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The debate over substitution policy. Its evolution and scientific basis.

Considerations about differences in bioavailability between brand-name drugs and generic formulations of these agents are discussed as are the meaning of drug quality, the national regulatory situation concerning generic substitution, and state-to-state variations in product selection laws. Actual and potential problems with generic substitution are described with regard to current and future prescribing practices. Proposed regulations permitting or mandating substitution of generic alternatives and therapeutic substitutes are mentioned. Although there is no consensus on the proper use of generic drugs, physicians should be aware of potential differences in bioavailability and therapeutic effectiveness that may arise when one drug product is substituted for another. Such differences are of particular concern for certain therapeutic categories such as psychotropic, cardiovascular, and endocrine/metabolic drugs, as well as for special population groups, such as the elderly, infants, and children. If physicians are to prescribe in an optimal manner, they should be knowledgeable about the bioavailability of different drug products and the national and state laws addressing substitution. Generic substitution is linked to current and future policy changes in the area of therapeutic substitution.

Age Factors↗

Effects of vaccine information pamphlets on parents' attitudes.

OBJECTIVES: To describe how parents actually use federally mandated vaccine information pamphlets and to evaluate the pamphlets' effects on parents' opinions about vaccination. DESIGN: A controlled trial of vaccine information pamphlets based on a survey mailed to parents who either received (n = 140) or did not receive (n = 167) the pamphlets. STUDY POPULATION: Parents of infants aged 2 to 8 months in a suburban, mainly upper-middle class private group practice in northern California. RESULTS: More than 90% of parents believed that they had enough information to decide whether their child should be vaccinated, even among those who did not receive the pamphlets. Among parents who received the pamphlets, fewer than half (38%) read them thoroughly, and most (63%) said that they should be distributed only on the first visit for vaccinations. Parents who received the pamphlets did not differ from those who did not in terms of the proportions who would have liked more time to be spent discussing vaccines (34% vs 34%) or who were anxious about how the diphtheria and tetanus toxoids and pertussis vaccine would affect their child (60% vs 52%). CONCLUSIONS: Vaccine information pamphlets, when used as an adjunct to discussions with physicians and nurses, have little effect on the opinions of well-educated parents. Future research and policy changes might focus on how to make the contents of the pamphlets less frightening and on allowing greater flexibility in how they are distributed.

Adult↗

Prevalence and risk factors for HBV infection among street youth in central Brazil.

PURPOSE: A seroprevalence survey was carried out among 496 street adolescents from 9 to 20 years old in central Brazil to determine the prevalence of hepatitis B (HBV) markers, as well as to assess the role of potential risk factors. RESULTS: The findings reveal that 20.4% of the participants were homeless adolescents without family links, living and/or working on the streets. The age at first sexual intercourse was as low as 9 years old, and approximately 60% of this population had had at least one sexual relationship by the age of thirteen, indicating prepubertal initiation of sexual experiences among street adolescents. 13.5% were HBV marker-positive (anti-HBc) and 2.0% had antigenemia. Street-based youth had a higher HBV marker-positive rate when compared to home-based teens (OR = 4.1, 95% CI: 2.1-8.5) and, similarly, higher HBV prevalence was obtained for those reporting sexual activity versus the group without sexual activity (OR = 2.1, 95% CI: 1.1-3.9), even after adjusting for potential confounders. CONCLUSIONS: We have found that street youth, particularly street-based adolescents, should be considered at-risk group for hepatitis B infection in our region. These findings may be used as a baseline information for policy changes not only in hepatitis B prevention but also to reverse the scenario of adolescents sexual abuse.

Adolescent↗

Fear of trying.

Unless the nutrition community intervenes in national and international policymaking, the world could well be headed for serious trouble with deaths from starvation on a consequential scale. There has been near-total dissociation between agricultural planning policies and food distribution and nutritional needs of populations. Unfortunately, the nutrition community is out of the mainstream of forces which affect nutritional status and which produce the macro-decisions. Why? Perhaps the professionals have too narrow a view of their role; although malnutrition is a health problem, the solution is not necessarily one of health delivery. Perhaps they don't seriously wish to be involved with policy change and the work it entails. Perhaps, by being unable to achieve consensus within their own ranks, they have generated a lack of credibility. The nutrition community needs to recognize a broader scope for nutrition and to take new approaches in advocacy directed to education policy-makers. No one else can play this role with authority.

Agriculture↗

Advertising and alcohol sales: a legal impact study.

According to the single distribution theory increases in the availability of alcoholic beverages in the general population are associated with increases in average consumption and increases in alcohol-related damage. If it can be demonstrated that advertising contributes to availability, perhaps in the form of what has been called social or subjective availability, then advertising could be considered an appropriate target of prevention. A 58-year ban on advertising of alcoholic beverages was lifted in Saskatchewan in 1983. Data on monthly sales of beer, wine and distilled spirits were examined for the years 1981 to 1987. Box-Jenkins time series techniques were used to estimate the statistical relationship between the policy change and volume of sales of alcoholic beverages. The results revealed that sales of beer increased and sales of spirits decreased following the change in legislation that permitted alcohol advertising in Saskatchewan. The main finding is that there was no impact on wine and total alcohol sales from the introduction of alcohol advertising. Alcohol advertising may have produced a substitution effect with respect to beer and spirits, but this was not predicted. This evaluation suggests that alcohol advertising is not a contributory force that influences the overall level of alcohol consumption. The place of advertising in the single distribution theory remains not proven, and the place of advertising as an instrument of public policy with respect to the prevention of alcohol-related damage remains in question.

Advertising↗

1984 update on the world economic crisis and the children: a United States case study.

A previously published report by these authors on the impact in the United States of recession on children's health emphasized four points: available monitoring systems are not adequate for reporting on the health of children in a timely fashion; the monitoring of maternal and child health must emphasize data on population subgroups, i.e., minorities, the poor and those hardest hit by recession; the health of poor children is adversely affected and their numbers dramatically increased during the recession of 1981-82; and comparisons between the recession of 1974-75 and that of 1981-82 suggest that expansion of health services and social support systems during the recession of 1974-75 had a cushioning effect that protected the health of children, while the curtailment of many of these programs during the 1981-82 recession is associated with adverse health trends, especially among the most vulnerable population subgroups. Data on these issues are appreciably better now than they were nine months ago, thus further validating the points made above. As with the previous report, officially released current data are abundant for economic indicators (even for early 1984), but are sparse for health status indicators. The previous report also observed that the health status of children is influenced by interdependent and interlocking factors that include economic well-being and access to health services and social supports. A new analysis attempts to unlock those relationships and measure the impact of lost welfare benefits, implemented as a result of the Omnibus Reconciliation Act of 1981 (OBRA), and the separate impact of the serious recession of 1981-82. That analysis shows the poverty rate for children increased by 7.6 percentage points between 1981 and 1982. Approximately 60 percent of the increase is attributable to the recession and 40 percent to social policy changes effected after 1981.

Child↗

The role of human rights and personal dignity in the rehabilitation of chronic psychiatric patients. A rural therapeutic community in Yanbian, Jilin.

In 1983 the branch hospital of the Yanbian Community Psychiatric Hospital, a rural residential centre for 120 chronic psychiatric patients who have no means of financial support, adopted a new treatment philosophy that emphasised psychosocial rehabilitation and made the protection of patients' human rights and respect for their personal dignity the central organising principles for the hospital's treatment programme. From being a boarding facility for chronic psychiatric patients, the hospital became a thriving community. Comparison of the status of the 81 continuously resident schizophrenic patients before and after the policy change showed that (a) the proportion who actively participated in agricultural labour increased from 10% in 1982 to 38% in 1990; (b) the proportion who worked at non-agricultural jobs increased from 7% in 1982 to 22% in 1990; and (c) their mean yearly income increased from 1.67 Rmb in 1982 to 246.70 Rmb in 1990. Moreover, the number of successful suicides among all the patients in the hospital dropped from 13 in 1975-1982 to 1 in 1983-1990. We conclude that the success of psychiatric rehabilitation programmes depends on the extent to which they address the core issues of personal dignity and basic human rights.

China↗

Assessing the potential of wastewater-based epidemiology to evaluate the impact of COVID-19 policy changes on stimulant use across 17 countries.

BACKGROUND AND AIMS: A limited number of studies have employed wastewater-based epidemiology (WBE) to assess the impact of specific COVID-19 public health directives on stimulant consumption. This study investigates the potential of WBE as a complementary information source to support decision-making, by examining drug use changes during the pandemic. METHODS: WBE data on stimulant use from 2019 through 2022 was obtained from 17 countries covering a total of 47 wastewater treatment plants worldwide. The Oxford Coronavirus Government Response Tracker stringency index was used to standardize the severity of the COVID-19 interventions across different countries. A multiple linear regression model was fitted for the population-normalized mass loads of amphetamine, cocaine (through its metabolite benzoylecgonine), MDMA, and methamphetamine to investigate whether changes in COVID-19 restrictions influenced stimulant use, controlling for possible week-weekend and spatial effects. RESULTS: In most locations, WBE suggests that stimulant use was not significantly affected by the COVID-19 interventions, or even increased under the stricter measures. Methamphetamine use showed the largest decrease with increasing policy stringency, with a negative linear relationship found in 19% of cities, followed by MDMA (18%), cocaine (15%) and amphetamine (6%). Social gathering restrictions mainly impacted cocaine and MDMA use, while methamphetamine consumption declined most under stringent travel restrictions. CONCLUSIONS: This study highlights the heterogeneous effects of the COVID-19 policy changes on stimulant use, even within countries. The ability of WBE to compile consecutive daily estimates proves to be particularly useful to assess the direct effect of specific policy changes on the consumption of different stimulants.

COVID-19 interventions↗

Differences in hospital resource allocation among sick newborns according to insurance coverage.

OBJECTIVE: To assess whether newborns' insurance coverage was associated with differences in the allocation of hospital services. DESIGN: Retrospective analysis of computerized hospital discharge data, comparing resource allocation among newborns according to insurance status, controlling for race/ethnicity, diagnoses, hospital characteristics (ownership, teaching status, nursery level), and disposition. SETTING: All California civilian acute-care hospitals. PATIENTS: Population-based sample, excluding out-of-hospital and military hospital births. Resource allocation was studied among all newborns discharged in 1987 with evidence of serious problems (N = 29,751). MAIN OUTCOME MEASURES: Length of stay, total charges, and charges per day. RESULTS: Sick newborns without insurance received fewer inpatient services than comparable privately insured newborns with either indemnity or prepaid coverage. This pattern was observed across all hospital ownership types. Mean stay was 15.7 days for all privately insured newborns (15.6 days for those with indemnity and 15.7 days for those with prepaid coverage), 14.8 days for Medicaid-covered newborns, and 13.2 days for uninsured newborns (P less than .001). Length of stay, total charges, and charges per day were 16%, 28%, and 10% less, respectively, for the uninsured than for all privately insured newborns (P less than .001). Resources for newborns covered by Medicaid were generally greater than for the uninsured and less than for the privately insured. Both uninsured and Medicaid-covered newborns were found to have more severe medical problems than the privately insured. CONCLUSIONS: The findings cannot be explained by differences in medical need or by differences in non-medically indicated services; they constitute prima facie evidence of inequities that need to be addressed by policy changes.

California↗

Theory of psychiatric treatment systems. An approach.

A theory of psychiatric treatment systems may be approached using stochastic probability models. Theory construction proceeds in six stages corresponding to broad assumptions about the causal relationships among variables affecting the life course and treatment encounters of members of a target population. The theory is progressively refined to describe short-term life changes, longer-term life-course modifiers, predictors of treatment utilization, treatment system policies, and treatment effects. The ultimate aim is to forecast the effects of policy change.

Health Policy↗

Community health centers and the elderly: a potential new alliance.

Community health centers (CHCs) are experiencing the effects of federal policy changes that are promoting an autonomous existence for many agencies. These policy shifts also challenge the original structure and mission of CHCs to serve underserved and/or low-income clientele. CHCs now need not only a stable clientele, but also a reimburseable clientele. Both of these criteria can be met by the elderly population with Medicare coverage. The needs of the CHCs are balanced by the growing needs of the elderly who are using CHCs more, according to the authors' research in 32 communities across the country. The most dramatic increases in CHC clientele between 1983 and 1984 was in the 75 years and older categories. This article reviews the factors underlying CHCs strategic advantage in expanding services to the elderly, the evolution of federal policy toward CHCs, and their response to the current policy environment. The discussion is based on findings from studies conducted between 1982 and 1985.

Aged↗

The age extremes for reproduction: current implications for policy change.

The changing demographic features of births in the United States include an increasing number of older women and a decreasing number of adolescents giving birth. Births in adolescents have lower risks than those in women more than 34 years of age and probably of those more than 30 years of age. There is an increase in complicated pregnancies in the United States, related, no doubt in part, to the above. Older women require more costly, high-technology prenatal care, such as genetic counseling, genetic antenatal diagnosis, amniocentesis, ultrasonography, and electronic fetal heart rate testing. The financing of health care needs to recognize these changes. Detailed studies of the economics of perinatal care, more specific to patient population mix and complication-treatment patterns are needed to establish priorities with the payment system to assure appropriate care.

Adolescent↗

Bayesian comparison of cost-effectiveness of different clinical approaches to diagnose coronary artery disease.

The objective of this study was to compare the cost-effectiveness of four clinical policies (policies I to IV) in the diagnosis of the presence or absence of coronary artery disease. A model based on Bayes' theorem and published clinical data was constructed to make these comparisons. Effectiveness was defined as either the number of patients with coronary disease diagnosed or as the number of quality-adjusted life years extended by therapy after the diagnosis of coronary disease. The following conclusions arise strictly from analysis of the model and may not necessarily be applicable to all situations. As prevalence of coronary disease in the population increased, it caused a linear increase in cost per patient tested, but a hyperbolic decrease in cost per effect, that is, increased cost-effectiveness. Thus, cost-effectiveness of all policies (I to IV) was poor in populations with a prevalence of disease below 10%, for example, asymptomatic people with no risk factors. Analysis of the model also indicates that at prevalences less than 80%, exercise thallium scintigraphy alone as a first test (policy II) is a more cost-effective initial test than is exercise electrocardiography alone as a first test (policy I) or exercise electrocardiography first combined with thallium imaging as a second test (policy IV). Exercise electrocardiography before thallium imaging (policy IV) is more cost-effective than exercise electrocardiography alone (policy I) at prevalences less than 80%. 4) Noninvasive exercise testing before angiography (policies I, II and IV) is more cost-effective than using coronary angiography as the first and only test (policy III) at prevalences less than 80%. 5) Above a threshold value of prevalence of 80% (for example patients with typical angina), proceeding to angiography as the first test (policy III) was more cost-effective than initial noninvasive exercise tests (policies I, II and IV). One advantage of this quantitative model is that it estimates a threshold value of prevalence (80%) at which the rank order of policies changes. The model also allows substitution of different values for any variable as a way of accounting for the uncertainty inherent in the data. In conclusion, it is essential to consider the prevalence of disease when selecting the most cost-effective clinical approach to making a diagnosis.

Angiography↗

The relationship between alcohol consumption and social status in Stockholm. Has the social pattern of alcohol consumption changed?

Data from the Stockholm Health of the Population Study in 1984 (n = 6217) show small differences in mean alcohol consumption and in the prevalence of high consumers in various socioeconomic and educational categories of both sexes. Among young people mean consumption was higher in those who had low formal education, equal to 18.8 g 100% ethanol among men aged 18-24 years and 5.9 g for those with public elementary school education, while the corresponding figures for young women were 16.7 and 1.8 g respectively. Those reporting a high alcohol consumption (greater than or equal to 35 g 100% ethanol/day among men and greater than or equal to 25 g among women) had a relative risk over 7 of having been inpatients with alcohol-related diseases during 1980-1984. Our results, together with other recent Swedish survey data, indicate a change in the socioeconomic distribution of alcohol consumption over time. This change is analysed in relation to Swedish alcohol policy, changes in various socioeconomic categories, and the increase in information about alcohol.

Adolescent↗

Geriatric dentistry and prevention: research and public policy.

Changing demographics, including the increase in life expectancy and the growing numbers of elderly, has focused attention on the need for dental research activities to be expanded for geriatric dentistry. The elderly are at greater risk for oral disease, since gains in longevity result in more medically compromising conditions or systemic disease with oral manifestations. Also, as edentulism decreases and as more teeth are retained by the elderly, the pattern of oral diseases and the treatment of dental conditions will be altered. Barriers to self-care and professional care must be removed, and prevention and early intervention strategies must be formulated to reduce the risk of oral disease. Risk factors for oral diseases in the elderly can be reduced by personal home-care regimens, professionally provided preventive, diagnostic, and therapeutic care, changes in high-risk behavior, and a supportive environment. Generating new information about the prevention of oral diseases and conditions that have an impact on the elderly requires a substantial research effort. A research agenda for the elderly should include: epidemiologic studies of relevant oral diseases and related risk factors; investigations of patient and provider attitudes and behavior related to oral health; studies of the relationship between general health and oral health; development and testing of preventive and treatment strategies for conditions such as xerostomia, root caries, secondary caries, and gingival recession; and studies for the evaluation of the impact of the aging population on the dental delivery system. Public policy options to support geriatric oral health care and research are limited by the Government's pre-occupation with cost containment and the lack of visibility for dental programs.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

The women's movement and older women's health: issues and policy implications.

Since women are an increasing proportion of the older population, the health issues that affect older Americans must be regarded in large part as women's issues. Women experience aging differently from men. The advantage in life expectancy of women over men is not always a boon. Older women have substantially lower incomes and higher poverty rates, are more likely to be widowed and living alone, and depend more on entitlement and social service programs. This paper traces the evolution of the women's movement and identifies some of the health care problems of older women in terms of psychological, socio-cultural, and economic factors. The role of the medical establishment and federal regulations that affect older women are examined. The White House Conference on Aging (1981) is seen as a prelude to the current policies of the Administration that affect older women. Necessary policy changes on the Federal and local levels are discussed as well as the need for redirection in the women's health movement.

Aged↗

Fertility intentions and subsequent behavior: a longitudinal study in rural India.

This report compares fertility and family planning intentions of rural Indian women in 1975 with actual outcomes in 1987. Ninety-four of 103 respondents who had fewer children than they wanted in 1975 and had stated definite intentions with respect to future fertility and contraceptive use were reinterviewed in 1987. Overall, women had fewer children than desired and stopped childbearing when they reached or closely approximated their ideal number of sons. Since sons were clearly the determinant of "reproductive success," it is argued that only a significant change in the status of rural women can bring about widespread compliance with the official family planning program's two-child norm.

Adolescent↗

The assessment of health policy changes using the time-reversed crossover design.

The time-reversed crossover design is a quasi-experimental design which can be applied to evaluate the impact of a change in health policy on a large population. This design makes use of separate sampling and analysis strategies to improve the validity of conclusions drawn from such an evaluation. The properties of the time-reversed crossover design are presented including the use of stratification on outcome in the sampling stage, which is intended to improve external validity. It is demonstrated that, although this feature of the design introduces internal validity threats due to regression toward the mean in extreme-outcome strata, these effects can be measured and eliminated from the test of significance of treatment effects. Methods for within- and across-stratum estimation and hypothesis-testing are presented which are similar to those which have been developed for the traditional two-period crossover design widely used in clinical trials. The procedures are illustrated using data derived from a study conducted by the United Mine Workers of America Health and Retirement Funds to measure the impact of cost-sharing on health care utilization among members of its health plan.

Costs and Cost Analysis↗