Regional
Safeguarding Transfusion Safety: The unique role of the Japanese Red Cross Medical Representatives
Naoko Goto
Japanese Red Cross Nagano Blood Center, Japan
Yuta Tokida
Japanese Red Cross Nagano Blood Center, Japan
Blood transfusion is a vital, life-saving medical procedure. Unlike synthetic pharmaceuticals, blood products rely entirely on human donation, making them scarce and fragile. Given potential risks such as transfusion-transmitted infections and immunological reactions, rigorous monitoring systems are essential.
In Japan, the Japanese Red Cross Society (JRCS) administers the national blood program, overseeing donor recruitment, processing, supply, and safety surveillance. Within this framework, the JRCS Medical Representative (MR) plays a unique role. Unlike sales-oriented representatives in pharmaceutical companies, JRCS MRs function as public health professionals who connect hospitals, blood centers, and regulatory authorities to ensure the safety of transfusion medicine.
Legal Definition and Mission Under Article 2, Paragraph 4 of Japan’s Good Vigilance Practice (GVP) Ordinance, an MR is defined as “a person who visits medical professionals to collect and provide safety management information for the proper use of pharmaceuticals.”
The mission of JRCS MRs is to deliver accurate information regarding the quality, efficacy, and safety of blood products, ensuring their proper use to protect patient safety. In contrast to pharmaceutical MRs, whose activities are driven by commercial objectives, JRCS MRs operate under a public health mandate, prioritizing patient welfare and transparency over profit.
Key Responsibilities in Blood Safety and Hemovigilance
The primary function of JRCS MRs lies in post-marketing safety management (GVP activities). Their main responsibilities include:
- Acquisition of Transfusion Adverse Reactions and Transfusion-Transmitted Infection cases MRs collect data on transfusion-related reactions such as fever, anaphylaxis, transfusion-related acute lung injury (TRALI), and transfusion-associated circulatory overload (TACO), as well as suspected transfusion transmitted infections from hospitals. These are reported to the Safety Management Department (JRCS Blood Services Headquarters). Serious cases will be reported by the Marketing Authorization Holder (JRCS) to the Minister of Health, Labour and Welfare (administrative duties are handled by PMDA).
- Donor-Derived Risk Investigations (Lookback study) Providing information to hospitals regarding donor-derived infection risks, such as positive conversion of viral markers on repeat donors, based on post-donation reports and conducting recipient tracing studies when necessary.
- Promotion of Appropriate Use Through the national guidelines or transfusion operating manuals, training sessions, and hospital meetings, advocate for the appropriate use of blood products, preventing issues like excessive transfusion or transfusion errors.
- Inquiry Support Acting as a consultative contact point for issues related to blood product handling, test result interpretation, and transfusion safety.
- Complaint and Recall Management Respond swiftly to issues like contamination, hemolysis, or suspected product quality defects, as well as recalls prompted by look-back investigations based on repeat donors’ seroconversion data.
- Participation in Transfusion Therapy Committees Engage in hospital transfusion committees and regional networks, and may serve as secretariats for prefectural joint transfusion therapy committees, supporting safe transfusion practices and proper blood use.
- Bidirectional Information Flow Relay hospital transfusion trends to blood centers to ensure stable supply, while disseminating national guidelines, academic updates, and JRCS’s safety measures to clinicians. This creates a continuous information exchange loop, known as the Transfusion Chain, linking clinical practice with the blood safety system.
Hemovigilance: A Distinctively Japanese Model Hemovigilance refers to the systematic surveillance of the transfusion process from donor to recipient. While many countries operate hemovigilance systems, Japan’s structure is distinctive in directly integrating MRs into the reporting pathway. Reports flow swiftly from hospitals to MRs and then to blood centers and blood service headquarters. Cases deemed serious by attending physicians or classified as such by JRCS (e.g., severe allergic reactions, hypotensions, respiratory distress, TRALI, or TACO) are reported to the Minister of Health, Labour and Welfare under the Pharmaceutical Affairs Law. The JRCS Central Blood Institute further investigates these cases using patient samples, and MRs conduct detailed interviews with physicians to aid root-cause analysis. This real-time, face-to-face monitoring strengthens patient safety. In contrast, many other countries rely on hemovigilance officers within hospitals or regulatory agencies. Japan’s JRCS, as the manufacturer of blood products, collects data directly through its MRs—a globally rare mechanism that significantly enhances transfusion safety and responsiveness.
Professionalism and Ethics To fulfill their responsibilities, JRCS MRs must demonstrate:
- Ethics: A patient-centered focus on safety.
- Knowledge: Expertise in medicine, pharmacy, transfusion science, and regulation.
- Skills: Competence in communication, reporting, and clinical dialogue.
- Conduct: Compliance with legal standards, respect for donors, and professional accountability.
They are not sales representatives but ethical custodians of national blood safety, upholding transparency and public trust.
International Comparison Japan’s MR system stands apart globally.
- United States: Multiple decentralized suppliers manage the blood supply. Hospitals report adverse transfusion events directly to the FDA; only fatal cases are mandatory. The CDC oversees voluntary data collection modules, and no MR-like role exists.
- Europe: Reporting of serious transfusion reactions is governed by EU directives, with annual national summaries submitted by member states. The UK (SHOT), France (ANSM), and the Netherlands (TRIP) maintain strong systems, but data are collected through hospital specialists or national registries rather than on-site field representatives.
- Asia: South Korea and Taiwan maintain centralized systems, but reporting is largely document-based without regular hospital visits. Japan’s hemovigilance model is unique in embedding MRs from the national blood operator as professionals linking clinical sites and regulatory authorities to ensure prompt, coordinated responses.
Comparison with Pharmaceutical MRs and Pharmacovigilance
Although sharing the same title, JRCS MRs differ fundamentally from pharmaceutical MRs:
- Pharmaceutical MRs
- Purpose: Sales promotion
- Scope: Specific products
- Pharmacovigilance: Based on post-market surveys
- JRCS MRs
- Purpose: Public health and safety.
- Scope: Entire transfusion medicine
- Hemovigilance: Direct, real-time hospital data
Both aim to safeguard patients, but pharmacovigilance depends on corporate structures, whereas Japan’s JRCS hemovigilance relies on the MR’s immediate field engagement.
The JRCS Medical Representative is not a salesperson but a guardian of transfusion safety. Legally defined and ethically guided, their duties encompass adverse reaction surveillance, donor-risk investigations, promotion of appropriate transfusion practices, and collaboration with transfusion committees.
By maintaining bidirectional information flow among hospitals, blood centers, and regulators, they ensure both transfusion safety and a stable blood supply. As Japan faces demographic changes such as an aging population and declining donor numbers, the oversight and ethical responsibility of JRCS MRs will become increasingly vital. This model, founded on transparency and public health, stands as a rare global example of prioritizing patient safety over profit.
