International Journal of Risk & Safety in Medicine - Volume 34, 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: Hand surgical procedures are common interventions in elective and emergency settings. The complex nature of the injuries and management by multiple specialities could be a potential source of medical errors and never events (NEs). Awareness of the common NEs could potentially help prevent their occurrence in the future. OBJECTIVE: To analyse the NHS England database to identify the common NEs in hand surgery and present a simple, practical safety checklist for hand surgery. METHODS: The NHS NEs database from 2012 to 2021 has been analysed to identify the common hand surgery-related never events. We identified…the common categories and themes within. Our theme development process is based on anatomical considerations and the nature of the incidents. Additionally, we designed a simple Safety Checklist for hand surgery. RESULTS: We identified a total of 3742 never events with 50 incidents related to hand surgery, representing (1.3%). Wrong-site surgery was the commonest category (n = 30), representing 60% of the hand surgery-related NEs. We identified seven different themes under wrong-site surgery. Wrong finger or digit surgery was the commonest theme, with 17 reported incidents representing 57% of wrong-site surgeries. This is followed by five wrong digits injections and three wrong k wire placements representing 16.6% and 10%, respectively. The second most common category was wrong incisions (n = 15), representing 30%; 13 patients had wrong finger incisions. Two patients had carpal tunnel incisions before surgeons realised that the procedures were for trigger finger release. The third category included four wrong procedures, with two incidents of carpal tunnel release instead of trigger finger operation or Dequervain tendon release. Finally, one patient had an injection for carpal tunnel intended for another patient. CONCLUSION: Hand surgery-related NEs represent a small fraction (1.3%) of all NEs within the NHS database. We identified 50 hand surgery-related NEs arranged into 14 different themes. Additionally, we proposed a hand surgery-specific safety checklist to reduce the incidence of these incidents in the future.
Keywords: Never events, medical errors, claims, NHS, patient safety
Abstract: BACKGROUND: Nurses, who are the last safeguard against and have the final opportunity to prevent medication errors (MEs), play a vital role in patient safety by managing medications. OBJECTIVE: This study described the characteristics of medical dispute cases, medication information, and stage and types of MEs in Korea. METHODS: We performed a descriptive analysis of 27 medical dispute cases related to MEs in nursing care in Korea. RESULTS: Around 77.7% of patients suffered serious harm or died due to MEs in this study. The types of medications included anxiolytics and analgesics, and 51.9% of…them were high-alert medications. Among cases of administration errors, failure to patient assessment before and after administration was the most common error followed by administering the wrong dose. CONCLUSION: Nurses should perform their duties to ensure safety and improve the quality of nursing care by monitoring patients after administering medications and should be prepared to take quick action to reduce harm.
Keywords: Medication error, nursing, patient safety, medical dispute, malpractice
Abstract: BACKGROUND: Never Events represent a serious problem with a high burden on healthcare providers’ facilities. Despite introducing various safety checklists and precautions, many Never Events are reported yearly. OBJECTIVE: This survey aims to assess awareness and compliance with the safety standards and obtain recommendations from the National Health Service (NHS) staff on preventative measures. METHODS: An online survey of 45 questions has been conducted directed at NHS staff involved in invasive procedures. The questions were designed to assess the level of awareness, training and education delivered to the staff on patient safety. Moreover, we designed a…set of focused questions to assess compliance with the National Safety Standards for Invasive Procedures (NatSSIPs) guidance. Open questions were added to encourage the staff to give practical recommendations on tackling and preventing these incidents. Invitations were sent through social media, and the survey was kept live from 20/11/2021 to 23/04/2022. RESULTS: Out of 700 invitations sent, 75 completed the survey (10.7%). 96% and 94.67% were familiar with the terms Never Events and near-miss, respectively. However, 52% and 36.49% were aware of National and Local Safety Standards for Invasive procedures (NatSSIPs-LocSSIPs), respectively. 28 (37.33%) had training on preventing medical errors. 48 (64%) believe that training on safety checklists should be delivered during undergraduate education. Fourteen (18.67%) had experiences when the checklists failed to prevent medical errors. 53 (70.67%) have seen the operating list or the consent forms containing abbreviations. Thirty-three (44%) have a failed counting reconciliation algorithm. NHS staff emphasised the importance of multi-level checks, utilisation of specific checklists, patient involvement in the safety checks, adequate staffing, avoidance of staff change in the middle of a procedure and change of list order, and investment in training and education on patient safety. CONCLUSION: This survey showed a low awareness of some of the principal patient safety aspects and poor compliance with NatSSIPs recommendations. Checklists fail on some occasions to prevent medical errors. Process redesign creating a safe environment, and enhancing a safety culture could be the key. The study presented the recommendations of the staff on preventative measures.
Keywords: Never Events, avoidable medical errors, claims, NHS, patient safety, survey
Abstract: BACKGROUND: Pharmacovigilance risk signals have proposed a relationship between the use of acid-suppressive medications and the development of certain autoimmune and immune-mediated inflammatory diseases. OBJECTIVE: A systematic review and a meta-analysis was performed. METHODS: We reviewed MEDLINE (Ovid) and Scopus for comparative observational studies between these diseases and previous exposure to proton-pump inhibitors (PPI), H2-receptor antagonists (H2RA), and antacids. The protocol was registered on the PROSPERO database (CRD42020192715). RESULTS: From 3,191 citations, 25 articles were eligible and covered 16 diseases. Microscopic colitis (MC) was studied the most (7 studies). In a random-effects meta-analysis, there…was low certainty evidence (GRADE approach) of a non-significant relationship between exposure to any PPIs and MC (meta-OR 3.28, 95% CI 0.98–11.0, I2 98.2%, six studies, 4,436 PPI-exposed MC patients). Moderate certainty evidence pointed towards large odds of collagenous colitis after exposure to lansoprazole (meta-OR 14.5, 95% CI 9.37–22.3, I2 10.2%, three studies, 1,725 lansoprazole-exposed patients). After PPI exposure, the risk of rheumatoid arthritis was slightly increased based on low certainty evidence from two cohort studies totaling 475 diagnoses (meta-RR 1.62, 95% CI 1.12–2.34, I2 34.5%). CONCLUSIONS: In patients with MC, it would be reasonable to carefully review the indication of PPI, especially in CC patients using lansoprazole.
Abstract: BACKGROUND: Antimicrobial resistance (AMR) is promoted by inappropriate use and is a greater burden for low to middle income countries (LMIC) than high income countries (HIC). OBJECTIVE: This systematic review aimed to compare the awareness of inappropriate use related to AMR among medical doctors from LMIC and HIC using published knowledge, attitude and practice (KAP) studies. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, sequential systematic literature search of PubMed and Web of Science databases for articles published since inception up to June 1, 2022 for KAP studies involving medical doctors. Using fifteen…KAP items related to promoting AMR, data on proportion of participants responding affirmatively was extracted and reported using means, ranges and 95% confidence intervals (CI). RESULTS: Forty-two studies met the inclusion criteria and involved 13,089 medical doctors from 11HIC and 21LMIC. All were cross-sectional studies, 71.4% involved non-probability sampling and 78.6% were of satisfactory quality. Knowledge items showed mean proportion of more medical doctors responding correctly. Similar affirmation trends were observed for attitude and prescribing practice items. Awareness appeared similar between medical doctors of the economic groups, except for a greater interest in training for LMIC (95.4%; 95%CI 93.0%, 97.9%) versus HIC (81.7%; 95%CI 65.6%, 97.9%). Countries with poor proportions were identified in both economic groups. CONCLUSION: For identified studies, trends suggest good awareness among medical doctors of the known inappropriate use and perceived threat of AMR, as well as prescribing practices to reduce the risk of AMR. Trends were similar across HIC and LMIC; however, countries with evidence of poor awareness exist in both economic groups.
Keywords: Antimicrobial resistance, medical doctors, inappropriate use
Abstract: BACKGROUND: Epilepsy is one of the most common chronic neurological disorders, affecting more than 50 million people globally. In this review we summarised the evidence from randomised controlled trials of gabapentin used as monotherapy for the treatment of focal epilepsy, both newly diagnosed and drug-resistant, with or without secondary generalisation. OBJECTIVE: To assess the effects of gabapentin monotherapy for people with epileptic focal seizures with and without secondary generalisation. METHODS: We searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 24 February 2020) on 25 February 2020. CRS Web includes randomised or…quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRA), and the specialised registers of Cochrane Review Groups including the Cochrane Epilepsy Group. We also searched several Russian databases, reference lists of relevant studies, ongoing trials registers, conference proceedings, and we contacted trial authors. RESULTS: We found five randomised controlled trials (3167 participants) comparing gabapentin to other antiepileptic drugs (AEDs) and differing doses of gabapentin as monotherapy for newly diagnosed focal epilepsy and drug- resistant focal epilepsy with or without secondary generalisation. Two review authors independently applied the inclusion criteria, assessed trial quality, risk of bias, and extracted data. We used the GRADE approach to assess the certainty of evidence and present seven patient-important outcomes in the “Summary of findings” tables. The quality of evidence was very low to moderate due to poor reporting quality, poor trial design, and other risks of bias, such as selective presentation of findings and potential heavy industry input. Better quality research may change our certainty in the effect estimates. None of the included trials reported on the number of people with 50% or greater reduction in seizures and time to withdrawal (retention time) in an extractable way. Gabapentin-treated participants were more likely to withdraw from treatment for any cause (285/539) than those treated with lamotrigine, oxcarbazepine, or topiramate pooled together (695/1317) (RR 1.13, 95% CI 1.02 to 1.25; 3 studies, 1856 participants; moderate-certainty evidence), but not carbamazepine. Fewer people treated with gabapentin withdrew from treatment owing to adverse events (190/525) than those treated with carbamazepine, oxcarbazepine, or topiramate (479/1238), (RR 0.79, 95% CI 0.69 to 0.91; 1763 participants, 3 studies; moderate-certainty evidence), but not lamotrigine. CONCLUSION: Gabapentin as monotherapy probably controlled seizures no better and no worse than comparator AEDs (lamotrigine, carbamazepine, oxcarbazepine, and topiramate). Compared to carbamazepine, gabapentin was probably better in retaining people in studies and preventing withdrawals due to adverse events. The most common side effects associated with gabapentin were ataxia (poor co-ordination and unsteady gait), dizziness, fatigue, and drowsiness.
Abstract: BACKGROUND: The prescription opioid epidemic in the United States (US) is well documented, and recent measures have reduced prescribing rates in that country. Evidence suggests opioid prescriptions have been rising recently in other countries too. OBJECTIVE: The current paper aimed to compare trends in opioid prescribing in England and the US. METHODS: Trends in rates of prescriptions per 100 members of the population were calculated for England and the US using publicly available government data on prescriptions and population statistics. RESULTS: Rates of prescribing are converging. At the peak of the US epidemic in…2012, there were 81.3 prescriptions per 100 people, but this had fallen to 43.3 by 2020. Prescribing peaked in England in 2016 at 43.2 prescriptions per 100 people, but has fallen only slightly, so that in 2020 there were 40.9 prescriptions per 100 people. CONCLUSION: The data indicate that levels of opioid prescribing in England are now similar to those in the US. They remain high in both countries, despite recent falls. This suggests the need for further measures to prevent over-prescribing and to support people who would benefit from withdrawing from these drugs.