Debate contribution: Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024

Debate contribution by Mr Mike Nesbitt on 3 June 2024.

MLA

Mr Mike Nesbitt

Party at the time

Ulster Unionist Party

Date

3 June 2024

Type

Debate contribution (made as a minister)

Business

Executive Committee Business

Heading

Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024

Assembly identifier

Official Report component 4493521

Read the official Assembly record

Text

I beg to move

I seek the Assembly's approval for the making of this set of draft regulations, which will amend the Human Medicines Regulations 2012 or, as they are commonly known, the "HMRs". The regulations will enable original pack dispensing of medicines and will require whole-pack dispensing of medicines containing valproate in Northern Ireland. The HMRs are a set of UK laws that regulate the use of medicinal products for human use. They set out a comprehensive regime for the authorisation of products; for their manufacture, import and distribution; for sale and supply of the products; for their labelling and advertising; and for pharmacovigilance.

The statutory rule creates a specific requirement for medicines containing all forms of valproate to always be dispensed in their original manufacturer's packaging. That is to ensure that girls and women receive warnings regarding the risks of taking these medicines when pregnant. The manufacturer's original packs include specific warnings and unique pictograms on the label. They include a patient card, along with a statutory patient information leaflet, and an additional patient booklet highlighting the risks of taking the medicine while pregnant. Medicines containing valproate are used in the treatment of epilepsy and bipolar disorder. There are known risks that are associated with medicines containing valproate, including significant risks to children of mothers who took medicine containing valproate during pregnancy. Exposure of an unborn baby to valproate during pregnancy is associated with a high risk of congenital malformations and neurodevelopmental disorders, which may lead to permanent disability. The aim of the amendment is to require manufacturers' original full packaging dispensing of those medicines and to further decrease the number of babies who are exposed to valproate in pregnancy. That having been said, pharmacists will be able to make an exception to whole pack dispensing on an individual patient basis, where a risk assessment is in place that refers to the need for different packaging, and where processes are in place to ensure the supply of patient information leaflets. The statutory rule will also introduce original pack dispensing (OPD) to allow pharmacists in Northern Ireland the flexibility to dispense up to 10% more or 10% less of a medicine compared to the quantity prescribed. That happens if it means that pharmacists can dispense the medicine in its original manufacturer's packaging. That will, again, support increased patient safety by improving patient access to safety information that is included in a medicine's original packaging. These provisions will also help community pharmacies to streamline how they manage workload by enabling greater use of automation in the dispensing process and releasing capacity in pharmacy teams to undertake patient-centred services that meet population health needs and support HSC transformation. The amendments are being made following the completion of a UK-wide consultation that took place in 2021. There were 84 responses to that consultation across the UK, five of which were from Northern Ireland. Although the majority of respondents were extremely supportive of the proposals generally, some respondents suggested that exceptions needed to be built in to support patients who have specific individually identified dispensing needs, such as patients who receive their medication in daily dosage packaging, such as a monitored dosage system to aid compliance. Further to the consultation responses, an exception is now included in these amending regulations whereby pharmacists will be able to make an exception to the 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. Amendments to the HMRs for original pack dispensing 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, judgement 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 original pack dispensing 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. That is because they may cause serious problems, such as dependency and harm, if they are not taken as intended by the prescriber, or if they are diverted for other uses. As a whole, the amendments will directly contribute to the overarching objective of safeguarding public health by improving patient safety in Northern Ireland. 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. The HMRs have a UK-wide territorial application and must be amended using powers set out in the Medicines and Medical Devices Act 2021. Subsequently, any amendments would normally be made jointly by my Department and the Secretary of State for Health and Social Care using the draft affirmative procedure, meaning that they would be debated and approved via the draft affirmative procedure in both the Houses of Parliament and here in the Northern Ireland Assembly. As Northern Ireland had no sitting Assembly until recently, the UK Government made the decision to proceed with the laying of a draft amendment statutory instrument that applies only in Great Britain. That statutory instrument was debated in the UK Parliament on 20 September 2023 and came into operation in Great Britain on 11 October 2023. In the absence of a Minister to bring forward those legislative amendments to the Assembly for application in Northern Ireland at that time, my Department issued a chief professional letter in relation to full-packaging dispensing of valproate-containing medicines to highlight that the Medicines and Healthcare products Regulatory Agency (MHRA) guidance relating to valproate-containing medicines should be considered as good practice in Northern Ireland until such times as similar legislative amendments to that which had taken place in Great Britain could be taken forward in Northern Ireland. The draft regulations that I bring before the Assembly therefore replicate the provisions already made for Great Britain. If these regulations are approved by the Assembly today, the respective legislative provisions will then extend to and apply in Northern Ireland in the same way that they currently apply in the rest of the United Kingdom. My officials attended the Health Committee at its meeting on 2 May to outline the policy intent of this draft statutory rule. I am pleased to confirm that the Committee raised no issues on the content of the draft regulations. It is with the Committee's support that I now bring this statutory rule before the wider Assembly and its Members. I therefore commend the motion to the Assembly.

Thank you very much, Mr Deputy Speaker. Thanks also to the Chair. On the broad point of working with the Committee, I repeat that, although I have only been in this role for six days, I have worked here for more than 13 years, in the Chamber and in Committees, so I feel a great sense of loyalty to that. If we get the relationships right, a lot of things are possible. I really look forward to working with the Chair and her colleagues on the Health Committee. I thank the Committee members for supporting the legislation. I will close by taking the opportunity to acknowledge the work of Dr Jim Morrow, a now retired consultant neurologist from the Belfast Health and Social Care Trust. His work in the field of epilepsy medicines in pregnancy has had a global impact. I declare that I have known Dr Morrow for a very long time, since school days. Dr Morrow founded the UK epilepsy and pregnancy register. His work has been absolutely key — instrumental — in highlighting the safety issues of valproate in pregnancy and in learning more about the safer alternatives for treating epilepsy in pregnancy. We all owe Dr Morrow a huge debt of gratitude. With that, I conclude.

1,353 words. Text as published by the Northern Ireland Assembly.

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