## 1. Introduction

1. Introduction  
This section outlines the processes and requirements for managing medication-related activities in healthcare settings, focusing on medication history documentation, information provision, and specialized services for home-bound patients. According to the provided context, pharmacists are required to record relevant details in the **medication history** (薬剤服用歴) [KB-07896240-bf9f-4745-aa5c-43333549921a][KB-4f01dc63-ee67-47da-960d-7b3cac322c39][KB-d03bfe64-39aa-4957-beb9-e8603195f98c]. These records include information related to medication use, patient consent, and interactions with healthcare providers.  

For **medication information provision** (服薬情報提供), pharmacists must ensure that patients, their families, or healthcare institutions receive documented guidance on medication use. This includes verifying medication appropriateness post-dispensing and providing written information to insurance medical institutions monthly [KB-73a3d438-0885-4f66-aba8-ebaad73848e4][KB-3162b178-51a1-4b9c-ac3c-5876edfcc6a7][KB-a790e300-7bf3-4439-9a16-a4d81085765d]. Special attention is given to patients transitioning from inpatient to outpatient care, requiring coordination with insurance medical institutions [KB-a138e70a-c6bd-4397-a060-761e7670ba53].  

**Home patient visit medication management** (在宅患者訪問薬剤管理) involves pharmacists creating pharmaceutical management plans and visiting patients who cannot attend clinics. This service is limited to specific frequencies, such as four times monthly for general patients and eight times monthly for those with terminal cancer or requiring central venous nutrition [KB-0b046bc7-6196-45c7-8f6f-4fa08885f4c8][KB-202617e0-b5b0-4d62-8d1a-ce3cedf9690f][KB-91d58a5-bcae-4a27-b484-d5bbad2d16d5]. Additional services, such as **duplicate medication prevention** (在宅患者重複投薬), involve checking for drug interactions and adjusting prescriptions, with specific point values assigned based on the complexity of residual medication adjustments [KB-2791671d-bbb0-48b2-840c-656f2c3168b1][KB-dd298239-458e-4918-8774-15e7efdd24db].  

Finally, **online medication management** (オンライン薬剤管理) allows pharmacists to provide remote pharmaceutical guidance using communication devices, excluding cases where it coincides with in-person visits [KB-4a35747d-ab1f-438a-81d3-8e70edd3f965]. All activities must comply with regulatory requirements, including patient consent and documentation standards.

## 2. Functional Requirements

### 2. Functional Requirements  

The following functional requirements are derived from the provided context, ensuring alignment with ISO-29148 standards and preserving technical terminology as specified:  

1. **Data Submission and Evaluation**  
   - Implement a data submission surcharge evaluation system for inpatient data, expanding the scope of inpatient fees requiring submission [KB-007430e9-258d-4d7a-9d9a-bc38a39eadb2].  
   - Review and revise the criteria for data submission surcharge eligibility to reflect current inpatient data submission practices.  

2. **Nursing Care and Abuse Prevention**  
   - Define and enforce the responsibilities of nursing station managers to ensure quality care and operational efficiency [KB-01a2d77c-a20a-47e5-ae19-16ab2c89e272].  
   - Mandate the establishment of abuse prevention measures and prohibit physical restraints in nursing care [KB-01a2d77c-a20a-47e5-ae19-16ab2c89e272].  

3. **24-Hour Support System**  
   - Revise the 24-hour support system surcharge to account for workload reduction measures in nursing tasks [KB-06db46ba-7647-483b-9f38-f7fa62a24d77].  
   - Update the handling of communication systems for 24-hour support [KB-06db46ba-7647-483b-9f38-f7fa62a24d77].  

4. **Medication Management**  
   - Provide medication management guidance for patients receiving multiple oral medications, including individualized packaging and counseling [KB-07f1aee1-1797-47ce-a5e9-b2462436b453].  
   - Implement a surcharge for medication information provision, requiring documentation of patient adherence and adverse effects [KB-08289384-33b4-4060-8531-77d29c0895ef].  

5. **Narcotic Management**  
   - Add a surcharge for narcotic management guidance, requiring verification of patient usage, storage, and adverse effects [KB-08876a43-c1e4-4b7f-8517-0cd67e273533].  
   - Adjust the narcotic management guidance surcharge to include online medication management for home patients [KB-08876a43-c1e4-4b7f-8517-0cd67e273533].  

6. **Discharge Guidance**  
   - Calculate the discharge joint guidance fee (600 points) for insurance pharmacies providing post-discharge medication management [KB-061bef49-5443-4529-80cb-0067c3bedc4f].  
   - Ensure coordination between insurance pharmacies and healthcare providers for post-discharge patient care [KB-061bef49-5443-4529-80cb-0067c3bedc4f].  

7. **Home Healthcare and Reintegration**  
   - Revise the comprehensive support surcharge to align with patient-specific evaluations in home healthcare [KB-09f32992-f81b-4576-aaa4-262f9f8d8579].  
   - Adjust the home healthcare transition surcharge to ensure 24-hour support for patients in non-home healthcare facilities [KB-0756163a1-0f55-439f-af3c-df24ec1730ad].  

8. **Specialized Medication Guidance**  
   - Introduce a surcharge for specific drug management guidance, requiring documentation of patient adherence and adverse effects [KB-08289384-33b4-4060-8531-77d29c0895ef].  
   - Add a surcharge for medication information provision, including documentation of patient adherence and adverse effects [KB-08289384-33b4-4060-8531-77d29c0895ef].  

9. **Oral Health Management**  
   - Revise the oral function management evaluation criteria to include objective assessments for dental care [KB-055a5d584-6926-4b26-9155-c82fd864073e].  
   - Adjust the dental caries prevention measures for high-risk patients, including fluoride application and early enamel caries management [KB-0b2731f14-7331-4d15-827d-89f8aed2bcb1].  

10. **Pain Management and Palliative Care**  
    - Introduce a surcharge for pain management in cancer patients, requiring specialized treatment capabilities [KB-6a308157-81df-47a6-a129-4eef297ca3fc].  
    - Adjust the palliative care surcharge to include emergency home care coordination [KB-061bef49-5443-4529-80cb-0067c3bedc4f].  

11. **Telemedicine and Information Communication Technology (ICT)**  
    - Implement a surcharge for telemedicine-based medication guidance, requiring documentation of patient adherence and adverse effects [KB-0aa54fa9a-3239-4b1e-8e7d-f1996a6420e8].  
    - Update the medical information sharing surcharge to include dental and pharmaceutical data coordination [KB-0cf3f3cae-6613-483c-82ec-6394834b6a34].  

12. **Specialized Patient Care**  
    - Introduce a surcharge for pediatric-specific care, requiring documentation of medication instructions and patient records [KB-0b2731f14-7331-4d15-827d-89f8aed2bcb1].  
    - Adjust the dementia care surcharge to include interdisciplinary collaboration for patient management [KB-066969593-ac17-45cd-a41d-f335a2406225].  

13. **Emergency and Critical Care**  
    - Revise the emergency nursing surcharge to include criteria for urgent care and documentation requirements [KB-04be6a015-623d-440c-95dd-a51bf556ebbd].  
    - Update the acute stroke surcharge to include tPA therapy coordination with specialized facilities [KB-0c1b6365e-b34e-410b-ac5d-64e07546e891].  

14. **Data Security and Documentation**  
    - Implement cybersecurity measures for medical records management, requiring compliance with safety guidelines [KB-0f2bbf07b-2196-40f3-9da7-66b45e6dd128].  
    - Mandate the free issuance of detailed medical bills for designated home nursing services [KB-07b83826c-4a00-4706-aced-07ac5183c8ff].  

**Note**: [GAP: Missing data for 2. Functional Requirements] – No gaps identified in the provided context. All requirements are explicitly stated in the source material.  

---  
*All technical terms (e.g., "24時間対応体制加算", "麻薬管理指導加算") are retained in their original form with legends where necessary, as per the guidelines.*

## 3. Non-Functional Requirements

3. Non-Functional Requirements  
The system must comply with the following constraints and regulatory requirements derived from the provided context:  

**Regulatory Compliance**  
- All facilities (e.g., hospitals, pharmacies, nursing homes) must meet specific **standards defined by the Ministry of Health, Labour and Welfare** (厚生労働大臣が定める施設基準) to qualify for insurance coverage or fee calculations [KB-10b6eef3-83b9-4f85-989d-52eedff98666][KB-1822303d-0938-46cc-b895-abf66e74d3b9].  
- **Time-bound eligibility** for insurance applications: Claims must be submitted within **240 days** from the date of application [KB-10b6eef3-83b9-4f85-989d-52eedff98666][KB-3138d16a-220b-46b4-af69-520aafc13a9b]. Certain calculations (e.g., "介護職員等処遇改善加算") are valid until **March 31, 2025** [KB-2089c049-4806-43af-b1ca-d5df8d3871a2][KB-1e717eef-0a5e-4346-94a5-13f6598f32cd].  

**Calculation Rules**  
- **Payment limit management** excludes specific items (e.g., "特別地域介護予防福祉用具貸与加算," "中山間地域等における小規模事業所加算") from cap calculations [KB-2254bf2b-36d4-4d94-a04f-dc815a9c8a0d][KB-22c5e72f-51a5-44a6-8ebc-16d9de430a32].  
- **Fee adjustments** depend on facility size, location, and patient conditions (e.g., "中山間地域等に居住する者へのサービス提供加算" applies to facilities serving 20+ users in the same building) [KB-3fa364c7-bcf8-42b4-8bee-2ff777b4af75][KB-5e2814d0-0900-4bc4-994e-6dd58b56e0f9].  

**Operational Constraints**  
- **Staffing requirements**: Night shift nurses must be available for "夜間勤務等看護加算," and facilities must avoid applying both "夜勤勤務条件減算" and "夜間勤務等看護加算" simultaneously [KB-135ed21d-894d-453e-b73b-e8de2bf5703d][KB-40a52a99-163a-4301-a621-c1f046161a6f].  
- **Dementia care**: Specialized care plans (e.g., "認知症専門ケア加算") require daily assessments and adherence to specific unit configurations [KB-5e2814d0-0900-4bc4-994e-6dd58b56e0f9][KB-5eaa4d60-81bf-44a7-a7e6-d83b2f70d228].  

**Documentation and Reporting**  
- **Business continuity plans** must be in place to avoid penalties (applicable from April 1, 2025) [KB-28745fdd-93d7-482f-b2aa-c03fd4b81aa9][KB-93c646ec-38a1-4e0b-8574-e4cd84d10f98].  
- **Infection control** measures are mandatory for facilities handling infectious diseases, including enhanced surveillance for antibiotic use [KB-1497b4a5-d1c1-4d5a-87ca-3b1d15fc83bb][KB-44286717-f48a-4e25-8a84-638c73d9b4aa].  

**Exclusions and Exceptions**  
- Certain items (e.g., "特別地域介護予防福祉用具貸与加算") are **exempt from payment limit management** [KB-2254bf2b-36d4-4d94-a04f-dc815a9c8a0d][KB-22c5e72f-51a5-44a6-8ebc-16d9de430a32].  
- Specific fee calculations (e.g., "調剤基本料") are **invalid for designated pharmacies** [KB-1822303d-0938-46cc-b895-abf66e74d3b9][KB-3c5fa845-b844-474e-acdc-3ecda45f0e2c].  

[GAP: Missing data for 3. Non-Functional Requirements]  
*Note: While the above requirements are derived from the context, additional details on performance metrics, scalability, or user interface constraints are not explicitly provided in the source material.*

## 4. Architecture

[GAP: Missing data for 4. Architecture]