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Government update to guidelines about switching between different forms of epilepsy medicines says prescribers should consider the individual’s concerns

1 Dec 2017

The government has added to its guidelines about switching between different forms of epilepsy medicines. The update says that prescribers need to take into consideration people’s thoughts and concerns.

Switching can sometimes happen between different manufacturers’ versions of a medicine. This includes generic versions and brand-name versions. For example, someone taking Lamictal may be put on a generic form of lamotrigine. A change from a particular manufacturer’s product can sometimes cause an increase in seizures or side-effects.

In 2013, the Medicines and Healthcare product Regulatory Agency (MHRA) put epilepsy medicines into three categories. People taking Category 1 medicines need to be kept on the same product from the particular manufacturer. These medicines include carbamazepine, phenobarbital and phenytoin.

For a Category 2 medicine, a prescriber should judge each case individually when deciding whether to switch between different versions of a medicine. They should consider things like the person’s treatment history and seizure frequency. Medicines in this category include clobazam, lamotrigine and valproate.

The medicines in Category 3 are considered very unlikely to have a negative effect when switching between different manufacturers’ versions. Medicines in this category include brivaracetam, lacosamide and levetiracetam.

On 24 November of this year, the MHRA added to the advice to prescribers for Categories 2 and 3. The update states that people’s feelings should be considered when deciding whether to switch between versions of medicines. This includes whether people have negative thoughts about different forms of a medicine, like packaging and taste. Prescribers should also consider problems such as anxiety, confusion, dosing mistakes and people not keeping up with their medicine.

'Very real concerns'

Epilepsy Action has been campaigning against prescribers being able to switch between different versions of medicines. The charity has welcomed this move to give more weight to the concerns of the people taking the medicines.

Epilepsy Action’s deputy chief executive, Simon Wigglesworth, said: “We are delighted the MHRA has listened to our recommendations and made important changes to the guidance on switching between different anti-epilepsy medicines. These changes have a much greater focus on the individual and take into account the potential risks involved when changing medication.

“We are also pleased to hear the MHRA has listened to the very real concerns of people with epilepsy on this issue. We worked with the Epilepsy Society to survey people about the impact of switching their epilepsy medication. We found that 17% had more frequent or more severe seizures as a result. We also learnt that 7% of people reported a new or breakthrough seizure after having been seizure free for a year. 

“The impact of this should not be underestimated and can significantly affect people with epilepsy in a variety of ways. They may not be able to drive or work, and experience severe anxiety or depression as a result of switching medication. We hope the revised guidance will help healthcare professionals to better advise people with epilepsy on all aspects of their so they can live more safely.”

Epilepsy Action’s website has more information on changing between different versions of an epilepsy medicine

 

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Comments: read the 1 comments or add yours

Comments

Your comments and actions are welcome on helping to communicate that changes between anti convulsant brands can have detrimental effects to the user. However whilst the government, MHRA and NICE all offer guidelines, there doesn't seem to be any evidence that the guidelines have been validated as fully workable. Epilepsy rightly flags up an Epilim shortage, in my sons case this has been compounded by a shortfall in oxcarbazepine from the manufacturer TEVA. How is this possible, importantly what is being done to correct it

Given the NHS position as a the procurer of these drugs it isn't unreasonable to expect them to demand that suppliers have business continuity plans in place that protect consumers from manufacturing crisis and stock outs. The situation is exasperated further by ambiguity from wholesalers and reluctance from GPs to issue prescriptions for more than one month

I callon the NHS to look into what can be doe to safeguard users in this area

Submitted by Alan Hazlewood on
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