International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press

Authors: Mulchandani, Rubina | Kakkar, Ashish Kumar

Article Type: Research Article

Abstract: Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug’s life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians’ perceptions towards reporting, problems with establishing reporting systems in hospitals and …insufficient training to recognize ADRs. Measures to improve the situation include greater involvement of nurses, pharmacists as well as consumers in the reporting of ADRs, making the process simpler and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading awareness about the reporting system amongst caregivers and receivers alike. Providing a momentum to the pharmacovigilance system and ensuring a robust reporting process is a challenge but proper planning, feasible solutions and focussed efforts can help bring about the change ensuring patient safety - the ultimate goal of pharmacovigilance. Show more

Keywords: Adverse drug reactions, spontaneous reporting, underreporting

DOI: 10.3233/JRS-180025

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-12, 2018

Authors: Omidi, Leila | Akbari, Reihane | Hadavandi, Esmaeil | Zareid, Esmaeil

Article Type: Research Article

Abstract: BACKGROUND: Patient safety culture (PSC) as a main component of the organizational culture plays a key role in providing safe, effective and economic cares and services in healthcare organizations. PSC provides a way to assist hospitals in order to improve patient safety and prevent medical errors. OBJECTIVE: The present study aimed to measure PSC and healthcare professionals’ attitude towards voluntary reporting of adverse events in two hospitals in Iran and to develop a hybrid intelligent approach for modeling PSC grades. METHODS: The Hospital Survey on Patient Safety Culture (HSOPSC) questionnaire and a two-part questionnaire were used …for examining the PSC and healthcare professionals’ attitude towards voluntary reporting of adverse events, respectively. Principal component analysis (PCA) was applied to extract of the main components in the HSOPSC questionnaire and to construct 12 dimensions of safety culture. The overall grade of patient safety culture was modeled using adaptive neuro-fuzzy inference systems (ANFIS) as a classification problem. RESULTS: Almost half of the participants have experienced a medical error and adverse events. The PSC grade was acceptable from the point of view of 55.5% and 50% of participants in hospital No.1 and hospital No.2, respectively. The overall accuracy of ANFIS in modeling overall grades of patient safety culture in both study hospitals was 0.84. Of those individuals gave an acceptable grade on patient safety culture in both study hospitals, more than 50% believed that all medical errors and near misses should be reported. CONCLUSIONS: The ANFIS algorithm was proposed for modeling and predicting of PSC for healthcare organizations. The results confirm the capability of the proposed model to predict patient safety grades in healthcare settings. Show more

Keywords: Patient safety culture, principal component analysis, ANFIS, medical error, adverse events

DOI: 10.3233/JRS-180036

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-14, 2018

Authors: Konishi, Yasutaka | Nakata, Yoshinori | Nemoto, Asuka | Ushijima, Masaru | Matsuura, Masaaki

Article Type: Research Article

Abstract: OBJECTIVE: Self-extubation of tubes and catheters causes various adverse events in postoperative patients. We investigated preoperative risk factors associated with self-extubation. DESIGN: A matched case-control study. SETTING: Teikyo University Hospital. PARTICIPANTS: Postoperative patients over 50 years old. METHODS: Sixty-five patients with a comment in the incident report about self-extubation within 7 postoperative days were recruited for the case group. One hundred ninety-five matched patients in the control group were randomly recruited from an electronic medical record. This group was three times larger than the case group. The matching factors were age, sex, …type of tube, duration of tube insertion, and year of the incident. Conditional multiple logistic regression analysis was performed. RESULTS: Sixty-five self-extubation events occurred, and constituted 6.5% of 996 postoperative incident reports. Three significant preoperative risk factors were abdominal operation (odds ratio [OR], 3.21; 95% confidence interval [95% CI], 1.05–10.83), history of dementia (OR, 10.71; 95% CI, 1.45–132.55), and preoperative hemoglobin level (OR, 0.77 per 1.0 g/dL increase; 95% CI, 0.62–0.96). CONCLUSIONS: Elderly patients with a history of dementia and low preoperative hemoglobin are at a risk of postoperative self-extubation, especially after an abdominal operation. These predictors can contribute to the more effective prevention of perioperative self-extubation. Show more

Keywords: Self-extubation, delirium, postoperative, predictor, elderly

DOI: 10.3233/JRS-180011

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-10, 2018

Authors: Schepel, Lotta | Lehtonen, Lasse | Airaksinen, Marja | Ojala, Raimo | Ahonen, Jouni | Lapatto-Reiniluoto, Outi

Article Type: Research Article

Abstract: BACKGROUND: 10– 30% of hospital stays by older patients are drug-related. The admission phase is important for identifying drug-related problems, but taking an incorrect medication history often leads to medication errors. OBJECTIVES: To enhance medication history recording and identify drug-related problems (DRPs) of older patients admitted to emergency departments (EDs). METHODS: DRPs were identified by pharmacists-led medication reconciliation and review procedures in two EDs in Finland; Helsinki University Hospital (HUS), and Kuopio University Hospital (KUH). One-hundred-and-fifty patients aged ≥65-years, living at home and using ≥6 medicines were studied. RESULTS: 100% of patients (N = 75) …in HUS and 99% in KUH (N = 75), had discrepancies in their admission-medication chart recorded by the nurse or physician. Associations between admission-diagnosis and drug-related problems were found in 12 patients (16%) in HUS and 22 patients (29%) in KUH. Of these, high-alert medications (e.g. antithrombotics, cytostatics, opioids) were linked to eight patients (11%) in HUS and six patients (8%) in KUH. Other acute DRPs were identified in 19 patients (25%) in HUS and 54 patients (72%) in KUH. Furthermore, 67 patients (89%) in HUS and all patients in KUH had non-acute DRPs. CONCLUSIONS: Medication reconciliation and review at admission of older ED patients requires improvement in Finland. Show more

Keywords: Emergency department, medication reconciliation, medication review, drug-related problems, older patients, clinical pharmacy, high-alert medications, polypharmacy

DOI: 10.3233/JRS-180030

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-13, 2018

Authors: Healy, David | Le Noury, Joanna | Jureidini, Jon

Article Type: Research Article

Abstract: The data supporting the use of “antidepressants” in children and adolescents is largely unavailable. Academic publications give a different picture as regards benefits and harms to publications from regulatory other sources. Despite disagreements about the data driving use of these medicines, in practice “antidepressants” may now be the most commonly used drugs by adolescent girls, and children’s mental health services are attracting increasing attention. This paper reviews the difficulties surrounding the data. It outlines a case for benefits (as well as risks) that would require physicians to exert a greater degree of professional autonomy than service managers might wish.

Keywords: Antidepressants, SSRIs, RCTs, anxiolytic, depression

DOI: 10.3233/JRS-180746

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-7, 2018