Implementing pharmaceutical track- and-trace systems: A realist review

Joeke Kootstra, Tineke Kleinhout-Vliek*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)
21 Downloads (Pure)


Introduction One way to prevent falsified medical products from entering the regulated pharmaceutical supply chain is to implement a pharmaceutical track- and-trace system (PTTS). Such systems in the most extensive versions generally mandate a scan at every point of contact with the medical product: from the point of entry to dispensation. There have been several attempts to implement such systems; for example, a 'full' PTTS in Turkey and the more pared-down version offered by the European Union's Falsified Medicines Directive and Delegated Act. This study aims to identify facilitators and barriers to implementing (elements of) a PTTS, with the Turkish system used as a benchmark. Methods We conducted a 'realist' review, which synthesises literature and aims to establish how a specific technology works, for whom, under which circumstances. We searched Embase, Medline Ovid, Web of Science, Cochrane Central and Google Scholar databases, yielding 2,790 scholarly articles. We selected 21 for review. Results Implementation of PTTS elements has been attempted in different compositions in several primarily high-income and middle-income countries. Factors that affected implementation included stakeholders like the government and supply chain actors, the coordination between them, and their awareness, knowledge, and skills, as well as regulation and legislation, monetary investments, and technical and digital requirements. Conclusion The interplay between contextual factors is crucial for successful PTTS implementation. Specifically, the findings indicate that aligning the incentives for all actors and allowing for adjustments in a continuous implementation process will likely facilitate implementation.

Original languageEnglish
Article numbere003755
JournalBMJ Global Health
Publication statusPublished - 28 May 2021

Bibliographical note

Funding Information:
We gratefully acknowledge Antoinette de Bont and Maarten Kok for their help outlining the paper's scope, Wichor Bramer and team for setting up the search string and directions for handling the search results, Koray Parmaksiz for invaluable insights into the Turkish ITS, and Elizabeth Pisani and two anonymous reviewers for aiding us in getting the final manuscript in shape.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.


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