2025-10-26 14:44:53
Both Houses of Parliament have recently debated the draft Order that would amend the Human Medicines Regulations so as to allow pharmacists to authorise pharmacy technicians to supervise the supply of medicines, to allow previously dispensed medicines to be supplied in the absence of a pharmacist, and to enable pharrmacy technicians to deal with aseptic dispensing in hospitals without pharmacist supervision. Details of the proposals are set out in earlier PLEA news items, so they are not repeated here.
The debates, especially the debate in the House of Lords, threw up a number of interesting features – and more questions than answers. The Department of Health and Social Care (DHSC) is clearly expecting that after implementation of the reforms, much of the heavy lifting will be done by the General Pharmaceutical Council and by the Royal Pharmaceutical Society.
In the House of Commons on 13 October https://hansard.parliament.uk/commons/2025-10-13/debates/d0a6b856-130e-4738-89c3-93b0dcda4170/DraftHumanMedicines(AuthorisationByPharmacistsAndSupervisionByPharmacyTechnicians)Order2025 the Minister for Care, Stephen Kinnock, said:
“Case law has led to restrictive practice and different interpretations of the law. We will allow pharmacists to authorise a registered pharmacy technician to undertake or supervise those activities. That will mean the pharmacist no longer has to supervise each transaction and can therefore spend more time with patients and delivering clinical services. The provision will not apply in Northern Ireland until pharmacy technician becomes a registered profession there.”
There was only one other contribution to the House of Commons debate. The Conservative shadow Minister said: “embedded within these provisions is a total reliance on ‘supervision’ and ‘authorisation’, yet clarity of definition is missing on how those will operate in practice for a pharmacist authorising a pharmacy technician to dispense medicines.”
In the Lords on 21 October https://hansard.parliament.uk/lords/2025-10-21/debates/F2C042EC-2817-4A91-9EE4-EC9D0A0D2C21/HumanMedicines(AuthorisationByPharmacistsAndSupervisionByPharmacyTechnicians)Order2025 , the debate was opened by the Parliamentary Under-Secretary of State at the DHSC, Baroness Merron. Amongst other things, she said:
- Case law has led to restrictive practice and different interpretations of the law.
- The new law demands that a pharmacist must have due regard to patient safety when giving an authorisation. This means in practice that a pharmacist will be authorising only staff who are trained, competent and confident to undertake a task.
- The pharmacist will still be expected to undertake a clinical check, which is critical to make sure that a medicine is safe and appropriate for each patient.?
- The Royal Pharmaceutical Society is updating its 2016 professional standards for the quality assurance of aseptic preparation services. This will define the required knowledge and training for both professions to support and ensure safe implementation.
- The proposals relating to pharmacy technicians will not be implemented in Northern Ireland until pharmacy technicians are registered there.
- DHSC intends to bring into force within 28 days of royal approval the provisions that will allow medicines dispensed under the supervision of a pharmacist to be handed out in the absence of a pharmacist.
- DHSC intends to bring the other measures into force through a separate Order in Council after a one-year transition period.
Other peers raised a number of questions, especially Baroness Hollins:
- Baroness Merton had said that pharmacists would be required to make a clinical check, but this is not mentioned in the draft order. With 16% of 237 million drug errors annually being due to dispensing errors, why is supervision not defined in legislation or in the draft SI?
- What is in place to prevent any one pharmacist—for example, one working centrally across a chain of stores—writing an authorisation for large groups of pharmacy technicians on the register to supervise medicines preparation, assembly, dispensing, sale and supply from, potentially, every pharmacy on the register, implying indirect supervision en masse?
- If this cannot be done in a single authorisation, could any one pharmacist write multiple authorisations to the same effect?
- Is it correct that an authorisation can be made without the explicit consent of the technician, and that, once made, it can be withdrawn or varied only by the pharmacist who gave it? If that is correct, individual pharmacists in pharmacies would be powerless to withdraw the authorisation if they were not the one who gave it, even if they were the pharmacist on the premises and had concerns. It seems that, even if the on-site pharmacist was not the one who issued the authorisation, they might be liable for something that occurred but which they were powerless to prevent.
- How will authorisations be tracked so that a local pharmacist can know whether a given authorisation is current or has been withdrawn orally or in writing or varied? The authorisation could have been given by a different person, on a different date and on different premises.
- It looks as if a pharmacy technician can hold two or more different authorisations—one of which could be oral, which may be useful in times of emergency or great pressure—but this order requires either verbatim recording or video recording at the time, stating either a date of expiry or that this overrides the previous authorisation. What happens if authorisations conflict? How will a conflict be resolved if, for example, one pharmacist allows the supply of certain drugs and another prohibits it?
- The Terminally Ill Adults (End of Life) Bill, in its current form, provides sweepingly extensive powers for the Secretary of State to amend the entirety of the Human Medicines Regulations 2012 and to make regulations regarding the preparation, assembly and supply of lethal substances —particularly in Section 37(4). This could allow pharmacy technicians to supervise, prepare, assemble and supply highly toxic lethal mixtures.
- On dispensing, the new rule allowing a sale or supply of ready-dispensed products in the pharmacist’s absence creates a challenge. For example, will a shop assistant who has been there for one day and works in the pharmacy be allowed to do this?
In reply, Baroness Merron said, amongst other things:
- Concerning definitions in respect of clinical checks, professional guidance, which will set out what the pharmacist’s role is to be—including when and how there will be a need for a clinical check. The government is aware that it needs to give the sector legal clarity regarding what “supervision” means.
- Regarding questions about indirect supervision en masse, the proposals do not remove supervision or change the legal requirement that a responsible pharmacist must be signed in at a registered premises when dispensing activities are taking place and when open to the public.
- Pharmacists will be able to authorise any member of staff to hand out checked and bagged prescriptions but they must be authorising only staff who are trained, competent and confident to undertake a task. There will be updated professional standards and guidance to ensure that good governance supports the safe implementation of these changes in practice. Therefore, it could not be, for example, an assistant in a supermarket who happens to be working in the pharmacy.
- As to the tracking of authorisations, practice matters cannot be set out in law. They will be addressed in professional standards and guidance. That will be set by the regulators and professional leadership bodies to support the implementation of these changes into practice. Training is to make clear to all staff – that they need to follow standard operating procedures for when the authorisation is given, when they should consult the pharmacist and when a supply should not go ahead.