Health minister Maria Caulfield has pledged that original pack dispensing will not increase costs for pharmacists.
In a debate on the Draft Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023
She said: “The aim is not to put costs on pharmacy by introducing these measures. We are acting … [to] give pharmacists flexibility, which will free up their time, so that they can focus more on clinical activity.”
The debate centred on two amendments to the Human Medicines Regulations, which apply across mainland GB:
- original pack dispensing of medicine when original packaging is required
- whole-pack dispensing of medicines containing valproate.
The first amendment will enable the pharmacist to dispense 10 per cent more or less of the medicines compared with the quantity prescribed if they can dispense them with the manufacturer’s original packaging.
The debate heard that manufacturer’s original packaging contains clear instructions and information about the medicines and, in addition, it reduces the amount of time spent splitting packs and counting packs and strips. Pharmacists will have professional discretion whether to use this 10 per cent discretion, for example, when dispensing steroids or antibiotics. Original Pack Dispensing (OPD) will not apply to controlled drugs.
Opposition MPs have raised questions over the two possible reimbursement scenarios: reimbursement based on the prescribed or the dispensed.
To enable reimbursement negotiations, in England there will be a transitionary period before the OPD regulations are implemented. This will not apply in Scotland.
The second amendment requires that valproate is dispensed only in manufacturer’s complete original packs, with limited exceptions in specific circumstances. Caulfield said despite the pregnancy prevention programme, at least three pregnancies a month in England are still exposed to medicines containing valproate.
Caulfield said that the valproate regulations will also take immediate effect across GB.
The minister also touched on hub and spoke dispensing during the debate, noting that the benefits of original pack dispensing will be synergistic. She said that the results of the consultation into hub and spoke dispensing will be published soon.