JMIR Publications

ABSTRACT

Background:

The dissemination of accurate, timely pharmaceutical product information is foundational to patient safety. Electronic labeling (e-labeling) has emerged as promising digital health approach that enables real-time updates, enhanced accessibility, and integration within digital health information ecosystems. Despite growing global adaptation, regulatory frameworks remain fragmented across jurisdictions, creating disparities in health information equity and posing challenges to patient safety in interconnected healthcare environments.

Objective:

This study aimed to systematically identify and compare national pharmaceutical e-labeling policies across major regulatory jurisdictions, assess regulatory readiness and policy maturity, characterize implementation strategies, identify critical governance gaps, and provide evidence-based recommendations for a harmonized global framework advancing digital health equity.

Methods:

We systematically searched and reviewed publicly available pharmaceutical e-labeling policy documents from International Coalition of Medicines Regulatory Authorities (ICMRA) member countries covering January 2012 to January 2024. Two independent reviewers screened and classified documents as “legal” (binding regulations) or “non-legal” (guidance) based on regulatory authority. A two-step analysis was employed: a hybrid thematic coding approach combining deductive coding based on three predetermined domains (scope and implementation, operational infrastructure, advanced digital health considerations) with inductive coding to generate nine themes from the data, followed by a comparative analysis of domain coverage, regulatory level, and regional distribution. Inter-rater reliability was assessed using Cohen's kappa coefficient. Policy maturity was classified across five levels based on regulatory authority and scope.

Results:

Among 22 ICMRA member countries, only 11 (50.0%) had accessible e-labeling policies, yielding 34 documents: 5 legal (14.7%), 29 non-legal (85.3%). All 11 countries addressed foundational implementation, scope and operational infrastructure, but only 9 (81.8%) covered advanced considerations including accessibility, interoperability, with electronic health records, or personalized information. Legally binding framework for basic implementation existed in merely 4 countries (36.4%) and only 2 countries (18.2%) had binding provisions for advanced features. The most sophisticated digital health capabilities, interoperability with clinical systems and personalized patient information, were addressed in only 3 countries (27.3%), through non-legal guidance. A sequential policy progression trend was observed, with nations prioritizing operational infrastructure before advancing to more complex considerations. Dual independent coding achieved excellent reliability (Cohen's kappa ≥0.95 for all domains).

Conclusions:

Global pharmaceutical e-labeling policy development remains substantially fragmented with critical gaps in legal binding frameworks, technical standards, and patient-centered digital health integration. Only one-third of major regulatory markets possess legally binding implementation frameworks, while advanced interoperability and personalization capabilities remains largely unexplored. These findings highlight the urgent need for international harmonization through inter-agency collaboration, including adoption of binding minimum standards, machine-readable format mandates, and interoperability protocols aligned with global health informatics standards.