Prospective systematic risk analysis of the digital technology use within pharmaceutical care

Digital technologies are present in every phase of a drug lifecycle, from drug design and development to its dispensing and use. However, given the rapid development and implementation of digital solutions, their monitoring, evaluation, and risk assessment are limited and lacking.

This research is aiming to identify potential errors, quantify and prioritize associated risks in the context of certain technologies used in pharmaceutical care, as well as define corrective measures to improve patient safety and the quality of pharmaceutical care.

A 10-member multidisciplinary team conducted Failure Mode and Effect Analysis (FMEA) to identify critical risks, their causes and effects, along with developing corrective measures within the selected digital health components: Telepharmacy, mHealth, Artificial intelligence (AI), and Software infrastructure and systems. Critical risks were determined by calculating risk priority numbers (RPNs) from severity, occurence, and detectability scores.

This study identified 42 risks regarding the 4 components. After calculating RPNs and the threshold RPN (RPN=30), 8 critical risks were identified. Corrective measures were proposed for these failure modes, after which the risks were re-evaluated (RPN sum was reduced from 414 to 156). The risk with the highest RPN value was Internet/identity fraud, while the rest included inadequate and incomplete data entry and management, flawed implementation, human and technology errors, and lack of transparency, personalization and infrastructure. For the critical risks, 42 different causes were recognized on a system, technological and individual level while their effects were discussed in terms of patient safety and business management in pharmacies.

Digitalization of pharmaceutical practice promises greater effectiveness of pharmaceutical care, but in order to achieve this, efforts, resources and initiatives must be directed toward timely identification of problems, appropriate monitoring, and building adequate infrastructure that can support safe implementation of digital tools and services despite the swift development of innovations.