’t want to take the tablets, that they still won’t take the tablets, but there’s an awful lot of compliance that we don’t appreciate at the moment because its hard to monitor,” he says.

But the company responsible for creating Helius says the device is intended to assist healthcare professionals and carers to help patients. 

“What we are trying to do is put better tools in the hands of people to help them with adherence and to allow [other] people to help them,” says David O’Reilly, chief product officer for Helius manufacturer Proteus Biomedical.

“If you can give information-based tools to support someone and to build feedback loops into that to educate, motivate and inform, we think people will be able to [adhere] more successfully,” he says.

Helius will initially be marketed to older patients living at home who need assistance from a carer. 

The patient could share the information transmitted by the sensor with their family carer and also their healthcare professional, either a pharmacist or GP, if they chose to, according to Mr O’Reilly. 

However, a Lloydspharmacy spokesperson said they had not yet explored the opportunity to share the information with a healthcare professional.

Then there’s the question of whether data transmitted by the sensor to the patient’s mobile device is secure. 

Mr O’Reilly says the sensor patch communicates with a mobile device or computer via Bluetooth radio and is therefore as safe as other Bluetooth devices like mobile phones.

“We are using highly encrypted private technologies that have been developed by the consumer electronics, financial and communications industries to protect these other types of communications,” he says.

Ric Day, professor of clinical pharmacology at UNSW and St Vincent’s Hospital, says Helius is an interesting and good idea to improve patient adherence, but any sharing of information between the patient and their doctor would need to be mutually agreed.

“Used well and judiciously and in full partnership with the patient, it could be helpful in some people,” he says. 

“I think you don’t want a differential power struggle going on with blame games, which could easily happen with this technology.

“It’s an interesting idea, and if it could be incorporated [into clinical practice] in a scaled way and used to help adherence, it’s a good direction, but it needs a lot more research,” Professor Day says.

He adds that if the rationale of Helius is to aid adherence, then clinical outcomes such as reduced exacerbations of a particular sort, such as cardiac failure, respiratory admissions, morbidity or mortality, have to be shown.

Published Helius data demonstrate that it detects the ingestible marker with 97% accuracy and is safe, but does not include any clinical outcome measures.3

Mr O’Reilly defends the lack of outcome data, saying it should be compared not with clinical trials for new drugs, but with other devices like blood pressure monitors or blood glucose metres.

“We are not developing a drug, this is not about the efficacy of a new drug, it’s about medications and therapies that have been demonstrated to work if used properly,” he says.

A Lloydspharmacy spokesperson says they will undertake the necessary due diligence to ensure the product will meet all regulatory requirements in the UK before launch. 

However, Professor Day says getting regulatory approval, at least in Australia, for a system such as Helius, is not straightforward.

“There are all sorts of issues when you put this [sensor] on a pill because it becomes the product… so it’s a drug-device combination,” he says.

“There’s also the matter of the detection system, which might be called a companion diagnostic, so there’s the regulatory side, the outcomes side, the cost effectiveness side, and then matching the need to particular subsets of people with what’s been proven.” 

Proteus Biomedical will eventually aim to get regulatory approval for Helius in Australia.

Professor Pearce says these kinds of mobile technologies are just the “tip of the iceberg” of what’s possible.

“I think it’s a whiz-bang idea and [there’s a feeling] that if you’ve got a new technology, you should start using it, but I don’t think we should do that,” Professor Day says.

“We should really have a good rationale and that requires evidence.”

How the Helius ‘intelligent medicine’ system works

1. Pharmacist includes placebo* tablet with 1mm ingestible marker in patient’s personalised blister medication pack for each dosing session.

2. Patient takes the sensor tablet, which dissociates and is activated by gastric fluids. It communicates a unique identifying signature to a personal monitor worn by the patient.

3. Personal monitor similar to a wound plaster is worn on the patient’s torso and time-stamps the drug taken, its dose and time of ingestion. It also reports heart rate, respiratory rate, physical activity and body position to a mobile device using Bluetooth technology.

4. Mobile device receives information from the body sensor.

*Proteus Biomedical has signed an agreement with Novartis to develop sensor-based technologies that are incorporated into organ transplantation drugs.

1. www.who.int/mediacentre/factsheets/fs338/en/index.html

2. Australian Department of Health and Ageing. Evaluation of the DAA/PMP programs. June 2010. 

3. Au-Yeung KY et al. Early clinical experience with networked system for promoting patient self-management. Am J Manag Care 2011; e277-e287