Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 Debate
Full Debate: Read Full DebateBaroness Ritchie of Downpatrick
Main Page: Baroness Ritchie of Downpatrick (Labour - Life peer)Department Debates - View all Baroness Ritchie of Downpatrick's debates with the Department of Health and Social Care
(1 day, 20 hours ago)
Grand CommitteeMy Lords, some concerns about the order have been drawn to my attention, so I have a few questions for the noble Baroness. Pharmacy technicians, on entry to the register, have an NVQ 3 qualification, which is equivalent to two A-levels. By contrast, pharmacists have a level 7 qualification, a master’s degree, which is a different basic training, with pharmacists obviously having much greater scientific and clinical knowledge. There is a worry that large pharmacy corporations could create pressure or targets which result in pharmacy technician supervision replacing pharmacist supervision for financial gain, which could put patients at greater risk because of the knowledge gap between the pharmacist and the pharmacy technician.
With 16% of 237 million drug errors annually being due to dispensing errors, I ask the Minister, who will, after all, be legally responsible in the event of any patient harm, why supervision is not defined in legislation or in the draft SI. I could not find any evidence of definition. The noble Baroness said in her introduction that pharmacists would be required to make a clinical check, but I cannot see that in the order.
I understand that, in the government consultation, 58% of all respondents and 76% of pharmacist respondents opposed allowing pharmacists to authorise pharmacy technicians to supervise the preparation, assembly, dispensing, sale and supply of prescription-only medicines in pharmacies. Also, 51% of respondents and 65% of pharmacists disagreed with allowing pharmacy technicians to supervise the preparation, assembly and dispensing of medicines at hospital aseptic facilities in the way that pharmacists do under current law.
That generates a few questions. First, 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. It just does not seem clear enough; that is the reason for my questions.
The government website states:
“Although the presence of a pharmacist in retail pharmacy is not explicitly stated in law, section 70(2) of the Medicines Act 1968 requires that a responsible pharmacist must be in charge of what happens at a retail pharmacy. This means, in law, the ‘physical presence’ of a pharmacist is inferred”.
Can the Minister confirm whether this inference is drawn from the responsible pharmacist regulations 2008, which have been revoked? The General Pharmaceutical Council’s rules are expected to allow for a pharmacist to be absent from a pharmacy, and for a pharmacist to be responsible for more than one pharmacy and, therefore, not physically present in all of them. 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?
This brings me briefly to the Terminally Ill Adults (End of Life) Bill, which, 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. Many medicines are incompatible when taken together, which is a concern.
I apologise for the complexity of the questions and the confusion that this order has provoked.
My Lords, it is a pleasure to follow the noble Baroness, Lady Hollins, in this debate. First, I declare an interest as a member of your Lordships’ House’s Secondary Legislation Scrutiny Committee. Only last week, I met the Company Chemists’ Association, which very much endorses this order. This morning, I chaired a round table on vaccinations, which showed quite clearly that, if community pharmacies are able to execute vaccinations on a widespread basis, their other work in terms of dispatching and gathering together prescriptions can be done by fully regulated pharmacy technicians.
However, I take on board the point from the noble Baroness, Lady Hollins, in respect of qualifications and the wide gap in those qualifications. There are also issues to do with terminally ill adults and medication and prescriptions, particularly around contraindications. If that happens, it could have severe consequences for the patient.
My Lords, I thank all noble Lords for their valuable contributions to today’s debate. I noted the discussion between noble Lords about whether they could agree with several noble Lords at one time; the answer is yes because I can do so, too. I feel that the questions asked will shine a useful light.
I am grateful for the support that this order has received and for the understanding that it is about releasing capacity and meeting what people need these days, as compared to the situation in 1933—or, indeed, at any time since then. This is about our move from hospital to community; our reliance on and welcoming of the whole pharmacy sector; and what that sector can bring to us. This sector is a tremendously important part of our National Health Service and allows us to provide services when, where and how we need them; I add my thanks to pharmacists, pharmacy technicians and their professional bodies for their work in this area. I hope that, overall—I picked this point up—noble Lords will see that this order is about supporting pharmacy services, supporting patients and cutting the red tape that frustrates both the sector and those who use it.
I turn to the specific questions asked by noble Lords; I will of course be glad to write if I do not manage to address any of them. The noble Baroness, Lady Hollins, my noble friend Lady Ritchie and the noble Lord, Lord Scriven, raised concerns about the order, particularly in respect of pharmacy technicians’ qualifications. Let me say at the outset—this is quite a good framing, really—that pharmacists are of course absolutely critical in delivering pharmaceutical services, but the fact is that they cannot deliver without a dedicated team. That is what we are building on.
Pharmacy technicians are ready for these changes. Their training and expertise enable them to take responsibility for many activities that would previously have been the sole responsibility of the pharmacist. I can certainly say that post-registration training and professional guidance will be supporting these changes into practice. I say this to noble Lords: the answer to a number of the questions that have been legitimately asked is the professional guidance, because, as I know noble Lords will understand, this cannot all be laid out in legislation.
The noble Baroness, Lady Hollins, and the noble Lord, Lord Kamall, asked about definitions in respect of clinical checks. Let me start by talking about the 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. It is important to say that the sector wanted pharmacy technicians to be able to work autonomously; that falls outside what “supervision” traditionally means. Therefore, we are introducing a second form of delegation, which will allow pharmacists to authorise a pharmacy technician to undertake or supervise dispensing activities without the need for direct supervision by the pharmacist. We are aware that we need to give the sector the legal clarity that noble Lords have asked for with regard to what “supervision” means in this context; I can refer noble Lords to a detailed annexe that was published alongside the consultation, but the point is well made.
The noble Baroness, Lady Hollins, my noble friend Lady Ritchie and the noble Lord, Lord Scriven, raised various questions in respect of what I will refer to as indirect supervision en masse and the need for a responsible pharmacist. So let me give the reassurance that these 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. We have stressed at every stage of formulating this policy our commitment to maintaining the legal requirement that noble Lords are rightly concerned about, whereby every community pharmacy must have a pharmacist on the premises.
The noble Lord, Lord Scriven, asked why there is a reference to “any member of staff”. The reason is that 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—the noble Lord might have had this in mind—an assistant in a supermarket who happens to be working in the pharmacy. That would not meet what is required. Again, that is an important point.
The noble Baroness, Lady Hollins, asked how authorisations will be tracked and what happens if there is conflict. I go back to my opening comments that practice matters cannot be set out in law. They will be addressed in professional standards and guidance, as I have said. That will be set by the regulators and professional leadership bodies to support the implementation of these changes into practice, and we look forward to working with those bodies. That should include professional expectations for record-keeping requirements when an authorisation is given. Training is to make clear to all staff—I return to the point raised by the noble Lord, Lord Scriven—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. That will all be part of that.
My noble friend Lady Ritchie and the noble Lord, Lord Kamall, asked about matters relating to Northern Ireland. As I mentioned, when pharmacy technicians become a registered profession in Northern Ireland, which is expected by April 2027, we will work with the Northern Ireland Department of Health to enact the other changes as soon as possible.
I thank my noble friend Lady Merron for that helpful information. Initially, up-and-running pharmacy technicians were to be registered by 2025. Why the two-year delay in terms of Northern Ireland? Maybe she would be so good as to ask Minister Nesbitt.
I cannot give a specific answer, but I will be pleased to write to my noble friend and other noble Lords about the timetable rather than land Minister Nesbitt in it in any way, which I would never wish to do. But I can give the assurance to noble Lords that officials are in regular contact with their counterparts in Northern Ireland, and the measures we are talking about have been developed in collaboration with the devolved Governments and the four chief pharmaceutical officers across the UK. I hope that will be helpful.
The noble Baroness, Lady Bennett, asked about a focus on improved training before the regulations. Pharmacy technicians undertake two years of focused training in clinical settings, and they can provide clinical and dispensing services that are appropriate to their level of training at the point of registration. However, additional post-registration training is widely available to support technicians to prepare for these new roles. Assurance is also provided by the annual revalidation for all pharmacy technicians across the country. If we combine this with robust standard operating procedures and professional guidance, it will provide a clear frame- work to ensure that pharmacists can be confident to authorise pharmacy technicians to carry out, or to supervise others carrying out, activities while ensuring patient safety, which is at the heart of this, as well as service.