Use of Antidiabetic drugs during pregnancy among U.S. women with Livebirth deliveries in the Mini-Sentinel system

BACKGROUND: As the prevalence of diabetes mellitus increases in the population, the exposure to antidiabetic drugs (ADDs) during pregnancies is expected to grow, as has been seen over the last decade. The objective of this study was to estimate the prevalence of ADD use during pregnancy among women in the Mini-Sentinel Distributed Database (MSDD) who delivered a liveborn infant. METHODS: We identified qualifying livebirth pregnancies among women aged 10 to 54 years in the MSDD from 2001 to 2013. ADD use was estimated using outpatient pharmacy dispensing claims and days-supplied among three cohorts: all livebirth pregnancies, pregnancies among women with pre-existing diabetes, and pregnancies among women without prior ADD use. RESULTS: Among the 1.9 million pregnancies in the MSDD that resulted in a livebirth from 2001 to 2013, 4.4% were exposed to an ADD. Of the 15,606 pregnancies (0.8%) with pre-existing diabetes, 92.8% were also exposed during the pregnancy period. The most commonly used product in these pregnancies was insulin (75.6% of pregnancies). In contrast, in pregnancies of women without prior ADD use, the most commonly used products were glyburide and insulin, and most of these users were diagnosed with gestational diabetes. CONCLUSIONS: Patterns of ADD use during pregnancy described here, along with changes in disease incidence and management, highlight the importance of continuing surveillance of ADD utilization patterns and examining the safety and effectiveness of these products in pregnancy

Antiemetic use among pregnant women in the United States: the escalating use of ondansetron

PURPOSE: To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births. METHODS: We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation. RESULTS: In over 2.3 million pregnancies, the prevalence of ondansetron, promethazine, metoclopramide, or doxylamine/pyridoxine use anytime in pregnancy was 15.2, 10.3, 4.0, and 0.4%, respectively. Ondansetron use increased from \u3c1% of pregnancies in 2001 to 22.2% in 2014, with much of the increase attributable to oral ondansetron beginning in 2006. Promethazine and metoclopramide use increased modestly between 2001 (13.8%, 3.2%) and 2006 (16.0%, 6.0%) but decreased annually through 2014 (8.0%, 3.2%). Doxylamine/pyridoxine, approved for management of nausea and vomiting in pregnancy in 2013, was used in 1.8% of pregnancies in 2014. For all antiemetics, use was highest in the first trimester. CONCLUSIONS: We observed a marked increase in ondansetron use by study year, prescribed to nearly one-quarter of insured pregnant women in 2014, occurring in conjunction with decreased use of promethazine and metoclopramide. Given the widespread use of ondansetron in pregnancy, data establishing product efficacy and methodologically rigorous evaluation of post-marketing safety are needed

Impact of socioeconomic status on cancer incidence and stage at diagnosis: selected findings from the surveillance, epidemiology, and end results: National Longitudinal Mortality Study

BACKGROUND: Population-based cancer registry data from the Surveillance, Epidemiology, and End Results (SEER) Program at the National Cancer Institute (NCI) are mainly based on medical records and administrative information. Individual-level socioeconomic data are not routinely reported by cancer registries in the United States because they are not available in patient hospital records. The U.S. representative National Longitudinal Mortality Study (NLMS) data provide self-reported, detailed demographic and socioeconomic data from the Social and Economic Supplement to the Census Bureau's Current Population Survey (CPS). In 1999, the NCI initiated the SEER-NLMS study, linking the population-based SEER cancer registry data to NLMS data. The SEER-NLMS data provide a new unique research resource that is valuable for health disparity research on cancer burden. We describe the design, methods, and limitations of this data set. We also present findings on cancer-related health disparities according to individual-level socioeconomic status (SES) and demographic characteristics for all cancers combined and for cancers of the lung, breast, prostate, cervix, and melanoma. METHODS: Records of cancer patients diagnosed in 1973–2001 when residing 1 of 11 SEER registries were linked with 26 NLMS cohorts. The total number of SEER matched cancer patients that were also members of an NLMS cohort was 26,844. Of these 26,844 matched patients, 11,464 were included in the incidence analyses and 15,357 in the late-stage diagnosis analyses. Matched patients (used in the incidence analyses) and unmatched patients were compared by age group, sex, race, ethnicity, residence area, year of diagnosis, and cancer anatomic site. Cohort-based age-adjusted cancer incidence rates were computed. The impact of socioeconomic status on cancer incidence and stage of diagnosis was evaluated. RESULTS: Men and women with less than a high school education had elevated lung cancer rate ratios of 3.01 and 2.02, respectively, relative to their college educated counterparts. Those with family annual incomes less than $12,500 had incidence rates that were more than 1.7 times the lung cancer incidence rate of those with incomes$50,000 or higher. Lower income was also associated with a statistically significantly increased risk of distant-stage breast cancer among women and distant-stage prostate cancer among men. CONCLUSIONS: Socioeconomic patterns in incidence varied for specific cancers, while such patterns for stage were generally consistent across cancers, with late-stage diagnoses being associated with lower SES. These findings illustrate the potential for analyzing disparities in cancer outcomes according to a variety of individual-level socioeconomic, demographic, and health care characteristics, as well as by area measures available in the linked database

A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data

Introduction: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings. Existing Methods: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects—two national observational electronic health care database safety monitoring programs. Future Surveillance Planning: Based on this examination, we suggest three steps for future surveillance planning in health care databases: (1) prespecify the sequential design and analysis plan, using available feasibility data to reduce assumptions and minimize later changes to initial plans; (2) assess existing drug or vaccine uptake, to determine if there is adequate information to proceed with surveillance, before conducting more resource-intensive planning; and (3) statistically evaluate and clearly communicate the sequential design with all those designing and interpreting the safety-surveillance results prior to implementation. Plans should also be flexible enough to accommodate dynamic and often unpredictable changes to the database information made by the health plans for administrative purposes. Conclusions: This paper is intended to encourage dialogue about establishing a more systematic, scalable, and transparent sequential design-planning process for medical-product safety-surveillance systems utilizing observational electronic health care databases. Creating such a framework could yield improvements over existing practices, such as designs with increased power to assess serious adverse events

Incidence of Cancers of the Oral Cavity and Pharynx Among American Indians and Alaska Natives, 1999–2004

BACKGROUND. Previous studies identified disparities in incidence rates of cancers of the oral cavity and pharynx between American Indians/Alaska Natives (AI/AN) and non-Hispanic whites (NHW) and differences between various AI/AN populations. Reporting among AI/AN has been hampered by: 1) heterogeneity among various anatomic sites of oral cavity and pharyngeal cancers obscuring unique patterns of individual anatomic sites; 2) race misclassification and under-reporting of AI/AN; and 3) sparseness of data needed to identify regional variations. METHODS. To improve race classification of AI/AN, data from US central cancer registries were linked with Indian Health Service (IHS) records. AI/AN incidence data from 1999 to 2004 were stratified by sex, age, stage at diagnosis, and anatomic subsite for 6 IHS geographic regions and compared with NHW populations. RESULTS. For all oral cavity and pharynx cancers combined, among residents of Contract Health Service Delivery Area counties, AI/AN overall had significantly lower incidence rates than NHW (8.5 vs 11.0). However, AI/AN rates were significantly higher in the Northern Plains (13.9 vs 10.5) and Alaska (16.3 vs 10.6), significantly lower in the Pacific Coast (7.7 vs 11.6) and Southwest (3.3 vs 10.4), and similar in the Southern Plains (11.4). Overall AI/AN males had higher incidence rates than AI/AN women. Nasopharyngeal cancer was more frequent (1.1 AI/AN vs 0.4 NHW), and tongue cancer less frequent (1.6 AI/AN vs 2.9 NHW) in AI/AN than NHW populations; however, rates varied by region. Stage distribution was modestly less favorable for AI/AN compared with NHW populations. CONCLUSIONS. Variation by region, anatomic site, and sex indicates a need for research into etiologic factors and attention to regional risk factor profiles when planning cancer control program

Using Population-based Cancer Registry Data to Assess the Burden of Human Papillomavirus-associated Cancers in the United States: Overview of Methods

Increased attention to human papillomavirus (HPV)-associated cancers in light of the recent release of an HPV vaccine, as well as increased availability of cancer registry data that now include reporting from a large proportion of the US population, prompted the current assessment of HPV-associated cancers. This article describes methods used to assess the burden of HPV-associated cervical, vulvar, vaginal, penile, anal, and oral cavity/oropharyngeal cancers in the United States during 1998 through 2003 using cancer registry data, and it provides a brief overview of the epidemiology of these cancers. Persistent infection with the human papillomavirus (HPV) is considered to be a cause of nearly all cervical cancer.1 It is believed that HPV also is associated with approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers; and 35% of oropharyngeal cancers.2,3 A quadrivalent HPV vaccine that protects against HPV type 6 (HPV-6), HPV-11, HPV-16, and HPV-18 has been approved for use in the United States for females ages 9 years to 26 years, and a bivalent vaccine that protects against HPV-16 and HPV-18 currently is under review by the US Food and Drug Administration. It has been demonstrated that the HPV vaccine reduces the incidence of cervical, vaginal, and vulvar precancers, offering hope for the reduction in incidence of these diseases and the corresponding invasive cancers among women.4,5 Current studies are assessing the efficacy of the vaccine on HPV-associated disease in men.6 Close surveillance of these cancers will be necessary to ensure that high-risk populations are being reached by vaccination programs. Increased attention to HPV-associated cancers in light of the recent release of the vaccine, as well as increased availability of cancer registry data, prompted the current Supplement of Cancer titled ‘‘Assessing the Burden of HPV-Associated Cancers in the United States’’ (ABHACUS). The major purposes of this Supplement are to assess the current burden of anogenital and oropharyngeal cancers associated with HPV within the United States and to provide a baseline for monitoring future trends in HPV-associated cancers. This article describes methods used to assess the burden of HPV-associated cancers in the United States—methods that are common to several articles in the Supplement. This article describes the data sources, case definitions, variables, and analytic methods of descriptive epidemiologic articles that are included in this Supplement, and it provides an overall picture of the burden of HPV-associated cancers

Adherence to guidelines for glucose assessment in starting second-generation antipsychotics

OBJECTIVES: In 2003, the US Food and Drug Administration issued warnings about hyperglycemia and diabetes with second-generation antipsychotics (SGAs); guidelines have recommended metabolic screening since 2004. However, little is known of contemporary practices of glucose screening among youth initiating SGAs. Our objective was to evaluate baseline glucose assessment among youth in the Mini-Sentinel Distributed Database starting an SGA. METHODS: The cohort included youth ages 2 through 18 newly initiating SGAs January 1, 2006, through December 31, 2011, across 10 sites. Baseline glucose was defined as fasting/random glucose or hemoglobin A1c (GLU) measurement occurring relative to first SGA dispensing. Differences in GLU assessment were evaluated with chi(2) tests and logistic regression. RESULTS: The cohort included 16,304 youth; 60% boys; mean age 12.8 years. Risperidone was most commonly started (43%). Eleven percent (n = 1858) had GLU assessed between 90 days before and 3 days after first dispensing. Assessment varied across SGAs (olanzapine highest), sites (integrated health care systems higher), ages (16-18 highest), years (2007 highest), and gender (female higher; all P \u3c .001). GLU assessment among those starting olanzapine was more likely than among those starting quetiapine (odds ratio [OR]: 1.72 [95% confidence interval (CI): 1.37-2.18]), aripiprazole (OR: 1.49 [95% CI: 1.18-1.87]), or risperidone (OR: 1.61 [95% CI: 1.28-2.03]). CONCLUSIONS: Few children and adolescents starting SGA have baseline glucose assessed. This is concerning because those at high diabetes risk may not be identified. Further, lack of screening impedes determining the contribution of SGAs to hyperglycemia development