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PubMed2001

Ethics and immunization policy: promoting dialogue to sustain consensus.

The societal consensus that has supported the United States' universal childhood immunization programs for the past 50 years shows signs of eroding. This article proposes a systematic approach to evaluate immunization policy options. Through a unifying framework that combines epidemiologic, economic, and ethical concerns, this approach promotes a clearer understanding of underlying issues and inherent tradeoffs between alternative policies. Such a systematic examination of policy options could facilitate the public dialogue necessary to continually recreate a broad consensus on immunization practices and enable us to choose policies most in accord with our fundamental values.

Ethics, Medical↗

PubMed1988

Family planning measures, February 1988.

In early 1988, family planning (FP) measures were announced by Mr. Liang Jimin, spokesman for the Chinese State FP Commission. The major points of the measures include: 1) stressing the leading role of the recent reform in general, 2) stabilizing FP policies, and 3) strengthening the organizational frameworks at the grassroots level and improving program performance in backward regions. The policies were explained in detail as follows: "1) to introduce a 'FP contract responsibility system' throughout the country, in order to guarantee the fulfillment of government targets of population plans, such as contracts between governments at different levels, contracts between local government and FP departments; 2) to include the performance of local FP programs as one of the criteria for evaluating the achievements of government officials at various levels, such as relevant provisions in officials' term contracts; 3) to sign FP contracts between couples at reproductive ages and local governments, such as local governments responsible for allocating birth quotas, providing contraceptive equipment and services, and paying incentives and subsidies; the couples would be responsible for using contraceptives and planning births; 4) to improve social security schemes with respect to FP, such as old-age pensions for couples with one child who have undertaken sterilization, only-child life insurance, and contraceptive operation insurance; 5) to increase the proportion of only children among all births and strictly control the quota of authorized second-births in rural areas; 6) to improve education and FP services by relying on community FP associations or "Key Households of FP", to help increase the use rate and reduce the failure rate of contraceptives, increase the quality of contraceptive operations, and reduce the incidence of induced abortion; 7) to adopt measures to eliminate early marriage and early reproduction and introduce population education in middle schools; 8) to enact new laws and regulations, such as 'regulations concerning FP administration at the grassroots level units' and 'regulations concerning FP administration of the highly mobile population'; 9) to increase international exchange and cooperation and import advanced technology and equipment for contraception."

Adult↗

PubMed2003

A building an education infrastructure for allied health.

This article discusses the emerging education information infrastructure. It uses a five-part framework (aggregating, organizing, using, tool building, and policy making) to describe this infrastructure, then uses the same framework to argue for a tightly coupled education information infrastructure specifically for allied health. This tightly coupled education resource would allow educators, allied health professionals, and the general public to gain improved access to education resources on the Internet through metadata and digital reference services. Specific benefits of the building effort are discussed.

Allied Health Occupations↗

PubMed2005

Health care reform in Portugal: an evaluation of the NHS experience.

Since 1979, the Portuguese health care system has been based on a National Health Service structure that is expected to promote equity, efficiency, quality, accountability and the devolution of power. In this article, we analyse the content and impact of policies designed to reform the system between 1979 and 2002. This article differs from previous studies in that it uses a stage-based framework to evaluate the policy-making process and the impact of health care reform throughout different political cycles. We show that the NHS model has never been fully implemented and that many policies have diverted the system from its original objectives. Different governments have endorsed a progressive split between financing and provision and the institution of 'new public management' rules in public providers. We conclude that most policies put forward by Social Democratic governments have aimed at influencing demand, while Socialist governments have targeted the supply side. These policies have led to increases in health expenditure that have been comparatively more cost-shared by the State under Socialist governments. We show some overriding trends, namely as follows: despite huge improvements in health outcomes, the system is nonetheless lasting to meet its goals, particularly in terms of the equity of access and utilisation; accountability problems, inadequacies in the use of operational reforming tools (such as resource allocation mechanisms) and a lack of mechanisms to promote efficient behaviour, are all associated with cost containment problems. Structural reforms have been undertaken since 2002 and these have offered some potential for improving accountability and efficiency. Nonetheless, the success of these reforms calls for certain conditions that do not seem to have been fulfilled.

Financial Management↗

PubMed1983

Product selection, bioequivalence, and therapeutic equivalence: the generic drug market.

Pharmacists are continually faced with drug product selection decisions. When is a generic drug product equivalent to the innovator product and, thus, a suitable candidate for generic substitution? The FDA policy has been that only drug products that are therapeutic equivalents are candidates for product selection decisions. This paper outlines the regulatory and scientific framework for the FDA's policies and requirements for generic drug products. The history and current status of the Drug Efficacy Study Implementation (DESI) project is described. Originally begun in 1966 as a review of about 3,400 drug products, the review in mid-1983 is more than 90% complete, but its impact has already affected more than 7,000 marketed drug products. The therapeutic equivalence policy and the manner in which decisions on therapeutic equivalence are communicated are reviewed. Regulatory policies for the approval of generic drug products are reviewed and specific litigation challenging the rights of generic drug manufacturers to produce generic "look-alikes" and challenging the FDA's policy that a generic drug product is a new drug requiring an approved New Drug Application for marketing is discussed. The conclusion reached is that the evaluation of regulatory requirements and science is leading to a point where all generic drug products will be known to be safe, effective and therapeutically equivalent, and pharmacists can be optimistic about the quality of products in the generic drug market.

Legislation, Pharmacy↗

PubMed2005

Improving the governance of health research.

Australia has so far been spared serious mishaps in health research, but rising pressures on researchers, deemed to have contributed to two deaths of research participants in the United States, clearly also exist in Australia. Health research investment in our institutions is large and represents an often overlooked area of risk by boards of management. Research governance (the framework through which institutions are ultimately accountable for the scientific quality, ethical acceptability and safety of research conducted in the institutions) has not received sufficient attention. An adequate governance framework requires institutions to have policies and procedures in place to meet national ethical, legal and research practice standards. We suggest that many institutions presently do not have such frameworks in place and inappropriately rely too heavily on human research ethics committees. To ensure ongoing adequate protection of research participants, we recommend some simple improvements for research governance and suggest ways by which institutions can demonstrate adherence to agreed national standards.

Advisory Committees↗

PubMed1995

A cost-effectiveness analysis of cervical cancer screening: health policy implications.

This paper presents a framework for comparison of screening programme designs, based on efficiency and cost effectiveness criteria. The design parameters, such as choice of screening interval, which population segments to screen and expected participation rates in the selected population segments, are varied simultaneously. The costs and effects for a range of existing and hypothetical screening programmes against cervical cancer are estimated, using a mathematical simulation model. On the basis of these estimates average costs per life year and marginal costs per life year are calculated for a range of programmes. These calculations result in the definition of a range of inefficient programmes. Moreover, it is illustrated that the cost effectiveness of the efficient screening programmes decreases at an increasing rate as programmes are intensified either by way of shortening the screening interval or extending the target population segment to encompass the very young and/or the very old. The conclusion of this paper is that one should probably not extend screening programmes against cervical cancer beyond screening women in the age group 25-59 years every 4 years. In addition, increasing the participation rate of this group is a more cost effective way of increasing the number of life years gained, rather than extending the target group or decreasing the screening interval.

Adult↗

PubMed2002

Development of guidelines for non-indigenous people undertaking research among the indigenous population of north-east Victoria.

The Department of Rural Health, University of Melbourne, has developed a framework for conducting research in partnership with Indigenous communities. The framework addresses past inappropriate research practices, incorporates cultural understandings, and outlines culturally appropriate protocols. The four parts of the framework are a committee to initiate, direct and oversee all research projects; a Koorie Team to guide research; a set of research guidelines; and a policy for the department. The framework has been used to develop strong relations with Koorie communities and conduct various health projects.

Ethics, Clinical↗

PubMed1997

Project 2000: a new preparation for practice--has policy been realized? Part I.

Project 2000 was established in the UK in 1984. The project report, published 2 years later, embraced the whole of the educational system for nursing, midwifery and health visiting. It is useful, 10 years on, to note what actually happened in what became an enormous undertaking and the biggest ever change in nursing, midwifery and health visiting training. But how well were policy formulation and implementation planned? Has the policy process been successful? What are the outcomes to date? This policy review chronicles policy initiation and formulation, decisions within the political system and policy outputs, implementation and outcomes in the context of the environment, using a combination of two policy models as the guiding framework. The focus is on implementation in England. The extent to which the original proposals in the project report have been realized is identified, together with policy changes and additions which occurred during the policy process. This macro-review of the whole of the policy process avoids the common faults of separating policy initiation from its implementation, or policy content from policy process. The record will enable past actions and events to be taken into account in the context of future plans for the 21st century.

Decision Making, Organizational↗

PubMed1993

Future pharmacists and public initiatives to control retail drug prices: a political economy framework.

While pressures mount for public policy makers to intercede in the pricing structure of pharmaceutical products, most pharmacists remain reluctant to substitute generic equivalents for branded drugs. This study suggests that pharmacist' aversion to external factors embedded in their channel environments. An adaption of the political economy paradigm reflects the complexity of the pharmaceutical channel relationships.

Attitude of Health Personnel↗

PubMed1999

The value of an evaluation framework for telehealth initiatives.

Healthcare managers and policy makers will, in the immediate and near future, make major decisions about the allocation of scarce healthcare resources for telehealth 'solutions'. In our haste to capitalize on what technology can do we may be obscuring discussion and research about what technology should do. For example, currently much attention is being paid to standardization for technological aspects of telehealth. In contrast few efforts have been made to seek standardization in regards to a broad evaluation framework for telehealth. A body of opinion believes that missing in our rush into the on-line world is a systematic approach to research into the human, social, cultural, economic, and political factors associated with healthcare. As a result we lack the tools and experience necessary to assess the true value and implications of telehealth 'solutions'. Developing general guidelines for an evaluation framework, from needs assessment through integrated research to post-study assessment, would greatly enhance the quality of decision making by healthcare managers and policy makers. We propose a model--the Telehealth Integrated Research Model (TIRM)--as the first step in encouraging discussion and development of an internationally accepted standardized telehealth evaluation framework.

Data Collection↗

PubMed2005

Treating children like people: a framework for research and advocacy.

Issues in child policy are often obscured by symbolic debates about the nature of child development and family life. There is a need for greater care in the identification of the interests at stake and articulation of the normative foundation for various policies and programs. The Convention on the Rights of the Child carries an implicit rights-focused agenda for social science research. Building on that agenda, this article presents topics that should be examined more closely by psychologists, and it also provides rights-grounded principles for design, conduct, analysis, and reporting of research. Although rights talk, especially the vocabulary of children's rights, is controversial, thoughtful application of such a framework leads to consensual adoption of policies and programs that are both more rational and more humane.

Biomedical Research↗

PubMed2004

Why research in family medicine? A superfluous question.

The ultimate answer to the question, "Why research in family medicine?" is to provide better care for our patients. Through research we want to improve quality of primary care by improving our understanding and practice of it. This research will inevitably be specific for family medicine as family medicine is a specific discipline. In this article we first explore what makes family medicine a specific discipline. In a second part we present a framework to grasp the various research questions that must be answered to achieve the complex and multifaceted goal of improving quality of care. Family medicine is a specific discipline for 3 reasons: it has a unique epidemiology, the context of care is important, and it has a strong link and responsibility to the community. Quality of care is a complex and multidimensional concept that raises diverse research questions. We propose to map these questions within a framework defined by the 3 dimensions of the Donabedian triangle--structure, process, and outcome-and within each of these dimensions by 5 foci-basic knowledge, diagnostic and therapeutic problem solving, practice implementation, policy context, and education. This framework may help to make the various research questions operational and to point out the gaps in our research. The questions and answers should be relevant to daily practice and comprise all domains of family medicine so that eventually most of our daily actions in practice will be underpinned with medical, contextual, and policy evidence and contribute to the improvement of the quality of care.

Biomedical Research↗

PubMed1989

Public opinion, public policy, and HIV infection.

An analysis of the interplay between public opinion and public policy in terms of HIV infection yielded a four-stage framework for considering the development of public policy in relation to a highly charged issue. The phases are denial, irrationality, acceptance, and the development of a rational response. As we move into Phase 4 in relation to HIV infection, we should take a lesson from the history of the development of public policy for persons with disabilities and promote strong federal leadership and a federal antidiscrimination policy that includes persons with HIV infection as a part of the group of persons with disabilities.

HIV Infections↗

PubMed1984

The political and administrative context of primary health care in the Third World.

Despite increasing knowledge about technical aspects of Primary Health Care (PHC), there has been as yet only limited research into political and administrative influences on the effectiveness of PHC programs. A three-stage model of the policy process is developed as a framework for organizing the relationships between elements of (1) the national political setting and PHC policy formulation; (2) the implementing agency and program administration; and (3) the community setting and service delivery. Drawing upon the literature on PHC and related programs, hypotheses are proposed for each of these stages as a basis for future study and practical application. Possible output indicators are suggested for each stage of the model. Several basic methodological issues must be addressed in the design of empirical research on political-administrative factors, including variable selection, identification of data sources, and choice of analytical approach. It is hoped that this review will encourage more systematic investigation in this area.

Community Health Services↗

PubMed1995

From paradigms lost to paradigms regained? The MILTON approach to health care reform.

Proposes the MILTON model of health care policy and management as a framework within which debates about the future reform of the UK National Health Service may be conducted. Reviews the economic, political, social and technological forces which have shaped health care policy and management. Suggests that, at the macrolevel, the paradigm has changed from one based on assessment of needs to one based on securing value for money. At the microlevel, there have been equally profound changes in the nature and availability of work. A theme common to both levels is that of rapid and continuous change. Claims the MILTON model offers a way for the protagonists in the health care debate to locate their arguments about policies of health care provision and the implications for the management of work in a changing world in four planes of the model. The benefits are that the differing positions may be seen more clearly and, arguably more important, that a wider range of options is appreciated when, all too often in the past, arguments have become polarized on a single plane.

Decision Making, Organizational↗

PubMed1996

Assessing alternative drug control regimes.

The debate over alternative regimes for currently illicit psychoactive substances focuses on polar alternatives: harsh prohibition and sweeping legalization. This study presents an array of alternatives that lies between these extremes. The current debate lacks an explicit and inclusive framework for making comparative judgments. In this study, we sketch out such a framework, as a reminder of possible policy levers and their costs and benefits that might otherwise be neglected or go unrecognized. The framework identifies a range of pharmacological and economic characteristics of substances, potential harms and their bearers, and the sources of those harms, including drug use, trafficking, law enforcement, and illegal status per se. The framework highlights the difficulty of making objective, rigorous comparisons among regimes, but we believe that it can serve a useful heuristic role in promoting more constructive debate and identifying fruitful questions for research.

Drug and Narcotic Control↗

PubMed2003

Comparative risk and policy analysis in environmental health.

There is increasing interest in the integration of quantitative risk analysis with benefit-cost and cost-effectiveness methods to evaluate environmental health policy making and perform comparative analyses. However, the combined use of these methods has revealed deficiencies in the available methods, and the lack of useful analytical frameworks currently constrains the utility of comparative risk and policy analyses. A principal issue in integrating risk and economic analysis is the lack of common performance metrics, particularly when conducting comparative analyses of regulations with disparate health endpoints (e.g., cancer and noncancer effects or risk-benefit analysis) and quantitative estimation of cumulative risk, whether from exposure to single agents with multiple health impacts or from exposure to mixtures. We propose a general quantitative framework and examine assumptions required for performing analyses of health risks and policies. We review existing and proposed risk and health-impact metrics for evaluating policies designed to protect public health from environmental exposures, and identify their strengths and weaknesses with respect to their use in a general comparative risk and policy analysis framework. Case studies are presented to demonstrate applications of this framework with risk-benefit and air pollution risk analyses. Through this analysis, we hope to generate discussions regarding the data requirements, analytical approaches, and assumptions required for general models to be used in comparative risk and policy analysis.

Air Pollution↗