Draft Pharmacy (Preparation and Dispensing Errors - Registered Pharmacies) Order 2018
(Limited Text - Ministerial Extracts only)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
I beg to move,
That the Committee has considered the draft Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018.
I do not believe we have danced before, Mr Brady, so it is very much a pleasure to serve under your chairmanship. The order was laid before Parliament on 13 November and extends to the whole of the United Kingdom. Its purpose 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 those 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. Let me make it clear that the order does not cover pharmacy professionals working in non-registered hospital pharmacies. That will be addressed in a separate order that we intend to consult on early next year.
The Mid Staffordshire inquiry highlighted the importance of putting patient safety at the heart of everything we do and achieving a careful balance between assuring accountability to the patient and developing a culture of openness and transparency, so that we learn from errors and improve practice and safety. Indeed, Professor Don 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 very much follows that philosophy.
Pharmacy professionals are highly regulated individuals —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. That can lead, we believe, to defensive practices. It has been demonstrated in other industries where safety is critical that working under such threat of sanction is a hindrance to the reporting of errors and accidents and therefore to wider learning.
Evidence suggests that patient safety and service quality can be improved through increasing the rate of reporting and learning from dispensing errors. That will have benefits to patients locally and throughout the NHS. By removing the fear factor of a strict liability offence for inadvertent dispensing errors, our aim is to create a much more open and transparent culture, which in turn should help to improve learning and prevent mistakes from happening in the first place. We will be working closely with pharmacy regulatory and professional bodies across the UK to make that a reality.
Let me be clear that registered pharmacies already have a range of systems and procedures in place to prevent dispensing errors from occurring. More than 1 billion prescription items are dispensed every year, and it is a testament to the professionalism of pharmacy staff that errors occur in only a very small proportion of cases. Dispensing errors can, however, occur within a registered pharmacy for a variety of reasons. For example, there are many thousands of medicines, and some have very similar names and brandings. Medications may also have complicated dosing schedules.
The order is not about accepting the inevitability of error in the system. It seeks to ensure that we collect information on errors that do occur and think hard about how they can be prevented in the future, including through spotting trends at a national level. That may involve improving systems and procedures and designing out errors as far as is practicable, but without knowledge of what has gone wrong that is just not possible.
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, as I have said. 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: it was overwhelmingly endorsed during the public consultation, including by patients, the public and groups such as Action against Medical Accidents, who will now want to see pharmacy professionals play their part and demonstrate increased learning from, and reporting of, errors. The order has also been some five years in gestation, so I am pleased to attempt to land it today through the Committee. I am fully committed to ensuring that that happens, and we have already taken action in that regard.
In each of the four home nations, a number of initiatives to support reporting and learning have been introduced, such as 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 those 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 their healthcare systems. It is a sobering fact that 5% to 8% of all hospital admissions are medication-related. In 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 how we use technology, understanding how best to engage patients in their medicines and advancing the transfer of information between care settings.
As I mentioned at the start, while the order provides a defence for pharmacy professionals working in registered pharmacies, it is important to recognise that pharmacy services can occur outside of those settings, and therefore that not all pharmacy professionals will be able to avail themselves of the defences set out in the order. That is deliberate. Work is progressing to develop similar measures for pharmacy professionals working in hospitals and other care settings. That will ensure that, regardless of their position in the healthcare system, pharmacy professionals will be encouraged to report and learn from errors.
In summary, the order supports improved patient safety by encouraging a culture of candid and full contributions from those involved when things go wrong. Within that culture, pharmacy professionals—I have to say, they are some of the most motivated and professional people I have met in our national health service during my time as an MP and a Minister—can increase their learning from dispensing errors and identify mitigating actions to make reoccurrence much less likely. I commend the order to the Committee.
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.