- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Dermatology and Paediatrics and neonatology
Isotretinoin should only be prescribed by consultant dermatologist-led teams and dispensed only by a hospital pharmacy.
Article date: August 2007
The prescribing of isotretinoin (brand leader Roaccutane) for the treatment of severe acne has been restricted to dermatologists since it was first authorised in the UK. Because of its known teratogenicity, additional precautions were introduced in 2005 for female patients through the pregnancy prevention programme.
Given the availability of new generic isotretinoin products, it is important to ensure that healthcare professionals who prescribe and dispense isotretinoin are fully aware of these controls, particularly in light of a change to the summary of product characteristics as a result of a European review.
Marketing authorisations or licences for isotretinoin products currently state that it can be prescribed by, or under supervision of, “physicians with expertise in the use of systemic retinoids”. In the UK, this definition refers to consultant dermatologists.
Isotretinoin should be prescribed only by a consultant dermatologist-led team, and prescriptions should be issued under the consultant’s name from a hospital-based pharmacy. This way, specialists with the most experience can advise patients about the important safety issues associated with isotretinoin.
See more information about the prescribing restrictions and key safety issues associated with the use of isotretinoin.
Article citation: Drug Safety Update August 2007; Vol 1, Issue 1: 9.