Draft Pharmacy (Preparation and Dispensing Errors - Hospital and Other Pharmacy Services) Order 2022
Draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022
(1 year, 10 months ago)
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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.
Feryal Clark (Enfield North) (Lab)
It is a pleasure to serve under your chairmanship, Mr Sharma.
It is the first duty of any Government to keep people safe, especially through the safe and secure running of our health service. Pharmacies play a crucial role in our healthcare system across the country, so it is vital that we put measures in place to ensure they are run with the safety of patients front and centre. Any steps that the Government take to do that are to be welcomed and, for that reason, we will be supporting the statutory instrument.
Managing and securing the pharmacy dispensing process is a significant challenge. More than one billion prescriptions were dispensed last year; with numbers like that, it is impossible to completely eradicate all errors. Given the vast numbers of prescriptions being dispensed, the error rate is remarkably low and pharmacists should be applauded for that. However, that does not mean we can sit back and relax, as more can and must be done to ensure patients are protected.
As well as patients, it is right that the statutory instrument looks at the effect on pharmacy staff. Most healthcare professional groups do not face criminal conviction and potential imprisonment for an inadvertent dispensing error, and it would be wrong for pharmacists to be the only group to do so. Therefore, it is welcome that the SI extends legal protections to pharmacists working in a range of locations, such as prisons, hospitals and care homes. Pharmacists working in those settings are often under increased stress, which has been exacerbated by the challenges of the pandemic. The Pharmaceutical Journal recently found there had been an approximate doubling in pharmacists reporting feeling “stressed” compared with previous years.
As they often work in pressured circumstances, it is right that we protect pharmacists, who are often people’s first point of contact with the healthcare system and are too often victims of abuse, from unintended mistakes. Ensuring the right to legal defence against prosecution in cases relating to inadvertent error will undoubtedly remove some of the fears these clinicians feel in admitting errors, helping to prevent and reduce patient harm through taking the wrong medication or dosage.
We welcome the greater clarity that the SI provides about how those legal defences are applied, but we have some concerns. There remain a number of offences that do not have a corresponding statutory defence laid out in the SI. Will the Minister put on record the offences for which no statutory defences are provided and the reasoning behind the decisions about them?
A key facet of the SI is the greater culture of transparency that providing security to pharmacists should hopefully foster, as set out by the Minister. Rather than creating a point-and-blame culture, we need a system that recognises errors in dispensing and preparation of medicines and puts active steps in place to ensure that they are not repeated. It is, however, absolutely right that the SI focuses on inadvertent errors. Where errors are made deliberately through staff acting in a negligent way, they will and must continue to face criminal prosecution—something we fully support.
There are a number of outstanding points that I would appreciate the Minister covering in her reply. There is particular concern about the reporting process for dispensing errors, which at present is at risk of letting too many fall through the gap. Only 5% of dispensing errors made each year are reported, making it very difficult for us to get a proper picture of the potential harm they are causing. Is the Minister therefore concerned that the 2017 legislation designed to increase protections has been largely unsuccessful in encouraging honesty among pharmacy staff? I would be grateful to hear what plans she has to ensure the number of errors being reported increases.
Furthermore, what steps will the Minister take to ensure pharmacists feel safe to come forward if they have made a dispensing error? The people affected by the legislation are often more isolated in their workplaces, without the benefit of a robust and easily accessible professional support network, so I would appreciate it if the Minister outlined how she will ensure that those affected by these changes are properly informed about them.
We are always looking to make further strides in the area of patient safety, and the orders are by no means the end of the road on this issue, but they are a welcome step. I look forward to the Minister announcing further improvements in the area in due course.
Steven Bonnar (Coatbridge, Chryston and Bellshill) (SNP)
I thank the Minister for tabling these SIs, and for laying out the reasoning behind them in such a detailed manner. We will support both motions. To that end, I only have a few comments that I would like to place on the record.
In relation to the first motion, we in the Scottish National party know that good-quality healthcare is the cornerstone of a decent society, and the Scottish Government will always strive to provide that for Scotland and all of our citizens. We know that the risk to patients is increased if pharmacists are not flagging up simple things such as poor labelling, difficult to read issues, or mistakes that someone else has made. Continuous improvements can be made through increasing the reporting of dispensing errors and learning from them. The SNP encourages a learning culture for those involved when errors happen, so that pharmacists can increase their learning from such errors.
Scotland is far ahead of England and Wales in electronic prescribing, which helps prevent prescribing errors. That system also flags up the dangers of—for example—prescribing penicillin to someone who is allergic, using the wrong doses, or bad interactions previously had by patients. I take this opportunity to again highlight the fantastic approach to these matters taken by Mackie Pharmacy in my constituency, which has a phenomenal track record in dispensing best practice. Also with a focus on safety and the aim of reducing harm in healthcare, the Scottish Patient Safety Alliance was established in 2007 by creating a partnership between the Scottish Government, NHS Scotland, the Royal Colleges and other professional bodies, the Scottish Consumer Council and the Institute for Healthcare Improvement. That is something that the UK Government could probably take on board.
Turning to the second motion, the SNP supports making the best use of the workforce by more fully using the skills and knowledge of community pharmacists. The Scottish Government introduced the Pharmacy First NHS service, backed by £10 million of investment from the Scottish Government, as part of the NHS recovery plan to expand the range of common clinical conditions that can be treated by a community pharmacist, avoiding unnecessary GP and out-of-hours appointments. In Scotland, community pharmacists are playing a fantastic role in ensuring that millions of people have their minor ailment needs addressed quickly without needing to see a GP or go to a hospital. They are a prime example of getting the right care in the right place at the right time.
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.)