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Drugs: Licensing

Question for Department of Health

UIN HL5503, tabled on 9 March 2015

To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 5 March (HL5130), how practising physicians should satisfy themselves that any unlicensed medicinal product or toxic substance that they consider appropriate for their patients can be safely prescribed in the absence of safety data from phase 1 clinical trials; whether adequate monitoring of patients and expert supervision should ideally take place within the context of a clinical trial; and, if not, why not.

Answered on

23 March 2015

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.

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.

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.

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

arrangements are in place for monitoring, follow-up and review, taking account of the patients’ needs and any risks arising from the medicines.