Safety Advisory Research Articles

Introduction of a Novel Patient Safety Advisory: Evaluation of Perceived Information With a Modified QPP Questionnaire-A Case-Control Study.

Adverse events (AEs) may result in serious injuries or death. AEs occur in approximately 9.2% of hospitalizations, with a potential preventability of 43.5%. The aim of this study was to examine whether use of an illustrated patient safety advisory affected information transfer to inpatients regarding how they can participate in their own care to decrease the risk of AEs. All patients in the control (n = 129) and case/intervention (n = 511) groups received verbal information from healthcare personnel. The intervention group also received the illustrated patient safety advisory, "Your safety at the hospital." Before discharge, patients completed the Quality from the Patient's Perspective questionnaire. Mean patient age was 64.6/62.4 years in the intervention/control group, respectively, and 50% were men. Significant differences between groups were observed for most questions presented from the perceived reality of care perspective, in favor to the intervention group. Patients at surgical wards indicated higher scores on 9 of 12 Quality from the Patient's Perspective questions. Patients with hospital stays ≥4 days, at surgical wards, and living with someone else, placed higher subjective importance to questions concerning, e.g., protection/infection, nutrition, risk of falls and pressure ulcers, and discharge information. Using an illustrated patient safety advisory to complement oral information about patient safety risks resulted in positive responses and a significant difference was demonstrated in how information is perceived. The safety advisory could be used as a tool to decrease AEs. Patients who live alone may need more focused patient safety information to encourage involvement in their own care.

Impact of the US Food and Drug Administration warning regarding increased risk of aortic aneurysms or aortic dissections on fluoroquinolone prescribing trends

BackgroundThe US Food and Drug Administration (FDA) issued a warning in December 2018 regarding an increased risk of aortic aneurysms and aortic dissections associated with fluoroquinolone (FQ) use. This warning...

Pendampingan Prosedur Keselamatan Kerja pada UMKM Produksi Furniture CV Rumah Menyala di Kabupaten Batang

The furniture industry is a strategic commodity supporting national foreign exchange. Indonesia has great potential in developing this industry, supported by the availability of raw materials such as wood, rattan, and bamboo and an abundant workforce. However, workplaces in this sector, both formal and informal, have various potential hazards that can affect the health and safety of workers. This research aims to provide stimulus in the form of Personal Protective Equipment (PPE) and work safety signs to CV Rumah Menyala furniture MSMEs in Tegalsari Village, Kandeman, Batang, to improve worker safety and health. This activity includes the formation of an Occupational Safety and Health Advisory Committee (P2K3), education regarding hazard and risk mapping, and preparing work safety SOP documents. The activity results show increased worker awareness regarding the importance of using PPE and managing work safety. However, ongoing efforts are still needed to implement work safety SOPs with discipline. In this way, it is hoped that the risk of occupational diseases and work accidents can be minimized to increase worker productivity

A rapid and efficient method using electroporation for releasing intracellular microcystin toxins from cultured and naturally occurring cyanobacterial cells in lake water

In cyanotoxin measurements, effective release of intracellular cyanotoxins through cell lysis is pivotal. The conventional method for cell lysis is repeated freeze-thaw (F-T), which has several disadvantages, including poor reproducibility since it is operator and equipment dependency and time-consuming. In this study, a rapid and sensitive method was developed using irreversible electroporation, reducing quantification time by over 6 h compared to F-T. Focusing on microcystins (MCs), we developed the most optimal electroporation medium (50 mM Tris (pH 7.0) with 0.5 % SDS) and determined the optimal intensity of electroporation using Microcystis culture. Microcystis cell rupture was validated by scanning electron microscopy. COMSOL simulations mirrored experimental conditions. Compared to F-T, this new method generated an average 13.7 % (6.7 ppb) more MCs from lake water samples (p ≥ 0.05). This innovation, surpassing the time-consuming F-T process, emerges as a valuable tool for timely decision-making in water safety advisory and cyanotoxin management in various settings.

Linking coastal environmental and health observations for human wellbeing.

Coastal areas have long been attractive places to live, work, and recreate and remain so even in the face of growing threats from global environmental change. At any moment, a significant portion of the human population is exposed to both positive and negative health effects associated with coastal locations. Some locations may be "hotspots" of concern for human health due to ongoing climatic and other changes, accentuating the need for better understanding of coastal environment-human health linkages. This paper describes how environmental and health data could be combined to create a coastal environmental and human health observing system. While largely based on information from the US and Europe, the concept should be relevant to almost any coastal area. If implemented, a coastal health observing system would connect a variety of human health data and environmental observations for individuals and communities, and where possible cohorts. Health data would be derived from questionnaires and other personal sources, clinical examinations, electronic health records, wearable devices, and syndromic surveillance, plus information on vulnerability and health-relevant community characteristics, and social media observations. Environmental data sources would include weather and climate, beach and coastal conditions, sentinel species, occurrences of harmful organisms and substances, seafood safety advisories, and distribution, proximity, and characteristics of health-promoting green and blue spaces. Where available, information on supporting resources could be added. Establishment of a linked network of coastal health observatories could provide powerful tools for understanding the positive and negative health effects of coastal living, lead to better health protections and enhanced wellbeing, and provide significant benefits to coastal residents, including the historically disadvantaged, as well as the military, hospitals and emergency departments, academic medical, public health, and environmental health programs, and others. Early networks could provide best practices and lessons learned to assist later entries.

Pedagogy of learning: a praxis of industrial safety

This research analyzes the teaching-learning process of the industrial safety training of the Basic Platform Safety Course, developed by the training company Sampling Planning and Industrial Safety Advisory. The course is compulsory for offshore activities in the oil and gas industry in Brazil. When dealing with safety at sea, it is important to start from the premise that navigation imposes an associated danger, derived from the fact that it develops in an environment not conducive to human life, therefore, this theme is of extreme importance. The objective of the research is to evaluate how the learning pedagogy is related to the safety praxis in the offshore work environment. The type of research was based on a case study developed through observation and on-site interview questionnaires. As a data collection instrument, we used document analysis from theoretical tests, practical exercise sheets, grade maps, frequency controls and evaluation questionnaire, provided from the institution. Consolidated data demonstrate that the selected target audience knows and applies industrial safety standards and that the concepts acquired during the course are important in preventing accident risks. It is concluded that education is characterized by being an instrument of theoretical-practical association through information that can intervene in the reality and promote changes in everyday attitudes, leading to new practices for the construction of citizenship.

Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories.

There have been substantial changes in the nature of reporting pathways and review of suspected adverse drug reactions (ADRs) in Australia since the establishment of the now defunct Advisory Committee on Safety of Medicines early in 2010. The aim of this study was to (1) examine the reporting in Australia of suspected ADRs from various sources, including general practitioners (GPs), since 1990; (2) compare the reporting of Australian GPs with that in two other countries (New Zealand and the United Kingdom [UK]) with comparable safety monitoring programmes for the period 2007-2019; and (3) explore the extent to which Australian reporting of suspected adverse reactions has motivated communication to healthcare professionals in the period 1995-2019. Annual reporting of sources of ADRs in Australia were obtained from Government reports, the Australian Statistics in Medicines and Therapeutic Goods Administration (TGA) websites. Details of the annual reporting by GPs in the UK were obtained from published sources and have been provided on request by the Medicines and Healthcare products Regulatory Agency. Details of the annual reporting by GPs in New Zealand were provided on request from the Centre for Adverse Reaction Monitoring. All issues of the Australian Adverse Drug Reactions Bulletin were accessed from the National Library of Australia, and issues of the Medicines Safety Update from February 1995 to December 2019 were accessed online from the TGA website. Each issue was searched to identify and score safety advisories. From 1990 to 2002 in Australia, overall reporting gradually increased, and the three major groups of reporters (GPs, hospitals and sponsors) each contributed about 30%. The relative contributions to reporting changed in the period 2002 to 2009. There was then a steep fall in reporting from GPs and the start of a very marked increase in reporting from product sponsors. GP reporting in Australia was lower than the two other comparable countries (New Zealand and the UK), and continues to fall, while in the UK at least, GP reporting is rising. The analysis of safety advisories shows a relatively stable Australian content from 1995 to 2008, followed by a sharp decline, so that by 2019 and 2020 there was barely any Australian reporting-driven content. In 1995 and 1996, Australian reports of suspected adverse reactions were the sole apparent reason for the publication of safety advisories. From 1997 to about 2008, Australian reports of suspected adverse reactions were the major reason for publication, but after this time, Australian reports became less important. During this later period, the apparent motive for publication of the safety advisory shifted to being based primarily on a publication in the medical literature, or publicity, but was sometimes based on an overseas regulator's advice or action, or action by a product sponsor. It is our contention that the decline in GP reporting in Australia and the current paucity in details of Australian reports in safety advisories are closely linked.

P186 Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis

P186 Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis

Pentosan polysulfate maculopathy: a brief primer for general practitioners, ophthalmologists, optometrists and urologists.

Pentosan polysulfate maculopathy: a brief primer for general practitioners, ophthalmologists, optometrists and urologists.

Patient Safety Advisory: Fentanyl Counterfeit Prescription Medications that Contain Fentanyl and Patient Safety

Patient Safety Advisory: Fentanyl Counterfeit Prescription Medications that Contain Fentanyl and Patient Safety

How might climate change impact water safety and boil water advisories in Canada?

A boil water advisory (BWA) informs the public that there is an increased level of risk associated with their water and that they should boil it before consuming. Studies show that small communities in Canada are particularly likely to experience repeat and long-term BWAs. Climate change has led to changes in precipitation and temperature patterns, leading to region-specific impacts such as increased frequency, severity, or variance in floods, forest fires, droughts, freezing rain, and sea water intrusion. Academic and non-academic “grey” literature was reviewed to establish the most likely impacts of climate change on water treatment and infrastructure. Anonymized data from public drinking water systems in Canada was analyzed to determine the most common causes of BWAs between 2005 and 2020. Most BWAs reported were related to breakdowns/malfunctions along the distribution, though inadequate disinfection residual and turbidity or coliforms in the treated water were also common. Furthermore, statistical analysis of the data showed seasonal trends in some of these parameters. The results of this study suggest that increased precipitation, flooding, permafrost degradation, and forest fires are likely to have significant impacts on water safety in Canada. Highlights: Climate change effects are expected to worsen many current water challenges. Climate change will disproportionately impact small, rural, and remote water utilities. Water distribution systems are the main source of water safety risk in Canada. Groundwater-supplied systems experience a disproportionate number of BWAs. Seasonal trends in BWA reasons provide opportunities for targeted mitigation.

Water Relief Through Safety or Relief Valves is not Just a Leak

Abstract Two Nuclear Safety Advisory Letters (NSALs), advise operators of PWRs that they may assume, in accident analyses, that certain safety and relief valves can open, relieve water, and then reseat properly. The NSALs claim water that exits the reactor coolant system (RCS) can be made up by water that is delivered into the RCS by the emergency core coolant system (ECCS). For example, during an inadvertent operation of the ECCS (IOECCS) event, The NSALs claim, “since the cause of the water relief is the ECCS flow, the magnitude of the leak will be less than or equivalent to that of the ECCS (i.e., operation of the ECCS maintains RCS inventory during the postulated event and establishes the magnitude of the subject leak).” A comparison of ECCS flow to water relief, at relevant RCS pressures, indicates that water relief, during an IOECCS, cannot be dismissed as a leak. Critical flow calculations indicate that ECCS flow cannot replace RCS inventory that is relieved, as water, through the pressurizer relief and safety valves when RCS pressures are near nominal operating levels. At much lower pressures, the ECCS could offset the water relief. However, by then the IOECCS will have been either resolved, or will have developed into a loss of coolant accident (LOCA). The NSALs were published in 1993 and 2007. NRC did not question the NSALs’ advice until 2015, when it was found in a licensee’s application for a power uprating. The licensee might have submitted a false statement, in support of its application.

IETS management of the challenges associated with embryo pathogen interaction

One of the very first challenges the International Embryo Transfer Society (IETS) addressed was concern about disease transmission via the transfer of in vivo–derived (IVD) bovine embryos. IETS commissioned its Import/Export Committee, later named Health and Safety Advisory Committee (HASAC), to resolve this matter, with the assistance of the Data Retrieval Committee following its formation in 1991. Since its first meeting in 1984, considerable achievements have been made, including meeting the numerous challenges created by the many innovations in this industry. Based on research studies and their designs, the IETS HASAC developed a system for categorising pathogens and diseases potentially susceptible to interaction with IVD embryos. This has been instrumental in defining safe operating protocols and ultimately leading to the development of the now universally accepted techniques for certification of embryo health. The close cooperation of IETS/HASAC with the World Organization of Animal Health (WOAH, formerly OIE) has facilitated the establishment of guidelines for regulators worldwide, thus ensuring the safety of international trade with embryos, while avoiding unjustified regulatory measures. In addition, IETS/HASAC produced and published the IETS Manual: A Procedural Guide and General Information for the Use of Embryo Transfer Technology Emphasising Sanitary Procedures for the embryo transfer industry (1st edition, 1987; 5th edition, 2023). This manual and its updates were designed to provide the industry world-wide with a source of information on safe and sanitary handling procedures for embryos, to describe the procedures necessary to ensure that the transfer of embryos does not result in transmission of pathogenic agents or disease, and to ensure consistent and accurate identification of embryos. The result of these 40 years of IETS/HASAC involvement is that embryo transfer technology is recognised as having a comparative advantage in international movement of germplasm.

Communicating Patient Safety Information Through Video and Oral Formats-A Comparison.

One way to decrease adverse events is to increase patient participation in their own care. Sahlgrenska University Hospital has introduced a patient safety advisory, consisting of an animated video and structured oral information. This article investigates how the animated video and structured oral information regarding was perceived by the patients and determines which communication method the patients preferred. In this study, we compared patients' attitudes toward patient safety information delivered in video or oral format. Data were collected after intervention through a survey consisting of 5 questions. One hundred thirty-four patients were recruited to the study. Ninety-two patients either watched the video or received oral information. Forty-two patients were given both oral information and viewed the video. Information received by the patients was rated as good or very good by 90% of those viewing the video and by 100% who received the oral presentation ( P = 0.007). Of the 42 participants who received both formats, 74% preferred the oral presentation ( P < 0.001). The patients thought the patient safety information to be good and beneficial. An informative video can complement the oral information, but not replace, when informing patients about patient safety. Providing patients with information in a manner they prefer may increase patient's involvement in their care and possibly reduce the risk of adverse events.

Approach to patients with Assurity® and Endurity® pacemakers : Recommendations from the nucleus of the Working Group Electrophysiology and Rhythmology of the German Cardiac Society

In asubset of patients with pacemaker models Assurity® and Endurity® (Abbott, Sylmar, California, USA; worldwide outside the USA approximately 83,000devices), amistake during production may have occurred resulting in insufficient adhesion between the pulse generator header and device housing which in turn may allow moisture to enter the header. This may cause loss of telemetry, switch to back-up mode, reduced battery longevity, or in worst case loss of pacing. Until June 2022, these malfunctions were reported for 128 devices worldwide (0.15%); no permanent harm to patients due to this issue has been reported. The nucleus of the AGEP suggests the following recommendations: (1)Patients with adevice under safety advisory should be informed. (2)The risks for the patient in case of loss of stimulation should be assessed. Patients should be categorized into "likely pacemaker-dependent" (e.g., indication permanent atrioventricular [AV] block, no intrinsic rhythm at the last follow-up, percentage of ventricular pacing in the device memory > 90%), "unknown", or "likely not pacemaker-dependent" (e.g., indication sick sinus syndrome, intrinsic rhythm > 50 bpm at the last follow-up, percentage of ventricular pacing in the device memory < 1%). (3)In likely pacemaker-non-dependent patients, information about this issue should be provided together with an unchanged follow-up or afollow-up with shortened intervals (e.g., every 3months) and/or remote monitoring. (4)In patients with unknown risk if stimulation failure occurs, at least follow-up intervals should be shortened to, for example, 3months and/or remote monitoring should be initialized. In addition, risks and benefits of adevice exchange should be weighed against each other. (5)In patients who are likely pacemaker-dependent, device exchange is recommended.

How do safety warnings on medicines affect prescribing?

ABSTRACT Introduction Many adverse effects of medicines only become known after approval, prompting regulatory agencies to issue post-market safety advisories to support safer care. Our team evaluated advisories issued by national regulators in Australia, Canada, Denmark, the United Kingdom, and the United States from 2007 to 2016 inclusive, comparing regulators’ decisions to warn, effects on prescribing, doctors’ awareness and responses to warnings, relevant regulatory policies, and specific case studies. Areas Covered Based mainly on our research program and a narrative review, this commentary describes how often regulators issue safety advisories and effects on clinical practice. We found extensive differences in decisions to warn, timing and content of warnings. Monitoring advice is often inadequate. The most systematic estimate suggests an average reduction in prescribing of around 6% compared with settings with no advisory. Interviews with doctors suggest limited awareness, uptake, and at times belief in these warnings. Expert Opinion Post-market safety advisories are an important intervention aiming to improve prescribing and use of medicines. However, differing warnings mean that some patients may be exposed to riskier prescribing than others. Better integration of safety information into clinical practice is needed, as well as improved transparency, independence, and public engagement in regulatory decision-making.

Persisting symptoms after concussion: Time for a paradigm shift.

Persisting symptoms after concussion: Time for a paradigm shift.

A Discussion on Accessibility, Inclusivity, Cultural Design Considerations, and Health &amp; Safety Advisories for Virtual Reality Head Mounted Displays

With the exponential growth in availability of Virtual Reality (VR) head-mounted displays (HMDs), this study aims to discuss Health &amp; Safety advisory information provided by VR products and observe the extent to which each platform considers accessibility and inclusive and culturally informed design. To this end, five commercially available PC-based VR HMDs, and their corresponding setup applications were assessed in this study - the Oculus Quest 2, Oculus Rift S, Samsung Odyssey, HTC Vive Pro, and Varjo XR-3. Three proto personas were created to evaluate these platforms from various perspectives. VR HMDs are moving in the right direction to consider diverse populations in animation design, but there is room for improvement regarding individuals with visual, auditory, or mobility restrictions. Advancements in multimodal sensory cues and inclusive design considerations may increase adoption of VR technologies as well as compliance with Health &amp; Safety advisory information

A Discussion on Accessibility, Inclusivity, Cultural Design Considerations, and Health &amp; Safety Advisories for Virtual Reality Head Mounted Displays

With the exponential growth in availability of Virtual Reality (VR) head-mounted displays (HMDs), this study aims to discuss Health &amp; Safety advisory information provided by VR products and observe the extent to which each platform considers accessibility and inclusive and culturally informed design. To this end, five commercially available PC-based VR HMDs, and their corresponding setup applications were assessed in this study - the Oculus Quest 2, Oculus Rift S, Samsung Odyssey, HTC Vive Pro, and Varjo XR-3. Three proto personas were created to evaluate these platforms from various perspectives. VR HMDs are moving in the right direction to consider diverse populations in animation design, but there is room for improvement regarding individuals with visual, auditory, or mobility restrictions. Advancements in multimodal sensory cues and inclusive design considerations may increase adoption of VR technologies as well as compliance with Health &amp; Safety advisory information

Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study

PurposeNational regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age‐ and sex‐based impacts in each country.MethodsInterrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs. <65 years) in each country.ResultsPioglitazone use fell in Australia (17%) and the United Kingdom (24%) following the safety advisories. Use of pioglitazone fell more for males (18%) than females (16%) in Australia, and more for females (25%) than males (23%) in the United Kingdom; however, neither difference was statistically significant (Australia p = 0.445, United Kingdom p = 0.462). Pioglitazone use fell to a similar extent among older people than younger people in the United Kingdom (23% vs. 26%, p = 0.354), and did not differ between age groups in Australia (both 18%, p = 0.772).ConclusionsThe results indicate that differences in the Australian and UK safety advisories resulted in substantial reductions in pioglitazone use at the population level in both countries, however, differences by sub‐groups were not observed.