Prescription Drugs

(asked on 17th November 2014) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, whether a licence for a treatment indication makes it more likely to be prescribed for that indication in (a) off-label and (b) unlicensed indication.


Answered by
George Freeman Portrait
George Freeman
This question was answered on 20th November 2014

In making prescribing decisions, a clinician should first and foremost consider a patient’s individual clinical needs and choose the medicine best fitted to meet those needs, whether the medicine is licensed, off-label or unlicensed. Clinicians will also take a range of other information into account including advice from sources such as the British National Formulary, the National Institute for Health and Care Excellence and any local prescribing policies.

Guidance to clinicians from both the General Medical Council and the Medicines and Healthcare products Regulatory Agency sets out a clear hierarchy for the licensing status of medicines, which supports them in making these decisions. In treating their patients, clinicians should 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. They must discuss the options with the patient and explain the reasons for their choice including the significance of the licensing status of the medicine.

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