Challenges and Opportunities for the Traceability of (Biological) Medicinal Products

Abstract

This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited traceability of biologics, in particular with regard to the batch number, is associated with incomplete recording of exposure information in clinical practice. The current pharmaceutical barcode standards in the EU do not support the automatic recording of dynamic product information, such as batch numbers and expiry dates, by means of electronic barcode scanning in clinical practice. New barcode requirements, such as the 2D DataMatrix with encoded batch numbers and expiry dates, provided on both the primary and the secondary package, can facilitate routine barcode scanning at all points in the supply chain in different healthcare settings. To build a full track-and-trace system for medicines with electronic capture of relevant exposure information, alignment with other topics, such as the Falsified Medicines Directive and initiatives to reduce medication errors, is needed to increase the buy-in from all stakeholders and to solve multiple issues with a joint effort.

Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice

“…The reason for the low batch reporting has previously been shown to be multifaceted and relates, among others, to inadequate recording of batch information in pharmacy dispensing and/or medical records, unavailability of the recorded information to the reporter at time of reporting, and unawareness regarding the need to report batch information in ADR reports . Efforts to improve traceability, therefore, requires a multifaceted approach, focusing both on ensuring the routine recording of exposure information in clinical practice, as well as enabling and encouraging healthcare professionals and patients to report the required exposure information …”

What Makes a National Pharmaceutical Track and Trace System Succeed? Lessons From Turkey

“…These benefits include real-time tracking throughout the entire supply chain, stock management for timely detection and prevention of stock-outs, targeted product recalls, and reduction of reimbursement fraud, theft, and medication errors. 1,[6][7][8][9] Recent studies show that the opportunity to enter the pharmaceutical supply chain differs between substandard and falsified medicines. Substandard medicines, which are defined as authorized products that fail to meet quality standards, enter the supply chain through manufacturers who might sacrifice quality to maximize profits.…”

Integration of a Commercial Barcode-Assisted Medication Dispensing System in a Teaching Hospital

“…To facilitate the routine electronic recording of dynamic product information, the use of unit-doses with two-dimensional (2D) barcodes as the 2D datamatrix which have the technical ability to encode dynamic data needing to secure the full track-and-trace system have to be preferred. 28 According to the pharmacy technicians' feedback, we recommend a longer training period to acquire the necessary skills to use the system, that should be objectified by accreditation and multiple user tests before implementation.…”