Safety Alerts Research Articles

Insulin safety: what is all the fuss about?

Errors in the prescribing, dispensing and administration of insulin can cause serious harm. Anne Cartwright raises awareness of the risks In 2010 National Patient Safety Alerts produced a rapid response report ‘Safer Use of Insulin’ in response to an increasing number of medication incidents leading to severe harm or death as a result of errors with insulin therapy. In 2017 the World Health Organization launched a global initiative to reduce avoidable medication error by 50% over 5 years. This article aims to raise awareness of the risks of insulin therapy, the common mistakes that can be made in the prescribing, dispensing and administration of insulin, and to inform health professionals who are involved in caring for people on insulin therapy how to reduce the risk of potential harm.

The Potential Teratogenicity Alert for Women Conceiving on Dolutegravir-Based Regimens: An Assessment of Risk Communication by an Urban HIV Clinic in Uganda and Choices made by Women.

A clinic response plan was developed in the first week following the alert and clinic staff were trained on safety guidance. All women aged < 55years taking dolutegravir were identified from the clinic database and contacted by phone for earlier appointments. Non-menopausal and non-surgically sterilized women were referred for urine pregnancy testing and evaluation of pregnancy intentions in the following 12months and effective family planning was offered. We describe the coverage of women who received the communication as well as the fidelity to the outlined plan from 21 May to 12 September, 2018. We used modified a Poisson regression analysis to determine factors associated with switching off dolutegravir. Of all active patients in the clinic, 9% (690/7963) were identified as female aged < 55years taking dolutegravir. Ninety-five percent (656/690) were reviewed by September 2018 and informed of the safety alert, implying a high level of uptake. Fidelity to standard operating procedures was also high at 72%. Twenty-two percent (146/656) of patients were menopausal or surgically sterilized. Five hundred and ten women were of reproductive potential with a median age (interquartile range) of 37years (30-42years). Five percent (23/510) were human chorionic gonadotrophin positive and all initial ultrasound reports revealed no deformities. Twenty-one percent (108/510) had intentions to conceive and opted to stop taking dolutegravir with 90% (97/108) switching to efavirenz. Seventy-nine percent (402/510) opted to remain taking dolutegravir. However, only 40% (160/402) chose effective contraceptive methods and 60% (242/402) opted for condoms only/no contraceptive method. A rapid well-coordinated response ensured prompt communication of the dolutegravir safety warning. The process developed by the clinic can act as a model for response during drug safety alerts. Women made informed decisions with most opting to remain taking dolutegravir; however, effective contraception uptake was low.

Long-Term Follow-Up of Patients With Idiopathic Pulmonary Fibrosis Treated With Pirfenidone or Nintedanib: A Real-Life Comparison Study.

BackgroundPirfenidone and nintedanib are the sole pharmacological therapies currently approved for idiopathic pulmonary fibrosis (IPF). Limited comparison data is available in literature, despite they are both prescribed for mild-to-moderate disease. Here, we describe our almost 10 years real-life experience with antifibrotic treatment to investigate potential differences in terms of efficacy.Population and MethodsWe retrospectively recruited patients diagnosed with IPF and treated with pirfenidone or nintedanib at Siena Referral Center. Clinical, functional, safety and radiological data was collected at baseline and during the follow-up, according to our Center protocol.ResultsWe retrospectively recruited 263 IPF patients (139 treated with pirfenidone and 124 with nintedanib) in the study. After 885.3 ± 559.5 days of observation, the median survival was 1224 days. No significant differences were found between pirfenidone and nintedanib in terms of survival and time to decline of forced vital capacity >10% (p = 0.8786 and p = 0.1677, respectively). A smaller lung diffusion for carbon monoxide (DLCO) decrease was found after 1 year of therapy with nintedanib in respect to pirfenidone (p = 0.0167). Overall, 21 patients permanently discontinued antifibrotic treatment due to side effects (14 with pirfenidone, 7 with nintedanib); no fatal adverse events were recorded.DiscussionOur results showed a similar effectiveness between pirfenidone and nintedanib in terms of mortality and functional disease progression. Both drugs confirmed their good tolerability profile and no new safety alerts were observed. Nintedanib was associated with a smaller reduction of DLCO after 1 year of follow-up compared with pirfenidone, maybe due to its antiangiogenic properties.

Management of Food and Feed Safety Alerts in ATS VAL PADANA (Italy)

Abstract Issue The rapid alert system is a procedure codified in the European Community, designed to guarantee the speed of communications and consequent measures, that should be adopted if a food or feed represents a serious risk for health. Description of the Problem ATS Val Padana implements several measures in cases of food or feed that don't satisfy safety requirements, imported, produced, processed, or distributed by companies located in its area of competence. ATS checks the completeness and effectiveness of the actions undertaken/planned by the food/feed industry operator. The checks are focused on: - Preparation of the distribution list Activation of withdrawal/recall procedures;information provided to consumers;management of the withdrawn products;adoption of measures to prevent the placement of product on the marketAdoption of the traceability systemNotification to the authorities Results In November 2018-November 2019, 205 alerts were registered (11 in 2018, 191 in 2019) and specifically: - Alert notifications (risk requiring rapid action in another country): 154 Information notifications for follow-up (product present or that could be placed on the market in another Member State): 22Information notifications for attention (product present only in the Notifier country or has not been placed on the market or is no longer on the market): 29 The notifications concerned: the Department of Veterinary and Safety of Animal Origin Food(89), the Department of Hygiene and Health Prevention (89), both departments jointly (27). ATS Val Padana has managed the alerts and closed them on average within 7.59 days (DS 5.80, range 0-42). In one case the alert was closed after a month. Lessons The effectiveness of the Alert System depends first of the communications speed, as well as of the guarantee of rapid times to analyze sampled matrices. Our results demonstrate how ATS Val Padana operates ensuring the maximum effectiveness of the Alert System. Key messages The rapid alert system is a codified procedure in the European Community, designed to guarantee the speed of communications and consequent measures. The effectiveness of the Alert System depends primarily on the speed of communications.

P13 Optimising paediatric intravenous fluid management plans: a quality improvement project

IntroductionIntravenous (IV) maintenance fluids are often prescribed post-surgery when enteral routes are contraindicated. Serious consequences have been documented when poor fluid management has occurred, as highlighted in the National Patient Safety Alert (NPSA) 22; reducing the risk of hyponatraemia; when administering IV fluids to children.1 In response to this, the National Institute for Health and Care Excellence (NICE) published their guidance in December 2015 regarding IV fluids in children.2 Based on NICE recommendations, a pan hospital fluid guidance was produced. Within the NICE and hospital’s own guideline it states that there should be a daily fluid management plan documented. It has been well recognised that this daily fluid management plan was not routinely been completed; hence showing non-adherence to our hospital policy and NICE recommendations.AimsPrimary aim was to improve the documentation of the daily fluid management plan; aimed at the medical staff and the secondary aim was to improve the monitoring requirements of IV fluids and documentation of these; largely aimed at the nursing staff.MethodsA simple sticker was designed and attached to continuous sheets for medical notes which had a checklist of monitoring requirements and a section for fluid balance. Additionally, 2 posters were produced; one aimed at medical staff for documenting a fluid management plan and one aimed at the nursing staff with the monitoring requirements. These posters were displayed on the paediatric surgical ward.ResultsA total of 22 patients who were prescribed IV fluids were identified for a baseline measurement, an equal number of patients were compared after the intervention. Neonates and children receiving total parenteral nutrition were excluded from the data collection. There were 41% of daily fluid management plans completed pre intervention and post intervention there were 56% completed; showing a 15% increase in completion. As regards the monitoring indications; there were increases for nursing fluid balance completed from 19% to 46%, blood glucose taken and recorded from 64% to 83% and the daily weight documented from 10% to 49%.ConclusionsThis short QI project shows that implementation of an intervention did improve outcomes across all indications investigated. The results are not as dramatic as first hoped, but this is largely due to the short time scale of 4 weeks to introduce our change and it coincided with the change-over month of junior medical staff. With further education and champions within the medical and nursing teams; further improvement is very much possible, with the main aim in reducing risk and improving patient safety.ReferencesNational Patient Safety Alert: Reducing the risk of hyponatraemia when administering intravenous infusions to neonates 2007. Available at https://www.sps.nhs.uk/articles/npsa-alert-reducing-the-risk-of-hyponatraemia-when-administering-intraveneous-infusions-to-neonates/ [Accessed 12th June 2019]NICE guidance: Intravenous fluid therapy in children and young people in hospital. Available at https://www.nice.org.uk/guidance/ng29 [Accessed 12th June 2019]

Drug-induced skin ulcers: A disproportionality analysis from the WHO pharmacovigilance database

Drug-induced skin ulcers: A disproportionality analysis from the WHO pharmacovigilance database

Drug and medical device product failures and the stability of the pharmaceutical supply chain

ObjectiveOur objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges. MethodsA cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls. ResultsMost recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20). ConclusionsThis study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.

Case Study: Application of a Systematic Quality Improvement Methodology to a Medical Device Safety Alerts Process.

Safety alerts are published by manufacturers of medical devices when unforeseen hazards are identified in the post-market phase of a device's lifecycle. Multiple problems were identified in 2017 with Lower Mainland Biomedical Engineering's process for identifying, assessing and actioning safety alerts. A quality improvement (QI) project utilizing "The Model for Improvement" methodology, was carried out to improve the process. The original process was centralized and relied on a single individual to carry out all alert management responsibilities. A new hybrid process was developed which involves both centralized and decentralized components with responsibilities shared across multiple stakeholders. The QI project resulted in the closure time for assessing and actioning high priority alerts to improve from 200 days in 2017 to 14 days in 2019.

Epipen Safety Alert.

Epipen Safety Alert.

Cuatro años del Programa Nacional de Reactivovigilancia en Colombia

Introducción. El Programa Nacional de Reactivovigilancia (PNR) es un programa pionero en la región de las Américas de vigilancia poscomercialización de los reactivos de diagnóstico in vitro, en Colombia. El objetivo de este estudio fue analizar los resultados de la implementación del PNR en el periodo comprendido entre enero de 2014 y enero de 2018. Materiales y métodos. En los archivos y bases de datos del Grupo de Vigilancia Epidemiológica de la Dirección de Dispositivos y Otras Tecnologías del Invima, se realizó una búsqueda de información para caracterizar las diferentes variables del programa, las cuales se analizaron de forma descriptiva, dependiendo de su naturaleza cualitativa o cuantitativa. Resultados. Se registraron 4.191 inscripciones nuevas en la red; de ellas el 76,7% correspondieron a entidades privadas o prestadores independientes, con cobertura aproximada del 66% de las instituciones colombianas. Se realizaron 78 capacitaciones, 93 asistencias técnicas, y 133 personas fueron certificadas de forma virtual. El 96% de los reportes fueron incidentes, 95,8% fueron realizados por Instituciones Prestadoras de Servicios de Salud (IPS), 17,2% debidos a falsos positivos y 44,3% correspondieron a productos con categoría II, de acuerdo con la clasificación del Invima para el riesgo sanitario. El 74% de los productos analizados pertenecían a la categoría II. Se reportaron 516 monitoreos internacionales. Conclusión. El PNR se constituye como el único en la región de las Américas, y después de cuatro años de iniciar su proceso de implementación, se ha logrado una cobertura importante en actores capacitados, en inscritos a la red y en el reporte de efectos indeseados.

The Problem with Amphotericin.

Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome®) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an organisational level, such as drug supply, storage, dose checking and specifying brand and generic names on prescriptions. None have considered or addressed the contributory factors relating to the products themselves, namely the similarity between the presentations of AmBisome and Fungizone, both of which are manufactured as 50mg vials despite their different dose recommendations. The need to use multiple vials of Ambisome to prepare infusions for adult patients is contrary to the usual practice of using only one or two vials to prepare doses of injectable medicines for adult patients, increasing the risk of error not only with injectable amphotericin formulations but potentially also with the preparation of other injectable medicines. Whilst the development of robust local risk reduction strategies are important, external factors, such as the design of medicines, should also be identified and highlighted to manufacturers and regulatory authorities as potential contributors to error and harm.

Overcoming Sovereignty for Space Traffic Management

The question of sovereignty, or authority over the space domain has created a barrier to development of space traffic management regimes, particularly those seeking to use air traffic control or air traffic management (ATM) as an operational model. States exercise control over sovereign airspace as the airspace over a state and its territorial waters is recognized as within its authority. States provide air traffic services over high seas airspace that is delegated to them by the Council of the International Civil Aviation Organization under the provisions of the Chicago Convention. This concept of air traffic management is built on a foundational understanding that a single authority is responsible for each defined volume of airspace.In the space domain, there is no specific delegation of volumes of space to specified authorities. The Outer Space treaty clearly reflects that no claim of sovereignty is to be made. Without the authority to exercise sovereign control over the domain, is space traffic management possible?Consider that space activities are launched from sovereign territory, transit through sovereign airspace, progress through high altitude/near space regions where sovereignty is ambiguous, and operate in orbits where no sovereignty exists; is too much emphasis placed on the sovereignty question? If we make a clear distinction between regulation and control, can we eliminate the sovereignty barrier? To apply the model of air traffic management to a space traffic management concept that is applicable from the on-orbit regime, down to the near space transition, to regulated airspace, a comprehensive understanding of the elements of ATM is needed to identify relevant tools that can be exported to STM. The concept of air traffic control over instrument flight rules (IFR) flights is less relevant to STM than other regulatory and advisory elements of ATM including flight services, traffic information services, and safety alerts. Similarly, dividing STM into its component parts allows for comparisons to elements of ATM that may provide operational models for the provision of a safety service that does not depend on sovereign authority or exclusive control over a volume of space. This paper will examine the legal, policy and technical barriers to the implementation of a space traffic management regime and specifically how the sovereignty barriers can be overcome to construct and implement a global safety service in space.

Tactical Separation and Safety-Alerting System for Terminal Airspace

The provision of tactical alerts to aid air traffic controllers in providing separation assurance in terminal airspace is hindered by the complexity of the airspace, its operations, and flight procedures. A prototype automation system is studied that provides controllers with both separation and safety alerts based on or derived from the separation standard for terminal airspace. The system models flight trajectories heuristically with the use of merged intent information from readily available sources: area navigation departure procedures, flight-plan routes, and arrival nominal interior routes used in terminal automation systems. Flight vertical intent is modeled according to standard procedural restrictions, except when superseded by controller-issued altitude clearances. Importantly, flight trajectories are modeled for all aircraft, including those conducting visual approaches. New safety-alert thresholds for aircraft conducting visual approaches are studied. Performance of the system is evaluated through fast-time playback of recorded air traffic data from high-fidelity human-in-the-loop simulations and real-world operations in two terminal radar approach control facilities. The prototype system is found to produce a false-alert rate of 8% for separation alerts. The number and validity of safety alerts are studied by comparing with the current Conflict Alert system, showing that the false alerts of Conflict Alert are at 85% and they are avoided in the prototype system.

Multimodal Smart Wheelchair Integrated with Safety Alert System

Elderly and people with disabilities often rely on others for their locomotion. With this emerging world of automation and technologically advanced society we live in a smart wheelchair with appropriate automation can be a life changing innovation for them. One might wonder what is the need for a wheelchair to be smart or for that matter why anything needs to be smart. The answer is simple, to overcome the limitations of the existing technology. We aim on integrating a simple Manually operated wheelchair with features like Obstacle Detection with appropriate technologies such as voice control or gesture control for people who are not able to locomote like a normal person can. With this project, not only do we help a person using a normal wheelchair more easily but also make life easier for those who have other disabilities which are standing as an obstacle making it difficult for them to walk. For instance, a blind person can use a smart wheelchair that allows voicecontrolled movement or even gesture-controlled movement. Another might be of a person who can’t speak, will now be able to control everything with his bare hands. Wheelchair coupled with the appropriate sensors that automatically detects the obstacles/objects in the proximity and takes appropriate action consequently and In addition to that it may also be controlled by another person taking care of the disabled by giving commands such as forward, backward, upright etc. This not only reduces the user's efforts but also helps people to take care of their elderly. Voice/gesture control system makes everything simple. Just visualize the application of it in a hospital where the nurse has to manually handle the patient's wheelchair for even the slightest of movement. This system on the other hand needs only text or voice input command, and based upon the predefined command received from the user, the system will execute the task. This project even enforces a GSM module which uses the sim card, which can help in tracking the wheelchair when required, like in case where a user is in difficulty and needs emergency help, a message asking for help can be sent to the intended person.

A compound attributes-based predictive model for drug induced liver injury in humans.

Drug induced liver injury (DILI) is one of the key safety concerns in drug development. To assess the likelihood of drug candidates with potential adverse reactions of liver, we propose a compound attributes-based approach to predicting hepatobiliary disorders that are routinely reported to US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Specifically, we developed a support vector machine (SVM) model with recursive feature extraction, based on physicochemical and structural properties of compounds as model input. Cross validation demonstrates that the predictive model has a robust performance with averaged 70% of both sensitivity and specificity over 500 trials. An independent validation was performed on public benchmark drugs and the results suggest potential utility of our model for identifying safety alerts. This in silico approach, upon further validation, would ultimately be implemented, together with other in vitro safety assays, for screening compounds early in drug development.

A Novel Safety Alert System for Small Scale Fishing Crafts

A Novel Safety Alert System for Small Scale Fishing Crafts

Effects of an assisted living platform amongst frail older adults and their caregivers: 6 months vs. 9 months follow-up across a pilot field study

Ambient Assistive Living (AAL) technologies provide promising solutions to support aging-in-place but still lack ecological validation. Frail older Individuals (FIs) are at high risk of losing their autonomy but are also acknowledged to be an optimal target population for dependency prevention based on environmental supports. In this context, a recent study revealed some promising short-term benefits of an AAL platform in supporting FIs’ everyday functioning and releasing caregiver burden. Research aim: Complementarily to this first study, we aimed to address near and far effects of an AAL platform on FIs’ everyday functioning and caregiver burden. Method: HomeAssist is an AAL platform providing environmental support thanks to services including activity verification, safety alerts, reminders, communication and leisure activities. HomeAssist efficacy has been evaluated in a field study including a nine-month deployment in the home of sixteen cognitively healthy (MMSE > 25) FIs living alone. Several efficacy measures were taken and compared to a control group (n=16), matched by age, gender, cognitive functioning and frailty condition. These measures included FIs’ autonomy (self-reported and reported by a caregiver) and caregiver burden (for supporting FIs’ autonomy and professional burnout) and were assessed at baseline, six, and nine months later. Results: Our results indicated that: (1) FIs’ autonomy reported by caregivers is improved over time for the equipped group, with a greater extent after 9 months; (2) FIs’ self-perception of everyday functioning remained constant after 9 months for the equipped group, whereas it slightly decreased for the control group; and (3) caregivers reported less burden across time in the equipped group compared to control group; while HomeAssist intervention did not significantly impact professional burden. Conclusion: Taken together, this suggests that near effects of HomeAssist are not only due to novelty, but rather benefits from HomeAssist intervention.

Implementation and Evaluation of a Standardized Non-Vitamin K Oral Anticoagulant (NOAC) Patient Safety Alert Card Across the Northern Region of England.

Many patients are prescribed anticoagulants. Newer non–vitamin K oral anticoagulants, NOACs, were launched in 2008 and are increasingly commonly used. However, they may still be unfamiliar to patients and health care professionals. It is mandated by the National Patient Safety Agency and European Society of Cardiology to provide written safety information for patients receiving anticoagulants. We developed a standard patient alert card with the support of the North of England Strategic Clinical network (NESCN) to clearly provide key safety information for patients and health care professionals. This is the only card in the United Kingdom that is used over such a wide geographical area. We recognized that this would avoid duplication of work devising a similar card across all the sites in primary and secondary care. Given that staff and patients commonly move about the region it would also lead to better ease of recognition. The NESCN card was developed with input from all the key stakeholders, including cardiology, stroke, hematology, acute medicine, primary care, and patient groups. It was launched in 2015 across the Northern region, which includes over 3 million people. It was distributed to general practitioners (GPs), primary and secondary care pharmacists. Electronic and face-to-face education was carried out alongside to pharmacists, GPs, and hospital physicians. We gathered patient and clinical staff feedback regarding the card and found the alert card was widely embedded within practice across the region and patient feedback was good. The evaluation shows a simple and inexpensive intervention delivered with no formal funding can address this patient safety concern. We have engaged with Clinical Commissioning Groups and secondary care trusts in the region to ensure the legacy of the project. In response to requests from other regions and organizations, the card has been widely shared and implemented across many areas of the United Kingdom.

Toxicity of quinolone antibiotics - new untoward effects andreevaluation of known side effects

Quinolones have recently been reevaluated based on new possible side effects and new risk assessments of known side effects. Several of the recently reported untoward effects are not new to the class, and they are very rare compared with the relatively common neuropsychiatric adverse events. New associations are aortic aneurysm/dissection and long-standing peripheral neuropathy, muscle weakness, mobility and gait disorders with unclear causal relationship to fluoroquinolone treatment and no known effective therapeutic interventions. Based on estimates from comparative data there could be slightly more than 1000 additional cases of adverse drug effects associated with fluoroquinolone treatment versus other common antibiotics per 100 000 treatment episodes - most of them being neuropsychiatric side effects in primary care, tendinopathy and - more rarely and uncertain - liver toxicity. Consequences were safety alerts in the USA and in European countries with recommendations that the use of the marketed fluoroquinolone antibiotics should be restricted and other antibacterial medicines be preferred if possible. The prophylactic use should be abandoned (travellers' diarrhea and prevention of relapsing cystitis) or critically reevaluated and individualized (prevention of neutropenic fever and of spontaneous bacterial peritonitis).

An Arduino Based Safety Alerts for Vehicle and Accident Detection System

This paper is about a system that prevents the accident of vehicles which gives more likely to lower the accidents takes place daily on roads and at the same time if any accident occurs the system will locate the vehicles location and informs to local emergency authorities automatically helps to take immediate and appropriate actions. This system is based on Arduino developed with Global Positioning System (GPS) to identify the vehicle's location and Global System for Mobile Communication (GSM) technologies. A motion sensor gyroscope with 3-axis gyroscope and 3-axis accelerometer is used that measures the vehicles velocity and tilting position when the vehicle hits by something. when the vehicle velocity is more than the defined maximum for the particular location a warning will be given automatically and if any accident occurs the geographical coordinates of place are located by GPS and sends an SMS to the authorities nearby. This system is low cost and easy to maintain.