Topics Workshop on "The ideal form of adverse drug reaction case evaluation work" was held
In recent years, Case Processing (CP), which plays a fundamental role in Pharmacovigilance (PV) activities, has become more important than ever before, and the amount and type of safety management information to be handled has continued to increase. As a result, more accuracy and efficiency are required in the day-to-day execution of CP operations. In light of this situation, the Pharmaceutical Cooperative Drug Evaluation Committee will hold a meeting on November 21, 2019, to provide an opportunity to ask ourselves and others what CP operations are truly required to do, and for those in charge of CP operations to share new perspectives, insights, and connections beyond the company that will be useful for tomorrow's operations. A workshop on "What should be the ideal form of adverse drug reaction case evaluation work" hosted by the PV Subcommittee Continuing Issues Study Team 2 (KT-2) was held at the Nihonbashi Life Science Building (Chuo-ku, Tokyo). The workshop was initially open to 80 participants from safety divisions of pharmaceutical companies, especially those in charge of CP and related tasks, but approximately 130 people applied, exceeding the number of applicants from the Pharmaceutical Manufacturers Association of Japan.
Scene at the venue
Program of the day (1/3): Opening, Group work (1)
For this workshop, nine facilitators were selected from the members of the Continuing Issues Study Team 2 (KT-2) of the PV Subcommittee of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers' Association of Japan (PMAJ), and participants were divided into groups for discussion.
The meeting began with an opening by KT-2 leader Chizuko Sato (explanation of the purpose and objectives of the meeting and sharing of the schedule), followed by group work (1). After brief self-introductions, the following framework was used to organize the discussion, and opinions were extracted on issues related to the current adverse drug reaction case evaluation (CP) work.
- Do you like CP work? Do you dislike it? (And why?) What is your motivation for CP work?
- What motivates you to do CP work?
- What do you think is the meaning and significance of CP work?
- What do you enjoy about CP work?
- What do you find difficult in CP work?
- Do you have any expectations or future prospects for CP work?
Group work (1)
Program of the day (2/3): Case study sharing
Two member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) shared examples of how they responded to safety bulletins (blue letters) and how they revitalized their CP operations.
As case study 1, Ms. Nano Kigawa, Case Management, Safety Information Department, Eli Lilly Japan, talked about the change in awareness of case evaluation work through the Blue Letter response, including the role of case management in the Safety Information Department, the process from pre-marketing of Virginio tablets to the issuance of the Blue Letter, the difficulties encountered when responding to the Blue Letter, and the changes in awareness of case evaluation work after the Blue Letter experience. The presentation included the role of case management in the Safety Information Department, the process from pre-marketing of the Virginio tablets to the issuance of the blue letter, the difficulties encountered when responding to the blue letter, the changes in the state of mind before and after the blue letter experience, and his thoughts on future case management.
As case study 2, Ms. Kyoko Haraguchi of the Case Processing Group, Kyowa Kirin Pharmacovigilance Department, talked about the efforts of the Case Processing Group, including the background of the establishment of the group specializing in case processing, the challenges the group faced when it was established and how it solved them, and the efforts made to keep the group motivated to do its job. She also introduced the challenges the group faced when it was established, how it has solved them, what it is doing to keep motivated, and its future outlook.
It was impressive that all participants listened to the case studies with great interest and enthusiasm, which is not something they usually get to hear.
Program of the day (3/3): Group work (2), Presentation, Closing
Based on the issues raised in the group work (1), the participants shared their impressions of the two companies' case studies with the group. Then, each group was divided into three or so groups to deepen the discussion on the ideal CP operations, and each group wrote down their thoughts on CP operations using the framework below.
- We imagine the future of CP work to be ________________, and we are excited about that future!
- We believe the value of CP is ________________.
- We hope to achieve ________________ through our CP work.
- We believe that we can achieve growth through our CP practice.
Then, based on the opinions of each group, we compiled our opinions as a group and presented them to the whole group. A variety of opinions were presented, some of which are summarized below, expressing candid thoughts that those engaged in CP work can deeply relate to.
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We imagine the future of CP work to be ________________, and we are excited about that future!
We are able to focus on the review of safety information by improving efficiency through innovation and outsourcing.
To understand the suffering of patients better than anyone else, and to continue to ensure safety by identifying trends in adverse drug reactions through close examination of raw data from important cases.
To be globalized and centrally managed by countries and companies -
We believe the value of CP is ________________.
Conscience of the pharmaceutical industry
Roots of PV
To meet the needs of medical professionals and provide safety and security for patients
To sublimate to useful information by interacting with cases, which AI (Artificial Intelligence) cannot do -
We hope to achieve ________________ through our CP work.
Patient-centered medicine
To make use of inconvenient information and apply it to the next stage of prevention
Maintaining the value of long-term listed products as well as new drugs -
We believe that we can achieve growth through our CP practice.
To contribute to the drug life cycle (drug development) by adding important safety information
To have antennae to identify necessary information
In response to Leader Sato's question about what kind of person he would like to be in charge of CP in the future, he answered, "A person who can collaborate with innovations such as AI and RPA (Robotic Process Automation), a person who can steadily evaluate each case based on science, a person who can manage the CP process, and a person who can manage the outsourcing of work. In response to the question from the participants, some of them answered that they are looking for people who can collaborate with innovations such as AI and RPA (Robot Process Automation), people who can steadily evaluate each case based on science, and people who can manage CP processes, and people who can manage outsourcing companies.
The meeting concluded with a closing speech by Mr. Toshihiko Nishitani, Vice Chairman of the PV Subcommittee.
Group work (2)
Questionnaire after the workshop
After the meeting, we conducted a questionnaire via e-mail and received responses from 61 participants.
The overall evaluation of the meeting was "very good" or "good" by 58 participants, "average" by 3, and "not so good" or "not so good" by 0.
The good points of the meeting were as follows: the opportunity to gather only CP specialists was very valuable and provided an opportunity to reflect on our own work system, the discussion among practitioners regardless of whether they are foreign- or domestic-capitalized and regardless of their scale made us aware of the high level of awareness of each company, the opportunity to review the essence of CP work and to improve our own attitude toward our work, and the motivation to improve our work. The discussion also provided an opportunity to review the essence of CP work, which led to an improvement in their attitude toward their own work and increased their motivation. On the other hand, as points for improvement, some participants pointed out that it was difficult to have a cohesive discussion due to the large number of people in each team, that it was difficult to discuss in depth what should be done in concrete terms, and that the discussion ended with conceptual discussions, and that it would have been better if there was time to share specific information with people from other companies.
Closing Remarks
In the planning stage, there were some concerns that there might not be enough participants and that the discussions would not go well on the day of the workshop, but I believe that the high level of participation by all the participants, who are sincerely committed to CP work on a daily basis, made this workshop a fruitful one. Even after the meeting was over, discussions continued here and there, and I could sense once again that many people were looking for a place like this. We hope that what was gained from this workshop will be of no small help to the participants in their CP work. We would like to plan and hold another workshop related to CP work in the next fiscal year (2020-21).
( Shunichi Sato, PV Subcommittee, Pharmaceutical Evaluation Committee)