## 1. Introduction # 1. Introduction This document outlines the requirements and procedures related to medication history management, provision of medication information, and home patient pharmaceutical management guidance. The content is based on regulations and processes applicable to insurance pharmacies, healthcare institutions, and related professionals involved in pharmaceutical care, particularly for patients who are homebound or have difficulty visiting healthcare facilities. Key topics addressed include: - Documentation and management of medication history (薬剤服用歴), including the requirement to record relevant information in the medication history records [KB-07896240-bf9f-4745-aa5c-43333549921a], [KB-4f01dc63-ee67-47da-960d-7b3cac322c39], [KB-db53d976-4bc5-4d7c-9e3e-992d24ff0eda], [KB-fdb39442-b8df-4e1b-b8f9-58652443ce9a]. - Procedures for providing medication information to patients, their families, healthcare institutions, and care managers, including the conditions under which information is shared and the frequency of such provisions [KB-73a3d438-0885-4f66-aba8-ebaad73848e4], [KB-d39d4ea1-5ba3-4b0a-ad41-b4d3a7e2355f], [KB-a138e70a-c6bd-4397-a060-761e7670ba53], [KB-a790e300-7bf3-4439-9a16-a4d81085765d], [KB-e6543407-eee4-49d6-a6f7-e87e1cfa74b7]. - Management and guidance for homebound patients, including the development of pharmaceutical care plans by insurance pharmacists, visit frequency limits, and the use of information and communication technology for remote pharmaceutical management [KB-0b046bc7-6196-45c7-8f6f-4fa08885f4c8], [KB-202617e0-b5b0-4d62-8d1a-ce3cedf9690f], [KB-2dc18274-c66c-48d9-b70e-65daaf70284f], [KB-3162b178-51a1-4b9c-ac3c-5876edfcc6a7], [KB-a91d58a5-bcae-4a27-b484-d5bbad2d16d5], [KB-f95a5c27-c855-4294-82c7-4d44f2ae6ba0], [KB-4a35747d-ab1f-438a-81d3-8e70edd3f965]. - Prevention and management of duplicate medication and drug interactions for home patients, including procedures for prescription review and communication with prescribing physicians [KB-2791671d-bbb0-48b2-840c-656f2c3168b1], [KB-dd298239-458e-4918-8774-15e7efdd24db]. - Requirements for documenting and providing necessary information to prescribing physicians and healthcare institutions, including the use of written communication and the limitations on calculation of certain fees [KB-b0d94fed-b90a-4143-b253-487915bbcbb1], [KB-eb3f5f53-5177-49b4-b852-d0f4ffbc34f6], [KB-fdb39442-b8df-4e1b-b8f9-58652443ce9a]. This document is structured in accordance with ISO/IEC/IEEE 29148 requirements and is intended for use by healthcare professionals, insurance pharmacists, and administrative personnel involved in the management of pharmaceutical care for patients, particularly in home care and transitional care settings. ## 2. Functional Requirements # 2. Functional Requirements This section specifies the functional requirements based strictly on the provided context, in accordance with ISO-29148 standards. ## 2.1 Medical Care and Evaluation - Promote outcome evaluation based on data, revise requirements and evaluation for data submission additions, and expand the scope of inpatient fees requiring data submission notifications. [KB-007430e9-258d-4d7a-9d9a-bc38a39eadb2] - Revise requirements and evaluation for comprehensive support additions for patients receiving home medical care, based on their condition. [KB-09f32992-f81b-4576-aaa4-262f9f8d8579] - Revise requirements and evaluation for terminal care additions to support end-of-life care in locations preferred by patients. [KB-3e410501-b1b1-45a9-8876-3e7fcf55b2dd] - Revise requirements for medical safety measures, especially in intensive care units and for laparoscopic surgery, making medical safety measures addition 1 notification mandatory. [KB-360b6f6e-0849-4755-9436-c9fda0dba185] ## 2.2 Home Medical Care - Revise evaluation for the number of home visits and comprehensive management fees for home medical care based on visit frequency and facility requirements. [KB-2fd8515d-d52d-4715-a3aa-a705706cd5f5] - Revise requirements for home care transition additions to ensure 24-hour support for patients receiving home care from non-home care support clinics/hospitals. [KB-75ca8a38-02f4-46be-9a1d-a9f8673d799c] - Revise requirements and evaluation for frequent visit additions to better reflect patient conditions. [KB-17ac1ec0-b2d4-4910-9884-a2e46ea25ce0] - Revise requirements and evaluation for 24-hour response system additions, considering efforts to reduce nursing workload and reviewing communication system handling. [KB-06db46ba-7647-483b-9f38-f7fa62a24d77] - Revise requirements and evaluation for emergency home visit nursing additions, including review of claim documentation. [KB-4be6a015-623d-440c-95dd-a51bf556ebbd] - Revise requirements and evaluation for home nursing management fees to strengthen the function of home nursing stations and ensure effective care. [KB-aeb72a17-5d44-4c8e-b3c6-e83c459da003] - Revise requirements and clarify responsibilities for home nursing station managers to ensure quality and efficient operation. [KB-01a2d77c-a20a-47e5-ae19-16ab2c89e272] - Mandate system establishment for abuse prevention measures in home nursing and prohibit physical restraints in principle. [KB-e14d657a-8970-4e3e-9ccb-5662af7d6525] ## 2.3 Medication Management and Pharmacy Functions - Provide necessary medication guidance and management for patients, including those receiving narcotics, and add points for each instance as specified. [KB-24385190-0703-42d1-a834-6854e998b904], [KB-ad7d4dc3-8896-4c1b-92c7-8d969120b377], [KB-66969593-ac17-45cd-a41d-f335a2406225], [KB-31de50ce-f3df-4fb0-a0bd-6a1ce5795463] - Provide medication management support for patients taking multiple drugs or having difficulty managing medication, including one-package dispensing and necessary guidance. [KB-07f1aee1-1797-47ce-a5e9-b2462436b453], [KB-ff3ce6e4-b5ec-4058-afe5-c24124781336] - Provide medication management and information sharing with medical institutions when patients or their families bring in medications for review. [KB-2f8bb1e8-7cd1-4808-802d-61cbf1dea96e] - Provide guidance and management for patients prescribed specific high-risk drugs, with additional points for each instance. [KB-f271747d-fadb-4d69-9ff8-ea0f4702f4f2], [KB-fde2b685-c7c4-44d8-9de7-3a7051dd9005] - Provide guidance and management for patients prescribed narcotics, with additional points for each instance. [KB-10f23eda-03d3-4220-8642-6ff7cbf64700] - Provide guidance and management for pediatric patients with disabilities, with additional points for each instance. [KB-ba91d9ab-b335-4929-9779-694ba115ef39], [KB-6bb697eb-fdad-4cda-a697-9d148e072b9d] - Provide guidance and management for patients using inhaled drugs, with additional points for each instance. [KB-604920cd-6896-4a10-97db-9faeb614d499], [KB-ef609548-ff37-4388-9fd5-c638d8bf6eab] - Provide medication information to medical institutions, care managers, and physicians as required, with additional points for each instance. [KB-c35807e4-304e-4ca5-8e86-e1404c20a9fd] - Provide guidance and management for patients prescribed drugs requiring special safety management, with additional points for each instance. [KB-fde2b685-c7c4-44d8-9de7-3a7051dd9005] - Provide guidance and management for patients prescribed drugs with specific risk management plans, with additional points for each instance. [KB-9720cc93-fb47-4376-9506-fbb4d8f61048] - Provide guidance and management for patients prescribed drugs with specific selection information, with additional points for each instance. [KB-5398730a-d7b5-4d8b-830e-5282b5bf61c8] ## 2.4 Discharge Guidance - Provide collaborative discharge guidance for hospitalized patients, including post-discharge home medication management, with specified points for each instance. [KB-061bef49-5443-4529-80cb-0067c3bedc4f], [KB-44db8f45-e972-47c4-ba46-8ad6a816615e], [KB-1eebb670-f513-40ab-a8bc-7127863e3404] ## 2.5 Oral and Dental Care - Revise requirements and evaluation for oral function management and training, including new evaluation for instruction/training. [KB-3ed45171-4c40-4e89-9640-f4c1995c3d49] - Revise requirements and evaluation for oral function evaluation tests. [KB-55a5d584-6926-4b26-9155-c82fd864073e], [KB-6325a096-0775-4575-b189-c388b3fb3707] - Revise requirements and evaluation for dental disease management for dementia patients, focusing on information sharing and collaboration. [KB-99f12607-f820-4879-9646-0167a0508c15], [KB-d5f332af-4a8d-4af8-a3a3-8261a8217cb1] - Revise requirements and evaluation for perioperative oral function management for patients undergoing scheduled surgery. [KB-2c3ae029-fe1e-4a01-9a81-f0d7106adac9] - Revise requirements and evaluation for dental caries prevention, including fluoride application for high-risk patients. [KB-b20115c0-dfac-4691-b5d7-1d6e8ec40744] - Revise requirements and evaluation for non-invasive management of early root caries. [KB-eebfa16b-b49a-4568-9b3d-d34515d668d9] ## 2.6 Cancer Care and Palliative Care - Provide high-quality pain relief treatment for cancer patients, including new evaluation for radiation therapy and nerve block treatment systems. [KB-6a308157-81df-47a6-a129-4eef297ca3fc] - Revise requirements and evaluation for outpatient cancer chemotherapy, including new evaluation for pharmacist pre-examination and information provision to physicians. [KB-f700221a-650f-4f32-ada0-aff43c6a8ba9], [KB-ae822bb5-db0a-4310-9d78-651887df1be2] - Provide guidance and management for injection-based narcotic administration in palliative care, including new evaluation. [KB-7feb02b9-5c22-4143-be1d-cbf364803425], [KB-a37a229d-a301-4e7f-8fcb-6324bf53e88d] - Provide high-quality palliative care for terminal cancer patients at home, utilizing ICT for information sharing among medical staff. [KB-fa0fdacb-f933-4296-8d0b-ac501b9102a5], [KB-ef95bdaa-ef0b-4848-bf4b-a5c073be5ba9] ## 2.7 Other Functional Requirements - Promote the minimization of physical restraints in medical institutions, requiring organizational measures. [KB-edc81296-4474-4138-a404-f797f293eb19], [KB-8445364a-473a-46bc-8207-fb1f2671bde6] - Revise requirements and evaluation for dementia care additions, including delirium risk assessment. [KB-c2bd624b-5c92-413c-be0e-30abb7e64211] - Revise requirements and evaluation for medical technology, including new evaluation for advanced and existing technologies. [KB-a64f1d1c-0908-41ba-837c-9ebc4bde0608], [KB-ffab649b-a67a-4acf-80e1-d2c52ddeea35], [KB-5a5f94bb-dd29-4f1f-8647-be1b9469aedb] - Revise requirements and evaluation for clinical laboratory tests, including new evaluation for newly insured tests. [KB-5d6133e4-cdeb-4afc-9baa-ce5451c553c3] - Revise requirements and evaluation for perinatal care, including intensive maternal-fetal care and high-risk pregnancy management. [KB-9c830a43-09a7-4754-8768-2280a1c7c4d0], [KB-bf7bf217-1227-4557-ba33-96e4e136aa44] - Revise requirements and evaluation for stroke care, including acute-phase additions and thrombectomy therapy. [KB-756163a1-0f55-439f-af3c-df24ec1730ad], [KB-c8459382-6685-4ba2-b7b8-f7a8be6f4afe], [KB-c1b6365e-b34e-410b-ac5d-64e07546e891], [KB-a1c5144b-9c03-4494-8d4f-ef88d8051c06] - Revise requirements and evaluation for information communication device-based medical management, including psychiatric therapy and pediatric developmental disorder management. [KB-e0dc4383-67ee-4091-918d-5e929ef99278], [KB-82af478a-eb1e-461e-befc-c32755e8d262] - Revise requirements and evaluation for medical institution operational efficiency, including electronic submission of facility standards and claim procedures. [KB-b952325d-d264-48ac-afd5-532c6ea95025] [GAP: Missing data for 2. Functional Requirements] (if any additional requirements are needed, please specify the missing data.) --- *All requirements are strictly based on the provided context and cited accordingly.* ## 3. Non-Functional Requirements # 3. Non-Functional Requirements ## 3.1 Regulatory Compliance - All requirements and constraints related to medical, pharmaceutical, and care services must comply with the conditions and periods specified by the Minister of Health, Labour and Welfare. For example, insurance coverage is only applicable within 240 days from the date of request and must meet facility standards as defined by the Minister [KB-10b6eef3-83b9-4f85-989d-52eedff98666], [KB-1db39487-01df-43ec-8332-a98fe5080a80], [KB-5ab9a8fb-c6b0-49f6-8519-dbe98c154013], [KB-852b7555-31af-4e5b-8e1a-0e085ed29976], [KB-9cab8459-80dc-4246-9f26-2fdc9a9c4cf2]. - Medical device approval and program medical device changes must adhere to the regulatory requirements, including partial change approval, usage purpose, and compliance with relevant articles [KB-1102d56d-2dce-4df7-9cd8-a5f9242dcf2f], [KB-1d5fff79-ad72-4795-9e4e-1f991e08f732], [KB-22e74deb-6aac-4721-877b-18d1d268f072], [KB-a7072a0c-9c31-469f-8d54-898517319aeb], [KB-c4ca1951-fb1a-40e5-b0de-d46e38483f8a]. ## 3.2 Calculation and Evaluation Constraints - Certain calculation items, such as "Special Regional Care Prevention Home Bathing Care Addition," "Small-scale Office Addition in Mountainous Areas," and "Service Provision Addition for Residents in Mountainous Areas," are excluded from the management of benefit limits and must be treated as such in all relevant calculations [KB-51596246-f941-4c95-b3eb-a5cfeb039e8e], [KB-97375cea-0072-4262-97f3-f0d571b501dc], [KB-70905c95-1c1e-409e-96d9-8669611c1709], [KB-4f918019-89ee-44de-91a4-9a94f0edeb8e], [KB-c1336494-c95b-4ccd-be27-67ba6f9d04ea], [KB-645385d4-54cb-467c-8144-5f22db52e6a1], [KB-3e409869-7eaf-4094-afd9-f719b02e82fb], [KB-32623906-89d8-4efb-8c30-40eb26bf3957], [KB-a3fcb284-15ed-44b7-a8a9-45a6b0b99c66], [KB-70905c95-1c1e-409e-96d9-8669611c1709], [KB-eba350f9-1ecf-4617-ac34-0e1c22f027e6], [KB-c658f0ca-be16-42b1-b726-34bf4b2fa5d4], [KB-d01af661-fcbe-46c9-b8af-eaad36d0670e], [KB-d9823346-1fec-4446-bafe-1a7213d8cf6e], [KB-c4101ee7-c01e-4160-a681-85fe5be2e38a], [KB-7327b196-bb40-401b-990c-89d131d76a66], [KB-97375cea-0072-4262-97f3-f0d571b501dc], [KB-645385d4-54cb-467c-8144-5f22db52e6a1], [KB-4f918019-89ee-44de-91a4-9a94f0edeb8e], [KB-70905c95-1c1e-409e-96d9-8669611c1709], [KB-97375cea-0072-4262-97f3-f0d571b501dc], [KB-c1336494-c95b-4ccd-be27-67ba6f9d04ea], [KB-645385d4-54cb-467c-8144-5f22db52e6a1], [KB-3e409869-7eaf-4094-afd9-f719b02e82fb], [KB-32623906-89d8-4efb-8c30-40eb26bf3957], [KB-a3fcb284-15ed-44b7-a8a9-45a6b0b99c66], [KB-70905c95-1c1e-409e-96d9-8669611c1709], [KB-eba350f9-1ecf-4617-ac34-0e1c22f027e6], [KB-c658f0ca-be16-42b1-b726-34bf4b2fa5d4], [KB-d01af661-fcbe-46c9-b8af-eaad36d0670e], [KB-d9823346-1fec-4446-bafe-1a7213d8cf6e], [KB-c4101ee7-c01e-4160-a681-85fe5be2e38a]. - "Care Worker Treatment Improvement Addition (V)" is only valid for calculation until March 31, 2025 [KB-51596246-f941-4c95-b3eb-a5cfeb039e8e], [KB-d9823346-1fec-4446-bafe-1a7213d8cf6e], [KB-a6475b2a-bd03-4612-b22d-705cd1ed4ba3], [KB-7fbe375f-4eb6-46bb-9d89-9d5c5f02cffe], [KB-ded165e5-0ffc-466d-a44a-e3f2f59911b9], [KB-e3b97330-45ab-463a-b6c1-0db106f77642], [KB-992e44e9-d5ba-4f88-9ed5-94bf14f522b8], [KB-44976d5a-d3c0-4bdb-b5fe-fdb32093eec9], [KB-9dee249a-0ce6-43a8-ae7b-b695d7ac7a17], [KB-603908c0-953d-49c5-a13a-cde6ba241825], [KB-8b25059d-8e2f-4ea4-b64b-39b0475cfe36], [KB-6454401b-880e-45df-9d50-276d993c88d7], [KB-5ccda32a-61f8-419d-8920-82e3bc595c08], [KB-e3a845c3-fa12-4e36-a01e-e974dc79fa93], [KB-d10a1682-f265-4290-8645-696a4eca8676]. ## 3.3 Security and Infection Control - Infection control measures must be implemented, especially for patients with infectious diseases requiring hospitalization. Necessary infection management and private room management must be newly evaluated [KB-1497b4a5-d1c1-4d5a-87ca-3b1d15fc83bb]. - The requirements and evaluation for outpatient infection control improvement must be reviewed to further promote appropriate responses to fever patients under proper infection management [KB-44286717-f48a-4e25-8a84-638c73d9b4aa]. - In dental outpatient care, infection prevention and medical safety must be ensured, and systems capable of responding to emerging infectious diseases must be evaluated [KB-2a531b65-c901-4e8c-a03c-35398406b73b]. - In care facilities, business continuity plans must be established, and if not formulated, a reduction will be applied from April 1, 2025. However, if infection prevention guidelines and disaster plans are in place, the reduction is not applied until March 31, 2025 [KB-b275d8f2-c60a-403d-851d-42b2e3a20b0e], [KB-fa59d176-d888-4794-ab96-3fcedc7caf89], [KB-bcafea09-eea4-4aab-b5ca-a62b71781c25], [KB-28745fdd-93d7-482f-b2aa-c03fd4b81aa9], [KB-3e26eb54-e253-4fcf-98c0-4a8b69a9d938], [KB-c1336494-c95b-4ccd-be27-67ba6f9d04ea], [KB-ded165e5-0ffc-466d-a44a-e3f2f59911b9], [KB-f54917b1-160d-40f6-bf5d-c4aec3e0d05b], [KB-b275d8f2-c60a-403d-851d-42b2e3a20b0e]. ## 3.4 Operational Constraints - Night shift condition reductions and night shift nursing additions are mutually exclusive; if the night shift condition reduction is applied, the night shift nursing addition cannot be applied [KB-135ed21d-894d-453e-b73b-e8de2bf5703d], [KB-40a52a99-163a-4301-a621-c1f046161a6f], [KB-5c416815-97da-47e4-a4c4-c464e209423f], [KB-b09df152-e38d-428e-b8e8-bea26fc03d7f]. - If "Ha" or "He" is applied, "※2" is not applied [KB-135ed21d-894d-453e-b73b-e8de2bf5703d], [KB-40a52a99-163a-4301-a621-c1f046161a6f], [KB-b275d8f2-c60a-403d-851d-42b2e3a20b0e], [KB-fa59d176-d888-4794-ab96-3fcedc7caf89]. ## 3.5 Financial Constraints - The calculation of food expenses during hospitalization must be based on revised standards reflecting the recent surge in food prices [KB-8a024751-edcd-440d-8648-a2232499d8f6]. ## 3.6 Service Provision Constraints - For care facilities and services, certain additions and reductions are specified based on the number of users, building conditions, and service types. For example, when providing services to 20 or more users in the same building, the pre-reduction unit count is included in the calculation of the benefit limit [KB-950c72a7-37bd-4bfd-adb4-63125baaad24], [KB-c58a4c86-0c61-4775-83a7-6d837a7b5e3e], [KB-3fa364c7-bcf8-42b4-8bee-2ff777b4af75], [KB-e182dd95-05eb-4b42-afca-24b93b386ee5]. --- [GAP: Missing data for 3. Non-Functional Requirements regarding performance, usability, reliability, maintainability, scalability, and other quality attributes not specified in the provided context.] ## 4. Architecture 4. Architecture [GAP: Missing data for 4. Architecture]