Big Brother is Monitoring your Adherence
What does FDA approval of a pill that tracks drug compliance mean for privacy?
Patient non-compliance is a known issue, with some sources touting alarming statistics. In the US, for example, 75 percent of adults do not follow the doctor’s orders when it comes to taking medicines, and 125,000 deaths in the US alone are thought to be attributed to nonadherence (1).
The issue needs to be tackled. A variety of factors can influence whether patients take their medicine and much attention has focused on how the color, shape and size of a pill can all play a role (2). Technology is also starting to come to the fore with ingestible sensors that can track when a patient takes their medicine – and report back to health practitioners. In mid-November, the FDA approved a new dosage form of Abilify (aripiprazole; used to treat schizophrenia) (3). Each Abilify MyCite tablet contains a sensor that, when in contact with stomach fluid, sends a message to a wearable patch which in turn connects to a mobile app. Patients can track their adherence on their smartphone and, if permission is given, so can care givers, family members and physicians via a web-based portal. The pill is made by Otsuka Pharmaceutical and the sensor – no larger than a grain of sand – comes from Proteus Digital Health.
The pill was initially rejected by the FDA last year, who requested additional information including data on “the performance of the product under the conditions in which it is likely to be used, and further human factors investigations” (4). The new approval suggests that the FDA’s concerns have been addressed, but the pill is likely to open a can of worms around privacy and ethics. Is it right to force patients to use digital pills? And will there be consequences from insurers or payers if patients do not comply? It’s worth pointing out that the patch can track more than just pill taking; Proteus’ technology can also measure patient activity and rest.
Whether the “Big Brother” pill can actually boost adherence remains to be seen – and the FDA release explicitly states that there hasn’t yet been an established association between the new pill and increased adherence. With schizophrenia and other psychotic disorders, adherence can help prevent relapse, but patients can also suffer from paranoia and delusions; would a digital pill induce further paranoia? However, it’s clearly useful for physicians and family members to know whether medication is being taken by patients at risk – and a reduction in nonadherence could remove a huge burden from healthcare in general.
It will certainly be interesting to see how real-world use plays out and who benefits most in the end.
Stephanie Sutton
Editor
- RM Benjamin, “Medication Adherence: Helping Patients Take Their Medicines As Directed”, Public Health Rep., 127, 2-3 (2012).
- RAPS, “FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence”, (2014). Available at bit.ly/1Dfwbhx. Last accessed November 15, 2017.
- Proteus, “Otsuka and Proteus Announce the First U.S. FDA Approval of a Digital Medicine System: Abilify MyCite (aripiprazole tablets with sensor)”, (2017). Available at bit.ly/2hytCHO. Last accessed November 15, 2017.
- Proteus, “FDA Issues Complete Response Letter for Digital Medicine New Drug Application”, (2016). Available at bit.ly/2es3RBg. Last accessed November 15, 2017.
Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.
