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

Lord Clement-Jones Excerpts

Wednesday 6th December 2017 Grand Committee

[Baroness Thornton (Lab)]

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?

[Lord Clement-Jones (LD)]

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.

[Baroness Jolly (LD)]

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.

[Lord Clement-Jones]

And the noble Earl, Lord Howe.

[Baroness Jolly]

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.