Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what information her Department holds on the proportion of patients aged 18 to 25 in England prescribed a selective serotonin reuptake inhibitor who received a follow-up review within one week, in line with NICE guideline NG222.

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken forward the recommendations of the Commission on Human Medicines. The timetable for the revised patient information leaflet (PIL) is for it to be available electronically from October and for hard copy availability within packs of medicines three to six months later. The patient card will also be available electronically from October and will begin to be available in or on the box of antidepressant medicine within three to six months.

As an interim measure, the MHRA is working with the manufacturers’ trade associations to evaluate the feasibility of earlier access to the hard copy of the card for patients via pharmacies. The ancillary leaflet is being developed with other healthcare system partners and should be available early in 2027.

The MHRA has requested updates to the PILs for all antidepressants involved in the review to be submitted for approval. The PIL updates require review by the MHRA to ensure accuracy of messaging, and it is the aim for electronic versions of the PILs to be made available as soon as practicable in October.

The MHRA logs all Prevention of Future Deaths reports it receives and can confirm that since 2020, four reports concerning the prescribing of antidepressants, or their safety information have been sent to the MHRA. Responses have been issued in each case. The MHRA sought the advice of several independent committees on the reports and the potential need for regulatory action. In response to some of these reports and the feedback from families and patients, the MHRA convened the Expert Working Group on antidepressant risk minimisation, which made several recommendations for the MHRA and wider healthcare system, including updates to clinical guidance and regulatory documents.

The independent Expert Working Group on antidepressant risk minimisation considered all regulatory options for improving awareness of the risk of suicidal thoughts and behaviours, including adding a warning on the box, in addition to updates to the PILs. For many antidepressant medicines, the inclusion of additional information beyond the statutory requirements is limited by space available on the box. The patient card will be available on or in the box and will be detachable and easily portable, and will provide context to safety messaging and signpost patients on where to get help.