Plasmavigilance-Adverse events among US Source plasma donors.

Area of Science:

• Biomedical Sciences
• Public Health
• Hematology

Background:

• Source plasma (SP) is crucial for manufacturing 87% of global plasma-derived medicines.
• Plasmavigilance programs monitor adverse events (AEs) in SP donors to ensure safety and support donor retention.
• Understanding AE predictors is vital for maintaining a safe and satisfactory donor experience.

Purpose of the Study:

• To analyze adverse event (AE) rates in source plasma (SP) donors.
• To identify SP donor characteristics that predict the occurrence of AEs.
• To inform strategies for enhancing donor safety and retention.

Main Methods:

• Analysis of 12,183,182 SP donations from 1.1 million donors over a 4-month period.
• Utilized the Standard for Recording Donor Adverse Events for AE classification.
• Examined demographic and physiological data to identify AE predictors.

Main Results:

• The overall AE rate was 15.85 per 10^4 donations.
• Hypotensive and phlebotomy events were the most frequent AEs (8.32 and 5.91/10^4 donations, respectively).
• Females, first-time donors, and individuals with specific weight, BMI, age, and blood volume characteristics exhibited higher AE rates.

Conclusions:

• Source plasma donors generally experience low adverse event rates, with most being minor (hypotensive or phlebotomy).
• Targeted mitigation strategies for young, lightweight, female, and first-time donors can further reduce AE incidence.
• Proactive interventions are essential for ensuring donor safety, improving the donation experience, and promoting long-term donor retention.