International Journal of Risk & Safety in Medicine - Volume 7, issue 1
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: The general public has a high degree of interest in information relating to health and illness. Family magazines and daily newspapers play an important role as sources of information about these subjects. Journalists writing about medicines in newspapers in the Netherlands have been found to use a series of complementary sources to obtain ideas and information on this subject; the pharmaceutical industry is one of the sources used by them. In this paper we explore the role of the lay press as a communication channel for pharmaceutical companies. The results of this study show that information from the pharmaceutical industry…to the general public has become increasingly extensive and emphatic. Pharmaceutical companies consider that it is important to inform a lay audience about their products and about the diseases for which they can be used. The lay press, both daily newspapers and family magazines, can play an important role in informing a lay audience about diseases and new or improved products. If the lay press pays attention to these products many potential ‘users’ can be reached. Pharmaceutical companies do approach mass media journalists with information about products in various ways at different moments. As long as independent and critical journalists and editors decide for themselves whether information about drugs coming from pharmaceutical companies is newsworthy enough to be published, what reaches the printed page is likely be genuine news and not hidden advertising. A journalist should make very clear to the reader which sources have been used to compile the article, so that the reader can decide for himself whether he wishes to regard the information as reliable.
Keywords: Pharmaceutical industry, Lay press, Drug information, Journalists
Abstract: The antihypertensive efficacy of Escor (nilvadipine) 8 mg (initial dose for n = 18 094) or 16 mg (initial dose for n = 3109), once daily, was evaluated in a multicenter drug monitoring study in 23 770 hypertensive patients over 10 months. Duration of treatment was 65 ± 24 days (mean ± s.d.). Mean age of patients was 63 ± 10 years, 51% males, 49% females, weight 78 ± 12 kg, height 170 ± 8 cm. Hypertension was known for 6 ± 6 years. The most frequent concomitant diseases were disturbances of lipid metabolism, ischemic heart disease, and arthrosis. 81% of patients…were maintained on the initial daily dose of 8 mg nilvadipine, in 13% of patients the initial dose of 8 mg was increased to 16 mg per day, in 1% of cases an initial dose of 16 mg per day was reduced to 8 mg. 29% of the patients reported full compliance with the nilvadipine drug regimen; 31% had rarely, 20% occasionally, 8% frequently, and 0.2% consistently not complied with the regimen. Compliance was improved vs. previous treatment by the once-daily regimen in 47% of patients. Therapy with Escor was continued in 76% of patients beyond study end because of efficacy of therapy and good tolerability. On a global assessment scale efficacy was rated excellent in 50%, good in 41%, moderate in 5%, insufficient in 2%. The ratio of responders, i.e., diastolic blood pressure > 95 mm Hg at baseline and < 90 mm Hg at end of study, or reduction of diastolic blood pressure by at least 10 mm Hg, was 59% at the first control visit and 84% at study-end visit. Diastolic blood pressure was lowered by 13 ± 9%, systolic blood pressure by 14 ± 8%. Adverse events had been documented in 7.9% of patients; most frequently the symptoms were associated with the therapeutic effect, i.e., vasodilatation (incidence 3.35%), headache (2.4%), tachycardia (1.18%), edema (0.95%), dizziness (0.78%). A relation of adverse events to Escor was rated very probable in 4%, probable in 2% and possible in 1%. Serious adverse events reportedly occurred in 0.2% (55) patients, including 36 cases of hospitalization or surgery; among the latter, 8 patients also experienced tachycardia, 3 vasodilatation, 2 increased sweating. Nine deaths were reported, but a relation to Escor treatment was denied. Tolerability was rated excellent in 52%, good in 40%, moderate in 3% and insufficient in 2% of patients.
Abstract: We studied the utilization of oral anticoagulants and the degree of completeness and validity of some key research variables from the Danish health service in the county of North Jutland (482 000 inhabitants), studying the records of 12 855 prescriptions of oral anticoagulants during 1991 and 1992. The utilization of oral anticoagulants showed an increase of 16% from 1991 to 1992, when 0.3% of all women and 0.4% of all men were treated during one year. The increase was less than expected based on newly introduced indications for treatment of atrial fibrillation. The following variables were studied: the name (ATC commodity number)…and amount of the prescribed drug, the defined daily dose, the personal registration number of the patient, type of prescription (e.g. in writing or by telephone), number of repeat prescriptions, date of prescription issued by the doctor, the registration number of the GP or hospital department (if the prescription is made by a hospital doctor) and date of expedition from the pharmacy. The number of wrong and missing data was less than 1%. The study suggests that Danish prescription information is of such quality that it can be used for pharmacoepidemiological studies.
Keywords: Oral anticoagulants, Drug utilization, Information systems, Validity
Abstract: The prevalence of complementary medicine in most industrialised countries is impressive and increasing. Discussions of the topic often focus on therapeutic approaches and neglect diagnostic methods specific for complementary medicine. The paper summarises the data available on such “alternative” diagnostics. Scientific evaluations of these are scant, and most techniques have never been properly validated. The ones that have can be demonstrated to be not reproducible, sensitive, or specific. The ones that have not should be regarded as such until shown otherwise by rigorous testing. Therefore it seems that “alternative” diagnostic methods may seriously threaten the safety and health of patients…submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.
Abstract: The vexed ethical and legal questions which arise as regards the maintenance of life in an individual who is not (or who is no longer) otherwise capable of meaningful survival have been discussed primarily as regards certain patients who are terminally ill. The issue has been thrown into a new perspective by discussions as regards the fate of an anencephalic infant. The two accounts which follow of the Virginia case of “Baby K” are reproduced with permission from the Summer 1994 Newsletter of the American Society of Law, Medicine and Ethics. Both provide an American medico-legal view of this prominent…case; in future issues of this journal, European contributors will provide their opinions.