Supply of extemporaneously prepared products containing Schedule 5 Controlled Drugs
The Prescription Only Medicines (Human Use) Order 1997, as amended,
defines the main classes of prescription-only medicines (‘Medicines,
ethics and practice: a guide for pharmacists’, 29th edition, p9).
One such class is medicinal products that are Controlled Drugs unless
a marketing
authorisation has been granted in which a medicinal product is classified
as being a pharmacy medicine or general sale list medicine.
Pharmacists are reminded that an extemporaneously prepared medicine or
nostrum containing a Schedule 5 Controlled Drug (eg, pholcodeine) is
classed as a prescription-only medicine and therefore cannot be sold
over the counter.
Similarly, pharmacists may not repackage Schedule 5 Controlled Drugs
from dispensing packs into smaller quantities for over-the-counter sale.
NB. The last paragraph on p9 of the MEP (“Some controlled drugs
… for further details”) should be deleted.
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Date-expired Controlled Drugs stock
Pharmacists are reminded of the need to segregate and clearly mark
date-expired and patient-returned Controlled Drugs stored in the CD cabinet
before destruction.
When dispensing Controlled Drugs the pharmacist must exercise caution and ensure
that date expired stock is not supplied in error.
Out-of-date stock of Controlled Drugs must only be destroyed in the presence
of a person authorised by the Secretary of State either personally or as a member
of a class. Authorised witnesses include inspectors of the Royal Pharmaceutical
Society, police chemist liaison officers, Home Office inspectors and authorised
personnel within primary care trusts.
Pharmacists may destroy patient-returned Controlled Drugs without an authorised
witness, and are advised to do so regularly to avoid them building up in the
CD cupboard.
Although there is no legal requirement, it is good practice to document the destruction
and to require a member of staff to witness it. The record of destruction should
be made somewhere other than the CD register — for example, at the back
of the prescription register.
For further details see ‘Medicines, ethics and practice: a guide for pharmacists’,
29th edition, p28. |
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Pharmaceutical Journal