Draft Pharmacy (Preparation and Dispensing Errors - Hospital and Other Pharmacy Services) Order 2022 Draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022

Maria Caulfield Excerpts

Monday 6th June 2022 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I beg to move,

That the Committee has considered the draft Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022.

[The Chair]

With this it will be convenient to consider the draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022.

[Maria Caulfield]

It is a pleasure to serve under your chairmanship, Mr Sharma.

The draft order, which was laid before Parliament on 28 April, extends across the United Kingdom. Both orders have been in development for a long time under the auspices of the rebalancing medicines legislation and pharmacy regulation programme board, membership of which includes representatives of the pharmacy sector, and professional and regulatory bodies from across the United Kingdom. The draft orders have benefited from full scrutiny by those experts, and they have been welcomed by pharmacy professionals working in hospitals and relevant pharmacy services. They also have the support of the four chief pharmaceutical officers of the United Kingdom.

During the covid pandemic, as I think hon. Members will agree, community pharmacies proved once again that they sit at the centre of our communities. They are a vital first port of call for healthcare advice. The Government want community pharmacy to deliver more patient-focused care. It is therefore right and proper to have a strong governance system to ensure that professionals and staff have clear frameworks within which to deliver the care they give to patients, and are enabled to have the roles, responsibilities and ability to deliver safe patient care.

The draft Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order is the next stage in our work to improve patient safety in pharmacy. About 52 million items a year are dispensed in secondary care, which covers hospitals and other settings. Despite the incredible work of our pharmacy teams, errors happen, but we estimate that only about 5% of the errors in secondary care are reported. In our efforts to create a culture of safety and a duty of candour when mistakes are made, the draft order aims to improve the statistic by reducing fear of prosecution and by incentivising reporting and learning from errors. We want the NHS to be a place of learning, and the order is key to improve patient safety, which should always be our goal.

The purpose of the draft order is to extend the defences already available to pharmacy workers in the community pharmacy setting under the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018. The draft order will ensure that registered pharmacy professionals who work in hospital and other settings such as prisons and care homes will have the same access to defences that community pharmacists have currently. It will provide them with access in defined circumstances to the defences against criminal offences set out in sections 63 and 64 of the Medicines Act 1968, which concern the standards of medicinal products and the sale of any medicinal product that is not of the nature or quality demanded by the purchaser. The order will make these defences available in defined circumstances and, importantly, will incentivise the reporting of errors when pharmacy professionals make a genuine dispensing errors, and will inform learning to prevent such errors happening again.

One important aspect of the conditions of the defence is that a pharmacy service must have a chief pharmacist, or someone with the duties of that statutory role, who is responsible for the pharmacy services, ensuring that necessary governance is in place to provide assurance to patients. The pharmacy regulator will be given new powers to set the standards for the role of chief pharmacist, mirroring the role of superintendent pharmacist, which I will discuss in the context of the second draft order, so that the hospital and secondary care settings match those of community pharmacy. Last year, a survey by the Community Pharmacy Patients Safety Group found that following the changes, 95% of pharmacists said they now report errors to improve practice and 80% said they now learn from their mistakes. The survey also found that fear of prosecution as a reason not to report an error has dropped from 40% in 2016 to 18% last year. That is largely attributed to the change in the law in 2018. We therefore expect a similar drop in the fear of being prosecuted for pharmacy professionals in the secondary care setting covered by the draft order.

The role of the draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 is to define and clarify the core purpose of the responsible pharmacist, who is in charge of a pharmacy of a particular retail outlet on a day-to-day basis, and the superintendent pharmacist, who is the person responsible for setting policies across the whole retail pharmacy business. They are two clearly defined, separate roles. The draft order gives powers to the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland to define in professional regulation how the purpose of these roles is fulfilled.

The regulators already have powers to set rules and standards around professional regulation, and it makes sense that pharmacy practice matters sit with the regulator rather than with Ministers, which is how things currently stand. That is already the case for the powers of the regulators of other healthcare professionals. We are putting in place a more flexible regulatory framework and the necessary systems to support and maximise the potential of the community pharmacy teams, and the skill mix within them to deliver more clinical services in the community and support the wider NHS capacity ideals.

The measures will apply across the United Kingdom and have been developed collaboratively with all four Health Departments across all four nations. I would like to draw hon. Members’ attention to two provisions specific to Northern Ireland, designed to better align Northern Ireland with Great Britain. At the request of the Department of Health in Northern Ireland and the Pharmaceutical Society of Northern Ireland, it is proposed to give the Department of Health in Northern Ireland the power to appoint a deputy registrar in respect of duties set out in the Pharmacy (Northern Ireland) Order 1976. The second change would be to extend the requirement that already exists for Great Britain that a superintendent pharmacist must inform the relevant pharmacy regulator when they stop holding the role in a pharmacy business in Northern Ireland. For Northern Ireland, that would be the Pharmaceutical Society of Northern Ireland.

I hope that I have outlined the two draft orders to Members, but I want to be transparent and clear that there was a consultation on them both in which there was general support for them, but also some concerns that I want to address. The first was about distrust of the regulator and giving more power to the regulator. I want to reassure colleagues that although powers are given to the regulator to outline the roles of the responsible pharmacist and superintendent pharmacist, if the regulator wants to make changes to those roles, there would be a statutory consultation and the same negative resolution procedure in Parliament. There would be proper scrutiny and proper debate on any changes made. I want to reassure Members that we are not just handing powers to the regulator; there will be proper scrutiny in place for any changes they want to make.

The second concern was about the impact of the measures on the supervision of the dispensing of medicines in retail pharmacy. I want to emphasise that the draft orders do not affect the legislation that governs the supervision, preparation, sale and supply of prescription-only medicines, including the legal requirement for a pharmacy to supervise the dispensing of prescription-only medicine. That concern came out of the consultation, but I want to reassure Members that that is not the case. Thirdly, there was concern about superintendent pharmacists being in charge of more than one business, but it is and still will be the case that every pharmacy must have a superintendent pharmacist who has a statutory duty in respect of safe and effective running of retail pharmacy businesses. That will not change following the orders. If the regulatory bodies wanted to change that in future, a statutory consultation and full scrutiny from Parliament would take place.

On the final concern about responsible pharmacists being in charge of more than one pharmacy at any one time, as a Minister I can already set out an exception to that in regulations, but that power has never been used to date. Today’s proposal does not change that but simply transfers the exception-making powers from Ministers to pharmacy regulators. Again, a statutory consultation and full parliamentary scrutiny would have to take place in order for pharmacy regulators to change those powers.

I hope the Committee will support these reforms so that we can put in place a strengthened and more flexible framework of organisational governance for registered pharmacies. The order will also support improved patient safety by reinforcing the professional duty of candour, encouraging a culture of candid and fulsome contributions from those involved when things go wrong, and creating an environment where people are not afraid to come forward when they have made a mistake, so that they are able to learn from those mistakes and prevent them from happening again in the future.

Should these orders be approved, I look forward to working with the regulators, setting out their programme of work to support these orders under the powers afforded to them and further scrutiny by both Houses.

--- Later in debate ---

[Maria Caulfield]

I thank Opposition Members for their support for both orders. I will touch on a couple of points that the shadow Minister, the hon. Member for Enfield North, raised. I want to reassure her that although the orders will make it easier for pharmacy teams to report mistakes in secondary care settings, there will still be offences retained when there is a deliberate disregard for patient safety, but she is right: if we are to improve patient safety, we need to foster a culture of openness, transparency and learning from mistakes. I am happy to write to her with the defences against prosecution. The regulator will take the work forward and we will have that detail shortly once they start work, after we have passed the orders.

I can reassure the hon. Lady that when we changed the law for community pharmacists in 2018, they felt more confident, as I set out in my speech, in reporting mistakes, and we hope that will be replicated in the secondary care setting following these orders. We have also passed separate legislation on the duty of candour across the NHS so that if a mistake is made in in any NHS organisation by a pharmacist, a doctor or a nurse, patients should be notified as soon as the mistake is discovered, told about the implications of it, and then about the process to resolve it. There is a statutory duty of candour across the NHS, and today’s order builds on that.

In answer to the hon. Member for Coatbridge, Chryston and Bellshill, I am pleased that we have been able to work with all four nations across the United Kingdom, who all support the measures. I hope that passing these orders and giving greater transparency to any mistakes that happen will build on the work that his Ministers in Scotland are doing. I put my hands up—I am a huge fan of the Pharmacy First model. We are working hard to try to replicate some of that in England. The hon. Gentleman is right that the pandemic has highlighted the experience, qualifications and vast wealth of knowledge of our pharmacists. They are held in high regard and I am glad that we are able to support them in the work that they do. Putting politics aside, I absolutely recognise the work on the Pharmacy First model in Scotland.

I am glad we have agreement on both of the orders.

Question put and agreed to.

DRAFT PHARMACY (RESPONSIBLE PHARMACISTS, SUPERINTENDENT PHARMACISTS ETC.) ORDER 2022

Resolved,

That the Committee has considered the draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022.—(Maria Caulfield.)