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Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023

Volume 832: debated on Monday 24 July 2023

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023.

I am grateful to be here today, as is right, to debate such an important issue. The Human Medicines Regulations 2012—the HMRs—set out when medicines need to be prescription only and requirements for pharmacists selling or supplying prescription-only medicines. This SI will make two amendments to the HMRs to enable original-pack dispensing of medicine—OPD—and to require whole-pack dispensing of medicines containing valproate.

The first amendment, on OPD, is to enable pharmacists and pharmacy staff under their supervision the flexibility to dispense up to 10% more or less of the medicine compared to the quantity prescribed if it means that the medicine can be dispensed in the manufacturer’s original packaging. The second amendment requires medicines containing valproate always to be dispensed in the manufacturer’s original packaging, supplying a quantity as close to the quantity prescribed as possible, with exceptions in specific circumstances when the prescribed quantity must be dispensed.

The aims of enabling OPD and requiring whole-pack dispensing of medicines containing valproate are to increase patient safety by ensuring that patients receive the necessary information that is included on, as well as inside, the manufacturer’s original packaging about the safe and effective use of a product. A further aim of OPD is to support efficiencies in community pharmacies.

The Human Medicines Regulations require that a pharmacy may not sell or supply prescription-only medicine except in accordance with a prescription given by an appropriate practitioner. Currently, we interpret dispensing

“in accordance with a prescription”

to mean that pharmacists must supply the exact quantity of medicine prescribed, with a few exceptions where it is practically impossible or very difficult to split the original pack. This means that, where the quantity prescribed on a prescription is not equal to or multiples of a pack size, pharmacy staff need to split the manufacturer’s original pack. In order to dispense the prescribed quantity, the medicine may be supplied in a plain dispensing box or bottle or in the manufacturer’s original packaging but with some taken out. In the case of tablets and capsules, this usually means snipping the strip of medicines.

When supplying in plain dispensing packaging, pharmacies look to provide patient information leaflets but this may not always happen. Patients certainly will not receive or have the opportunity to read the safety information printed on the manufacturer’s original packaging. Further, they may get a collection of snipped strips in a plain dispensing box, which makes it difficult to know whether they have taken their tablet that day or how many tablets they have left and therefore when they need to reorder their medicines. Where patients get the manufacturer’s original pack but with some tablets taken out, and where any tamper-evident seal is broken, they may be concerned that their medicines have been interfered with.

In the case of medicines containing valproate, these amendments will mean that they must always be dispensed in whole packs in the manufacturer’s original packaging, regardless of the conditions that we set around other products for original package dispensing. The requirement is that the nearest number of whole packs to the quantity prescribed—either rounding up or down—will be supplied so that the patient receives only the manufacturer’s complete original packs. These must not subsequently be repackaged into plain dispensing packaging.

Further to the consultation responses, an exception is being included: pharmacists will be able to make an exception to whole-pack dispensing of medicines containing valproate on an individual patient basis where a risk assessment is in place that refers to the need for different packaging, such as a monitored dosage system, and where processes are in place to ensure the supply of patient information leaflets. The risk assessment might identify that the patient needs different packaging to support them taking their medication. Otherwise, while dispensing in original packs may support increased access to patient information, there is a danger that it may undermine measures being taken to support individual patients to take their medicine appropriately.

Amendments to the HMRs for OPD will enable pharmacists, or pharmacy staff under their supervision, to dispense 10% more or less of the medicine compared to the quantity prescribed if it means that they can dispense the medicine in the manufacturer’s original packaging. However, judgment by the responsible pharmacist will remain a critical part of the process; for instance, there are some prescriptions, such as a course of steroids or antibiotics, where a decision may need to be made to supply the exact quantity prescribed.

It is important to note that OPD will not apply to controlled drugs, which are medicines that have further legal controls on top of those that apply to all prescription-only medicines. This is because they may cause serious problems, such as dependence and harm, if they are not taken as intended by the prescriber or are diverted for other uses. Furthermore, OPD does not apply where a medicine is in a form that is not practicable to dispense in the exact quantity ordered, where there is an integral means of application, where splitting the packaging could adversely affect the medicine, such as inhalers, or where the packaging is keeping the medicine sterile.

Although the flexibility of 10% will not enable all medicines to be dispensed in manufacturers’ original packs, it will deal with the issue of whether a month’s supply is 28 days or 30 days and multiples. For example, if a prescription is for 28 days but the pack has 30 tablets, the 10% flexibly enables the full pack to be supplied and vice versa.

The amendments for OPD will apply across Great Britain and are enabling, so pharmacists can decide whether they utilise OPD 10% flexibilities. A transitional provision has been included so the flexibility to dispense up to 10% more or less does not automatically apply in NHS pharmaceutical services in England and Wales. This will allow these administrations to decide how they want to apply this in their respective NHS services. In Scotland, the OPD 10% flexibility will apply immediately.

The amendments will directly contribute to the overarching objective of safeguarding public health by improving patient safety. Ensuring that patients receive the necessary information included in and on the manufacturer’s original packaging will support them taking their medicine safely and effectively. More patients will receive their medication with any tamper-evident seal intact, which reduces concerns that someone has somehow interfered with the medicine. This amendment will lead to a reduction in the use of plain dispensing packaging so that patients will stop getting lots of small “snips” from a blister strip, which we know will make it easier for them to manage their supply and supports compliance as it makes it easier for patients to identify whether they have taken their tablet that day.

OPD is a commitment in the community pharmacy contractual framework 2019-2024 to support efficiencies for pharmacies. This will help pharmacists and their staff become more efficient as the number of times that they have to snip blisters, repackage medicines and source extra patient information leaflets are reduced, freeing up their time for other tasks such as providing clinical services to patients.

Both OPD and expanding hub-and-spoke dispensing arrangements are recognised in the primary care recovery plan, published in May 2023. The NHS long-term workforce plan, published in June 2023, highlights hub-and-spoke arrangements alongside the greater use of automation, which would be facilitated by OPD. These plans recognise OPD and hub-and-spoke arrangements as important foundations in the transformation of community pharmacy that, together, aim to facilitate the greater use of automation in order to increase efficiency and free up pharmacists and their staff to be able to provide more clinical interventions.

The benefits of OPD will be synergistic with the benefits of expanding hub-and-spoke arrangements, which we are also progressing and which will need separate further legislative amendments. Hub-and-spoke arrangements are where parts of the dispensing process are undertaken in separate pharmacy premises. Typically, there are many spoke pharmacies to one hub pharmacy. The concept is that the simple, routine aspects of assembling prescriptions can take place on a large scale in a hub that usually makes use of automated processes.

Splitting packs typically cannot be done by machines that automate the dispensing process. By giving flexibility for supply to be 10% more or less than the prescribed quantity, the number of medicines dispensed in the manufacturer’s original packaging will increase, which in turn increases the number of prescriptions that can be dispensed through the highly automated processes that hubs are likely to employ. The greater use of automation brought about by OPD and hub-and-spoke arrangements, as well as increased efficiency, has the objective of contributing to an improvement in patient safety. By splitting the routine aspects of dispensing for community pharmacists and their staff, hub-and-spoke arrangements can deliver an environment that supports pharmacists and their staff, at both hub and spoke, to focus on the specific tasks they are doing, which in turn protects patient safety. The use of hub-and-spoke dispensing arrangements has been consulted on and the consultation response will be published in due course.

As I have already mentioned, there is a specific amendment for medicines that contain all forms of valproate. Valproate is an effective medicine prescribed for the treatment of epilepsy and bipolar disorders but it is associated with birth defects and neurological disabilities in unborn babies. For children whose mothers took valproate during pregnancy, the risk of having neurodevelopmental disorders is estimated at 30% to 40%, in addition to an 11% risk of congenital abnormalities.

Valproate is an umbrella term for medicines including sodium valproate, valproic acid and valproate semisodium. Products may also be referred to using various brand names. These regulations require that the nearest number of whole packs to the quantity prescribed, so rounding either up or down, will be supplied so that the patient receives only the manufacturer’s complete original packs, with limited exceptions in specific circumstances. Those exceptions, in specific circumstances, to the whole-pack dispensing of medicines containing valproate is when a risk assessment is in place identifying that the patient needs to be supplied with the medicine in different packaging than its original packaging—for example in a monitored dosage system, which helps patients to comply with their medicine—and processes are in place to ensure that the patient continues to get the manufacturer’s patient information leaflet.

This provision is mandatory across Great Britain. There is no transition for the amendments on the whole-pack dispensing of medicines containing valproate, as it will apply in legislation as soon as the amendments come into force.

Sodium valproate and its associated valproate medicines were considered as part of the independent medicines and medical devices review undertaken by the noble Baroness, Lady Cumberlege, to whom we offer our thanks. For some women, valproate may be the only effective treatment for their epilepsy. The regulatory measures are robust and clear that sodium valproate must not be prescribed to any girl or woman of child-bearing potential, unless she has a pregnancy prevention programme in place and is fully informed of the risks.

The requirement for a pregnancy prevention programme was introduced in April 2018. While wider regulatory measures such as the pregnancy prevention plan have already reduced the number of pregnancies exposed to valproate, the latest data indicates than an estimated three pregnancies a month in England are being exposed to medicines containing it. This new legislative amendment, requiring the supply of the manufacturer’s original packaging, is a further measure to ensure that those taking valproate have access to information setting out the risks and need for a woman or girl of child-bearing potential to have a pregnancy prevention programme in place before taking valproate.

The manufacturer’s original packs include specific warnings and pictograms on the labelling, including a patient card, along with the statutory patient information leaflet and an additional patient booklet, which highlight the risks of taking the medicine while pregnant. The aim of the whole-pack dispensing of medicines containing valproate is to decrease further the number of babies who are born with serious complications, thereby improving their lifespan and quality of life.

The exemption to whole-pack dispensing still requires processes to be in place to ensure that the patient receives the patient information leaflet while not cutting across any mitigation put in place to support them taking their medicine appropriately. This exception to whole-pack dispensing has been put in place in response to feedback that we received as part of the consultation. There was concern that, while dispensing in the manufacturer’s original packaging may support increased access to patient information and reduce risk to unborn babies, there is a danger that it may undermine measures such as different packaging, such as monitored dosage systems, which support individual patients to take their medicine appropriately.

No patient should stop taking their medicine without medical supervision. If patients are concerned about the reproductive risks of medicines containing valproate, they should talk to their healthcare provider. Valproate is subject to a range of safety measures. All girls and women taking it should meet the requirements of the pregnancy prevention plan.

Before this important debate is opened, I hope I have set out what we have done and the rationale behind amending the HMRs to enable original-pack dispensing and the whole-pack dispensing of valproate. I look forward to what I know will be an informed and constructive debate.

My Lords, I rise very briefly to raise a point. I was intrigued when reading the title of these regulations that they are for England, Wales and Scotland, but they do not include Northern Ireland. While the regulations are designed to increase patient safety and create efficiencies in the pharmacy sector—I agree with all that and think we can all subscribe to it—I would be grateful if the Minister could tell the Committee whether a decision has been made not to apply them to Northern Ireland, whether is it the case that we have no power in this Parliament to apply them to Northern Ireland, whether the Northern Ireland Assembly has any power in this area, or whether, despite what the Minister said in outlining potently and clearly the reasons for these changes, this is something that no elected representative in Northern Ireland, here or in Stormont, has any power over. I would be grateful for clarification.

My Lords, I start with the point made by the noble Lord, Lord Dodds. Reading the Explanatory Memorandum, it was curious that in paragraph 10.2 we are told that the consultation was carried out by all the United Kingdom authorities, including

“the Department of Health in Northern Ireland”

yet the regulations clearly state

“England and Wales and Scotland”.

This does not surprise me. We are dealing with two instruments on the same day, one of them Northern Ireland-only and one England, Wales and Scotland-only.

I was curious about the answer on the Northern Ireland instrument, which is that we would need primary legislation, so it is easier to regulate tobacco products in Northern Ireland than it is in England, Wales and Scotland. I hope the reverse does not apply here, and that Northern Ireland is not included because some kind of legislative barrier means that they would find it harder than we would to regulate something which, on the substance of it, seems eminently sensible. Many people outside here might be surprised that pharmacists did not already have some discretion over how they dispense, given that packs are quite often in odd numbers. Having dealt with the scope point, again, the substance of it seems entirely sensible.

This must be a pre-recess present, as it is rare that people bring before us regulations which are good for patients, pharmacists and GPs. It is not only that everybody wins from the change being promoted; the Government have managed to get a “two for the price of one” by incorporating another change, which I know has come up. The noble Baroness, Lady Cumberlege, and others have campaigned for some time to improve the information given to women who are prescribed sodium valproate. So here we are: we are making two sensible changes in one instrument, and the Government should be congratulated on that.

For once, we have an impact assessment. We have four pages of regulation and 40 pages of impact assessment. My heart always sinks when I see a huge impact assessment but this one was really good. Whoever prepared it should be congratulated. There are lots of really good facts and figures about how prescribing works in the United Kingdom to help support the case, so I thought it was very well worked out. The fact that savings were identified independently for patients, GPs and pharmacists was extremely helpful in trying to assess the impact of the regulations. It highlighted that there is a potential increase in drug costs but that that is far outweighed by the savings that all those other constituencies make.

I would be interested in the Minister’s reaction to one number in it that surprised me. The impact assessment said that the cost of an e-consultation that would be saved—I assume it is for some sort of repeat prescribing —was £1.40. That is a very precise amount, but less than the saving from a patient going to the pharmacist to pick up their drugs. That figure surprised me because it felt low. I would expect a greater saving from reducing the number of e-consultations for people being represcribed drugs. Again, I am curious about where that came from.

I thought the model of trying to price out where the savings are, in a sort of piecework way, was extremely helpful, down to the 45p that will be saved by assistants in pharmacies not spending 90 seconds on splitting packs. That is super precise, but it is the kind of data that we want, and which can be tested to really understand how you are making savings all through the chain.

The other numbers that came out, that were just fascinating, were on the spread of prescriptions of paracetamol. There were two prescriptions for 10,000 paracetamol in there that were checked and found to be correct, which did surprise me. Even more surprising than the two prescriptions for 10,000 were two prescriptions for 1,009 paracetamol each. 1,009 is a very large prime number, so there is no “so many per day”; you cannot divide it by anything to get anything else. I assume that is a mistake, and that they meant to write 1,000 or 100 and stuck a nine on the end, because that is the only way I can think of that any GP would ever prescribe a large prime number of paracetamol.

I welcome more impact assessments like this with fun numbers in them, as they are extraordinarily helpful on a Monday before we head off for our break. More substantively, I genuinely hope that we will see more innovation such as this around prescribing and dispensing, because this is one of the areas that we have talked about a lot with the Minister. If we are to see improvements in primary care, we have to look for the kinds of efficiencies that benefit patients and make everything quicker and easier for the patient, but also make it more cost-efficient, because there are savings to be made that can in turn be ploughed back into the new enhanced services that we want to get from our pharmacists.

Again, as a substantive point, the general sustainability of community pharmacies is a problem. They are not getting the kind of income they need to continue to be present in all our communities. We see that in the closure rates; there are hundreds closing every year. As we look at changes such as this—the Minister talked about things such as the hub and spoke model—we have to bear in mind all the time that if we are making savings and are able to put those savings back into community pharmacies, that will be essential if we are to continue to have the kind of network that we need for the Minister’s ambitious plans.

This is a very welcome development. It is great to get two for the price of one; reducing the risks to pregnant women from sodium valproate is very welcome, but in terms of the scale of the dispensing operation, it is the 10% change that will potentially have a significant impact. As I say, I hope the Minister can commit that savings made through this will go back into that community pharmacy network that we all depend on.

My Lords, as the Minister said in his introduction, this is an important issue. I too express my enthusiasm for this SI. We do not have a lot of SIs for which we have a lot of enthusiasm, so I hope the Minister and his team will be very happy with that. The reason for that is that this is common-sense and practical, and provides savings that can be diverted to benefit elsewhere, but also increases patient safety and is a better service to patients. It also allows pharmacists and their teams to do the job they are there for. That, in itself, is somewhat liberating for members of the healthcare team, so it is very welcome.

I also felt that the Minister had given an extremely detailed and welcome introduction, so I will just focus on a few questions in that regard. The first is about pharmacists. Given the changes and the impetus on pharmacists’ professional judgments, will there be any extra training, checks, reviews or similar put in place? I talk about the review not just to ensure that it is doing the job; are there other innovations that we can welcome in SIs in the future? That would be a very positive outcome.

Turning to the matter of valproate, I, too, acknowledge the contribution of the noble Baroness, Lady Cumberlege, who undertook the independent medicines and medical devices review and identified this as a special case. Again, it is good to hear that be responded to. My question for the Minister here is about the exception, which, as he outlined, talks about where there is a risk assessment in place. To that point, where that exception exists, even if it is based on risk assessments and balances with the need to ensure that individuals take their medicine appropriately, it still potentially leaves some unquantifiable risk. With this in mind, what will be done to ensure that pharmacists receive the correct guidance and support to carry out risk assessments accurately? Again, how will this use of the exception be monitored and reviewed?

I turn to the impact assessment. There must be few Ministers who get an accolade for an impact assessment. I very much share the views expressed by the noble Lord, Lord Allan. I say to the Minister, in a serious way, that I hope this will be an example of good practice that we see across all SIs from all departments because it is clearly doable and the right thing to do. Indeed, it creates around the regulations a real statement of importance as well as application to making lives, costs and arrangements better. I really feel that the impact assessment supports what we are talking about; it is good to be able to say that rather than arguing about where the impact assessment is, asking why it is not thorough enough and saying that it is of no use to us. We are not saying that at all today. I hope that this will be an impetus for the Government to ensure that this is the standard.

I want to make a couple of points on impact. It would be helpful if the Minister could clarify what he feels the overall impact of this change will be on GPs. In this regard, I am thinking in particular about GPs’ capacity to handle these changes amid wider pressures. I ask the same question about pharmacists and pharmacy teams. Does the Minister expect any changes in how repeat prescriptions are managed as a result of this regulation, particularly with respect to in-patient appointments compared with online requests and the like? Will there be any requirement for additional in-person appointments to ensure that the implementation of this change is well monitored by GPs?

With that, as this is the last SI—certainly the last health and social care SI—for us to discuss before the summer, I wish the Minister, his officials, the Whip and all noble Lords a very enjoyable and happy Recess.

As ever, I thank noble Lords for their constructive comments and general welcoming of the proposals.

On the points made by the noble Lord, Lord Dodds, unfortunately, we do not have the power. It is one of those bizarre situations whereby the Windsor agreement enabled us to follow what is happening in the EU but, for other matters such as these, it requires the involvement of the Northern Ireland Executive and Northern Ireland Assembly where we instigate moves from this side. It is a concern; I am concerned. We have all welcomed the benefits here today as an example, but they are benefits that Northern Ireland obviously will not receive.

One of the things that I am responsible for in the department are the rule changes that are happening. It is a general concern in Northern Ireland. We will talk about this in the new year but there are some very exciting medicine developments, for instance point-of-care medicines. We see as one of the benefits that we can get on and move quickly in those areas. It is a concern that we may, again, have to do them as GB-only if there is no functioning Northern Ireland Executive and Assembly. I have met Northern Ireland Office Ministers to express this concern; they are aware of it. From their point of view, they are doing everything they can to try to get the Northern Ireland Executive and Assembly up and running, but I appreciate that these are complex issues. I know that that is not an ideal response but that is the position that we find ourselves in at the moment.

On the other points, I appreciate the welcome given to these regulations and, in particular, the impact assessment. I will directly, for the benefit of Hansard, thank the team for it. It is appreciated. As has been said, there is incredible attention to detail in it. I am impressed by the attention to detail shown by the noble Lord, Lord Allan; I wonder how he is going to occupy himself over the Recess without impact assessments. Seriously, these are a set of well-thought-out, sensible arrangements and, as has been said, are an exemplar of how we should be doing these things.

On the question about savings, my understanding is that they will be seen by pharmacists themselves and people in their stores. They will be getting paid and they will be keeping it in the system, so to speak. This will help their viability, which the noble Lord, Lord Allan, mentioned.

The point on extra training and checks is well made. I know that that is being kept under review. It is a good point that we need to make sure that it is diarised formally so that we can assess it, particularly in terms of risk assessment. How it was explained to me is that we are talking more about where a person has many medications so it is better for them to have a blister pack-type format and they may not be of child-bearing age so making sure that they can take the correct medicine each day outweighs the risk of side effects for an unborn baby. That is one of the examples that have been described to me of where a logical case can be seen.

Noble Lords might be aware that there is also concern about potential fathers taking valproate pre-conception and how that can have an impact. This is primarily a concern for women of child-bearing age but potentially for males as well, hence the suggestion about the packaging.

As ever, I will respond in writing, but I am not aware that this will specifically impact GPs because they will continue to prescribe in the same way. It will be for pharmacists to use their judgment to make sure that they round up or down for the packaging or dispensing, in the case of valproate in its original form. I repeat that I will write in detail but, off the top of my head, I do not think it will have an impact on GPs.

The wider point is that this should help pharmacists in a lot of their processes. The need to sometimes make judgment calls means that they will obviously need to apply a bit more intelligence but, on balance, we believe that those cases will be isolated enough to be outweighed by the benefits of whole packaging. In response to the points made earlier, that is exactly the sort of thing we should consider when we review it all. As the noble Baroness, Lady Merron, mentioned, the whole point is to free up some pharmacy time so that pharmacists can spend it where they want to on patient care.

I will happily follow up in detailed writing on all the questions. I thank noble Lords for their input; as ever, it was a very interesting debate. I echo the wishes for a happy recess; personally, I cannot wait. Although I will be doing a lot of hospital visits, as I mentioned, it will indeed be lovely. On that note, I commend the regulations to the Committee.

Motion agreed.

Committee adjourned at 6.26 pm.