A Step in the Right Direction – Update on Pilot Scheme

Last week I travelled to north Wales for a meeting with one of the doctors and practice nurses of the health centre that is hoping to introduce a pilot programme that will see patients with Pernicious Anaemia self-administering their injections.

Of course, many patients already self-inject using small ‘diabetic needles’. Most self-injectors use sub-cutaneous injections (sub-cut) rather than the trickier intra-muscular method of delivery (IM). But the vast majority of these patients do so without the knowledge or consent of their doctors and with serum preparations from a wide variety of sources where various compounding pharmacies around the world are only too happy to supply the growing demand from patients for various types of injectable B12.

The most popular form of B12 is Methylcobalamin which isn’t licensed in most countries. I won’t get into the debate about which type of B12 is the best, but I do know that two years ago 10% of our members were using Methyl to treat themselves. That figure has to be taken in context however; the other 90% were mostly being treated with Hydroxocobalamin supplied by their doctors.
Anyway, back to the meeting. I was eager to find out how the scheme has progressed. Well, it’s been written and submitted and is now being considered by the regional Medical Ethics committee. I was asked if I would appear at any hearing of the committee to give the patients’ perspective which, of course, I will be happy to do.

I remember that eight years ago the then Chairman of the NHS Trust for the Bridgend area, who was aware of the work of the PAS, requested that the Trust’s Chief Pharmacist and the Head of Nursing pay a visit to my office to discuss the possibility of patients self-injecting. My hope was that if they were allowed to self-administer their treatment they could receive treatment according to their individual need. They arrived one morning. It was obvious from their faces that they didn’t want to be where they were. It was the Chief Pharmacist who spoke first.
“Right let’s get this over with. Hydroxocobalamin is only licensed for IM injections which are very difficult to self-administer”.
Then it was the turn of the Head of Nursing;
“And most of our patients are elderly ladies who wouldn’t be able to self-inject”.
And that was that. Off they went.

I now know that when it was originally licensed, the instructions were that Hydroxocobalamin could be delivered either sub-cut or IM. Over the years the sub-cut bit was dropped, or lost, but originally it was licensed as either sub-cut or IM.
So there we are; the application is with the local Medical Ethics Committee and hopefully it will be approved and patients can take more control of their treatment with the knowledge and consent of their doctor.

But what about all the other delivery methods used by our members? Transdermal Patches, Sub-Lingual Sprays and Nuggets, Nasal Sprays to name a few are all used by our members with varying degrees of success, yet none have, as far as I can tell, been fully evaluated as to their effectiveness. And any evaluation should concentrate not on how effective is the delivery method in correcting any B12 Deficiency, but how good it is in helping the patient feel well.

The only alternative to injections that has been subject to what I would consider to be an inadequate evaluation, is high dose oral tablets – a treatment that relies on the patient hopefully ‘passively’ absorbing some of the tablet in his or her gut. Yet it makes sense that any other alternative to injections should by-pass the stomach and make use of any other method of absorption into the blood stream – but none of these methods, that stand a much better chance of treating a deficiency caused by Gastric Atrophy than tablets, have been subject to any evaluation. And remember, it’s not just treating any deficiency that needs to be evaluated – it’s how ‘well’ the patient feels that needs to be determined. And that’s a difficult thing to do.

For the time being there is the hope that sometime in the future patients will be able to take control of their treatment using the much preferred sub-cut injection that they can not only administer themselves but also with the knowledge and consent of their doctor; and that has to be a step in the right direction.