ABSTRACT
BACKGROUND: Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts. METHODS: A narrative literature review was conducted to identify biosimilars' policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations. RESULTS: The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30-40% less than its originator's price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary. CONCLUSIONS: A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.
ABSTRACT
OBJECTIVES: The aim of this study was to describe the pattern of viral infections in infants and children admitted to the Paediatric Intensive Care Unit (PICU) at Sultan Qaboos University Hospital (SQUH) in Muscat, Oman. METHODS: A retrospective review of patient records was carried out on all patients admitted to the PICU between January 2011 and December 2012. In order to detect viruses, polymerase chain reaction (PCR) technology was used to detect viruses in nasopharyngeal aspirates, tracheal aspirates, plasma, stool and urine samples. All infants and children below 13 years old, who were admitted to the PICU at SQUH during the study period and with confirmed viral infections, were included in the study. RESULTS: A total of 373 infants and children were admitted to the PICU during the study period. Viruses were detected in 34 patients. The most frequently detected viruses were cytomegalovirus (CMV) in 29.4%; this virus was noted predominantly in immuncompromised patients (80%, P = 0.023) and was associated with increased mortality (50%, P = 0.031) and prolonged PICU stay (70%, P = 0.045). Fatalities before discharge were recorded in 23.5% of the patients. The most frequent risk factors for viral infections were an age of <12 months old (47.1%), assisted ventilation/intubation (52.9%) and a prolonged PICU stay (55.9%). CONCLUSION: The results of this study found that CMV was the most common viral infection among infants and children admitted to the PICU in SQUH. CMV was also the leading cause of mortality.
ABSTRACT
INTRODUCTION: Iatrogenic injuries to the urogenital tract are rare, with the bladder being the organ most affected. We describe a case of a vesical calculus that formed on non-absorbable sutures that were used to repair an inguinal hernia. PRESENTATION OF CASE: A 45-year-old male presented with frank haematuria and dysuria 2 years following an open left inguinal hernia repair. A CT urography showed a vesical calculus adherent to the left anterio-lateral wall of the bladder. Cystoscopy revealed that the calculus formed on non-absorbable sutures. Cystolapaxy was performed followed by cystoscopic excision of the sutures. The patient's post-operative course was uneventful. DISCUSSION: Foreign bodies in the urinary bladder always act as a nidus for formation of a calculus. Iatrogenic bladder injuries are common during hernia repair. It is however rare for sutures used to repair an inguinal hernia to involve the urinary bladder wall. The patient most likely had a full bladder at the time of hernia repair or the bladder was part of the contents of the hernia sac. CONCLUSION: This case illustrates the need to ensure that the bladder is empty prior to pelvic surgery and for surgeons to have a good understanding of inguinal anatomy to avoid injuring the contents of the hernia sac.
ABSTRACT
PURPOSE: We determined the time course of malondialdehyde, a measure of free radical damage, in patients undergoing standard surgical treatment for testicular torsion. MATERIALS AND METHODS: Patients presenting with testicular torsion were studied prospectively. Blood samples were obtained after administering general anesthesia but before surgical incision, and 10 minutes, 30 minutes and 24 hours after detorsion. Orchiopexy was performed in patients with viable testes (group 1) and orchiectomy was performed in those with nonviable testes (group 2). Further blood samples were obtained 1 and 3 months after surgery. Similar blood samples were taken from controls, including patients younger than 40 years undergoing other operations involving manipulation of the testis, such as hydrocelectomy or orchiopexy (group 3). The level of malondialdehyde in each serum sample was determined by the thiobarbituric acid reaction. RESULTS: A total of 65 patients were studied, including 56 with testicular torsion and 9 controls (group 3). Of the 56 patients 11 (19.6%) with testicular torsion underwent ipsilateral orchiectomy and contralateral orchiopexy (group 2). The remaining 45 patients (80.4%) underwent bilateral orchiopexy (group 1). However serum malondialdehyde was estimated in only 34 of the 56 patients with torsion. Mean malondialdehyde at 0, 10 and 30 minutes, 24 hours, and 3 and 6 months was 3.3, 3.69, 3.69, 2.9, 2.65 and 2.39 nmol./ml. on the 24 group 1 patients, 3.53, 4.56, 3.87, 2.87, 2.82 and 2.64 nmol./ml. in the 10 group 2 patients, and 3.6, 3.08, 3.18, 2.95, 2.88 and 2.65 nmol./ml. in the 9 group 3 controls, respectively. The highest serum malondialdehyde was at 10 minutes after detorsion in groups 1 and 2. There was a statistically significant difference in malondialdehyde between groups 1 and 2 compared with group 3 at 10 minutes (p <0.04). Serum malondialdehyde returned to baseline at 24 hours in all patients. CONCLUSIONS: The results of this study indicate that testicular torsion and its treatment with detorsion is an example of ischemia-reperfusion injury, producing measurable changes in malondialdehyde in humans. Thus, serum malondialdehyde could be used to determine the extent of injury.
