International Journal of Risk & Safety in Medicine - Volume 26, issue 1

Authors: Rehan, Harmeet S. | Chopra, Deepti | Holani, Sonika Newar | Mishra, Ritu

Article Type: Research Article

Abstract: BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting form is a vital tool for collecting information about ADRs, which helps in establishing the causal assessment and generating a signal. This is feasible if quality information is translated into the reporting form by health care professional (HCPs). Hence, present study was carried out to compare efficiency of HCPs in translating suspected ADR information in the spontaneous reporting forms and to compare the ADR reporting forms of different countries and their duration of training in pharmacovigilance. METHODS: In a cross-sectional study, 50 doctors, 50 Nurses and 50 Pharmacists were asked to fill different …reporting forms (CDSCO form, Medwatch, Yellow card and the Blue form) using different simulated ADR case reports. Filled forms were analysed for their contents, information captured and time taken to fill these forms. They were also asked about their training and exposure to pharmacovigilance related activities. RESULTS: All the spontaneous ADR reporting forms had 24–26 data elements to furnish information. Information regarding dechallenge was lacking in the Yellow card and Blue form. Blue form also lacked the information on rechallenge. Overall nurses took longer time to fill all the ADR reporting forms as compared to the doctors and pharmacists. Majority of HCPs missed to fill reporter's information in all the forms. CONCLUSION: Study suggested that the quality of information translated by the HCPs needs improvement for which they should be sensitized periodically on the basic elements of pharmacovigilance. Show more

Keywords: ADR, spontaneous ADR reporting form, CDSCO form, medwatch, yellow card, blue form, pharmacovigilance

DOI: 10.3233/JRS-140608

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 1, pp. 1-8, 2014

Authors: Maggi, Cátia Bauer | Griebeler, Isabel Heinzmann | Dal Pizzol, Tatiane da Silva

Article Type: Research Article

Abstract: BACKGROUND: The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain. OBJECTIVE: To assess the incorporation of the CONSORT statement extension's recommendations in randomised clinical trials (RCTs) evaluating drug therapies published in high-impact medical journals. METHODS: Using Medline, 122 RCTs published in 2009 were selected from BMJ, JAMA, Lancet, and NEJM. A structured form was used to identify the harms information reported in the RCTs, following the recommendations of the CONSORT statement extension. RESULTS: The …most frequently met CONSORT recommendation was the mention of harms in the title or abstract of the paper (72.1% of the papers analysed); the least-met recommendation was the reporting of how the harms information was collected (10.7%). The studies that focused on harms presented better information on safety, but only 10.8% met all recommendations in the CONSORT statement. CONCLUSION: The adverse event information was insufficient for the RCTs published in four high-impact medical journals five years after the publication of the extension of the CONSORT statement. Show more

Keywords: Adverse drug reactions, adverse events, drug safety, randomised clinical trials, CONSORT statement, quality

DOI: 10.3233/JRS-140609

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 1, pp. 9-22, 2014

Authors: Horberry, Tim | Teng, Yi-Chun | Ward, James | Patil, Vishal | Clarkson, P. John

Article Type: Research Article

Abstract: BACKGROUND: Central Venous Catheterisation (CVC) has occasionally been associated with cases of retained guidewires in patients after surgery. In theory, this is a completely avoidable complication; however, as with any human procedure, operator error leading to guidewires being occasionally retained cannot be fully eliminated. OBJECTIVE: The work described here investigated the issue in an attempt to better understand it both from an operator and a systems perspective, and to ultimately recommend appropriate safe design solutions that reduce guidewire retention errors. METHODS: Nine distinct methods were used: observations of the procedure, a literature review, interviewing CVC end-users, task analysis construction, CVC …procedural audits, two human reliability assessments, usability heuristics and a comprehensive solution survey with CVC end-users. RESULTS: The three solutions that operators rated most highly, in terms of both practicality and effectiveness, were: making trainees better aware of the potential guidewire complications and strongly emphasising guidewire removal in CVC training, actively checking that the guidewire is present in the waste tray for disposal, and standardising purchase of central line sets so that differences that may affect chances of guidewire loss is minimised. CONCLUSIONS: Further work to eliminate/engineer out the possibility of guidewires being retained is proposed. Show more

Keywords: Central venous catheterisation, guidewire, patient safety, human factors, safe design

DOI: 10.3233/JRS-140610

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 1, pp. 23-37, 2014

Authors: Yudina, Ekaterina V. | Ziganshina, Liliya E.

Article Type: Research Article

Abstract: Over the past two decades Russia has gone through dramatic “democratic” changes resulting in unprecedented deterioration of health, loss of lives and extinction of population. The health system turned into a ridiculous monster of poorly organized business exploiting reminiscent social values of the past to build profits on selling sickness-for-all in consumer culture. We present facts and conclude that introduction of palivizumab into clinical practice for the most vulnerable patient category was done without confirmation of efficacy, without pharmacoeconomics evaluations, without any precautionary measures in a country with undeveloped pharmacovigilance system. The situation calls for immediate action of responsible authorities …and the society as a whole. Show more

DOI: 10.3233/JRS-140606

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 1, pp. 39-43, 2014

Authors: Grech, Victor

Article Type: Research Article

Abstract: AIMS: The Windscale (UK) fire of 1957 carried radioactive fallout according to the then prevailing wind patterns, in a North-Easterly direction across the Nordic countries, toward Norway. The male:female ratio at birth (M/F) is known to be increased after parental exposure to ionising radiation due to foetal losses that affect female more than male pregnancies. This study was carried out in order to ascertain whether the Windscale fire had any effects on M/F and birth rates in the United Kingdom and Scandinavia. METHODS: Annual live births by gender were obtained from a World Health Organization dataset. The null hypothesis was …that there were no significant changes in M/F or in births in temporal association with the 1957 Windscale event in abovementioned countries. RESULTS: There were no significant effects on the UK and most of Scandinavia but there was a significant rise in M/F for Norway and Finland with an aggregate deficit of around 4000 births in each country. CONCLUSIONS: A recent study suggests that the plume from the reactor extended further east than previously believed. This study confirms that contamination from the Windscale fire had a negligible impact on the UK (as measured by birth effects) but had a significant impact on births in Norway and Sweden. Show more

Keywords: Great Britain/epidemiology, Scandinavia, sex Ratio, birth Rate/*trends, infant, newborn, radiation, Ionizing

DOI: 10.3233/JRS-140607

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 1, pp. 45-53, 2014