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Prescription drug products; revocation of patient package insert requirements--Food and Drug Administration. Final rule.

The Food and Drug Administration (FDA) is revoking its final rule establishing requirements for the preparation and distribution of patient package inserts (PPI's) for prescription drug products for human use. This action is taken because the agency has determined that a mandatory pilot PPI program is unjustifiable, and that it is now preferable to encourage alternative patient information efforts. The agency believes that cooperation with health professionals and others in both the public and private sectors and reliance upon expanding privately sponsored initiatives in patient education should serve to provide patients with needed information about prescription drugs.

Drug Labeling↗

Mapping international challenges for managed care.

The author in this presentation discusses the factors which he believes constitute the 5 mega-challenges confronting the global managed care industry; namely: Challenge One: Contest the bogus falsehoods and factual errors about managed care. Challenge Two: Engage the debate on the rightful place of private health care in the global economy. Challenge Three: Make the healthcare industry an integral part of every nation's economic development plan. Challenge Four: Lead the public policy debate on the side of safe, health, peaceful, caring communities. Challenge Five: Join with colleagues from pharmaceutical, medical device and information technology companies to promote a robust private health sector.

Global Health↗

Improving quality of care and use of contraceptives in Senegal.

In the 1990s, the government of Senegal implemented a series of policy changes for the provision of family planning services through the public sector. A strategy to provide high quality services through reference centres was adopted. This paper presents findings from a longitudinal survey of 1,320 Senegalese women who had sought family planning services at ten public sector facilities--five reference centres and five health centres. Information was collected on the quality of care they received at the time they adopted family planning. One thousand one hundred and ten of the respondents were followed up sixteen months later to ascertain their contraceptive status. The first principal finding was that attendees at reference centres reported receiving relative better care than those who attended health centres. On average, clients at reference centres received 4.3 out of five units of care, compared to 3.8 units as reported by health centre clients. Second, multivariate analyses indicated that quality of care received at the time of adopting a contraceptive has a significant influence on subsequent contraceptive use. Those who received good care were 1.3 times more likely to be using a method than others.

Adult↗

[Cortical neuronal connections and reconstruction of visual space].

We investigated distribution of retrograde-labelled cells in cortical areas 17, 18, and the transition zone 17/18 of both hemispheres in cats after microiontophoretic horseradish peroxidase (HRP) injections into the single cortical columns of area 17, 18, 19 or 21a. On the base of clustered pattern of intrinsic labelling, asymmetric location of labelled callosal cells that was associated with the appropriate pattern of labelling in layers A and A1 of lateral geniculate nucleus, we suggest that cortical neuronal connections are eye-specific and may provide for each eye a separate binding of visual hemifields. After HRP injections into columns of area 19 or 21a, the disparate inputs from areas 17, 18 and transition zone 17/18 were revealed. Such connections may provide a local depth information and the selection of stereoscopic surfaces in central sectors of visual space.

Animals↗

Economic aspects of the use of impregnated mosquito nets for malaria control.

The use of pyrethroids to impregnate mosquito nets has had a good impact on the incidence of morbidity and mortality from malaria. These nets are therefore likely to be used on a large scale as an important strategy of malaria control in the future. Published information on the cost and effectiveness of mosquito nets is presented and analysed. In two examples, from Malawi and Cameroon, the per household expenditure to purchase and use impregnated mosquito nets compares favourably with the costs of malaria. Thus, we expect that the economic losses from malaria would be reduced by 37.3% over a 3-year period in Malawi. Even if the impact of malaria on productivity is not taken into account, the introduction of nets will result in gains, as shown in Cameroon; savings of 9.3% and 11.2% in two places resulted as a consequence of a diminished need for case treatment. The role of government programmes in the promotion of bednets is indirect and concerned mainly with facilitation and the dissemination of information. Much depends on the capability of the private sector and the willingness of the target population to buy the nets for a programme to be effective. Specific studies by health economists on this subject are lacking.

Bedding and Linens↗

Environmental information systems in malaria risk mapping and epidemic forecasting.

Every year between one and two million African children under five die of malaria. If one adds to this the contribution of malaria to all-cause infant mortality then clearly the burden of the disease is catastrophic--a disaster quietly happening each and every year. New tools are needed urgently to support those currently available for control of the disease. An effective vaccine remains elusive. This article outlines the potential contribution to malaria control services of satellite information, which is being used by resource managers in other sectors. In particular, it highlights the lessons which can be learned from early warning systems in other areas, especially those designed to respond to famine. An appendix provides a brief introduction to satellite data and their interpretation.

Africa South of the Sahara↗

[Evaluation of health system decentralization and reform of the Social Security system in Colombia].

The aim of this study is to present the results of the reforms in the health sector that have taken place in Colombia since 1990. These reforms replaced the previous national health system and the so-called Bismarkian social security system. The new system has three basic characteristics: a) the public subsidies are decentralized in the municipalities and territorial departments; b) the public hospitals have been converted into state social enterprises, which has led them towards a management model, and c) the health and social security system monopoly has been abolished and a system of health subsidies has been created for the poorest citizens. This article systematically collects secondary information extracted from the most important studies evaluating the health sector reforms in Colombia. The present author participated in some of these studies. The reforms have increased financial resources, which, has led to an increase in public system staff and their salaries. The availability of hospitals' budgetary resources has increased and the social security system has become wider, including 20% of the poorest population who have benefited from subsidies on demand. Ease of access and equity in the health system have significantly improved. However, indicators of public health have fallen and health professionals are critical of a system based on mediation, which increases transaction costs.

Colombia↗

The private-public divide: impact of conflicting perceptions between the private and public health care sectors in India.

SETTING: India's private health care sector manages half the nation's tuberculosis (TB) patients, accounting for an estimated sixth of global TB cases. While several studies have demonstrated private physicians' dubious diagnosis and treatment styles and lack of cooperation with public physicians, very little is still known about the private sector. OBJECTIVES: Using a detailed questionnaire to randomly survey private and public practitioners in Ahmedebad, Gujarat, India, we quantified perceptions held by each sector. STUDY DESIGN: Cross-sectional survey of private and public physicians. RESULTS: Significant conflicts in perception were found regarding interpretation of general facts, attitudes towards each sector, and effectiveness and social implications of DOTS. We also found that such differences in perception were likely to result in mistrust, differing views on reform propositions, conflicting mindsets about social agendas, and unwillingness to cooperate. CONCLUSION: Our data suggest that reconciliation is attainable by obtaining and distributing unbiased, evidence-based information and exposing physicians to both private and public health care sectors in a professional setting.

Attitude of Health Personnel↗

Are you ready for the year 2000?

The new millennium will bring information systems challenges that have broad implications for health plans. Experts offer advice for assessing and preparing core information systems.

California↗

Sex offender treatment and legislation.

The current issue of the Journal contains three articles related to sex offenders. The first, by Scott and Holmberg, discusses legislation that mandates either "chemical or surgical castration." The second, by Saleh and Guidry, reviews diagnostic and treatment considerations. The third, by Scott and Gerbasi, discusses sex offender registration and community notification. Much of the relevant sex offender legislation, including that pertaining to testosterone-lowering treatments, has been enacted in response to intense public passion. When it comes to the issue of sex offenders, there is a pressing need to develop a coherent body of evidence-based forensic concepts and knowledge that can rationally inform both clinical practice and future public policy. That may require a closer collaboration between both the criminal justice and legislative sectors, and the scientific-medical communities. The three papers published in this issue provide useful information that may assist toward such a goal.

Androgen Antagonists↗

Managing environmental uncertainty: an analysis of executive behavior in the health and social service sector.

Executives who are involved in a variety of professional associations may be in a more favorable position to manage environmental uncertainty because of their ability to access information through the informal network. This study examined the professional involvement of 116 executives in the health and social service sector and found that leadership status within a professional association influenced contractual agreements between executives and a regional area agency on aging.

Administrative Personnel↗

['Public health status and perspectives' 1997. VII. Health care needs and health care consumption].

In the 'Public health status and forecasts' 1997 attention is given to the relationship between health status and health care. The theme report 'Health care need and health care consumption' integrates information about both phenomena and about waiting lists in the different sectors of health care. It is difficult to quantify the need for health care, because statements about need always imply a judgment by parties involved. In the literature need for health care is often operationalized by historical data on health care consumption or by health status indicators. At the national level only limited quantitative information is available to support policy on waiting lists and waiting times. The data are seldom disease-specific. Changes in size and distribution (by age and sex) of the population will increase health care cost over the period 1994-2015 in the Netherlands by 0.9-1.0% per year. More detailed demographic projections, however, indicate that there are large disease-specific differences.

Age Distribution↗

Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.

Attitude of Health Personnel↗

Knowledge management prerequisites for building an information society in healthcare.

The European Research Area requires either technological development or information literacy of health professionals. This information literacy shall be understood much deeper and broader than a basic preparation to use ICT tools in everyday life only. The author's first aim is to present the literature review and analysis of different definition of the "information" concept in Polish and foreign sources for health sciences, to emphasize a problem fundamental for an information society development, i.e. lack of adequate "information" understanding. Health professionals' information literacy shall also build an awareness of conceptual differences among numerous classifications, thesauruses, and information-retrieval languages, which result in different information received in a retrieval process. This problem can be of crucial effect for either health research or practice. Understanding the problem shall mobilize the researchers, classifiers, and indexers to co-ordinate efforts aimed in organizing "a translator" covering the most popular classifications' and thesauruses' concepts, to make an international research co-operation easier, relevant, and safe for the patients.

Artificial Intelligence↗

[AHP analysis of activities expected of public health nurses at a public health center].

The activities expected of Public Health Nurses (PHN) at a Public Health Center (PHC) were evaluated by the AHP technique based on the results of a Focus Group Discussion among 7 PHNs working in K PHC, Fukuoka. Among the five PHN activities, "Collection and analysis of information" was evaluated as the most important, followed by "Consultation", "Coordination of different sectors", "Control and support of patients with chronic diseases", and "Health education for the public". However, the investigated PHNs concluded that their knowledge of and skill in doing "Collection and analysis of information" are insufficient. It is therefore recommended that continuous training courses on statistics and epidemiology be organized for the PHNs.

Decision Making↗

[The medical records of home health care patients: a complement or alternative to an electronic file?].

Home health care services for dependant people involve participation and interventions of professionals from the health care, medico-social and social sectors. In order to ensure quality care, the flow of information must appropriately circulate between all of the various care providers. The establishment of an electronic medical file for these patients is a possible solution which has been proposed to be conducted in next years. A paper medical record is the property of the patient and offers the possibility of an alternative and complementary solution. The electronic file would use the existing available file as a starting point, and without any additional organisational structures being implicated, it allows for better coordination of the health, medical and social activities. An experimental implementation of this in the Franch-Comte region of France demonstrated the advantages and benefits of such a tool based on a logic centered upon the individual and the open sharing of practices between professionals in the medical and social sectors.

Continuity of Patient Care↗

Usability: a critical success factor for managing change in the clinical info-structure.

There can be no doubt that the clinical info-structure is being significantly enriched with the deployment of new systems throughout the health sector. From a technological perspective, the initial emphasis has been mainly on functionality and only latterly on the usability of these clinical information systems. However, the large scale and rapid pace of the changes being wrought in the health sector will have a major impact on clinicians and patients, not least in how they interact with the technology. Therefore, it is not only hardware and software but people-ware, too, that needs to be actively managed; not simply a one-off functional specification but an ongoing, complex relationship. Usability is the human factor that encompasses the ethical, educational, and evaluative aspects of design. There is also a strong case for regarding usability of clinical information systems as a key critical success factor for the management of change within the health-care domain. In particular, the relationship between usability, and education and training is examined.

Information Systems↗

Chemoarchitectonics of axonal and perikaryal acetylcholinesterase along information processing systems of the human cerebral cortex.

The distribution of axonal and perikaryal acetylcholinesterase (AChE) was studied in whole-brain sections. All cytoarchitectonic sectors and cortical layers of the human cerebral cortex contained AChE-rich axons. These axons displayed multiple varicosities which appeared to come in contact with AChE-rich and AChE-poor cortical perikarya. The upper layers of cortex tended to contain the highest density of AChE-rich axons. The AChE-rich axons were more dense in limbic-paralimbic areas of cortex than in primary sensory-motor and association areas. Within unimodal sensory association areas, the parasensory (upstream) sectors had a slightly lesser density of AChE-rich axons than the downstream sectors. Within paralimbic areas, the nonisocortical sectors displayed a distinctly higher density of AChE-rich axons than the more differentiated isocortical sectors. These observations indicate that the distribution of AChE-rich axons displays orderly variations that obey the organization of information processing systems in the cerebral cortex.

Acetylcholinesterase↗