Use of unapproved medicines and medical devices
Pharmaceuticals and medical devices are required by law (the Pharmaceutical and Medical Device Act) to be used in a manner approved by the Ministry of Health, Labor and Welfare, and the details are stated in the package insert. However, due to the necessity of treatment, they may be used in a manner that does not necessarily conform to the approved details (known as off-label use, etc.). In such cases, an internal hospital meeting is held to review the necessity of use based on academic evidence and the effects of the pharmaceutical or medical device, as well as its effectiveness and safety, and use is only approved.
When using a drug off-label, medical professionals usually provide written or verbal explanations and obtain consent from the patient. However, when a use is considered to be beneficial to the patient, with sufficient scientific evidence and minimal ethical issues, the hospital has approved an exceptional simplification of the written or verbal explanation and consent process by publishing the information on its website.
If you do not wish to receive these treatments or have any questions, please contact the contact information listed in the explanatory materials for each treatment. Please note that even if you do not consent to these treatments, you will not suffer any disadvantages in your medical treatment.
In-hospital approved treatment
For details, please see "Implementation Details"
| Implementation details | Target Audience | Approval Date | Approval period |
Potassium correction using high-concentration potassium injections |
Patients with severe hypokalemia treated at our hospital | December 16, 2019 | December 16, 2019 - Permanent |
| Patients who require administration of calcium folinate to reduce methotrexate toxicity | April 13, 2023 | From April 13, 2023 until stable supply of Leucovorin Injection is resumed | |
| Patients who can undergo vitreous surgery at our hospital | July 6, 2023 | From July 6, 2023 until stable supply of Macuaid® is achieved | |
Vasopressin administration in patients with distributive shock |
Patients with distributive shock requiring intensive care | September 9, 2024 | September 9, 2024 - Permanent |
Regarding "concomitant use of catecholamine preparations" when necessary for treatment |
Patients who are deemed by a doctor to require the concomitant use of catecholamine preparations | September 9, 2024 | September 9, 2024 - Permanent |
Administration of psychotropic drugs (all medical departments) |
Patients with delirium | September 9, 2024 | September 9, 2024 - Permanent |
| Patients with delirium | September 9, 2024 | September 9, 2024 - Permanent |
