INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

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.

Background: Two-drug regimens antiretroviral therapies are increasingly prescribed to HIV patients, as they are recommended by international guidelines, and they show an excellent efficacy, safety, and tolerability profile. Regimens administered as single tablets (STRs) are usually preferred by patients and they are associated with higher adherence.

Case report: We report two cases of drug-induced hypersensitivity (DIH) that occurred after switching from dolutegravir (DTG) plus rilpivirine (RPV) in separate pills to a fixed dose combination containing the same molecules (DTG/RPV; Juluca®). Following the DIH event, DTG/RPV coformulation was discontinued. At symptomatic resolution, they continued to receive DTG plus RPV in separate pills uneventfully. The component present only in the DTG/RPV coformulation was iron oxide red (E172), contained in the film-coating. Iron oxide red is an approved colorant, used as drug excipient. Patch test with DTG/RV coformulation performed several months after the DIH event was negative. Drug allergy to excipients remains underappreciated and underreported and frequently leads to inappropriate medication discontinuation.

Conclusion: Our case underscores the role of meticulous medication allergy history in differentiating true medication allergy from excipient allergy. This observation may be useful in the era of antiretroviral simplification to two-drug regimens.

Background: Healthtech has become a nascent sector of the internet economy since the emergence of the COVID-19 pandemic in 2020. Telemedicine features are facilitated, such as teleconsultation, e-diagnosis, e-prescribing, and e-pharmacy. However, the intention to use digital health services in Indonesia is still underdeveloped though the sales of other risk-free e-commerce products are high enough.

Objective: This study aims to assess the human perception of perceived value and social influences regarding the intention to use digital health services.

Methods: Google Forms web link is employed to disseminate a set of 4-Point Likert scale questionnaires. In total, 364 complete responses are collected. A descriptive approach is employed to process the data using Microsoft Excel and SPSS software. Validity and reliability are quantified using the item total-correlation method and Cronbach's Alpha coefficient.

Results: Only 87 respondents (24%) ever used digital health services, of which Halodoc (92%) is the most preferred application, and teleconsultation became the most popular service to access. Out of four, the average score is 3.16 for perceived value and 2.86 for the social influence dimension.

Conclusion: Most respondents, not dependent on user experience, perceive more values obtained using digital health services, such as time and money savings, convenience, flexible order time, undiscovered identity, adventurous experience, and enjoyment. Another finding of this research proves that some social influences from family, friends, and mass media also bring effect to amplify the intention to use. A low level of trust is assumed to be the cause of a small number of users.

Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries. In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed. This paper uses three clinical trials to illustrate the problems to be addressed.

Background: Intravenous medications have greater complexity and require multiple steps in their preparation and administration, which is considered a high risk for patients.

Objective: To determine the incidence of intravenous medications preparation and administration errors in critically ill patients.

Methods: This was an observational, cross-sectional, prospective study design. The study was performed in Wad Medani Emergency Hospital, Sudan .

Results: All nurses working at the study setting were observed over nine days. During the study period, a total number of 236 drugs were observed and evaluated. The total error rate was 940 (33.4%), of which 136 (57.6%) errors with no harm, 93 (39.4%) errors with harm and 7 (3%) of errors associated with mortality. 17 different drug categories were involved, in which antibiotic was the highest error rate 104 (44.1%) and 39 different drugs were involved, in which metronidazole was the most drug involved 34 (14.4%). The total error rate was associated with nurse experience, OR (95% CI); 3.235 (1.834-5.706), and nurse education level, OR (95% CI); 0.125 (0.052-0.299).

Conclusion: The study reported high frequency of IV medications preparation and administration errors. Nurse education level, and experiences were influenced the total errors.

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.

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.

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.