In response to the problem of hypnotics being mixed in therapeutic drugs manufactured by Fukui Prefecture's drug maker Kobayashi Kako, the national government is requesting prefectures to increase on-site investigations without prior notice to drug makers. However, in response to an NHK questionnaire, more than one-third of the prefectures answered, "We plan to increase the number, but we have no concrete prospects."
Many local governments have pointed out the shortage of staff and the difficulty of training.
Regarding the problem of Kobayashi Kako, a survey by the Ministry of Health, Labor and Welfare and Fukui Prefecture revealed that systematic fraud was concealed by manufacturing in a process not approved by the government and creating so-called "double books". ..
In response to this problem, in February, the Ministry of Health, Labor and Welfare notified prefectures to increase on-site inspections without prior notice to pharmaceutical manufacturers as a measure to prevent recurrence, and NHK interviewed the status of the response last month. Did.
As a result, the number of site inspections without this year's prior notice,
▽ while the answer was from the 22 municipalities of "increase was", or "the prospect of such specific timetable in the plan to increase the standing",
▽ 16 local governments and more than one-third of the respondents answered, "We plan to increase the number, but there is no concrete outlook."
In addition, when asked about the issues of the current system with multiple answers,
▽ "the number of staff to increase / continue the number of inspections is small / insufficient" was the most common in 26 local governments,
▽ "of the staff involved in the inspection" "Sufficient training is difficult" was raised to 24 local governments.
In the free-form answers, "High expertise is required, but there are few opportunities to receive appropriate education and training," and "While it takes a lot of time for education and training, regular transfers are inevitable." There was an indication to do.
In addition, some respondents pointed out the difficulty of corona damage, such as "It is not possible to increase the number of surveys and trainings on-site because it is a target area for priority measures such as declaration of emergency and prevention of spread."
When asked freely about what they would like to request from the national government to resolve the issues, they decided to strengthen on-site inspections without prior notice, such as providing educational opportunities such as training and training, and enhancing survey guidelines. Many respondents asked for national support.
On-site inspection Differences in staff system depending on the local government
In the questionnaire interviews with prefectures, we also asked about the system of staff involved in on-site inspections of pharmaceutical manufacturers.
The monitoring of pharmaceutical manufacturers is outsourced from the national government to prefectures as "legal contract work", and according to the Ministry of Health, Labor and Welfare, the number of staff to be assigned is determined by each prefecture. ..
As a result of the questionnaire interview, 11 local governments have full-time staff in the department in charge of inspection, which is only about a quarter of the total, and many respondents said that they also have other duties.
In addition, the number of staff in the department in charge was 2 to 30, which varied depending on the local government.
Although there seems to be a difference in the number of manufacturing plants of pharmaceutical manufacturers to be surveyed in the background, some prefectures have fewer staff in charge even if the survey targets are more than other local governments.
On-site inspection without notification Even in prefectures where the number has increased significantly, other operations have been improved.
Shizuoka Prefecture is working to improve operational efficiency in order to increase on-site inspections without prior notice to pharmaceutical manufacturers.
Shizuoka Prefecture has the third largest pharmaceutical production value in Japan at about 840 billion yen in 2019, and there are nearly 70 pharmaceutical manufacturers' factories in the prefecture.
The prefecture has set up two full-time teams to monitor and guide pharmaceutical manufacturers, and has a system of 13 people, including staff members who also serve concurrently, and has conducted on-site inspections more than a dozen times a year.
In response to the notification from the Ministry of Health, Labor and Welfare, we plan to significantly increase the number of on-site inspections without prior notice from this year.
On the other hand, the staff system remains the same, so we are trying to improve the efficiency of operations other than on-site inspections.
Specifically, in principle, the meeting between the full-time team in charge, which is located about 40 kilometers away from the prefectural office, and the main office was switched to an online meeting to eliminate wasted travel time.
In addition, we will not go to the other party as much as possible for consultations from about 1000 pharmaceutical manufacturers a year, and will switch to telephone or online meetings.
Yoshimitsu Yoshizawa, Chief of the Pharmaceutical Affairs Review Group, Pharmaceutical Affairs Division, Shizuoka Prefecture, said, "Unannounced on-site investigations are extremely burdensome for both the investigating side and the receiving manufacturing side, but on the other hand, trust in pharmaceutical products is currently very high. It's in a state of sway, and even if it's difficult, we have to do it. "
Expert "Limitation in monitoring by prefecture"
Regarding the results of the questionnaire, Professor Keishi Murata of the Faculty of Pharmaceutical Sciences, Hokuriku University, who specializes in pharmaceutics, pointed out that "there are differences in the testing system and experience in each prefecture, and there is a limit to monitoring by prefecture."
On that basis, he said, "The current system is not organized on the premise that problems will occur, and we should secure personnel with specialized knowledge, replenish them to local governments, and utilize them for investigations." The government should secure human resources such as maker OBs to support prefectures.
In addition, Professor Hiroyuki Sakamaki of Kanagawa University of Health Services Graduate School, who is familiar with pharmaceutical policy, said, "In the future, we must consider the possibility that the company is maliciously preparing for data falsification, etc. It is necessary to conduct the survey in a different way, such as by listening to a wide range of staff from other departments within the company. ”He pointed out the need for the national government to review the survey methods and procedures and show them to the prefectures.
On top of that, "It is important for the government to be actively involved, such as making the manufacturing and quality control processes of each company more" visible "so that the public can be explained that the manufacturing process of pharmaceutical companies is safe." It is said.
Ministry of Health, Labor and Welfare "Promote support from prefectures"
The Ministry of Health, Labor and Welfare's Monitoring and Guidance and Drug Countermeasures Division, which is in charge of drug monitoring, said, "We believe that prefectural surveys play an extremely important role in ensuring thorough drug manufacturing control and quality control and providing safe drugs. Based on the opinions of prefectures, the Ministry of Health, Labor and Welfare would like to promote efforts to support the investigation work of prefectures, such as creating survey guidelines and conducting workshops and mock inspections. "Keywords: