Resource category: Medicines

MHRA approval of the first licensed low-dose atropine treatment for childhood myopia

The British and Irish Orthoptic Society (BIOS) welcomes the recent approval by the Medicines & Healthcare products Regulatory Agency (MHRA) of the first licensed low dose atropine (LDA) product for slowing the progression of childhood myopia in the UK.

Ryjunea® (low-dose atropine 0.1 mg/ml), licensed by Santen, is indicated for children aged 3–14 years with myopia between –0.50 DS and –6.00 DS, and evidence of progression of 0.50 DS or more per year.

The product is a prescription-only medicine (POM) and will initially be available as a private prescription. NICE has received ministerial approval to commence a technology appraisal for this treatment, and until this is complete, low-dose atropine remains a privately funded intervention across the UK.

The BIOS firmly stands by the appropriate use of Medicine Exemptions by Orthoptists with annotation of Medicine Exemption. We emphasise the importance of understanding the exemptions outlined in Schedule 17 of the Human Medicines Regulations 2012 and Human Medicines (Amendment) Regulations 2016. The legal framework advocates against the use of PGDs when exemptions exist. Registrants are not required to undertake further training or competencies once annotated with Medicines Exemptions.

This is an update for members regarding medicines and medicine exemptions. The Medicines CAG is committed to ensuring that members are supported in implementing the use of exempted medicines within their scope of practice.

This document provides information which should underpin the decision-making and actions of orthoptists who are annotated with the Health and Care Professions Council (HCPC) as having access to exemptions within Human Medicines Regulations 2012 to be able to supply and administer listed prescription only medicines (POMs) and pharmacy (P) medicines.

This document provides information which should underpin the decision-making and actions of orthoptists who are registered with the Health and Care Professions Council (HCPC) as having access to exemptions within Human Medicines Regulations 2012 to be able to supply and administer listed prescription only medicines (POMs) and pharmacy (P) medicines.

This document is ‘guidance’. ‘Guidance’ is information which an orthoptist has a duty to consider and is expected to take into account as part of their decision-making process. This document provides advice on the behaviours and conduct expected of orthoptists who are annotated on the HCPC register as able to access exemptions. Throughout this document the use of the word ‘must’ indicates a legal and/or regulatory requirement and describes a mandatory action and/or behaviour. The use of the word ‘should’ indicates behaviours and/ or actions that would be expected to occur in all normal circumstances. Each section of this guidance carries equal weight and the document is not ordered in any priority.

This outline curriculum framework is aimed at education providers intending to develop education programmes and individuals interested in education programmes for orthoptists to fulfil the requirements for annotation on the Health and Care Professions Council register as qualified to use exemptions within Human Medicines Regulations 2012 to sell, supply or administer any eye drops or ointments, for any condition within their scope of practice and competence, for topical administration.