Regulation 214 of the Human Medicines Regulations 2012 requires Prescription Only Medicines to be supplied in accordance with a prescription, but there are exemptions from this requirement. In our Members’ blog When Pharmacy Law Goes Wrong no.3, we wrote about how the Human Medicines Regulations were amended to allow “a person carrying on the business of a school” who is trained to do so to administer a salbutamol inhaler. We pointed out that the businesses of schools are mostly carried on by local authorities, companies and charities, not by individuals: local authorities, companies and charities cannot be “trained”
In 2017, a similar amendment to the Human Medicines Regulations was made to allow the provision of a prescription only medicine comprising an auto-injector containing adrenaline in an emergency to a pupil known to be at risk of anaphylaxis.
The MHRA is now consulting on amending the Human Medicines Regulations with a view to giving schools an additional option to support children at risk of life-threatening allergic reactions. The proposal would maintain the existing safeguards that apply to school-held adrenaline products. Spare adrenaline supplies could only be used for pupils known to be at risk of anaphylaxis and administered by appropriately trained school staff. Schools would be able to choose whether to stock Adrenaline Auto-Injectors, Adrenaline Nasal Sprays, or both, and either product could be used in an emergency regardless of which type of adrenaline device the pupil has been prescribed.
The consultation is open until 14 December 2026.
PLEA will consider submitting a response to the consultation.