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Safe Use of Recent New Drugs-Current Status and Challenges.

Abstract  In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.
PMID
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Authors

Mayor MeshTerms

Databases, Pharmaceutical

Drug Information Services

Drug-Related Side Effects and Adverse Reactions

Pharmaceutical Preparations

Pharmacovigilance

Risk Management

Keywords

pharmaceutical company

pharmacovigilance

risk communication

risk management plan

safety information

Journal Title yakugaku zasshi : journal of the pharmaceutical society of japan
Publication Year Start




PMID- 29386431
OWN - NLM
STAT- MEDLINE
DCOM- 20180228
LR  - 20180228
IS  - 1347-5231 (Electronic)
IS  - 0031-6903 (Linking)
VI  - 138
IP  - 2
DP  - 2018
TI  - [Safe Use of Recent New Drugs-Current Status and Challenges].
PG  - 177-183
LID - 10.1248/yakushi.17-00174-3 [doi]
AB  - In Japan and overseas, Chugai Pharmaceutical Company handles numerous
      biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with
      innovative modes of action. Expert safety evaluation is essential for promoting
      the appropriate use of these pharmaceuticals around the world and in gaining
      acceptance from patients and healthcare professionals (HCPs), while speedy
      decision-making is crucial for the timely collection and provision of safety
      information and thus ensuring safety. In 2015, we collected safety information on
      more than 180000 cases and evaluated it from a medical standpoint. We have
      established a system for recording the collected information in a global
      database, and are conducting signal detection of adverse drug reactions using
      this database. With this system, we promptly disclose information to regulatory
      authorities in Japan, the US, Europe and Asia. We have in-house medical doctors
      with abundant clinical experience who conduct expert safety evaluations. Many
      innovative drugs, such as anticancer drugs or biopharmaceuticals, require
      wider-ranging, more rigorous management, including the provision of appropriate
      safety information to HCPs, management of distribution through wholesalers and
      dispensing pharmacies, and confirmation of conditions of use, in addition to
      all-case registration surveillance. With progress in the development of
      individualized medicine and drugs with new modes of action, in order for HCPs to 
      understand the characteristics of these new drugs and use them appropriately,
      pharmacists and pharmaceutical companies should cooperate in promoting their
      appropriate use in the spirit of 'All Pharmacists for Patients'.
FAU - Ohashi, Yoshiaki
AU  - Ohashi Y
AD  - Quality & Regulatory Compliance Unit, Chugai Pharmaceutical Co., Ltd.
AD  - Drug Safety Division, Chugai Pharmaceutical Co., Ltd.
LA  - jpn
PT  - Journal Article
PL  - Japan
TA  - Yakugaku Zasshi
JT  - Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan
JID - 0413613
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Biopharmaceutics
MH  - *Databases, Pharmaceutical
MH  - Decision Making, Organizational
MH  - Drug Industry
MH  - *Drug Information Services
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - *Pharmaceutical Preparations
MH  - Pharmacists
MH  - *Pharmacovigilance
MH  - Precision Medicine/trends
MH  - *Risk Management
MH  - Safety
OTO - NOTNLM
OT  - pharmaceutical company
OT  - pharmacovigilance
OT  - risk communication
OT  - risk management plan
OT  - safety information
EDAT- 2018/02/02 06:00
MHDA- 2018/03/01 06:00
CRDT- 2018/02/02 06:00
PHST- 2018/02/02 06:00 [entrez]
PHST- 2018/02/02 06:00 [pubmed]
PHST- 2018/03/01 06:00 [medline]
AID - 10.1248/yakushi.17-00174-3 [doi]
PST - ppublish
SO  - Yakugaku Zasshi. 2018;138(2):177-183. doi: 10.1248/yakushi.17-00174-3.