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. METHODS: Patients ≥ 18 years old with at least one antidiabetic between 2016 and 2022 were included. Follow-up started from the earliest to the last prescription.Two modification types were evaluated: "add-on," prescribing new antidiabetics within a treatment episode, and "switching", starting a new treatment episode after the preceding ends. Descriptive statistics were used to characterize patients and estimate events proportions. RESULTS: Of 122,291 patients, 47.2 % had treatment interruption or modification, totaling 303,781 events. Interruptions accounted for 54 %, add-on for 11 %, and switching for 35 %. The median time to first event was 159 days. The most add-on included dipeptidyl peptidase-4 inhibitor (DPP-4) inhibitors to biguanide and sulfonylurea (8 %), and sulfonylurea to biguanide (8 %). Among 106,405 switching events, 23 % shifted from dual to monotherapy and 17 % from monotherapy to dual therapy. CONCLUSION: Nearly half of patients experienced modifications or interruptions, with notable shifts between monotherapies and dual therapies. These findings highlight the evolving landscape of treatment patterns in Saudi Arabia and guide future research and decision-making.

Real-World Evidence on Levetiracetam-Induced Hypokalemia: An Active Comparator Cohort Study.

BACKGROUND: Levetiracetam is an anti-seizure medication (ASM) with an established safety profile. However, a potential safety signal of hypokalemia following levetiracetam use was published in the World Health Organization newsletter. OBJECTIVE: To investigate the possible causal association between the use of levetiracetam and the development of hypokalemia. METHOD: This was a new-user, active-comparator retrospective cohort study using Real-world Evidence Research Network data at the Saudi Food and Drug Authority from 2016 to 2022. Adults (≥ 18 years old) with an incident prescription for either levetiracetam or carbamazepine were followed for up to 6 months from the prescription date. Hypokalemia was ascertained by using diagnostic code (i.e., E87.6) or by serum potassium level below 3.5 mmol/L. A Cox proportional hazards model, adjusted with stabilized inverse probability of treatment weight, was fitted to compare the hazard of hypokalemia between levetiracetam and carbamazepine exposed patients. RESULTS: A total of 8,982 patients entered the study cohort. The incidence rate of hypokalemia was 303 cases per 10,000 patient-years in the levetiracetam-exposed cohort compared to 57 cases per 10,000 patient-years among carbamazepine users. Compared to carbamazepine users, patients exposed to levetiracetam had an adjusted hazard ratio related to induced hypokalemia of 1.99 (95% confidence interval, 0.88-4.49). Results of sensitivity analyses were comparable to the main analysis. CONCLUSION: The hazard ratio for hypokalemia with the use of levetiracetam versus carbamazepine was statistically comparable. However, the potential association between levetiracetam use and hypokalemia cannot be ruled out given the elevated hazard ratios from the main and sensitivity analyses. Further studies may provide a more precise assessment of this association.

Implementation of risk minimization measures to reduce the risk of tuberculosis among tumor necrosis factor medication users.

PURPOSE: To examine the adherence to risk minimization measures (RMMs) in newly treated patients with anti-tumor necrosis factor-alpha (anti-TNF-α) medications at one of the largest tertiary care hospitals in Saudi Arabia. METHODS: We included patients who had at least one prescription of infliximab or adalimumab. The index date was the first recorded date of infliximab or adalimumab prescription. New users of anti-TNF-α were divided into pre- and post-RMM implementation groups. The outcome of interest was the proportion of patients that received tuberculosis (TB) screening, including a chest X-ray (CXR) or a QuantiFERON test within 1 month prior to the index date. RESULTS: A pre-post RMM implementation comparison of TB screening among infliximab users showed a significant increase in the rates of CXR tests (from 7.5% before RMM implementation to 13.8% after RMM implementation, p < 0.001) and the rates of QuantiFERON tests (4.5% before RMM implementation to 24.1% after RMM implementation, p < 0.001). RMMs were introduced to the study site at the same time as adalimumab was approved and the proportion of patients receiving TB screening was 25.2%. CONCLUSION: TB screening prior to initiation of infliximab or adalimumab was not optimal. However, we noted an improvement in TB screening after the implementation of RMMs for infliximab. Future research may address reasons for low adherence to testing requirements for TB prior to initiation of anti-TNF-α medications.

The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets.

Introduction: Drug recalls may impact treatment plans or access to suitable therapies. Thus, they inadvertently affect treatment outcomes. Objective: We aimed to examine the impact of recalls on patients' safety using pantoprazole-containing products recall as a case study in terms of the occurrence of potential drug-drug interactions (pDDIs). Methods: This retrospective study used de-identified electronic health records of adult patients who had a prescription for oral proton pump inhibitors (PPIs) including pantoprazole, esomeprazole, lansoprazole, or omeprazole from April 2020 through September 2021 from a large tertiary care hospital. The study outcome definition was the prevalence of pDDIs in PPIs users before and after the recall date (March 2021). Changes in the prevalence of pDDIs were modeled using interrupted time-series. The rate ratio of pDDIs in the 12 months before and 6 months after the recall was modeled using negative binomial regression. Results: A total of 1,826 pDDIs were identified, and the median monthly prevalence of pDDI before the recall was 102.5 which increased to 115.5 after the recall. A change in the level of pDDIs occurred immediately after the recall date, followed by a gradual decrease over time. The rate of pDDIs was 69% higher after the recall compared to the baseline (rate ratio 1.69; 95% confidence interval, 0.75-1.91). Discussion: Recall of pantoprazole-containing products was associated with a higher rate of pDDIs. However, the prevalence of pDDIs gradually decreased over time. We highlight the importance of planning of recall process and coordinating all potential stakeholders to avoid potential harms.Word count: 1450.

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. Saudi Arabia has a well-established passive pharmacovigilance system that monitors drugs and vaccines safety. However, recent development in health digitalization in Saudi Arabia may provide a unique opportunity to harvest existing resources to generate high-quality evidence. This commentary provides an overview of the available systems that can be utilized to monitor the COVID-19 vaccines' safety and discusses opportunities for data integration to improve data quality and generate real-world evidence on COVID-19 vaccine safety.

Antidepressant Use During Pregnancy and the Potential Risks of Motor Outcomes and Intellectual Disabilities in Offspring: A Systematic Review.

BACKGROUND: There is a risk of adverse neurodevelopmental outcomes in offspring from exposure to antidepressants during pregnancy. OBJECTIVE: This study was performed to systematically review the available evidence regarding the impact of in utero exposure to antidepressants on motor and intellectual disability outcomes in children. PATIENTS AND METHODS: A systematic literature search for published observational studies examining the effects of antidepressants on motor development or intellectual disabilities in children was conducted using the Cochrane Central Register of Controlled Trials, PubMed/Medline, and Google Scholar. RESULTS: A total of 14 studies were included in this review. Studies have reported conflicting effects on motor development in infants with maternal exposure to antidepressants. Furthermore, not all of the studies included that assessed intellectual disabilities in infants found an association between maternal exposure to antidepressants and intellectual disabilities. However, methodological flaws existed in the studies, such as the use of scales with inadequate reliability or validity, a lack of statistical power, or confounding by indication or disease severity. CONCLUSION: The available literature provides inconclusive evidence on the relationship between in utero exposure to antidepressants and adverse effects on motor development outcomes or neurocognitive skills. Further observational studies with robust methodologies are needed to comprehensively evaluate the potential risks of prescribing antidepressants during pregnancy.

Real-world data in Saudi Arabia: Current situation and challenges for regulatory decision-making.

PURPOSE: To present the process of establishing a pharmacoepidemiological database in Saudi Arabia, challenges and models used. METHODS: The database establishment has started in 2017 by piloting the conversion of electronic health records of one hospital to the Observational Health Data Sciences and Informatics (OHDSI), Observational Medical Outcomes Partnership's Common Data Model (OMOP). RESULTS: During the pilot phase we have faced several challenges such as limited contribution in providing data by local medical institution due to uncertainty about data governance, diversity of systems used by hospitals, inconsistent coding of medical information, and limited awareness about data structure from participating hospital. The pilot phase was completed in 2019 containing information about patient attributes, medical care, therapies, and other additional services for around 130 000 patients in Saudi Arabia. The majority of patients were below the age of 50 years (89%), and acute respiratory infections were the most frequent diagnosis. The data quality was acceptable and no major anomalies were detected during the conversion. CONCLUSIONS: We demonstrated a successful creation of a pilot database using OHDSI Common Data Model. Our experience with the pilot database could be extended to other institutions to create a national dataset that could be used to generate real-world evidence.

Risk for Tympanic Membrane Perforation After Quinolone Ear Drops for Acute Otitis Externa.

BACKGROUND: This study examined whether the use of quinolone ear drops increased the risk of perforation with intact tympanic membranes and acute otitis externa (AOE). METHODS: This was a retrospective cohort study using Medicaid clinical encounter and pharmacy billing records from 1999 through 2010. Children and adults had to have 24 months continuous enrollment in Medicaid prior to the first antibiotic ear drop dispensing (index date), and they had to maintain their enrollment for at least 18 months thereafter. Included ear drops were ofloxacin, ciprofloxacin plus hydrocortisone, ciprofloxacin plus dexamethasone, and neomycin plus hydrocortisone. Tympanic membrane perforation (TMP) was identified as 2 inpatient or outpatient encounters associated with TMP diagnosis at least 30 days apart. A Cox regression model adjusting for patient demographics, calendar year, and the number of ear drop prescriptions was used to compare TMP risk between quinolone and neomycin-exposed patients. RESULTS: A total of 94 333 patients entered the study cohort. Use of quinolone ear drops was associated with increased risk for TMP compared with neomycin plus hydrocortisone, with an adjusted hazard ratio of 2.26 (95% confidence interval [CI], 1.34-3.83). Adjusted hazard ratios were 2.53 (95% CI, 1.27-5.05) for ofloxacin, 2.24 (95% CI, 1.03-4.85) for ciprofloxacin plus hydrocortisone, and 2.30 (95% CI, 1.09-4.87) for ciprofloxacin plus dexamethasone. Sensitivity analyses were consistent with the primary analysis. CONCLUSIONS: Use of quinolone ear drops to treat AOE is associated with a previously unreported increased risk of developing TMPs. Selection of otic preparations to treat self-limited conditions with intact tympanic membranes should consider TMP risk.

Clinical Utility of Pharmacogene Panel-Based Testing in Patients Undergoing Percutaneous Coronary Intervention.

We aimed to estimate the utility of panel-based pharmacogenetic testing of patients undergoing percutaneous coronary intervention (PCI). Utilization of Clinical Pharmacogenetic Implementation Consortium (CPIC) level A/B drugs after PCI was estimated in a national sample of IBM MarketScan beneficiaries. Genotype data from University of Florida (UF) patients (n = 211) who underwent PCI were used to project genotype-guided opportunities among MarketScan beneficiaries with at least one (N = 105,547) and five (N = 12,462) years of follow-up data. The actual incidence of genotype-guided prescribing opportunities was determined among UF patients. In MarketScan, 50.0% (52,799/105,547) over 1 year and 68.0% (8,473/12,462) over 5 years had ≥ 1 CPIC A/B drug besides antiplatelet therapy prescribed, with a projected incidence of genotype-guided prescribing opportunities of 39% at 1 year and 52% at 5 years. Genotype-guided prescribing opportunities occurred in 32% of UF patients. Projected and actual incidence of genotype-guided opportunities among two cohorts supports the utility of panel-based testing among patients who underwent PCI.

Concomitant Use of Quinolones and Stimulants and the Risk of Adverse Cardiovascular Symptoms: A Retrospective Cohort Study.

OBJECTIVE: To examine whether concomitant use of quinolones and stimulants increases the risk of cardiac events in adults. STUDY DESIGN: A retrospective cohort study of privately insured adults using MarketScan® claims data from 2008 to 2015. PATIENTS: Stimulant (methylphenidate or mixed amphetamine salts) users (18-65 yrs old) with continuous health plan enrollment for the 6 months (baseline) prior to the first dispensation (index date) of oral quinolones or comparators (amoxicillin ± clavulanate or azithromycin). OUTCOMES DEFINITION: (1) Cardiac symptoms (palpitation, tachycardia, or syncope); (2) cardiac arrhythmias (ventricular arrhythmias, paroxysmal ventricular tachycardia, or cardiac arrest). ANALYSIS: Baseline covariates adjustment was through inverse probability of treatment weighting. Adults were followed until the antimicrobial therapy ended. The hazard of cardiac events in stimulant-quinolones-exposed adults was compared to those who were treated with stimulant-comparator antibiotics using a weighted Cox regression model. Several sensitivity analyses were performed to challenge the results robustness. RESULTS: The study cohorts comprised 390,490 stimulants users who initiated either quinolone or amoxicillin, and 387,574 patients receiving stimulants who initiated quinolone or azithromycin. The unadjusted incidence rate for cardiac symptoms in stimulant-quinolones users was 471 cases/10,000 patient-years, and it was 244 cases/10,000 patient-years in patients exposed to stimulant-amoxicillin; whereas the unadjusted incidence rate for cardiac symptoms was 728 and 358 per 10,000 patient-years for stimulant-quinolones and stimulant-azithromycin cohorts, respectively. Compared to stimulant-amoxicillin use, the adjusted hazard ratio (HR) for cardiac symptoms with stimulant-quinolones use was 1.61 (95% confidence interval [CI], 1.30-1.98). The HR for cardiac symptoms for patient exposed to stimulant-quinolones was 1.69 (95% CI, 1.32-2.13) when compared to stimulant-azithromycin. The sensitivity analysis findings were consistent with the primary analysis. A few patients across the study comparison groups developed cardiac arrhythmias. CONCLUSION: Concomitant use of stimulants and quinolone was associated with an increased hazard of cardiac symptoms in comparison to concomitant use of stimulants and amoxicillin or azithromycin, but there was no apparent difference in cardiac arrhythmias.

Prevalence of Maternal-Risk Factors Related to Neonatal Abstinence Syndrome in a Commercial Claims Database: 2011-2015.

BACKGROUND: Despite the rising incidence of neonatal abstinence syndrome (NAS), data evaluating trends in maternal risk factors associated with NAS have not been available for recent years, a period characterized by declining opioid prescriptions. The objective of this study was to examine the prevalence of opioid- and non-opioid-related factors associated with NAS, and by mutually exclusive subgroups of deliveries without prescription-opioid use, with prescription-opioid use, and with opioid-use disorder (OUD). METHODS: A cohort of pregnancies resulting in live births in a commercial claims data base in 2011-2015 was identified. Examples of maternal risk factors of interest included antepartum prescription-drug use (e.g., opioids, selective serotonin reuptake inhibitors [SSRIs], antipsychotics) and nonprescription-related factors (e.g., smoking, OUD). RESULTS: A total of 659 cases of NAS among 621,940 deliveries was identified. Among NAS deliveries, prescription opioids were the most commonly used drug-class (39.0%). Adjusted relative risk (RR) for NAS was 5.43 (95% confidence interval [CI] 4.25-6.95), followed by SSRIs (20.9%; RR 3.16, CI 2.43-4.11); OUD was noted in 36.3% of the deliveries (RR 40.74, CI 22.64-73.32). In the subgroup of deliveries without a prescription opioid (33% of overall NAS deliveries), the absolute incidence of NAS was low (0.3 cases/1000 deliveries), and SSRIs were the most commonly used medication class (32.7%; RR 10.21, CI 7.28-14.31). In the subgroup of deliveries with an opioid prescription, the absolute incidence of NAS was 7.7/1000 (29% of all overall NAS deliveries), and 22.7% of these deliveries were exposed to one other psychotropic agent in addition to the opioid, most commonly an SSRI (18.0%). In the subgroup of deliveries with a diagnosis of OUD, the NAS incidence was high (214.3/1000 [36% of all NAS cases]). CONCLUSION: A third of NAS deliveries did not have evidence of prescription opioids. Other psychotropic medications, especially SSRIs, were strong predictors of NAS in this stratum but had no relevance among deliveries with OUD, suggesting varying etiologies and the need for tailored preventive approaches to reduce NAS effectively.

Model-based standardization using an outcome model with random effects.

Model-based standardization uses a statistical outcome model or exposure model to estimate a population-average association that is unconfounded by selected covariates. With it, one can compare groups using a distribution of confounders identical in each group to that of a standard population. We develop an approach based on an outcome model, in which the mean of the outcome is modeled conditional on the exposure and the confounders. In our approach, there is a confounder that clusters the observations into a very large number of categories. We treat the parameters for the clusters as random effects. We use a between-within model to account for the association of the random effects not only with the exposure but also with the cluster population sizes. We review alternative approaches presented in the literature, and we compare the outcome-modeling approach to recently proposed exposure-modeling approaches incorporating random effects. To illustrate, we use 2014 to compare proportions of acute respiratory tract infection diagnoses with an antibiotic prescription for emergency department versus outpatient visits, adjusting for confounding by unmeasured patient level variables and measured diagnosis-level variables. We also present results of a simulation study.

Azithromycin and Sensorineural Hearing Loss in Adults: A Retrospective Cohort Study.

OBJECTIVE: To examine whether short-term use of azithromycin increases the risk of sensorineural hearing loss (SNHL) in adults with uncomplicated infections. STUDY DESIGN: A retrospective cohort study using Medicaid claims data, 1999 to 2010. PATIENTS: Adults (18-64 years old) who had continuous enrollment in Medicaid for the 12 months (baseline) before the date of first dispensation (index date) of oral azithromycin or amoxicillin ±â€Šclavulanate for uncomplicated infections. MAIN OUTCOME DEFINITION: We operationalized sensorineural hearing loss (SNHL) by a charge for audiometry and followed by a diagnosis of SNHL within 30 days. ANALYSIS: We adjusted for the baseline covariates through propensity score matching. Adults were followed for up to 120 days after the index date. The hazard of SNHL in azithromycin-exposed adults was compared with those who had amoxicillin ±â€Šclavulanate using a Cox proportional hazard model. We performed several sensitivity analyses by varying the follow-up time, SNHL definition, adjusting for cumulative antibiotic use, and switching exposure status during the follow-up period. RESULTS: A total of 493,774 patients entered the study cohort. The unadjusted incidence rates of SNHL were 38 and 41 cases per 10,000 patient-years following exposure to azithromycin and amoxicillin ±â€Šclavulanate, respectively. The adjusted (matched) hazard ratio (HR) of SNHL for azithromycin versus amoxicillin ±â€Šclavulanate was 0.91 (95% confidence interval [CI], 0.77-1.07). The sensitivity analyses findings were consistent with the primary analysis. CONCLUSION: Azithromycin short-term use was not associated with an increased risk of SNHL in comparison to amoxicillin ±â€Šclavulanate.

Trends of Neonatal Abstinence Syndrome Epidemic and Maternal Risk Factors in Florida.

OBJECTIVE: This study aimed to examine secular trends of (i) maternal prescription opioid use in late pregnancy, (ii) neonatal abstinence syndrome (NAS) stratified by late maternal prescription opioid use, and (iii) maternal risk factors among NAS deliveries. METHODS: Women with a live birth who were enrolled 90 days before and 30 days after delivery in Florida Medicaid Analytic Extract billing records linked to birth certificates from 2000 to 2010 were identified for the study. Changes in the annual prevalence of prescription opioid use during pregnancy were tested with use of the Cochran-Armitage trend test. Temporal trends of NAS deliveries were estimated with the use of Poisson regression and stratified by prescription opioid exposure in the last 90 days of pregnancy in the study period. To identify contributors to the increase in NAS cases, variations in prevalence of opioid dispensing, tobacco use, antidepressant use, and substance use disorder among NAS and non-NAS deliveries were examined. RESULTS: There were 41,968 (9.4%) deliveries exposed to at least one opioid prescription in late pregnancy, and this rate remained stable from 2000 to 2010. Among prescription opioid-exposed deliveries, frequency of NAS increased from 1.6 to 25.2 per 1000 live births during the study period (p<0.05). Although the prevalence of maternal use of prescription opioid, tobacco, and antidepressants remained stable among NAS deliveries from 2000 to 2010, the prevalence of substance use disorder diagnoses increased substantially from 38.9% in 2000 to 67.9% in 2006 (p<0.05). CONCLUSIONS: The prevalence of NAS increased dramatically whereas the prevalence of major risk factors, including maternal prescription opioid use, remained stable in Florida between 2000 and 2010. The increase in substance use disorder may be responsible for the sharp increase in NAS deliveries.

Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study.

Background: This study investigated whether quinolone ear drops, with or without corticosteroids, increase the risk of perforation requiring tympanoplasty following tympanostomy tube (TT) placement in children. Methods: This was a retrospective cohort study using Medicaid encounter and pharmacy billing data from 29 US states between 1999 and 2006. Children <18 years old without predisposing factors for perforation during a 6-month look-back period entered the cohort after TT placement and first dispensing of antibiotic ear drops. Included ear drops were quinolones (ofloxacin, ciprofloxacin plus hydrocortisone, or ciprofloxacin plus dexamethasone) or neomycin plus hydrocortisone. Children were followed until end of 2006, end of Medicaid enrollment, or occurrence of study outcome. A Cox regression model, adjusted for age, sex, race/ethnicity, initial TT indication, reinsertion of TT, adenoidectomy, and number of ear drop prescriptions was used to compare the rate of perforation between quinolone and neomycin plus hydrocortisone ear drop-exposed children. Perforation was defined by its diagnosis code followed by a tympanoplasty code. Results: A total of 96595 children entered the study cohort. Patients exposed to quinolone ear drops had a higher risk of perforation, with an adjusted hazard ratio of 1.61 (95% confidence interval [CI], 1.15-2.26). The adjusted hazard ratios were 1.49 (95% CI, 1.05-2.09) for ofloxacin, 1.94 (95% CI, 1.32-2.85) for ciprofloxacin plus hydrocortisone, and 2.00 (95% CI, 1.18-3.41) for ciprofloxacin plus dexamethasone. Conclusions: Exposure of children with TT to quinolone ear drops is associated with increased risk of perforations requiring tympanoplasty, which appears to be further exaggerated by corticosteroids. Clinicians should consider the risk of perforation and counsel patients/families accordingly when prescribing quinolone ear drops.

Epidemiology of Persistent Tympanic Membrane Perforations Subsequent to Tympanostomy Tubes Assessed With Real World Data.

OBJECTIVE: To quantify the incidence of persistent tympanic membrane perforation (TMP) after tympanostomy tube (TT) surgery using a large population-based cohort. STUDY DESIGN: A retrospective cohort study. SETTING: Medicaid claims data from 1999 to 2006. PATIENTS: We studied healthy children who had Medicaid eligibility within 6 months of birth that received TTs and had 2 to 7 years of follow-up. MAIN OUTCOME MEASURES: We operationalized persistent TMP by a charge for tympanoplasty and/or one or more diagnoses of TMP. RESULTS: We identified 47,724 children who received TTs and had ≥2 years eligibility. The incidence of persistent TMP varied, based on definition and follow-up. The 2 and 7-year TMP rates were: 0.38% and 3.81% for two TMP diagnoses 6 months apart or tympanoplasty; 0.26% and 2.94% for two TMP diagnoses 6 months apart; 0.13% and 1.73% for tympanoplasty, alone; 0.04% and 1.21% for tympanoplasty preceded by one TMP diagnosis; and 0.01% and 0.52% for tympanoplasty and two TMP diagnoses 6 months apart. Reinserting TTs was associated with an increased likelihood of persistent TMP (adjusted hazard ratio [HR] = 1.98, 95% CI 1.49-2.63). Each year increase in age was associated with 49% increase in the risk of persistent TMP. CONCLUSION: Billing claims data may be used to assess the rate of persistent TMP after TT placement in large populations, yielding results consistent with findings from cohort studies and meta-analyses. Our findings may serve as the basis for future TMP research using real world datasets.

Are Discrepancies in Waiting Time for Chest Pain at Emergency Departments between African Americans and Whites Improving Over Time?

BACKGROUND: One of the Healthy People 2010 goals was to eliminate racial disparities in the U.S health system. To date, we have limited knowledge about the impact of Healthy People on racial disparities at emergency departments (EDs). OBJECTIVE: We sought to investigate whether there has been an improvement in ED waiting time to see a physician for African Americans (AAs) compared to whites with chest pain symptoms that suggest acute coronary syndrome (ACS). METHODS: A retrospective analysis of the National Hospital and Ambulatory Care Survey data from 2004 to 2011 was conducted in adults with visits related to ACS. We compared covariate-adjusted odds ratios for race for each study year and 2011. In addition, adjusted average differences in waiting times (i.e., time to see a physician) for AAs and whites for each study year were compared. RESULTS: A total of 15,438 visits related to ACS symptoms were made during the study period. The waiting time for AAs (median, 33 min) was statistically longer compared to whites (median, 21 min). In addition, the adjusted waiting time for AAs was 30% longer compared to whites (95% confidence interval, 24-36%). Pairwise comparison of adjusted odds ratios between the year 2011 and other years was not significantly different (all p values = 0.32), suggesting no change in the difference in waiting times during the study period. CONCLUSION: Among patients presenting to the ED with symptoms suggesting ACS, AA compared to whites waited longer to receive care. In addition, this difference in waiting time persisted during the study period, even after the implementation of the Healthy People 2010 initiative. Additional research is warranted to investigate the underlying reasons for unequal care offered to AAs at EDs and the implications on disease outcome.

Knowledge and attitude of healthcare professionals toward medication pregnancy category systems in Saudi hospitals.

OBJECTIVE: To assess the knowledge and attitudes of healthcare professionals (HCPs) toward systems used in describing the safety of medications use during pregnancy. METHODS: A cross-sectional self-administered survey was conducted in 4 tertiary hospitals in Riyadh, Saudi Arabia between March and May 2012. The targeted HCPs were physicians and pharmacists. The survey was validated and contained 4 main sections. Descriptive statistics were used to report responses to the survey's questions. RESULTS: A total of 393 HCPs responded to the survey, with a response rate of 97%. Half of the respondents were physicians. Of the participants, 60% were males. Most respondents (66%) stated that they have prescribed/dispensed a drug that may cause teratogenicity. Moreover, 87% of the respondents (48% pharmacists and 39% physicians) were aware of the Food and Drug Administration (FDA) pregnancy category, and most (72%) found it helpful. Only 11% of the participants strongly agree to use the European Medicine Agency (EMA) system for pregnancy category system as their main reference. CONCLUSION: In general, HCPs in Saudi Arabian hospitals have good knowledge of and attitudes toward pregnancy category systems, with more familiarity with the FDA system. The FDA system is preferred over the EMA system.

Community pharmacists' knowledge of isotretinoin safety.

OBJECTIVE: To explore the practice and knowledge of community pharmacists in Saudi Arabia regarding dispensing isotretinoin-containing products. METHODS: This was a cross-sectional study conducted in 2012 that included community pharmacists from 3 cities in Saudi Arabia. A validated and piloted self-administered survey collected demographics and information on the pharmacist's knowledge regarding isotretinoin precautions, as well as his dispensing, and counseling practices. RESULTS: One hundred and sixteen questionnaires were returned with a 72.5% response rate. Only around half of the participants (56%) knew the correct pregnancy risk classification category for oral isotretinoin. Most participants (78%) correctly identified teratogenicity as the most serious risk associated with the use of oral isotretinoin. However, only 6.2% of the pharmacists recommended using 2 methods of contraception. Almost one-fifth of the pharmacists dispensed isotretinoin without a prescription. Finally, 11% of the pharmacists did not ask whether the patient performed a pregnancy test prior to dispensing oral isotretinoin. CONCLUSION: Pharmacists at community pharmacies are not adequately aware of the risks for female patients using isotretinoin. Additionally, an alarming proportion of pharmacists dispense isotretinoin without a prescription. It is essential to implement risk minimization plans for certain medications to limit and prevent adverse drug reactions.

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. METHODS: A cohort study was conducted in Riyadh, Saudi Arabia. Patients were included if they were aged between 6 and 18 years and had received one dose of the H1N1 vaccine. A control group involved children from the same school system who had not received the vaccine. Six months following vaccination, a clinical pharmacist called the caregiver of the child to ask about hospitalization, emergency room visits and events related to H1N1 vaccine administration using a standardized questionnaire. RESULTS: Caregivers of 372 school-age children were contacted. The response rate was 97% (n = 359). A total of 169 children who received at least one dose of the H1N1 vaccine were compared with 190 children in the control group who had not received the vaccine. Controlling for age, sex, education and use of medications, the odds ratio (OR) of hospitalization or emergency room visits for children within the 6 months after vaccination relative to the unvaccinated children was 1.25 (95% CI 0.47, 3.35). The risk of influenza-like symptoms was significantly reduced in vaccinated children compared with unvaccinated children (OR 0.63; 95% CI 0.41, 0.99). CONCLUSION: School-age children in Saudi Arabia who received the H1N1 vaccine did not have an increased risk of hospitalization or emergency room visits. Larger studies are needed to confirm these results. Proactive pharmacovigilance is important in assessing the safety of vaccines and other medications. It is feasible to collect information on adverse drug reactions using mobile telephones, a method that can be of benefit in both developed and developing countries.