Summary
• Effective from 23 October 2023
• Government amendments made to the Human Medicines Regulations 2012
(HMRs)
Key Requirements
• Full pack dispensing required for medicines containing valproate
• Flexibility for pharmacists to supply 10% more or less than the prescribed amount
for medicines other than valproate to enable original pack dispensing (OPD)
Aims of Original Pack Dispensing
• Increase patient safety by including patient information leaflet (PIL)
• Enhance pharmacy efficiency by reducing repackaging time
Exceptions
• Controlled drugs
• Medicines that are impractical to dispense in exact
quantities
• Medicines that cannot be dispensed without affecting their quality (e.g. inhalers)
Using Professional Judgement
• Critical for ensuring patient best
interests
• Document reasons for decisions
• May override original pack dispensing if it conflicts with medication regimen
Transition Period
• The new rules won't automatically apply to other NHS prescriptions in England and Wales unless specified
Valproate-Containing Medicines
• Full pack dispensing mandatory from 11 October
2023
• Aim to protect women during pregnancy
Exceptional Circumstances for Valproate
• Risk assessment allowing different packaging
