Products requiring reconstitution – pack size changes

Following the changes to pack sizes for Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension, six more products that require reconstitution have had their pack sizes updated in the NHS dictionary of medicines and devices (dm+d) and the Drug Tariff from May 2024. This follows the identification by Community Pharmacy England of pack size listing discrepancies where the pack sizes previously listed did not represent the actual usable volumes after reconstitution as set out in their respective SmPCs.

Following representations made by Community Pharmacy England, the NHS dm+d Content Committee agreed that where an SmPC for an oral solution or oral suspension publishes both a reconstituted volume and a usable volume, and these are different, the pack size on dm+d will be based on the published usable volume.

The table below shows the six products listed in the dm+d and Drug Tariff with updated pack sizes based on the usable volumes.

Product Previous pack size listing New pack size listing based on actual usable volume after reconstitution (effective 1 May 2024) Listed in the Drug Tariff Special container (complete pack size)
CellCept® (Mycophenolate mofetil) 1g/5ml oral suspension 175ml 160ml* Yes Yes
Revatio® (Sildenafil) 10mg/ml oral suspension 112ml 90ml Yes Yes
Sprycel® (Dasatinib) 10 mg/mL oral suspension  (Imported (Germany)) 99ml 90ml No Yes
Tamiflu® (Oseltamivir) 6mg/ml oral suspension 65ml 50ml Yes Yes
Valcyte® (Valganciclovir) 50mg/ml oral solution 100ml 88ml Yes Yes
VFEND® (Voriconazole) 40mg/ml oral suspension 75ml 70ml Yes Yes

* Where a usable volume range is presented in the SmPC the lowest level of the usable volume will be the pack size published on dm+d and in the Drug Tariff, where applicable.

Due to the lag in updating of prescribing systems to reflect these changes, pharmacies may continue to receive prescriptions for the older pack sizes. Until prescribing systems have updated and ‘mapped’ across new product codes (with updated pack sizes) by using the latest dm+d extract, pharmacy teams may need to seek clarity from the prescriber regarding the quantity required by the patient and request amendments to prescriptions, where appropriate.

Please note: All the affected products are classed as special containers and payment will continue to be based on special container rules. For example if 175ml (old pack size) of CellCept® is ordered on an NHS prescription, pharmacy owners will continue to be reimbursed for the complete pack size dispensed.