Article date: September 2009
New warnings and tighter controls on the sales of over-the-counter (OTC) medicines containing codeine or dihydrocodeine 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). The package of measures includes changes to indications, labels and leaflets, pack size, and advertising.
This action is being taken in parallel with the Department of Health’s review of policy on addiction to prescription and OTC medicines.
The CHM’s predecessor, the Committee on Safety of Medicines, considered the risk of addiction to OTC medicines containing codeine and dihydrocodeine in 2005. At that time warnings were added to product information and pack sizes were reduced.
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.
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, 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. The following warning will appear 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.
All packs greater than 32 of codeine or dihydrocodeine containing OTC medicines, including effervescent formulations, will no longer be available as P products.
The advertising and promotion code of practice will be updated to reflect the new indications and warnings, and all advertisements will carry the statement: ‘Can cause addiction. For three days use only’.
Timing and action required
Changes to Marketing Authorisations will be completed by 31 December 2009 and all products with the updated information will be on pharmacy shelves 3–6 months later. Existing packs of greater than 32 effervescent tablets and marked for dispensing purposes should be supplied only in accordance with RPSGB guidance.
Key messages for pharmacists:
You are asked to support the public health measures taken by:
- recommending codeine or dihydrocodeine containing products appropriately within the OTC analgesic range
- giving key safety messages regarding short-term use and avoidance of addiction if taken as recommended
- noting that packs of more than 32 tablets are for dispensing use only
The MHRA will monitor the effect of this package of measures, reviewing sales data and ADR reports at 6 months and 12 months after amendment of the Marketing Authorisations, and will take further action if necessary.
Article citation: Drug Safety Update Sept 2009, vol 3 issue 2: 6.