The European Medicines Agency (EMA) has received reports of three fatal cases of administration error that occurred with bortezomib in the EU, where the drug was accidentally given intrathecally instead of intravenously. The Agency’s Committee for Medicinal Products for Human Use (CHMP) is reminding healthcare professionals that bortezomib should only be given by intravenous injection and is recommending precautionary measures to prevent further administration errors from occurring.

A letter is to be sent out to healthcare professionals reminding them that bortezomib should only be given intravenously and they are advised to consider the following precautionary measures:

• When possible, different connectors should be used for medicines to be administered via intrathecal or IV route.

• When possible, intrathecal chemotherapy should be administered at a different time than any other parenteral chemotherapy (chemotherapy given by injection or drip into a vein).

• Syringes should be clearly labelled with the name of the medicine and route of administration to be used.

• Procedures should be in place for double checking the labelling of syringes before administration.

• IV and intrathecal injections should be handled only by suitably trained healthcare professionals.

• Healthcare professionals involved in administration or management of cancer chemotherapy should be trained and informed of the dangers of intrathecal administration of bortezomib and of the recommended measures to prevent this from occurring.