Epilepsy Action has prepared detailed replies to most of the questions in the formal consultation document. If you agree with these comments feel free to copy them and include them in your own response to the consultation.
Epilepsy Action does not believe Option 3 is the preferable approach.
Epilepsy Action strongly favours Option 2, provided anti-epileptic drugs (AEDs) are on the associated list of drugs not to be substituted. This option would be best to ensure that people with epilepsy are not put at unnecessary risk.
Epilepsy Action strongly believes anti-epileptic drugs should be excluded from any automatic generic substitution. There is strong evidence that brand switching for many people with epilepsy has caused breakthrough seizures, worsening of their seizure control or worsening of side-effects. These are major issues for many people with epilepsy, and can affect employment, education, and social life. For example a single seizure can cause the loss of a driving licence for a year, and this may impact on a person’s quality of life.
Epilepsy Action will be attaching a detailed document explaining why AEDs should be excluded to their submission. If you wish to do so you can download a summary of the reasons why AEDs should be excluded.
It is pleasing that epilepsy is specifically mentioned as one condition where substitution may not be suitable, on page 8 of the consultation document.
Epilepsy Action believes Option 3 of the proposals would be acceptable provided two changes are made to the proposals. Without these changes (or, as a minimum, the second proposed change), Epilepsy Action opposes Option 3:
- There should be a second list to accompany the substitution list. This list should be of drug groups that cannot be added to the substitution list under any circumstance. We would expect this to include AEDs for the reasons outlined above.
- There should be a formal consultation mechanism for any drugs that are to be added to the flexible dispensing list – see answer to question 5.
Epilepsy Action will not be expressing a preference for either the ‘tick-box’ or endorsement schemes (pages 12-14), designed to opt an individual patient entirely out of a scheme. Either scheme would be acceptable if introduced.
Epilepsy Action would like to stress that we are not opposed to generic drugs and many people with epilepsy are successfully treated by generic drugs. Epilepsy Action promotes the importance of ‘consistency of supply’, receiving the same version of an AED each time when a successful treatment plan has been found. It is the switching of versions which could endanger a person’s control of their epilepsy.
We are not be opposed to people with epilepsy receiving ‘generically substituted’ drugs for other conditions or ailments, where no questions of patient safety have arisen. However AEDs should be excluded on clinical and safety grounds.
This is a technical question about how to define whether drugs are the same and could therefore be substituted. We will be submitting a response along the following lines. It basically states that Epilepsy Action believes that different versions of the same drug don’t necessarily have the same effect:
“Epilepsy Action believes that drugs subject to the arrangements should be shown to be therapeutically equivalent to the original brand. Epilepsy Action is not aware that the proposals satisfactorily demonstrate therapeutic equivalence.
“Epilepsy Action is not qualified to comment on the detailed definitions but understands that generic forms of AEDs may satisfy the proposed definitions. We believe strongly, as evidenced in the supporting documentation, that generic versions of AEDs are not all therapeutically equivalent, That being the case Epilepsy Action does not believe the proposed definitions provide adequate safeguards for patients.”
See answer to question 2.
Epilepsy Action is concerned that AEDs could be added to a substitution list without warning or further discussion (clause 60 on page 18).
This would be a particular concern to us if the initial drug list does not provide the anticipated financial savings. AEDs meet the Department of Health’s other criteria for being added to the list (page 18, clause 57). There is nothing to prevent AEDs being added to this list at a later date. We are therefore calling on the Department of Health to put in place a formal process for adding drugs to this list.
Epilepsy Action further believes that excluding consultation on additions to the list would directly contravene the requirement in clause 4 of the NHS constitution.
NHS services must reflect the needs and preferences of patients, their families and their carers.
Patients, with their families and carers, where appropriate, will be involved in and consulted on all decisions about their care and treatment.
There are four criteria for selecting drugs to be added to the substitution list. Epilepsy Action believes that “general clinical or patient safety concerns with regard to interchange between different manufacturer’s products” is the most important of the criteria. We believe it should have the power to mean a drug is not added to the list, even if the drug meets the other three criteria (see page 18).
We are pleased to note that no anti-epileptic drugs are listed in the initial select list in Annex A. We hope that the Department of Health has taken notice of the information provided to them by epilepsy professionals and organisations about the potential risks.
Epilepsy Action does not have any comment to make regarding the Department of Health’s cost-benefit analysis for Option 3. However, this cost-benefit analysis does not take into account the impact of adding other drugs to the list in the future.
Epilepsy Action feels the cost-benefit analysis would be no longer be correct if AEDs were added to the list of drugs allowable under flexible prescribing.
The attached document shows that the proposed savings could be outweighed by the additional costs of treating and supporting people with epilepsy whose condition has been made worse by AED substitution. No such calculation of costs has been included in the Department of Health’s cost-benefit analysis.
Any introduction of generic substitution that does not explicitly exclude AEDs could discriminate against people with epilepsy classed as disabled under the Disability Discrimination Act. This is because successful drug treatments, in other words consistent supply of brand of AED, could not be safeguarded for the future. We would like to see an exclusion for AEDs guaranteed in the secondary legislation when it passes through parliament.
We have been told by many of our members that it is important we emphasise that the obligation to monitor this scheme should not be placed on the patient. By this we mean that no individual patient should have to ensure their drug has not been substituted, or to explain why this is important. Epilepsy Action would expect the administration to be carried out and followed up by the Department of Health.
From our research we know that not all people with epilepsy are aware of the potential problems. They rely upon the advice and guidance of their prescriber and dispenser when receiving their medication.
We are aware that some people, although a small minority, have been misinformed about the risks of drug switching when they have approached medical professionals (see survey results). It is crucial to remember that some people who take anti-epileptic medication are not able to question medical staff or ‘speak up’ for themselves. They should not experience worse health outcomes as a result.