2025-07-18 10:18:24
The Government has now published the amendments that will be made to amend the law on supervisiona across the UK. These are in the draft Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025.
In a letter to PLEA as a responder to its consultation, the Department of Health and Social Care says:
“The draft Order makes three core changes:
i. enabling pharmacists to authorise registered pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, and sale and supply of medicines;
ii. enabling pharmacists to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist – avoiding repeat visits from patients when a pharmacist is not there; and
iii. allowing registered pharmacy technicians to take primary responsibility for the preparation, assembly and dispensing of medicinal products in hospital aseptic facilities that do not have a specials manufacturer’s licence.”
Amendments i and iii will come into force a year after the Privy Council makes the Order – which is expected to be done in late 2025. This delay is to allow time for professional standards and guidance to be developed to support safe implementation of the changes. Amendment ii will come into force 28 days after the Order is made.
Authorisations to pharmacy technicians may be oral or in writing, but the Pharmacy Order 2010 will be amended to allow professional standards require oral authorisations to be documented. The Pharmacy Order and its equivalent legislation in Northern Ireland will also be amended so that the pharmacy regulators can address the question of whether superintendent pharmacists can override a responsible pharmacist to give authorisation a pharmacy technician.
“Supervision” is not defined. The Department says that the changes are “not about removing the need for pharmacists to undertake appropriate clinical checks linked to the dispensing process”, although appropriate clinical checks are not necessarily a legal requirement rather than a professional one when appropriate.
On its website, the Department says:
“The detail of how the changes will operate in practice]does not come at the legislative phase. Government legislation sets the broad framework with the detail set out and consulted upon by the pharmacy regulators and professional bodies. This includes but is not limited to:
- new standards for superintendent pharmacists and responsible pharmacists
- updating the Royal Pharmaceutical Society of Great Britain (RPSGB – the precursor to RPS and GPhC) interim guidance for pharmacist supervision and private consultation (December 2005)
- updating the Quality Assurance of Aseptic Preparative Services (QAAPS) Standards”
The Department adds:
“For the avoidance of doubt, nothing in these proposals represents a move towards remote supervision. The presence of a pharmacist in a registered pharmacy as the default position remains the standard patients and the public expect and is enshrined in primary legislation.”
The GPhC has issued as statement https://www.pharmacyregulation.org/about-us/news-and-updates/gphc-sets-out-next-steps-following-introduction-draft-legislation-pharmacy-supervision linking the changes in the law to its development of standards for responsible pharmacists and superintendent pharmacists and there will be a public consultation later this year. PLEA plans to respond to this and will invite comments from members.