A ‘digital pill’ is a pharmaceutical dosage form that contains an ingestible sensor inside the pill. The sensor begins transmitting medical data after it is consumed, once it is activated by acid in the stomach, generating a signal that is picked up (usually by a patch worn by the patient) and transmitted to a smartphone app. A missed signal indicates a missed dose, giving the smartphone app an opportunity to remind the patient to take his or her medication.

Evolving World of Pharma: Digital pills – should I be more excited?

The first digital pill to be approved by the US Food and Drug Administration (FDA) was a version of aripiprazole (Abilify; Otsuka Pharmaceutical), which is primarily used in the treatment of schizophrenia and bipolar disorder. The drug is taken by people with schizophrenia. People with the condition tend to have problems with adherence, and the digital pill could help with that, as the purpose of the sensor is to determine whether the person is taking their medication or not. The sensor – made of copper, magnesium and silicon – is designed to send an electrical signal to an external receiver once the pill mixes with stomach acid, providing clear confirmation that the medication has been taken.

Clearly, for any drug to be efficacious, it must be taken as prescribed. However, with up to 50% of patients not complying with their treatment regimens, medication adherence is a huge challenge for healthcare systems across the world. The number of ‘a(chǎn)dherence tools’ – special packaging (labelled with days of the week), reminder charts, pill organizers and dispensers, and even fridge magnets and toys – that have been developed to address this problem is testament itself to the size of the challenge. More recently, text message reminders and other digital solutions have joined that list, but none of these provided validated evidence that a person has actually taken their medicine.

This is why the digital pill was celebrated to such wide acclaim when it was first approved. Assuming that people taking digital pills remember to wear the accompanying detector patch (which needs to be replaced every week to collect signals from the pill sensors), and assuming they pay attention to any reminders issued by the smartphone app in the case of a missed signal, its arrival offers a novel, validated way of tracking and encouraging drug compliance. This is already available for people with schizophrenia, and the technology is also being applied to other areas of medicine, such as uncontrolled hypertension and type 2 diabetes. Plans to measure adherence in people with Alzheimer’s disease and hepatitis C have also been documented.

The technology offers a path for better self-management for a range of chronic conditions which, by the very nature of their chronicity, are associated with adherence problems. With my widely known passion for digitalization of all things medical, this should fill me with excitement. But while I can see some of my nerve endings standing up in anticipation, I don’t think I feel as excited as I could.

Why am I not more excited?

Well, firstly, I know that not all non-adherence is unintentional. Some non-adherence to prescribed drugs is deliberate – perhaps because patients feel they no longer need it, they don’t wish to risk or experience side effects, they want to make expensive drugs last longer, or they just don’t like the taste. In fact, a 2016 study of elderly patients with hypertension suggested that as many as a half of those not complying with their medication regimens did so deliberately (Bae et al, Patient Prefer Adherence 2016). For those patients this technology isn’t going to make any difference. I don’t think that reminding people to take a drug that they don’t intend to take will make them take it, so the idea that a digital pill can resolve the issue of non-adherence is – in my own view – over-simplifying the problem.

Secondly, with such an array of biometric data available to us, focussing on medication adherence feels like a bit of a wasted opportunity. I will be excited – I promise – when the first digital pill for collecting other biometric information, such as vital signs, is approved. And I will be very excited indeed when that information feeds back automatically into a treatment loop for that patient, creating a holistic picture of one person taking a specific drug and helping to optimize that individual’s treatment plan and dosage for a truly personalized medical management approach. 

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and has more recently taken up the role of Editorial Director at Chemicals Knowledge. She continues to also provide independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

-----------------------------------------------------------------------
Editor's Note:

To become a freelance writer of En-CPhI.CN,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.