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The incidence rate of suicidal ideation among current and former smokers versus never smokers is not known. In this study, the age-adjusted incidence of suicidal ideation was highest among current smokers, followed by former, then never smokers. The adjusted hazard for suicide ideation was 2.22 (95%CI = 1.48, 3.33) and 1.19 (95%CI = 0.78, 1.82) for current and former smokers, respectively, compared to never smokers. Results indicate that current smokers have increased risks of suicidal ideation above and beyond the risk for never and former smokers regardless of age, gender, history of depressive disorder or anxiety symptoms, and alcohol abuse/dependence. Smoking cessation might be beneficial for some suicide prevention efforts.

In view of the prevalence of drug use among criminals, the assessment of drug dependence is a valuable responsibility of the criminal justice system. Obtaining accurate and expeditious assessments, however, has traditionally been a difficult goal to achieve because of limited time and resources. While several scales have been developed to screen for drug dependence, none have been developed for specific drugs of abuse within criminal populations. We used data from the Substance Abuse Need for Treatment among Arrestees (SANTA) study in Baltimore to develop screening instruments for cocaine and heroin dependence. The SANTA interview is a module of questions that diagnoses alcohol and other drug (AOD) abuse and dependence according to the Diagnostic and Statistical Manual of Mental Disorders, third edition-revised (DSM-III-R) criteria. Extensive inquiries about AOD-using behaviors are made using a computer-assisted module of the Diagnostic Interview Schedule, Version III-Revised (DIS-III-R), a structured interview that operationalizes the nine DSM-Ill criteria to diagnose substance abuse and dependence and estimate treatment need based on interview responses. The Center for Substance Abuse Research (CESAR) Arrestee Drug Screener (CADS) developed in the current study utilizes two sets of three questions each from the DIS-III-R for the purpose of identifying cocaine and heroin dependence among arrestees. The high sensitivities and negative predictive values of the CADS make them especially useful for identifying those arrestees most likely to be diagnosed dependent on the respective drug. Implications for using the screeners with criminal populations are discussed.

Physicians who have had a medical malpractice claim in the past may be more likely to face a malpractice claim in the future. Researchers studied medical malpractice data on 8,247 practicing Florida physicians between 1975 and 1983. A total of 18,431 claims were recorded during this period. Almost 60% of the physicians had no medical malpractice claim, approximately 13% had one paid claim and approximately 7% had more than one paid claim. Physicians who had a claim between 1975 and 1980 were more than twice as likely to have a subsequent claim between 1981 and 1983 as those who had no claims in the 1970's. The monetary amount and frequency of the claims occurring between 1975 and 1980 did not affect the likelihood of a subsequent claim. Overall, the number of claims reported per year and the size of the financial settlements tended to increase from 1975-1980 to 1981-1983., Objective.--To investigate whether an association exists between physicians' past and subsequent claims of medical malpractice, particularly whether a history of even unpaid claims ($0) or small claims ( Data.--All medical malpractice claims closed in the state of Florida from January 1975 through August 1988 (N=20 016, 92% involving physicians), matched with the American Medical Association's Physician Masterfile on all practicing physicians in the state of Florida during that period. Claims history was automated into physician-year claims files, then partitioned into a baseline period (1975 through 1980) and a subsequent period (1981 through 1983). Inconsequential claims were excluded, ie, cases closed without a named claimant and without expense for investigation (30.4% of raw claims). Methods.--Descriptive analysis of all physician claims; odds ratio analysis of physicians in practice throughout both periods (N=8247), comparing claims experience in baseline vs subsequent period, adjusted for specialty of practice. Results.--For all consequential physician claims, 60% were unpaid claims, 17% were small paid claims, and 23% were large paid claims. The 8247 continuously practicing physicians had a total of 6614 claims, averaging 0.9 per year, but 59.2% of physicians had no claims in 9 years, only 13.4% had any paid claims, and 7.2% had multiple paid claims. Less than 8% of physicians had any large paid claims during the baseline period, and less than 7% had any in the subsequent period. Physicians with any baseline claims (whether paid or unpaid, small or large, single or multiple) had elevated odds of subsequent claims (whether defined as any claims, any paid claims, any large claims, or multiple claims) relative to physicians with no baseline claims. With a baseline of all small claims, the adjusted odds ratio for any subsequent claim was 2.84 (95% confidence interval [Cl], 2.32 to 3.49), for any subsequent paid claim was 2.97 (95% Cl, 2.34 to 3.77), for all large subsequent claims was 2.42 (95% Cl, 1.76 to 3.33), and for subsequent multiple claims was 2.83 (95% Cl, 2.08 to 3.86). Even having a single unpaid baseline claim approximately doubled the odds. Conclusions.--Claims history had predictive value, even with only unpaid claims. Small paid claims were better predictors than unpaid claims, large paid claims were better predictors than small paid claims, and multiple paid claims were better predictors than single paid claims. Claims history of all kinds is a reasonable statistical measure, eg, for the screening purposes of the National Practitioner Data Bank. (JAMA. 1994; 272:1421-1426)

Black dialysis patients do not appear less likely to receive recombinant human erythropoietin (EPO) than white patients. EPO administration was approved as a covered charge by Medicare in 1989 as treatment for anemic patients with end-stage renal (kidney) disease. Both the Medicare and dialysis-unit records of 3,994 patients were analyzed. Different statistical analyses were used to take account of variations between the records. Results consistently indicated no significant difference in access to EPO between black and white dialysis patients. However, when measures of anemia were compared there appeared to be some indication that black patients may need EPO more often than white patients., Objective.--To quantify access to recombinant human erythropoietin (EPO) among patients with dialysis-dependent end-stage renal disease (ESRD). Design.--National random sample of hemodialysis patients from a random sample of dialysis units, using data abstracted from patients' medical records. Setting.--All US hemodialysis units. Participants.--A total of 4024 Medicare-entitled in-center hemodialysis patients. Main Outcome Measures.--The relative odds that black patients received EPO (compared with white patients). Results.--There was no evidence in this national study that black hemodialysis patients were more or less likely to receive EPO than white patients (P=.74) Conclusions.--Three years after Food and Drug Administration approval and Medicare coverage of EPO, there was no evidence of racial disparity in access to EPO among Medicare patients with ESRD who were receiving long-term hemodialysis. However, there was evidence of greater need for EPO among black patients. (JAMA. 1994;271:1760-1763)

Background: Among patients with chronic pain using long-term opioid therapy, the incidence of opioid abuse, addiction, overdose, and associated death are not well quantified. The range of estimates for these adverse outcomes varies drastically and may depend on how they are measured (i.e. study definitions of outcomes) and on patient characteristics and opioid-use factors (e.g. regimen, daily dose).Methods: Based on a review of the literature, the US Food and Drug Administration (FDA) required companies that manufacture and sell extended-release/long-acting (ER/LA) opioids conduct as a postmarketing requirement (PMR) a series of observational studies to estimate the rates of treatment-emergent misuse, abuse, addiction, overdose, and death using validated measures. The companies formed a consortium, the Opioid PMR Consortium (OPC), to conduct the studies.Results: The FDA initially requested four observational studies (a cohort study, a questionnaire validation study, a code validation study, and a doctor-shopping validation study), but in order to achieve the FDA's goals of the 4 studies, OPC and FDA agreed to 10 observational studies (a prospective cohort study, a retrospective database cohort study, three questionnaire validation studies, two code validation studies, and three doctor-shopping validation studies). The studies are continuing through 2020.Conclusions: A series of 10 observational studies was or are being conducted in response to the FDA's postmarketing requirement. All studies have been feasible to conduct, although a validated algorithm for measuring abuse and addiction in databases was not successful. [ABSTRACT FROM AUTHOR]

Purpose To examine risks of adverse birth outcomes in women exposed to varenicline during pregnancy. Methods: Population‐based cohort study including live‐born and stillborn infants from 1 May 2007 to 31 December 2012. Data from health and administrative registries in Denmark and Sweden, two Nordic countries with universal health care and routine registration of major life and health events. Infants were allocated to three cohorts on the basis of their in utero exposure: the exposed cohort consisting of infants whose mothers were dispensed varenicline during pregnancy; the unexposed cohort comprised infants unexposed to varenicline, but exposed to maternal smoking in utero; and the reference cohort of infants unexposed to varenicline and maternal smoking in utero. The primary outcome was major congenital malformations diagnosed from birth to the first year of life. Secondary outcomes included stillbirth, fetal growth restriction (measured as small for gestational age), preterm delivery, preterm premature rupture of membranes, and sudden infant death syndrome. We estimated the prevalence of the primary outcome and secondary outcomes in the exposed, unexposed, and reference cohorts. Prevalence odds ratios with 95% confidence intervals (CIs) were computed using logistic regression with propensity score adjustment to control for potential confounders. Results: The combined cohort included 885 185 infants. Of these, 335 infants were exposed, 78 412 were unexposed, and the remaining 806 438 comprised the reference cohort. Major congenital malformations were detected among 3.6% of exposed infants, 4.3% of unexposed infants, and 4.2% of infants in the reference cohort. The propensity score–adjusted prevalence odds ratio for major congenital malformations was 0.80 (95% CI, 0.45‐1.42) for exposed vs unexposed infants. All analyses of primary and secondary outcomes comparing exposed with unexposed infants yielded odds ratio estimates below or close to unity. Use of varenicline during pregnancy does not appear to increase the risk of major congenital malformations or other adverse birth outcomes. [ABSTRACT FROM AUTHOR]

Background: Drug adverse event (AE) signal detection using the Gamma Poisson Shrinker (GPS) is commonly applied in spontaneous reporting. AE signal detection using large observational health plan databases can expand medication safety surveillance. Methods: Using data from nine health plans, we conducted a pilot study to evaluate the implementation and findings of the GPS approach for two antifungal drugs, terbinafine and itraconazole, and two diabetes drugs, pioglitazone and rosiglitazone. We evaluated 1676 diagnosis codes grouped into 183 different clinical concepts and four levels of granularity. Several signaling thresholds were assessed. GPS results were compared to findings from a companion study using the identical analytic dataset but an alternative statistical method—the tree-based scan statistic (TreeScan). Results: We identified 71 statistical signals across two signaling thresholds and two methods, including closely-related signals of overlapping diagnosis definitions. Initial review found that most signals represented known adverse drug reactions or confounding. About 31% of signals met the highest signaling threshold. Conclusions: The GPS method was successfully applied to observational health plan data in a distributed data environment as a drug safety data mining method. There was substantial concordance between the GPS and TreeScan approaches. Key method implementation decisions relate to defining exposures and outcomes and informed choice of signaling thresholds. [ABSTRACT FROM AUTHOR]

A multi-site collaborative study of mental disorders analyzed data from self-reported interviews to investigate suspected differences between 611 cocaine users and 126 heroin users in the community with respect to various indicators of drug dependence. Cocaine users were less likely than heroin users to report dependence-related problems. Thus it may not be valid to generalize from self-reported data on cocaine dependence.