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RISK ASSESSMENT OF STERILE PREPARATIONS PERFORMED IN THE HOSPITAL PHARMACY SERVICE

RISK ASSESSMENT OF STERILE PREPARATIONS PERFORMED IN THE HOSPITAL PHARMACY SERVICE

European Statement

Patient Safety and Quality Assurance

Author(s)

A. HERREROS FERNÁNDEZ, P. FERNÁNDEZ-VILLACAÑAS FERNÁNDEZ, R. AÑEZ CASTAÑO, P. ORTIZ FERNÁNDEZ, M.A. MEROÑO SAURA, I. GARCÍA MASEGOSA, R. GUZMÁN LAIZ, P. SELVI SABATER, C. CABALLERO REQUEJO, L. RENTERO REDONDO, E. URBIETA SANZ.

Why was it done?

The preparation of sterile magistral formulas involves significant risks due to complex processes, material handling, and sterility requirements. A systematic risk assessment was essential to identify vulnerabilities, classify risk levels, and implement preventive measures to improve safety and compliance with regulatory standards.

What was done?

Sterile magistral formulas are personalized medications prepared in hospital pharmacy services to meet individual patient needs. In 2023, a risk matrix was implemented to systematically evaluate the risks associated with their preparation. This initiative aimed to enhance patient safety and ensure compliance with the “Guide to Good Practices for the Preparation of Medications in Hospital Pharmacy Services” (GGP).

How was it done?

Sterile magistral formulas prepared in the pharmacotechnics area of a hospital during 2023 were identified from a Microsoft Access® database. A Microsoft Excel® database was specifically designed to apply the GGP-based risk matrix, categorizing formulas into low, medium, or high risk. Each formula was evaluated across six key criteria: preparation process, route of administration, drug safety profile, number of units prepared, preparation vulnerabilities, and distribution process. Risk levels were assigned using a combination of letters (A-D) based on the matrix. Challenges included standardizing data collection and ensuring multidisciplinary collaboration to refine the matrix and ensure its applicability.

What has been achieved?

A total of 80 sterile magistral formulas were assessed. Of these, 38.75% were classified as medium risk, 36.25% as high risk, and 25% as low risk. Among medium-risk formulas, 67.7% included a “C” in the matrix, while 96.6% of high-risk formulas contained at least one “D.” The most frequent risk combinations were “BBAAAA” (11.25%) and “BBBAAA” (10%). The preparation process and administration route were the primary contributors to overall risk. Medium- and high-risk formulas, primarily intravenous mixtures of antibiotics and biological drugs, required preparation in a cleanroom environment, as recommended by the GGP.

What next?

This initiative demonstrated the value of a risk matrix in identifying and managing risks in the preparation of sterile magistral formulas. It represents a best practice model with significant potential for adaptation in other healthcare settings, enhancing patient safety and standardizing risk management in hospital pharmacy operations.

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