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Poor adherence to prescribed medications is a major public health problem in the USA and worldwide, leading to substandard management of diseases and their associated symptoms, as well as increasing healthcare costs.1 The development of innovative technologies to improve medication adherence is important and may hold promise, but any new technologies need to be supported by robust evidence of patient benefit and safety prior to regulatory approval, clinical uptake and payer reimbursement.
Most technologies developed to improve medication adherence are ancillary or supportive: automated pill dispensers, mobile phone applications that remind patients to take their pills, or smart pill bottles that track when a pill is removed.2 Proteus Digital Health’s ingestible sensor reimagines the way technology is used in medicine. The sensor is embedded within an oral tablet and transmits a signal to a wearable patch after exposure to stomach acid, providing patients and their clinicians with trackable ingestion data on medication use. The intent of the product is to improve medication adherence, but it may also have additional benefits, such as mitigating the risks of overdose and abuse.3 Since the sensor was cleared by the Food and Drug Administration (FDA) as a stand-alone device through the 510(k)-premarket notification process in 2012, Proteus has collaborated with several manufacturers to embed the sensor directly into FDA-approved drugs.4 In November 2017, Abilify MyCite, which combines the atypical antipsychotic, aripiprazole, with Proteus’ digital sensor, became the first FDA-approved digital medicine system, a drug–device combination that measures and reports medication ingestion.5
In this issue of BMJ Evidence-Based Medicine, Cosgrove et al systematically reviewed the evidence supporting FDA’s …
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