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

Valerie Vaz Excerpts

Tuesday 5th September 2023 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I beg to move,

That the Committee has considered the draft Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023.

It is a pleasure to serve under your chairmanship, Ms Nokes. I will set out the purpose of the draft statutory instrument. The Human Medicines Regulations 2012 set out when medicines need to be prescription only and the requirements of pharmacists selling or supplying prescription-only medicines. This draft statutory instrument makes two amendments to the Human Medicines Regulations. First, it enables original pack dispensing of medicine when original packaging is required. Secondly, it requires whole-pack dispensing of medicines containing valproate.

The first amendment, under proposed new regulation 217B, will enable the pharmacist to dispense 10% more or less of the medicines compared with the quantity prescribed if they can dispense them with the manufacturer’s original packaging. Dispensing in the manufacturer’s original packaging brings a number of benefits. First, it improves patient safety because original packaging contains clear instructions and information about the medicines. Secondly, it frees up pharmacy time by reducing the amount of time spent splitting packs and counting packs and strips. However, the responsible pharmacist will need to make a judgment as to whether to use this 10% discretion. For example, the flexibility should not be applied to some medicines, such as courses of steroids or antibiotics, and the exact quantity prescribed should be the quantity supplied.

Original pack dispensing will not apply to controlled drugs, where the exact quantity prescribed will continue to need to be dispensed. Nor will it apply where a medicine is already dispensed in a full pack, for example because it is in a form that is not practical to dispense in the exact quantity ordered.

While the flexibility of 10% will not enable all prescriptions to be dispensed in the manufacturer’s original packs, it will deal with the issues of whether a month’s supply is for 28 or 30 days, and with multiples. For example, if a prescription is for 28 days but the pack has 30 tablets, currently the pharmacist has to remove those two extra tablets. The new flexibility will enable the full pack to be supplied and vice versa. The amendments for original pack dispensing will apply across Great Britain and they are enabling, so pharmacists can decide whether to utilise the original pack dispensing with the flexibility of plus or minus 10%.

A transitional provision has been included, so pharmaceutical services in England will need to further negotiate with Community Pharmacy England on pricing arrangements following the draft regulations. I understand that in Scotland, however, they are ready to move forward with this, so it will apply immediately.

[Valerie Vaz (Walsall South) (Lab)]

The Minister gave the example of 28 days or 30 days. Will pharmacists be able to explain to patients that they will not necessarily have to take them for 30 days?

[Maria Caulfield]

Absolutely, and pharmacists are very keen to do this. This will often be used for repeat medication. A GP may prescribe a month’s pack—which, depending on the supplier, will be for either 28 days or 30 days—but when dispensing the packs the pharmacist will be able to give advice to patients so that they are absolutely clear on the instructions, which will also be written on the pack.

That goes to my point that by ensuring that patients receive the necessary information that is included in the original manufacturer’s packaging, they will be supported in taking their medicines more safely and effectively. The amendments will lead to a reduction in the use of plain dispensing packaging—those little white boxes—so that patients can stop getting lots of small snips from blister strips. When they get full strips, that will make it easier for them to manage the supply and support compliance, because they will be able to identify more easily whether they have taken their tablet that day and how many they have left.

Original pack dispensing also helps pharmacists and their staff to become more efficient, as the number of times they have to snip blisters, repackage medicines and source extra patient information leaflets is reduced, freeing up time for other tasks such as providing clinical services to patients. The benefits of original pack dispensing will be synergistic with the benefits of expanding hub and spoke arrangements, which we are rolling out across the pharmacy sector. The use of hub and spoke dispensing arrangements has been consulted on, and we will publish that consultation in due course. Both today’s measures and the expansion of hub and spoke dispensing are a commitment to the community pharmacy contractual framework and are important foundations in transforming community pharmacy.

The second regulation, proposed new regulation 217C, is about the whole-pack dispensing of valproate. “Valproate” is a term for medicines containing sodium valproate, valproic acid and valproate semisodium; it includes various brands such as Epilim. 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 babies exposed to it during pregnancy. The risk to children of mothers who have taken valproate during pregnancy of having neurodevelopmental disorders is estimated at 30% to 40%, in addition to an 11% risk of congenital abnormalities.

A number of measures are already in place to try to prevent pregnancies while women are taking valproate, such as the pregnancy prevention programme, which has already reduced the number of pregnancies exposed to valproate. But the latest data suggests that in England at least three pregnancies a month are still being exposed to medicines containing valproate. More needs to be done.

The regulations will require that patients receive only the manufacturer’s complete original packs, with limited exceptions in specific circumstances. The manufacturer’s original packs contain specific warnings and pictograms. There is a patient card along with statutory patient information leaflets, which outline the risks of taking the medicine. If patients are concerned about taking valproate, they should talk to their healthcare provider and should not stop taking their medicines without medical supervision.

The provision will be mandatory across Great Britain. There is no transition period and it will apply as soon as the regulations come into force. I hope I have set out the rationale for original pack dispensing for the majority of medicines and using the specific manufacturer’s complete original pack when dispensing valproate medicine. I commend the regulations to the Committee.