Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020.

Background: Despite its high efficacy in treating severe acne, isotretinoin is associated with serious side effects, including teratogenicity. However, the extent of isotretinoin exposure during pregnancy in Saudi Arabia remains unknown.

Objectives: This study aims to quantify the extent of fetal exposure to isotretinoin in Saudi Arabia and to evaluate adherence to risk minimization measures approved by the Saudi Food and Drug Authority.

Treatment modification patterns of glucose-lowering agents in Saudi Arabia: A retrospective real-world data analysis.

Aim: The growing number of antidiabetics has broadened therapeutic options, leading to heterogeneity in prescribing patterns. Studies identifying antidiabetics modification patterns are lacking in Saudi Arabia. Therefore, the aim of this study is to describe modification patterns in Saudi patients.

Safety and quality of AI chatbots for drug-related inquiries: A real-world comparison with licensed pharmacists.

Introduction: Pharmacists play a pivotal role in ensuring patients are administered safe and effective medications; however, they encounter obstacles such as elevated workloads and a scarcity of qualified professionals. Despite the prospective utility of large language models (LLMs), such as Generative Pre-trained Transformers (GPTs), in addressing pharmaceutical inquiries, their applicability in real-world cases remains unexplored.

Objective: To evaluate GPT-based chatbots' accuracy in real-world drug-related inquiries, comparing their performance to licensed pharmacists.

Comparing pregnancy and pregnancy outcome rates between adolescents with and without pre-existing mental disorders.

Background: There are limited population-based data on the role of mental disorders in adolescent pregnancy, despite the presence of mental disorders that may affect adolescents' desires and decisions to become pregnant.

Objective: This study aimed to examine the relationship between specific types of mental disorders and pregnancy rates and outcome types among adolescents aged 13-19 years, using single-year age groups.

Methods: We conducted a retrospective cohort study using data from the Merative™ MarketScan Research Databases.

The effectiveness of single and two-dose Pfizer-BioNTech vaccine against SARS-COV-2: A real-world evidence from Saudi Arabia.

Background: Several studies proved the effectiveness of Severe Acute Respiratory Syndrome Corona Virus (SARS-CoV-2) vaccines; however, the number of doses and the period between doses that warrant the highest protection remain unclear. This study aims to assess the effectiveness of the Pfizer-BioNTech vaccine and to evaluate the effectiveness of early and delayed second-dose administration of the vaccine.

Methods: This is a retrospective cohort study that was conducted using the data from March 1st, 2021, to August 31st, 2021.

Concordance of neonatal critical condition data between secondary databases: Florida and Texas birth certificate Linkage with medicaid analytic extract.

Background: Limited information is available about neonates' critical conditions data quality. The study aim was to measure the agreement regarding presence of neonatal critical conditions between Medicaid Analytic eXtract claims data and Birth Certificate (BC) records.

Methods: Claims data files of neonates born between 1999-2010 and their mothers were linked to birth certificates in the states of Texas and Florida.

Generalizability and accuracy of IBM MarketScan health risk assessment instrument data for augmentation of commercial claims data.

Purpose: We evaluated the generalizability and accuracy of the IBM® MarketScan® Health Risk Assessment (HRA) data to assess its suitability as supplement to linked claims data.

Methods: We identified adult private insurance enrollees in the IBM® MarketScan® Commercial Claims & Encounters (CC&E) and HRA databases between 2012 and 2017. In the claims data, for each enrollee, we sampled the first calendar year with continuous enrollment indicating full capture of claims data and extracted linked HRA survey data if available.

Covid-19 Vaccine Surveillance in Saudi Arabia: Opportunities for Real-time Assessment.

After months of confronting COVID-19 pandemic, several countries, including Saudi Arabia, have recently approved newly developed vaccines to prevent COVID-19 infection. With the new technology utilized to develop some vaccines, questions arise about their long-term safety. To provide rapid response to emerging safety issues, robust surveillance programs that provide near real-time analysis of vaccines effects are required.

Glucagon-Like Peptide 1 Receptor Agonists and Chronic Lower Respiratory Disease Exacerbations Among Patients With Type 2 Diabetes.

Objective: Emerging data from animal and human pilot studies suggest potential benefits of glucagon-like peptide 1 receptor agonists (GLP-1RA) on lung function. We aimed to assess the association of GLP-1RA and chronic lower respiratory disease (CLRD) exacerbation in a population with comorbid type 2 diabetes (T2D) and CLRD.

Research Design And Methods: A new-user active-comparator analysis was conducted with use of a national claims database of beneficiaries with employer-sponsored health insurance spanning 2005-2017.

Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015.

Introduction: Several studies have evaluated the effects of changes in isotretinoin risk mitigation programs, but little is known about actual fetal exposure rates in the context of other acne treatments.

Objective: Our objective was to quantify fetal exposure rates during the use of common acne treatments.

Methods: Employing the insurance claims data of > 100,000 acne treatment users between 2006 and 2015, we created three user cohorts: (1) isotretinoin (strong teratogen/mandatory risk mitigation program), (2) doxycycline/minocycline (mild teratogen, label warning), and (3) topical clindamycin/erythromycin (no fetal risk).

Evaluation of statin discontinuation stratified by primary versus secondary prevention following bariatric surgery: a retrospective cohort study.

Background: Bariatric surgery leads to an improvement in hyperlipidemia and a subsequent decline in the use of hyperlipidemia-related medications, including statins. In patients with a history of atherosclerotic cardiovascular disease (ASCVD), it is recommended to continue statins; however, it is unknown whether there is a differential risk for statin discontinuation in patients with and without a history of ASCVD.

Objectives: To estimate the rates and factors associated with statin discontinuation following bariatric surgery.

Impact of the Transition from ICD-9-CM to ICD-10-CM on the Identification of Pregnancy Episodes in US Health Insurance Claims Data.

Background: Before October 2015, pregnancy cohorts assembled from US health insurance claims have relied on medical encounters with International Classification of Diseases-ninth revision-clinical modification (ICD-9-CM) codes. We aimed to extend existing pregnancy identification algorithms into the ICD-10-CM era and evaluate performance.

Methods: We used national private insurance claims data (2005-2018) to develop and test a pregnancy identification algorithm.

Validation of algorithms to estimate gestational age at birth in the Medicaid Analytic eXtract-Quantifying the misclassification of maternal drug exposure during pregnancy.

Purpose: Accurate ascertainment of gestational age (GA) has been a challenge in perinatal epidemiologic research. To date, no study has validated GA algorithms in Medicaid Analytic eXtract (MAX).

Methods: We linked livebirths of mothers enrolled in Medicaid ≥30 days after delivery in 1999-2010 MAX to state birth certificates.

Risk of pregnancy loss in patients exposed to mycophenolate compared to azathioprine: A retrospective cohort study.

Purpose: To evaluate the relative risk of pregnancy loss associated with mycophenolate (MPA) vs azathioprine (AZA) use.

Methods: We conducted a retrospective cohort study using the IBM MarketScan Research Databases (2005-2015). Patients with ≥1 MPA or AZA prescription claim during the first trimester were included.

Comparative effectiveness of risk mitigation strategies to prevent fetal exposure to mycophenolate.

Background: In 2012, the US Food and Drug Administration approved a Risk Evaluation and Mitigation Strategy (REMS) programme including mandatory prescriber training and a patient/provider acknowledgement form to prevent fetal exposure to mycophenolate. Prior to the REMS, the teratogenic risk was solely mitigated via written information (black box warning, medication guide (MG period)). To date, there is no evidence on the effectiveness of the REMS.

Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia.

To assess the general public awareness and perception about Adverse Drug Reactions (ADRs) reporting and pharmacovigilance. A cross-sectional study conducted on June 2012 during awareness campaign held in two malls in Riyadh city for two days. A self-administered questionnaire consisting of three parts was distributed to the attendees who accepted to participate in the study.

The safety of H1N1 vaccine in children in Saudi Arabia: a cohort study using modern technology in a developing country.

Background: With its rapid introduction in 2009, concerns about the safety of the H1N1 vaccines have been raised. Data were especially limited on the pediatric safety of H1N1 vaccine in Saudi Arabia.

Objectives: The objectives of this study were to investigate the safety of the H1N1 vaccine (Pandemrix(®)) in children and examine the feasibility of obtaining information on possibly associated adverse reactions using mobile telephone contact with child caregivers.