pills

By Claire Sweeney, Research Scientist, ARCH.

Medication non-adherence is not a new problem and despite the seemingly exhaustive body of work on the topic, a one size fits all pill to cure this ill has thus far eluded researchers and policy makers. It’s estimated that up to 50% of patients with chronic conditions are to some degree, non-adherent with their medication regime. The consequences of medication non-adherence are far-reaching and include poorer clinical outcomes, poorer quality of life and early mortality for patients. The effects are also felt further downstream- medication non-adherence is estimated to cost European governments €125 billion annually1.

The benefits of adherence seem self-evident; medication only works if you take it. As Haynes et al asserted “increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments”. Pharmaceutical companies have recognised the gains which improving patient adherence offers to them, including increasing revenue through increased sales and providing proof of value to healthcare payers by improving patient outcomes. To this end, pharma companies are investing significantly in medication adherence initiatives.

There are many examples of digital interventions to combat medication non-adherence and these include digital tools and mobile technologies that provide alerts and reminders to take medication, wireless smart pill bottles and other electronic medication packaging devices. The most recent development in the digital artillery against medication non-adherence is the “digital pill” with the FDA approving the first such pill in November 2017. The drug licensed is Abilify MyCite, a drug manufactured by Otsuka Pharmaceutical containing the active ingredient aripiprazole, used in the treatment of schizophrenia and bipolar disorder. Medication non-adherence is particularly challenging in the context of these illnesses due to a number of factors including patients lack of awareness about their condition, social stigma and fragmentation of health service provision2.

adherance

Abilify MyCite combines the aripiprazole formulation with the Proteus Digital Health developed technology consisting of a tiny sensor, no larger than a grain of sand. Upon ingestion of the medication, the pill passes through the acidic stomach contents. This activates an electronic signal which transmits to a patch worn by the patient which then sends data including the time the medication was taken and the dosage to a smart phone via Bluetooth. There is also an app in which patients can log information about their mood and rest. With the patient’s permission, this information may then be accessed by up to four people, including the patient’s physician. Crucially, patients are custodians of this information and can revoke access at any time they wish, with immediate effect.

Digital pills are unique in that the data obtained definitively corresponds to a patient actually taking their medication (and not just opening the bottle as in the case of smart bottles). The reliability of this information, combined with the information about the patient’s moods may give valuable insight into the barriers which patients’ experience in adhering to their medication. It has been predicted that such digital monitoring systems may improve medication adherence and consequently overall patient outcomes. However, Abilify MyCite is the first drug licensed to use a digital ingestion tracking system and the ability of this technology to improve patient adherence with their medication regime has not yet been proven, only usability has been demonstrated in a small patient cohort3.

The choice of a medication used to treat mental disorders, often characterised by bouts of paranoia and delusions as the first partner for this new technology which monitors behaviour and sends a signal to doctors seems to me a little incongruous. To some degree, this is emblematic of many digital interventions aimed at targeting medication adherence. In many cases, the multidimensional constructs which are antecedent to medication adherence behaviour are largely ignored by those designing interventions. It is crucial to remember, knowing how technology works is insufficient, the question should we use them needs to be of equal importance. Pharmaceutical companies may have a conflict of interest with respect to pairing existing drugs in their repertoire with digital technology as this may create an opportunity to obtain fresh patents on drugs which have lost their exclusivity. The primary driving force of any technological advancement must be improved patient care and not increased revenue.

Digital tracking systems are under research in other areas too and could provide a cost-effective alternative to expensive directly observed therapy for tuberculosis therapy monitoring. In addition, a recent pilot study in the US illuminated upon the role of digital pills in fighting the escalating opioid epidemic4. Digital tracking of opioid consumption in outpatients could shed light upon the dosing requirements of patients; at present opioids are frequently prescribed on an “as required”  basis, leaving frequency of dosing at the patient’s discretion. It could also allow for early detection of those at risk of developing addictive partners, allowing for expeditious early intervention.

With patient empowerment becoming evermore prominent in the delivery of healthcare, the “digital pill” provides a paradox of sorts. On the one hand, digital pills may empower patients by allowing them to manage their own medication for longer and remain in their own homes by preventing unintentional non-adherence. In contrast, digital pills may be regarded as a sort of “biomedical big brother” as coined by the New York Times, subjugating patients’ control over their own medication regime. One of the most prominent concerns raised in relation to the digital pill is the potential for it to become a coercive tool where doctors, family members or even health insurers convince patients to use the digital tracking systems. As with any technology harnessing patient specific data, there are also concerns regarding the confidentiality and privacy of this information.

adherance

For some, digital pills may represent a retrograde step into paternalistic and to some extent, punitive models of patient care. However, this can be surmounted when the patient is a fully willing participant and is primary gatekeeper of the data created. Furthermore, there needs to be strict terms of use of the data, to prevent patients who are not fully adherent from experiencing blame or admonishment. Undoubtedly, technology is at the very core of driving process improvement within healthcare. But it is crucial to not always think digital first. Rather, the complex pathways underpinning non-adherent behaviour should first be explored, followed by digital deployment to alter crucial nodes in this pathway.

 

  • European Council Policy Makers Debate. An EU response to medication non-adherence. Brussels, 2010.
  • Haddad PM, Brain C, Scott J. Nonadherence with antipsychotic medication in schizophrenia: challenges and management strategies. Patient Related Outcome Measures. 2014;5:43.
  • FDA approves pill with sensor that digitally tracks if patients have ingested their medication [press release]. Maryland: FDA 2017.
  • Chai PR, Carreiro S, Innes BJ, Rosen RK, O’Cleirigh C, Mayer KH, et al. Digital pills to measure opioid ingestion patterns in emergency department patients with acute fracture pain: a pilot study. Journal of medical Internet research. 2017;19(1).