Toward an Integrated Conceptual Framework for Traceability and Chain-of-Custody Integrity in Pharmaceutical Distribution

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@article{1719692,
      author = {Oluchi Beatrice Aneke, Abimbola Caleb Adesemoye},
      title = {Toward an Integrated Conceptual Framework for Traceability and Chain-of-Custody Integrity in Pharmaceutical Distribution},
      journal = {Iconic Research And Engineering Journals},
      year = {2019},
      volume = {3},
      number = {4},
      pages = {655-672},
      issn = {2456-8880},
      url = {https://www.irejournals.com/formatedpaper/1719692.pdf},
      abstract = {Modern pharmaceutical distribution moves medicines through long, multi-actor networks in which identity, provenance, custody, and condition can each be compromised. Regulatory and technical responses have advanced quickly, including serialization mandates, data exchange standards, good distribution practice guidance, and a growing body of work on distributed ledger and sensing technologies, yet they remain fragmented. Most concentrate on traceability, the technical capacity to follow a product through the chain, while the assurance that every custody transfer was authentic, authorized, and unbroken, here termed chain-of-custody integrity, is left implicit or treated as a separate concern. This paper argues that traceability and chain-of-custody integrity are distinct but interdependent constructs, and that integrity assurance requires their deliberate integration rather than the accumulation of point solutions. Drawing on supply chain traceability theory, the forensic conception of custody, and the contemporary regulatory and technical landscape, it proposes an integrated conceptual framework built on four integrity dimensions, namely identity, provenance, custody continuity, and condition, and a five-layer architecture spanning unique identification, event capture and data exchange, custody verification and authentication, condition and environmental integrity, and governance, trust, and accountability. Cross-cutting enablers of interoperability, security, and trust anchoring connect the layers, and the lower layers are shown to deliver traceability while the upper layers convert it into assurance. The framework is applied to a stylized distribution scenario to demonstrate how it locates integrity gaps that traceability-centric approaches leave hidden, and a set of propositions translates it into testable relationships. The framework offers regulators, supply chain actors, and technology providers a structured vocabulary for diagnosing where integrity is genuinely at risk and for designing systems in which traceability and custody assurance reinforce one another.},
      keywords = {Pharmaceutical Distribution, Traceability, Chain of Custody; Supply Chain Integrity, Serialization, Provenance, Conceptual Framework},
      month = {October},
      doi = {https://doi.org/10.64388/IREV3I4-1719692}
  }