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F.A.B.L.E supports
Epilepsy Action’s e-Petition against automatic substitution of
generic
anti-epileptic drugs
From January 2010 new dispensing regulations will be in place throughout the UK. Pharmacists will be expected to change the brand of drug named on a prescription and replace it with a different, generic brand. This is as part of the Department of Health’s 2009 Pharmaceutical Price Regulation Scheme agreement.
This agreement will make 'generic substitution' legal. This means a pharmacist can (and will) replace more expensive branded versions of drugs for cheaper generic versions. They will not have to consult with either the patient or the doctor who wrote the prescription. The National Health Service estimates this will save £40 million a year.
Unless epilepsy is excluded from this legislation it could lead to thousands of people with epilepsy having their medication switched, for purely financial reasons. There will be no consideration of how this will affect them, or their epilepsy.
Background
From January 2010 pharmacists will be expected to change the drug named on a prescription and replace it with a different generic. This is against the National Institute for Health and Clinical Excellence (NICE) guidelines for epilepsy. NICE provide guidance on the treatment and care of people with epilepsy. There is also significant evidence from doctors and patients that some people with epilepsy have difficulties when changed between different versions of the same drug.
Generic drugs have to follow ‘bioequivalence’ rules. These allow the amount of active ingredients to vary between 80 and 125 per cent. Being given a different version may mean receiving a different dose. It is recommended that people with epilepsy, taking anti-epileptic drugs (AEDs), need to maintain very precise levels of active ingredients in the bloodstream.
A doctor with a special interest in epilepsy should change someone’s epilepsy medication, not a pharmacist or health economist. People with epilepsy should receive the same version of their AED unless their doctor prescribes otherwise for medical not financial reasons.
Petition
Epilepsy Action (as part of the Joint Epilepsy Council) has started an e-Petition on the Downing Street website. This is an online petition to the Prime Minister asking him to take action in this area. You can read the words of the petition below. We need as many people as possible to sign, to show how important this is for people with epilepsy. With enough signatures the government is committed to respond to everyone who signs about the issues raised. We are campaigning to make AEDs exempt from the rules of generic substitution.
You can sign by going to http://petitions.number10.gov.uk/epilepsygenerics
Once you have filled in your details, you will need to confirm your signature to the petition by clicking a link you will receive by email.
If you are able, please show your support and sign, please also ask your friends and colleagues to sign as well. We believe people with epilepsy should receive the same version of their AED unless their doctor prescribes otherwise for medical, not financial, reasons.
Wording of the petition
“We the undersigned petition the Prime Minister to ensure an exemption for epilepsy from the new generic prescribing proposals, on the grounds that the active ingredients in different brands of anti-epileptic medication can legally vary by up to 45% and that unnecessarily switching between versions can have a profound negative effect on a person’s health and quality of life, can cause breakthrough seizures, worsening of seizures or increased side effects, leading to loss of employment, driving licence, educational opportunity, serious injury and, in the most severe cases, death, and that consistent effective treatment should not be altered on questionable cost grounds.”
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