Hi,
In BNF this statement appears in the entry for carbamazepine
MHRA/CHM advice
Antiepileptic drugs: new advice on switching between different manufacturers' products for a particular drug (November 2013)
The CHM has reviewed spontaneous adverse reactions received by the MHRA and publications that reported potential harm arising from switching of antiepileptic drugs in patients previously stabilised on a branded product to a generic. The CHM concluded that reports of loss of seizure control and/or worsening of side-effects around the time of switching between products could be explained as chance associations, but that a causal role of switching could not be ruled out in all cases. The following guidance has been issued to help minimise risk:
- Different antiepileptic drugs vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers' products of a particular drug may cause adverse effects or loss of seizure control;
- Antiepileptic drugs have been divided into three risk-based categories to help healthcare professionals decide whether it is necessary to maintain continuity of supply of a specific manufacturer's product. These categories are listed below;
- If it is felt desirable for a patient to be maintained on a specific manufacturer's product this should be prescribed either by specifying a brand name, or by using the generic drug name and name of the manufacturer (otherwise known as the Marketing Authorisation Holder);
- This advice relates only to antiepileptic drug use for treatment of epilepsy; it does not apply to their use in other indications (e.g. mood stabilisation, neuropathic pain);
- Please report on a Yellow Card any suspected adverse reactions to antiepileptic drugs (see Yellow Card Scheme);
- Dispensing pharmacists should ensure the continuity of supply of a particular product when the prescription specifies it. If the prescribed product is unavailable, it may be necessary to dispense a product from a different manufacturer to maintain continuity of treatment of that antiepileptic drug. Such cases should be discussed and agreed with both the prescriber and patient (or carer);
- Usual dispensing practice can be followed when a specific product is not stated.
Category 1
Phenytoin, carbamazepine, phenobarbital, primidone. For these drugs, doctors are advised to ensure that their patient is maintained on a specific manufacturer's product
Category 2
Valproate, lamotrigine, perampanel, retigabine, rufinamide, clobazam, clonazepam, oxcarbazepine, eslicarbazepine, zonisamide, topiramate. For these drugs, the need for continued supply of a particular manufacturer's product should be based on clinical judgement and consultation with the patient and/or carer taking into account factors such as seizure frequency and treatment history
Category 3
Levetiracetam, lacosamide, tiagabine, gabapentin, pregabalin, ethosuximide, vigabatrin. For these drugs, it is usually unnecessary to ensure that patients are maintained on a specific manufacturer's product unless there are specific concerns such as patient anxiety, and risk of confusion or dosing errors
Robert
From: epilepsy@yahoogroups.com [mailto:epilepsy@yahoogroups.com]
Sent: 09 November 2015 20:16
To: epilepsy@yahoogroups.com
Subject: RE: [epilepsy] Re: changing brands of tegretol
Hi
Yes I am in the uk now. I phoned my pharmacist on Saturday morning, explained that I had been on tegretol retard for a long time and she checked to see what she had given me, she told me not to take it as it was the instant release version, I had to ring 111 to get a prescription for prolonged release, I was very low on tegretol, not knowing that they had changed me, you have to keep a tight check on these things, I am speaking with my doctor tomorrow to get her to change my records. As for keppra, I have only been on that for just over two years and am on a low dose so that is not a problem, my keppra comes in square boxes, I believe it is proper keppra.
Regards
Adrien
-----Original Message-----
From: epilepsy@yahoogroups.com [mailto:epilepsy@yahoogroups.com]
Sent: Monday, November 09, 2015 1:55 PM
To: epilepsy@yahoogroups.com
Subject: [epilepsy] Re: changing brands of tegretol
If you are in the UK and getting UK care try asking your doctor for the
'real thing'. I was put on generic Keppra when it came on the market as
it was cheaper for the National Health Service and last year for the
first time in 10 years or so I had a seizure. I asked to be put back on
Keppra which has climbed rapidly in cost ; all the petit mals
disappeared almost immediately but still after a year my system hasn't
settled back 100% and I had a seizure a few months ago. So if you are
eligible for NHS drugs have a word with your doctor
Suzanne
-----
No virus found in this message.
Checked by AVG - www.avg.com
Version: 2016.0.7227 / Virus Database: 4457/10966 - Release Date: 11/08/15
Posted by: "Robert" <group@late-effects-radiotherapy.co.uk>
| Reply via web post | • | Reply to sender | • | Reply to group | • | Start a New Topic | • | Messages in this topic (8) |
No comments:
Post a Comment