International Journal of Risk & Safety in Medicine - Volume 18, issue 2
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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: Studies of drug-induced birth defects require large sample sizes from high-quality datasets. The Danish discharge registries allow large sample sizes, but the quality of the diagnosis coding is largely unknown. We therefore examined the validity, expressed as the positive predictive value, of discharge diagnoses of cardiac malformations registered in the Danish population-based North Jutland County Hospital Discharge Registry. We reviewed the medical records of 418 (99%) of the 423 children with a first-time diagnosis of cardiac malformation between 1 January 1994 and 31 March 2002. Record review confirmed the diagnosis in 372 children, yielding an overall positive predictive value of…89% (95% confidence interval 86%, 92%) and a prevalence rate of 7.6 per 1000 livebirths. The positive predictive value was between 82% and 86% for three of the four commonest malformations, whereas that of the fourth, patent arterial duct, was only 41%. In conclusion, this registry is a valuable resource for studies of risk factors for cardiac malformations as a group and for studies of risk factors for several types of cardiac malformation. Prevalence rates based on data from this registry should be interpreted with caution.
Abstract: Neuroleptics' safety and use survey was conducted with the aim to develop a drug use monitoring system at a regional psychiatric hospital as an efficient tool of improving use of anti-psychotics. 7080 Side-effects report slips included into the regular medical charts for the period of 4 years (2000–2003) and 385 medical charts for the twelve months of the year 1960 were studied. The total daily neuroleptic load was calculated with the help of Chlorpromazine equivalents and ATC/DDD methodology. It was confirmed that clinical form of paranoid schizophrenia, age and gender contribute to the increased susceptibility of patients to development of…movement disorders: women, patients over 60 years of age and youngsters, and patients with cerebral-organic deficiency being the most vulnerable. The most common patterns of inadequate prescribing practice included needless overuse of neuroleptics; combination treatment of highly dosed neuroleptics; simultaneous prescribing of anticholinergics (trihexyphenidyl) with neuroleptics; clozapine use only as a sedative component. Pharmacovigilance system proved to be an effective instrument in monitoring but not necessarily improving prescribing practices.
Abstract: Background: Cutaneous Adverse Drug Reactions (ADRs) are most frequently reported because, in contrast to systemic ADRs, these are generally easily visible and hence, detected by the patient even if he is symptom free. Objectives: To study the spectrum of cutaneous ADRs and the drugs implicated in these reactions. Methods: Data on cutaneous ADRs was collected prospectively over a period of one year among in and out-patients in a North Indian tertiary care hospital, after Dermatological consultation. No rechallenge with the drug was done. Results: Fifty-four cutaneous ADRs were recorded, the common ones being maculopapular rash (29.6%), Stevene Johnson Syndrome (SJS)…± Toxic Epidermal Necrolysis (TEN) (22.2%) and urticaria (9.3%). Serious/life-threatening reactions were 38.9%. Common drug groups implicated were antimicrobials (33.3%), antiepileptics (16.7%) and NSAIDs (14.8%). Fifty-two cases had probable and two had possible causal relationship with the drug. Majority of the cases (61.1%) were in the age group of 20–50 years with males showing predominance (33:21) over females. H/O drug allergy was seen in 7.4% cases. Conclusion: High frequency of serious cutaneous reactions was recorded in the study. Mortality was prevented by prompt and intensive care of the patients.
Abstract: Aim: To investigate the pharmaceutical care issues in individual patients in a hospital setting. Method: A total of 130 patients from the inpatient department of a hospital were studied in a ten month period. Seven different pharmaceutical care issues were addressed and were analyzed using standard references like British National Formulary and Stockley's drug interactions. Result: A total of 1432 medicines were prescribed to 130 patients (an average of 11 medicines per patient). A total of 564 pharmaceutical care issues were identified in 130 patients and the average number of pharmaceutical care issue per patient was over four. The most…commonly prevalent issue was drug–drug interaction. In the second place was inappropriate dose, followed by the requirement of monitoring and inappropriate frequency of drug administration. The need for education was also identified in 42 patients. However, there was no pharmaceutical care issue related to the route of administration. Conclusion: The professional practice of pharmacy is in infancy in India and the results point to the need for not only sensitizing but also training the pharmacists so that they could start working on such patient-centered activity and lead to improvement in the delivery of healthcare.
Keywords: Pharmaceutical care issue, inappropriateness, drug–drug interactions
Abstract: The statutory disciplinary system for physiotherapists in the Netherlands was introduced at the end of 1997. The aim of this system is to monitor the quality of physiotherapy. All the complaints that were dealt with by the five regional disciplinary boards in the period 1998–2002 were studied with regard to the number and nature of the complaints, the complainants, the accused and the verdicts. Furthermore, questionnaires were sent to 300 physiotherapists working in primary health care were asked about their views on the statutory disciplinary system (response 76%). During the study period 33 complaints were made about physiotherapists. The annual…number of accused physiotherapists increased from zero in 1998 to 11 in 2002. Male physiotherapists were accused relatively more often than their female colleagues. A sanction was imposed 11 times (33% of the verdicts), mostly a reprimand or suspension. Most complaints concerned sexual intimacies or abuse. The statutory disciplinary system appears to be an important corrective instrument by imposing sanctions for serious forms of professional misconduct in physiotherapy. However, with regard to the development of standards for other aspects of the profession, i.e. treatment and advice, the system (still) plays a limited role.
Keywords: Disciplinary system, quality control, professional misconduct, physiotherapists