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Unwanted Immunogenicity: From Risk Assessment to Risk Management
Published in Raj Bawa, János Szebeni, Thomas J. Webster, Gerald F. Audette, Immune Aspects of Biopharmaceuticals and Nanomedicines, 2019
The immune response to biologic products often involves B or T cells. The former produce antibodies that bind to proteins and thus reduce or eliminate their therapeutic effects. Potential complications can be life threatening. Thus, measuring the tendency to trigger antibody formation is an important part of determining the clinical safety and efficacy of protein-based drugs. T cells help activate B cells, especially for disease cases in which a patient’s natural protein is defective in some way. That patient’s T cells could treat protein therapeutics as if they were foreign invaders because they are different from the native protein. Such a response has been noted, for example, in some hemophilia patients, whose blood factor VIII is genetically defective. They may develop ADAs when infused with a correct factor VIII therapeutic protein (e.g., Bayer’s Kogenate or Baxter’s Advate products), presenting a significant impediment to such treatment. It is, in fact, considered to be “the most important problem in hemophilia A care today” [1]. Rheumatoid arthritis is another condition for which treatments are complicated by immunogenicity [2].
Broadening the Patient Safety Movement: Listening, Involving and Learning from Patients and the Public
Published in Emma Rowley, Justin Waring, A Socio-cultural Perspective on Patient Safety, 2017
Coulter and Ellins (2006) have reinforced this evidence in their systematic review of the patient safety literature. They note that whilst research in this area is still in its infancy, key findings show that patients want greater openness and honesty from health professionals when affected by patient safety incidents (PSIs). Patients were also thought to have the most potential in ensuring the safety of their care and to prevent the occurrence of errors in key areas such as making informed choices about providers, helping to reach an accurate diagnosis, sharing decisions about treatment and procedures, contributing to safe medication use, participating in infection control initiatives, checking the accuracy of medical records, observing and checking care processes, identifying and reporting treatment complications and adverse events, practising effective self-management, including treatment monitoring and shaping the design and improvement of services (Coulter and Ellins 2006). To develop this agenda further, they recommend the development of innovative strategies to support patients and health professionals to work in partnership, while arguing that these would ‘need to be subjected to formal evaluation so that best practice could be identified and applied across settings’ (Coulter and Ellins 2006: 172).
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement
Published in Expert Review of Medical Devices, 2023
Infusion therapy for patients is predominately performed through the connection of a fluid medication bag and administration tubing, all attached to a patient’s indwelling IV catheter. Continuous infusions of medications or solutions require the patient to maintain a constant connection to the IV. The normal patient activity of bed transfers, transportation to different departments, movements in bed, frequent trips to the bathroom, and even patient confusion can all result in excessive pulling on IV tubing. As the tubing becomes stretched, the tension is transferred to the catheter and dressing with subsequent loosening of securement and accidental removal of the IV catheter. Forceful removal of the catheter and dressing can cause injury to the patient, skin damage, and loss of venous access. Prevention of accidental catheter dislodgement through the insertion of a safety releasing valve can relieve the tension on the tubing and catheter to protect the patient and facilitate uninterrupted treatment. The Infusion Nurses Society (INS) Standards recommend using catheter protection devices for specific patient populations, including pediatric, elderly, and those with cognitive dysfunction at risk for the catheter being accidentally dislodged or removed [5]. A responsibility to patients exists to provide safety devices, when available, to prevent these types of complications.
The effect of ambient temperature on hand, foot and mouth disease in Qingdao, China, 2014-2018
Published in International Journal of Environmental Health Research, 2022
Xueling Xin, Xiaowen Hu, Long Zhai, Jing Jia, Bei Pan, Yalin Han, Fachun Jiang
Hand, foot, and mouth disease (HFMD) is an infectious gastrointestinal disease primarily caused by Coxsackie A16 (CA16) and Enterovirus 71 (EV71). It occurs mainly in children under 5 years old (Gopalkrishna et al. 2012; Liu et al. 2013). The typical clinical features include fever, painful papules and blisters over the extremities and genitalia and an exanthema involving ulceration of the mouth, palate, and pharynx (Ventarola et al. 2015). While usually not fatal, a small proportion of patients who have neurological and systemic complications have been known to develop rapidly, which may lead to death (Xing et al. 2014). Many serious HFMD outbreaks have been reported in Asian countries over the past few decades, including Vietnam, Japan, Hong Kong, Taiwan (Ho et al. 1999; Taniguchi et al. 2007; Ma et al. 2010; Khanh et al. 2012). The epidemic situation of HFMD in mainland China was quite serious. From 2008 to 2012, at least 6.5 million cases of HFMD were recorded, of which more than 2000 died (Zeng et al. 2013). Compared with other cities in Shandong Province, the incidence of HFMD in Qingdao City is higher, with an average annual incidence of 117.6/100,000 (Jiang et al. 2016). Despite decades of research, there is no vaccine or effective curative treatment for all types, hence it is especially important to identify related risk factors to prevent it.
Evaluation of the Macy Catheter®: a rectal catheter for rapid medication and fluid administration
Published in Expert Review of Medical Devices, 2018
Kim Marie C. Macygin, Erik Kulstad, Robert K. Mokszycki, Morgan Goldsmith
When PIV fails, is unattainable, or if more aggressive or prolonged treatment is needed, a CVL may be the alternate choice for fluids and medications [7]. Increased cost and complications can be associated with CVL placement and use. Complications of CVL insertion and maintenance include vascular and pulmonary injury as well as thrombus formation and infection [1]. Cost includes the device plus the use of a higher-level provider and the need for multiple providers for insertion. To minimize complications, strict sterile procedures must be followed, and use of ultrasound guidance and after-placement quality monitoring are necessary. Payers such as Medicare and Medicaid will not reimburse providers for the therapy or cost of complications if strict guidelines are not followed and preventable complications arise [1,7,8].