I know the details are on PA site somewhere but I want to be absolutely up to date with my evidence please.
Today I was refused my 8weekky injection because I was 5 days early and doctor would not sanction it because 'out of licence'. My original result was 72, about 7years ago and I had terrible neuro symptoms. My request for a referral to a Neurologist was not followed up by the doctor. I was too ill to fight at the time. I struggle to get to 8 weeks and suffer severe headaches,tiredness and depression. Is there anything I can do? I really dont feel able to self inject. Does anyone know or can refer me to licencing terms etc. Is there any possibility of getting gp to increase dose and stay within licencing terms?
Thanks in advance. Hope you are all keeping safe and well.
Written by
lesley12
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I honestly don’t know about licensing . I only know that self-injecting saved me from further harm when 3 monthly injections were nowhere near enough . I see that you can’t face the thought of injections , . There is a device called an auto injector which might help you . I’ll post a help sheet that I’ve devised and you will find the details. Sub-cutaneous injections work also . They use much shorter needles , which you might prefer . Best wishes .
Yes, the license is for administration every two to three months. But five days will make no difference at all.
Doctors, well, stupid doctors, use this 'out of license rubbish all the time. Some will even tell you it's illegal to administer something outwith the terms of the license. That is rubbish and they know it's rubbish. Such prescribing is called 'off label' and it is very common.
The rules regarding off-label prescribing are, essentially -
That it be in the best interests of the patient.
Stopping you from being unwell would seem to fit the bill.
For safety you can point out to them that hydroxocobalamin is licensed for administration every 1 month in cases of tobacco amblyopia and for Leber's Optic Atrophy. bnf.nice.org.uk/drug/hydrox...
My GP prescribes B12 injections off label. So do many, many others.
What's really annoying is that I bet the 'can't do that it's off-label' brigade are the same lot who are happily churning out 1000 mcg tablets of cyanocobalamin - despite it only being licensed up to 150 mcg.
I have 2 weekly b12 injections at my surgery so dont know what they mean.
I was refused to be allowed to do subcutaneous injections at home as that is 'off licence'
I think they are saying f as the bnf sat 2 -3 monthly a few days early will be 'off licence ' that's rubbish. It's their ignorance . They can prescribe om an individual basis .
What is different is if on your notes it states 8 weekly injections. The nurse cannot do it a day early.
Saying this though when an appointment was changed by the surgery I did have mine a day early!!
The doctor should've been asked if it possible for you to have had it.
Hi. Thanks . The medical assistant,nir a nurse gives me the injection and sje always checks its been 8weeks, when realusing it was early she asked the doctor who refused it. . So frustrating and just affs to the symptomatic depression. Why is life such a fight?
All medications used in the UK are licensed. This lays down the terms under which the medication medication is licensed to be used. However, there are a number of issues with the way the licencing procedure works - not least of which is the fact that it is driven by applications from the suppliers of medications. This means that it isn't an independent review of safety of the medication and whether using it outside licensing arrangements would be safe.
I have no idea why the manufacturers have arranged licencing as 2 monthly for hydroxocobolamin in the UK - there was probably some too and fro with government because when it was originally introduced it was used monthly. Many other European countries - who will have similar licencing bodies - include monthly treatment in their patient leaflets (eg Germany).
Unfortunately yourGP seems to be bit of a jobs-worth in referring to licensing rather than doing research that would clearly show that more frequent use isn't dangerous.
Another problem with the Product Licence system is that we do not have access to the actual documents.
We can get as far as the Public assessment Report (PAR) - and the Summary of Product Characteristics and Patient Information Leaflet. Well, for one product we have the PAR which was issued in 2018 (I think any other products were before PARs were made accessible).
We have to try to reverse-engineer what the product licence itself says!
I looked at the PAR and could not see any information about frequency.
PAR
Gerot Lannach B12 1mg/1mL ampoules
The product is a Prescription Only Medicine (POM)and is indicated in the treatment of Addisonian pernicious anaemia, prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency, tobacco amblyopia and Leber’s optic atrophy.
The patient will be given a starting dose and then a maintenance dose. The injection may need to be repeated depending on the patient’s response.
Your doctor will decide the correct dose for you depending on your circumstances. You will be given a starting treatment and then maintenance.The injection may need to be repeated depending on your response. Hydroxocobalamin injection is also suitable for use in children and the elderly.
Addisonian pernicious anaemias and other macrocytic anaemias without neurological involvement.
Initially 250 to 1000 micrograms intramuscularly on alternate days for one or two weeks, then 250 micrograms weekly until the blood count is normal
Maintenance: 1000 micrograms every two to three months
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement
Initially: 1000 micrograms on alternate days as long as improvement is occurring.
Maintenance: 1000 micrograms every two or three months.
Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and strict vegetarianism
1000 micrograms every two or three months.
Tobacco amblyopia and Leber’s optic atrophy Initially: 1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is occurring.
Maintenance: 1000 micrograms every one to three months as required
It is only in the SPC we see repeat frequencies - of one to three months. The PAR and PIL seem to allow any frequency determined by a prescriber.
I guess any doctor now refusing a repeat because you can store enough in your liver for 6, 12 or some other arbitrary period (as we have seen several times recently) is also using it outside the licence? No frequency less that three monthly appears to be allowed.
Just to emphasise the comment at the end of my big response.
If the licence says three months, and you go five days early, and are refused, what if the doctor doesn't fit you in at exactly three months - and you have to wait a day or five longer?
That is just as much a failure to abide by the licence as providing a "too soon" dose with the added issue of actually being likely to cause damage to the patient.
Yes. And how many GPs stick to the 'every other day' loading dose regimen for those with neurological involvement? I'll bet none of them do injections on a Sunday.
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seeing neurologist, advice on b12 injections welcomed…
Serum ferritin too high?
