Restriction on OTC pack sizes of analgesics containing codeine or dihydrocodeine
Following a voluntary agreement between manufacturers and the Medicines and Healthcare products Regulatory Agency, over-the-counter (OTC) pack sizes of analgesics containing codeine or dihydrocodeine have been restricted to a maximum of 32 tablets or capsules. This applies to both effervescent and non-effervescent preparations.
The MHRA has also asked manufacturers to update the patient information
on all such products to include warnings in relation to addiction and
overuse headache. The new warnings state:
• If you need to use this product for more than three days at a time
see your doctor, pharmacist or health care professional.
• Taking codeine/dihydrocodeine regularly for a long time can lead
to addiction which might cause you to feel restless and irritable when
you
stop the tablets.
• Taking a pain killer for headaches too often or for too long can
make them worse. As there have been no changes in the legislation, a pharmacist may still
legally supply larger OTC pack sizes of products containing codeine or
dihydrocodeine until current stocks are exhausted. Pharmacists are expected
to exercise their professional judgement in deciding whether or not to
make such a supply and would need to be satisfied that the supply of
a larger pack size was in the patient’s best interest.
Where a pharmacist intends to supply a larger pack size over the counter,
he or she must ensure that the pack is intended for over-the-counter
sale. Therefore, the pack should not contain words to the effect of “dispensary
pack only”. Pharmacists wishing to sell packs intended for over-the-counter
sale that do not contain the new warnings (see above) are advised to
counsel the patient verbally on these warnings.
Good practice currently recommends that the supply of products containing
codeine or dihydrocodeine should be restricted to only one pack, of any
size, per purchase. |
The
Pharmaceutical Journal