2016 Volume 6 Issue 3 Pages 245-253
Objective : “blue letter” is one of the warning measures about medicines in Japan. “blue letter” is issued by pharmaceutical company when the Japanese Ministry of Health Labour and Welfare (MHLW) judges to take safety measure after sale. The objective of this study is to research whether pharmaceutical company and MHLW found each Serious ADR reported by “blue letter” when each clinical trial was completed. When they discussed side effects before sale, we researched how they provide the information for health care workers. Method : With the medicines on which “blue letters” were issued between 2006 and 2015. We researched each review reports about side effects and whether pharmaceutical companies and MHLW noticed the side effect before sale. And we researched each label information about side effects and whether health care workers were able to get enough information on the side effect before “blue letters” were issued. Result and discussion : Between 2006 and 2015, 11 “blue letters” were issued. In 8 letters of 11 letters Pharmaceutical companies and the MHLW realized each side effects in clinical trial. And they provided each side effects information in each label information. But, most information was vague expression before “blue letter” was issued. We suggest that pharmaceutical companies release more specific information in drug labels as a communication tool. Conclusions : Many of pharmaceutical companies had provided side effect information before “blue letters” were issued. But it was not clear enough to change the medical professional`s behavior for patients.
