Administering IMP

[David]

Is it required that a nurse administer IMP to the subject or is this just an expectation? Can another suitably trained technician perform the dosing procedures if they are not a medically trained member of staff (i.e. nurse, doctor or pharmacist)?

[ilyas ali]

I dont think that pharmacist or technician allowed to administer the IMP. It is part of nursing care that they are responsible for administration of drugs to patient.

[MHRA Moderator]

While the response would be the ideal situation and may be appropriate for certain methods of administration (i.e. iv administration of chemotherapy) patients can also self-administer in clincial trials. Therefore, when considering the risk assessemnt of the clincial trial, considerations should be given to who can administer the IMP. If it is a simple tablet for example, it may be that someone that is not medically qualified can administer this, provided they a suitably trained in the protocol and dosing activity (they could not make the decision to prescribe though, this must be a suitably qualified medic).

[B18]

Please could you clarify the statement that the decision to prescribe must always be made by a suitably qualified medic? In normal circumstances (i.e., outside a clinical trial), the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order of May 2006 and associated regulations enable nurses who have successfully completed a nurse independent prescribing course to prescribe any licensed medicine for any medical condition within their clinical competence. Is a nurse independent prescriber who is part of the study team unable to make prescribing decisions in the context of a clinical trial, even if the trial uses only authorised medicines?

[MHRA Moderator]

Within the terms of the legislation, it should be a medic. However, in light of the UK allowance of nurse prescribers in standard practice, provided the clinical trial prescribing is that which the nurse prescriber would do within the terms of his/her routine job description (as identified during the risk assessment or site set-up activties) and is delegated this activity by the PI, this would be acceptable.

[juggared14]

Is a nurse independent prescriber who is part of the study team unable to make prescribing decisions in the context of a clinical trial, even if the trial uses only authorised medicines?