Draft Pharmacy (Preparation and Dispensing Errors - Registered Pharmacies) Order 2018

Julie Cooper Excerpts

Monday 4th December 2017 General Committees

[Julie Cooper (Burnley) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Brady, and to respond on behalf of the Opposition to the important order in front of us.

As the wife of a retired community pharmacist—I have no interest that I am obliged to declare—I have to say that 24 years’ experience of owning and running a community pharmacy has given me an in-depth understanding of the sector and the challenges that community pharmacists and their staff face every day. As the Minister mentioned, more than 1 billion prescription items are dispensed every year—the vast majority from community pharmacies—and the trend is that prescription numbers will increase each year, reflecting the general increase in demand in the national health service and the ageing population. An average community pharmacy dispenses between 300 and 500 prescriptions a day.

It is important to consider that that volume of work is only one part of the role performed by community pharmacists. They are an integral part of the primary care team and make a huge contribution, including giving advice on a range of health and wellbeing issues; providing support for public health initiatives, such as those employed to reduce smoking, drug abuse and obesity; medication use reviews; diagnostic testing; diabetic and asthmatic care; and minor ailment schemes. The list is endless.

In that context, genuine errors will happen occasionally. As the Minister mentioned, it is a credit to the profession that those are very few and far between, but it remains a fact that pharmacy professionals are one of the few health professional groups to face criminal conviction and potential imprisonment, for an inadvertent dispensing error—that is, where there is a discrepancy between the prescription and the medication supplied to the patient. The prosecution of pharmacists and dispensing technicians is very rare, but it does occur, so pharmacy professionals always have that fear hanging over them.

The principal beneficiaries of the order will be professional community pharmacists and registered dispensing technicians practising in registered premises—and, of course, patients. The draft order, which will amend the Medicines Act 1968, will be welcomed by community pharmacists, technicians and their professional bodies. I am aware that the National Pharmacy Association, the Pharmaceutical Services Negotiating Committee, the Royal Pharmaceutical Society and patient groups support the proposed changes; I am sure they agree that they are long overdue.

Most products are prepared outside registered premises and arrive ready to be dispensed. Errors in such cases may take the form of selecting the wrong product or providing incorrect dosage instructions. However, there are still many instances in which pharmacy staff members are required to prepare medications on site, in which case errors may take the form of miscalculation of required quantities, addition or subtraction of necessary ingredients or incorrect instructions for use. The order will introduce a new defence against criminal liability that will apply to both preparation and dispensary errors and will be open to pharmacy professionals who can prove that the error occurred when they were acting in the course of their profession.

Such a defence really is overdue. In 2009, the chairman of the Pharmacists’ Defence Association warned:

“Inappropriate use of the criminal sanction will lead to defensive practice…less innovation”.

During the passage of the Health and Social Care Bill in 2011, Earl Howe said that the legislation needed to be reviewed so that criminal liability did not arise as a result of genuine dispensing errors.

Ensuring the right to legal defence against prosecution in cases relating to an inadvertent error will undoubtedly remove some of the fear burden and lead to a greater willingness to admit errors. It will also assist in promoting a culture of transparency that will help to inform future learning and improve protocols for the dispensing and preparation of medicines. The better practice learned will result in fewer errors and improved patient safety and is therefore eminently desirable.

The order will offer protection to pharmacists and dispensing technicians, but its main purpose is quite rightly 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 new duty of candour has the potential to lead to a major cultural change.

Pharmacy professionals who show deliberate disregard for patient safety will not benefit from any of the defences in the order. Where they are found to be wilfully negligent or intent on causing deliberate harm, they will continue to face criminal prosecution. 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 registered premises involved in the medicine supply chain.

The Opposition welcome the order and believe firmly that it is a step in the right direction, but it does not go far enough. 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 they 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. I welcome his comment that the situation for pharmacy professionals not covered by the order will be consulted on early next year; I ask that it be looked at as early as possible, because pharmacists in hospitals need these defences.

There is an 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 upon 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.

As we all want to prioritise patient safety and wellbeing, I hope the Minister will undertake further work to positively promote patient safety within the pharmacy setting. One really useful suggestion I would like to make is to allow pharmacies full read and write access to patient records. All health professionals involved in the care of a patient surely need access to the fullest information, without the danger of knowledge gaps or incorrect information regarding past medications. That would aid continuity of care and contribute to safer patient outcomes.

There is so much more to do, but we welcome the order as a starting point and look forward to the Minister bringing forward further improvements.

--- Later in debate ---

[Steve Brine]

I thank my shadow, the hon. Member for Burnley, and the hon. Members for Central Ayrshire and for Newport West for their contributions and their support for this measure.

I am well aware that the hon. Member for Burnley has in-depth understanding and knowledge of this issue from her previous life supporting her partner, a community pharmacist. She is absolutely right to highlight the wide portfolio that community pharmacists hold. I sometimes think it is even wider than mine, and I have said in the House, and will say again now, that community pharmacists are absolutely central to me and to the primary care objectives that I hold in this job for primary care and for the public health and prevention agenda. Primary care and public health are pulled together under my portfolio for a reason, and community pharmacists sit together as a hub in the middle of those two bits of my work.

The hon. Lady is absolutely right to say that the order will be welcomed—I think alongside the hashtag #abouttime. For many people in the community pharmacy sector, the changes are long overdue. I spoke to the Royal Pharmaceutical Society’s conference in the summer—I suspect she was there—and I said that this was long overdue and that I would sort it. I have tried to remain true to my word, and I have.

I think the defences in the order strike the right balance, which the hon. Lady outlined coherently, while not leaving the door wide open. We still have to make sure that patient safety is protected—the current Secretary of State above all would say that—but I do believe that it strikes the right balance. I note her request for early work in respect of hospital pharmacists, and I am very amenable to that. I do not want that to drag on for many years; I want it sorted quickly, and officials know that.

On read and write access to patient records, many pharmacists already have read access and some already have write access. I am interested in making the change, and I am exploring more with officials how to make it happen; it is of some frustration to me that it seems to be an IT issue as much as anything else. If pharmacists are to be integrated within our primary care system as much as I want them to be, I suggest that that is very important.

[Julie Cooper]

This all centres on acknowledging that pharmacists are the experts when it comes to medication. I think that most GPs who work alongside pharmacists day in, day out will hold their hands up and say that. GPs used to be regularly on the phones to us saying, “Can I just ask you about this? I am thinking of prescribing this, but I am not sure. Is this best, or would it be better with something else?” That is good teamwork between people who are specialists in their areas.

In the light of that, it is quite ridiculous that pharmacies cannot record their advice and intervention on a patient record for other health professionals to see. It would be entirely in the patient interest, and in the interests of making sure that patients do not fall through the gaps between the different health professionals.

I will make one further point about recognising that expertise, if you will allow me to, Mr Brady. Pharmacists could be used to do more, as I have said many times in the House. When he talked about protections, my hon. Friend the Member for Newport West reminded me of the work that is happening on antibiotics and a recent Westminster Hall debate on their overuse and the development of antimicrobial resistance. Pharmacists could lead on that in the interests of wider patient wellbeing and safety.

[Steve Brine]

The hon. Lady is absolutely right. Pharmacists have been absolutely brilliant, focused and motivated supporters of the “Keep Antibiotics Working” campaign. I responded to that Westminster Hall debate on antibiotics, as she knows.

On the hon. Lady’s wider point, I believe, and I believe the evidence backs me up, that in the best health economies, the three planks—secondary care, primary care and pre-primary care, which is where we could see a community pharmacy as being—work hand in hand. The sustainability and transformation partnerships are supposed to be a one-NHS solution for different areas and different health economies to help the population achieve good health when they become unwell, but also to practise good preventive health. I absolutely agree with her that pharmacists know their patients and customers, and that they spot things because they see those patients much more regularly than GPs do. That is why they are absolutely central.

On the point about the obligation to report, which was mentioned by the hon. Members for Central Ayrshire and for Burnley, I said in my opening speech that the Government are already working with the regulators and professional bodies to ensure that pharmacy professionals are supported in the implementation of the order. An absolutely critical part of that is making sure that they report errors, because if they do not, this will all be somewhat wasted. There are a huge number of examples that I could give; maybe I can write to the hon. Member for Burnley with the details. The national reporting and learning systems were established in England to collect data and report on safety incidents. The health service safety investigations Bill, which is in draft and undergoing pre-legislative scrutiny at the moment, also adds power to this argument.

I think that, with this order, we have something of a rare gem in Committee Room 9: it is something that we all agree is needed. We are delivering it as a Government, as I promised we would. It will add further impetus to the work already under way to reduce medical errors across the health service and will provide much-needed assurance to pharmacy professionals that they can do their job with confidence. I know they have that confidence, but there has been this little niggling thing undermining them. I hope the order addresses that.

As the Whip next to me coughs—I am sure that was purely accidental, as opposed to a hint—I will finish by saying that, should both Houses approve the order, commencement orders will be drafted to enact the changes in England, Scotland, Wales and Northern Ireland. I thank hon. Members for their attentiveness, their interest and their contributions, and I commend the draft order to the Committee.

Question put and agreed to.