1. About the P-MICS DB
P-MICS DB is a medical information database built in the P-MICS established by the Pediatric Drug Information Collection Network Development Project, which has been implemented by the NCCHD as a project subsidized by the MHLW since 2012. The P-MICS is a system that collects more accurate information by combining EMR information from pediatric medical facilities that cooperate in this project and interview information from patients (or their legally authorized representative). The system consists of SS-MIX servers that aggregate medical information (disease information, prescription/injection drug information, specimen testing and results information, and related information) from the EMR systems of cooperating medical institutions according to SS-MIX format, gateway servers that eliminate patients' personal information and have encryption functions, a medical interview information system that collects patient condition, symptoms and signs, and the P-MICS DB that integrates and manages data as information that can be searched and analyzed. Medical information and medical interview information are henceforth collectively referred to as "medical information".
(1) Objectives of the P-MICS DB
Pediatric drug development targets a wide range of patients, from newborns to adolescents, and therefore, requires a detailed response to each age group in terms of drug formulation and dosage, as well as difficult safety and efficacy evaluations, and also requires pediatric-specific considerations in planning clinical trials and obtaining consent. These requirements place high barriers against the pharmaceutical companies implementing pediatric drug development on their own initiative. In addition, because of the difficulties in conducting clinical trials for pediatric drugs, sufficient data on the efficacy and safety of the drugs cannot be collected, and as a result, pediatric dosage and administration are often not established or specified in the package inserts. Even under such circumstances, healthcare professionals in the medical field use drugs for which pediatric dosage is not clearly stated in the package inserts by reducing the dosage or changing the formulation as needed. This project aims to contribute to further improvement of safety measures for pediatric drugs and promotion of pediatric drug development by establishing an infrastructure to collect, analyze, and evaluate information on adverse events and dosage from cooperating medical institutions.
(2) Outline of P-MICS DB usage
The P-MICS DB has been collecting medical information from cooperating medical institutions since July 2015. This information is sensitive and must be handled with careful consideration. The current use of the P-MICS DB is as a "Trial Use", which should be academic research that contributes to the improvement of pediatric medical care within the scope of the following purposes.
① Academic research on the actual administration (dosage, route of administration, and occurrence of adverse events), safety, and efficacy of drugs used for pediatric patients
② Academic research of strong public interest conducted by academia, government agencies, and similar institutions
In principle, decisions on whether or not to use the P-MICS DB will require the opinion of the Expert Review Committee consisting of independent third-party experts, with some exceptions, such as when urgent action is required from the standpoint of public health. Furthermore, the results obtained from the use of the P-MICS DB will, in principle, be disclosed from the viewpoint of public interest. In such cases, measures must be taken to prevent the identification of individuals, and a judgment will be made as to whether or not the results can be published based on the publication criteria. The opinions of the Expert Review Committee should be taken into account for the final judgment.
(3) Information handling in the P-MICS DB
Medical information stored in the P-MICS DB should be collected in accordance with the research plan of "Research on the Usage of Medical Information Using the Pediatric Medical Information Collection System", which was approved by the Ethics Review Committee of the NCCHD based on the "Ethical Guidelines for Medical and Health Research Involving Human Subjects" (Notification No. 3, December 22, 2014, Ministry of Education, Culture, Sports, Science, and Technology/MHLW) and used in accordance with the Guidelines for Medical Information Use in the Pediatric Medical Information Collection System (P-MICS Use Guidelines). There are three types of information stored in the P-MICS DB, namely, patient information, medical information per se, and medical interview information.
| ①Patient information | ②Medical information | ③Medical interview information |
|---|---|---|
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Unique ID: Patient ID converted by RSA cryptography
The cooperating medical institutions take personal confidentiality protection into consideration, and anonymize medical information (i.e., the information is processed or managed in such a way that it cannot be immediately identified as the sample or information of a research subject), and transmit it to the P-MICS DB. Personal information, such as patient name, address, zip code, and telephone number, is not transmitted from the cooperating medical institutions to the P-MICS DB. The transmitted patient information includes unique ID, gender, and age information (age or date of birth), but does not include the patient ID number. When the results obtained by using the P-MICS DB are publicized, the personal information of the individual should be protected before publicizing them.
2. Privacy policy
The cooperating medical institutions will publicly announce that the medical information of the person who has been anonymized as described above will be used and guarantee that the person (or their legally authorized representative) will have the opportunity to refuse the transmission and use of their medical information. In addition, the NCCHD will disclose the use of the medical information. If the individual (or their legally authorized representative) refuses the transmission of medical information, the cooperating medical institution will not, in principle, transmit medical information to the P-MICS DB from the day after being notified about the refusal. The NCCHD will not discard medical information that has already been transmitted before the refusal of the transmission of medical information and statistical information generated from such medical information because it is impossible to identify an individual patient (a corresponding table that could identify the individual patient is not created).
3. Information on publication of results
In principle, the results obtained through the use of the P-MICS DB will be publicized from the viewpoint of the public interest corresponding to the purposes of the P-MICS DB usage and should not be published in a manner that may lead to the identification of specific individuals through cross-checking with other information or by other means. In order to ensure this handling, the user must apply in advance to the secretariat for permission to publicize materials that are to be published.
Publication criteria: All of the following criteria ①, ②, and③ must be satisfied.
① The purpose of use should be consistent with the approved purpose of use.
② As for the number of patients, in principle, no aggregation unit less than 3 (excluding 0) should be included (in the case of less than 3 [excluding 0], a decision should be made after hearing the opinions of the Expert Review Committee).
③ The specific name of each cooperating medical institution that served as a data source for the obtained results should not be indicated.