I am VERY concerned re the impending change to the dispensing of AED's in January 2010. Over 4 years ago I insisted that I be prescribed the same brand AED. With one exception (due to pregnancy) I have been seizure free since. I am now pregnant again and will be subjected to this change - it goes without saying that this is a MAJOR CONCERN for me. I have spoken directly to my epilepsy nurse and she has said that not only does pregnancy make management of AED's crucial, but combine this with the proposed change presents potential horrific problems.
QUESTION: who has the right to decide that cost cutting is more important than the quality (and safety) of someone's life who has such a significant condition?
ANSWER: Someone who doesn't have epilepsy.

I came across your site by chance and wanted to take the opportunity to play devils advocate and respond to some of your concerns about brand substitution. Perhaps you would be gracious enough to humour my ramblings?

It's understandable for anyone to be anxious about changes to their medication. Especially if such changes are not initiated by a doctor. But the key here is substitution. Like for Like. And if a brand of drug cannot be substituted for a generic version which is equivalent, then it should not be substituted. Full-stop. Anti-epilepsy drugs are just one example of where different formulations are often not equivalent. Other examples include lithium, theophylline, ciclosporin, diltiazem and nifedipine to name but a few.

But here's the good news. Pharmacists are drug experts. This is where our strength lies. And we use this knowledge everyday when dispensing prescriptions and advising patients on their medicines. Unfortunately, there will be times when people are not happy with the service a pharmacy provides. There are good and bad pharmacists just as there are good and bad doctors. But I would like to think that the bad are few and far between. There are also a lot of misconceptions about prescriptions amongst the general public. If a prescription is written generically pharmacists are under no obligation to dispense a particular brand. And why should they if they're all equivalent? However, if a patient prefers a particular brand for whatever reason, most pharmacists would go out of their way to obtain and dispense that particluar brand (even if they lose money by doing this!). Just ask. I hope you'll be pleasantly suprised (please bare in mind, when a patient wants an expensive branded medicine but their doctor has only prescribed the cheaper generic version, the pharmacy will only get paid for the cheaper generic product-do this enough times and there will be no pharmacy).

Brand substitution will enable patients to get the medicines they need in a more timely manner. For sometime now there have been huge supply problems for a wide variety of drugs. The situation only seems to be getting worse. How many people have been asked to come back to a pharmacy because there are supply problems for one or more of their medicines? Most people I would guess. Brand substitution will enable equivalent medicines to be dispensed where it is appropriate. In fact, this practice already takes place. The only difference is that at present the pharmacist needs to phone the doctor to confirm this substitution. This sounds fine in theory but just think of the trouble it takes to make an appointment with a GP. Pharmacies have to use the same phone numbers that the general public use. So it should come as no suprise that this process usually takes a minimum of one to two days. I would call this is a waste of everyones time. For the patient, the GP and the pharmacist. It is also an unnecessary delay in patient treatment. A GP has never objected to my suggestion of a brand substitution. And as mentioned earlier, pharmacists are more than competent to make such decisions.

The importance of a multi-disciplinary team within the NHS has grown and grown over the past few years. Healthcare is bigger than just doctors and nurses. Podiatrists, OTs, speech therapists, physiotherapists, microbiologists, radiographers, HCAs, dieticians, audiologists and even pharmacists are all unsung heroes of the NHS. We all play our part, regardless of how big or small. And each is trained to ensure that patient safety is maintained at all times. This will always be our primary concern. And this is the primary driver for brand substitution. So if you are concerned about the medicines you are dispensed, just speak to your local pharmacist. I'm confident they'll do whatever they can to help. I'd bet my nan on it.

I got my weekly prescription delivered this week & when i got it i looked & something was not right there was tablets in it that were big & white with crosses , so i phoned and asked and was told it was a different brand and there was nothing to worry about , so i asked when would the other brand be back but they were not sure . Since then i have done nothin but worry & i am going to see them Monday because my epilepsy is uncontrollable as it is i am not running the risk of anything else happening , i just wish the people who decided this were as reliant on these meds as alot of us are because i bet that wud soon change their mind .

I am appalled at the suggestion that people who suffer from Epilepsy will be subject to what will be experimentation.
Having suffered from Epilepsy for the last 50 years and now in the last 13 years being free but still having to take ten tablets a day Epenutin, tegretol, and phenobarbitone changes would also have disastrous effects on the warfarin that i also have to take.
I have been told I am on a highly dangerous cocktail of drugs and under no circumstances should i stop or miss a dose. These drugs are the only ones that control the massive Grand Mal attacks that i use to suffer. This is dangerous ground that the NHS is getting in to. I know when my tablets were changed some 18 years ago that I suffered for three years until my attacks came under control.
Epileptic Drugs are very dangerous and such experimentation will cause untold medical problems and emergencies for the disaster that will happen.
By the way my Epilepsy was caused by a drug I was given in a Mental Hospital after suffering a nervous breakdown that drug was LSD yes LSD 4000+ patients were experimented on causing untold misery and in my case disability.
It seems that people who suffer mental disabilities can always be experimented on. The hidden costs that this will cause to Epileptics has not been assessed all that has been done is find a way to save a few pennies.

I signed the petition because it's on the right track but there are a couple of points I think should be checked.

I don't know European Law and regulations (and "Ph.Eur." does differ from "USB"), but I believe the U.S. Food and Drug Administration (FDA) approves a "new drug application" (NDA) by public process, and the drug is then manufactured on patent by the drug company which developed the drug. When time had elapsed and it's off patent, there is a quicker process which is not a public process: an "abbreviated new drug application" (ANDA) may be granted if the generic meets 4 criteria, one of which is bioavailability. I believe the standard set by regulation is +/- 8% within 90% confidence intervals (please anyone correct this if wrong: I haven't had time to check it up, and the real issue here is the European regulations) of the reference drug.

The standard set by US regulation for lot-to-lot variation in the generic (or original company's) drug isn't as big.

The FDA must grant an ANDA if it meets these 4 criteria. If it "differs", it won't be considered substitutable or "therapeutically equivalent" and the company will have to file a "suitability petition". When an ANDA is granted, but a suitability petition has been filed, then that particular manufactured drug can't be substituted for the brand name drug even when state law specifies generics are to be substituted.

I think what you are petitioning for here is a limitation on what is substitutable. Regulations which are fine for many drugs aren't adequate to protect people taking AEDs for epilepsy because many AEDs aren't soluble and are metabolised in the liver which metabolises a lot of other things too. So there's competition (what you eat with AEDs matters) and as well, the dose you take isn't related to the blood serum level in a way that allows you to calculate one from the other. There are a lot of unmeasurables and personal differences. It's easy to be sub-therapeutic or toxic. Either is dangerous.

Secondly you may be petitioning for a tighter definition of "tablet" vs "capsule" (one of the 4 criteria), because tablets don't work the same as capsules and it isn't just a question of wrapping the tablet in gelatin and calling it a capsule. Fast-melt tablets really work quite differently. A less formalistic definition, with more recognition of the importance of form and excipients, might be helpful.

Finally, manufacturing capacity is important: it takes 2-4 weeks to reach "steady state" with some AEDs and you start again if you change the amount you're taking. So you don't want to have to change manufacturing labs, or even excipients used by your usual brand (as has happened in the US with "dilantin"). It may be that one month's supply isn't adequate. I'd personally like 6-12 months' supply, leaving plenty of time for re-ordering and allowing drug manufacturers to anticipate demand. Generics aren't necessarily cheaper than brand name drugs, and aren't necessarily better or worse or more or less reliable, but I do think some labs are more consistent than others.

As prevalence of epilepsy is estimated at 5-10 per thousand, and seizures are in a way unique like fingerprints, I feel a healthcare professional whose experience is limited to one or two patients with seizures of any particular kind is differently placed than a specialist epileptologist who sees many many patients in a weekly clinic and copes with the fallout of breakthrough seizures or toxicity. I also feel epileptologists and tertiary/quarternary hospitals are better placed to note if there's a shortage of any particular drug or a new manufacturer, or a lot of patients complaining suddenly that a well-established product doesn't seem to be working as well as it did. I'd like to be forewarned if I'm going to have to make a change so that I can layer old and new over a period of months if I have to. I'd like to feel that my prescription refill would take priority over any "off-label" use.

You only very briefly touched on cost/benefits: repairs to my face following my last seizure cost approximately twenty times a lifetime's supply of the drug I was using until a prescription change 3 months before it occurred. I'm still suffering from post-concussion syndrome and will miss the last 10-15 years of my professional career.

In terms of risk analysis, likelihood of event x seriousness of event will be different for everyone but I'm told another bad seizure on half-strength AEDs would be likely.

I appreciate the efforts Epilepsy Action is making in this campaign.

Anny

This substitution is aimed merely at saving a few pounds, at the expense of those with epilepsy who have in many instances paid dearly already, perhaps (as with me) by loss of livelihood. I was dismissed as a languages lecturer on the grounds that I surely wouldn't live long enough to see my pension. That was 38 years ago. I'm still here, with my bus pass regularly in use. My wife, under this strain, didn't make it.

We now have the clearest indication that epilepsy isn't thought worth troubling about. Note the fanfare about cancer diagnosis and treatment: much more eye-catching and ever so much sexier. Just the right headline. Now, it's time to fulfil the recent campaign and Come Out Of the Shadows. Make a noise about this mindless, false economy. The last time - and it will be the last - I had a substitute, I was in hospital for three weeks after multiple seizures, so severe they were thought to be a stroke. They were continuous for 14 hours. Afterwards, I received al of 40 minutes' occupational therapy. I had to teach myself to walk and speak again, for my left side was effectively paralysed. It took months to become functional again.

No, Gordon et al, you can forget it. You must have heard of SUDEP. You have already enough deaths on your conscience in senseless wars. Do you want to start on your own people too - the 'inferiors' with epilepsy? If the economy's in a mess, whose fault is that? It's not ours.

We found out about the medicine swaps after my daughter not only had more seizures than usual but was allergic to the swapped version, she was very ill and also covered in an itchy rash... We told the chemist about this but they insisted on giving us the other generic versions. In the end we were told that we could only have her preferred makes if the doctor stated it on the script, we made sure this was done for the future. We do however still check before leaving the chemist that she has been given the right tabs so that any errors can be corrected at the time. We are not at all happy about the lack of care the government seems to have for people on medication. None of us want to be on them in the first place but now we are we like to know we can rely on consistency, changing things is just messing with peoples lives...

Hi
If they change the brand name for lamotrigine does that mean they will change the formula for it
Reply soon

A couple of years ago I had a sudden increase in my rate of seizures. It was a few days before I noticed that my new batch of Tegretol had changed from the usual 'Geigy' to something different. I think this was the cause.

I read about thhe proposed change in epilepsy action a couple of monts ago but did not get any response to signing the petition on line.

I went into BOOTS my nominated chemist last week to ask if they woud be substituting and two of the staff behind the prescription counter had not heard of the proposed changes. Is this nationwide ignorance ? . a few years ago my usual "Geigy" brand of tegretol retard was substituted for an un-labled box though a similar alooking tablet. I had a bad reaction. I hope it does not happen again. maybe only time will tell.

do other pharmasists know of the iminent changes

Regards to all
Stewart

my son is epileptic also he is autistic so are the government going to stop or alter his other medication ?.i think what they are doing is wrong why should we suffer when we were borne and bred in england .my father fought for this country only for governments to give all they fought for away to other countrys that have nothing to do with this country .also they do this to the pentioners that have arthritus take away medication and give them infrior medication so they are still in pain .how can this be stopped m.j.daw

I work with adults with severe learning disabilities who have associated conditions, one of which is Epilepsy. I have been working in this area of work for over 28 years and by experience know that changing peoples medication just because of cost can have devastating consequences. A lot of adults & children with Learning Disabilities are very sensitive to medication and or any changes that are made. I think that the Government need to do much more research on this before they make any blanket decisions. Epilepsy can be such a debilitating condition and has far more risks attached than people generally realise. It can be extremely distressing to see and have seizures and often ends up with hospital admissions, injections etc and leads to complete exhaustion and disruption of the persons life. What about their dignity?
Most of the people I work with do not have capacity to understand that their GP may change their medication, are we to do mental capacity paperwork & best interest decision making on their behalf - who's responsibility is this?

Iv just seen this and its very disturbing. Im on epilim & if this is changed one seizure & im out of work. I have not had a seizure for 6 years and use a driving & fork lift licence for work. I think others would be in the same boat, DLA + cant be cheaper than the drugs if saving money is the reason.

Please listen to the people that these changes are going to affect the most.

I have had epilepsy for more than 50 years now and I'm a middle aged woman now. I have complex partial and simple partial seizures which are fairly frequent and tonic clonic seizures very rarely. My condition took a turn for the worse about 15 years ago and I was suffering the most awful post ictal symptoms which included memory loss, migraine, colours before my eyes and depression. This went on for some time until I was eventually given medication which made my life worth living again. I have already been told that the one drug I take is very expensive, but it does work. I also know that, being realistic, using a cheaper generic drug may not cause me any problems, but if it does I know that I will have to do what I almost did when my epilepsy was at its worst. That is, find the courage to commit suicide. I cannot go back to the state I was in 15 years ago and do not feel that any should have to. The whole thing terrifies me.

Hi Pete ("Epilepsy Action") The point you made in the response above this one is that "generic" forms of the same medicines do change in basic drug quanity, outside coating and effectiveness within one's bloodstream. This is true, just like a so-called "natural orange juice" will be world's different from one company's to another's. However, if the UK is anything like the USA, it will be possible for patients to ask pharmacies to stay on one brand's version of the doctor-prescribed pill--as opposed to merely buying the ones currently available, or there for less money. And no, even the finest drug stores cannot tell you about the physical components of the pills they sell, whether brand-name or generic. It is we, the paying customers, who are best at that. I merely asked my pharmacist to stay with the same generic brand, and so far, excellent results. They are most cooperative, and if they cannot fill my 90-pill bottle of Keppra with the same generic pill, rather than mix them, they'll ask if I'd be willing to wait a day so that I'll have them all from the same "factory." And yes, I usually can wait, for I never, ever go in for a re-fill on the day I notice my bottle is empty!

Although I am not a resident of the UK, here in the USA we did go through much the same thing with regard to "automatic switching" from brand-name drugs to generic drugs. At first, I didn't like the idea basically because I felt that a generic pill would not work as well. This, of course, has been attributed basically to patients' assumptions. That is, until actually tried for several months, it's virtually impossible to determine this. But...the way around it over here is to have one's neurologist phone or write to the pharmacy, stating that the pill prescribed (in my case, Keppra and Depakote ER) should be sold in ONLY the brand name because of the doctor's sincere belief that his or her patient will not do well on the generic. I assumed that I wouldn't do well on the generic until I tried it. Both pills in their generic forms are still working well for me. But no, I don't think that any pharmacy should assume that generic forms "must be substituted." One suggestion, however. Do try generic before just figuring that "it'll never work!". You might be surprised.

Hi,
I forwarded the email round a large number of friends, one of whom is a medical lecturer. He consulted a senior pharmacologist, who sent the following reply:

"I was not aware that the Department of Health were proposing this change. Generic versions of drugs must be approved and are included in the BNF. The generic and trademarked versions come in the same doses. I do not see how anyone can say that a generic version can have between 80-125% of the drug found in the trademarked version.

It is true that GPs have been encouraged to prescribe the generic version since they became responsible for their own budgets.

I find the statement you sent very misleading."

Could anyone at Epilepsy Action clarify this for me as, although I suffer from epilepsy, I do not want to carry on forwarding the petition if it is in fact misleading.

Thanks.

This is total disgrace by the government- my consultant and doctors at neuroscience have all the knowledge after putting me though various tests and a scan- there is no way on earth can this be justified to put someones health before costs
I am not sure what a small change would do to me and not willing to find out- these important decisions should and mst be left up to consultants,specialists

epilepsy is a condition i have, which with the correct brand medication and mg's i can just about manage to keep it under control. i would like to continue to take the right amount of medication along with the right medication.
this condition is not totally understood and there is many factors which can trigger seizures.
personally for myself knowing that i am not taking the corrrect brand and correct measurement for my epilepsy can cause me a negative effect.

I got a letter from my MP today to say he has written to Rt Hon Andy Burnham MP, Secretary of State for Health. I will be contacted again when he has a reply.

Hi Felicity,

It actually sounds as though you understand the planned scheme fairly well.

From January;

- If your prescriber does not write ‘Lamictal’ on your prescription, you will receive a different version of lamotrigine rom your pharmacist.

- If your prescriber writes Lamictal but does not ‘opt-out’ of this scheme (by using a tick box on the prescription), you will receive a different version of lamotrigine.

- If your prescriber writes Lamictal and opts out of the scheme, you will continue to receive Lamictal.

As you can see this is not straightforward. This scheme will rely upon consultants and pharmacists recognising potential problems, and being consistent in their prescribing and dispensing.

We believe this scheme will result in many people switching to a different brand of their drug. Receiving the same brand of your anti-epileptic medication every time plays an important role in gaining control of your epilepsy and dealing with your medication’s side effects.

Thanks for the comment,

Pete at Epilepsy Action.

I have been diagnosed with epilepsy for just under 2 yrs and it has taken this long for my conusltant to find my the right drug for me. I have been on different medication for this but now I am finaly settled on Keppra and it seems to be workin I have done 5 months seizure free and I want to stay like this. The goverment needs to think that its people's health they are messing with its wrong !!!

Hi,

I agree that AED's should not be altered by anyone other than a specialist doctor. It does indeed have an affect on the 'life' of a person.

My ex-fiance and I went through hell when his seizures started up again. Some of the seizures had been caused by a change in medication, the change being that it was supposedly 'the same drug'. How can it be, it may have the same generic medical name, but it was obviously manufactured by a different company - why manufacture the same drug by different companies if there isn't some kind of difference? It would be like Nurofen saying they put exactly the 'same ingredients, and amounts of' in their pills as other leading brands. Why would anyone buy their pills over another companies then if there was no difference? Of course there IS a difference. In either the base ingredient, it's source, the methods used, or the ratios and amounts used. I know a little of this to be fact as I worked at a University (a well known one) that worked very closely with a major drugs company and others.

To think that my ex's seizures could have been better maintained, and he need not have cut his face open, or damaged himself so frequently because of the amount of seizures is so sad to me and our little boy. At one point I thought we had lost him forever when he wouldn't cease fitting, and the hospital had to administer drugs to help him out of his seizures.

We thought the drug was the 'same'. We were told it was, but it obviously had bad effects on him. I'm not saying they caused all the seizures, but some of them could have been avoidable and it would have made such a difference to his life. Surely he alone as one human being is worth something more than financial gain? Let alone all the thousands of other people who rely on their drugs to keep them 'safer' or more controlled, if at all possible.

I just can't understand the flippant decision of the government. Obviously a decision made by someone who knows nothing about either Epilepsy or other serious medical illnesses that people have to live and cope with.

Truly shocking, and it must be stopped. If one person gets injured... or worse, then someone in 'charge' should pay for such a silly decision to swap to cheaper unpredicatble drugs, and by pay I mean more than a fine, perhaps a prison sentence would suit. It might make 'law makers' think twice before dabbling in the lives of so many.

Jody.

I think we need to point out that there are actually financial implications - if you lose your job, you stop paying tax and you start claiming unemployment benefit.

I have written to my MP to draw his attention to this problem over anti-convulsants and to ask him to sign our e-petition! I don't think he'll do that(!), but I also asked him to support our plea for our health not to be undermined by this proposal.

I think we can all help by writing to our members of parliament - I got the email address of mine by searching google for 'find my mp'! The more letters and emails they get, the more likely they are to see a problem as serious and so the more likely they are at least to think about it.