MITA Home

Drug information and Internet(医薬品情報とインターネット)

Kensuke Baba

16 April 2003


 

Drug information

 Data available to laypersons

   Internet  drug manufacturing companies’ homepages (HPs)

             JPMA (Japanese pharmaceutical manufacturers association) HP

Ministry of Health, Labour and Welfare’s HP(厚生労働省)

             http://www.pharmasys.gr.jp   医薬品情報提供ホームページ

The Organization for Pharmaceutical Safety and Research, OPSR,

医薬品機構)

       academic society HP(学術団体、学会ホームページ)

 

DRUG MANUFACTURER DI

 Drug in general

 Drug the company sells domestically

 Disease in general

Disease associated with drugs marketed

 

When to begin or stop marketing

Packages(包装)

 In connection with malpractice(医療過誤)

 Brand name, labeling, etc.(商品名、包装・添付文書等)

Labeling(添付文書)―PDRPhysician’s Desk Reference,E-labelinge-添付文書)

Chemical entities, and their characteristics(薬効成分、構造式、物性)

Ingredients(成分)-Additives

Indications(効能・効果)

Drug dosage(用法・用量)

Contraindication(禁忌)

Warning(緊急安全性情報)

Precautions(慎重投与)

Clinical studies

Pharmacology

Long-term administration

Drug Interactions(薬物相互作用)

Adverse (Drug) Reactions(副作用)

Overdosage(過量投与)

 

Off-label use(適用外使用)

  Indication

  Drug dosage

ADR

  Incidences

  Detailed information

  Overdose

   Countermeasures against overdose

  Mechanism of ADR

  Toxicity-Target organ

Drug interactions

Special population

 Geriatric(高齢者)

 Pediatric(小児)

 Pregnant, Nursing mother(妊婦、授乳婦)

Renal impairment(or dysfunction)(腎機能障害、腎機能低下)

 Hepatic impairment(hepatic dysfunction)(肝機能障害、肝機能低下)

 

Recent movements

1) Evidence-Based MedicineEBM

 

2) Complain and Claim: HOTLINE

complain: state a grievance concerning; say that you are annoyed, unhappy or not

satisfied about somebody/something 不平・不満を表明する、苦情を持ち込む

claim: demand as one’s due or property; ask for money from the government or a

company because you have a right to it, demand or ask for something because you

believe it is your legal right to own or to have it (権利などを)主張する、損害賠償

要求する、(貿易商取引に使われることが多い)、苦情より主張に近い

企業などで顧客の苦情処理にあたる部署complaints section, subscribers(or customers)

servicesection; 苦情処理にあたる人:complaints officer, trouble shooter

section

3) The Act for Protection of Computer-processed Personal Data Held by Administrative Organs個人情報保護法

4) FOIFreedom of Information-FOIA

  Information-disclosure law, Legislation on information disclosure(情報開示法)

 

5) Direct-to-ConsumerDTCAdvertisement

 

6) Generic

A drug not protected by a trademark. Also, the scientific name as opposed to the

proprietary, brand name.

 

Information

  In-house data

Confidentiality機密性、秘密性;機密保持

Reliability信頼性、確実性

 

Future

1) Ad deregulation of ethical drugs

2) Encouragement of use of generic drugs

3) Embargoed sale of drugs at retail stores


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