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

Jovana Ilkic; Milos Milovanovic; Valentina Marinkovic

doi:10.1016/j.japh.2024.102081

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

J Am Pharm Assoc (2003). 2024 Apr 3:102081. doi: 10.1016/j.japh.2024.102081. Online ahead of print.

Authors

Jovana Ilkic¹, Milos Milovanovic², Valentina Marinkovic³

Affiliations

¹ PhD student, Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia. Electronic address: jovanailkic@gmail.com.
² Professor, Department of Information Technology, Faculty of Organizational Sciences, University of Belgrade, Belgrade, Serbia.
³ Professor, Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.

PMID: 38579967
DOI: 10.1016/j.japh.2024.102081

Abstract

Background: 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.

Objective: 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.

Methods: A ten-member multidisciplinary team conducted Failure Mode & 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.

Results: 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.

Conclusion: Digitalization of pharmaceutical practice promises greater effectiveness of pharmaceutical care, but in order to achieve this, efforts, resources and initiatives must be directed towards 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.

Keywords: Artificial Intelligence; Failure Mode and Effect Analysis; Pharmacy; Risk Assessment; Telemedicine; mHealth.