(P-081) Assessment of Adherence to Deferasirox Risk Minimization Measures in Saudi Arabia

Background: Deferasirox is associated with increased risk of renal or hepatic failure. Thus, the Saudi Food and Drug Authority (SFDA) imposed risk minimization measures (RMMs), which included requirements for hepatic and renal function monitoring before initiation of therapy and on a monthly basis thereafter.

Objectives: To assess adherence to deferasirox’s RMMs.

Methods: Using electronic health records from King Abdulaziz Medical City in Riyadh, we conducted a retrospective analysis of patients who had ≥1 deferasirox prescription. We defined the pre-RMM implementation phase as all treatment episodes from April 2015 until May 16, 2016. While post-RMM phase started from RMM implementation date to March 2017. The index date was first recorded deferasirox prescription. Adherence to RMMs was measured by calculating the proportion of patients who had serum ferritin, serum creatinine, bilirubin, aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) testing at initiation of therapy (up to 7 days before the index date), and one month after starting therapy (30±7 days after the index date). Proportion of patients receiving the tests was measured before and after RMMs implementation date.

Results: Eighty-six patients (55% female) were included in the study. Forty-four (51%) patients were ≥18 years old. The pre-RMMs implementation group comprised 42 patients, while the number of patients in the post-RMM was 44. At initiation of deferasirox therapy, monitoring tests have notably increased upon the introduction of RMMs for serum ferritin from 12% to 39%, from 17% to 59% for bilirubin, and from 17% to 59% for ALP. However, there was no remarkable difference in ordering serum creatinine, ALT, or AST tests between pre and post implementation of RMMs period. After one month of deferasirox therapy, there was no notable difference in the proportion of patients who had the required laboratory monitoring between pre and post implementation of RMMs.

Conclusions: Although there has been a partial adherence to RMMs recommendations, implementation of RMMs was not adequate, especially for monthly monitoring parameters. The SFDA, pharmaceutical companies, healthcare institutions and healthcare providers should collaborate to improve RMMs adherence in Saudi Arabia.