International Journal of Risk & Safety in Medicine - Volume 22, issue 2
Purchase individual online access for 1 year to this journal.
Price: EUR 155.00
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: A survey was carried out of all consultant psychiatrists and a sample of senior healthcare professionals in North Wales to establish attitudes towards Adult ADHD following the recent publication of NICE guidelines on the condition. Although the sample size was relatively small (N = 50 consultants) it should be noted that 100% completion rate was achieved which was supplemented with responses from twelve senior ward staff.The survey results showed an increasing appreciation of the possible prevalence of Adult ADHD. Considerable variation was observed between consultants in different specialist areas, with child and adolescent mental health consultants showing more consistent beliefs…and adult mental health consultants showing a shift in recognition of Adult ADHD. This survey aimed to map changing attitudes towards Adult ADHD. From a therapeutic perspective it makes sense to recognise the reality of the condition. However it should also be acknowledged that perceptions of the prevalence of such conditions may in part be tied into effective marketing.
Abstract: Background: The ultimate goal of pharmacovigilance is to protect patients from drug-induced harm and allow them to derive maximum benefits from medicines. All pharmacovigilance centres have an interest in showing the extent to which they achieve this aim. A core activity is spontaneous reporting. We have considered here whether it is possible to construct appropriate performance indicators for this method. Methods: We set out the stages in the process of pharmacovigilance and sought to decide what specific objectives of the centres could be helpful as practical indicators related to desired outcomes of pharmacovigilance and considered criteria to assess the practicality…of an indicator. Results: We constructed a model of the pharmacovigilance process, listed the core functions and deduced a series of potential performance indicators that would be used in practice. Examples included number of reports per million population; proportion of valid reports; number of signals identified; regulatory or clinical action taken. For example data from USA compared to African country show how huge resources in USA give myriad reports, signals and regulatory decisions compared to Africa. Discussion: Pharmacovigilance centres have limited influence over the many complex interactions between patient, prescriber, manufacturer, government and media. However the proposed indicators can be measured in different countries, regions and at different times and allow comparisons. Conclusion: The pharmacovigilance system is a subsystem of a larger healthcare system and is affected by many factors. It is not easy to demonstrate the benefits of pharmacovigilance towards patient safety. However pharmacovigilance centres need to show the extent to which they achieve their objective such as number of reports, number of signals identified, regulatory or clinical action taken. These allow comparison between countries and overtime.
Abstract: This paper analyses the cost structure of pharmacovigilance in investigator-initiated clinical trials. A total of 24 cost estimates, which were provided by five different German Coordinating Centers for Clinical Trials, were included in the study. The highest costs were caused by the processes of Safety Management. At least 30% of the total pharmacovigilance costs were connected with the planning phase and 70% were connected with the implementation phase of a clinical trial. The analysis shows the importance of aspects of costing and funding at an early stage in the planning process.
Abstract: Introduction: Proximal femoral fractures (intracapsular and extracapsular) most commonly occur in the elderly due to falls, with a higher incidence in women. With the UK population ageing, the incidence of fracture neck of femurs (NOF) has been steadily increasing. In 2007 there were 70,000 NOF fractures treated in the NHS. This number is expected to rise to 91,500 per annum by 2015. The aim of this observational prospective study was to see whether consent comprehension was related to AMTS in an elderly patient with a proximal femoral fracture. Materials and methods: Sixty four patients with hip fractures were included in…this study. The patient was consented and an abbreviated mental test score (AMTS) was recorded on admission. Preoperative comprehension was judged using a questionnaire. Univariable linear regression analysis was performed. Results: A significant correlation between the AMTS and consent comprehension scores was found r2 = 0.680 (p<0.0001). Conclusion: We showed a strong correlation between the AMTS and consent comprehension in this patient group. We concluded that due to variation in comprehension scores for a defined AMTS, we could not state above what AMTS a patient can be deemed to have significant comprehension of their consent. Consent training should me mandatory for surgical doctors and that it should not be a one off event, but instead a continuum of events.
Keywords: Consent, comprehension, fracture, hip, surgery
Abstract: Background: Medicines Regulatory Authorities (MRAs), among other core regulatory functions, play a vital role in stimulating the rational use of medicines by providing regulatory information of good quality to all stakeholders. Little research has attempted to report on existence and maintenance of MRA websites at global level, as well as the types of information made publicly available. Objectives: To identify functioning MRA websites on a global level, to update a study carried out in 2001 on the development of the quality and types of information of 51 websites, and to identify model components within existing websites. Methods: The Internet was…searched and WHO Medicines Regional Advisers and WHO medicines country advisers (National Professional Officers) were contacted in order to identify MRA websites. The 51 websites assessed in 2001 were assessed again, using the same criteria for the quality and types of information as in 2001. Results: The number of MRA websites identified has risen from 53 to 116. Most criteria, such as frequency of updates, pharmacovigilance information and regulatory guidance for applicants for medicines marketing authorization (registration) have improved substantially. However, navigability of websites has weakened. Conclusion: Quantitative growth of the number of MRA websites is impressive. The quality of information provided on the 51 assessed websites has improved. Exemplary website components are proposed to help MRAs to improve transparency by developing and maintaining high-quality websites.
Abstract: Electroconvulsive therapy (ECT) and the machines that deliver it have never been tested for safety and efficacy in order to receive approval from the FDA. The American Psychiatric Association and ECT advocates protested when the FDA took steps to classify the machines as posing “an unreasonable risk of illness or injury”, which would have required their testing before approval. Without requiring this testing, the FDA is now preparing to classify the treatment and the machines as safe. This article reviews evidence demonstrating that ECT is very harmful to the brain and mind, and concludes that the FDA should demand the…usual testing, starting with animals, that is required before psychiatric treatments and machines are approved for marketing and use.
Abstract: Objective of this study is to identify the attitudes of Ayurvedic physicians about Ayurvedic drug safety in clinical practice. A sample attitude survey among institutionally qualified Ayurvedic physicians from a prespecified part of India through a self administrable questionnaire was adopted as a method to reach at this objective. Survey shows majority of the respondents accepting the potential adversity from Ayurvedic drugs. A substantial number of the respondents have also accepted their ignorance about the idea of pharmacovigilance in Ayurveda. It highlights the need of more guidance about drug safety and usage to Ayurvedic physician to ensure a safe Ayurvedic…clinical practice.
Keywords: Attitude, Ayurvedic physician, drug reaction
Abstract: In Africa there is currently not a wide knowledge of patient safety and healthcare quality. There is inadequate data to measure the scale of medical error and its impact on the healthcare. We investigated the frontline staff experience, their awareness of medical error and willingness to participate in patient safety initiatives. This is a qualitative survey involving 60 healthcare professionals in 2 private and 2 public hospitals in Nigeria and Uganda. Findings highlighted that frontline staff have a good knowledge and understanding of medical error. Thirty percent of the participants said errors occur frequently while only 3.3% were not sure…of how often errors occur in their hospitals. Inadequate research on patient safety in literature at present does not mean that medical errors or other issues that undermine patient safety do not occur in Africa. Factors that cause medical errors and the impact of such errors are known to healthcare professionals. They are willing to participate in healthcare improvement programmes. Our findings show the relevance of patient safety in the region and provide a focus for further work that would ultimately contribute to the identification of appropriate interventions that could improve patient safety in Africa.
Keywords: Patient safety, medical error, Africa, healthcare professionals
Abstract: Acute drug induced dystonias are commonly reported with antipsychotic drugs, however there have been reports of extrapyramidal symptoms following the use of 4-aminoquinolones such as chloroquine and amodiaquine for treating malaria especially in adults and adolescents. The aim of this report is to sensitize health care providers to the possibility of amodiaquine induced dystonia in children. We report a case of acute dystonic reaction following the use of artesunate-amodiaquine in a 7 year old boy who presented with tongue protrusion, inability to talk, torticollis, opistothonus and laryngeal spasm. Symptoms began about 22 h after treatment with artesunate-amodiaquine was initiated. The…reaction was aborted with intravenous diazepam and the artesunate-amodiaquine was discontinued. Therefore, there is the need to conduct research on the prevalence of acute drug induced dystonia following the use of artesunate-amodiaquine in children especially in the community to evaluate the magnitude of this problem.