| answer text |
<p>Guidance to prescribers sets out a clear hierarchy for the licensing status of
medicines which supports them in making decisions. In treating their patients, clinicians
must first consider using a licensed medicine within its licensed indication, but
if that will not meet their patient’s needs they can consider a licensed medicine
outside its licensed indication and only if that is not suitable should they consider
using a medicine that is not licensed. Unlicensed medicines are commonly used in some
areas of medicine such as in paediatrics, psychiatry and palliative care.</p><p> </p><p>
</p><p> </p><p>Prescribers must discuss the options with the patient and explain the
reasons for their choice including the significance of the licensing status of the
medicine. Prescribing decisions need to be made in discussion with the patient concerned
and prescribers need to be able to justify their actions, if challenged.</p><p> </p><p>
</p><p> </p><p>Ideally, all medicinal products should go through clinical trials process.
When they do so it is a clear requirement of the process that adequate monitoring
and supervision takes place. In the absence of clinical trials, and in the case of
unlicensed medicines physicians should follow the guidance of the General Medical
Council that patients are adequately monitored and that, where necessary, expert hospital
supervision is available.</p><p> </p><p> </p><p> </p><p>Prescribers are ultimately
responsible for their own prescribing decisions. They should always satisfy themselves
that the medicines or other substances they consider appropriate for the patients
can be safely prescribed and that suitable</p><p> </p><p>arrangements are in place
for monitoring, follow-up and review, taking account of the patients’ needs and any
risks arising from the medicines.</p><p> </p>
|
|
