International Journal of Risk & Safety in Medicine - Volume 25, issue 3
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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: Health care workers (HCWs) and hematological patients needing blood/ blood product transfusion are particularly vulnerable to blood born infections (BBI) including viral hepatitis. OBJECTIVE: To evaluate knowledge, attitude and practice (KAP) of these target groups regarding viral hepatitis B (HBV) transmission and its change with implementing infection control policy and procedures. METHODS: An anonymous questionnaire with closed questions was used to evaluate KAP including vaccination status in 2 target groups, in Children Hospital, Ain Shams University, Cairo, Egypt: 184 nurses and 210 children and adolescents with blood diseases. One year after instituting infection control as a part of hospital…procedures, the same questionnaire was reused to evaluate KAP towards HBV. RESULTS: Baseline knowledge regarding HBV transmission, sequelae and preventive measures, was poor in both groups. Among nurses, only 62% wore gloves on withdrawing or giving blood to patients, 43.5% routinely washed hands between patients and 37.5% reported exposure after sharp injury. Only 38% of patients and 40% of nurses received HBV vaccination. Targeted infection control policy and procedures significantly improved KAP regarding HBV in both groups. Vaccination coverage significantly increased and reached 88.7% for nurses and 72% for patients. CONCLUSIONS: Hospital based infection control units with established policy and procedures against BBI significantly improved KAP towards HBV including a significant increase in vaccination intake.
Keywords: Knowledge, attitude and practice, Hepatitis B virus, hepatitis B vaccination, health care workers, haematological patients
Abstract: BACKGROUND: Recent reviews of the benefits and risks associated with electroconvulsive therapy (ECT) have often reported mixed and conflicting results. Although there are very few qualitative studies on ECT, qualitative research offers the advantage of in-depth explorations into how people perceive and experience ECT. OBJECTIVE: The objective of this qualitative study was to explore women's experiences and perceptions of the benefits and side effects associated with having ECT. METHODS: The authors used narrative inquiry and in-depth interviews to obtain nine women's accounts and stories of ECT, focusing particularly on their accounts of perceived benefits and side effects associated with ECT.…RESULTS: Qualitative thematic analysis of the interviews with nine women resulted in four main themes emerging from the interviews: “it's sort of like housecleaning,” “I don't remember the wedding,” made me stupider,” and “putting them in a cage with a bear.” CONCLUSIONS: Three of the women were able to articulate some perceived benefit arising from ECT, although these women also acknowledged the benefits did not last more than two weeks. The majority of women complained of significant and persistent autobiographical memory loss, cognitive deficits, and fear of the procedure.
Keywords: Electroconvulsive therapy (ECT), women, memory, qualitative research, mental health
Abstract: AIM: Our objective was to explore communications from drug agencies about benzodiazepine dependence and selective serotonin reuptake inhibitors (SSRIs) withdrawal reactions over time. METHODS: Documentary study. We searched the web-sites of the European Medicines Agency and the drug agencies in USA, UK, and Denmark for documents mentioning benzodiazepines or SSRIs. We supplemented with other relevant literature that could contribute to our study. The searches were performed in 2009 in PubMed, Google, BMJ and JAMA. RESULTS: It took many years before the drug regulators acknowledged benzodiazepine dependence and SSRI withdrawal reactions and before the prescribers and the public were informed. Drug…regulators relied mainly on the definitions of dependence and withdrawal reactions from the diagnostic psychiatric manuals, which contributed to the idea that SSRIs do not cause dependence, although it is difficult for many patients to stop treatment. In the perspective of a precautionary principle, drug agencies have failed to acknowledge that SSRIs can cause dependence and have minimised the problem with regard to its frequency and severity. In the perspective of a risk management principle, the drug agencies have reacted in concordance with the slowly growing knowledge of adverse drug reactions and have sharpened the information to the prescribers and the public over time. However, solely relying on spontaneous reporting of adverse effects leads to underestimation and delayed information about the problems. CONCLUSION: Given the experience with the benzodiazepines, we believe the regulatory bodies should have required studies from the manufacturers that could have elucidated the dependence potential of the SSRIs before marketing authorization was granted.
Keywords: SSRI, benzodiazepine, dependence, withdrawal reaction, drug regulators
Abstract: BACKGROUND: Patient safety culture (PSC) has been postulated to have a significant influence on the quality of health care. OBJECTIVE: This study aims to evaluate the psychometric properties of the TUKU PSC questionnaire. METHODS: The questionnaire development was based on the view that patient safety constitutes not only the absence of adverse events, but also the presence of certain organizational attributes that enable safety. The TUKU questionnaire has two parts: a measure of psychological dimensions, and a measure of employees' perceptions of organizational functions. The TUKU questionnaire was validated using a sample of 1162 health care professionals from seven Finnish…health care organizations. Two studies were carried out, one focusing on construct validity and the other on criterion validity. RESULTS: Regarding construct validity, the empirical model matched the theory quite well. The results of Study 2 concerning criterion validity were more ambiguous. Four of the organizational dimensions and two of the psychological dimensions were related to patient safety incidents occurring 16 months after administering the questionnaire. CONCLUSIONS: The study provided evidence on the key organizational dimensions that comprise patient safety culture and affect patient safety. The study further contributed towards validation of an instrument for measuring these dimensions.
Keywords: Safety management, questionnaire studies, adverse events, patient safety culture, health care management
Abstract: BACKGROUND: Adverse Drug Reactions (ADR) are a major cause of morbidity and mortality worldwide. In spite of this, ADR are largely underreported and unrecognized. PURPOSE: Identify and characterize ADR related admissions to our internal medicine ward using a proactive multidisciplinary pharmacovigilance approach. METHODS: Within 24 hrs of admission 1045 patients admitted to the Internal Medicine Ward between August 2010 and February 2012 were screened for possible or probable ADR related admissions. RESULTS: Probable ADR accounted for 112 of 1045 admissions (10.7%, 95% Confidence Interval [CI]: 8.8–12.6%), of which only 16 (14.3%) were classified as unavoidable. NSAIDs were the drug group…more commonly implicated in probable ADR-related admissions (17.0%), followed by antiplatelets (16.1%). In-hospital mortality of patients admitted due to probable ADR was 8.0% (95% CI: 2.9–13.1%). During this study period, 6% of internal medicine ward and 4% of critical care unit beds were occupied by patients with probable ADR. The estimated cost of care of these patients was 641,000 US dollars (USD). CONCLUSION: ADR are a frequent reason for admission to an Internal Medicine Ward in Argentina. The culprit drugs and interactions are similar to those reported in the literature. The cost is substantial and most of the ADR are potentially avoidable.
Keywords: Drugs, pharmacovigilance, adverse drug reaction