Safe Dispensing of Roaccutane® (isotretinoin)

This pharmacy practice update provides clarification on the regulatory framework in place to ensure the safe and appropriate dispensing of Roaccutane® (isotretinoin).

Published: 7 July 2025

Following recent queries regarding the dispensing of Roaccutane® (isotretinoin), we would like to take this opportunity to remind pharmacists of the regulatory framework in place to ensure its safe and appropriate use, especially for women of childbearing potential:  

  • Oral retinoids, such as acitretin and isotretinoin, are highly teratogenic. Consequently, a pregnancy prevention programme has been established to mitigate associated risks. 
  • Pharmacists must adhere to the PSI Code of Conduct  and apply their professional judgement and clinical expertise in their daily practice. This involves making informed decisions while complying with relevant legislation, practice standards, and guidance. An ethical decision-making tool is available to assist with any dilemmas that may arise in practice.
  • Prescriptions for Roaccutane® (isotretinoin) intended for women of childbearing potential must be dispensed within seven days of the prescription date. Additionally, the treatment duration must not exceed thirty days. 
  • Pharmacists have a responsibility to review medicines therapy and provide patient counselling in the supply of medicines on foot of a prescription. The PSI has developed guidelines to support medicine therapy review, counselling, and prescription extension.
  • Pharmacists can access the Summary of Product Characteristics (SmPC) for Roaccutane® (isotretinoin) on the Health Products Regulatory Authority (HPRA) website. Additionally, pharmacists can find educational resources and materials, including a pharmacist checklist for dispensing Roaccutane® (isotretinoin) and a patient card to counsel patients on the associated risks and relevant information about this medicine.   

In September 2024, a Direct Healthcare Professional Communication was issued regarding oral retinoids (acitretin and isotretinoin) as a reminder of the pregnancy prevention programme.  

By following this regulatory framework, pharmacists can help ensure the safe dispensing of Roaccutane® (isotretinoin), thereby supporting patient health and wellbeing.