AUTOMATIC substitution of biological medicines may be safe when pharmacy changes include counseling and care coordination.
Automatic Substitution of Biological Medicines in Rheumatology
Rheumatology nurses generally viewed automatic substitution of biological medicines positively, but emphasized that safe implementation depends on patient counseling, clear professional coordination, and adequate clinical resources.
Automatic substitution refers to a community pharmacy dispensing practice in which a pharmacist replaces a prescribed biological medicine with an interchangeable biologic product without first contacting the prescriber. The approach may help reduce healthcare expenditure by increasing price competition among biological medicines, but its use also introduces safety considerations in specialties where patients often rely on precise injection technique, device familiarity, and ongoing support.
The qualitative study explored rheumatology nurses’ perspectives because their role in patient care, injection training, and device guidance is central to safe biologic use. Researchers conducted individual semistructured interviews in 2025 with 10 rheumatology nurses who had clinical experience supporting patients receiving injectable biological medicines. Interview data were analyzed using inductive content analysis, with reporting guided by the Consolidated Criteria for Reporting Qualitative Research checklist.
Counseling and Coordination Drive Safety
Four main categories emerged: perceptions of automatic substitution, factors supporting implementation, concerns related to substitution, and safe implementation. Across interviews, rheumatology nurses recognized the importance of both community pharmacies and healthcare personnel in maintaining medication safety.
Perceptions were broadly favorable, and nurses generally considered biological medicines suitable for automatic substitution. Supportive factors included patients’ previous experience with biological medicines and with generic substitution, as well as the suitability of the medicines themselves for substitution.
However, nurses also raised practical and medication related concerns. These included possible challenges linked to different products, devices, and patient understanding, as well as increased workload for healthcare professionals providing patient counseling.
Patient Safety Requires Resources
The findings suggest that automatic substitution of biological medicines should not be treated as a simple dispensing change. In rheumatology care, substitution may affect patient confidence, injection routines, and the need for timely support when a product or device changes.
Sufficient resources, consistent counseling, and coordination between pharmacies and healthcare teams will be essential to protect patient safety. For clinicians, the study highlights the need to anticipate counseling demands and ensure patients understand any change in their biological medicine before and after substitution occurs.
Reference
Oikarinen R et al. Rheumatology nurses’ perspectives of automatic substitution of biological medicines in community pharmacies and its safety: a qualitative study. BMC Health Serv Res. 2026;doi: 10.1186/s12913-026-14848-w.
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