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

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.