Current state of biologic pharmacovigilance in the European Union: improvements are needed

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.

Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.

Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.     

The development of a research human milk bank.

Although there are well-established clinical human milk banks in the United States, there are no milk banks specifically intended to foster research on human milk. The authors' goal was to establish a milk bank with a core data set to support exploratory and hypothesis-driven studies on human milk. Donations to the Cincinnati Children's Research Human Milk Bank are accepted within the context of ongoing, hypothesis-driven research or on an ad hoc basis. Donors must give informed consent, and scientists wishing to use the samples must have Institutional review board approval for their use. Development of more research human milk banks can potentially provide resources for multidisciplinary collaboration and advance the study of human milk and lactation.     

创伤后迟发性脑肿胀的临床特点与治疗

目的 探讨创伤后迟发性脑肿胀的临床特点、发病机制与治疗。方法 回顾性分析1998年1月～2005年6月年收治的17例迟发性脑肿胀患者的临床特点和救治情况。结果 所有颅脑损伤患者采用保守治疗后均有好转，但于伤后5-10d出现恶化，CT复查有脑肿胀，经加强综合脱水等治疗后16例治愈，1例死亡。结论 迟发性脑肿胀好发于对冲性额、颞叶挫裂伤伴明显蛛网膜下腔出血、硬膜下薄层血肿及早期CT有脑肿胀者。其发病机制可能与创伤后的迟发性脑血管痉挛、微循环障碍、静脉回流障碍及甘露醇作用下降等因素有关。此类患者病情隐蔽性强，应加强观察、积极行CT复查，如能早期明确诊断，保守治疗多数效果良好。     

New South Wales Nurse Education Project

Abstract: The development of a teaching package for nurse educators on drug and alcohol problems is described and the contents of its 16 modules outlined.     

Retrorenal colon: implications for percutaneous diskectomy

It has been recommended that computed tomography (CT) with the patient prone be performed in every patient undergoing percutaneous diskectomy; this would enable detection of a retrorenal location of the colon, which could interfere with the percutaneous procedure. In this evaluation of 346 prone CT studies, only one patient (0.29%) was found to have retrorenal or retropsoas bowel that would have been perforated at diskectomy. Because of this extremely low prevalence, the performance of prone CT in every patient undergoing percutaneous lumbar diskectomy is not believed to be necessary.     

Load to failure of common meniscal repair techniques: Effects of suture technique and suture material

Success of meniscal repair with early or immediate motion depends on the ability of the suture fixation to withstand the loads applied. Vertical and horizontal mattress suture techniques were tested using 2-0 Ethibond, and 0-PDS and 1-PDS sutures (Ethicon, Somerville, NJ). Mulberry knot technique was tested with 0-PDS and 1-PDS sutures. Twenty menisci (60 sutures) were tested for each suture material. Sutures were placed 3 to 4 mm from the peripheral edge of the meniscus with double barreled cannulas for vertical and horizontal mattress techniques or a spinal needle for the mulberry knot technique, reproducing clinical techniques of meniscal repair. Mechanical testing of suture fixation was performed to failure at a rate of 10 mm/min on a MTS material testing system (MTS Systems Corp. Minneapolis, MN). Suture pullouts were reported as the load displacement to failure from the inner fragment only, because clinical failure would ensue should a suture pull through the inner fragment of a tear. Vertical mattress technique with 1-PDS suture had significantly greater load to failure than any other combination (P < .05). Analysis of variance showed that the vertical mattress technique had statistically superior pullout strength (P < .0001) compared with the horizontal mattress and mulberry knot techniques, which were statistically similar. There were significant differences (P < .0001) between suture types, with 1-PDS proving best compared with 0-PDS, which was stronger than 2-0 Ethibond. Selection of suture material had the greatest impact on vertical mattress load to failure and was not important to the strength of the other techniques.