Cost consequence analysis of adding semaglutide to treatment regimen for patients with Type II diabetes in Saudi Arabia.

Introduction: Semaglutide, a Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA), is often prescribed for managing type 2 diabetes, particularly in cases unresponsive to other hypoglycemic agents. Despite its popularity, the real-world efficacy and cost-effectiveness of Semaglutide relative to other treatments remain understudied. Objective: This study aimed to examine the direct medical cost and consequences of adding Semaglutide to the treatment regimen for patients with type 2 diabetes in Saudi Arabia. Methods: We conducted a single-center, retrospective review of Electronic Medical Records (EMRs) for adults with type 2 diabetes. Patients who had been on Semaglutide for at least three months were matched with those receiving alternative hypoglycemic therapies. Exclusions were made for patients with cancer, incomplete EMRs, or lacking prescription data. Investigated outcomes included changes in HbA1C levels and weight, and the direct costs comprised medications, clinic visits, and emergency care. Baseline adjustments were made through inverse probability treatment weighting, and uncertainty was assessed via bootstrapping with 10,000 replications. Results: Out of 350 patients meeting the criteria, 116 were on Semaglutide. Predominantly females (62%), the cohort had an average age of 60 and a disease duration of 22 years. The difference in HbA1C (%) reductions between Semaglutide and non-Semaglutide users over 3,6, and 12 months were 0.154 (95% CI: -0.452-0.483), -0.031(95% CI: -0.754-0.239), -0.16(95% CI: -1.425-0.840), respectively. Semaglutide users did experience modest weight reductions ranging from 0.42 kg to 1.16 kg. The annual additional direct medical cost for Semaglutide was USD 4,086.82 (95% CI: $3,710.85 - $4,294.99). Conclusion: Although Semaglutide induced modest weight reductions, it did not offer significant advantages in lowering HbA1C levels compared to other hypoglycemic treatments. These findings suggest the need for further research involving larger and more diverse cohorts to corroborate these findings.

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.

Prevalence and Factors Associated With Polypharmacy Use Among Adult Patients in Saudi Arabia.

BACKGROUND: Polypharmacy is very common in clinical practice, especially among adult patients. The use of multiple medications may increase the risk of adverse drug events, medication cost, and medication errors. In addition, polypharmacy exacerbates treatment complexity, which consequently leads to poor patients' adherence to their medications. Despite being a well-recognized problem, few studies have investigated the prevalence and predictors of polypharmacy in Saudi Arabia. OBJECTIVES: The aims of the study were to investigate the prevalence of polypharmacy among adult patients in a tertiary teaching hospital and to determine patients' characteristics that are associated with polypharmacy. METHODS: This was a retrospective cross-sectional study using data extracted from the electronic health records database for a period of 6 months between January and June 2016 in outpatient setting. Descriptive statistics were used to analyze the study sample. A multivariate logistic regression model was used to examine the association between different variables and polypharmacy. Statistical analysis software (SAS 9.2) was used to analyze the study data. RESULTS: A total of 17,237 observations (67.2% females) were included in the final analysis. Of these, nearly 54% (n = 9222) of reported observations were found using up to four prescription drugs and the other 46% (n = 8015) were using five or more prescription drugs. Interestingly, the prevalence of polypharmacy use was doubled among adults with hypertension as compared with those without hypertension (odds ratio [OR] = 2.68, 95% confidence interval [CI] = 2.51-2.87). In addition, polypharmacy use was two times more prevalent among adults with diabetes as compared with those without diabetes (OR = 2.31, 95% CI = 1.99-2.28) and five times more prevalent in patient with dementia (OR = 5.57, 95% CI = 1.26-24.7). Moreover, polypharmacy in adult patients was significantly influenced by sex (OR = 1.69, 95% CI = 1.59-1.80) and nationality (OR = 2.15, 95% CI = 2.00-2.31). CONCLUSIONS: Polypharmacy is common among adult patients especially those who are older than 60 years. Polypharmacy may affect the overall process of drug therapy. It can be a risk factor to develop undesirable adverse drug events, especially in those with chronic health conditions. A special care should be taken to manage polypharmacy among adults in Saudi Arabia.

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.

Oral antidiabetic medication adherence and glycaemic control among patients with type 2 diabetes mellitus: a cross-sectional retrospective study in a tertiary hospital in Saudi Arabia.

OBJECTIVES: The purpose of this study is to measure the adherence rates of oral antidiabetic drugs (OADs) in patients with type 2 diabetes mellitus (T2DM) and assess the relationship of glycaemic control and adherence to OADs after controlling for other associated factors. DESIGN: Cross-sectional retrospective study. SETTING: Large tertiary hospital in the central region of Saudi Arabia. PARTICIPANTS: 5457patients aged 18 years and older diagnosed with T2DM during the period from 1 January 2016 to 31 December 2016. PRIMARY AND SECONDARY OUTCOME MEASURES: The modified medication possession ratio (mMPR) was calculated as a proxy measure for adherence of OADs. The factors associated with OADs non-adherence and medication oversupply were assessed using multinomial logistic regression models. The secondary outcomes were to measure the association between OADs adherence and glycaemic control. RESULTS: Majority of patients with T2DM were females (n=3400, 62.3%). The average glycated haemoglobin was 8.2±1.67. Among the study population, 48.6% had good adherence (mMPR >0.8) and 8.6% had a medication oversupply (mMPR >1.2). Good adherence was highest among those using repaglinide (71.0%) followed by pioglitazone (65.0%) and sitagliptin (59.0%). In the multivariate analysis, women with T2DM were more likely to have poor adherence (adjusted OR (AOR)=0.76, 95% CI=0.67, 0.86) compared with men. Also, medication oversupply was more likely among patients with hyperpolypharmacy (AOR=1.88, 95% CI=1.36, 2.63), comorbid osteoarthritis (AOR=1.72, 95% CI=1.20, 02.45) and non-Saudi patients (AOR=1.53, 95% CI=1.16, 2.01). However, no association was found between glycaemic control and adherence to OADs. CONCLUSION: The study findings support the growing concern of non-adherence to OADs among patients with T2DM in Saudi Arabia. Decision makers have to invest in behavioural interventions that will boost medication adherence rates. This is particularly important in patients with polypharmacy and high burden of comorbid conditions.

Measuring the quality and completeness of medication-related information derived from hospital electronic health records database.

OBJECTIVE: Electronic Health Records (EHRs) database is a great source for pharmacoepidemiological research as thousands of patients' clinical and medication information is stored in the database. However, the use of EHRs database for research purposes depends greatly on the accuracy and completeness of the data being used. This study mainly aimed to assess the completeness of EHRs patients' medication-related information. DESIGN: A retrospective cross-sectional study using data extracted from the EHRs database was conducted. SETTING: The EHRs data was obtained from a single tertiary hospital in Saudi Arabia. MAIN OUTCOME MEASURES: The completeness of data was measured considering if a patients' record contains all desired types of data (i.e., patients' demographics, clinical diagnosis, and medication-related information). RESULTS: A total of 23,411 unique individuals were identified after extracting the data from the EHRs. The study found that 89.9% of the patients had a complete data (i.e., age, gender, marital status, nationality, encounter type, and clinical diagnosis). Further, 83.1% of the patients had complete medication-related information. Subgroup analysis by the encounter type indicated that the data was 91.0% complete for outpatient encounter and 93.2% complete for inpatient encounter. CONCLUSION: The study findings indicate that the completeness of the data varies by the desired types of data. EHRs can be a potentially great resource to conduct research to assess medication use. Further studies focusing on the content and completeness of EHRs for a specific patient population and evaluate other dimensions of EHRs data quality are needed.

Factors associated with glycemic control in type 2 diabetic patients in Saudi Arabia.

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.

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.