AQW 11874/22-27

Mr Danny Donnelly
Alliance Party
East Antrim

Tabled Date: 14/05/2024
Answered On Date: 22/05/2024
Priority Written: Yes

Question:
To ask the Minister of Health, pursuant to AQW 7479/22-27, to detail (i) the contingency plans that are in place; (ii) how they will be activated; and (iii) when they will be activated.

Answer:

As referenced in AQW 7479/22-27, the Department of Health and Social Care (DHSC) lead on the maintenance of medicine supply chains to the UK, and there are national and locally tried and tested measures that can be implemented to ensure patients have access to medicines during periods of disruption.

Due to manufacturing issues and an increase in global demand for attention deficit hyperactivity disorder (ADHD) medicines, marketing authorisation holders have notified DHSC of UK wide and global disruptions of their ADHD products. Consequently, several national and local measures have been implemented during this period of disruption.

Following notification of supply issues to DHSC, a management plan was agreed by the UK-wide Medicines Shortage Response Group (MRSG) in line with agreed shortage protocols. MSRG is a multi-disciplinary group, including representatives from my Department, that meets fortnightly to discuss shortages that are likely to have a higher risk impact on patients and / or the overall health service. Concerns regarding the supply of ADHD medicines were brought to MSRG in September 2023, and subsequent updates have been provided to the group in relation to the ongoing supply disruptions. MSRG has agreed the UK wide management measures including the communication plans detailed below to healthcare professionals which have been published in Northern Ireland (NI).

Information provided at MSRG is shared at a local level through the NI Medicines Shortage Advisory Group (NIMSAG). NIMSAG is chaired by my Departmental officials and includes relevant representatives from across Primary and Secondary Care organisations. This group has led and co-ordinated actions required locally to implement agreed UK-wide mitigations.

In line with the communication plans agreed at MSRG and NIMSAG, a National Patient Safety Alert was initially issued by my Department on 28 September 2023, providing healthcare professionals with the required actions to take during the period of disruption to the various strengths and preparations of these medicines-

https://www.health-ni.gov.uk/sites/default/files/publications/health/doh-hss-md-48-23.pdf.

While the supply of some ADHD medicines has now been resolved, some strengths and preparations are continuing to experience ongoing supply disruptions. As a consequence, several Medicines Supply Notifications have been issued, and these have provided healthcare professionals with updated guidance on the actions to take regarding the various strengths and preparations that continue to be affected by these global disruptions. Both the National Patient Safety Alert and the Medicines Supply Notifications are reflective of messaging agreed by the UK administrations. If the supply situation changes, there may be further discussions at MSRG and NIMSAG and agreed updated communications may be issued by my Department to healthcare professionals.

As detailed in AQW 11792/22-27, healthcare professionals are also encouraged to use the Specialist Pharmacy Service (SPS) medicines supply tool to provide the most up-to-date information on medicine supply disruptions, which includes affected ADHD medicines. Additionally, SPS has published a dedicated webpage for prescribers to assist them when prescribing ADHD products for their patients- https://www.sps.nhs.uk/articles/prescribing-available-medicines-to-treat-adhd/. These resources are updated regularly by DHSC based on the information they receive from the marketing authorisation holders of these products.

The Medicines and Healthcare products Regulatory Agency (MHRA) has also permitted the importation of unlicensed stock into the UK by specialist importers to meet patients’ clinical needs. Information on what preparations and strengths of unlicensed/ imported stock are available, where to access this stock and possible lead times, can be found in the published guidance and/ or on SPS medicines supply tool.

ADHD products affected by this global supply disruption were added to the UK’s export and hoarding ban list on 10 October 2023. This list prevents wholesalers from exporting or hoarding medicines listed, helping to ensure supplies in the UK can be made available to patients. As seen in the link below, ADHD medicines currently remain on this list. https://assets.publishing.service.gov.uk/media/663b774a74933dccbbb6c3ea/restricted-medicine-list-8-may-2024.csv/preview.

Additionally, in terms of an additional local measure, Intuniv® (guanfacine) 4mg modified release tablets were added to the NI MHRA Authorised Route (NIMAR) list on 28 March 2024, which permitted the movement of Great Britain (GB) authorised stock into NI to meet patients’ clinical needs. This product was subsequently removed from the NIMAR list on 10 May 2024 following improvements in the availability of NI compliant stock. It is important to note that until Windsor Framework arrangements are implemented from 1 January 2025, NIMAR can be used when authorised stock is available in GB and there is no compliant authorised stock available in NI to meet patients’ clinical needs. If required, my Department will help to identify and assess any products that may require addition to the NIMAR list and work with DHSC to ensure patients’ clinical needs in NI are met.

These are the measures that are in place or have been in place since my Department became aware of supply disruptions to ADHD medicines in September 2023. Healthcare professionals should follow the guidance that has been issued as they provide them with actions to take to ensure patients can have access to ADHD treatments. Additional measures can be introduced if required, such as further guidance and advice to healthcare professionals, Serious Shortage Protocols or additions to the NIMAR list.