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Background: Risk minimization measures (RMMs) are interventions intended to mitigate or prevent the occurrence of adverse reactions associated with medications. Having consistent measures across regulatory bodies (i.e., the Saudi Food and Drug Authority (SFDA), the United States Food and Drug Administration (US FDA), and the European Medicines Agency (EMA)) benefits medication use and safety and ultimately the patient. Objectives: This study aimed to investigate whether there is variability in these published RMMs between the three regulatory bodies. Methods: A specific data collection form was created to extract information from the SFDA’s RMM list, US FDA’s Risk Evaluation and Mitigation Strategy (REMS) list, and EMA’s Risk Management Plan (RMP) list, as of February 2022 all RMMs that were available on the websites were reviewed. Medications with the same trade name were matched across regulators, and unmatched medications were checked for approval status. For medication groups such as NSAIDs in the SFDA’s RMM list, they were matched by searching for the groups individually in the regulatory websites. All risks and types of minimizing measures were compared. Results: A total of 317 medications were retrieved from the SFDA’s RMM list. The majority of medication classes were immunosuppressants (n = 60), antihypertensive (n = 33), and oncology medication (n = 29). There were only 62 medications with REMS from the US FDA website, a total of 14 medications were approved by the SFDA, and only nine medications were matched with the SFDA’s RMM list. Also, there were 828 medications with RMP from the EMA website, a total of 334 has RMM, 128 are approved by the SFDA, and 71 matched with the SFDA’s RMM list. Furthermore, seven medications were matched between SFDA, US FDA and EMA. After content review, four medications had similar risks and measures across the regulators and three medications had different risks and measures across the regulators. For the medication groups, a total of 36 groups were in the SFDA’s list, 18 groups were matched with the US FDA, and 14 were matched with the EMA. Conclusions: Our study showed substantial differences among the regulatory authorities regarding RMMs. Harmony in published risk measures can have a significant impact on medication safety.

Objective: To identify factors associated with glycemic control in type 2 diabetes mellitus patients in tertiary academic hospital. Research design and methods: This was a retrospective cross-sectional study of adults with type 2 diabetes mellitus. Data were extracted from the electronic health record (EHR) database for the period from 1st of January to 31st of December 2016. Participants were considered to have a glucose control if the HbA1c level was less than 7% [53 mmol/L]. Descriptive analysis and multivariable logistic regression model were performed to assess the factors associated with glycemic control. Results: A total of 728 patients were included in the study for which (65%) were female, and about 60% of the sample size was between 45 and 60 years old. Multivariate logistic regression model showed participants older than the age of 65 were less likely to have controlled diabetes compared to the younger participants (OR: 0.53 [CI: 0.30–0.93]). Moreover, those who had hypertension (OR: 0.61 [CI: 0.43–0.86]) and dyslipidemia (OR: 0.53 [CI: 0.38–0.74]) were less likely to have controlled diabetes, while those with asthma (OR: 2.06 [CI: 1.16–3.68]) were more likely to have controlled diabetes. The model also showed that vitamin D deficiency was not associated with glycemic control in type 2 diabetes patients (OR 0.80 [95% CI 0.58–1.12]). Conclusion: These findings highlighted the need for appropriate management in older adult patients to prevent the complication of type 2 diabetes. Furthermore, attention should be exercised for patients with factors associated with poor glycemic control such as hypertension and dyslipidemia. Keywords: Saudi Arabia, Type 2 diabetes, Factors