The Pharmaceutical Journal
Vol 274 No 7348 p537
7 May 2005

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News summary

Joint NPSA/MHRA safety alert issued for Repevax and Revaxis

Repevax and Revaxis vaccines are the subject of a safer practice notice issued by the National Patient Safety Agency and the Medicines and Healthcare products Regulatory Agency last week.

The vaccines, both manufactured by Sanofi Pasteur MSD, have similar names, labelling and packaging and this has led to staff mistakenly administering the wrong vaccine. Repevax (diphtheria, tetanus, five-component acellular pertussis and inactivated polio vaccine dTaP/IPV) is recommended for pre-school children and Revaxis (tetanus, diphtheria and inactivated polio vaccine Td/IPV) is recommended for adolescents. In the most recent report to the NPSA, 93 schoolchildren were wrongly vaccinated with Repevax.

The packaging of Repevax is currently being redesigned to help staff to distinguish it from Revaxis and stocks of Repevax with the new packaging are due to be distributed during the second half of 2005. In the meantime, remaining stocks of Repevax are being overlabelled with the words “pre-school booster”.

The notice advises that NHS acute trusts, primary care organisations and local health boards in England and Wales should take the following action immediately:

· Ensure procedures are in place to check the correct vaccine has been selected

· Raise awareness of the proposed packaging changes — this may include displaying photographs of the packaging in all locations where the vaccine is stored and administered

· Review and strengthen procedures for risk assessment and management of new vaccine products introduced locally

· Continue to report patient safety incidents

Refrigerator boxes with the name of the vaccine on the front or laminated cards picturing the vaccines are available from the manufacturer.

In addition, the notice advises that Diftavax (tetanus and diphtheria vaccine Td), a third vaccine manufactured by Sanofi Pasteur MSD, also poses a safety risk since it has similar packaging to Repevax and Revaxis, and the three are often stored together. This vaccine is no longer recommended in childhood vaccination schedules and the MHRA expects stocks to be exhausted before packaging changes to Repevax are made.

David Cousins, head of safe medication practice at the NPSA, comments that this situation is a symptom of a wider problem that pharmacists can help to address. “Pharmacists should identify other look-a-like medicine packs that have or may cause patient safety incidents and report these risks via the National Reporting and Learning System.”