To ask the Minister of Health whether his Department plans to review its policy allowing interchangeability of anti-seizure medication brands, following advice from the Epilepsy Society recommending consistency in brand to ensure stable dosage and to minimise side effects.

Different antiepileptic drugs vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss of seizure control.

Guidance on interchangeability of antiepileptics is produced by the Medicines and Healthcare products Regulatory Agency (MHRA), following advice received from the Commission of Human Medicines (CHM). This guidance classifies antiepileptics into one of three risk-based categories which help healthcare professionals decide whether it is necessary to maintain continuity of supply of a particular manufacturer’s product. Prescribing recommendations for HSC healthcare professionals, outlined in the Northern Ireland Formulary, incorporate this MHRA guidance.

The MHRA guidance indicates that some antiepileptic drugs such as levetiracetam and lacosamide do not need to be prescribed by brand name and can be prescribed generically, as the potential for clinically relevant differences to exist between different manufacturers’ products is considered to be extremely low.

It is my Department’s policy that medicines should be prescribed generically in all appropriate circumstances. Generic medicines contain the same drug and are as safe and effective as the branded product, and appropriate use of generic medicines helps us to make better use of limited health service resources because generic medicines are more cost effective.

In line with the MHRA advice, clinicians will also consider their patient’s particular circumstances before deciding whether their antiepileptic medicine is suitable for switching to the generic equivalent. Patients will have the opportunity to discuss any proposed change with a healthcare professional before deciding if they wish to try the generic medicine.

Where MHRA guidance indicates that a patient should be maintained on a specific manufacturer’s product, this should be prescribed either by specifying a brand name, or by using the generic drug name and name of the manufacturer.