Information Technology Reference
In-Depth Information
Medical practice entails forms of consumption and, in this context, the idea of
building a mobile medication checking system has emerged. These mobile devices
allow the user to take them away from the staff station, enabling the checking of
medication order lists and consumed medications at the same time. However, there
are many problems peculiar to the healthcare field; trials using mobile terminals
with ICT support have a long way to go before being acceptable for medical use.
We will give an outline of the background of BCMA (Bar-Corded Medication
Administration) (Koppel et al.
2008
), introduce some trials on it, and discuss the
way forward.
6.2
Issues Relating to BCMA
6.2.1
Institutional Background
In Japan, “The Drugs, Cosmetics and Medical Instruments Act” and “The law to
revise the drawing of blood and blood donation business control methods” came
into effect in 2005 (Pharmaceutical and Food Safety Bureau
2004
). Biogenous
medical products, except plasma derivatives, require management of the production
history. Not only is a product's history tracked during the initiation stage and during
production but the selection of the donor (the source of raw materials) should also
be able to be confirmed. In addition, it is necessary to maintain records of antipol-
lution maintenance and manufacturing tracking.
MHLW mandates drug companies to keep detailed records of followup of the
donor user, the infectious disease submission report, the mandatory display of
primary material if a drug is biogenous product, and the monitoring of proper
usage at the post market. Drug companies must make sure that all records are
connected and verified to ensure accountability in case of
future incident
investigation.
Historical background of the constitution of the law was the experience of the
lawsuit on adverse drug reactions and the investigation of the casual association
between administered drugs and the adverse drug reactions had processed with
difficulty because of lacking sufficient records. We recognize that extensive trace-
ability is required in order to undertake root cause analysis into the harmful effects
of drugs.
In September 2006, to prevent accidental misunderstandings on drug
applications and to ensure traceability, guidelines for implementing medication
barcodes were given in office notice No.0915001 “The barcode display on an
ethical drug” by MHLW (Ministry of Health, Labour and Welfare) Pharmaceutical
and Food Safety Bureau (
2006
). The ethical drugs were categorized into five kinds:
biogenous products, specific biogenous products (among biogenous products, main
raw material is from human blood or tissue), oral medicine, intravenous, and
external medicines. Packaging schemes are categorized into three kinds: dosage
