Psychiatric disorders with oral retinoids — HPRA Reminder Notice

The HPRA in their most recent Drug Safety Newsletter (August 2025) issued a reminder of existing warnings in relation to the risk of psychiatric disorders with oral retinoids.

Cases of depression, depression aggravated anxiety, mood alterations and psychotic symptoms have been reported in patients taking oral retinoids. Additionally, aggressive tendencies, suicidal ideation, suicide attempts, and suicide have been reported in patients treated with isotretinoin.

The oral retinoids marketed in Ireland are isotretinoin available as Roaccutane 10mg and 20mg capsules, indicated for the treatment of severe forms of acne, and acitretin as Neotigason 10mg capsules, indicated for severe extensive psoriasis and other skin conditions:

• The EMA, following a review of safety data in 2018, concluded that the limitations of the available data did not establish whether the risk of neuropsychiatric disorders was due to the use of retinoids. However, it was considered that patients with severe skin conditions may be more vulnerable to neuropsychiatric disorders due to the nature of the disease, and the prescribing information was updated to include a warning about the possible risk;
• A further routine review of national and EU-level pharmacovigilance data from recent years indicates that psychiatric adverse reactions associated with oral retinoids continue to be reported. This includes cases of completed suicide associated with isotretinoin;
• The HPRA is highlighting the existing warning to reinforce awareness amongst healthcare professionals of the importance of discussing potential psychiatric risks with patients before, during, and in the case of isotretinoin, after treatment;
• All patients should be monitored for signs of depression and referred for appropriate treatment if necessary. Particular care is advised in patients with a history of depression;
• Awareness by family or friends may be useful in detecting mental health deterioration; and

Refer patients to the package leaflet that comes with the medicine pack or is accessible online and discuss any questions or concerns that they may have.

IPU Practice Support

The IPU vaccination hubs (COVID-19, Flu and LAIV) have been updated with resources to support community pharmacists with the delivery of an Autumn/Winter Vaccination Programme 2025/2026. For more information about this matter, visit ipu.ie > Professional > Vaccines and Injectables.

Specialist Pharmacy Service (SPS) — Safe Use of Transdermal Patches

Transdermal patches offer a convenient and consistent method of drug delivery. However, while serious incidents are uncommon, they can lead to significant harm or even death. In health and social care settings, each step of the process, from prescribing to disposal, carries potential safety risks.

In July 2025 the Specialist Pharmacy Service (SPS) published a series of articles on the safe use of transdermal patches, see sps.nhs.uk > Guidance > Administering > Use filter for ‘Buprenorphine’ > Using transdermal patches safely in healthcare settings (published 9 July 2025)*.

This series of articles provides information on the safe use of transdermal patches, including application, recording of application, monitoring during use, and removal of patches. They also provide some useful troubleshooting information on switching between patches and other formulations, adhesion issues, skin reactions and considerations when cutting patches.

Antibiotic classification for animal use

The European Medicines Agency (EMA) set up an Antimicrobial Advice Ad Hoc Expert Group (AMEG) to guide the impact of public and animal health on the use of antibiotics in animals and on the measures to manage the possible risk to humans.

The AMEG has developed a guide, which categorises antibiotics based on their impact and consequences to public health when used in animals and the need for their use in veterinary medicines. This guide provides information regarding which antibiotics should be avoided, have restricted use, or should be used with caution or prudence. Therefore, pharmacists may consider using this tool when assessing antibiotic veterinary prescriptions from an antimicrobial stewardship perspective

This information is available as Infographic – Categorisation of antibiotics for use in animals for prudent and responsible use, available at ema.europa.eu > News and Events > News > ‘Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health’ (published 28 January 2020).

Additionally, the Department of Agriculture, Food and the Marine (DAFM) issued an information note regarding a regulatory change relating to antimicrobials or group of antimicrobials reserved for the treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council. This note is available at assets.gov.ie/static/documents/1InfoNotePharmacistsVeterinariansAntimicrobHumanUse170625.pdf.