Question for Short Debate (Lords) on Healthcare: Controlled Drugs - Sep 14

Asked by

Lord Butler of Brockwell

To ask His Majesty’s Government, further to the Written Answer by Lord Sharpe of Epsom on 24 July (HL9391), when they plan to introduce legislation to enable prescribing of controlled drugs by paramedic independent prescribers, as well as other changes to the use of controlled drugs in healthcare.

Lord Butler of Brockwell (CB)

My Lords, I want to thank the noble Lord, Lord Sharpe, for having raced from business in the Chamber in order to answer this short debate.

I start by saying that I need to declare no personal interest in the subject of the debate—my only interest is to try to do the world a bit of good. I should also declare that I have no difference of policy with the Government. The issue is this: the Government have said that, following the approval of the Advisory Council on the Misuse of Drugs, they will extend the list of drugs which paramedic independent prescribers and therapeutic radiographer equivalents may prescribe and administer to patients. These drugs include morphine, morphine sulphate and four other drugs.

This process has taken a considerable time. The advisory council submitted its approval in relation to paramedics in 2019—four years ago—and in relation to radiographers in 2020, three years ago. More than two years later, on 30 September 2022—nearly a year ago—the Minister of State in the Home Office wrote to the secretary of the advisory council and said that he had asked Home Office officials to commence the process for making these regulatory changes.

My purpose today is to ask the Minister to give us a date by which this will be done. I put two Written Questions to the Home Office, which the noble Lord, Lord Sharpe, has courteously answered. He has confirmed that the changes are capable of being made by statutory instrument, which the Government will bring forward

“as soon as possible, but this will remain subject to Parliamentary procedure”.

What is this parliamentary procedure? I am advised that it is a statutory instrument under the negative procedure, which means that the instrument comes into law without any parliamentary procedure unless someone dissents, which in this case is effectively unthinkable. So, the statutory instrument simply has to be drafted and laid.

The delay does not seem to be parliamentary procedure but the Home Office’s order of priorities. We know that Home Office lawyers have been very busy, but it is very difficult to understand why they have not been able to find time for this very simple instrument. I understand that the Advisory Council on the Misuse of Drugs approved the wording as long ago as 2019—four years ago. Home Office lawyers could simply take it out of their drawer. Equivalent amendments were required with respect to physiotherapists and podiatrists when these groups were given prescribing rights 10 years ago. They were made by the Home Office in a little over 18 months. Today, by comparison, paramedic independent prescribers have been waiting over five years for the necessary amendments to be made, and therapeutic radiographers have been held in limbo since April 2016—over seven years.

I said at the outset that I had no personal interest to declare, but that is not quite true. We all have a personal interest in this issue. I could describe to your Lordships a case study in which, in the absence of the changes we are discussing today, an advanced paramedic practitioner could not prescribe oral morphine to deal with an acute onset of pain without the patient having to have a further appointment with a GP, prescribing nurse or pharmacist. Following this statutory instrument, that paramedic would be able to prescribe oral morphine for the continuing treatment of pain. If I may make this personal, I do not welcome the prospect some time in the future of unnecessarily lying in acute pain which could be relieved by this simple statutory instrument. Nor do I want others to have to do so.

The statutory instrument offers a double whammy. It will both remove some unnecessary pressure on general practitioners, which the Government and all of us must surely welcome, and make available more immediate treatment for patients. If the Department of Health were responsible for this statutory instrument, I wonder whether it would have been made with more dispatch.

I am too long in the tooth to be fobbed off by statements saying that the Government will make the statutory instrument

“as soon as possible, but this will remain subject to Parliamentary procedure”.

I repeat that it is simple for the Home Office to make and lay this statutory instrument. It effectively requires no parliamentary procedure whatever. I hope the Minister will be able to clearly answer my question and say that the statutory instrument will be made forthwith, I hope by the end of the current Session.

1.06pm
Lord Patel (CB)

My Lords, it is a pleasure to follow the noble Lord, Lord Butler of Brockwell. I thank him for initiating this important debate. Like him, I hope it will result in the Government bringing in much-needed legislation to allow advanced paramedic practitioners to prescribe some of the controlled drugs in Schedules 2 to 5. I will speak briefly in support of the noble Lord. I may repeat some of what he said, but do not apologise for doing so because it is worth emphasising.

I thank the College of Paramedics and the House of Lords Library for their detailed, informative briefing on allowing paramedics to prescribe controlled medicines. I recognise the need to look at expanding prescribing by other health professionals, such as radiographers, as have been mentioned, and widening the list of drugs that can be prescribed by them. However, I shall confine my comments today to paramedics.

There is a misconception that highly trained, efficient paramedics work only in ambulances and are not allowed to prescribe and administer medicines, including some controlled drugs. Paramedics are now deployed in a whole range of healthcare settings, from emergency departments to GP practices, out-of-hours services and general and specialised wards. Some 25% of paramedics now work in wider healthcare settings. They are a versatile, experienced and valuable part of the healthcare system. There are more than 1,500 advanced paramedic practitioners, and the workforce plan recently published by the Government has the ambition to expand this workforce considerably in future.

Once qualified as an independent prescriber, a paramedic can prescribe any drugs, except controlled drugs such as morphine sulphate, as has been mentioned, Diazepam, Midazolam and codeine phosphate. Qualified paramedics can and do work independently in making the correct diagnosis. If the treatment involves giving controlled medicines, she or he has to seek assistance from another prescribing healthcare professional. This results in delay in care, disturbs the work of both professionals and increases the risk to patient safety.

I will give some real examples—the noble Lord, Lord Butler of Brockwell, already gave one such. A young man, having fallen off his bike, is brought to the emergency department by ambulance. He is in considerable pain and, after initial tests, the advanced paramedic practitioner makes a correct diagnosis of a closed tibia and fibula fracture. The advanced practitioner knows what he has to do next but is unable to prescribe morphine to alleviate the pain and has to seek assistance, disturbing the work of other clinicians, who have to leave the patient they may have been looking after to help the paramedic. This delays treatment and creates possible patient safety issues.

Another such example is a young woman, a known epileptic, who is brought by ambulance having had seizures at home. The practitioner is unable to prescribe prescribed drugs such as intravenous lorazepam to control the young woman’s epileptic seizures.

Another example is a young man with a shoulder injury who is brought in by ambulance. The paramedic makes a correct diagnosis of a dislocated shoulder and is competent to treat the patient. However, before she or he can perform the manipulation of the shoulder, they must seek the advice and assistance of another health professional to administer a mild anaesthetic such as midazolam. Being unable to prescribe and having to seek assistance means that the treatment is delayed and the young man remains in pain; this risks the dislocation causing more shoulder damage, with possible long-term effects.

Legislation, possibly introduced as a statutory instrument, as already mentioned, is urgently needed to allow highly trained, experienced advanced paramedics to prescribe some controlled medicines. Such legislation is a long time in coming. The concept of paramedics prescribing was consulted on in 2015. As the noble Lord, Lord Butler, mentioned, in 2018 legislation to approve the concept was accepted. In October 2019, the Advisory Council on the Misuse of Drugs approved the list of drugs that advanced paramedics could prescribe, which was also approved by the MHRA. Apparently, a letter was sent to the Home Office in 2019, so we have been waiting since then for the Home Office to approve and bring in the legislation.

I know that the noble Lord, Lord Sharpe of Epsom, is sympathetic to the proposals from the correspondence I have seen which others have had with him. I hope he will surprise us when he responds by telling us when the legislation will be brought forward—I hope before 7 November or soon after. Whenever it is, I cannot imagine that Parliament will do anything other than promptly approve it.

Once paramedics are able to prescribe some of the medicines in the controlled list of drugs, patients will benefit from prompt treatment, and it will free up the time of other clinicians and improve patient safety. If there is no action from the Home Office, I hope that the noble Lord, Lord Butler of Brockwell, will continue to badger the Government on a regular basis. He will have my support.

1.13pm
The Earl of Sandwich (CB)

My Lords, I too support my noble friend, and I am grateful to him for this chance to address a related subject of great concern: the highly damaging effects of the use of certain drugs prescribed in good faith. Older colleagues may recall that some years ago a member of my family had a bitter experience with benzodiazepine and sudden withdrawal from it at her doctor’s request. I introduced various debates and asked various questions at that time. I therefore declare my interest as a founder member of the Prescribed Drug Dependence—PDD—All-Party Parliamentary Group, which is soon to be renamed the “Beyond Pills” APPG. Most of the intellectual backup for the all-party group comes from the Council for Evidence-based Psychiatry, or CEP UK, which has found that the prescription of antidepressants and other drugs is still increasing rapidly year by year.

The Pharmaceutical Journal reported in July that the number of antidepressants prescribed in England rose by 5.1% in 2021-22, compared with the previous year, which was the sixth annual increase in a row. Over the same period, the number of antidepressant items prescribed increased by 34.8%, rising to 83.4 million items in 2021-22. According to Public Health England, as many as one in four adults in England over 18 are being prescribed benzos, Z-drugs, opioids or some form of antidepressant.

In 2019, following a lot of pressure from the APPG, Public Health England published a comprehensive evidence review of dependence-forming drugs. This showed that 26% of the adult population in England was prescribed a dependence-forming drug in the previous year. In its earlier review of data, PHE found that more people were being prescribed medicines inappropriately, and often for longer than good practice guidance recommended.

A recent BBC “Panorama” programme, I think in June, showed that there are still almost no NHS services to support patients who have been harmed by taking drugs as prescribed by their doctor. The programme detailed how patients experiencing severe and prolonged withdrawal symptoms have resorted to online peer groups for validation, support and safe drug tapering advice. My noble friend knows the inner processes of government from over many years, and he will have a lot more patience than me with the inability of officials to act on agreed principles. We have heard his frustration, and we can all easily sympathise with it. When it comes to helping those suffering from withdrawal, at least two promised policies involving a helpline and the support of the voluntary sector have been, if not shelved, then placed firmly on the shelf.

In response to the 2019 PHE review, NHS England published its framework for action, Optimising personalised care for adults prescribed medicines associated with dependence or withdrawal symptoms. This was published in March and was intended to encourage integrated care boards to develop services. While that has been widely welcomed as a further positive step by government, a recent FOI revealed that only 6% of the ICBs are considering taking any action on the framework. The same PHE review also recommended that a national helpline to support people going through intense withdrawal from prescribed drugs should be set up in partnership with those with relevant experience—in other words, something very practical. At a time when issues of patient safety are very much in the public mind, it is disappointing that the DHSC has recently confirmed that it cannot find the £2 million necessary to set up this lifeline, which is urgently needed until local services start to become available.

There are a number of small voluntary organisations scattered across the country—in Camden, north Wales, Bristol, for instance—providing a vital service to patients. But their relations with the NHS are tenuous. As the BBC reported again this morning, many are so frail that without funding, some, such as the Bristol Tranquilliser Project, have ceased or are ceasing to operate. In another survey of 500 patients, 92% said that they were not told about withdrawal effects when they were first prescribed antidepressants. This seems unimaginable. Surely, this is a service much too valuable to public health to be allowed to collapse. I have seen the rather negative letter from the DHSC, dated 3 August. This was a key recommendation of the review. When will it be reconsidered?

On the specific Question and paramedics, I draw attention to the NICE guidelines concerning safe prescribing and withdrawal management for medicines associated with dependence. Will paramedics who are able to prescribe be required to comply with guideline NG215, entitled Medicines Associated with Dependence or Withdrawal Symptoms: Safe Prescribing and Withdrawal Management for Adults? The practicalities associated with following such guidelines in an emergency situation, such as my noble friend described, need to be assessed and specific provision made for informed consent and follow-up by a GP to put in place NICE’s recommended management plan for such drugs.

Secondly, patients who have had difficulty withdrawing from dependence-forming medications frequently choose not to take such drugs in future. Would the Minister agree that paramedics need to take account of that? They must be able to check records for any history of discontinuation or protracted withdrawal syndrome, or advanced decisions made about the future administration of those medicines.

Following the PHE review, the all-party group is aware of efforts by NHSE to create an internal information hub on drugs associated with dependence, agreed in principle to be held on the NHS Specialist Pharmacy Service website. Can the Minister also confirm that paramedics will be signposted to this information in the event of any questions?

As I said, I warmly congratulate my noble friend. He has made a point and created a scene of what might happen to any of us. I hope the Minister will give him a really solid reply.

1.22pm
Lord Allan of Hallam (LD)

My Lords, we are grateful to the noble Lord, Lord Butler of Brockwell, for pressing this issue for some time now, not just in this debate but in previous Questions, because it is frustrating when a policy decision has been taken that will bring benefits to people but its implementation is held up for months or even years for want of a technical change to regulation. It seems entirely misplaced that we have an important policy decision yet, as the noble Lord described very accurately, something quite trivial—drafting an instrument and getting it before us—is holding up that change.

It might be helpful to put this change into the wider health context to understand the weight of that frustration and why it is ringing alarm bells. This specific change to prescribing paramedics is in a context of changes to prescribing rules more generally. There is a recognition among policymakers of all parties and none, and among the health and care professional community, that there is a need for innovation in working practices, especially those practices around prescribing. That is essential if we are to meet the demand for health services, even if we keep putting more resources in. Resources on their own will not provide the answer; it is the kind of innovation where we use a broader group of healthcare and allied professionals to deliver services that will enable us to meet that growing demand. Prescribing is one of the key areas where innovation is happening and cost-benefit analyses are being constructed for potential changes to the prescribing model.

On the benefits side, these accrue to individual patients, who can have easier access to the drugs they need. The noble Lord, Lord Patel, elegantly set out the kind of situations in which an individual patient would certainly benefit from the change being considered—the paramedic being able to prescribe controlled drugs. However, we all will indirectly benefit if healthcare professionals can work in the most efficient way and professional A does not have to ask professional B to take time out to prescribe the drug that professional A could have prescribed themselves. The whole system benefits with that increased efficiency, as well as the individual who is immediately at risk.

There are of course some potential risks to individuals and society from any of these changes. Again, the noble Earl, Lord Sandwich, set out for us the kind of problems that can occur if drugs are prescribed inappropriately. We need to bear that in mind and that is why, with any of these changes, the analysis should look at those risks and the things that need to be put in place to manage and mitigate them. That is precisely what has happened here, with the report we had as far back as 2019 from the Advisory Council on the Misuse of Drugs, and other work that has taken place. People have looked at the benefits and risks of the change and concluded that the benefits significantly outweigh the risks, and therefore that we should proceed. That process has happened as it should, by looking at things within the full context. Now all we need is that enabling regulation.

I hope the Minister is going to explain to us today, first, why it has taken so long and why we are forced, in a sense, to bring him here to answer rather than it having just appeared on the Order Paper at an earlier date; and, secondly, whether he can point to a resolution in the near future. The noble Lord, Lord Butler of Brockwell, used the word “forthwith”, which was a novel take on this. I have heard that things will happen in due course or shortly. These are all terms of art, rather than precise dates, in government-speak. Forthwith is one that I like, as it conveys even more of a sense of urgency, but the noble Lord was right that better than any of these formulations would be a date. Having “12 October” is better than “shortly” or “soon” or any such formulation. I hope the Minister will be able to offer us a date.

I would also like to raise with the Minister a specific question, which I hope he can touch on in his remarks. Have the Government given any consideration to the impact on healthcare professionals of making nitrous oxide a class C controlled substance, which the Government are doing through a statutory instrument that I think will come before us next Tuesday? Again, it is interesting to note that the Government managed to produce that instrument in double-quick time, even though it goes against the advice of the Advisory Council on the Misuse of Drugs, while here we have one which is aligned with that council’s advice but has taken much longer. The noble Lord, Lord Butler of Brockwell, may have put his finger on it when he said that if this regulation was owned by DHSC it would have proceeded much faster, because if the change in regulating controlled substances is one the Home Office wants for its own policy agenda, it seems to be able to do that much more quickly than if it is being asked to assist the Department of Health. That is a shame, in what is supposed to be an era of joined- up government.

I have looked at the Explanatory Memorandum for the instrument that will be debated next week. It says that the impact for the public sector of this classification relates only to law enforcement and criminal justice, with no effect on anyone else. I hope that is true and that the Government have done all the work needed to ensure that healthcare professionals and those in allied professions who use nitrous oxide quite widely will not experience any change to their practices, or their ability to use nitrous oxide, post the reclassification. However, the fact that we are debating this today around other class C controlled substances, such as diazepam, suggests to me that there is some complexity. When I read some of the background notes, I understood that there are NICE guidelines and specific exemptions, so it is a very complex world where health service regulation and Home Office regulation come together.

As I say, I hope that the Home Office has done its homework and that when we classify nitrous oxide as a class C controlled substance, the Minister will be able to assure us that no health professional or allied professional needs to worry about that and that there will be no negative implications. If not, and if changes will be required pursuant to that reclassification, I hope he can indicate that those are in hand and nitrous oxide will not suddenly fall into this area, with some professionals being unable to prescribe it as and when they need to, as with the other substances we are talking about. I hope the Minister will have answers to this, as well as that crucial answer of a date when the changes that were already agreed so long ago might come into force.

1.29pm
Baroness Merron (Lab)

My Lords, I too would like to thank the noble Lord, Lord Butler of Brockwell, for giving us the opportunity to air what we should not have to air, which is the need for the legislation for this important change. I would also like to pay tribute to his elegant tenacity on the subject, which is important in improving the provision of health care. The Government are failing to do that because they have not brought forward the necessary legislation. The noble Lord also set out clearly the background to what is a very long and winding road over many years which brings us to a position I am sure the Minister would rather not be in. It is a somewhat uncomfortable position, because it is so obvious that this should be done; all the agreements and approvals are in place, and yet we wait.

I am glad that the Minister has confirmed on a number of occasions that legislation will be brought forward as soon as possible and that this could be dealt with by statutory instrument. When it does come before us again, I hope that what the noble Earl, Lord Sandwich, said about the need to confirm that full consideration has been given to patient safety will be taken into account. The noble Earl helpfully flagged up a number of points, which I would regard as advanced warning to the Minister.

I agree with the point made by the noble Lord, Lord Butler of Brockwell, emphasised by the noble Lord, Lord Allan, that if this matter was sitting with the Department of Health and Social Care it would have been dealt with—I feel sure of that. The Minister shakes his head, and I am sure we will have an explanation later as to why that is not the case, but that is the feeling in the room, and for good reason. As the noble Lord, Lord Patel, explained, paramedics do not just work in ambulances, and what they need is the tools to do the job that is before them.

NHS England also states that advanced paramedics who have undergone additional master’s level training are increasingly taking on roles in varied critical settings. As the noble Lord said, these include GP practices, minor injuries units, urgent care centres and A&E, and they are prescribing in such settings. This aligns with the NHS long-term plan’s emphasis on multi-disciplinary care, which includes the aim to relieve pressure in accident and emergency units and to provide immediate care for people wherever they are. To have this change in legislation would be a considerable contribution to that.

Why do we need to go down this road? It is worth reiterating some of the points that have been made. I too was grateful to the Lords Library for the briefing it provided and was interested to read the 2021 study in the British Paramedic Journal. It reported that paramedics who participated in this study, and who had

“longer experience in primary care, out-of-hours or house calls or with an extended remit to provide end-of-life or palliative care”,

described not being able to prescribe controlled drugs as a “limitation”. I am sure that the Minister, who is a Home Office Minister, has heard many debates in the Chamber in which his ministerial colleague in the Department of Health and Social Care was pressed on why we cannot see change to existing staff practices in order to provide better healthcare. Indeed, the NHS workforce plan, which we have long called for and which has finally appeared—with its limitations—will be successful only if the question of how people can do their jobs is looked at. Here is an opportunity to equip people to do their job.

In answering a Written Question put to the Department of Health and Social Care in December last year, the noble Lord, Lord Markham, described who could prescribe beyond doctors and dentists. He gave a list of professions, referred to as non-medical prescribers in this case, and they included physiotherapists, therapeutic radiographers and so on. Interestingly, the Care Quality Commission lists the great benefits in this extension to non-medical prescribers, so there is a lesson to be learned here. The CQC talks about the enablement of “quicker access … to medicines” for patients, making the

“best use of the range of skills of healthcare professionals”,

and addressing “demand and workforce issues”. I say to the Minister: these are all things we have been pressing for in the Chamber, and which I think Ministers would also like to see. Here we have an opportunity to get on and meet that requirement.

I have a few questions for the Minister. As we have discussed, experienced paramedics have had prescribing powers since 2018. What assessment have the Government made of the success of this, and what can be learned from implementing the extension? Crucially, can the Minister tell us how much discussion has been had on this matter with the Department of Health and Social Care, as it seems to have fallen between the two departments? How many paramedics currently hold independent prescribing powers? Do the Government have any plans to encourage more paramedics to access prescribing training? What consultation have the Government undertaken, or will they undertake, on how to roll out these changes?

In a study on the introduction of prescribing for paramedics, those who had begun prescribing expressed concern about confusion in multidisciplinary settings about the different prescribing powers that colleagues possessed. What work can the Government and the NHS do to ensure clarity throughout the health service so that current powers and the new powers, when they are introduced, are clear to all clinical colleagues?

As the Minister knows, there is one main thing we would like to hear: the date when this matter will finally be dealt with. I hope he can offer us that today, with clarity, and that he will also explain to noble Lords present and the many people outside who are waiting for his response why there has been this delay. I look forward to his response.

1.38pm
The Parliamentary Under-Secretary of State, Home Office (Lord Sharpe of Epsom) (Con)

My Lords, first, I offer my thanks to the noble Lord, Lord Butler, for securing this debate. If I may say, I hope that no noble Lords, including the noble Lord, ever have personal need on this particular subject. I note his points on the simplicity of making this statutory instrument and the delay in legislating, and I shall come back to that in a moment.

I want to start by stressing at the outset, as the noble Lord and others noted, that the Government recognise the importance of this issue and the value that independent prescribing by front-line health professionals, such as paramedics, brings to the National Health Service. Doctors and vets are generally able to prescribe medicines containing controlled drugs, with accompanying rights to administer and direct others to administer them. In addition, other healthcare professionals can undergo specialist training to prescribe, supply and administer controlled drugs. Paramedic independent prescribers are therefore distinct from other paramedics and will be able to prescribe medicines specified in the legislation.

I am grateful to the noble Lord, Lord Patel, for going into some detail in this regard, because it gives me an opportunity to expand the definition of “advanced paramedics”, and perhaps add some colour. The number is expected to increase in line with the recommendations of the new long-term workforce plan, as referenced by the noble Baroness, Lady Merron. This change in legislation supports that development. As has been noted, that will benefit both the patient and the wider healthcare systems.

All paramedics are required by law to register with the Health and Care Professions Council. In answer to the noble Baroness’s question, according to its register, as of March, there are 1,708 paramedic independent prescribers and 219 therapeutic radiographer independent prescribers in the UK. Paramedic independent prescribers are utilised in a wide range of settings, which can include, but are not limited to, things like emergency departments—same-day emergency care, air ambulances, GP surgeries, out-of-hours services, walk-in centres, community palliative care teams, virtual wards and hospital-at-home services, hospices and so on, as well as on general and specialised wards.

Independent prescribing supports an expectation that patients should be cared for and treated by the most appropriate healthcare professional to meet their needs where it is safe and appropriate. The main purpose of paramedic independent prescribers is to allow those working at an advanced level of practice to be able to independently assess, diagnose and treat patients in a single episode of care, rather than refer them on to another healthcare professional. This is in line with the example that the noble Lord provides, in that, under this new legislation, a patient with an acute onset of pain could be prescribed oral morphine by a paramedic independent prescriber rather than being referred on to a GP or otherwise.

With all that in mind, the Government are wholly supportive of the proposals to enable prescribing of the five specified controlled drugs by paramedic independent prescribers, which is why we accepted the recommendations of the Advisory Council on the Misuse of Drugs, or ACMD, last year. We intend to legislate to make this change alongside other changes relating to the use of controlled drugs in healthcare by podiatrists, therapeutic radiographer independent prescribers, and those acting under patient group directions. As the noble Lord points out, the changes can be achieved by a negative Statutory Instrument, and we intend to bring forward this legislation by the end of the year. I have become a master of obfuscation while doing this job, but there is no need in this case.

The prescribing and supply of medicines is a policy lead for Ministers at the Department of Health and Social Care, as has been noted, and it is governed by medicines legislation. In the present case, the drugs involved are controlled under the Misuse of Drugs Act 1971, which is the responsibility of the Home Office. The 1971 Act makes specified activities in respect of controlled drugs generally unlawful. But because many controlled drugs have legitimate uses in healthcare, the 1971 Act enables Ministers to provide exemptions that are set out in the Misuse of Drugs Regulations 2001.

Under the 1971 Act, Ministers are required to consult the Advisory Council on the Misuse of Drugs, an independent scientific advisory body, before making changes to drugs legislation. Therefore, there are two departments, the Home Office and the Department of Health, working together on issues connected to controlled drugs in healthcare, taking advice from the ACMD and through consultation. The ACMD provided advice to Ministers regarding the prescribing of controlled drugs by paramedics, as has been noted, in October 2019. The Home Office and the DHSC worked together to consider this advice. After the report was published, the Government were required to focus on addressing the threat of Covid-19, as I am sure noble Lords will understand. Alongside other pressures on healthcare, the topic of independent prescribing was not prioritised. As noble Lords will be aware, the Government responded, accepting the ACMD recommendations in September 2022.

I assure your Lordships that Home Office and DHSC officials are working on the necessary amendments to the legislation, and we intend to introduce them by the end of the year. Where I referred to parliamentary procedure in the letter mentioned by the noble Lord, I am afraid that that is just standard language; there is no particular attempt to confuse or, to use my earlier word, obfuscate. We are carefully working through the legal drafting to ensure that each of the professions will have clarity on their new rights and responsibilities so that they can confidently carry out their duties. These include such details as whether the professional can direct others to administer the specified controlled drugs; whether the professional can compound the drugs; and whether they are obliged to record information about their prescribing and, when required, furnish information about it.

In addition, technical amendments need to be made to ensure that the measures are effective: for example, to ensure that patients supplied with controlled drugs in accordance with a prescription from the professional are in lawful possession, and to ensure that interdependencies between the 2001 regulations and those for which the DHSC are responsible under medicines legislation are properly aligned.

In his speech, the noble Lord described these changes as simple. Although the amendments to be made may seem simple, the complexity of the 2001 regulations should not be underestimated. My officials tried to explain them to me the other day and they will cheerfully attest to the fact that I looked very confused for a very long time. Officials from the Home Office and the DHSC have worked alongside lawyers to draft these regulations over several months to ensure that they are accurate and aligned with medicines legislation. I hope it is clear that the Government understand the imperative of this work and are prioritising the legislation accordingly.

To answer a few specific questions, the noble Lord, Lord Hallam, asked whether the forthcoming ban on nitrous oxide will have any impact on healthcare. I can assure him that it will remain available in healthcare as a Schedule 5 drug, and that can also be achieved by a negative statutory instrument. I suspect that we may return to that next week.

The noble Earl, Lord Sandwich, asked me about patient safety in prescribing. Prescribing policy is a matter for the DHSC, but I will make sure that he gets a detailed response on that subject. I can say that benzodiazepines—forgive my pronunciation—are controlled under drugs legislation, with three novel benzos being added in 2021. I hope that he does not intervene on me to ask for clarification because I am not sure that I will be in a position to provide much.

The noble Earl and the noble Baroness, Lady Merron, asked about the safety of prescribing. The ACMD advised that prescribers will have comprehensive training, and existing auditing and sanctions processes will manage inappropriate prescribing, should it occur.

In closing, I thank Members for all their contributions to today’s discussion, which has been both instructive and insightful. I particularly thank the noble Lord, Lord Butler, for securing the debate. He is absolutely right to highlight this important topic. I also thank Mr Johnny Hood, senior advanced clinical practitioner, who wrote to both the noble Lord, Lord Butler, and me. I rudely did not reply to his letter, but I hope he is paying attention to this debate. I thank him for his letter, which I read and noted.

I have heard what has been said and I hope I have provided some clarity and reassurance around the current position. As I have set out, we fully recognise the significance of this issue and work is at an advanced stage to address it as soon as possible by the end of this year.