Using this guideline | Right Decisions

Statement of intent

This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results.

The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at through a process of shared decision making with the patient, covering the diagnostic and treatment choices available. It is advised, however, that significant departures from the national guideline or any local guidelines derived from it should be documented in the patient’s medical records at the time the relevant decision is taken.

Influence of financial and other interests

It has been recognised that financial or academic interests may have an influence on the interpretation of evidence from clinical studies.

It is not possible to completely eliminate any possible bias from these sources, nor even to quantify the degree of bias with any certainty. SIGN requires that all those involved in the work of guideline development should declare all financial and academic interests, whether direct or indirect, annually for as long as they are actively working with the organisation. By being explicit about the influences to which contributors are subjected, SIGN acknowledges the risk of bias and makes it possible for guideline users or reviewers to assess for themselves how likely it is that the conclusions and guideline recommendations are based on a biased interpretation of the evidence.

Signed copies of declaration of interests forms are retained by the SIGN Executive and are available on request from the SIGN Executive.

Prescribing of licensed medicines outwith their marketing authorisation

Recommendations within this guideline are based on the best clinical evidence. Some recommendations may be for medicines prescribed outwith the marketing authorisation also known as product licence. This is known as ‘off-label’ use.

Medicines may be prescribed ‘off label’ in the following circumstances:

for an indication not specified within the marketing authorisation
for administration via a different route
for administration of a different dose
for a different patient population.

An unlicensed medicine is a medicine which does not have MA for medicinal use in humans.

Generally ‘off-label’ prescribing of medicines becomes necessary if the clinical need cannot be met by licensed medicines within the marketing authorisation. Such use should be supported by appropriate evidence and experience.³¹

“Prescribing medicines outside the conditions of their marketing authorisation alters (and probably increases) the prescribers’ professional responsibility and potential liability”. ³¹.

The General Medical Council (GMC) recommends that when prescribing a medicine ‘off label’, doctors should:³²

be satisfied that there is no suitably licensed medicine that will meet the patient’s need
be satisfied that there is sufficient evidence or experience of using the medicine to show its safety and efficacy
take responsibility for prescribing the medicine and for overseeing the patient’s care, including monitoring the effects of the medicine, and any follow-up treatment, or ensure that arrangements are made for another suitable doctor to do so.
make a clear, accurate and legible record of all medicines prescribed and, when not following common practice, the reasons for prescribing an unlicensed medicine.

Non-medical and medical prescribers should ensure that they are familiar with the legislative framework and the Royal Pharmaceutical Society’s Competency Framework for all Prescribers.³³

Prior to any prescribing, the licensing status of a medication should be checked in the summary of product characteristics (www.medicines.org.uk). The prescriber must be competent, operate within the professional code of ethics of their statutory bodies and the prescribing practices of their employers.³⁴

Health technology assessment advice for NHSScotland

Specialist teams within Healthcare Improvement Scotland issue a range of advice that focuses on the safe and effective use of medicines and technologies in NHSScotland.

The Scottish Medicines Consortium (SMC) provides advice to NHS boards and their Area Drug and Therapeutics Committees about the status of all newly-licensed medicines, all new formulations of existing medicines and new indications for established products. NHSScotland should take account of this advice and ensure that medicines accepted for use are made available to meet clinical need where appropriate.

The Scottish Health Technologies Group (SHTG) provides advice to NHSScotland on the use of new and existing health technologies (excluding medicines), likely to have significant implications for people’s care.

References

31 The British National Formulary. Guidance on prescribing. [cited 11 Sep 2024]. Available from url: https://www.medicinescomplete.com/mc/bnf/current/PHP97234-guidance-on-prescribing.htm

32 General Medical Council. Good practice in prescribing and managing medicines and devices. [cited 11 Sep 2024]. Available from url: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices

33 Royal Pharmaceutical Society. Prescribing competency framework. [cited 11 Sep 2024]. Available from url: https://www.rpharms.com/resources/frameworks/prescribers-competency-framework

34 Medicines and Healthcare products Regulatory Agency. Off label use or unlicensed medicines: prescribers' responsibilities. Drug Safety Update 2009;2(9):6-7.