Initial results of a prospective study and identification of new strategies to increase traceability of plasma-derived medicines

Document Type: Research article

Authors

1 Tehran University of Medical Sciences, Faculty of Pharmacy

2 Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy, Department of Pharmacoeconomics and Pharmaceutical Management Head of Biologics Office, Food and Drug Administration

Abstract

Background: Plasma medicine is an innovative and emerging field used in a broad range of medical conditions.
Objective: The present study focused on consumption, documentation pattern and traceability of plasma-derived medicines in a teaching and referral hospital.
Method: A two-step study was conducted from October to December 2015. During the first phase, the patient records receiving plasma-derived medicines including Coagulation Factor VIII, IX, Prothrombin Complex Concentrate, Factor VIII/Von Wilberand Complex, Anti-Hepatitis B Immunoglobulin, Intravenous Immunoglobulin, Anti-Tetanus Immunoglobulin, and Albumin were checked to assess recording details of these medications at the time of administration. Adverse events reported with the mentioned products were examined from traceability viewpoint from patients to donors and vice versa. The second step concentrated on practical strategies to improve documentation status of plasma-derived medicinesin the hospital. We proposed national regulation as the first strategy and a new barcoding systemto track and identify drug information of plasma medicines.
Result: Of the expected information of plasma-derived medicines, only generic name, dosage from, and strength were recorded after administration. Safety surveillance of the plasma products was poor similarly. Unavailability of suitable instructions was the main reason for documentation deficiency. A regulation was designed and implemented to inform healthcare professionals about necessity of appropriate documentation for plasma-derived medicines. Updated results of the ongoing phase will be submitted soon.
Conclusion: Our survey highlights the importance of improvement of documentation and traceability as a key component of plasma-derived medicines surveillance within the hospitals.

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