Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023
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Lord Markham
That the Grand Committee do consider the Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
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.
Lord Markham (Con)
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.