Considered in Grand Committee
My Lords, the Pharmacy (Preparation and Dispensing Errors—Hospitals and Other Pharmacy Services) Order 2022 was laid before Parliament on 28 April. This draft order extends to the United Kingdom. I note that the noble Lord, Lord Hunt, has submitted a Motion to Regret in relation to the draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022. This will now be subject to a separate debate.
The draft order before your Lordships has been in development for a long time under the auspices of the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, whose members include representatives from across the pharmacy sector and professional and regulatory bodies. The draft order is welcomed by pharmacy professionals working in hospitals and relevant pharmacy services, and has the support of the four Chief Pharmaceutical Officers of the UK.
I apologise for the parliamentary time taken to progress this order. The Government had to make some difficult decisions to deprioritise non-urgent legislation following the general election in 2019, EU exit and the Covid-19 pandemic. We are now returning to more business-as-usual matters.
The purpose of the order is to extend the defences already available to pharmacy workers in community pharmacy premises made under the Pharmacy (Preparation and Dispensing Errors—Registered Pharmacies) Order 2018 to ensure that registered pharmacy professionals working in hospitals and other settings, such as prisons and care homes, have access to the same defences. This would provide them with access to the defences to the criminal offences set out in Sections 63 and 64 of the Medicines Act 1968, which concern the adulteration of medicinal products in Section 63 and the sale of any medicinal product which is not of the nature or quality demanded by the purchaser in Section 64. The order makes these defences available in defined circumstances and, importantly, incentivises the reporting of errors where pharmacy professionals make genuine dispensing errors, improving learning to prevent such errors occurring.
In summary, the order will support improved patient safety by encouraging a culture of candid and fulsome contributions from those involved when things go wrong. This is a culture we want to see right across the NHS. Within this culture, pharmacy professionals can increase their learning from dispensing errors and identify mitigating action to make recurrence less likely in the future. I therefore commend the draft order to the Committee.
My Lords, I have always thought that the purpose of highlighting errors in the health service should be to learn and to avoid repeats, rather than to lay blame. That is why I supported the HSSIB, which was made mandatory in the recent Health and Care Act 2022. For that reason, I also support this order, which can contribute to patient safety by extending the removal of the threat of criminal sanctions for inadvertent dispensing errors beyond current community pharmacies and into other places where medicines are legitimately dispensed. These will include hospitals, care homes, prisons and detention centres. Anything which deters people shining a light on errors is a bad thing and should be addressed; anything which enables learning from them is welcome. However, although the order is welcome, I ask the Minister whether there has been evidence that staff have been deterred from exposing or informing patients about a mistake that has been made.
It is vital that the duty of candour that applies to all health professionals is upheld. I welcome the news from the General Pharmaceutical Council that it plans to develop new learning resources to help pharmacists understand how to fulfil this duty and, crucially, why they should do so. Of course, the duty already appears in the Standards for Pharmacy Professionals. This is where actual offences come into the picture. It is right that pharmacists could still be prosecuted if they can be shown to have had deliberate disregard for patient safety, as such a person would not be acting in the course of his profession, so patient protection still applies.
Identifying such a situation would probably rely on whistleblowers, who need protection and confidence that they would not be penalised for revealing information. Will the Minister say who would be responsible for making this judgment? Would it be the General Pharmaceutical Council or a magistrate with professional advice?
May I also ask about the introduction of the statutory term of “chief pharmacist” with professional standards set by the GPhC? As I read the order, a defence for inadvertent dispensing errors cannot be called in aid if the service where it happened did not have a chief pharmacist responsible for the safe running of that service. Does that mean that if a service did not identify a chief pharmacist, or if he or she were not on the spot, the staff would be more exposed to discipline over errors than those working at a site where the work was supervised by a chief pharmacist? Will the Minister please explain?
My Lords, I welcome the Minister’s helpful introduction and his acknowledgment of the delay in bringing this statutory instrument before us. These Benches welcomed the initial preparation and dispensing errors instrument when it came before Parliament in 2017. That welcome was in line with that of a number of organisations, including the National Pharmacy Association, the Pharmaceutical Services Negotiating Committee and the Royal Pharmaceutical Society. Today, we are very happy again to give that welcome to this statutory instrument, not least because it is entirely focused on patient safety and on improving safety for patients. It also brings parity across the pharmacy profession, something that has been much called for.
There were some 1 billion prescriptions dispensed last year. At this volume, it is, of course, impossible to avoid all errors, and it is certainly a credit to the pharmacy profession that they are statistically very few and far between. Most professional groups in the health service do not face criminal conviction and potential imprisonment for an inadvertent dispensing error, and therefore it would be quite wrong for pharmacists to be the only ones who do. It is therefore very welcome that this SI extends legal protections to pharmacists working in a range of locations, such as prisons, hospitals and care homes.
Those working in these settings are often under increased stress, and this has been exacerbated by the challenges of the pandemic. The Pharmaceutical Journal has found an approximate doubling of pharmacists reporting that they feel extremely stressed compared with recent years. In often very pressured circumstances, it is right that we, in the way we are discussing today, protect pharmacists—who are often people’s first point of contact with the healthcare system and 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 fear these clinicians feel when it comes to admitting errors. It will help to prevent and reduce patient harm through taking the wrong medication or dosage.
It will also assist in promoting a culture of transparency, as has been referred to already. That will help to inform future learning and improve protocols for the dispensing and preparation of medicines. I agree that this is very much a helpful step towards cultural change and towards a more positive and candid workforce, which, as we have already referred to, can only serve to make patients safer.
Of course, again, it is right that this SI extends only to inadvertent errors. Where they are wilfully negligent or intent on causing deliberate harm, those who are responsible will continue to face criminal prosecution. This is critically important and we certainly support that.
I move on to my outstanding questions on the SI. I am concerned that, of the 523,000 dispensing errors that occur each year, only 5% are reported. Does this not suggest that the 2017 legislation increasing protection for inadvertent errors has been largely unsuccessful in encouraging honesty? What more are the Government doing to increase that number? How will the Government further encourage individual pharmacists to feel safe to come forward if they have dispensed the wrong medication? I should like to understand further how the professionals affected by this legislation, especially those who are more isolated than those who have the benefit of a network of pharmacists easily accessible to them, are informed about these changes.
There is always so much more to do when it comes to patient safety, but this is a very welcome step forward. I look forward to the Minister bringing forward further improvements in due course.
I begin by thanking noble Lords for their questions. I shall try to answer as many as I can and, in the usual way, if I have missed any of them, I will go through Hansard and make sure I respond in more detail. The noble Baroness, Lady Walmsley, asked about deterrence. I have some statistics here. In 2021, a survey of community pharmacists found that 95% of pharmacists said that they report errors to improve practice and 80% to learn from mistakes. In response to her specific question about fear of prosecution as a reason not to report an error, it dropped from 40% in 2016 to 18% in 2021, largely attributed to the 2018 change in law. Therefore, we expect a similar drop in the fear of being prosecuted for the pharmacists covered by this order.
The noble Baroness also asked about the chief pharmacist. This is a statutory role that mirrors the statutory role of the superintendent pharmacist in registered retail pharmacies. This aims to strengthen the governance of pharmacy services by incentivising the creation of this role, if a hospital, prison or care home does not already have one, in order to benefit from these defences. However, to reflect the diverse arrangements in different health settings, organisations do not necessarily need a specific chief pharmacist role, but should ensure that the statutory functions of a chief pharmacist are included in the relevant individual’s job responsibilities if they want to benefit from the defences.
There was a specific question about where there is no chief pharmacist officer. I understand that, at the moment, existing pharmacists can have that duty extended to them, but I shall have to write to the noble Baroness with more detail. What is really important, as she acknowledged, is the duty of candour. We want to encourage an environment where people do not feel afraid to come forward in order to learn. Of course, there is always the right balance between those who have acted maliciously compared to those who have made a mistake. As the noble Baroness, Lady Merron, rightly said, when you are dispensing this number of prescriptions, statistically and probability-wise, there is probably bound to be some error.
To go back to the point about the chief pharmacist officer, given the flexibility, people do not need to adopt the statutory term of chief pharmacist as a job title; they can have the role of chief pharmacist assigned them. I just wanted to clarify that; if I have not been clear, I shall write to the noble Baroness.
I just want quickly to give a bit of a flavour of the errors to show how something might not necessarily be malicious but could be an error. A medicine intended for another patient could be dispensed to the wrong patient. The wrong medicine could be dispensed. An ingredient could have inadvertently been omitted or added when making up a medicine. A medicine could be dispensed at the wrong strength or in the wrong dosage form. These things happen, not intentionally but unintentionally, which is why we want to make sure that we learn from such mistakes.
Given that we have already introduced these offences for the majority of pharmacy professionals in the retail sector, it is right that we extend them to colleagues working in hospitals. By introducing this order, we are not only removing the fear factor for pharmacy professionals but helping to protect the patient under their care. We know from patients that it is important for them to know that, when an error is made, responsibility is taken and the service learns lessons. This legislation supports and incentivises that principle.
I am not clear whether I have answered every question, but I will check and write to the noble Baronesses as appropriate. I thank noble Lords for their interest and the positive debate today. I commend this draft order to the Committee.