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PubMed1998

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Consumer Product Safety↗
PubMed1999

Commentary: issues and perspectives affecting CRNA practice. Regulation of health professionals, Part 1: Telepractice.

Although the requirement to protect the public welfare and safety is a right guaranteed to the states by the US Constitution's 10th amendment, which grants states the "police powers" of government, it is not an absolute power. The Commerce clause of the Constitution limits the power of states in creating barriers to intrastate commerce. Changes in the health care delivery system of the US, such as the use of corporate models such as managed care entities and health maintenance organizations, as well as health insurers' development of utilization reviews before approval of reimbursable procedures in individual cases, has prompted concerns with regard to the care of patients occurring outside the state in which the patient resides, by health care professionals not licensed in that state. Many states have considered such decision making an "unauthorized practice of medicine, or other practice" creating the necessity for some providers to obtain an many as 20 licenses to cover their practice. The practice of telemedicine (or telenursing or telehealth) falls into this quagmire, and thus efforts are ongoing to try to find ways to permit such practices while maintaining quality control, with or without additional state licenses.

Humans↗
PubMed1999

Healthcare @ the speed of thought.

It is daunting to realize that we have just touched the surface of health-related Internet web sites. The use of the Internet as a vital patient care tool is a very real prospect on the near horizon. Yet most hospital systems and physicians groups today just use the Net to post "billboards.'' In the rest of America, the Internet has been much more than a billboard. It has changed the way business is conducted. There's e-mail. There's e-trading for those who invest. On mother's day moms receive e-cards, and there is e-commerce which includes buying and selling online, and also collecting and organizing data that will help a business serve customers better, building that relationship. The Internet is a transaction tool. The latest survey indicates that the volume of commerce on the Net has grown 300% this year over last. According to a survey sponsored by Cisco Systems. Net sales volume accounts for $200 billion and is doubling every 6 months. And, the search for health information is among the top three reasons people use the web. The surveys indicate that people would like better communication with their physicians and most would like to communicate by e-mail. Yet, very few physicians are interested. As part of the research for this article we reviewed dozens of web sites for hospitals and medical groups. While some of these sites are attractive, most simply don't do anything more than provide maps and telephone numbers. People might as well look in the Yellow Pages for the information they can find on th web. Meanwhile, a number of well-funded health sites have sprung up just in the past few months. We searched the web to find sites that would actually allow people to interact in ways that went beyond just finding information. Clearly there is movement toward the ability to conduct transactions over the Net, i.e, patient monitoring, checking on status of claims, ask-a-doc, etc. But, we are just at the front end of this movement and physicians and hospitals have an opportunity to play a leadership role. A number of the sites reviewed for this article, for example, offer the patient the ability to develop his or her own health record and maintain it on the web. It is not conceivable that a healthcare system, along with its affiliated physician, might develop a secure web site that included a combined inpatient and outpatient rcord, accessible electronically by patients and authorized providers from any telephone in the world. It is clear that armed with Internet data, consumers will play an increasingly important role in their own care. Employers are acquiescing to their demands for increasing choice. Copayments are also going up and employees are likely to vote with their feet in selecting providers. Companies like WebMd, Physicians Online, Planetrx.com, drugstore.com, Yahoo and the other mentioned above are filling a need. It should be a wakeup call for healthcare systems and physicians. According to the latest data from Medimetrix, (see medimetrix.com), the most frequently visited health sites on the web today are Intelihealth.com (Johns Hopkins), Mayohealth.org, and OnHealth.com. These sites provide a highly interactive experience for consumers and tons of news and information. They are compelling and traffic-building, have fresh news that is frequently updated and many are transaction. That's what people want. There are so many potential uses of the Internet for physicians and hospitals that it is difficult to properly cover them in this article. Why shouldn't a patient be able to check the status of their account? Has the insurance paid? Is there a patient balance? Consumers can check their bank balances on the Internet. Why not their hospital or medical office accounts? Why not let them pay their balances online? As noted above, some the the HMOs are providing account status information to patients already. Why not the hospitals and physicians? Web sites are multiplying like rabbits. It's going to take a lot of effort to

Consumer Behavior↗
PubMed2000

Creating knowledge structures in the pharmaceutical industry: the increasing significance of virtual organisation.

This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceutical companies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceutical companies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceutical companies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly.

Drug Industry↗
PubMedDate not supplied

Patient-provider connectivity and the role of e-health.

Patient-provider connectivity (PPC) offers innovative approaches to control costs, improve quality, and sustain a healthy workforce. The application of e-commerce to health care is one facet of PPC and provides solutions to educating, informing, and more efficiently using scarce resources to sustain the nation's health. Technology is available to provide real-time access to clinical results, medical records, health-care providers, and other time-sensitive patient information. This is the first article in a series on PPC that explores the application of e-commerce to the health-care industry from the consumers' and providers' points of view and examines and assesses trends and data from various interdisciplinary sources and studies. Two models exemplifying PPC are explored including the Science Business & Education, Inc., proof-of-concept patient demonstration project, and the emerging application of peer-to-peer (P2P) technology. PPC promises to improve efficiency, facilitate communication between physician and patient, monitor compliance with medical regimens, and positively affect the quality of health care provided and the overall health of the patient. Future articles will address the growth of telemedicine, issues of confidentiality and e-risk, and other PPC applications.

Clinical Laboratory Information Systems↗
PubMed2004

OxyContin abuse and diversion and efforts to address the problem: highlights of a government report.

Representative Frank R. Wolf, Chairman of the U. S. House of Representatives Subcommittee on Commerce, Justice, State, and the Judiciary, Committee on Appropriations; and Representative James C. Greenwood, Chairman of the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, requested that the U.S. Government Accounting Office (GAO) investigate OxyContin Abuse and Diversion. The GAO is the audit, evaluation and investigative arm of Congress. On December 23, 2003, the GAO submitted a 57 page report to the Representatives describing the outcomes of the investigation. The full report includes appendices that describe the scope and methodology of the investigation, summaries of FDA changes to the original approved OxyContin label, databases used to monitor abuse and diversion of OxyContin and oxycodone, and comments from the FDA and DEA. This special report is an abstract of the GAO report and includes the conclusions and recommendations for action form the full report.

Analgesics, Opioid↗
PubMed1988

Intravenous drug abuse and AIDS transmission: Federal and State laws regulating needle availability.

This paper has surveyed the laws restricting the use of hypodermic needles and syringes for injection of illegal drugs. It has reviewed the constitutional basis for these laws and concluded that they are on sound footing. There is a new Federal law regulating needles and syringes in interstate commerce, but it is too early to tell how expansively it will be implemented. A large majority of States have drug paraphernalia laws that govern needles and syringes, and a smaller number have laws that require prescriptions for the sale and possession of needles and syringes. Some local jurisdictions also have laws, but these were not specifically reviewed. Altogether, a breadth of relevant laws govern the manufacture, sale, use or possession, advertisement, and interstate commerce of needles and syringes intended for use with illegal drugs. Any attempt by scientists or public health officials to accurately study the effect of these legal restrictions on the HIV infection rates in differing jurisdictions must comprehensively consider the applicable laws. Likewise, attempts at legislative change must also identify each law that would apply. Prosecutorial discretion has been discussed as it relates to the decision not to prosecute offenses involving the illegal use of needles and syringes. While prosecutorial discretion is most likely to be used by prosecutors in individual cases, it provides a legally sound approach for a prosecutor who decides not to enforce the needle and syringe laws across the board as part of an HIV infection control program. Although this approach has not yet been adopted in this country, a prosecutor's decision not to enforce these laws might allow the establishment of an experimental program, such as one for needle exchange, that could serve as a laboratory for legislative initiatives.

Acquired Immunodeficiency Syndrome↗
PubMed1985

Epidemiological investigations into multiple sclerosis in Southern Hesse. III. The possible influence of occupation on the risk of disease.

In order to discover possible exogenous risk factors in the etiology of multiple sclerosis, the pattern of the patients' occupation during adolescence and at disease onset was analysed in an epidemiological group of MS patients in Southern Hesse (West Germany) and compared with that of the German population in the corresponding years. During adolescence, male patients were more frequently occupied in metal processing and electrical trades and female patients more commonly in commerce and administration than expected. At onset, some more female patients than expected were working in commerce and administration whereas male patients did not deviate from the pattern in the general population.

Adolescent↗
PubMed1993

Demographic characteristics of retroviral infections (HIV-1, HIV-2, and HTLV-I) among female professional sex workers in Lagos, Nigeria.

In 1990/1991, 885 prostitutes residing in 11 of the 12 Local Government Areas (LGAs) of Lagos State, Nigeria, participated in a cross-sectional study to determine current seroprevalence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2), and human T-cell lymphotropic virus type I (HTLV-I). The overall prevalence of HIV-1 was 12.3%, of HIV-2, 2.1%, and of HTLV-I, 2.8%. HIV-1 seropositivity did not vary significantly by age, socioeconomic class, or nationality, but HIV-1 seroprevalence was significantly elevated for prostitutes resident in the Port area of Lagos which serves as a crossroads for international and national commerce (OR = 2.3; 95% CI = 1.1, 4.6). HIV-2 infection was significantly associated with low socioeconomic class (OR = 3.7; 95% CI = 1.2, 10.8) and non-Nigerian nationality (OR = 6.7; 95% CI = 2.5, 18.4). Prevalence of HTLV-I infection increased significantly with age (OR = 2.3; 95% CI = 1.0, 5.3). The high seroprevalence of HIV-1 in this survey, compared with previous surveys reported in the last several years and the correlation between high prevalence and areas of international commerce suggest that HIV-1 is spreading in this area of Nigeria. Intensified prevention campaigns are needed to address this possible emerging epidemic.

Adolescent↗
PubMed1994

Outcome of bought living non-related donor kidneys followed up at a single centre.

Between October 1985 and November 1991, 16 dialysis patients travelled to Bombay and bought kidneys from living non-related Indian donors for U.S. $7,372. One patient died peri-operatively; one contracted HIV and another hepatitis B virus infections. Six patients are presently positive for hepatitis C virus antibody compared to two cadaver graft recipients (P = 0.03); two of the six patients have chronic active hepatitis. Five-year patient and graft survival rates (75% and 43%, respectively) were similar to those of recipients of 24 cadaver grafts obtained in the United States (67% and 55%, respectively), as was graft function during the first 5 years of follow-up. Graft survival may have improved following commercial kidney transplantation in Bombay, but this practise still poses a risk of dangerous infections and exploitation of donors and recipients. The establishment of a centralized programme of anonymous "rewarded gifting" in countries that cannot eradicate rampant organ commerce may help to expunge exploitation and to ensure uniform, acceptable clinical standards and the safety of patients.

Adult↗
PubMed1978

[Swiss federal work inspection in the light of a century of workmen's protection].

A hundred years ago, on March 24, 1877, the first federal law on factory workers protection was passed in Switzerland. It was updated in 1914, and in 1964 it was replaced by the present legislation which protects not only factory workers but also most other employees, such as in trade and commerce. The Cantons are responsible for the execution of the law, whereas on the federal level, four federal inspectorates and a medical division exercise supervisory functions. Their task is to see to it that there is countrywide uniformity in following the law.

Accidents, Occupational↗
PubMed2005

The UK House of Commons report on the influence of the pharmaceutical industry: lessons for equitable access to medicines in Australia.

This paper examines the recent UK House of Commons Health Committee report on the Influence of the Pharmaceutical Industry in relation to its findings and recommendations concerning access to medicines, and in particular the continuance of cost effectiveness or reference pricing. This mechanism of bargaining down the price of drugs on social justice grounds recently has been targeted by the US Department of Commerce as an unjustifiable non-tariff barrier to trade that should be eliminated in all OECD countries. Concerns have been raised that certain provisions in the AUSFTA may have been designed to achieve this end, in defiance of norms of democratic legitimacy, moral responsibility and the international right to health. Here we examine some implications of the UK House of Commons Report for the PBS in Australia.

Australia↗
PubMed2002

Ethics of paid organ donation.

As the waiting list of patients requiring organ transplantation grows, there is a subtle but noticeable shift in society towards accepting organs as a commodity which can be paid for. Although nowhere is the organ trade legal, the commerce of organs goes on in different parts of the world, especially in developing countries such as India. This is largely due to societal and governmental failure to implement the existing "transplant laws". It is high time the medical profession ceased being an accomplice to this unscrupulous trade, which exploits the poor, deters altruism retarding the living-related and cadaver transplant programs, commercializes the human body and jeopardizes human dignity.

Altruism↗
PubMed2003

Non-instrumental roles of science.

Nowadays, science is treated an instrument of policy, serving the material interests of government and commerce. Traditionally, however, it also has important non-instrumental social functions, such as the creation of critical scenarios and world pictures, the stimulation of rational attitudes, and the production of enlightened practitioners and independent experts. The transition from academic to 'post-academic' science threatens the performance of these functions, which are inconsistent with strictly instrumental modes of knowledge production. In particular, expert objectivity is negated by entanglement with political and commercial interests. We cannot go back to the old academic model for science, but need to consider how to maintain its vital non-instrumental roles.

Commerce↗
PubMed2003

G.A.T.S. and universities: implications for research.

The likely impact of applying the General Agreement on Trade in Services (GATS) to higher education are examined. GATS aims to "open up" services to competition: no preference can be shown to national or government providers. The consequences for teaching are likely to be that private companies, with degree-awarding powers, would be eligible for the same subsidies as public providers. Appealing to the inadequate recently introduced "benchmark" statements as proof of quality, they would provide a "bare bones" service at lower cost. Public subsidies would go: education being reduced to that minimum which could be packaged in terms of verifiable "learning outcomes". The loss of "higher" aspirations, such education of critically-minded citizens of a democratic and civilized society would impoverish the university's research culture which demands honesty and openness to public scrutiny. Most university research is substantially supported by public subsidy. Under GATS discipline, commercial providers of research services could be entitled to similar public subsidies. Publicly funded fundamental research would fade, leaving university research totally dependent for funds upon the good will of industry and commerce. Present problems, such as the suppression of unwelcome results and the use of questionable results to manipulate public opinion, would considerably increase. The public would lose a prime source of trustworthy knowledge, needed in political discourse, legal disputation, consumer protection and in many other contexts.

Capitalism↗
PubMed1992

Eosinophilic meningitis beyond the Pacific Basin: the global dispersal of a peridomestic zoonosis caused by Angiostrongylus cantonensis, the nematode lungworm of rats.

The principal etiologic agent of human eosinophilic meningitis, Angiostrongylus cantonensis, was first detected in rats in Canton, China in 1933. The first human case was detected on Taiwan in 1944. Epidemic outbreaks were noted on Ponape (E. Caroline Is.) from 1944 to 1948. The disease may present as transient meningitis or a more severe disease involving the brain, spinal cord and nerve roots, with a characteristic eosinophilia of the peripheral blood and CSF. Since 1961 it has been known that human infections are usually acquired by purposeful or accidental ingestion of infective larvae in terrestrial mollusks, planaria and fresh-water crustacea. There is no effective specific treatment. The African land snail, Achatina fulica played an important role in the panpacific dispersal of the organism: it will be important in Africa in the future as well. Rats were, and will continue to be the principal agents of expansion of the parasite beyond the Indopacific area. During and just after WWII the parasite was introduced, and/or spread passively from South and Southeast Asia into the Western Pacific islands and eastward and southward through Micronesia, Melanesia, Australia and into Polynesia, sequestered in shipments of war material and facilitated by post-war commerce. In the 1950s numerous cases were identified for the first time on Sumatra, the Philippines, Taiwan, Saipan, New Caledonia, and as far east as Rarotonga and Tahiti. Then cases were detected in Vietnam, Thailand, Cambodia, Java, Sarawak, the New Hebrides, Guam and Hawaii during the 1960s. Subsequently in the Pacific Basin the disease has appeared on Okinawa, other Ryukyu islands, Honshu, Kyushu, New Britain, American Samoa and Western Samoa, Australia, Hong Kong, Bombay, India, Fiji and most recently in mainland China. The parasite in rats now occurs throughout the Indopacific Basin and littoral. Beyond the Indopacific region, the worm has been found in rodents in Madagascar (ca 1963), Cuba (1973), Egypt (1977), Puerto Rico (1984), New Orleans, Louisiana (1985) and Port Harcourt, Nigeria (1989). Human infections have now been detected in Cuba (1973), Réunion Island (1974) and Côte d'Ivoire (1979) and should be anticipated wherever infected rats of mollusks have been introduced. Caged primates became infected in zoos in Hong Kong (1978) and New Orleans and Nassau, Bahamas (1987). The use of mollusks and crustacea as famine foods, favored delicacies and medicines has resulted in numerous outbreaks and isolated infections. Economic and political instability, illicit trade, unsanitary peridomestic conditions and lack of health education promote the local occurrence and insidious global expansion of parasitic eosinophilic meningitis.(ABSTRACT TRUNCATED AT 400 WORDS)

Africa↗
PubMed2003

Positive, accurate animal identification.

Positive, accurate identification of animals and their products would be very helpful in livestock commerce, prevention of theft and fraud and in tracing animals and products to origin. Food safety, animal health, and prevention of epidemics, would be enhanced by combining identification with location. Identification may be by electronic chips, iris or retinal scans, antibody or DNA analysis. A cross listing of one or more means in a central repository would facilitate tracing origin of animals and build confidence in transactions of all kinds.

Animal Identification Systems↗
PubMed1997

Public-private partnerships in the Canadian environment: options for hospital pharmacies.

This brief report explores the direction being pursued by hospitals interested in outsourcing non-core activities within the pharmacy department. Private sector logistics companies are looking to position themselves in the drug product supply chain to facilitate seamless transfers of drug products, ordering information and payments between drug manufacturers and hospitals. Opportunities for implementing consolidated purchasing, unit dosing, just-in-time inventory and electronic commerce systems are discussed.

Commerce↗