e-Petition against automatic substitution of anti-epileptic drugs

Finding out that my medication is likely to be changed by using a different brand concerns me greatly, as the smallest change in them has already almost fatal to me!. My GP agrees with me that allowing pharmacists to provide alternatives that will contain other ingredients, or even miss out on important ones that are not recognised will ultimately lead to unavoidable deaths!

I haven't signed the petition yet because I have a question before I do so.

I'm not epileptic, but I do have a bunch of other medical conditions, and have had problems with generics. The question I have is about this:

the active ingredients in different brands of anti-epileptic medication can legally vary by up to 45%"

Surely rather than campaigning for a blanket ban on generic for drugs for epilepsy a better (and safer for all) campaign would be to campaign against such variation, full stop?

Having being diagnosed with epilepsy in February 2009 having had 4 night seizures in the space of 6 weeks, I was put onto a 300mg dose of epilim and have not had an attack since. My mother has also been on epilim but for about 10 years and she has been free the whole time. If we are forced to change medication, this could prove potentially devastating for the family.

Hi Lisa, thanks for the comment.

I don’t think we would be able to carry out a successful campaign to limit the window of bioequivalence.

At the moment, we are struggling to get many health professionals and government advisors to accept that there are differences between versions of ‘the same’ drug.

In addition, drugs for the same condition can be made in different factories, in different countries and by different companies. Harmonising bioequivalence rates would require a lot of regulation and would not necessary lead to less adverse reactions and side-effects.

Aside from the bioequivalence, there are the pharmacokinetic issues. In your medication, there are other ingredients as well as the ‘drug’. They may ‘pad’ out a pill, or hold other ingredients together. These too vary from drug to drug, and we believe people can have differing reactions to these ingredients.

The simplest solution is to ensure that people collect the same drug every time.

We are not campaigning for a blanket ban on generic drugs for epilepsy. We are happy for people to receive generic versions of drugs, and many people are successfully treated on generic versions.

We are campaigning against allowing pharmacists the right to change the medication written on your prescription.

We believe that if you receive version ‘X’ of a drug, you should always receive version ‘X’, if that is what your specialist has prescribed and it is an effective treatment. ‘X’ could be a generic drug, or an imported drug, it would not matter as long as you receive that same version every time you pick up your prescription.

Pete Scott
Epilepsy Action

My husband picked up my new prescription this week, the writing on my Tegretol Retard is foreign! So was a couple of my other meds.

i am totally against the government allowing the pharmacists to change to 'generic substitutions'. I have had bad experiences in the past due to different brands of epilepsy drugs being issued and would not like it to be repeated. I am currently taking Keppra and Tegretol Retard. The epilepsy is better with these drugs so therefore do NOT wish to have any generic substitutions. Had difficulty finding out on the computer how to complain about this subject.

I too had an adverse effect when the pharmacist issued a generic lamotrigine instead of Lamictal. I was seizure-free for 5 years and suffered a seizure within a week of taking the generic. At the time of this happening there was a scare about rogue drugs getting into the supply chain and I put it down to that. The pharmacist was very good in dealing with me and had to request that my GP prescribes lamictal. Since going back on the branded drug I have been seizure-free again. I am absolutely against the government's proposal and have signed the on-line petition and I am encouraging others to do so as well.
I also agree with a previous correspondent that this proposal could affect all patients taking critical medication.

I had epilepsy for 20 years before it was finally brought under control with a very carefully adjusted combination of drugs. I have then had 10 year + with no seizures, but I have had problems with generics - I have had to keep at least 6 months' supply of drugs to be able to slide from one to another without a sudden lurch which could be catastrophic. When I finally saw a consultant again, he explained what the differences could be and was horrified to be told that one month my supply of just one of the drugs came from 3 different sources. He immediately insisted that I should have only the branded drugs.

I have been employed succesfully partly because I have had no seizures and partly because I have my driving licence. If I lose my licence I lose my job. IF I LOSE MY LICENCE I LOSE MY JOB. That looks over dramatic but that is the end of the story. For me that is a disaster. It is not exactly good for my family. It takes a worker out of the economy. Frankly it probably adds a new cost to the NHS because I don't think I will be able to cope and will find myself under the doctor for clinical depression. That looks a bit over dramatic as well, but it is realistic nevertheless.

It is just so destructive - and ends up more expensive in all ways than simply sticking to what we know works. If it ain't broke don't fix it.

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.

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 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 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 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.

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.

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

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.

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 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!

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.

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

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.

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?

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 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

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.