Switching between epilepsy drugs
New guidance on prescribing and dispensing epilepsy medication takes no account of the real world issues of people who live with epilepsy. You can help inform future advice on anti-epileptic drugs by filling in our survey. Sarah Vibert, head of policy and development at Epilepsy Society, explains.
Every day we hear stories from people affected by epilepsy about whether services are good or bad, and what changes are needed. It is because of our strong connections that charities such as Epilepsy Society and Epilepsy Action have a critical role to play in the development of public policy. We seek to ensure the real world experiences of people with epilepsy inform and shape the policy debate.
The importance of this was sharply demonstrated to me recently when a public body - The Medicines and Healthcare products Regulatory Agency (MHRA) - failed to consult with epilepsy charities about a change in the guidance around epilepsy medicine.
The MHRA is responsible for ensuring medicines are safe. Previously there has been no guidance about epilepsy medicine - known as anti-epileptic drugs or AEDs - in relation to whether drugs can be switched and how AEDs are named and labelled.
The MHRA therefore assembled a group of leading academics, scientists and medical experts to develop some guidance. This group agreed that 'pharmacological evidence' suggests that for AEDs with a 'narrow therapeutic index' it is safe to switch people between different versions of the same AED. In other words, the medical evidence suggests that for certain AEDs, taking a different manufacturer’s version of the same drug will not make any difference to the way in which it affects the body.
What they missed was the reality of being an individual with epilepsy, going to the doctors to get a prescription and then to the chemist to collect your medicine. And this is where the epilepsy charities come in with our evidence.
Memory and anxiety problems
Firstly, a substantial number of people with epilepsy also have memory difficulties, anxiety, autism or learning disabilities. For this group of people changing from taking three blue tablets to two yellow ones is not as straight forward as the science might suggest - even though the total amount of the active ingredient administered has not changed.
For someone with autism, it may be distressing if a tablet tastes different to normal. For someone with memory difficulties, it may cause confusion leading to taking the wrong number of tablets. Many people in this group are prescribed drugs for which the MHRA have concluded that ‘no specific measures are normally required and these AEDs can be prescribed generically’ (category 3).
We know this because we talk to people with epilepsy every day and work closely with medical specialists providing support to people with epilepsy which is resistant to treatment. We also know that if medicine looks or tastes different, an individual may just decide not to take their medicine at all - leading to breakthrough seizures. Let’s not forget that having just one seizure can result in losing your driving licence, can impact on employment and social life, and even lead to death.
GPs not specialists in epilepsy
Secondly, general practitioners (GPs) are, by definition, not specialists in epilepsy. People with epilepsy repeatedly tell us that their GP does not understand their epilepsy. This means that the new guidance on AEDs is going into a vacuum where there is little, if any, information about epilepsy. GPs, who are also under pressure to keep drug costs down, are likely to take the guidance at face value and see it as a green light to prescribe by generic name.
A third and related point is that the guidance may mean that people have to be more 'pushy' to get continuity of supply if they are prescribed an AED in category 3. Again, people with epilepsy tell us that, in the context of a 10 minute GP appointment, it is unlikely that a GP will be able to fully assess the whole person. This means the GP is unlikely to be able to assess ‘specific concerns such as patient anxiety, and risk of confusion or dosing errors’ - which is the caveat the MHRA have added to category 3. While some people will pro-actively ask for (and get) the same version of AED each time, there is group of patients with epilepsy who are more vulnerable and less likely to advocate in this way. They may only realise they have a different product when they collect their medication from the pharmacy and it looks different. Or it may be a carer who collects and administers their medication.
Overall, whether or not the scientific evidence stands up to scrutiny, the new guidance takes no account of the real world issues of prescribing, dispensing and taking AEDs. People with epilepsy are experts in their condition, which is why they must be involved in policy decisions that affect the services they access and medicines available to them.
Take part in our survey
Of course, the other responsibility that charities such as Epilepsy Society and Epilepsy Action have in advocating for the people they represent, is to ensure they are genuinely listening and representing their views. This is why we are continuing to gather information about the experiences of people with epilepsy in switching versions of AEDs.
Please share your experiences by completing our survey so we can ask the MHRA again to reconsider their evidence, this time including evidence about the real world as well as the science.