Topics Held "FY2020 Workshop for Persons Responsible for Product Information Outline Management and Persons Responsible for Practice
On March 19, 2021, the "FY2020 Training Course for Persons Responsible for Product Information Overview Management and Practitioners" was held for the first time in an online format. On the day of the workshop, approximately 550 people participated, mainly those in charge of product information overview management and practical affairs at member companies as well as those in charge of material review at their own companies. The following is a summary of the workshop.
Program of the "FY2020 Training Seminar for Persons Responsible for Product Information Overview Management and Persons in Charge of Product Information Management" (in Japanese)
1. opening remarks
Mr. Tokuo Tanaka, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), started the session by expressing his appreciation for the understanding and cooperation of member companies in the activities of the PMAJ.
The Product Information Outline Review Committee requests the Tokyo Hospital Pharmaceutical Association to monitor materials, and receives guidance if there are any inappropriate materials or activities. Today's special speaker, Dr. Susumu Wakabayashi of the Department of Pharmacy, Kyorin University Hospital, will give us guidance from the viewpoints of medical professionals and pharmacists. In the monitoring of sales information provision activities, the number of inappropriate materials has been decreasing, but there is a strong impression that inappropriate activities and wording by medical representatives (MRs) are still a problem. However, it is important to note that even if we use appropriate materials, if a medical professional feels something is inappropriate, we should listen carefully and correct what needs to be corrected. Of the "3 no's" (do not create inappropriate materials, do not pass inappropriate materials through internal review, and do not inappropriately use materials that have passed internal review), which I always introduce whenever I have a chance, "do not inappropriately use" may not be directly relevant to today's audience (persons responsible for managing product information overview and persons in charge of practical business). The code may not be directly relevant to today's audience. While the code is based on the Pharmaceutical Affairs Association code and the company code is formulated based on the Pharmaceutical Affairs Association code and the company code is to be complied with, the preparation guideline is a must. Since we receive guidance in close cooperation with the Monitoring Guidance and Narcotics Control Division of the Pharmaceuticals and Consumer Health Bureau of the Ministry of Health, Labour and Welfare, it is necessary to comply with the preparation guidelines themselves. I hope that you will understand this and continue to promote the "3 No's" campaign. I would like you to listen carefully to the end of today's session.
2. questions about the report of the review meeting 4. closing remarks
After October 1, 2020, we request that all materials, including existing materials, be prepared in accordance with the "Preparation Guideline for Outline of Product Information on Ethical Drugs" (abbreviated as "Preparation Guideline") revised in April 2019. We have been introducing examples of cases pointed out by the Product Information Outline Review Board and informing the public through the Board Report as a notice from the Board, with reference to cases where there is a possibility of misunderstanding regarding the interpretation of the Guidelines.
This time, questions regarding the interpretation of the creation procedure that could not be resolved only by the information in the Board Report were solicited in advance, and the Board's views on these questions were shared in the form of answers.
Some of the answers that could not be presented at this meeting will be made known to the public through the Board Report and other means in the future.
Explanation (1) Efficacy
Tomohiro U ratsuji, Member, Product Information Outline Review Committee, The Pharmaceutical Association of Japan
"Description in terms of pharmacodynamics, non-clinical, characteristics of mechanism of action (sex), description of evaluation items, and the concept of scientific basis".
Explanation (2) Safety
The Pharmaceutical Association of Japan, Product Information Outline Review Committee, Hiroyuki Tatsumi, Member
"Points to keep in mind when describing safety in clinical results, graphing of safety information, and font size of safety information".
Explanation (3) Others
Tomohiro Inoue, Member of the Product Information Outline Review Committee, Pharmaceutical Association of Japan
"Misleading expressions, description of results that are reference information, and description of statistical analysis results
3. special lecture Toward Appropriateness of Information Provided by Pharmaceutical Companies
Dr. Susumu Wakabayashi, Department of Pharmacy, Kyorin University Hospital
At the beginning of the lecture, Mr. Wakabayashi introduced the activities he has been involved in. He mentioned that one of the activities of the "Fourth Subcommittee of Tokyo Metropolitan Hospital Pharmaceutical Association" is to investigate and evaluate various materials provided by pharmaceutical companies and report inappropriate cases of product information outline to the Pharmaceutical Manufacturers Association as a suggestion.
In the midst of various types of team medicine, what is required of work to provide drug information as pharmaceutical work in hospital wards is to collect, transmit, and disseminate that information (information collection and provision), as clearly stated in the Pharmaceutical Manufacturers Association Code and as has been asked in the national examinations for pharmacists, He stated that this is the same as the duties of a medical representative (MR).
He stated, "We have heard that some information provision activities have been restricted after the Ministry of Health, Labour and Welfare issued the "Guidelines on Information Provision Activities for the Sale of Ethical Drugs," but we hope that information will be provided appropriately in response to requests from medical professionals. With the tightening of regulations on visits to medical institutions and increased opportunities for web interviews, it has become difficult to receive necessary materials. We believe that pharmaceuticals are only as good as the information they provide, and the medical community still expects MRs to provide information. We believe that pharmaceutical companies are not the enemy. However, now is the time when it is difficult to meet face-to-face with the medical community, and we hope that MRs will provide information by any means possible, including the use of IT," he concluded.
4. closing remarks
In closing, Mr. Tomohiro Nakatani, Chairperson of the Product Information Outline Review Committee, expressed his gratitude to the many people who participated in this workshop and listened to it for a long time. He also expressed his gratitude to Dr. Susumu Wakabayashi of Kyorin University Hospital, who gave a lecture in his busy schedule.
He also expressed his gratitude to Mr. Susumu Wakabayashi of the Kyorin University Hospital Pharmaceutical Department for taking the time out of his busy schedule to give us this lecture. "The Pharmaceutical Cooperative Code," which Mr. Wakabayashi mentioned during his lecture, allows for the provision of information requested by medical professionals as long as it is provided in an appropriate manner. The review meeting report introduced today is presented as something I would like everyone to read, so please refer to it as a reference for your daily review. He concluded with the following words: "Although the contents of the guidelines are to be followed without fail, they are not fixed, and as new ideas emerge, they are periodically reviewed and enhanced.
( Yoshimoto Minamoto, Product Information Outline Review Committee)