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RESEARCH PRODUCT

2SPD-025 Application of hazard vulnerability analysis to evaluate the risk level of medicine shortages

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Background and importance Drug shortages have become a worldwide phenomenon which has repercussions on patient care and on the hospital’s budget. Aim and objectives The aim of our study was to assess the risk of shortages of drugs included in our hospital therapeutic formulary (HTF), for which there is shortage reporting, using a hazard vulnerability analysis (HVA). Material and methods We performed an HVA on 43 drugs in our HTF, which were also included in the Italian Medicines Agency list of shortages. The HVA used to assign the risk of shortage (ROS) included three macro areas: probability that the shortages will occur based on shortages in the past 2 years; magnitude factors which increase the risk of shortages; and mitigation factors which reduce it. Probability was assigned a score from 0 to 2 based on previous shortages. Magnitude factors were relevance of active substance; budget impact; and percentage of patients treated. Mitigation factors were: therapeutic alternative; stock availability; and import of drug. For each of these items a score from 0 to 3 was assigned. For magnitude factors, a higher score was assigned for increasing severity values. In contrast, for mitigation factors, a higher score was assigned in relation to mitigation reduction. The value of the risk was calculated multiplying the percentage of probability (P) and the percentage of severity (S). According to the score obtained, three classes of ROS were assigned: low ( 60%). Results No drug was found to be at high risk of shortage (>60%), 32/43 (74.4%) were at low risk of shortage and 11/43 (25.6%) were at medium risk of shortage. The latter had previously been lacking; 6/11 had the same active ingredient as a therapeutic alternative, 3/11 had a different active ingredient as an alternative while 2/11 had no alternative. Conclusion and relevance The HVA is an important method to assess the ROS and implement targeted strategies for drugs at risk of shortages. Knowledge of the risk level facilitates the timeliness of the interventions to resolve the shortages themselves. References and/or acknowledgements No conflict of interest.