Evaluation and monitoring of isotretinoin use in Iran.

BACKGROUND Isotretinoin (13-cis retinoic acid) is used for treatment of nodular cystic acne unresponsive to conventional therapy. It is an expensive, potent teratogenic drug with serious adverse drug reaction (ADRs). Recently, use of this drug has increased in Iran. To date, there are no published data about the use of isotretinoin in Iran; therefore, this study aims to assess its use in this country. METHODS This was a prospective, drug utilization evaluation (DUE) study conducted in an institutional community pharmacy affiliated with Tehran University of Medical Sciences (TUMS). Drug prescription, administration, and evaluation of appropriateness were recorded and compared with standard protocols. Collected data were analyzed by SPSS software. RESULTS A total of 274 outpatients treated with isotretinoin enrolled in the study. Of these, 51.3% were prescribed isotretinoin under the usual recommended daily doses of 0.5mg/kg/day. Data also indicated that 33.5% of the patients were given total doses of less than 100 mg/kg (72.4 ± 17.2 mg/kg) and 12.2% received more than 150 mg/kg. With regards to the teratogenic effects of isotretinoin, only 6.8% of couples simultaneously used two methods of contraception (P = 0.001). In addition, we detected improper use of isotretinoin for mild and moderate acne in about 20% of cases. CONCLUSION The most important finding of this study is that the doses of isotretinoin are incorrect in many cases. Incorrect dosages would decrease drug efficacy and increase the risk of relapse. In addition, patients have not been adequately counseled about isotretinoin's teratogenicity and the seriousness of its adverse effects.