Question to the Department of Health and Social Care:

To ask His Majesty's Government when post-selective serotonin reuptake inhibitors sexual dysfunction (PSSD) was added as a yellow card reporting option; who requested it and why; and whether the Medicines and Healthcare products Regulatory Agency plans to update PSSD reports made before the addition of that option with the MedDRA code 10086208.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.

The MHRA uses the Medical Dictionary for Regulatory Activities (MedDRA) to code suspected adverse drug reactions reported by patients and healthcare professionals via the Yellow Card scheme. MedDRA is an international, clinically validated medical terminology used by regulatory authorities and the biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing safety monitoring. MedDRA is updated twice annually, and new terms can be proposed by any MedDRA users. The term Post Selective Serotonin Reuptake Inhibitor Sexual Dysfunction (PSSD) was added to MedDRA as a lower-level term in version 24.1 which was and implemented by the MHRA as a term available to users of the Yellow Card website in February 2022 as part of routine updates.

As part of current routine MHRA processes, Yellow Card reports are not recoded to reflect the changes in the reaction terms available but remain as reported with the terms selected by the original reporter.

As a lower-level term in MedDRA, PSSD is recorded if the reporter has specifically used this term at the time of the report, and since this term can include a wide range of symptoms it would not be appropriate to recode cases not reporting this specific term received prior to 2021. All Yellow Card reports received prior to the availability of PSSD as a MedDRA term will have the individual symptoms reported coded as MedDRA terms and available for signal detection and assessment processes.