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Home  »   Latest News   »   PDA responds to the MHRA consultation to make Codeine linctus a prescription only medicine

PDA responds to the MHRA consultation to make Codeine linctus a prescription only medicine

The Medicines and Healthcare products Regulatory Agency (MHRA) recently undertook a ‘Public Consultation on proposal to make Codeine linctus and Codeine Oral Solutions available as a prescription only medicine (POM).’

Thu 17th August 2023 The PDA

The MHRA stated in the consultation that it had received a surge of referrals from law enforcement agencies around activities involving codeine linctus. The consultation acknowledged that pharmacists have experienced some violent aggression from repeat buyers.

The MHRA also shared data from the Office of National Statistics that the number of registered deaths in England and Wales involving codeine (not from compound formulation) had increased from 88 in 2011 to 200 in 2021. It was noted that there was no information available about prescription status in these fatal events.

Considering the information contained in the MHRA consultation document, the PDA agreed with the MHRA proposal to reclassify oral codeine solutions as Prescription Only Medicines (POM). The PDA’s approach to this consultation was that it:

  • Would support any move which improves patient safety and the appropriate use of medicines.
  • Would support changes to the re-classification of medicines if this is likely to reduce the risk of circumstances where abuse and aggression may occur towards pharmacists and pharmacy teams.
  • Advocate that it is essential that the government puts into place a well-resourced and well-executed public awareness campaign to inform people/patients if this change was put into place.

Read the full PDA’s full response below

thumbnail of 00 2023 MHRA Codeine Consultation Response FINAL

Read the MHRA Consultation document below

thumbnail of MHRA Codeine_Linctus_reclassification_consultation_July_2023

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