International Journal of Risk & Safety in Medicine - Volume 17, issue 1-2
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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: Ten cases of amodiaquine-induced dystonic reactions observed in a single ward in Ghana's Premier Teaching Hospital, over a period of 4 years are presented. All the reactions resolved without sequalae on treatment with diazepam and benztropine. The importance of increased safety monitoring of amodiaquine as it is (in combination with artesunate) introduced as first line treatment for uncomplicated malaria in Ghana is highlighted.
Abstract: Pregnant women in 20 administrative districts of Ghana are being monitored intensively for adverse events following intermittent presumptive treatment with sulphadoxine–pyrimethamine. Preliminary results indicate a low level of adverse events (0.16%) suggesting good tolerability of the drug, despite the relatively high G6PD deficiency prevalence of more than 20%. Since the real possibility of under-reporting cannot be overlooked, the focused surveillance approach being used in the study is being complemented with in-depth interviews following home visits and focus group discussions with patients and healthcare workers.
Abstract: During the last decade public sympathy for the pharmaceutical industry has gradually been eroded because of excessive protectionism and profit margins. Its reputation as a healthy, profitable and prosperous industry has recently been seriously damaged by several errors of judgement. Data from early trials proved to be less positive than expected. The responsible drug manufacturers decided to cover the results up. So far the pharmaceutical industry has managed to weather the criticism, but recently a multitude of damaging data was published by an unexpected outsider. Angell, a former editor in chief of one of the most respected, peer-reviewed medical journals…in the world, the New England Journal of Medicine, decided to collect such data and to analyze them critically. She also used this analysis to draw up recommendations for improving of what she regarded as an unhealthy situation. The book gained bestseller status on the American market and received much praise from reviewers. Although quickly denounced by the industry as controversial and excessively negative, it contains a lot of data, opinions and conclusions that also apply directly to the European situation.
Abstract: The Drug Controller General of India (DCGI) and Indian Council of Medical Research (ICMR) have established ADR monitoring centres in many hospitals in the major cities of India. Despite these efforts and the presence of a large number of tertiary care facilities, pharmacovigilance is still in its infancy in India. Gross under reporting of ADR is a cause of concern, the reasons for which may be many. It is important to understand these reasons to improve the sad state of ADR reporting in India. The present study was carried out to study awareness about ADR and ADR reporting among private…practitioners (PPs) and prescribers in government hospitals (PGHs) and to get some feedback and suggestions from them for improving the same. A total of 200 doctors of different clinical disciplines working in government setup (100) or private setup (100) in Delhi were included in the study. Each doctor was given a questionnaire to answer. The responses to the questionnaire were studied under three sections: (i) assessment of ADR and ADR reporting awareness, (ii) ADR feedback data, (iii) suggestions to improve ADR knowledge and its reporting. The responses of the two groups were analysed and compared with each other using the chi-square test. There was a lack of general awareness about adverse drug reactions and the factors that can lead to ADRs among the doctors in the present study. The overall knowledge of ADR reporting was also very poor in both the groups. Only 15 PPs and 3 PGHs knew where to report a suspected ADR and less than one third in both cases knew which ADR to report and the information to be included while reporting an ADR. Ignorance and lack of resources were voted the most important barriers in reporting ADRs in India while spontaneous reporting was ticked as the method of choice for ADR reporting by 66% PPs and 81% PGHs. There were only a few significant differences in awareness between the two groups. The present state of unawareness of ADRs and their reporting can be improved by incorporating the suggestions given by the doctors themselves in the present study, i.e. establishment of more ADR reporting and monitoring centres, more CMEs and workshops to create awareness, a multi-disciplinary team approach in reporting ADRs and legalized ADR monitoring of their products by the pharmaceutical companies.
Keywords: Adverse drug reactions, awareness, reporting, monitoring
Abstract: Objective: To evaluate the functioning of the reserved procedures regulations in the Netherlands, which are included in the Individual Health Care Professions Act (1997), the experiences and views of psychiatrists and the views of management of mental health care institutions were studied with regard to risky procedures in mental health care. Method: Postal questionnaires were sent to all 105 mental health care institutions in the Netherlands and a random sample of 300 psychiatrists. Results: Response rates were 60% for the psychiatrists, 67% for the psychiatric hospitals and 62% for the ambualtory care institutions. According to 32% of the…psychiatrists there were procedures in mental health care that are not legally regulated, but are so risky that they should only be carried out by or on the orders of psychiatrists. Two thirds of the psychiatrists (66%) thought that psychotherapy should be classified as a reserved procedure. The majority of the psychiatrists (65–96%) were of the opinion that assessment of the need for seclusion, treatment in a crisis situation and the termination of treatment can only be safely carried out by or on the orders of psychiatrists. Although 60% of the psychiatrists working in an institution had protocols, 72% were of the opinion that these guidelines were not, or partially satisfactory. Over two thirds of the institutions (69%) thought that the reserved procedures regulations provide adequate protection for patients. Conclusions: More attention should be paid by legislators, institutions and professional organisations to risky procedures in mental health care, in particular in the field of diagnostics and therapeutic procedures.
Abstract: Inappropriate use of medicines is a prominent limitation in ensuring the accessability of the community to essential medicines. Worldwide more than 50% of all medicines are prescribed, dispensed, or sold inappropriately, while 50% of patients fail to take them correctly. Improving the use of medicines in developing countries is not a simple task. The complexity of medicine supply, imbalance between incentives and desinsentives, weaknesses in financing schemes, low salaries, market failure, inadequate information to the patients, etc., may contribute to the problem. Systematic approaches to promote rational use of medicines in low income countries was started in 1989, when clinical…pharmacologists/pharmacologists of ten countries from Asia and African regions involved themselves in the establishment of the International Network for Rational Use of Drugs (INRUD). Each country-INRUD member consist of at least a clinical pharmacologist or pharmacologist, health manager, clinician, pharmacist and a behavioral scientist. The mission was to develop well-proven strategies to improve medicine use through comprehensive transdisciplinary approaches. Experiences have been discussed during the International Conference in Improving the Use of Medicine (ICIUM) in 1997, and recently in April 2004. Round-table discussions were conducted in Indonesia and Nepal in 2001, to redefine the role of clinical pharmacology in developing countries. The discussions involved representatives of stakeholders, e.g., clinicians, drug regulatory authority, professional afiliations, health managers, social scientists, health economics, community, and pharmaceutical industry. The major recommendation was to expand the scope and functions of clinical pharmacology beyond laboratory and clinical work to improving rational use of medicines on a country level. Without undermining the importance of laboratory and clinical activities, at present clinical pharmacology in developing countries should focus more on how medicines are selected and used in healthcare settings and in the community. To strengthen clinical pharmacology at the country level, networking and collaboration on a global scale is urgently needed. Such networking and collaboration is of high priority to facilitate the exchange and sharing of quality teaching materials, expertise, and experience in clinical pharmacology training, teaching, research, and services.
Abstract: This article gives an overview of the development of the European regulatory system. In 1965 the First Directive on medicinal products was adopted. In 2005 a total revision of the system will come into force. How effective the European Union legislation and regulatory system has been and why has the focus of regulation changed over the years? A famous philosopher said that to know the future, the past has to be explored. From the history of EU pharmaceutical legislation it becomes clear why the law has become as it is.
Abstract: Aim: To describe the prevalence, characteristics and impact of community-based adverse events severe enough to warrant hospital admission in New Zealand, to compare them to in-hospital adverse events (AEs) and to consider their potential as a tool to monitor the quality of primary care. Methods: Two-stage retrospective review of 6579 medical records, selected by systematic list sample from admissions for 1998 in 13 generalist hospitals providing acute care. After initial screening, medical records were reviewed by trained medical practitioners using a standardised protocol. Results: Approximately 2.5% of all admissions (12,800 hospitalisations in 1998) to public hospitals in New Zealand may…be associated with community-based adverse events. Nearly 20% of all AEs occurred in the community most often in a doctor's office, patient home, or rest home. Patients who sustained a community-based AE were usually elderly, and most frequently related to medications. System issues were important for both inpatient and community-based AEs. AEs regardless of location were most frequently related to the musculoskeletal system. Conclusions: Community-based AEs are a significant public health and hospital workload issue in New Zealand and other Western countries. Urgent attention needs to be directed at developing systems to identify their presence and monitor the effect of interventions to prevent their occurrence. Hospital-based information systems can generate useful data about AEs in the community and can provide an important review of primary care prescribing. Compared to in-hospital events, community-based AEs were most often related to medications, and were more frequently preventable.