The Health Advisory (HA) Program of the Office of Water provides informal technical guidance to Federal, State and local officials responsible for protecting health when emergency spills or contamination situations occur. Under this program, first initiated in 1985, HA values are developed for 1-day, 10-day, longer-term (approx. 7 years) and lifetime exposures based on data describing non- cancer endpoints of toxicity. For substances that are known or probable human carcinogens, lifetime HAs are not recommended. In these situations, the HA document provides an estimate of the drinking water concentration that is equivalent to a l0(-4) 10(-6) cancer risk. US EPA has HA documents for over 175 chemicals dating from 1987 to 1998. A tabular summary of HA values can be accessed through the EPA Office of Science and Technology (OST) web page. The HA support documents provide a concise technical summary of and references for information on chemical, physical and toxicological properties, analytical methods, and treatment technologies. Some of the lifetime HA and cancer values in the HA documents may no longer agree with the most recent Agency assessment for Reference Dose (RfD) and cancer effects. However, the lifetime HA and cancer values presented in the HA tables have been updated to correspond with agency consensus values as presented in the Integrated Risk Information System (IRIS) database.
Publications
2002
BACKGROUND: Spending on prescription drugs is the fastest growing component of the health care budget. There is public concern about the possibility that direct-to-consumer advertising of prescription drugs will result in inappropriate prescribing and higher costs of care. Guidelines issued in 1997 by the Food and Drug Administration (FDA) regarding advertising to consumers through electronic media are considered by some to be responsible for unleashing a flood of direct-to-consumer advertising.
METHODS: Using data on spending for promotional purposes and sales of prescription drugs, we examined industrywide trends for various types of promotion. We also tracked the relation between promotional efforts and sales over time. Finally, we documented the variation in direct-to-consumer advertising among and within five therapeutic classes of drugs and compared the variation in the intensity of such advertising with variation in the intensity of promotion to health care professionals.
RESULTS: Annual spending on direct-to-consumer advertising for prescription drugs tripled between 1996 and 2000, when it reached nearly $2.5 billion. Despite this increase, such advertising accounts for only 15 percent of the money spent on drug promotion and is highly concentrated on a subgroup of products. Within a therapeutic class, there is marked variation in the intensity of direct-to-consumer advertising, and the amount of such advertising for specific products fluctuates over time. The initial surge in direct-to-consumer advertising preceded the 1997 FDA guidelines that clarified the rules for electronic direct-to-consumer advertising, and thus the 1997 guidelines may not have been the most important reason for the overall increase.
CONCLUSIONS: Although the use of direct-to-consumer advertising has grown disproportionately to other forms of promotion, it continues to account for a small proportion of total promotional efforts. Nevertheless, physicians must assist patients in evaluating health-related information obtained through direct advertising.
BACKGROUND: It has been suggested that pharmacological challenges that induce panic attacks are confounded by effects of environmental stress, elevated baseline arousal, and expectancy bias.
METHODS: To control for effects of arousal and cognition on the panicogenic effects of pentagastrin, pharmacological challenges were conducted during sleep in seven patients with panic disorder or social phobia. All patients had previously experienced pentagastrin-induced panic while awake. Infusions of normal saline and pentagastrin (0.6 microg/kg) were administered in fixed order and timed so that pentagastrin infusions took place during the transition from Stage 2 to Stage 3 sleep. Long intravenous lines were placed for remote blood sampling and subsequent analysis of plasma adrenocorticotropic hormone and cortisol. Measures of anxiety and panic were obtained at baseline and upon awakening after pharmacological challenge.
RESULTS: All seven subjects awoke within seconds following pentagastrin infusion. Four patients reported symptoms that met criteria for panic. Neither baseline anxiety nor neuroendocrine measures were predictive of panic.
CONCLUSIONS: These data demonstrate the ability to induce panic during a period of diminishing arousal and indicate that panic attacks can occur in the absence of elevated arousal and environmental stress.
2001
OBJECTIVE: To assess the perceptions of US Department of Veterans Affairs (VA) physicians regarding effects of a National Formulary (NF) on patient care, access to drugs, physician workload, and resident training approximately 1 year after it was implemented.
STUDY DESIGN: Cross-sectional survey.
METHODS: A questionnaire was sent to attending physicians working within the VA healthcare system. Participants included general internists (n = 2824), neurologists (n = 238), psychiatrists (n = 997), general surgeons (n = 429), and urologists (n = 152). The response rate was 45%.
RESULTS: Most physicians (63%) thought that they could prescribe needed drugs; 65% agreed that patients could obtain needed nonformulary drugs. One third disagreed that access to prescription pharmaceuticals had increased; 29% stated the NF impinged on providing quality care to their own patients, and 21% thought it did so to patients from other VA facilities. Thirty eight percent of physicians perceived the NF to be more restrictive than private sector formularies; 16% thought that the NF diminished the ability to train residents for managed care. Forty percent thought that the NF added to workload. Generalists more often perceived that the NF improved their ability to provide care compared with neurologists (27% vs 18%, P = .046), psychiatrists (27% vs 22%, P = .027), and internal medicine subspecialists (27% vs 18%, P = .001). Physicians with more clinic time were more likely to perceive that the NF increased workload.
CONCLUSION: Although differences of opinions among physicians were noted, most responding VA physicians did not perceive that the NF adversely affected patient care, access to pharmaceuticals, physician workload, or resident training.
2000
OBJECTIVE: To examine changes in healthcare utilization resulting from a formulary switch to cimetidine from nizatidine at the Veterans Affairs Pittsburgh Healthcare System.
STUDY DESIGN: A retrospective analysis of administrative and clinical data 6 months before and 6 months after the therapeutic substitution.
METHODS: The 704 patients who were switched from nizatidine to cimetidine were included in the study. Administrative data included total and primary care clinic visits, emergency room visits, gastrointestinal (GI)-related radiological studies, and GI endoscopic procedures. Discharge summaries were examined, and rates of total and GI-related hospitalizations were calculated.
RESULTS: There was no evidence of increased utilization of healthcare resources during the 6 months after the formulary switch. Estimated monthly pharmaceutical savings for the Veterans Affairs Pittsburgh Healthcare System were $7260.
CONCLUSIONS: A formulary switch from nizatidine to cimetidine can be accomplished at significant pharmaceutical cost savings, and this retrospective study suggests that this can be done without increasing other aspects of healthcare resource utilization.
BACKGROUND: Black patients undergo coronary artery bypass grafting and percutaneous transluminal coronary angioplasty less often than white patients. It is unclear how racial differences in clinical factors contribute to this variation.
METHODS: A retrospective cohort study was performed of 666 male patients (326 blacks and 340 whites), admitted to 1 of 6 Veterans Affairs hospitals from October 1, 1989, to September 30, 1995, with acute myocardial infarction or unstable angina who underwent cardiac catheterization. The primary comparison was whether racial differences in percutaneous transluminal coronary angioplasty and coronary artery bypass grafting rates persisted after stratifying by clinical appropriateness of the procedure, measured by the appropriateness scale developed by the RAND Corporation, Santa Monica, Calif.
RESULTS: Whites more often than blacks underwent a revascularization procedure (47% vs 28%). There was substantial variation in black-white odds ratios within different appropriateness categories. Blacks were significantly less likely to undergo percutaneous transluminal coronary angioplasty (odds ratio, 0.30; 95% confidence interval, 0.14-0.63 [P<.01]) when the indication was rated "equivocal." Similarly, blacks were less likely to undergo coronary artery bypass grafting (odds ratio, 0.44; 95% confidence interval, 0.23-0.86 [P<.01]) when only coronary artery bypass grafting was indicated as "appropriate and necessary." Differences in comorbidity or use of cigarettes or alcohol did not explain these variations. Using administrative data from the Veterans Health Administration, we found no differences in 1-year (5.2% vs 7.4%) and 5-year (23.3% vs 26.2%) mortality for blacks vs whites.
CONCLUSION: Among patients with acute myocardial infarction or unstable angina, variation in clinical factors using RAND appropriateness criteria for procedures explained some, but not all, racial differences in coronary revascularization use.
This article addresses issues related to the privatization of various functions within the mental health system. It acknowledges the contributions of Robert Dorwart, who explored trends with regard to the privatization of inpatient psychiatric services. The authors then highlight changes in the division of labor between the public and private sectors regarding the financing and delivery of mental health services and the management of the system. Responsibility for funding the mental health system has remained largely a public responsibility while responsibility for production or delivery of services in the mental health system is typically held by private, for-profit, and not-for-profit organizations. The roles of managing the mental health system and setting policy are now shared between the private and public sectors in a number of states that have implemented Medicaid behavioral health carve-out programs. This article explores the impact of such privatization on cost, access, and quality of services by examining the experiences of three states with carve-outs. The authors suggest that while organizational form is an important issue, concerns about privatization should be tempered by attention to the contracting decisions made by purchasers, the level of resources devoted to services, and the adequacy of administration of the system.