BACKGROUND: The 'off-label' use of a drug beyond the specifications of its Marketing Authorization is widespread in palliative care.It is legal, but there are implications for prescribers, outlined by regulatory bodies such as the General Medical Council. A previous survey suggested that few doctors in palliative medicine always follow these recommendations. AIM: To obtain a contemporary view of how medical and non-medical independent prescribers adhere to current regulatory guidance. DESIGN: Selected doctor, nurse and all pharmacist members of www.palliativedrugs.com from the United Kingdom were invited to complete an online questionnaire. There were 332 respondents, a response rate of 9% based on number of e-mails delivered. Most worked within an inpatient hospice, although for nurses it was the community; there was a wide range of experience. RESULTS: Few respondents (15%) reported that their services operated a policy on providing information about off-label use. Most (65%) would always make a clear record of the drug prescribed, and this was highest for doctors, with 39%-73% always operating in line with the 'must do' aspects of General Medical Council guidance. This proportion was lower for nurse (42%-55%) and pharmacist (0%-30%) responders in part because their guidance is based on the previous, less pragmatic General Medical Council guidance. Examples given for off-label use, together with general comments, provided additional insight into respondents' practice. CONCLUSIONS: Compared to before and to nurse and pharmacist prescribers, doctors appear better able to adhere to their regulatory body guidance. Given that all the independent prescribers in palliative care can prescribe the same drugs, consistent regulatory guidance is required.
BACKGROUND: The 'off-label' use of a drug beyond the specifications of its Marketing Authorization is widespread in palliative care.It is legal, but there are implications for prescribers, outlined by regulatory bodies such as the General Medical Council. A previous survey suggested that few doctors in palliative medicine always follow these recommendations. AIM: To obtain a contemporary view of how medical and non-medical independent prescribers adhere to current regulatory guidance. DESIGN: Selected doctor, nurse and all pharmacist members of www.palliativedrugs.com from the United Kingdom were invited to complete an online questionnaire. There were 332 respondents, a response rate of 9% based on number of e-mails delivered. Most worked within an inpatient hospice, although for nurses it was the community; there was a wide range of experience. RESULTS: Few respondents (15%) reported that their services operated a policy on providing information about off-label use. Most (65%) would always make a clear record of the drug prescribed, and this was highest for doctors, with 39%-73% always operating in line with the 'must do' aspects of General Medical Council guidance. This proportion was lower for nurse (42%-55%) and pharmacist (0%-30%) responders in part because their guidance is based on the previous, less pragmatic General Medical Council guidance. Examples given for off-label use, together with general comments, provided additional insight into respondents' practice. CONCLUSIONS: Compared to before and to nurse and pharmacist prescribers, doctors appear better able to adhere to their regulatory body guidance. Given that all the independent prescribers in palliative care can prescribe the same drugs, consistent regulatory guidance is required.
Authors: Caroline Lücke; Jürgen M Gschossmann; Teja W Grömer; Sebastian Moeller; Charlotte E Schneider; Aikaterini Zikidi; Alexandra Philipsen; Helge H O Müller Journal: Ann Gen Psychiatry Date: 2018-02-08 Impact factor: 3.455