Self-Reported COVID-19 Vaccines' Side Effects among Patients Treated with Biological Therapies in Saudi Arabia: A Multicenter Cross-Sectional Study.

OBJECTIVE: The aim of this study was to explore the side effects of COVID-19 vaccines among a mixed gender sample of patients on monoclonal antibody biologics (mAbs) in Saudi Arabia. METHODS: This was a prospective questionnaire-based cross-sectional study in which adult patients (≥18 years) on mAbs who had received at least one dose of COVID-19 vaccine from three tertiary care centers in Saudi Arabia were included. Descriptive statistics and univariate logistic regressions were conducted to present the vaccine side effects and examine the association between the reported side effects and vaccine type. RESULTS: Four-hundred and seventeen patients, with a mean age of 39 years, consented to participate. Approximately 82% and 18% of the participants received Pfizer-BioNTech and Oxford-AstraZeneca vaccines, respectively, and nearly 71% received two doses of the vaccine. Diarrhea (9.59%), fever (51.32%), headache (32.13%), hypotension (13.67%), palpitation (9.11%), and temporary loss of smell (5.28%) were the most commonly reported side effects. CONCLUSION: COVID-19 vaccines are generally safe for patients treated with mAbs. Future studies should examine the rates of side effects across different COVID-19 vaccines among patients on mAbs using more robust study designs and representative samples.

Retrospective descriptive assessment of clinical decision support medication-related alerts in two Saudi Arabian hospitals.

OBJECTIVES: To determine the frequency of clinical decision support system (CDSS) medication-related alerts generated, accepted, or overridden, to assess appropriateness of alert display and overrides, and to characterise the documentation of clinician justification for these overrides in an academic medical centre in Saudi Arabia. MATERIALS AND METHODS: System-generated CDSS reports for the period June 2015 to December 2017 were retrospectively reviewed and analysed. Alerts were classified into different types, and rates of alert overrides calculated as percentages of all generated alerts. A subset of 307 overridden alerts was assessed for appropriateness of display and override by two clinical pharmacists. Physician documentation of reasons for overriding alerts were categorised. RESULTS: A total of 4,446,730 medication-related alerts were generated from both inpatient and outpatient settings, and 4,231,743 (95.2%) were overridden. The most common alert type was 'duplicate drug', accounting for 3,549,736 (79.8%) of alerts. Of 307 alerts assessed for appropriateness, 246 (80%) were judged to be appropriately displayed and 244 (79%) were overridden appropriately. New drug allergy and drug allergy alerts had the highest percentage of being judged as inappropriately overridden. For 1,594,313 alerts (37.7%), 'no overridden reason selected' was chosen from the drop-down menu. CONCLUSIONS: The alert generation and override rate were higher than reported previously in the literature. The small sample size of 307 alerts assessed for appropriateness of alert display and override is a potential limitation. Revision of the CDSS rules for alerts (focusing on specificity and relevance for the local context) is now recommended. Future research should prospectively assess providers' perspectives, and determine patient harm associated with overridden alerts.

Gene Therapy Knowledge and Attitude Among Healthcare Professionals: A Cross-Sectional Study.

This study aimed to assess healthcare professionals' knowledge, attitudes, and concerns toward gene therapy in Saudi Arabia. We conducted an online cross-sectional survey via convenience sampling during the period from December 2018 to March 2019. A total of 419 (358 pharmacists and 61 physicians) responded to our questionnaire. Three hundred and nine (73.7%) were male, and the mean (±SD) age of 32.0 ± 7.7 years. The mean knowledge scores of all participants, pharmacists, and physicians were 3.8 ± 1.9, 3.8 ± 1.9, and 3.7 ± 1.9, respectively (P = 0.73). Higher knowledge score was associated with younger age (Coefficient: -0.03; P = 0.02), male (Coefficient: 0.57; P = 0.01), master's degree (Coefficient: 0.93; P = 0.003) and Ph.D. holders (Coefficient: 1.10; P = 0.01), and participants graduated from Canada (Coefficient: 2.10; P = 0.01).Moreover, about half of the respondents (55%) were concerned about gene therapy, and genetics training at college was considered the best gene therapy education method by 69.4%. Attitude score was not significantly associated with the profession (P = 0.88) but positively correlated with the knowledge score (rho= 0.4; P < 0.001). In conclusion, pharmacists and physicians showed limited knowledge with a positive attitude toward gene therapy. Therefore, educational programs on gene therapy need to be considered, focusing primarily on the safety, and social acceptance of such new therapeutic management.

National pharmacovigilance programs in Arab countries: A quantitative assessment study.

PURPOSES: The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activities of the national PV centers in Arab countries. METHODS: A cross sectional study was conducted between March and May in 2018. The current survey was adopted and modified from a study that used the questionnaire designed by the World Health Organization Collaborating Centre for International Drug Monitoring. The national PV centers of 22 Arab countries were invited to participate in this study. Descriptive analyses were conducted utilizing the analysis services provided by SurveyMonkey. RESULTS: In total of, 15 countries responded to our invitation (response rate: 68%). Most Arab countries started their PV program in the last decade, with Palestine implementing its program in 2017. Among the respondents, nine (60%) were members of the WHO International Drug Monitoring Program and were all users of the software provided by the WHO Uppsala Monitoring Center (VigiFlow or VigiBase), except Sudan. In 2017, a total of 27 502 reports were received by the centers in the studied countries, ranging from three reports received in Lebanon to a total of 7362 reports received by the national program of Algeria. CONCLUSIONS: An improvement was noticed among the national PV programs in the Arab countries. However, a considerable difference still exists among the countries in terms of the implementation and practice of PV.

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010-2015.

PURPOSE: To analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years. METHODS: Reports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases. RESULTS: A total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65-12.97) for dabigatran, 15.61 (95% CI 14.42-16.90) for warfarin, and 18.86 (95% CI 15.31-23.23) for rivaroxaban. CONCLUSIONS: The signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.