Trend Analysis of Patient Safety Incidents and Their Associated Factors in Korea Using National Patient Safety Report Data (2017~2019)

This study analyzed trends in patient safety incidents (PSIs) and the factors associated with the PSIs by analyzing 2017–2019 Patient Safety Report data in Korea. We extracted 2940 records in 2017, 5889 in 2018, and 7386 in 2019, from hospitals with more than 200 beds, and used all 16,215 cases for analysis. SPSS 25.0 was used for a multi-nominal logistic regression analysis. The PSI trend analysis, the standardized Jonckheere–Terpstra test was significant. On analyzing the probability of adverse events based on near misses, the significant variables were patient age, the season when PSIs occurred, incident reporter, hospital size, the location of PSIs, the type of PSIs, and medical department. Additionally, the factors that were likely to precipitate sentinel events based on near misses were patient sex, patient age, incident reporter, the type of PSIs, and medical department. To prevent sentinel events in PSIs, female and older patients are required to pay close attention. Moreover, it is necessary to establish a patient safety reporting system in which not only all medical personnel, but also patients, generally, can actively participate in patient safety activities and report voluntarily.

Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

Trend of strengthening clearance regulation in Japan and concerns about its worldwide effects on regulations for natural and artificial radionuclides

The Nuclear Regulation Authority (NRA) of Japan invited comments from the public on a revised guide on measurement and evaluation for clearance in 2019, which included a strict decision on how to treat uncertainties in the measurement and the nuclide vector. To resolve the issue on the uncertainty in clearance, a probabilistic approach had been established previously in the Atomic Energy Society of Japan Standard and incorporated into International Atomic Energy Agency (IAEA) Safety Report No. 67. NRA’s new decision on the uncertainty in clearance was up to 10 times stricter than the probabilistic approach. This issue has been discussed at an international level in the framework of the ongoing revision of IAEA Safety Guide RS-G-1.7. This discussion on the uncertainty in clearance has raised serious concerns about its effects on other radiological protection regulations worldwide. This is because if we need strict treatment for the uncertainty in clearance, the same or even stricter treatment for conformity assessment may have to be applied to other radiological protection criteria for doses exceeding 10 µSv year−1. Radiological protection experts including regulators, professionals, and operators should be aware of the essential meaning of the radiological protection criteria by considering the background scientific basis on which they were established.

245. The impact of patient safety report and sentinel events on the prescribing and practice habits of infectious disease physicians

Background Adverse events associated with antimicrobials range from mild to severe and may cause distress or harm to patients, and anxiety for prescribers. The basic tenets of prescribing antimicrobials are based on knowledge of the disease, pharmacokinetics, and pharmacodynamics of the prescribed agent, and effectiveness of the therapy. Inappropriate prescribing can increase costs and may cause reactions or the emergence of resistance. There is a paucity of published data on the prescribing habits of physicians after a sentinel event or patient safety report. Thus, we carried out this study to ascertain whether patient safety reports and sentinel events influence physician antimicrobial prescribing practices Methods We invited Infectious Disease physicians at the University of Florida to participate in a survey of their perception of risks and prescribing habits after a sentinel event. Participants were interviewed using a standardized questionnaire. Data were analyzed using Epi Info statistical software. Thematic analyses were performed on the open-ended interview questions. Results Of 17 faculty and fellows who participated in the survey, 5 (29.4%) had been practicing infectious disease for 1–3 years, 3 (17.6%) for 4–6 years, 2 (11.7%) for 7–9 years, and 7 (41.1 %) for >nine years. Two (11.7%) had a patient safety report filed against them. All participants had experienced at least one sentinel event involving an antimicrobial agent. Sixteen (94%) changed their practice after sentinel events; 8 (47%) increased the frequency of ordering laboratory tests, and 7 (41%) indicated they might change to more expensive antimicrobials with better safety profiles. Eight (47%) participants endorsed hypervigilance when using antibiotics Conclusion We found that sentinel events affect physicians’ prescribing practices and monitoring of antimicrobial therapy. The most frequent changes included closer follow-up and obtaining more laboratory tests. However, some participants avoided certain antimicrobial agents or used more expensive therapies with better safety profiles. Although physicians use evidence-based medicine to alter their prescribing habits, serious adverse events can have an impact on the way we practice Disclosures Jonathan J. Cho, MD, Novartis (Shareholder)