Approval of Proteus's Digital Pill Gives Boost to Medicine Adherence
Medicine adherence is a major issue with some estimates that up to half of medicines are not taken as prescribed, leading to ineffective treatment, unwanted medical complications and extra costs to healthcare payers.
The US Food and Drugs Administration has now approved doctors to prescribe a "chip on a pill" which can measure whether and when patients have taken their medicines.
The digital pill has been pioneered by Proteus Digital Health, who spoke at the PING (Pharmaceutical Industry Network Group) 2015 annual seminar. Now the pill has been approved under the name 'Abilify MyCite'. Otsuka will now use the tracking in conjunction with Abilify - Otsuka's treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder and as an add-on treatment for depression in adults.
The way the system works is by sending a message from the pill’s sensor to a wearable patch. The patch then transmits the information to a mobile app so patients or other approved people can track the ingestion of the medication on a smartphone. Patients are able to permit certain nominated caregivers and physicians to access the information through a web-based portal.
Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill could improve public health, particularly where patients want to take their medicines but forget. However, he warned that if used improperly, it could foster more mistrust instead of trust.
This form of medication has led some to warn of a 'Big Brother' society. In addition, some have raised questions about privacy and whether patients might feel pressure to take medication in a form their doctors can monitor, as well as concerns over how secure the health data is kept.
In 2016, Proteus' sensors were approved as a medical device by the European Medicines Agency as a qualified method for measuring adherence in clinical trials in Europe.
Comment
We were delighted to award the PING Innovation Award to Proteus in 2015. We saw great potential and it is exciting to see them continue on their journey. Ultimately, this could make a difference to patients and payers, although they will need to persuade the doubters and how the concerns will be addressed.