12 November, 2013
National charity Epilepsy Action has expressed major concerns over new guidance on prescribing epilepsy medicines. The new guidance has been released today by the Medicines and Healthcare Products Regulatory Agency (MHRA). It means that epilepsy medicines will now be classified in three categories depending on the supposed risk attached to switching between different versions of the same medication. Epilepsy Action is calling for one of these categories to be suspended pending wider consultation on its implications.
Evidence suggests that switching between branded and generic versions of epilepsy medicines can cause problems for patients. These include loss of seizure control and adverse side effects. Loss of seizure control is a major issue for many people with epilepsy, affecting employment, education and social life. For example, a single seizure can cause the loss of a driving license for a year, and this may impact on a person’s quality of life.
Simon Wigglesworth, deputy chief executive at Epilepsy Action, said: “We are surprised and disappointed that this decision has been taken without wider consultation. We have major concerns about the introduction of category 3 of this guidance. We would ask that the MHRA suspend this category, pending wider consultation on the evidence that its introduction is based on.
“Category 3 gives the green light for some drugs to be switched without input or discussion from patients. We know that clinical evidence has shown that switching between the branded and generic versions of levetiracetam (Keppra) – one of the category 3 drugs - can have an adverse effect on patients. Under these new regulations, levetiracetam could be automatically switched without any discussion with the patient.
“Also, some drugs listed in category 3 currently have no generic version. As such, there is no evidence that switching between preparations of these drugs is safe. It is a concern that these drugs will remain in category 3 by default when a new generic is released.
“We support the development of category 1 as there is substantial evidence to suggest that drugs listed in this category should not be switched. Category 2 is in accordance with NICE clinical guidance and is current practice.
“We want to see category 3 suspended and would ask that the MHRA makes available the full report or review of the evidence, and a list of the evidence used, as a priority. Understanding how this decision has been reached is crucial in wide-range acceptance of the new advice among people with epilepsy, their carers and their doctors. Patients must be reassured that decisions are based on sound evidence and will not adversely affect care or seizure frequency.”