Using Preliminary Risk Analysis (PRA) to Ensure Safety in the Preparation Process for Parenteral Nutrition Bags in Hospital Pharmacy

Abstract

Abstract: The aim of this paper is to use the Preliminary Risk Analysis (PRA) method to assess the criticality of the different stages in the process of preparing parenteral nutrition bags for use in neonatal resuscitation and, if necessary, improve the handling of the process itself.: A functional analysis of the preparation process was carried out, and three main phases were identified: Phase 1 – Fielding the request; Phase 2 – Production; Phase 3 – Checks. Risks were mapped under 5 category headings (legal, environmental, physical, human and managerial). After the evaluation criteria had been identified, scenario descriptions were drawn up for each dangerous situation in order to ascertain the criticality level (C1–C3, C1 being the least critical) of the different risks and to seek out risk mitigation measures.: The PRA method identified 63 dangerous situations, 77.7 % of which had a very high level of vulnerability. The highest number of such situations was in the production phase. Seventy one scenarios were drawn up (19 for phase 1, 40 for phase 2 and 16 for phase 3, as the same scenario may occur in more than one phase). The study enabled a reduction in system criticalities: initially there were 6 C1 scenarios, 44 C2’s and 21 C3’s and following the study there were 45 C1’s, 26 C2’s and 0 C3 scenarios. The most significant initial risks were linked to environmental, managerial and human factors whilst the most significant residual risks were environmental or legal in nature.: PRA is a viable assessment method in the health sector and has enabled the establishment of new measures seeking to minimise risk levels in the preparation process of parenteral nutrition bags.