概述
Since its introduction into clinical trials in the mid 1970s, and
its widespread use since the early 1980s, isotretinoin has
proved a very effective therapy for severe and persistent acne.1
The current Product Licence indications for the use of isotretinoin
are severe forms of acne (such as nodular or conglobate
acne or acne at risk of permanent scarring) resistant to
adequate courses of standard therapy with systemic antibacterials
and topical therapy. The profile of side-effects has been
well described, and the need for appropriate care in its use,
particularly in women at risk of pregnancy, is well understood.2
The Medicines and Healthcare Products Regulatory
Agency (MHRA) has adopted the recommendations of the
European Medicines Control Agency with regard to prescribing
isotretinoin for women, with the introduction of the Pregnancy
Prevention Programme (PPP). The availability of generic
isotretinoin has also resulted in a standardization of the Summary
of Product Characteristics (SPC) across all suppliers, with
resulting changes to advice for in-treatment monitoring and
to the limitations of prescribing only by hospitals that had
previously existed.