February 4, 2013 by admin
All prescribers should have consistent regulatory guidance for ‘off-label’ prescribing in palliative care, according to the conclusions of a survey of over 300 doctors, nurses and pharmacists who prescribe in this area.
The non-medical prescribers were less likely to follow the ‘must-dos’ of the relevant guidance, but this is partly because nurses’ and pharmacists’ guidance is based on an older, less pragmatic, version of the General Medical Council (GMC) guidance that doctors use. The proportion of doctors adhering to GMC guidance also compared favourably with a previous study.
Culshaw J, Kendall D and Wilcock A. Off-label prescribing in palliative care: A survey of independent prescribers. Palliat Med 2012; 21 November, published online ahead of print.
January 26, 2013 by admin
NICE has published some more of its new ‘evidence summaries’. These are not formal NICE guidance but critical reviews of the available evidence to aid decision making. In the ‘unlicensed/off-label medicines’ series, NICE has recently published evidence summaries for: Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin and Chronic anal fissure: 2% topical diltiazem hydrochloride. In the ‘new medicines’ series, it has looked at aclidinium bromide and glycopyrronium bromide for chronic obstructive pulmonary disease and lixisenatide for Type 2 diabetes.
October 23, 2012 by admin
NICE has published the first of its evidence summaries of unlicensed/off-label medicines, about the use of tranexamic acid to prevent or treat significant hemorrhage after trauma, an off-label use. The publication of evidence summaries for insulin degludec in Type 1 and 2 diabetes is expected later this autumn, under new medicines evidence summaries.
NICE has also just published guidance on Crohn’s disease in adults, children and young people, and on headaches in young people and adults. The headache guidance highlights the importance of correct diagnosis in deciding on the most appropriate treatment and also urges healthcare professionals to consider the possibility of medication overuse headaches, a “vicious cycle”, according to the GP who chaired the development of the guideline.
June 12, 2012 by admin
The General Medical Council (GMC) is halting plans to loosen its guidance on doctors prescribing off-label and unlicensed medicines, and is seeking further legal advice, according to papers of a recent Council meeting. This follows a legal challenge by Novartis, which manufactures ranibizumab (Lucentis) over the off-label prescribing in some areas of the country of the cheaper drug, bevacizumab (Avastin), for wet age-related macular degeneration (AMD). Bevacizumab is licensed as a cancer drug but not for the treatment of wet AMD.
The Nursing and Midwifery Council (NMC) is planning to review prescribing standards, although it announced recently that the review of medicines management standards would not be going ahead, so this issue may face the nursing regulatory body very soon.
Press coverage has talked about far-reaching consequences, depending on what legal advice is forthcoming: current GMC guidance allows off-label prescribing where the medicine will “better serve” the patient than the appropriately licensed alternative. The proposed change would have also allowed unlicensed or off-label prescribing where the medicine was “as safe and effective” as the appropriately licensed alternative, on the basis of authoritative clinical guidelines. The proposal was in response to the very high costs of licensed drugs for rare conditions, and to avoid doctors being unable to follow both GMC guidance and NICE/employer guidance simultaneously.
The difference in costs can be dramatic - the BMJ reported recently that using bevacizumab instead of ranibizumab for wet AMD could save the NHS £84 million annually, and that new data suggest similar performance.
Nurse prescribers can prescribe unlicensed medicines following a change in the law in 2010 and the NMC has set out certain conditions, one of which is that an alternative, licensed medication would not meet the patient’s needs. For off-label prescribing, the medicine must “better serve” the patient’s needs than the appropriately licensed alternative.
June 8, 2011 by admin
There are ‘relatively high levels of potential overdosing in the youngest children and potential underdosing in the oldest children’ in paracetamol prescribing in primary care, according to the conclusions of this study. It analysed a year’s data about paracetamol prescriptions in children aged 0-12 in general practices in Scotland.
About one-fifth of the paracetamol prescriptions were defined as off-label - being outside the BNF for Children age and dose recommendations - with incorrect doses being the most common reason. In addition, another 15% of prescriptions did not have dosage instructions.
The risk of over-dosing in young children carries a risk of toxicity, particularly as parents and carers often use paracetamol for children before they seek professional advice. For older children receiving doses that are too low, there is a risk of treatment failure and prescribing not being cost-effective.
Kazouini A et al. Paracetamol prescribing in primary care: too little and too much? Br J Clin Phamacol 2011; in press.
November 27, 2009 by admin
I am undertaking the non-medical prescribing programme and am unclear about unlicensed medicines and off-label prescribing. Can I prescribe an unlicensed medicine or off-label as an independent prescriber?
To read the reponse to this question, click here.