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DataBase of Priscription Drugs and DataBase of Priscription Drugs and Medical Devices in Japan Medical Devices in Japan Oct.30,2008 Manager of Standardization Promotion Dept. The Medical Information Systems Development CenterMEDIS-DC) Ryoji Takekuma 1

National Pharmaceuticals & Medical Devices database in Japan

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DataBase of Priscription Drugs and DataBase of Priscription Drugs and

Medical Devices in JapanMedical Devices in Japan

Oct.30,2008

Manager of Standardization Promotion Dept.

The Medical Information Systems

Development Center((((MEDIS-DC)

Ryoji Takekuma1

Outline of MEDIS-DC

� Founded JUL. 15. 1974

� Supported by MHLW and METI

� Cooperated with Scientific Society (JAMI,

2

� Cooperated with Scientific Society (JAMI, JRS, JSRT, etc)

� Cooperated with Industrial Society (JHIS, JIRA, etc)

� Cooperated with other related healthcare organizations

Position of MEDIS-DC

Government

Health academic society

3

MEDIS-DC Health service provider

Patient/Consumer

Industry

Health academic society

Role of MEDIS-DCStandardization of terminology and codeof terminology and code

・・・・Master of disease

・・・・Master of surgery and treatment ・・・・Master of drug((((HOT code))))・・・・Master of clinical laboratory・・・・Medical device DataBase, etc

It’s important to speak the same language

5

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Priscription Drugs

Standard code of

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Standard code of

Priscription drugs

(HOT code)

DB

Priscription drugs code

for Patient Safety

(GS1-128,DataBar,etc)

DB

Standard code of Priscription drugs

(excluding OTC drugs)

・The key codes of the master is

HOT codes,

・Each of which corresponds to that

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・Each of which corresponds to that

of the JAN codes (Japanese Article

Number system) that is used to

identify articles in commercial

distribution.

HOTHOTHOTHOTHOTHOTHOTHOT

codecode1313131313131313figuresfigures

JANcodeJANcode

RecieptReciept codecode

YJYJ codecode

HOTHOTHOTHOTHOTHOTHOTHOT 1313131313131313

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DrugDrug tarifftariff codecodeHOTHOTHOTHOTHOTHOTHOTHOT 99999999

HOTHOTHOTHOTHOTHOTHOTHOT 77777777

<HOTcode Structure>

Ordering Company Immediate

Container unitPackageunit

111177 99 1133figurefigure

Drud tariff code

JANJANJANJAN code

Reciept code,YJcode

We can use HOTcode

separately

HOT 7777 ::::Ordering 7777figure

HOT 9999 ::::Company

2figureUnique

Drug tariff code:3122007F1024Notice name :5mgアリナミンF糖衣

Company :TAKEDA

YJcode : 3122007F1024Brandname :5mgアリナミンF糖Brandname :5mgアリナミンF糖

衣錠

HOTHOTHOTHOT11111111::::Immidiate container unit

2figure

Distinction of container

Bottle 500Tab.

1bottle

10682451068245^^0101^^0101^^0101

PTP 10Tab.

10sheets

10682451068245^^0101^^0202^^0101

HOTHOTHOTHOT 13131313 ::::Package unit

2figure

Correspond toJAN

BRAND

NAME

COM

PANY

Immediate

Container

UnitPackage

UnitJANcode

HOT

7 9 11 13

A tab.

X

PTP

10Tab.

Sheet

50Tab. 4987999888818

01

01

01

100

Tab.4987999888825 02

PTP

11

A tab.

50mgmgmgmg

1234567PTP

21Tab.

Sheet

210

Tab.

498799988883202 01

Y

Bottle

500Tab.500

Tab.4987999891115 02 01 01

A tab.

10mgmgmgmg X

PTP

10Tab.

Sheet

100

Tab.4987999888917 1234000 01 01 01

Around 50 thousand Prescription

drugs are registered with JANcodes

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drugs are registered with JANcodes

How to use

・Ordering

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・Ordering

・Drug administration

Ministry of Health, Labour and Welfare

(MLHW) made a public notification in

August 2006 that GS1 codes (GS1-128 and

RSS, etc.) should appear on the package of

Patient Safety code

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RSS, etc.) should appear on the package of

pharmaceuticals, and that bar codes

should be printed to the package and label

of injections from the shipment starting in

Sept.2008

The indication of codes and bar

codes, which is primarily for

commercial purpose, can also be

regarded as promoting patient

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regarded as promoting patient

safety and product traceability.

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Medical Devices

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Standard code of

Medical devices

DB

Medica devices code

for traceability

(GS1-128,DataBar,etc)

DB

No. of Items registered in the No. of Items registered in the

Data Base exceeds 540,000Data Base exceeds 540,000

Items registered in MEDISItems registered in MEDIS--DC Data Base DC Data Base ((as of Sep. 22, 2008as of Sep. 22, 2008))

Total No. of registered Items Total No. of registered Items ;;542,990542,990

Medical Equipments ; 8,835 Medical Apparatus ; 480,877

In vitro Diagnostics ; 6,478 Miscellaneous ; 46,800

2-2. Examples of Marking GS1-128 Barcode

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TERUMO

ALCARE MIZUHO

3 M Healthcare

A similar notification on medical

devices was previously issued by

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devices was previously issued by

MHLW in March 2008.

Supply chain management Plan of Medical Device

Licenced marketing

aproval holders

Wholesaler

Medical DeviceDB

MEDIS-DC

Medical DeviceDB

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MeBiTs

MedicalInstitution

@MD-Net

VAN/order(((( DB)DB)DB)DB)

Vender((((ProdugtsDB)DB)DB)DB)

Thank you very much

for your kind attention

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for your kind attention

Contact details

Ryoji Takekuma

Manager of Standardization

Promotion Dept. MEDIS-DC

Contact details

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Promotion Dept. MEDIS-DC

T. +81 3 5805 8205

E. [email protected]

W. www.medis.or.jp

It’s important to speak the same language

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