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Pharmacy (Preparation and Dispensing Errors—Registered Pharmacies) Order 2018

Volume 787: debated on Wednesday 6 December 2017

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Pharmacy (Preparation and Dispensing Errors—Registered Pharmacies) Order 2018.

Relevant document: 11th Report from the Secondary Legislation Scrutiny Committee

My Lords, I thank the rebalancing programme board for its advice, which has formed the basis for this order. The purpose of the order is to create, for registered pharmacy professionals working in a registered pharmacy, new defences to the criminal offences set out in Sections 63 and 64 of the Medicines Act 1968. The order makes these defences available in defined circumstances to pharmacy professionals making genuine dispensing errors. This marks an important step forward in addressing barriers to providing a safer, higher-quality service.

The Mid Staffs inquiry highlighted the importance of putting patient safety at the heart of everything we do and taught us about the importance of achieving a careful balance between assuring accountability to the patient and developing a culture of openness and transparency so that we learn from errors, improving practice and safety. Indeed, Professor Berwick stated:

“The most important single change in the NHS in response to this report would be for it to become, more than ever before, a system devoted to continual learning and improvement of patient care”.

The order follows that philosophy. Pharmacy professionals are highly regulated—in relation to dispensing errors, more so than any other healthcare professionals. Indeed they are subject to “triple jeopardy” in the event that they commit a dispensing error. They face prosecution for strict liability offences under Sections 63 and 64 of the Medicines Act 1968, prosecution for offences under general criminal law and sanctions under professional regulation requirements.

This can lead to defensive practices. It has been demonstrated in other industries where safety is critical that working under such a threat of sanction is a hindrance to the reporting of errors and accidents and therefore wider learning. Evidence suggests that patient safety and service quality can be improved through increasing the rate of reporting and learning from dispensing errors. This will have benefits to patients locally and throughout the NHS system.

By removing the fear factor of a strict liability offence for inadvertent dispensing errors, we aim to create a much more open and transparent culture, which in turn should help to improve learning and prevent mistakes from happening. We will work closely with pharmacies’ professional and regulatory bodies across the UK to make this a reality. That said, registered pharmacies already have a range of systems and procedures in place to prevent dispensing errors occurring. More than 1 billion prescription items are dispensed every year and it is testament to the professionalism of pharmacy staff that errors occur only in a small proportion of cases.

However, dispensing errors can occur within a registered pharmacy for a variety of reasons. For example, there are many thousands of medicines and some have similar names and brandings; medications may also have complicated dosing schedules. But this order is not about accepting the inevitability of error. Instead, it seeks to ensure that we collect information on errors that do occur and think hard about how they can be prevented in future, including through spotting trends at a national level. This may involve improving systems and procedures, designing out error as far as practicable. Obviously, without knowledge of what has gone wrong, this will not be possible.

However, we are not removing all safeguards for patients. There will remain offences under general criminal law—for example, in cases of gross negligence and manslaughter—and sanctions under professional regulation. In such circumstances, the professional regulators—the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland—can still subject individuals to regulatory fitness-to-practise procedures. Sanctions would depend on the circumstances of the error but could ultimately include the individual being removed from the professional register and no longer being permitted to practise.

The order is well supported. During the public consultation, it was overwhelmingly endorsed, including by patients and the public, and groups such as Action against Medical Accidents. They will now want to see pharmacy professionals play their part and demonstrate increased learning and reporting of errors. The Government are committed to ensuring that this happens and we have already taken some action in this regard. In each of the four home nations, a number of initiatives to support reporting and learning have been introduced; for example, medication safety officers or champions, and national reporting systems. Regulatory and professional bodies in pharmacy have also put in place standards and guidance to support the desired culture change, with community pharmacy trade bodies encouraging their members to follow the standards and encouraging pharmacy teams to report, learn, act, share and review.

Action is also being taken in each of the home nations on medication error more generally throughout the healthcare system. It is sobering that 5% to 8% of all hospital admissions are medication-related. This September, the Secretary of State for Health and the Chief Pharmaceutical Officer for England launched an initiative that focuses on reducing prescribing and medication errors throughout the National Health Service in England. The programme will look at a number of areas, including improving how we use technology, understanding how best to engage patients with their medicines, and advancing the transfer of information between care settings.

Finally, I make it clear that while the order provides a defence for pharmacy professionals working in registered pharmacies, it is important to recognise that pharmacy occurs outside these settings and therefore not all pharmacy professionals will be able to avail themselves of the defences set out in the order. So work is progressing to develop similar measures for pharmacy professionals working in hospitals and other care settings, and we intend to consult on this early next year. This will ensure that, regardless of their position within the healthcare system, pharmacy professionals will be encouraged to report and learn from dispensing errors.

In summary, the order supports improved patient safety by encouraging a culture of candid and fulsome contributions from those involved when things go wrong. 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 commend the draft order to the Committee.

I thank the Minister for introducing this order with such clarity, and in the process answering several of the questions I had intended to ask her, which may shorten the proceedings. As she said, the order makes a change to the legislation governing the way in which pharmacists who make a mistake are prosecuted, by making certain new defences available to them. As the Minister also said, at the moment they face triple jeopardy from their professional regulator, health legislation and, potentially, criminal law for manslaughter. I recognise that this order is based on the premise that reducing the risk of prosecution will increase the number of errors reported. Over time, we hope that learning from a greater number of errors should lead to improvements in practices and therefore enhance patient safety.

The order will offer protection to pharmacists and dispensing technicians, but its main purpose, quite rightly, is to improve patient safety. Proposed new Section 67B(5) will require the accused to prove in their defence that on discovery of the error, every step was taken to report it at the earliest opportunity to the person in receipt of the medication. That provision will give pharmacy professionals the chance to minimise the effect of errors and will positively incentivise them to admit them, as the act of so doing will aid their defence. This is therefore a new duty of candour, which has the potential to lead to major cultural change. As the Minister also said, this does not mitigate pharmacy professionals who show deliberate disregard for patient safety and who will not benefit from this defence. The order will protect only those practising in registered premises who are already subject to professional regulation. For the sake of the protection of patients, it will not provide a defence for other groups or individuals external to the registered premises and involved in the medical supply chain.

It has to be said that this has been a long time coming. I recall the issue being raised in 2009, and I was there when, during the passage of the Health and Social Care Act in 2011, the noble Earl, Lord Howe, said that the legislation needed to be reviewed so that criminal liability did not arise as a result of genuine dispensing errors. While we welcome this order as a step in the right direction, we therefore feel that it does not go far enough and we hope that it does not take as long as it already has to complete this project.

Even after it is implemented, pharmacists will still not be on a level playing field with other healthcare professionals; they may benefit from access to improved defences, but, as the Pharmacists’ Defence Association maintains, they will still face the prospect of a police investigation and a lengthy trial. They will have to hold on to the hope that they can successfully use the defences but may still face prosecution under other provisions of the 1968 Act. I hope that the Minister will consider further legislation to ensure that inadvertent errors are totally decriminalised. Why are we still asking that those errors should be decriminalised? I hope that the Government will move on this.

Is there some kind of omission in the order? We know that learning from reported errors is anticipated, but there is no formal requirement in the order to deliver on that. It is reliant on good will. I am sure that many pharmacists and pharmacy dispensary technicians will want to take it upon themselves to improve their existing protocols so that errors cannot reoccur, but there is no formal requirement in the order for them to so do.

I am pleased to learn that hospital pharmacies, which are not included in this but should be, because there are many such pharmacies, will be included in due course. We support that very much.

As acknowledged in the Department of Health consultation report, the risk of prosecution under Section 269 of the Human Medicines Regulations 2012 for inadvertent labelling errors still remains for pharmacy businesses. In fact, since a pharmacy business cannot be put in jail, it seems that the risk is to pharmacy owners, who may also be pharmacists.

Finally, the Department of Health has projected a 100% increase in error reporting and a 30% reduction in errors. On what basis has it arrived at those conclusions?

My Lords, as someone who has followed pharmacy policy for many years, I have a strong sense of déjà vu. However, that is for all the right reasons because I can assure the Minister that I heartily approve of the order before us. It was only six years ago that I and the noble Baroness, Lady Jolly, put forward an amendment in reasonably similar terms, specifically on 19 December 2011. The favourite Bill of the noble Baroness, Lady Thornton, the Health and Social Care Bill, was under discussion. The noble Earl, Lord Howe, for whom we all have huge respect, said:

“I also wish to reiterate our commitment to bring forward a suitable legislative change at the earliest possible opportunity. I hope that with those assurances, my noble friend will feel able to withdraw his amendment”.—[Official Report, 19/12/11; col. 1559.]

I am not sure whether that was the first or the last time that I have heard those words from a Minister, but six years does seem to be a fairly long time even in politics. I wonder whether it does not reflect a little the way that the wheels of government can turn slowly. Also, although I am afraid that this is the rather downbeat aspect, I do not think that community pharmacy in particular, of which I am a great proponent, is really central to government thinking in the way it should be. It is very much the unsung hero of the health service and we should be making much greater use of it.

I have to refer back to the original debate. One of the objections to the amendment at the time was the fact that Northern Ireland was not properly included in it. Northern Ireland is now included, but of course the arrangements are slightly different because only registered pharmacists will be subject to this order. I am not sure in my own mind whether that means that only registered pharmacists can make use of these defences or whether they are free and clear of the duties entirely. I hope that the Minister can give some clarity on that aspect.

Another aspect I am very interested in is one on which the noble Baroness made a strong point, as did her honourable friend Julie Cooper in the Commons, who I believe is married to a pharmacist so probably feels pretty strongly about these things. As I read the order, the Government have chosen not to change the offence; rather, they have opted to change the defence. That still means, therefore, that the criminal offences are all there. That really illustrates the point made by the noble Baroness, Lady Thornton. It seems to keep a sword hanging over the pharmacist in an unhelpful way.

The Minister mentioned hospital pharmacists. Can she put a date on which they might be brought in, because time passes? It is only six years since we last talked about this issue. However, I was heartened to hear what she had to say about the culture of learning, because that was the motive behind the original amendment. It is absolutely what the Royal Pharmaceutical Society is seeking. I pay huge tribute to the society because it has been extremely patient about this matter. I shall read Hansard with considerable interest.

In closing, of course today is not the time for a full debate on the future of pharmacy. There are a great many aspects to it, including the Murray report and various other related developments, but I hope that the Government will start to grasp much more effectively the opportunity to make the best use of the real and valuable resource that is represented by community pharmacy. It is a gap in our health policy and I hope that the Government will take it forward.

My Lords, I shall be brief in my support of this statutory instrument. I too had a feeling of déjà vu when preparing for this debate. I looked up the debate and sure enough, it was on 19 December 2011 that I spoke, as did my noble friend and the noble Baroness, Lady Thornton, and as indeed did the noble Baroness, Lady Finlay, who is currently our Deputy Chairman of Committees. The only person we are missing is the noble Lord, Lord Patel.

Indeed, yes.

My noble friend Lord Clement-Jones has given the Committee the detail. I, too, champion local community pharmacies and pharmacists. This SI covers some of the content of his original amendment and will have a considerable impact on the profession. We are all human; we make mistakes. In the previous debate, I outlined a mistake which happened within my own circle at home and caused a large high-street pharmacy to change the way in which it dispensed and stored medicines. The measure will have an impact in that some pharmacists and pharmacy assistants will feel more confident in owning up to making mistakes. We are encouraging people within the health and social care service to do this because we will then learn and share good practice. It is good legislation: mistakes are confessed to and rectified, and lessons are learned.

We heard from the Minister at the outset of this debate that more legislation will be coming down the track to look at other things. When that legislation comes before us for debate, I hope that all the areas that have been exposed today as being in need of tidying will be tidied up.

I hate it when notes come over one’s right shoulder just as one is about to stand up, because one never has time to read them.

I thank all noble Lords for their points. The noble Baronesses, Lady Thornton and Lady Jolly, and the noble Lord, Lord Clement-Jones, all said that the measure was a long time coming. I certainly agree; six years is clearly far too long. I say in mitigation that we were hoping to bring it forward in 2015, but several things happened which I am sure noble Lords will remember: an election, followed in 2016 by a referendum, which rather held things up. Even so, 2009 to 2015 was quite a long time, but we must welcome it now.

The noble Baroness, Lady Thornton, referred to there being no formal requirement to report. We want to encourage pharmacists to feel that they can come forward and report. We do not want to put strong legislation in place for that; we want there to be a feeling of openness, that they can come forward without feeling that that they are likely to be prosecuted. With the champions and the guidance in place, that should happen, and they should get used to this just being part of what they do without fear of further prosecution.

The noble Baroness, Lady Thornton, mentioned pharmacy owners. We want pharmacy owners to have systems in place whereby anyone who discovers an error makes sure that the patient is notified. If this needs doing, the legislation deliberately incentivises candour on the part of all responsible people at the pharmacy. The noble Baroness asked also whether there should be a mandate for reporting errors. As I said earlier, the defences have been drafted to incentivise the reporting of errors not just by the error maker; in addition, all pharmacy professionals are already subject to professional standards set out by the pharmacy regulators, the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland. These standards include duty of candour, which includes an obligation to be open and honest.

The noble Lord, Lord Clement-Jones, mentioned pharmacy technicians in Northern Ireland. They are not registered in Northern Ireland as they are here, so they cannot come under these defences. The criminal offences are still there, so this measure makes the right balance. If there is gross negligence or serious errors are made, there is still legislation in place whereby pharmacists can be prosecuted.

I do not have the date for this to go forward for care and hospital settings, but come this summer they will be starting to look into how to bring that forward. It will be interesting to learn how this works in the pharmacy setting and then to bring that forward. We are keen that that happens.

I certainly hear what the noble Lord, Lord Clement-Jones, said about appreciating pharmacies. We do indeed, and we realise what a very important role they have to play not only for supplying medicines but for giving advice. The noble Baroness, Lady Jolly, mentioned one of the errors we hope will be picked up in the new form—coloured boxes. I remember so well as a nurse the danger if you have different medicines in the same coloured boxes when you grab them quickly. Luckily you always had two people checking the medicines in nursing so errors rarely occurred, but that is exactly what we hope this will pick up.

I hope I have answered all the questions raised, in which case I finish by saying that we feel the order will add further impetus to the work already under way to reduce medical errors across the health service and provide much-needed assurance that pharmacy professionals can discuss inadvertent dispensing errors without fear of prosecution. It is important that the pharmacy professions build on this, help to underpin a learning culture that puts the patient first, and ensure that patients receive excellent care and service from registered pharmacies.

Motion agreed.