Updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC)

2 September 2009

A letter was sent to healthcare professionals about updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC)

Issue
New warnings and tighter controls on the sales of over-the-counter (OTC) medicines containing codeine or DHC are being introduced to minimise the risk of overuse and addiction to these medicines in line with recent advice from the Commission on Human Medicines (CHM).

Action required
Current stock can be sold through, but pharmacists are asked to support these public health measures by:

• recommending codeine or DHC containing products appropriately for moderate pain in accordance with revised indications within the OTC analgesic range
• giving key safety messages regarding short-term use and avoidance of the risk of addiction by taking for no more than three days as recommended
• noting that packs of more than 32 in effervescent form are for dispensing use only.

Background – reason for change
The CHM’s predecessor, the Committee on Safety of Medicines (CSM) considered the risk of addiction to codeine and DHC containing OTCs in 2005. At that time, warnings were added to product information and pack sizes were reduced, by voluntary agreement, to 32 with any pack sizes above 32 (namely the effervescent forms) labelled as “dispensing only”. Feedback from patient groups has indicated that the existing warnings of the risks of addiction and overuse headache have not proved effective. Also, analysis of sales data has shown that pharmacists appear to be selling more packs of 100 effervescent paracetamol and codeine products since the reduction in pack size of the other forms.

CHM has now further strengthened its advice to recommend that:

• the warnings on the labels and leaflets of medicines containing codeine or DHC should be further clarified and strengthened
• large packs of effervescent tablets should be restricted to 32
• the existing advertising self regulatory code should be strengthened in line with the new warnings.

Products affected
All OTC solid dose medicines containing codeine or DHC including brands, generics and effervescent forms.

Details
Indications
All indications related to colds, flu, coughs and sore throats, and references to minor painful conditions will be removed. The remaining list of indications will be for the short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Patient information leaflets (PIL) and labels
The PIL and labels will state that the products are for short-term use only (up to three days) for the treatment of moderate, acute pain, and that the products can cause addiction or overuse headache if used continuously for more than three days. In particular, the following warning will be positioned clearly and prominently on the front of the pack:

‘Can cause addiction. For three days use only’

The PIL will also carry information about the warning signs of addiction, ie if the medicine is needed for longer periods and in higher doses than recommended, and if stopping the medicine makes you feel unwell but you feel better when you start taking it again.

This action is being taken in parallel with the Department of Health’s review of policy on addiction to prescription and OTC medicines.

Pack size
All packs greater than 32 of codeine or DHC containing OTC medicines, including effervescent formulations, will no longer be available as pharmacy (P) products.

Advertising
The advertising and promotion code of practice for manufacturers and retailers will be updated to reflect the new indications and warnings, and to remove references to painkilling power and strength. Also, all advertisements will include the statement ‘Can cause addiction. For three days use only’.

Timing
Changes to marketing authorisations will be completed by 31 December 2009 and all products with the updated information will be on pharmacy shelves three to six months later. Existing packs of greater than 32 effervescent tablets and marked for dispensing purposes only should be supplied only in accordance with Royal Pharmaceutical Society of Great Britain (RPSGB) guidance.

Further information
For further information on this advice please refer to our website or contact the MHRA Information Centre by email (info@mhra.gsi.gov.uk) or by telephone (020 7084 2000). Visit www.yellowcard.gov.uk for an online Yellow card report.

Yours faithfully

Shirley Norton
Deputy Director, Vigilance and Risk Management of Medicines
Medicines and Healthcare products Regulatory Agency