New regulations to accompany the introduction of HRT prepayment certificates (HRT PPCs)

The Department of Health and Social Care (DHSC) has introduced new pharmaceutical regulations, to take effect on 1 April 2023, to accompany the introduction of the HRT PPC. They are within the  National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023.

The HRT PPC is a new, limited scope, less expensive, prepayment certificate applicable only to listed HRT items. We announced the Government’s decision to roll the certificates out here.

As a consequence of its limited scope, a patient with an HRT PPC will continue to pay the prescription charge for any other (non-HRT) medicines (unless another exemption reason applies). While GPs will be required to write HRT items on separate prescriptions, on occasion both an HRT item and another medicine will be prescribed on the same prescription– a mixed prescription. This presents a problem for a patient who has an HRT PPC because a prescription cannot be processed as both ‘exempt’ and ‘paid’ within the NHS prescription processing and pricing systems.

Therefore, the new regulations give 3 options to contractors/pharmacists facing mixed prescriptions presented by patients with an HRT PPC:

  1. First, refuse to dispense a mixed prescription issued to the patient – refuse to dispense both the listed HRT item and the other medicine – and ask the patient to return to the GP for two separate prescriptions.
  2. Second, either:
  • dispense the listed HRT item (the patient or the patient’s representative signing to claim the HRT prescription exemption), or
  • dispense the other non-HRT medicine(s) with the prescription charge(s) paid.

 (This may be appropriate if the patient has an urgent clinical need for the HRT item or other medicine) The patient will need to obtain another prescription for any items not dispensed.

  1. Third, dispense both the listed HRT item and the other medicine – and complete an FP57 refund form for the HRT item and charge for the other medicine.

The table below sets out various scenarios that may apply.

Prescribed HRT PPC Prescription Charge FP57 form issued
Listed HRT item only Yes No No
Listed HRT item only No Yes Yes if requested by the patient
Listed HRT item and another medicine Yes Mixed prescription – 3 options apply
Listed HRT item and another medicine No Yes for both items Yes if requested by the patient

Shortly, DHSC will be issuing guidance on the HRT PPC and PSNC will also issue supplementary guidance.

PSNC has argued against the Government’s proposal saying that HRT PPCs do not work within existing NHS prescription processing and pricing systems. PSNC suggested that all HRT items should instead be provided to patients free of charge.

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