Drug Safety Update: New safety measures for antidepressants
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update (DSU) on new safety measures being implemented to improve how the risks of suicidal thoughts and behaviours and persistent sexual dysfunction are communicated to patients taking antidepressant medicines.
The changes to be implemented involve a new boxed warning in the Patient Information Leaflet (PIL), a new patient card, and a supporting safety leaflet. The term post SSRI sexual dysfunction (“PSSD”) is also being added to the PIL for some antidepressant medicines.
Advice for healthcare professionals, and advice for healthcare professionals to provide to patients who are prescribed antidepressants is also included in the DSU.
As well as the general advice for healthcare professionals, the DSU provides information about the new patient card. Initially the card will be available electronically and the DSU states it may be given to the patient by dispensers as an interim measure ahead of cards becoming available. A link to the electronic card, which can be shared with patients, is available via the following QR code:
Read the Public Assessment Report on the updated safety communications on antidepressants
Read the new MHRA guidance on use and safety of antidepressants
New Medicine Service
Depression is an eligible therapeutic area for patients to receive the New Medicine Service (NMS). If NMS is being offered to a patient with depression, pharmacists should ensure they are aware of the advice to provide to patients contained within the DSU, as well as when providing advice to patients who have been dispensed antidepressant medicines.
Suicide awareness training
Many pharmacy team members will have completed suicide training as part of the Pharmacy Quality Scheme in 2020/21. Since the DSU includes providing information to patients on potential suicidal thoughts and behaviours, pharmacy teams may wish to consider updating their knowledge on suicide awareness by completing the Zero Suicide Alliance (ZSA) suicide awareness training.
