Information Technology Reference
In-Depth Information
accountability by tracking personnel access and preventing fraudulent activity. In
other words, guaranteeing immediate access to patient information, determining
who accesses it, and recording these logs in a tamper-proof format are more
important than preventing illegal access to patient information in healthcare.
6.2.6 Ethical Drugs and Traceability
Traceability in the healthcare domain is the ability to track ethical drugs from
production to patient use. To that end, product information should accompany
medical supplies from production to distribution. However, barcode re-labeling
may be performed during physical distribution, hence it may not be possible to
locate critical information, such as the lot number, and a medical center may also
get the wrong ethical drugs if the re-labeling process itself is done in error.
One problem in this regard is that the information management units are
different between the production, physical distribution and dosage stages. To bridge
the gap between information management units, barcode re-labeling is undertaken.
The production phase and the dosage phases require “Unit Dose”, but in the
physical distribution phase, labeling is done according to various packaging
forms, such as palette, lot, the cardboard box, etc. Every time drugs are packaged
and unpackaged, re-labeling may be required.
GS1 (Association of the old international EAN) has standardized the physical
distribution process to resolve these issues. In the GS1 standard, GS1-128 (UCC/
EAN-128), RSS (Reduced Space Composite Symbology) and RFID are used as
Data Carriers. GTIN (Global Trade Item Number) and SSCC (Serial Shipping
Container Code) are approved as the standard data format. GTIN focuses on
consumption while SSCC focuses on physical distribution; GTIN and SSCC are
mutually interchangeable. In the healthcare domain, most pharmaceutical
companies use the EPC Global code, and it has become the de facto standard.
The EPC uses SGTIN (Serialized GTIN) that has interchangeability with GTIN. In
Japan, JAN (Japanese Article Number) is specified based on EAN and also has
interchangeability with GTIN.
Japan has mandated that all ethical drugs are to be labeled with barcodes after
2008. Unit item management can identify the kind (name) of ethical drugs, but
cannot identify individual ampoule bottles. Single item management can use the
serial number to distinguish individual products, and it is indispensable for ensuring
medical safety. Accidents in which practitioners mistake the mixed injection drug
for another because the bottles appear the same will be avoided by distinguishing
the individual bottles (Kondoh et al.
2008
).
Therefore, SGTIN enables single item management and is regarded as an
important component in the medical field. However, as the barcode is not currently
displayed on all medical supplies, complete source marking is not now available.
Every medical institution has to apply private “in-house” markings in each medical
institution, which creates additional administrative burdens.
