Capsules

Brexit Update

The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced at the beginning of August 2018. The temporary suspension or reduction of additional activities in this phase allows the Agency to safeguard core activities related to the evaluation and supervision of medicines while the Agency prepares for the consequences of the United Kingdom’s (UK) exit from the European Union (EU) - both in terms of the impact on the Agency’s operations, as well as its physical move to Amsterdam. It will also help the Agency cope with anticipated staff loss, the EMA said.

“EMA will now temporarily suspend or scale back additional activities to ensure that resources can be redeployed so that its core activities can continue without interruption and to the same quality,” said Noël Wathion, EMA’s Deputy Executive Director. “Over the next few months, EMA will continue to carefully monitor staff intentions to relocate and the anticipated impact on its activities whilst planning for the critical time period when the Agency will be moving to its new premises in Amsterdam.”

Vitamin D in adults does not prevent fractures

Vitamin D supplementation does not prevent fractures or falls, or improve bone mineral density in adults, according to a new meta-analysis of 81 randomised trials published in The Lancet Diabetes & Endocrinology journal. Furthermore, the study found no differences in the effects of higher versus lower doses of vitamin D.

The authors conclude that there is therefore little justification to use vitamin D supplements to maintain or improve musculoskeletal health, except for the prevention of rare conditions such as rickets and osteomalacia in high risk groups, which can occur due to vitamin D deficiency after a prolonged lack of exposure to sunshine.

Vitamin D supplements have long been recommended for older people to treat or prevent osteoporosis, with some early evidence suggesting benefits for bone health. However, recent large-scale reviews have reported no effect of vitamin D supplementation on bone mineral density, falls or fractures.

“Since the last major review of evidence in 2014, more than 30 randomised controlled trials on vitamin D and bone health have been published, nearly doubling the evidence base available. Our meta-analysis finds that vitamin D does not prevent fractures, falls or improve bone mineral density, whether at high or low dose. Clinical guidelines should be changed to reflect these findings. On the strength of existing evidence, we believe there is little justification for more trials of vitamin D supplements looking at musculoskeletal outcomes,” says lead author Dr Mark J Bolland, University of Auckland, New Zealand, in a note from the journal.

DNA-based blood compatibility test

The US Food and Drug Administration has approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.

“The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” said Peter Marks,director of the FDA’s Center for Biologics Evaluation and Research. “We know that DNA testing holds great promise – to provide more informative, accurate and cost-effective methods that can enhance patient care.”

Human blood can be classified into different groups based on the antigens on the surfaces of red blood cells. In addition to the ABO blood group antigens, the presence or absence of other specific blood group antigens can be important when matching blood for transfusions since some people develop antibodies to non-ABO antigens. People who receive repeated blood transfusions, such as individuals with sickle cell disease, are more likely to develop these antibodies. If red blood cells with poorly matched non-ABO antigens are transfused, red blood cell destruction and a transfusion reaction can occur in a transfusion recipient.