The Pharmaceutical Journal
Vol 272 No 7282 p70
17 January 2004

Society summary

An occasional feature, prepared in the Royal Pharmaceutical Society’s Professional Standards Directorate, to highlight problems and inquiries currently being handled

Law and Ethics Bulletin, 2001 to present
See also Good Practice Points, 2003 to present

• Aspirin and aloxiprin labels and inserts
• Amendments to emergency first aid booklet

Aspirin and aloxiprin labels and inserts

Further to two previous Law and Ethics Bulletins (PJ, 27 September 2003, p432) and 4 October 2003, p477), this bulletin is to consolidate and further clarify information the Society has obtained from the Medicines and Healthcare products Regulatory Agency.

Since 1 October 2003 all relevant medicinal products containing aspirin or aloxiprin must:

• Be labelled with the words: “Do not give to children aged under 16 years, unless on the advice of a doctor.” This applies to general sale list (GSL) medicines, Pharmacy (P) medicines and prescription only medicines (POMs). There is no requirement for the new warning to appear on dispensing labels of dispensed medicinal products. The use of a dispensing label does not preclude the requirement for the container/packaging to bear the warning, where an original pack has been dispensed.

• Be supplied with a patient information leaflet (PIL), which must bear the new wording: “There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.” This requirement applies to patient packs and to supplies from bulk packs made against a prescription.

It is the responsibility of the marketing authorisation holder to produce the PIL as part of the authorisation application; therefore overlabelling of existing stock would not achieve compliance since the leaflets also require amendment. The requirement is, however, that every container and every package immediately enclosing a container of such products carries the warning. The MHRA has stated that there is no offence if this requirement is met and an amended PIL is included. The MHRA is the enforcement authority for these regulations and instances of non-compliance should be directed to it.

Back to Top

Amendments to emergency first aid booklet

The Society’s booklet “Emergency first aid: guidance for pharmacists” provides guidance on action in life-threatening situations. A copy of this booklet was sent to all registered pharmacy premises in April 1999. Pharmacists should be aware that the following changes have been made to the original guide:

• Page 3: Anaphylactic shock —
under the heading “Action”, the adult dosage should now read:
“ [Adult dosage 500mcg (0.5ml of a 1:1000 solution)]”

• Page 19: Telephone numbers — Under the heading England and Wales, the contact numbers should now read:
St John Ambulance 020 7324 4000
British Red Cross 0870 240 4198
WCPPE 02920 874784.

Further copies of the booklet can be obtained at a cost of £3 each or £25 for 10. Requests should be sent to the Fitness to Practise and Legal Affairs Directorate with a cheque made payable to “RPSGB”.