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Controlled drugs
Milligrams or millilitres?
From Mr N. K. K. Aling, MRPharmS
I was recently presented with a FP10MDA prescription where the right
portion had been cut out and destroyed. It was for 490mg of methadone
mixture 1mg/ml (sugar free). From my interpretation of the guidance provided
in “Medicines, ethics and practice”, the total quantity should
be expressed as 490ml rather than 490mg. This was confirmed by calling
the National Pharmacy Association and the Royal Pharmaceutical Society.
The Pharmacists’ Defence Association initially responded that the
prescription was fine even when the total quantity was expressed in milligrams
rather than in millilitres. But, after my input and further investigations
on their part, I was advised that the prescription was not actually correct
to dispense as such.
I then got in touch with the doctor who wrote the prescription, but he
was not prepared to write the prescription with the total quantity of
methadone mixture expressed in millilitres. He told me that he always
writes his methadone mixture prescriptions with the total quantity to
supply expressed in milligrams rather than millilitres to be safe in
the event that the wrong concentration of methadone mixture has been
either written on the prescription or dispensed at the pharmacy. In each
of those cases, the patient would still receive the intended dose of
methadone. Furthermore, he added that he had never had a pharmacist advise
him to express the total quantity of methadone mixture in millilitres
rather than milligrams. So, was I being difficult?
This shows that there is still some confusion over how the total quantity
of schedule 2 and 3 Controlled Drugs should be expressed on prescriptions.
It would be of great help if the Royal Pharmaceutical Society would issue
some clear guidance on this issue. This will resolve the issue of pharmacists
giving out different advice.
The National Pharmacy Association added that:
“If there was a local agreement to express the total quantity of
methadone mixture to be supplied in terms of milligrams rather than millilitres
for safety, it would have to be initially approved by the Home Office,
otherwise the prescriptions would not be complying to CD requirements.”
I would also like to know what can be done in cases where the right portion
of the prescription has been cut out and destroyed. Can we staple a blank
sheet of paper to the FP10MDA prescription so that details of the items
dispensed and supplied can be recorded as usual? Would that be legal
and accepted by the Prescription Pricing Authority?
Nicholas Aling
London
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CAROLE GREEN, pharmacist adviser, Fitness to Practise and Legal Affairs
Directorate at the Royal Pharmaceutical Society, responds:
Regulation
15 of the Misuse of Drugs Regulations 2001, as amended, states that
a prescription should specify, in the case of a prescription containing
a Controlled Drug which is a preparation, either the total quantity
(in
both words and figures) of the preparation or the number (in both
words and figures) of dosage units to be supplied; in any other case,
the total
quantity (in both words and figures) of the Controlled Drug to be
supplied.
The Home Office, as the enforcement authority for the Misuse of Drugs
Regulations, has confirmed that where a Controlled Drug is available
as a dosage unit, the
total quantity on a prescription should be expressed in terms of the number
of dosage units, eg, the number of tablets or capsules and where the
total quantity
is of a liquid preparation, such as methadone mixture, it should be expressed
as millilitres (ml). Therefore, the total quantity of methadone mixture as
referred to in your letter should be expressed as 490ml. Further information
can be obtained
from the Home Office Drug Legislation and Enforcement Unit by telephoning
020 7035 0464.
In response to Mr Aling’s second question, Regulation 16, paragraphs
(2) and (4) of the Misuse of Drugs Regulations 2001, as amended, state that
a person
supplying a Controlled Drug, other than a Controlled Drug in Schedules 4 or
5, on a prescription, shall mark the prescription with the dates on which each
instalment
of the drug is supplied. This is a legal requirement. The endorsements made
by the pharmacist on the right side of the FP10 (MDA) of instalments supplied
are
to comply with this requirement.
Importantly, the right side of the prescription includes columns to record
additional information that is invaluable for maintaining a complete audit
trail. The additional
columns allow the recording of the quantity of methadone supplied on each
occasion and the supplying pharmacist’s initials for each instalment given. This
information should be recorded, since it is a Code of Ethics requirement that
there is a retrievable record of the pharmacist who has taken responsibility
for the provision of a particular pharmacy service and that there is an accountable
identifiable pharmacist for each activity.
If the right side of the prescription is missing, the Prescription Pricing
Authority has confirmed that they will accept a blank piece of paper stapled
to the prescription
for the marking of these endorsements. However, the marking of the date of
supply would still have to be made on the prescription. Pharmacists should
exercise
caution if considering making a supply against such a prescription. The pharmacist
would have to make any necessary checks to ensure that the prescription was
genuine and establish that the prescription has not been previously dispensed,
before
making any supplies. If the pharmacist is satisfied that the prescription
is authentic, then there is no legal restriction on making a supply provided
that
he or she has added the required information to the prescription. |
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The
Pharmaceutical Journal