Decision

September 2016: Multiple sales of analgesic-containing in retail outlets

Published 19 October 2016

A BMJ article - “How well are national guidelines relating to the general sales of aspirin and paracetamol, adhered to by retail stores: a mystery shopper study” - of 18 January 2016, and a Chemist and Druggist (C+D) article - ‘The paracetamol challenge’ - of 27 November 2015 that provided evidence that some retailers were not adhering to the MHRA Best practice guidance on the sale of medicines for pain relief, were brought to our attention. In addition some of the sales exceeded the legal limit of 100 tablets of paracetamol or aspirin per transaction. Above this level, the supply becomes subject to prescription control.

MHRA met with the British Retail Consortium (BRC) to discuss the issues raised. BRC agreed to work with their members to ensure that they and their staff were aware of the legal and voluntary restrictions and understood that they were in place to protect vulnerable individuals.

MHRA also wrote to all retailers on the list kindly supplied by the BMJ article authors and to those identified in the C+D article. The majority responded that they fully support the MHRA Best Practice Guidance and committed to review and strengthen their procedures to ensure compliance with the legal requirements and our guidance. They reported that they have a range of measures in place including till restrictions, training and safety posters to help staff to understand the requirements and information barkers on the shelves to explain the restrictions to customers.

A small number of discount retailers still do not adhere to the best practice guidance and MHRA remains concerned about multiple sales of analgesics in these outlets. MHRA guidance does not, however, have the force of law and so the Agency is not in a position to take statutory action to prevent such practices.

MHRA advice

MHRA strongly discourages the sale and supply of large quantities of over-the-counter analgesics (paracetamol, aspirin and ibuprofen) since they may undermine the intention of the pack size restrictions that the government introduced for the protection of public safety. MHRA Best practice guidance on the sale of medicines for pain relief states that no more than two packs should be supplied at any one time and that promotional offers that encourage the sale of more than one pack should not be used.

MHRA continues to monitor the safety of analgesics in use. Should there be evidence of a significant risk to public health, MHRA would consider whether further regulation was necessary.