scholarly journals Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Author(s):  
Vesa Halimi ◽  
Armond Daci ◽  
Katerina Ancevska Netkovska ◽  
Ljubica Suturkova ◽  
Zaheer-Ud-Din Babar ◽  
...  

Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.

2021 ◽  
Vol 24 (82) ◽  
pp. 28-33
Author(s):  
Jelena Marjanović ◽  
Sanja Šumonja ◽  
Hajnalka Požar

Introduction: Intrahospital infections have a great impact on the mortality rate and morbidity of hospitalized patients. The importance of nosocomial infections makes it important for nurses to know and implement preventive measures during provision of nursing care. Objective: To analyze knowledge and attitudes of nurses about nosocomial infections. Material and methods: The research was conducted on a population of nurses and technicians employed at the General Hospital in Subotica. The sample included 44 participants. The research instrument was a questionnaire designed for the purposes of the research. Data were analyzed using descriptive statistics and hi-square test. Results: The definition of nosocomial infections was known to 68% of respondents, but only 50% of respondents knew that the hands of healthcare professionals were the most common way of spreading nosocomial infections. Basic preventive measures against nosocomial infections were familiar to 82% of respondents, and 95% of the respondents thought that nurses have important role in the control and prevention of nosocomial infections. Significantly more respondents who have more than 20 years of work experience thought that nurses do not have contribution in prevention and control of nosocomial infections (p=0.011). Conclusion: Most participants were familiar with the definition of nosocomial infections and basic preventive measures. It is necessary to improve the knowledge about the ways of spreading and the risks for the occurrence of nosocomial infections.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Rehab Abdelhamid Aboshama ◽  
Ahmed Mohamed Abdelhakim ◽  
Mohammad Abrar Shareef ◽  
Abdulhadi A. AlAmodi ◽  
Mohammad Sunoqrot ◽  
...  

AbstractObjectivesTo compare the safety and efficacy between high dose and low dose oxytocin administration for labor augmentation.MethodsWe searched for the available studies during March 2020 in PubMed, Cochrane Library, Scopus, and ISI Web of science. All randomized clinical trials (RCTs) that assessed safety and efficacy of high dose vs. low dose oxytocin for labor augmentation were considered. The extracted data were entered into RevMan software. Dichotomous and continuous data were pooled as odds ratio (OR) and mean difference (MD) respectively, with the corresponding 95% confidence intervals (CI). Our main outcomes were cesarean delivery rate, spontaneous vaginal delivery rate, uterine hyperstimulation and tachysystole, and labor duration from oxytocin infusion.ResultsEight RCTs with 3,154 patients were included. High dose oxytocin did not reduce cesarean delivery rate compared to low dose oxytocin (OR=0.76, 95% CI [0.52, 1.10], p=0.15). After solving the reported heterogeneity, high dose oxytocin did not increase the rate of spontaneous vaginal deliveries vs. low dose oxytocin (OR=1.06, 95% CI [0.84, 1.32], p=0.64). Low dose oxytocin was linked to a significant decline in uterine hyperstimulation and tachysystole (p>0.001). A reduction in labor duration was found in high dose oxytocin group over low oxytocin regimen (MD=−1.02 h, 95% CI [−1.77, −0.27], p=0.008).ConclusionsWe found no advantages for high dose oxytocin over low dose oxytocin in labor augmentation except in reducing labor duration. Low dose oxytocin is safer as it decreases the incidence of uterine hyperstimulation and tachysystole. More trials are needed to confirm our findings.


2020 ◽  
pp. 003022282098465
Author(s):  
Anjana A. Karumathil ◽  
Ritu Tripathi

We examine and integrate last two decades of research on euthanasia from a cultural perspective. After an exhaustive search from Scopus and Web of Science, 40 studies matching our criteria are included in the review. We qualitatively summarize the literature country-wise and use text map of co-occurring terms in the titles, keywords, and abstracts of these articles to determine the similarities and differences among sub-themes in continental clusters. Research done in Asian, European, North American, and multi-cultural studies suggests that attributes unique to each culture are instrumental in shaping public attitudes towards euthanasia. We also find that some cultures, despite the prevalence of euthanasia, are underrepresented in empirical research. This review of literature on the cultural nuances in end-of-life decisions such as euthanasia is pertinent to social scientists, healthcare professionals and social workers in any given time, but more so during such critical events as worldwide COVID-19 pandemic.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
A. Anastasia Salame ◽  
Mohammad J. Jaffal ◽  
Fatin Khalifeh ◽  
Dalia Khalife ◽  
Ghina Ghazeeri

Objectives. Hormone replacement therapy (HRT) had been the gold standard for the treatment of menopausal symptoms until the publication of the World Health Initiative (WHI) study. After the WHI study, the use of HRT changed among the physicians and patients all over the world despite newer more reassuring data. This study aimed to investigate the knowledge and attitudes of women towards HRT and the factors affecting it for better counseling. Study design. A clinic-based cross-sectional study using a survey was offered to women aged 40 years and above coming to the women’s health center at the American University of Beirut Medical Center (AUBMC) from October 1st, 2017, till March 31st, 2018. The questionnaire included questions about demographics and menopausal symptoms in addition to knowledge and attitudes towards menopause and HRT. Main outcome measures. Our main hypothesis was that women would be aware of HRT as a treatment modality; however, the majority would have a negative attitude towards its usage. Results. The response rate was 87.8%. Seventy-three percent of the respondents had already heard about HRT with 57.9% supporting the use of HRT; however, 47.9% did not know when to use it. The significant predictor for having heard about HRT and a positive attitude towards HRT were having HRT prescribed as a part of treatment and employment status, respectively. Conclusions. Lebanese women are aware of HRT as a treatment option; however, a lack of both proper information and positive attitude towards HRT use was noted.


2016 ◽  
Vol 40 (6) ◽  
pp. 679 ◽  
Author(s):  
Lindsey Ross ◽  
Catherine Harding ◽  
Alexa Seal ◽  
Geraldine Duncan

Objectives The aim of the present study was to investigate healthcare provider perceptions of the impact of refugee patients at two public hospitals, one rural and one urban, in designated refugee resettlement areas. Healthcare professionals’ views regarding improvements that could be made in this area were also sought. Methods Two-page anonymous questionnaires containing demographic, quantitative and open-ended questions were distributed to 150 healthcare providers at each research site. Results Response rates at the rural and urban sites were 50% and 49%, respectively. Refugees were seen at least monthly by 40% of respondents. Additional support was requested by 70% of respondents. Confidence was associated with being born overseas (P = 0.029) and increased time working with refugees (rs = 0.418, P < 0.001). Only 47% of respondents felt confident managing social and psychological needs of refugees. Midwives saw refugees more than nursing and allied healthcare staff combined, and this was significant at the rural hospital (P < 0.001). Rural respondents reported that working with refugees enhanced their practice (P = 0.025), although felt significantly less confident (P < 0.001) than urban respondents. Themes that arose regarding barriers to care included language and cultural barriers, paucity of knowledge and issues accessing available services, including appropriate interpreters, Medicare eligibility and patient factors, including lack of patient trust in government systems. Desire for support was more pronounced in the rural setting (P = 0.001). Conclusions Refugees were seen frequently in both settings and most respondents requested additional support, highlighting that caring for refugees in Australian hospitals is a significant challenge. Additional support and education should be targeted to those caring for refugees most frequently, particularly midwifery services, to reduce barriers to care. What is known about the topic? Refugees are a vulnerable group, often with complex health needs. These needs are often unmet because of issues including language and cultural barriers. What does this paper add? Refugees were seen frequently in the two public hospital settings involved in the present study and most often by midwifery services. Healthcare professionals require more support, more information about available services and better access to interpreter services. These issues were more pronounced in the rural setting where very limited research exists. What are the implications for practitioners? Implementing additional support and education regarding refugee health needs could increase knowledge and confidence when managing refugees, reducing barriers to care and improving quality of care.


2021 ◽  
pp. 106002802110098
Author(s):  
Linguang Gan ◽  
Xiaohong Zhao ◽  
Xiangjian Chen

Background: This study systematically evaluated the safety and efficacy of dexmedetomidine for procedural sedation and postoperative behaviors in a pediatric population as well as whether the results met the information required to draw conclusions. Objective: To evaluate the safety and efficacy evaluation of dexmedetomidine for procedural sedation and postoperative behaviors in a pediatric population. Methods: PubMed, Cochrane library, Web of Science and Ovid MEDLINE were searched to obtain randomized controlled trials (RCTs) comparing dexmedetomidine with control medicine and comparing different doses of dexmedetomidine. Results: There were a total of 16 RCTs for a total of 3240 patients. Dexmedetomidine slowed down the heart rate (HR; mean difference: −13.27; 95% CI: −16.41 to 10.14; P < 0.001) and reduced postoperative delirium (risk ratio [RR]: 0.31; 95% CI: 0.20-0.50; P < 0.001), the number of pain patients (RR: 0.48; 95% CI: 0.30-0.75; P = 0.002), and desaturation (RR: 0.34; 95% CI: 0.13-0.89; P = 0.03) compared with the control group. The limitation was that it was difficult to determine the range of low- and high-dose dexmedetomidine. Conclusion and Relevance: Dexmedetomidine slowed down intraoperative HR within the normal range, which might reduce myocardial oxygen consumption. It reduced postoperative pain and postoperative complications: delirium and desaturation. Dexmedetomidine showed no dose-dependent increase in the procedural sedation time of pediatric patients. Clinically, dexmedetomidine can improve pediatric procedural sedation and postoperative behavior, and it can be considered as a related medicine for safety in pediatric surgery.


2021 ◽  
Vol 100 (5) ◽  
pp. 35-45
Author(s):  
K.E. Belozerov ◽  
◽  
A.D. Kupreeva ◽  
I.S. Avrusin ◽  
V.V. Masalova ◽  
...  

Multisystem inflammatory syndrome in children and adolescents associated with SARS-CoV-2 (MBS-D) is a new challenge for pediatricians around the world. Scientific data is updated daily and patient treatment regimens are developed. The involvement of the heart in the inflammatory process complicates the course of the disease and further rehabilitation of patients. The article describes 12 patients with heart disease in the structure of MVS-D, who underwent laboratory tests and instrumental studies, including MRI of the heart, and also provides detailed descriptions of three clinical cases and a review of literature data.


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