(241) Evaluation of Published Data on Risk Minimization Measures in The Gulf Region: A Systematic Review

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1286

Presenting Author(s)

Leena A. Al-Sheikh
– Leena Al-Sheikh, Riyadh, Al Riyadh, Saudi Arabia

Co-Author(s)

Sadeem Fahad Alelayan
– King Saud University, Colleg of Pharmacy, Clinical Pharmacy Department, Riyadh, Al Riyadh, Saudi Arabia
Haya Almalaq
– College of Pharmacy, Department of Clinical Pharmacy, King Saud University, Saudi Arabia
Nasser Alqahtani
– Alfaisal University, Saudi Arabia
Hadeel Alkofide
– College of Pharmacy, Department of Clinical Pharmacy, King Saud University, Saudi Arabia
Rahaf Almesned
– PharmD, KSUMC, Saudi Arabia
Lujain K. Alnoghaimshi
– Saudi food and drug authority, Riyadh, Ar Riyad, Saudi Arabia
Maryam Badah
– Master Student at King Saud University - College of Phamracy, Ar Riyad, Saudi Arabia
Noura Altulahi
– King Saud University, Saudi Arabia

Background: In the past two decades the Gulf region, and the Kingdom of Saudi Arabia specifically, made more attention to monitor and improve pharmacovigilance activities and risk minimization measures (RMMs). The Saudi Food and Drug Authority (SFDA) provides RMMs activities on their website for several drugs for both patients and healthcare professionals. The assessment of the effectiveness of RMMs is critically important to ensure that their objectives are fulfilled correctly. This study was designed to synthesize the available studies evaluating RMMs in the Gulf region.

Objectives: To systematically review and synthesize the available data and reports on RMMs in the Gulf region.

Methods: A systematic search was performed across MEDLINE, Embase, and reference list of retrieved studies to identify eligible reports evaluating RMMs in the Gulf region, regardless of the type of measure and drug studied. Two investigators screened and abstracted the data. Studies were categorizing by study endpoints, research design and data source. Clinical knowledge, clinical behaviour, safety outcomes were considered as the study endpoints. Research designs were categorized into observational and interventional. Data sources were categorized into electronic healthcare databases and chart reviews. Two researchers assessed the quality of each study independently using the ROBINS-I tool.

Results: Six eligible studies were included. All the studies were published in Saudi Arabia. The RMMs evaluated were either educational programs or focusing on antibiotics stewardship programs. Two studies assessed clinical behaviour, and four assessed multiple endpoints, three of which included safety outcomes. One study used an observational design, and five studies used interventional non-randomized design. In terms of data sources, all six studies used chart review as the source of data. All six studies reported an improvement in study outcomes when RMMs were implemented. Generally, studies were assessed as having a low to moderate risk of bias.

Conclusions: To our knowledge this is the first study to evaluate the published data on RMMs in the Gulf region. Even though the results of the studies included show a favourable benefit-risk balance using different RMMs, it is hard to specify or quantify the effect of each measure separately. Measuring the effectiveness of the RMMs is a complex task and specifically when studying safety outcomes, which remains the main objective when evaluating RMMs. One possible solution is adopting a framework for future studies planning to evaluate RMMs.