The Health (Pricing and Supply of Medical Goods) Act 2013 provides the legislative basis for using ‘Do Not Substitute’. ‘When a branded interchangeable medicinal product is prescribed for a patient and the prescriber is satisfied that the medicinal product should, for clinical reasons, be exempted from substitution in accordance with Chapter 2 the prescriber shall write, legibly and by hand, “do not substitute” on the prescription beside the name of the medicinal product.’ The circular accompanying the change in legislation from 2013 is available here.
With the introduction of Healthmail in 2020, where the prescriber wishes the patient to access the proprietary product rather than the reference priced generic alternative, ‘Do Not Substitute’ can be computer generated on the prescription rather than in the prescriber’s own handwriting.
If ‘Do Not Substitute’ is not written or typed on the prescription but the patient wishes to take the brand, the payment of this supplement is in addition to the prescription levy for the GMS Patients, and the DPS co- payment for DPS patients.
Any deviation from this legislative process for ‘Do Not Substitute’ is deemed an invalid claim by the PCRS. Failure to adhere strictly to the legislative process is the subject of a number of ongoing claims investigations by the PCRS.