Smoking and healthcare expenditure reductions associated with the California Tobacco Control Program, 1989 to 2019: A predictive validation.

BACKGROUND: Previous research used data through 2008 to estimate a model for the effect of the California Tobacco Control Program (CTCP) that used cumulative real per capita tobacco control expenditure to predict smoking behavior (current adult smoking prevalence and mean cigarette consumption per current smoker). Predicted changes in smoking behavior due to the CTCP were used to predict its effect on health care expenditure. This research updates the model using the most recently available data and estimates CTCP program effect through 2019. METHODS: The data used in the previous research were updated, and the original model specification and a related predictive forecast model were re-estimated. The updated regression estimates were compared to those previously published and used to update estimates of CTCP program effect in 2019 dollars. RESULTS: There was no evidence of structural change in the previously estimated model. The estimated effect of the CTCP program expenditures on adult current smoking prevalence and mean consumption per adult current smoker has remained stable over time. Over the life of the program, one additional dollar per capita of program expenditure was associated with a reduction of current adult smoking prevalence by about 0.05 percentage point and mean annual consumption per adult current smoker by about 2 packs. Using updated estimates, the program prevented 9.45 (SE 1.04) million person-years of smoking and cumulative consumption of 15.7 (SE 3.04) billion packs of cigarettes from 1989 to 2019. The program produced cumulative savings in real healthcare expenditure of $544 (SE $82) billion using the National Income and Product Accounts (NIPA), and $816 (SE $121) billion using the Center for Medicare and Medicaid Services (CMS) measure of medical costs. During this time, the CTCP expenditure was $3.5 billion. CONCLUSION: A simple predictive model of the effectiveness of the CTCP program remained stable and retains its predictive performance out-of-sample. The updated estimates of program effect suggest that CTCP program has retained its effectiveness over its 31-year life and produced a return on investment of 231 to 1 in direct CMS medical expenditure.

Improved Label and Liver Warning for Nonprescription Acetaminophen Products.

OBJECTIVE: To compare consumer preferences for a revised and current acetaminophen over-the-counter "Drug Facts" labels (ODFL) on warnings and self-reported correct intended action following signs of overdose. METHODS: Adults visiting a community center were randomly assigned to revised or current ODFLs using previously reported label comprehension methodology. RESULTS: Participant (N = 110) ratings for both ODFLs were comparable for ease of finding and understanding information. In response to an emergent overdose scenario, the proportion reporting the correct intended action using the revised ODFL was significantly greater than the proportion using the current ODFL (91% [97.5% CI, 0.82-0.99] vs. 76% [97.5% CI, 0.64-0.89]). In side-by-side comparisons, the revised ODFL was superior for overall consumer preference, usefulness for first-time use, and better overdose-related directions. A revised bottle cap statement also outperformed the current statement used on brand acetaminophen. CONCLUSION: Findings support revision of acetaminophen ODFLs to improve liver damage warnings and to optimize labeling likely to be useful in prevention of and response to overdose.

Pharmacy students teaching prescribers strategies to lower prescription drug costs for underserved patients.

BACKGROUND: The rising costs of health care and, in particular, prescription drugs remains a challenge. Health professionals' ability to promote cost-effective prescription drug use is critical, yet this subject is not included consistently in the curriculum of most health professional schools. As experts in prescription drug selection, use, and cost, pharmacists are in a unique position to help manage prescription drug regimens for the best therapeutic outcome, while also helping to keep patients' out-of-pocket (OOP) prescription drug costs low. In addition to promoting interprofessional collaboration, pharmacy student-led lectures may provide an effective means to teach prescription drug cost-savings strategies to other health professional students and current prescribers. OBJECTIVE: To describe and evaluate the impact of a 60- to 90-minute standardized, case-based lecture on prescribers' attitudes and knowledge about drug cost-containment strategies. METHODS: Four trained pharmacy students delivered a lecture that focused on strategies to help underserved patients with their OOP prescription drug costs. This lecture was given to health professional students and prescribers across disciplines. For purposes of this study, underserved patients included those with no drug insurance, those with limited financial resources who were unable to pay for their prescription drugs, and those whose drug insurance had significant gaps in coverage (e.g., Medicare Part D patients). Lectures targeted future and current prescribers and were delivered in multiple settings (e.g., residents' seminars, medical grand rounds, required health policy courses for medical and nursing students). Pretest/posttest surveys were administered to assess the impact of the lecture on learners' (a) knowledge of strategies to improve underserved patients' access to needed prescription drugs; (b) willingness to address and discuss cost issues with patients; (c) likelihood of collaborating with other health care professionals; and (d) perception of pharmacists as patient advocates. The survey collected demographic information about learners and assessed their knowledge through 5 case-based, multiple-choice questions. The survey also asked learners to rate their agreement with 5 statements using a 4-point Likert rating scale (4 = strongly agree to 1 = strongly disagree). To control for potential test-retest bias for the case-based knowledge questions, an alternate version of the pretest/posttest survey was developed without the pretest knowledge questions included. Learners received either 1 of the 2 surveys randomly before the lecture began and were instructed to complete the pretest portion of the survey before the start of the lecture and to complete the posttest portion of the survey at the conclusion of the lecture. RESULTS: From October 2010 to June 2012, trained pharmacy students delivered 19 presentations to 626 learners from other health professions. Compared with the baseline, there was a statistically significant increase in the proportion of correct answers for each knowledge-based question after delivery of the lecture (overall significance P less than 0.001). Furthermore, there was a significant increase in the proportion of learners responding that they were more confident in their ability to select prescription drug cost-saving strategies; more likely to consult with other providers to lower OOP prescription drug costs; more likely to consider costs when making prescribing decisions; and more likely to ask their patients about prescription drug affordability (overall significance of P less than 0.05). In addition, after the lecture, more learners felt that pharmacists were patient advocates. Finally, 96% of learners felt that the lecture promoted interprofessional collaboration and would recommend it to other health care professionals. CONCLUSIONS: This study demonstrates that a single lecture given by pharmacy students to other health care professional students and current prescribers can improve knowledge of prescription drug cost-saving strategies targeted toward vulnerable patient populations and may increase the likelihood of collaboration between prescribers and pharmacists. The format of this lecture is an efficient and effective way to disseminate important and timely policy information to health care professionals.

Association between smokefree laws and voluntary smokefree-home rules.

BACKGROUND: More states and localities are passing restrictions on smoking in public places and workplaces. PURPOSE: To determine what, if any, association exists between enactment of strong laws making public places or workplaces smokefree on adoption of voluntary smokefree-home policies, particularly whether such laws are associated with increased smoking at home. METHODS: Logistic regressions were used to estimate the OR of a person living with a 100% smokefree-home rule as a function of individual characteristics, household composition, and whether or not the residential region is covered by clean indoor air laws. The data came from successive waves of the Tobacco Use Supplement to Current Population Survey (TUS-CPS) for the years 1992-2007, and the American Nonsmokers' Rights Foundation database of state and local government clean indoor air laws. Analysis was conducted in 2010 and 2011. RESULTS: Living in a county fully covered by a 100% clean indoor air law in workplaces or restaurants or bars is associated with an increased likelihood of having a voluntary 100% smokefree-home rule both for people living with smokers (OR=7.76, 95% CI=5.27, 11.43) and not living with smokers (OR=4.12, 95% CI=3.28, 5.16). CONCLUSIONS: Strong clean indoor air laws are associated with large increases in voluntary smokefree-home policies both in the homes with and without smokers. These results support the hypothesis of norm spreading of clean indoor air laws.

The impact of the aging population on coronary heart disease in the United States.

BACKGROUND: The demographic shift toward an older population in the United States will result in a higher burden of coronary heart disease, but the increase has not been quantified in detail. We sought to estimate the impact of the aging US population on coronary heart disease. METHODS: We used the Coronary Heart Disease Policy Model, a Markov model of the US population between 35 and 84 years of age, and US Census projections to model the age structure of the population between 2010 and 2040. RESULTS: Assuming no substantive changes in risks factors or treatments, incident coronary heart disease is projected to increase by approximately 26%, from 981,000 in 2010 to 1,234,000 in 2040, and prevalent coronary heart disease by 47%, from 11.7 million to 17.3 million. Mortality will be affected strongly by the aging population; annual coronary heart disease deaths are projected to increase by 56% over the next 30 years, from 392,000 to 610,000. Coronary heart disease-related health care costs are projected to rise by 41% from $126.2 billion in 2010 to $177.5 billion in 2040 in the United States. It may be possible to offset the increase in disease burden through achievement of Healthy People 2010/2020 objectives or interventions that substantially reduce obesity, blood pressure, or cholesterol levels in the population. CONCLUSIONS: Without considerable changes in risk factors or treatments, the aging of the US population will result in a sizeable increase in coronary heart disease incidence, prevalence, mortality, and costs. Health care stakeholders need to plan for the future age-related health care demands of coronary heart disease.

Projected effect of dietary salt reductions on future cardiovascular disease.

BACKGROUND: The U.S. diet is high in salt, with the majority coming from processed foods. Reducing dietary salt is a potentially important target for the improvement of public health. METHODS: We used the Coronary Heart Disease (CHD) Policy Model to quantify the benefits of potentially achievable, population-wide reductions in dietary salt of up to 3 g per day (1200 mg of sodium per day). We estimated the rates and costs of cardiovascular disease in subgroups defined by age, sex, and race; compared the effects of salt reduction with those of other interventions intended to reduce the risk of cardiovascular disease; and determined the cost-effectiveness of salt reduction as compared with the treatment of hypertension with medications. RESULTS: Reducing dietary salt by 3 g per day is projected to reduce the annual number of new cases of CHD by 60,000 to 120,000, stroke by 32,000 to 66,000, and myocardial infarction by 54,000 to 99,000 and to reduce the annual number of deaths from any cause by 44,000 to 92,000. All segments of the population would benefit, with blacks benefiting proportionately more, women benefiting particularly from stroke reduction, older adults from reductions in CHD events, and younger adults from lower mortality rates. The cardiovascular benefits of reduced salt intake are on par with the benefits of population-wide reductions in tobacco use, obesity, and cholesterol levels. A regulatory intervention designed to achieve a reduction in salt intake of 3 g per day would save 194,000 to 392,000 quality-adjusted life-years and $10 billion to $24 billion in health care costs annually. Such an intervention would be cost-saving even if only a modest reduction of 1 g per day were achieved gradually between 2010 and 2019 and would be more cost-effective than using medications to lower blood pressure in all persons with hypertension. CONCLUSIONS: Modest reductions in dietary salt could substantially reduce cardiovascular events and medical costs and should be a public health target.

Black box warning contraindicated comedications: concordance among three major drug interaction screening programs.

BACKGROUND: Black box warnings represent the strongest safety warning that the Food and Drug Administration can issue for a marketed prescription drug. Some black box warnings recommend against coadministration of specific medications due to an increased risk for serious, perhaps life-threatening, effects. OBJECTIVE: To determine the level of agreement in presence, clinical severity scores level of documentation ratings, and alert content among 3 leading drug interaction screening programs with regard to contraindicated comedications that are mentioned in black box warnings. METHODS: We reviewed the prescribing information for currently marketed prescription drugs with a black box warning that mentioned a contraindicated drug combination. We selected the drug interaction databases Facts & Comparisons 4.0, MICROMEDEX DRUG-REAX, and Lexi-Comp Lexi-Interact to evaluate the interactions. Discrepancies in the inclusion of interactions and level of agreement in clinical severity scores and level of documentation ratings for each interaction were assessed, using descriptive statistics, Spearman's correlation coefficient, Kendall-Stuart tau-c, and Cronbach's alpha. RESULTS: We identified 11 drugs with black box warnings that contained information on 59 unique contraindicated drug combinations, only 68% of which were covered by any source. Lexi-Comp detected the most interactions (n = 29) and DRUG-REAX the least (n = 18). Only 3 drug combinations were detected and rated as contraindicated or potentially life-threatening in all 3 databases. The severity scores and level of documentation ratings varied widely. CONCLUSIONS: There are discrepancies among major drug interaction screening programs in the inclusion, severity, and level of documentation of contraindicated drug combinations mentioned in black box warnings. Further studies could explore the implications of these inconsistencies, particularly with regard to the integration of black box warning information in clinical practice. Clinicians should consult multiple drug resources to maximize the potential for detecting a potentially severe drug interaction.

Declines in acute myocardial infarction after smoke-free laws and individual risk attributable to secondhand smoke.

BACKGROUND: The estimated effects of recent pubic and workplace smoking restriction laws suggest that they produce significant declines in community rates of heart attack. The consistency of these declines with existing estimates of the relative risk of heart attack in individuals attributable to passive smoking exposure is poorly understood. The objective is to determine the consistency of estimates of reductions in community rates of heart attacks resulting from smoking restriction laws with estimates of the relative risk of heart disease in individuals exposed to passive smoking. METHODS AND RESULTS: Meta-analyses of existing estimates of declines in community rates were compared with a mathematical model of the relationship between individual risk and community rates. The outcome measure is the ratio of community rates of acute myocardial infarction (after divided by before implementation of a smoking restriction law). There is a significant drop in the rate of acute myocardial infarction hospital admissions associated with the implementation of strong smoke-free legislation. The primary reason for heterogeneity in results of different studies is the duration of follow-up after adoption of the law. The pooled random-effects estimate of the rate of acute myocardial infarction hospitalization 12 months after implementation of the law is 0.83 (95% confidence interval, 0.80 to 0.87), and this benefit grows with time. This drop in admissions is consistent with a range of plausible individual risk and exposure scenarios. CONCLUSIONS: Passage of strong smoke-free legislation produces rapid and substantial benefits in terms of reduced acute myocardial infarctions, and these benefits grow with time.

Coronary heart disease attributable to passive smoking: CHD Policy Model.

BACKGROUND: Passive smoking is a major risk factor for coronary heart disease (CHD), and existing estimates are out of date due to recent and substantial changes in the level of exposure. OBJECTIVE: To estimate the annual clinical burden and cost of CHD treatment attributable to passive smoking. OUTCOME MEASURES: Annual attributable CHD deaths, myocardial infarctions (MI), total CHD events, and the direct cost of CHD treatment. METHODS: A Monte Carlo simulation estimated the CHD events and costs as a function of the prevalence of CHD risk factors, including passive-smoking prevalence and a low (1.26) and high (1.65) relative risk of CHD due to passive smoking. Estimates were calculated using the CHD Policy Model, calibrated to reproduce key CHD outcomes in the baseline Year 2000 in the U.S. RESULTS: At 1999-2004 levels, passive smoking caused 21,800 (SE=2400) to 75,100 (SE=8000) CHD deaths and 38,100 (SE=4300) to 128,900 (SE=14,000) MIs annually, with a yearly CHD treatment cost of $1.8 (SE=$0.2) to $6.0 (SE=$0.7) billion. If recent trends in the reduction in the prevalence of passive smoking continue from 2000 to 2008, the burden would be reduced by approximately 25%-30%. CONCLUSIONS: Passive smoking remains a substantial clinical and economic burden in the U.S.

Effect of the California tobacco control program on personal health care expenditures.

BACKGROUND: Large state tobacco control programs have been shown to reduce smoking and would be expected to affect health care costs. We investigate the effect of California's large-scale tobacco control program on aggregate personal health care expenditures in the state. METHODS AND FINDINGS: Cointegrating regressions were used to predict (1) the difference in per capita cigarette consumption between California and 38 control states as a function of the difference in cumulative expenditures of the California and control state tobacco control programs, and (2) the relationship between the difference in cigarette consumption and the difference in per capita personal health expenditures between the control states and California between 1980 and 2004. Between 1989 (when it started) and 2004, the California program was associated with $86 billion (2004 US dollars) (95% confidence interval [CI] $28 billion to $151 billion) lower health care expenditures than would have been expected without the program. This reduction grew over time, reaching 7.3% (95% CI 2.7%-12.1%) of total health care expenditures in 2004. CONCLUSIONS: A strong tobacco control program is not only associated with reduced smoking, but also with reductions in health care expenditures.

Comparison of the packaging and labeling of Target ClearRx with conventional prescription drug packaging and labeling.

OBJECTIVE: To compare consumer preferences for Target pharmacy's clearrx packaging and labeling with conventional prescription drug packaging and labeling. DESIGN: Prospective, hands-on comparison of packaging and labeling formats. SETTING: Two suburban shopping malls in northern California in February and March 2006. PARTICIPANTS: Volunteer participants from local communities. INTERVENTIONS: Self-administered questionnaire. Participants were asked to compare ClearRx bottles with conventional cylindrical prescription bottles (both labeled as containing fluoxetine). They also were asked their opinions on three ClearRx bottles (labeled as containing albuterol, amoxicillin, or atenolol) with different color rings corresponding to three fictitious family members. MAIN OUTCOME MEASURES: Consumer preference for ClearRx or conventional packaging and labeling, consumer ability to differentiate between two types of packaging and labeling, consumer perception of safety design, and reasons for consumer preferences. RESULTS: The majority of consumers (85%) preferred ClearRx packaging and labeling over the conventional format (10%; 5% uncertain; P < 0.0005). Consumers described distinct differences between the packaging and labeling formats, citing ClearRx as better designed for safety, easier to read, and having better organized warnings with larger type size. The ClearRx patient information card was rated by the majority of consumers as easy or very easy to access (91%; P < 0.0005), important or very important to retain as a reference during use (94%; P < 0.0005), and helpful for improving medication safety (91% agree or strongly agree; P < 0.0005). Features designed to avoid medication mix-ups (i.e., color rings, large type face for medication name) allowed consumers to easily distinguish among bottles of ClearRx. These findings were consistent across various demographic categories. CONCLUSION: ClearRx represents an important advance in meeting consumer needs for patient-centered designs in prescription packaging and labeling.

Cost-effectiveness of bupropion, nortriptyline, and psychological intervention in smoking cessation.

Sustained-release bupropion and nortriptyline have been shown to be efficacious in treating cigarette smoking. Psychological intervention is also recognized as efficacious. The cost and cost-effectiveness of the 2 drug therapies have not been estimated. It was hypothesized that nortriptyline would be more cost-effective than bupropion. Hypotheses were not originally proposed concerning the cost-effectiveness of psychological versus drug treatment, but the 2 were compared using exploratory analyses. This was a 3 (bupropion versus nortriptyline versus placebo) by 2 (medical management alone versus medical management plus psychological intervention) randomized trial. Participants were 220 cigarette smokers. Outcome measures were cost and cost-effectiveness computed at week 52. Nortriptyline cost less than bupropion. Nortriptyline was more cost-effective than bupropion; the difference was not statistically significant. Psychological intervention cost less than the 2 drug treatments, and was more cost-effective, but not significantly so. Prospective investigations of the cost and cost-effectiveness of psychological and pharmacological intervention, using adequate sample sizes, are warranted.