International Journal of Risk & Safety in Medicine - Volume 18, 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: This literature review outlines a brief history of Direct-to-Consumer Advertising (DTCA) of prescription drugs. Concerns about the safety and effectiveness of DTCA, particularly as it relates to the marketing of Eli Lilly's widely-used anti-depressant drug Fluoxetine (Prozac), are also discussed. Additionally, this paper raises questions about Fluoxetine's stimulant-like properties, and highlights various concerns about the way in which the Food and Drug Administration's product safety trials were conducted during Fluoxetine's approval process.
Keywords: Advertising, anti-depressants, clinical trials, consumer psychology, consumer safety, deceptive advertising, depression, depression treatment, direct to consumer advertising, DTCA, drug companies, drug lawsuits, drug recalls, drug research, drug testing, drugs, Eli Lilly, Food and Drug Administration, FDA, Fluoxetine, marketing, medicine, off-label, pharmaceuticals, prescription drugs, product liability, product testing, Prozac, psychiatry, psychology, psychotropics, selective serotonin reuptake inhibitors, SSRIs, suicide, suicide prevention, Zoloft
Abstract: This paper reviews the European Union mandatory Vigilance Reporting System and voluntary user reporting systems for medical devices. Differences between these systems and the reporting system for pharmaceuticals are highlighted. Device vigilance is run as a single harmonized system within the European Union and increasingly there are international links. Recent trends in reporting patterns within the United Kingdom are highlighted along with initiatives to improve the number and accuracy of reports. Drug/device combination products are becoming increasingly important. The handling of adverse events for these and other new technology products are described.
Keywords: Medical devices, pharmacovigilance, vigilance, user error, drug/device combinations
Abstract: Objective. To provide insight into practice and policy regarding the publication of disciplinary verdicts in Dutch health care. Design. Descriptive. Methods. All verdicts of the disciplinary boards and courts of justice, published in the Netherlands Government Gazette during the period 1995–2002, were studied with regard to the year of publication and verdict, the disciplinary board concerned, the accused professional, the type of complainant, the nature of the complaint and verdict, and the journals that were offered the verdict. The published verdicts were related to the total number of verdicts and cases during the study period. Questionnaires were used to investigate…the publication policy of the disciplinary boards and the three journals which were offered the majority of verdicts for publication. Results. A total of 4% of all verdicts were published in the Netherlands Government Gazette (323/8902). The central disciplinary board decided to publish more often than the regional disciplinary boards (8% and 2%, resp.). There were considerable differences between the various regional disciplinary boards (min–max 0.9–5%). Per professional group the percentage of verdicts in cases that were published varied from 2% to 23%. The decisions were offered to over 20 journals, but mainly to the TvGR (92%) and the MC (88%). The TvGR published almost two thirds of the verdicts that were offered (63%), and the MC published almost three quarters (74%). With regard to decisions concerning publication, the disciplinary boards differed in their interpretation of the concept of ‘general importance’. Conclusion. If disciplinary proceedings are to achieve the desired quality-promoting effect on professional practice, then more attention will need to be paid to the publication policy, and the disciplinary boards will have to develop a collective code of conduct. More verdicts could be published, also in discipline-specific journals.
Abstract: Objectives. We know very little about how best to react to medical disputes in order to resolve them at an early stage. Therefore, in order to examine negotiation styles, this study examined how gender and medical factors affect the consequences of telephone consultations. Methods. We used telephone consultation data for a medical association in Japan for the period from January 2000 to December 2001. Associations between relevant variables, such as the gender of the caller or consultant, and the consultant's medical experience, and the consequences of telephone consultations were examined using the chi-squared test or multiple logistic regression analysis. Results.…The analyses showed that: the gender of the consultant was related to outcome (p=0.04 and 0.01); the type of consultant (i.e., MD or non-MD) was related to outcome (p<0.001); and the type of consultation was related to outcome (p<0.001 and p=0.01). Conclusion. Female gender and being a physician were related to problem resolution in telephone consultations, implying that straightforward attitudes toward problems and medical knowledge are important for resolving medical disputes. Since the patients who used telephone consultations had a problem with a doctor other than the one they consulted by telephone, further study is necessary to verify whether these points are applicable in regular face-to-face consultations.
Keywords: Medical disputes, second-opinion, gender, telephone consultation
Abstract: In various studies outside the Netherlands, it has been shown that a substantial number of patients suffer some kind of injury during their treatment in a hospital. The incidence of these so-called adverse events varies between 2.9% and 16.6%; of these, estimates between more than a quarter and up to half are considered to have been avoidable. Preventable adverse events can offer a starting point for interventions to increase patient safety. Therefore, a study has been initiated in Dutch hospitals investigating the nature and extent of adverse events and their causes. Important goals of the study are to reach a…consensus on basic concepts and to improve the research methodology.
Abstract: Epidemiological research is needed to determine how many medical errors are made in hospitals. An estimation of error risk requires knowledge of the number of errors made and the total number of patients treated. But how do we define the term ‘error’? The outcome of a medical intervention alone is insufficient; the entire treatment process has to be taken into account. For the estimation of error, two different approaches are available: retrospective chart review or prospective ethnographic observation. Both methods should account for processes and outcomes. Both methods have their limitations and can produce measurement errors. In particular, the low…reproducibility of the determination of error is worrisome. To achieve safer health care, emphasis should be placed on control of processes, rather than outcomes.