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Removing classification of prescription only medicine from injectable vitamin B12

Volume 683: debated on Monday 2 November 2020

The petition of the residents of the constituency of Loughborough.

Declares that a lack of B12 can have far reaching and significant effects on both physical and mental health; notes that a significant number of people who are B12 deficient are unable to absorb the vitamin from food or supplements, and so need to inject it, which they can only do at their GP practice; further notes that NICE CKS guidance states that treatment of B12 deficiency in people with neurologic involvement should include injections on alternate days until there is no further improvement; further notes that a restricted maintenance dose of just four injections per year is what is normally allowed, which can leave people physically and mentally unable to contribute to either family or society, and lead to permanent neurological damage; further notes that, in response to a Freedom of Information request asking for the clinical evidence for the three monthly maintenance dose, the Medicines and Healthcare products Regulatory Agency stated that they were unable to obtain this information; further notes that B12 injectables should be made available over the counter at pharmacies, which would bring our approach in line with that of other countries, affording those with B12 deficiency the same dignity and control over their own health as a diabetic using insulin, and reducing the workload and financial burden on GP practices, District Nurses and other NHS services; further notes that a petition started by the petitioners on this issue has garnered over 94,000 signatures.

The petitioners therefore request that the House of Commons urges the Government to remove the classification of Prescription Only Medicine from injectable vitamin B12.

And the petitioners remain, etc.—[Presented by Jane Hunt, Official Report, 23 September 2020; Vol. 680, c. 1076 .]


Observations from The Parliamentary Under Secretary of State for the Department of Health and Social Care (Lord Bethell of Romford):

The medicines and healthcare products regulatory agency (MHRA) is committed to making more medicines available over the counter (OTC) where it is safe to do so.

MHRA has a well-established procedure for moving medicines from prescription only status to OTC. Before a medicine can be switched from a prescription only medicine (POM) to a pharmacy (P) medicine, Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription. This means that it is a medicine which no longer meets any of the criteria for a POM, set down in the Human Medicines Regulations 2012, regulation 62(3). In other words, it is a medicine which:

is not likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor; or

is not frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or

does not contain substances or preparations of substances of which the activity requires, or the side effects require, further investigation; or

is not normally prescribed by a doctor for parenteral administration (that is, by injection).

Vitamin B12 could not legally be classified as a medicine that can be made available for sale without prescription in pharmacies because it is an injection and because the condition it is licensed to treat, pernicious anaemia, needs a clinician to diagnose it, and monitor its treatment (see above). The same applies to insulin injections and to the diagnosis and monitoring of treatment of diabetes.

Vitamin B12 injection is currently licensed for use in maintenance therapy for pernicious anaemia every 2-3 months depending on the type of pernicious anaemia. Even if the product could be reclassified to make it available for sale in pharmacies, it could not be used more frequently than every 2-3 months, so reclassification to a pharmacy medicine would not help those who require more frequent injections.

It is for the GP or other responsible clinician to decide on the most appropriate course of treatment for their patient, including selecting the most appropriate method of supplying any required medication. Some patients are able to administer their own B12 injections, but this is not a suitable option for all and is at the discretion of the clinician who prescribes the B12.

Clinically urgent treatment must always be provided, with the patient's clinical needs being paramount. Any patient who wishes to discuss their need for vitamin B12 injections can request a review with their GP or other responsible clinician.