Unlicensed and off label medicines used in children
The term off label is often used to describe this because
Many of these medicines will have been produced in adult dose forms such as tablet!
In case of tablet, it is necessary to prepare extemporaneously in a suitable liquid preparation for the child.
Process of extemporaneous preparation from tablet
This may be made from the largest dosage form’s sample. by crushing tablets and adding suitable excipient of appropriate chemical ingredients in preparation.
Applied formula with a validated expiry period and ingredients of approved standard should be used, care must be taken to ensure accurate operations particularly when using formula or ingredient which are unfamiliar on some occasions!
The drug with no product licence are often used, it is only just because that particular product is undergoing clinical trials in adults. Such products may be imported from another country or prepared under special manufacturing licence or is being used for area condition for which it has not previously been employed!
We should take care of things on “off label use”
As with off label use, there must always be information to support the quality assurance and safety of the medicine as well as information on the intended use, there’s always a risk in using such a medicine which must be balanced against the seriousness of child illness! In practice, such cases are discussed with the patient’s attendant before treatment started.
Patient should always informed if the medicine prescribed is unlicensed or off label..
And even that, written informed consent be obtained before treatment begin in many situation in practice to avoid any inconvenience!