Concern over extemporaneous preparation of methadone oral solution
The Council is to develop a policy on the extemporaneous preparation of methadone oral solution.
At the December
Council meeting, the Law and Ethics Committee suggested
that a policy was needed because of the availability of licensed products.
The Code of Ethics currently requires that “Where a product is
ordered on prescription a pharmacist must supply a product with a marketing
authorisation, where such a product exists and is available, in preference
to an unlicensed medicine or food supplement.” Additionally, service
specification 21 (Extemporaneous preparation/compounding) states: “A
product should only be extemporaneously prepared when there is no product
with a marketing authorisation available and where the pharmacist is
able
to prepare the product in compliance with accepted standards.”
It was pointed out that the Society had not rigidly enforced these requirements
in respect of the extemporaneous preparation of methadone mixture, even
though products with a marketing authorisation were now widely available.
A major reason was storage. Storing sufficient quantities of licensed
methadone mixture posed difficulties for pharmacists who had a large
number of methadone patients. The licensed products had to be stored
in a Controlled Drug cabinet in line with the Misuse of Drugs Safe Custody
Regulations, whereas the diluent used to prepare the extemporaneous product
did not require safe custody until the methadone powder was added. Another
problem was that the Society received complaints from patients alleging
deficiencies in the strength and quality of extemporaneously prepared
methadone mixture. There was concern as to the robustness of the current
standards and systems for preparing methadone mixture in pharmacies.
Presenting the committee’s concerns to the Council, Douglas Simpson,
committee chairman, said that if the Council insisted on enforcing the
Code of Ethics, a significant number of pharmacies might withdraw from
providing a methadone service.
John Gentle said that the supervised consumption of methadone by patients
within the pharmacy is probably the single biggest most nationally recognised
new advance enhanced service that community pharmacies operate. If pharmacists
were unable to make up methadone oral solution in their pharmacies that
would be a serious disincentive for them. The risk to patients’ health
was far greater from not being on a supervised consumption scheme than
from any kind of failure among the profession in making up the solution.
Mr Gentle added that he was shocked that the preparation of methadone
oral solution was seen as extemporaneous dispensing. He regarded it as
reconstitution, in the same way that antibiotic suspensions were made
up by adding water to a powder.
Colin Ranshaw said that the Council had to consider legislation as well
as the Code of Ethics. It had to consider Section 10 of the Medicines
Act 1968. It has to consider guidance produced by the Medicines and Healthcare
products Regulatory Agency, which made it clear that if a licensed product
was on the market, that product should be used. Allowing extemporaneous
dispensing to continue could be in conflict with the MHRA.
Mr Simpson said that the committee would look at a possible policy in
the light of what had been said by Council colleagues.
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The
Pharmaceutical Journal