Pancreatitis with use of new diabetic medications: a real-world data study using the post-marketing FDA adverse event reporting system (FAERS) database.

Background: Pancreatitis is characterized by inflammation of the pancreas and significantly affects quality of life. Less than 5% of pancreatitis cases are drug-induced, but recent evidence suggests a substantial risk associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The aim of this study was to compare the risk of developing pancreatitis between those using GLP-1 RAs and those using sodium-glucose transport protein 2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors. Methods: This study was done using the FDA Adverse Event Reporting System (FAERS) database from 2019 to 2021. This database contains information from diverse submissions from healthcare providers, patients, and manufacturers. To ensure fairness and accuracy, the risk of pancreatitis associated with other hypoglycemic agents (SGLT2 inhibitors and DPP-4 inhibitors) was also investigated. Traditional and Bayesian statistical analysis methods were used to identify disproportionate statistics and included the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). A drug-adverse-event combination that met the criteria of all four indices was deemed a signal. Results: The analysis of 2,313 pancreatitis reports linked to hypoglycemic agents revealed a predominant association with GLP-1 RA (70.2%) compared to DPP-4 inhibitors (15%) and SGLT2 (14.7%). Most of these reports involved female patients (50.4%), and the highest incidence occurred in those over 50 years old (38.4%). Additionally, 17.7% of the reports were associated with serious events. The ROR was significant for the risk of pancreatitis when using DPP-4 (13.2, 95% confidence interval (CI) 11.84-14.70), while the ROR for GLP-1 was 9.65 (95% CI 9.17-10.16). The EBGM was highest with DPP-4 (12.25), followed by GLP-1 (8.64), while IC was highest with DPP-4 inhibitors (3.61). Liraglutide had the greatest association with pancreatitis among the GLP-1 RAs (ROR: 6.83, 95% CI 6.60-7.07). Conclusion: The findings show that pancreatitis has a strong link with DPP-4 inhibitors and GPL1 agonists, which pose a greater risk. Among the GLP-1 agonist medications, liraglutide has been found to have an association with pancreatitis.

Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy.

ABSTRACT: The management of inflammatory bowel disease (IBD) in pregnant women is challenging and must be addressed on a patient-by-patient basis. Optimal patient management requires a multidisciplinary team and clear evidence-based recommendations that cater to this subset of patients. In this article, we provide concise guidelines and clinical care pathway for the management of IBD in pregnant women. Our recommendations were developed by a multidisciplinary working group that includes experts from the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacology. All recommendations are based on up-to-date information following an extensive literature review. A total of 23 evidence-based expert opinion recommendations for the management of IBD in pregnant women are herein provided.

Estimating the potential economic impact of the Wasfaty program on costs of antidiabetic treatment: An initiative for the digital transformation of health.

Introduction: The Saudi health care transformation is taking place through the implementation of many initiatives and programs to serve Saudi Vision 2030, which aims to improve health care services by focusing on digitalization and privatization. This study aimed to evaluate the economic impact of implementing the new digital health transformation initiative (Wasfaty service) on the health care budget using diabetes mellitus as an example. Methods: This study presents a cost analysis evaluation following the implementation of the Wasfaty program during the period between 2017 and 2021. The study compared the pre-Wasfaty period and the Wasfaty period in terms of direct medical costs. Data sources were the Ministry of Health for pre-Wasfaty data and the National Unified Procurement Company, which runs the Wasfaty program, for Wasfaty data. The study focuses on diabetic medications for outpatients. This health economic evaluation used the cost per visit, and sensitivity analyses were conducted utilizing the cost per patient according to the prevalence of diabetes mellitus. Results: After implementing the transformation using the Wasfaty service, the estimated annual mean cost savings per visit were USD 109.18 (SAR 409.43), and the cost savings per patient with a prevalence of 11% were USD 13.89 (SAR 52.1). The saving costs were USD 11,750,600 (SAR 44,064,750) for human resources and USD 97,473,469 (SAR 365,525,508) for pharmacies' operation costs without including warehouse expenditures. The savings from the clinical decision support system preventing undesirable medication costs were estimated at USD 9,842,720 (SAR 36,910,201), and savings from the prevention of undesirable adverse events were estimated at USD 137,332,615 (SAR 514,997,308) for a 6% prediction. The total healthcare expenditure savings were USD 258,762,981 to 274,972,971 (SAR 970,361,178 ± 1,031,148,640). Conclusions: Implementing the new digitization and privatization initiatives (i.e., the Wasfaty program) as a result of the transformation in the health care sector had led to a significant reduction in health care expenditures and cost savings with respect to clinical and pharmacy services using diabetes mellitus as an example.

Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease.

Optimal management of inflammatory bowel disease (IBD) relies on a clear understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This article provides concise guidelines for the management of IBD in adults, based on the most up-to-date information at the time of writing and will be regularly updated. These guidelines were developed by the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacy. After an extensive literature review, 78 evidence-and expert opinion-based recommendations for diagnosing and treating ulcerative colitis and Crohn's disease in adults were proposed and further refined by a voting process. The consensus guidelines include the finally agreed on statements with their level of evidence covering different aspects of IBD diagnosis and treatment.

Health economic burden of COVID-19 in Saudi Arabia.

Background: The coronavirus disease 2019 (COVID-19) pandemic has added a massive economic burden on health care systems worldwide. Saudi Arabia is one of the numerous countries that have been economically affected by this pandemic. The objective of this study was to provide real-world data on the health economic burden of COVID-19 on the Saudi health sector and assess the direct medical costs associated with the management of COVID-19. Methods: A retrospective cohort study was conducted based on data collected from patients hospitalized with COVID-19 across 10 institutions in eight different regions in Saudi Arabia. The study calculated the direct medical costs of all cases during the study period by using SAS statistical analysis software. These costs included costs directly related to medical services, such as the health care treatment, hospital stays, laboratory investigations, treatment, outcome, and other related care. Results: A total of 5,286 adult patients admitted with COVID-19 during the study period were included in the study. The average age of the patients was 54 years, and the majority were male (79%). Among the COVID-19 patients hospitalized in a general ward, the median hospital length of stay was 5.5 days (mean: 9.18 days), while the ICU stay was 4.2 days (mean: 7.94 days). The total medical costs for general ward and ICU patients were US$ 38,895 and US$ 24,207,296.9, respectively. The total laboratory investigations ranked as the highest-cost services US$ 588,975 followed by treatment US$ 3,886,509.8. Overall, the total cost of all medical services for patients hospitalized with COVID-19 was US$ 51,572,393.4. Conclusion: This national study found that COVID-19 was not only a serious concern for patients but also a serious economic burden on the health care system in Saudi Arabia.

The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study.

Purpose: This study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database. Methods: A retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form's fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022). Results: For 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, P < 0.05).Antimicrobial drugs (26.9%), hematologic drugs (19.7%), and neuropsychiatric drugs (12.9%) were responsible for most ADRs. Most of the reactions were associated with the use of ciprofloxacin (7.7%), followed by the combination of lopinavir and ritonavir (4.1%). Two deaths resulted from salbutamol and cefazolin use. Based on the results of the Naranjo assessment of causality, cardiovascular events (9.9%) exhibited the highest score (≥9) for a causal relationship with the suspected drugs, followed by dermatological events (9.5%). Conclusions: The spontaneous report database is an important and valuable source of aftermarket authorization safety information. In our study, most drugs used as antimicrobial, cardiovascular, and hematologic therapies were associated with a higher risk of developing severe and serious events. We recommend monitoring and using medications optimally to ensure patient safety.

National Saudi Consensus Statement on the Management of Atopic Dermatitis (2021).

Atopic dermatitis (AD) is a chronic inflammatory skin disease with an increasing prevalence regionally and globally. It is characterized by intense itching and recurrent eczematous lesions. With the increase in the availability of treatment options for healthcare practitioner and patients, new challenges arise for treatment selection and approach. The current consensus statement has been developed to provide up-to-date evidence and evidence-based recommendations to guide dermatologists and healthcare professionals managing patients with AD in Saudi Arabia. By an initiative from the Ministry of Health (MOH), a multidisciplinary work group of 11 experts was convened to review and discuss aspects of AD management. Four consensus meetings were held on January 14, February 4, February 25, and March 18 of 2021. All consensus content was voted on by the work group, including diagnostic criteria, AD severity assessment, comorbidities, and therapeutic options for AD. Special consideration for the pediatric population, as well as women during pregnancy and lactation, was also discussed. The present consensus document will be updated as needed to incorporate new data or therapeutic agents.

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.

Coronavirus disease 2019 in Saudi Arabia: A nationwide real-world characterization study.

Background: On March 11th, 2020, The World Health Organization (WHO) declared that the COVID-19 is a pandemic due to its worldwide spread. The COVID-19 pandemic has extended its impact to Saudi Arabia. By mid-February 2021, The Kingdom of Saudi Arabia has reported more than 373,000 COVID-19 cases impacting different population categories (i.e., male, female, different age groups, comorbidities status). The objective of this nationwide study was to describe and explore the characteristics of hospitalized patients diagnosed with COVID-19 in Saudi Arabia. Methods: This study was an observational epidemiological study based on collected clinical data from ten health institutions across all regions in Saudi Arabia. The study was conducted during the period from March 2nd, 2020, to January 31st, 2021. The data were collected included demographics, medical information, medications, and laboratory and diagnostic. More detailed information on usually missing factors such as smoking status, comorbidities, length of hospital stay were also collected. Both descriptive and inferential analyses were conducted using the statistical analysis software "SAS®" version 9.4. Results: During the study period, 5286 patients were included in this study. Of these, (79.15%) were male. Of all 5286 patients, quite a high number of the studied population 2010 (38.02%) were smokers. The majority of the patients 3436 (65%) were reported to have comorbidities, with hypertension being the most common disease 1725 (32.6%), followed by diabetes 1641(31.04%). A high proportion of the patients, 2220 patients (41.99%), were admitted to the intensive care unit; of these, (33.52%) were on mechanical ventilation. Most patients received anticoagulant prophylaxis medications (n = 4414, 83.5%). All patients were given more than one antibiotic prophylaxis. Overall, the median hospital stay was 5.5 days, and the median length in the intensive care unit was 4.26 days. Around (89.14%) of patients were discharged from the hospital, and (10.8%) died. Conclusion: In this real-world study utilizing a large sample size, this study provides confirmatory results on the COVID-19 patients characteristics that are similar to other populations. Healthcare professionals need to give COVID-19 patients with specific characteristics including smoking, diabetes mellitus and cardiac disease more care to avoid losing these patients.

Current Situation of Medication Errors in Saudi Arabia: A Nationwide Observational Study.

OBJECTIVES: Medication errors are common and highly preventable events that significantly affect patients' health. This nationwide study primarily aims to quantify the rate and level of harm from the reported medication errors and to determine the medication process stages in which the reported errors occurred. METHODS: This retrospective observational study concerns medication errors reported to the General Department of Pharmaceutical Care database from March 2018 to June 2019. The database stores all aspects of medication error information, including patient, medication, and error information, along with the job position of the staff involved and contributing factors. The medication use process was categorized into these stages: ordering/prescribing, transcribing, dispensing, administering, and monitoring. We recorded each medication error based on categories from the U.S. National Coordinating Council for Medication Error Reporting and Prevention. RESULTS: A total of 71,332 medication error events were reported to the database. Physicians made 63,120 (88.5%) reported errors, and pharmacists most frequently detected the errors (75.9%). The majority of reported errors appeared at the prescribing phase (84.8%), followed by the transcribing (5.8%) and dispensing (5.7%) phases. A total of 4182 (5.8%) errors reached the patient. Health care professionals' work overload and lack of experience were associated with 31.6% and 22.7% of the reported errors, respectively. CONCLUSIONS: Our study highlights the concern regarding medication errors and their low reporting by indicating that pharmacists reported and detected the majority of errors. Promoting a no-blame culture and education for health professionals is vital for improving the error-reporting rate.

Hepatotoxicity Induced by Fluvastatin: A Reversible Acute Cholestatic Liver Injury.

BACKGROUND Fluvastatin, a commonly prescribed statin, is indicated for treatment of hypercholesterolemia in persons at high risk for coronary, cerebrovascular, and peripheral artery disease. However, there have been rare reports of liver injury or renal failure associated with use of fluvastatin. CASE REPORT We describe the case of a 69-year-old Saudi man with a medical history of diabetes mellitus and hypercholesterolemia for 2 years, on metformin, gliclazide modified release, daily aspirin, and simvastatin. Fluvastatin 40 mg daily was administered instead of simvastatin for 7 weeks before the patient was admitted to the hospital with fatigue, weakness, abdominal pain, loss of appetite, vomiting, itching, and elevated liver enzymes. Discontinuation of fluvastatin and other combined therapies led to a decrease in liver enzymes. He was diagnosed with fluvastatin-induced cholestatic liver injury and acute kidney disease. CONCLUSIONS The Naranjo scale indicates a probable relationship between cholestatic liver injury and fluvastatin, as well as a possible relationship between cholestatic injury and gliclazide and metformin. In our case report, we describe the synergistic effect of several factors in contributing to liver injuries, such as age, long-term gliclazide intake, and fluvastatin. Accordingly, we recommend close monitoring of patients' liver and kidney function, especially in the elderly and those with polypharmacy, while allowing sufficient time for the liver function to recover from a reversible reaction to fluvastatin.

Alteration of Coagulation Test Results and Vaginal Bleeding Associated With the Use of Feverfew (Tanacetum parthenium).

Tanacetum parthenium (feverfew) is a member of the daisy family; it is used to prevent and treat migraine and rheumatoid arthritis. It has a long history of use as a traditional and folk medicine in Chinese, Greek, Indian and Arabic medicine, having been used for hundreds of years. The term feverfew comes from the Latin word febrifugia and means fever reducer. However, Short term use of feverfew (up to 4 months) is considered safe in adults. According to a few clinical trials, Tanacetum parthenium was not associated with serious adverse events but rather with mild and reversible events. Adverse events leading to withdrawals were mainly of a gastrointestinal nature. There is no major safety issue. Nevertheless, we report one case of a 36-year-old woman with known migraine who visited the obstetrics and gynecology clinic upon developing vaginal bleeding, prolonged duration of the menstrual cycle, and reddish skin without bruising. The patient suffered from these symptoms over a period of 3 months prior to the clinic visit. Based on history, the patient began taking 800 mg capsules of feverfew three times per day 9 months ago. We applied the Naranjo scale in our case, and it indicated that a probable relationship exists between feverfew and vaginal bleeding. Feverfew should be used cautiously by patients planning elective surgery, having coagulant disorders or taking antithrombotic drugs.

Are countries' precautionary actions against COVID-19 effective? An assessment study of 175 countries worldwide.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has affected many countries negatively, particularly in terms of their health care and financial systems. Numerous countries have attempted to employ precautions to address this pandemic. This study was aimed at exploring and assessing the early precautionary actions taken by 175 countries on six continents to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: An observational study utilizing available public data was conducted on the basis of data collected from December 31, 2019 until the end of April 2020 and then compared with data in January 2021. Several data were extracted, including information related to the date of the first reported case of SARS-CoV-2, total confirmed cases, total active cases and more. In addition, seven validated indicators were used to assess the countries' preparedness and precautionary actions. RESULTS: A total of 175 countries were included in the study. The total COVID-19 infection rate increased exponentially and rapidly in North America and Europe from March to April. The application of precautions (indicators) varied between countries. School closures, quarantines and curfews were the most-applied indicators among all countries. As for the relationship between the indicators and their effects on the infection rate, Italy and Spain were the top countries in Europe and adopted all the indicators. Nevertheless, they faced high infection rates: 239,639 and 205,463 COVID-19 cases in Spain and Italy, respectively. CONCLUSION: The precautionary actions might have played a role in limiting the spread of COVID-19 in several countries. However, many countries might not benefit from applying these indicators.

Importance of early precautionary actions in avoiding the spread of COVID-19: Saudi Arabia as an Example.

Late in 2019, several cases of infection with a new strain of coronavirus were reported in China. This new strain was later officially named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by the World Health Organization (WHO). This new virus (SARS-CoV2-) mainly affects the respiratory system and causes coronavirus disease 2019 (COVID-19). The first case of COVID-19 was reported to the WHO on December 31st, 2019, and the virus has spread dramatically in many countries worldwide. On March 11th, 2020, the WHO declared that COVID-19 had affected most of the world, and many deaths were linked to COVID-19. Unfortunately, there is no available treatment for COVID-19, and there is no available vaccine against SARS-CoV-2. Thus, preventive methods are the only way to limit the spread of the virus. Preventive actions have been taken by many countries, such as travel bans, closing borders and working from home. Saudi Arabia was one of the countries that took very early precautionary actions in the belief that these actions are the best way to fight the virus. Therefore, we present the actions that were taken by the Kingdom of Saudi Arabia to fight the new viral pandemic.

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.

Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries.

Pharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some are able to meet the requirements for conducting pharmacovigilance activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other countries such as Libya, Yemen, and Palestine remain in the very early stages of implementing and developing pharmacovigilance systems. Countries such as Somalia, Djibouti, Mauritania, and Comoros Island have no pharmacovigilance system or culture. Asian Arab countries have some advantages over those in Africa because 50% of them are a part of the Gulf Cooperation Council (GCC), meaning that most of them can utilize similar approaches for the application of the majority of activities related to the healthcare system, including pharmacovigilance. Thus, participating in the GCC enables increased connections among these countries. However, one of the strengths in Africa is that Morocco is partnering with the WHO through the WHO Collaborating Center to enhance and strengthen pharmacovigilance across the Eastern Mediterranean Region and the Francophone and Arab countries. This partnership could have a role in enhancing the pharmacovigilance culture among African Arab countries. This review provides a general overview of the current situation regarding regulatory agencies related to pharmacovigilance in Arab countries.