Equipping People To Make Sense Of What They Are Told
Occasionally a medicine can be prescribed that is unlicensed, on a named-patient
basis, meaning that a patient has a special need for the medicine and there is no
existing alternative.
In these cases, doctors can prescribe unlicensed medicines in small quantities for
a particular patient (a ‘named-patient’).
The funding for this may be covered by the Primary Care Trust or may not, meaning
patients may be charged extra.
An unlicensed medicine is one that does not have a product licence such as:
A person may have agreed to receive an unlicensed product as part of a clinical trial.
The product may be waiting for approval.
The product may be prescribed in a form that is not readily available. In other words
it has to be specially prepared.
The health professional may consider that a specific medicine may work possibly for
a condition, even though it has not been licensed for that condition.
The product may be required in liquid form when it has been licensed in tablet /
capsule form.
There may be no commercial interest (profit) in marketing the product if it is only
required for a small number of people.
Unlicensed products are usually made specially and can be difficult to obtain. The
pharmacist will have to make special arrangements and either:
Make the product. The product may be made up individually as a special preparation
from raw ingredients. This is known as extemporaneous dispensing
Obtain the product from the manufacturer. The pharmacist will make arrangements to
obtain a unlicensed product from the relevant manufacturer who makes it specially
under a ‘Specials’ manufacturing licence.
The supply of unlicensed relevant medicinal products for individual patients guidance.
Just because a medication has received a licence does not guarantee that it is completely
safe, many medicines cause serious side effects and medicines use in combinations
have not undergone rigorous research to discover what potential problems may arise
when they are used in combination.
This also applies to”over the counter medicines”
UK medicines legislation requires that medicinal products be licensed before they
are marketed in the UK. Accordingly, no medicinal product may be placed on the market
unless a Marketing Authorisation (formerly known as a Product Licence) has been issued
by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Unlicensed products are not subject to any assessment by the Licensing Authority.
Neither prescribers nor pharmacists can make the same assumptions of quality, safety
and efficacy about unlicensed products as they do for licensed medicines.
Unlicensed medicines should only be used where the clinical needs of the patient
cannot be met by a licensed medicinal product.
Unlicensed medicines can be either those with no license at all or not licensed for
the proposed indication.
When a licensed medicine is used, the liability for an untoward event caused by the
medicine remains with the manufacturer or license holder provided it has been used
in accordance with the terms of its licence.
When the medicine is unlicensed, or is used in an unlicensed way, any untoward event
becomes the responsibility of the prescriber[s].
Some licensed products are utilised for unlicensed uses, and although situations
vary it may be that there is a recognised body of evidence in support of such therapeutic
use.
When medicines are prescribed for unlicensed indications, prescribers are professionally
accountable for their judgement, and may be called upon to justify their actions.
This includes non-medical prescribers where eligible to prescribe unlicensed medicines.
Those involved in the prescribing or administration of an unlicensed medicine should
be aware of the product’s unlicensed status, and any known relevant risks associated
with its use.
Advice on the licensed status of a product should be obtained from a pharmacist.
