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Biomedical subjects

H H Tilson

Publications and source records attributed to H H Tilson.

36 records · Page 2Linked to original sources
PubMed1989

Atracurium--a post-marketing surveillance study: methods and U.S. experience.

Two companion post-marketing studies have evaluated the frequency of adverse events amongst patients receiving atracurium. In this first report, we describe the study methods used in both centres and the findings of the study conducted at the Group Health Co-operative of Puget Sound, U.S.A. In this study, the frequency of adverse events in 1013 patients receiving atracurium was substantially the same as that in 851 patients receiving other neuromuscular blocking agents. In both groups there were no instances of cardiac arrest, anaphylaxis or death, no adverse effects associated with failure to antagonize neuromuscular block, and no instances of previously unreported types of adverse effects. We conclude that the safety profile of atracurium is similar to that of other neuromuscular blocking agents and that this type of observational study of anaesthetic agents may prove a useful tool for surveillance of new drugs used primarily in hospitals.

Anesthesia Recovery Period↗
PubMed1988

Monitoring the safety of antivirals. The example of the acyclovir experience.

The obligation to monitor the safety of newly introduced medicines is as old as the medical epidemiologic obligations of medicine itself. But society's expectations, the resources and methodologies for such monitoring, and the practices of the pharmacologic community have all evolved rapidly over the past decade. This report describes an extensive program of scientific epidemiologic monitoring of the safety of acyclovir during the first five years following approval. The presentation highlights the emerging field of pharmacoepidemiology, describes new and important resources and approaches for investigators concerned about drug safety monitoring, and presents safety data from the first five years of monitoring. The data thus far provide no reason for new safety concerns regarding this important antiviral; however, it is cautioned that, as in all such areas of public health protection, continued vigilance is needed.

Acyclovir↗
PubMed1988

Acyclovir in Pregnancy Registry. An observational epidemiologic approach.

Observational epidemiologic methods are being used to evaluate the safety of acyclovir in pregnancy. An essential component of this research is the establishment of a baseline expectation of pregnancy outcomes among women with herpes not receiving acyclovir. Continuing studies will be described in this report. To supplement these structured studies, an international case registration study was established. Through the Acyclovir in Pregnancy Registry, all cases of reported prenatal exposures to acyclovir are tracked to ascertain maternal exposure, risk factor, and pregnancy outcome information. The reports originate in all countries where oral acyclovir is marketed; data consolidation and analysis are coordinated at Burroughs Wellcome Co. with the assistance of a government/industry advisory panel. This presentation summarizes provisional data from the prospective reports, including trimester of exposure and reported outcomes of pregnancy. The total number of monitored pregnancies remains too small to support conclusions about the safety of acyclovir during pregnancy at this point. The potential for the registry and other epidemiologic studies to address the safety-in-pregnancy question will be discussed.

Abnormalities, Drug-Induced↗
PubMed1988

Pharmacoepidemiology: the future.

Like all other futures, the future of pharmacoepidemiology is not entirely clear. Major forces exist that are driving the agenda for pharmacoepidemiology. This article reviews and weighs these factors and the roles of the major related actors. Like all health futures, that of pharmacoepidemiology can be positively influenced by responsible contributions, particularly by the pharmaceutical community.

Epidemiologic Methods↗
PubMed1988

Pharmacoepidemiology: the industry's perspective.

The pharmaceutical industry has a vital interest in, and plays a central role regarding, the issues of safety of the medicines it produces. Not only does industry have the basic and broadest expertise and "ownership" in drugs, it also is in an ideal position to receive and evaluate important information. At the center of spontaneous voluntary reporting (particularly in the US) it is a partner in generating signals of potential safety problems. And, as a scientific leader, it is a vital partner with academia and government in developing and using the evolving capacity for pharmacoepidemiology for proper examination of these signals using structured epidemiology study. Particularly, the importance of the large automated database in this regard is emphasized. Where the public's health is concerned there is no "different" industry perspective.

Arthritis, Rheumatoid↗
PubMed1987

Pharmaco-epidemiology--an operational model (translating the vision into realistic plans and objectives).

The author, previously the State Public Health Officer of the State of North Carolina, and subsequently building the pharmaco-epidemiological programme of the Wellcome Foundation, describes the programme using a number of illustrative examples in tracing drug/disease associations and particularly the use of automated data base-supported linkage projects. The limitations of pharmaco-epidemiology are defined, and in conclusion the application of this discipline is discussed in countries other than the USA such as Italy.

Cataract↗
PubMed1986

Social policy and drug safety.

Drug safety policy for the elderly says more by its relative silence and ambiguity than it could by any single affirmative set of rules and principles. The difficulties in developing such social policies embody the interaction of the complexities of each of three dimensions: social policy, which requires consensus on roles, responsibilities, and the sharing of costs; drug safety monitoring, which requires a maturing and evolving body of science, technology, and practice to converge; and geriatric pharmacology, about which the answers are only now beginning to materialize. The social forces of incomplete consensus, incomplete science, and incomplete technology beg for a solid public policy. However in the next breath they beg, yet more urgently, for the first step in such public policy, a step that remains to be taken and is of great urgency. All of those concerned with the goal of minimizing the morbidity and disability, regardless of the state of disease, in the elderly must collaborate to chart the course for each of these three forces to reach the level in which responsible social policy can be made. This will require a good faith collaboration among government, the pharmaceutical industry, the health professions, the university community, and patients or their advocates. Although the recommendations of the Melmon Commission for the creation of a "Center for Drug Safety," jointly funded by government, the industry, and the universities, may never be fulfilled and may not, in fact, be needed in bricks and mortar, certainly the spirit of such a center must be the essential first step. The ground rules--for collaboration, capacity building, nurturance, support, and professional development and technology, particularly linkage-extension--must similarly be discussed broadly in open forum. Otherwise, multiple empires, separate mutually incompatible systems, and epidemiologic squabbling will surely carry the day. Finally, research must be done better to define, understand, and address special problems of the elderly. In the end, it is this special population who must receive the unique attention of drug safety policies and their implementing systems. Just as the processes of health and of ill health need better understanding, so too must the processes of aging and their impacts upon drug risk be better understood. This research must go beyond the high-tech spheres of pharmacology and pharmacokinetics. The addition of epidemiologic analysis of risk factors for therapeutic misadventure (iatrogenic and self-induced) and for health status specific long- and short-term adverse drug experience will contribute substantially to drug safety in the elderly.

Aged↗
PubMed1985

Pharmaco-epidemiology--drugs, arthritis, and neoplasms: industry contribution to the data.

The real possibility that exogenous chemicals, including pharmaceuticals, increase risk of cancer is not a surprise. Epidemiologic systems to monitor exposure, as well as risk with or without such exposure, have been very hard to develop and very expensive to implement, and often have yielded ambiguous or questionably useful findings. The pharmaceutical industry is rising to the challenge of this situation, with attention to epidemiologic responsibilities and potential contributions deriving from them. This paper reviews the overall methodologic and public policy context surrounding pharmaco-epidemiology in the 1980s and then depicts an evolving program in pharmaco-epidemiology at one company, Burroughs Wellcome, as an example of one possible contributor. It discusses the company's epidemiologic approach to the question of association between treatment with disease-modifying antirheumatic drugs, one of which is manufactured by Burroughs Wellcome Company (Imuran brand azathioprine) and a possible increased risk of neoplasms in patients receiving these drugs as treatment for their rheumatoid arthritis. The paper will highlight specific epidemiologic applications of data bases derived from the published literature as well as voluntary reporting to industry. It will describe a proactive program in the development and conduct of epidemiologic studies to address these difficult problems.

Arthritis, Rheumatoid↗
PubMed1977

A ray of hope.

Explore the source record for details and available documents.

Health Planning↗
PubMedDate not supplied

Inventory of knowledge and skills relating to disease prevention and health promotion.

An inventory of the knowledge and skills appropriate for the instruction of medical students in the disciplines of disease prevention and health promotion was developed by a steering committee of medical practitioners and teachers, with the input of over 70 colleagues. The inventory, which is intended as a guide for curriculum planners, defines the fundamentals of subject areas appropriate for the general education of all physicians, including the skills and knowledge related to delivery of personal disease prevention/health promotion services, quantitative methods, health services organization and delivery, and community dimensions of medical practice, as well as attitudes and philosophy.

Attitude of Health Personnel↗