Department of Health consultation

Department of Health consultation

Epilepsy Society welcomes the Department of Health’s announcement that it is now consulting on proposals to substitute cheaper generic drugs for branded drugs in NHS prescriptions.

Epilepsy Society has been campaigning for several months to exclude anti-epileptic drugs (AEDs) from the proposals, arguing that cutting costs on epilepsy drugs doesn’t add up - it could provoke seizures or side effects. One breakthrough seizure is devastating and could cause serious injury and harm, rob someone of their driving licence and affect their job.

Acknowledging the risks imposed by switching from one drug to another, the Department of Health has stated that its preferred option would be to limit substitution to a selected group of medicines which would not include AEDs.

Epilepsy Society’s detailed report to the Department of Health about the risks of substitution of AEDs  has been acknowledged in the consultation document, and epilepsy has even been used as an example of a condition where generic substitution might not be appropriate.

We are very pleased to see that the Department’s preferred option in the consultation document would limit substitution to a selected group of products which does not include AEDs.  We believe this gives greater clarity than currently exists and recognises the individual needs of patients in relation to the drugs they are prescribed.

However, we also note in the consultation document that further drugs could potentially be added to the scheme in the future, so it important that we all continue to make our voice heard on this issue and make sure that epilepsy drugs are excluded from the scheme once and for all.

The battle is not yet won. Epilepsy Society’s chief executive Graham Faulkner has emphasised the importance of continued vigilance: "The Government has shown a real appreciation of the fact that consistency of supply is key to seizure control. But it is still vital that we keep up public pressure and underline this very clear message via the consultation document."

The consultation is open until 30 March 2010 and the Department of Health is keen to hear patient views. The consultation document – and the suggested pro-forma for responses – is quite complex for individuals, however.

Epilepsy Society is currently formulating its response to the consultation. We will set out the issues for people affected by epilepsy, and create a consultation response which you could download and personalise. Look out for this on the website. 

Let’s all make sure the government exempts AEDs from plans in the Pharmaceutical Price Regulation Scheme to switch to cheaper, generic drugs

Background documents and the consultation paper are available on the Department of Health website (opens in a new window).

Epilepsy Society's report to the Department of Health

We submitted key considerations and a full report of the round table discussion to the Department of Health. The key considerations are detailed below.

1. The risks of substituting any one formula of an anti-epileptic drug (AED) for another are too high, as such risks far outweigh any potential cost consideration.
2. The highest risk is of breakthrough seizures for somebody whose epilepsy has previously been well controlled. Just one of these is enough to rob somebody of their driving licence, possibly lose their job, and substantially increase the likelihood of accident, hospitalisation and even death. Increased risk of hospitalisation and injury has been demonstrated to be related to AED formulation switches. This is what makes epilepsy and anti-epileptic medication a special case. When breakthrough seizures occur advice to physicians is to ask the patient if they have noticed a change in their medication.
3. AEDs need to be excluded from any plan for GPs or pharmacists to dispense any version of AED different from the one the patient normally takes. In fact guidance needs to be issued to explain that this is unacceptable and highly risky practice.
4. Branded and generic versions of the same AEDs are expected to have the same levels of active ingredient. The non-therapeutic contents of the drugs (the excipients), however, can be very different, and these affect the bioavailability of the drug and can vary its therapeutic effect by up to 50 per cent. The excipients may vary in different generic versions of a drug, and from the original brand name version. In a worst case scenario somebody who took their prescription for a generic AED to different pharmacists over a period could end up with a range of different generics being prescribed - all with different formulations - potentially causing havoc to their seizure control and leading to substantial risks.
5. Many of the patients who arrive at the National Society for Epilepsy’s specialist medical facilities with severe and uncontrolled epilepsy have a sorry tale to tell of their AED management, and bring with them a whole bag of assorted AEDs - branded and various formulas of generic - that they have been prescribed. This is one indication of the lack of understanding and unacceptable face of epilepsy management in the UK today.
6. Having a tick in or a tick out box on the prescription form could lead to further confusion and mistakes in prescribing. It should explain on the form/template that epilepsy medication is exempt, and that people with epilepsy should have total consistency of supply of their specific AED. If GPs are prescribing a generic drug, they should state the manufacturer so that the patient gets the exact consistency of supply they need.
7. If pharmacists - community or hospital - do not stock that manufacturer’s generic AED, they should not substitute it for another or for a branded product, but either obtain a supply if they can do so in the time frame or refer the patient to another pharmacist who may stock that particular version.
8. We are not arguing for branded over generic, or for one generic over another. There is no inherent superiority, and all versions can be usefully taken. It is switching between different versions of the same drug that brings about risks. However, it is topical to note that NICE are currently reviewing their epilepsy guidelines and considering a range of new epilepsy drugs which could potentially have good results for people whose seizures have not been well controlled so far. Any emphasis on generic prescribing could undercut use of such potentially useful new drugs.
9. Slow-release medication (also known as modified release or controlled release) in particular should never be substituted for non-slow-release versions, as slow-release versions have different pharmacokinetic effects
10. There is a question of legal liability, in addition to clinical and economic considerations. If generic substitution goes ahead without the exemption of AEDs, and a person with epilepsy has a breakthrough seizure, suffers a major accident and decides to take action, who takes responsibility for the medical negligence claim?  The individual pharmacist, the GP, the Department of Health, the PCT?
11. The Department of Health proposal also undermines health policy on ‘choice’, which has been a key driver in recent NHS reforms. Such a proposal would massively reduce the patient’s choice of preferred AED and lead them to increased risk. It has been demonstrated in a number of world wide studies that when people with epilepsy are given the chance to switchback to a branded drug, many take the opportunity to do so. Perhaps this is to maintain a consistency of supply, rather than any inherent preference for the branded drug itself.
12. All the countries globally who have introduced generic substitution have ultimately done so with an exemption for AEDs. There is also an economic question of whether the overall NHS budget would actually benefit, when the costs of the extra treatment, hospitalisation, compensation (not to mention lack of work, disability benefit etc) potentially caused by switching people’s AED formula are taken into account. The cost-benefit analysis would seem to indicate that generic substitution of AEDs would be a disastrous idea.