The ethics of smart pills in South Africa

Abstract

Smart pills are a new form of medical device technology that combines traditional pharmaceutical tablets and capsules with digital microchips. The primary function of smart pills is to detect medication ingestion events and monitor adherence. After ingestion, the smart pill sends a signal to a receiving device which collects data such as the medicine name, type, dosage and time of consumption. Objective adherence monitoring leads to improvements in adherence parameters and clinical outcomes in diseases such as diabetes, hypertension, TB and HIV. Reduced wastage of medicines and better healthcare resource utilization are additional benefits. Clinical trials have demonstrated the efficacy, safety, convenience and cost-effectiveness of smart pills.

Smart pills may enable a new standard of digital adherence monitoring in TB treatment programs, where wirelessly observed therapy (WOT) could replace the current mandatory approach of directly observed therapy (DOT). The ethical issues of smart pills include patient privacy concerns due to pervasive surveillance, confidentiality and data management and trust relationships between clinicians, patients and payers. Affordability and access to smart pills are important considerations in poorer communities.

Smart pills are ethically justified in South Africa, when viewed from a bioethical principle-based perspective. The principles of respect for autonomy, beneficence, non-maleficence and justice can be upheld with appropriate oversight of smart pill technology. The opportunity to improve clinical outcomes and reduce wastage is particularly appealing from a utilitarian point of view. Local ubuntu communitarian culture may also support smart pills, because of the emphasis on community wellbeing rather than individual autonomy.