E-DRUG: Hydroxocobalamin injection, not an essential medicine
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Dear e-Druggers,
Frank Bueno de Mesquita studied vitamin B12 deficiency and vitamin B12
treatment in Suriname and together we prepared an article that has been
submitted for publication in the 'Surinaams Medisch Journaal'
(see Title and Abstract below; the article itself is in Dutch and can be made
available on request).
We like to bring to your special attention the following part of the Abstract:
Since 1968, it is known that oral vitamin B12 is not inferior to parenteral administration. However, in almost all countries oral vitamin B12 is not being considered a medicine and Essential Medicine Lists only include injection of vitamin B12 as antianeamia medicine.'
I would like to add that from the very first edition in 1977 the
WHO Model List of Essential Medicines only includes vitamin B12 injection,
in the form of hydroxocobalamin injection, while vitamin B12 tablets are
excluded.
In the formularies we studied, only the ones for Canada-Ontario
and Sweden recommend tablets as treatment. Recently, a direction has been
included in The Netherlands Farmacotherapeutisch Kompas to use vitamin B12
tablets although a product description is lacking in this reference guide.
A quick check also revealed that vitamin B12 tablets are not registered as
medicines in most countries.
Given the above, we are curious why, despite longstanding evidence, the WHO
Model List of Essential Medicines and almost all countries ignore vitamin
B12 tablets as an essential medicine in favour of the (non-essential
medicine) vitamin B12 injection. We would appreciate any view you may have.
Preventing overdiagnosis and rationalization of therapy in vitamin B12
deficiency
Hydroxocobalamin injection, not an essential medicine
Abstract:
In recent years, there has been a sharp increase in the use of vitamin B12
injections in Suriname. The only indication for this medication is vitamin
B12 deficiency.
In order to establish the ratio of the current diagnostics and therapy, we
reviewed the literature and studied patient records of 344 individuals
treated with hydroxocobalamin injection in the first half of 2014.
Most patients were tested, although only 51 patients (15%) showed symptoms
consistent with vitamin B12 deficiency. The validity of vitamin B12 tests
is poor due to a low sensitivity and a low specificity, risking under- and
overdiagnosis if not restricted to symptoms associated with deficiency or
in high risk patients.
Under- and over-treatment as a consequence of vitamin B12 test results can
be minimized by choosing a cut-off point of 350 pg/ml vitamin B12 and
applying a vitamin B12 trial treatment. The diagnosis of vitamin B12
deficiency can be rejected if anaemia is not corrected within two months or
neurological symptoms do not disappear in up to 6 months. A positive
response to the trial treatment should lead to life-long therapy.
Since 1968, it is known that oral vitamin B12 is not inferior to
parenteral administration. However, in almost all countries oral vitamin
B12 is not being considered a medicine and Essential Medicine Lists only
include injection of vitamin B12 as antianeamia medicine.
Rationalisation of the use of vitamin B12 tests and vitamin B12 therapy
will prevent people being exposed, tens of millions of times every year, to
the disadvantages of unnecessary tests, treatment and injections, and
significantly higher costs.
[Abstract ends]
Best regards,
Rob
Rob Verhage, Pharmacist, hera
Senior Partner - Pharmaceutical systems consultant (www.hera.eu), Tawajakoerastraat 4, Paramaribo, Suriname; +597
438966 of 888647
Frank Bueno de Mesquita, Paediatrician, Director of the Foundation for
Promotion of Evidence-based Medicine in Suriname (Stg. EBGiS),
Paramaribo, Suriname.
rob verhage <verhager@gmail.com>