International Journal of Risk & Safety in Medicine - Volume 28, 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: BACKGROUND: We modified the departmental mortality and morbidity (M&M) meetings to evaluate whether patient safety incident review as a part of this meeting was associated with reduced patient safety incidents. METHOD: A pilot programme of peer review of patient safety incidents (PSI) supported by education relevant to that event and follow-on action plan was introduced as a part of an extended morbidity and mortality meeting in a university hospital orthopaedic department. The pilot programme was conducted over six months (January 2012–June 2012). This programme involved junior and senior doctors including consultants although multidisciplinary groups were invited to…attend. We investigated PSI rate/1000 hospital admissions for trauma and elective surgery, which were collected prospectively and independently between Jan 2011 to June 2013. We noted if the incident was caused by a medical or a nursing error and compared PSI rates. RESULTS: Rates of PSI (33/1000) were 7.8 times higher in trauma cases (80.2/1000) than in elective admissions (11.2/1000). There was 18% reduction in trauma and 27% reduction in planned elective admissions. The rate increased after the pilot programme finished but there was still a 7% reduction compared to the pre-pilot period. This study found a significant reduction in the PSI rate for medical error but no change in the rate of nursing error. CONCLUSION: This continuous reflection, education and action process, where safety events are reviewed as a part of the extended morbidity and mortality meeting, is associated with reduction of patient safety incidents. We recommend that PSI reflection should be introduced in Mortality and Morbidity meetings with mandated attendance of the entire multidisciplinary health care team.
Keywords: Patient safety, morbidity and mortality meeting, education, patient safety
incidents, orthopaedic surgery
Abstract: BACKGROUND: Medication errors are preventable causes of patient harm with significant contributions to adverse drug events but they remain understudied in Nigeria. OBJECTIVES: To estimate the prevalence of self-reported medication errors among health professionals and examine their knowledge of medication errors with the hope of identifying appropriate measures to promote medication safety. METHODS: A cross sectional survey among doctors, pharmacists and nurses in 10 tertiary hospitals. Information was obtained using a self-administered structured questionnaire. Correct responses evaluating the knowledge of prescription, dispensing and administration errors were scored one mark each and the composite scores computed.…Appropriate statistics were applied to summarize and establish the relationship between variables at 5% level of significance using SPSS 17.0. RESULTS: A total of 2,386 professionals participated in the study (46.3% nurses, 44.9% doctors, 8.8% pharmacists).The prevalence of self-reported medication errors was 47%. The professional groups differ in their knowledge of all the aspects of medication errors with professional cadres influencing knowledge. Overwork was the most reason for being error prone (59.2%) and only 35.5% had ever reported medication error. 33.4% did not think reporting was necessary. CONCLUSIONS: The prevalence of medication errors is high among health care professionals in Nigeria. Knowledge gaps and practice deficiencies were identified requiring interventions.
Keywords: Medication errors, health professionals, Nigeria
Abstract: OBJECTIVE: The study aimed to identify healthcare providers’ obligation towards medical errors disclosure as well as to study the association between the severity of the medical error and the intention to disclose the error to the patients and their families. DESIGN: A cross-sectional study design was followed to identify the magnitude of disclosure among healthcare providers in different departments at a randomly selected tertiary care hospital in Dubai. SETTING AND PARTICIPANTS: The total sample size accounted for 106 respondents. Data were collected using a questionnaire composed of two sections namely; demographic variables of the respondents…and a section which included variables relevant to medical error disclosure. RESULTS: Statistical analysis yielded significant association between the obligation to disclose medical errors with male healthcare providers (X2 = 5.1), and being a physician (X2 = 19.3). Obligation towards medical errors disclosure was significantly associated with those healthcare providers who had not committed any medical errors during the past year (X2 = 9.8), and any type of medical error regardless the cause, extent of harm (X2 = 8.7). Variables included in the binary logistic regression model were; status (Exp β (Physician) = 0.39, 95% CI 0.16–0.97), gender (Exp β (Male) = 4.81, 95% CI 1.84–12.54), and medical errors during the last year (Exp β (None) = 2.11, 95% CI 0.6–2.3). CONCLUSION: Education and training of physicians about disclosure conversations needs to start as early as medical school. Like the training in other competencies required of physicians, education in communicating about medical errors could help reduce physicians’ apprehension and make them more comfortable with disclosure conversations.
Abstract: BACKGROUND: Actual assessment methods for identifying adverse events (AEs) in clinical trials have received less scrutiny than underreporting of AEs. OBJECTIVE: To investigate whether AE assessment has changed over time for three psychotropic drugs with turbulent histories of safety concerns since their U.S. approval. METHODS: From industry-funded published trials of atomoxetine, duloxetine, and olanzapine retrieved from PubMed for 1996–2004 (n = 33) and 2009–2014 (n = 40), verbatim AE assessment and numbers of words describing efficacy and safety assessment were extracted. RESULTS: Closest to drug approval (1996–2004), 77.8% of atomoxetine trials used open-ended questioning only,…50% of duloxetine trials used spontaneous self-report or clinician observation only, and 66.7% of olanzapine trials used a scale (primarily for extrapyramidal symptoms) and one former method. Recent studies (2009–2014) showed less rigor and transparency: 35.3% of atomoxetine and 64.7% of duloxetine studies reported no AE assessment method and 50% of olanzapine studies no longer used scales. Overall, the mean number of words describing efficacy assessment increased from 202 to 309 but decreased from 83 to 63 for safety. CONCLUSION: Trial methodology for assessing psychotropic drug safety remains an underdeveloped area with major public health implications.
Keywords: Drug safety, clinical trial methodology, psychotropic drugs, adverse events
Abstract: BACKGROUND: There is limited information on actions taken in response to drug safety signals originating from a spontaneous reporting system (SRS) in pharmacovigilance. In The Netherlands the Pharmacovigilance Centre Lareb is an independent organization that works in close collaboration with the Dutch regulatory agency, the Medicines Evaluation Board (MEB). OBJECTIVE: The objective of this study is to gain insight in steps undertaken on signals originating from the SRS and disseminated by Lareb from 2008–2012. METHOD: For all signals the recommendations of Lareb and the following steps proposed by the MEB were analyzed. Secondary outcomes were…prioritization of the signal, the year of dissemination and if Lareb published (inter)nationally about the signal. Pearson’s Chi-square (X2 ) and Mantel-Haenszel statistics were used for statistical analysis. RESULTS: Of all signals disseminated by Lareb from 2008–2012, 90,7% resulted in an action: in 87% a regulatory action and in 36% an (inter)national publication. Generally, Lareb’s recommendations correspond to steps undertaken by the MEB. CONCLUSION: This study found influence of signal prioritization on Lareb’s recommendations but not on the steps undertaken by the MEB. Trends over time were only seen for steps undertaken by the MEB. These differences are most probably due to responsibilities of the different EU member states of various drugs.
Keywords: Adverse drug reactions (ADRs), pharmacovigilance, signals, post marketing drug safety