Aspects of roaccutane prescription in South Africa.
A nationwide postmarketing surveillance study on the use and outcomes of use of isotretinoin has been conducted in South Africa. A representative sample of prescribers of the drug was identified from drug utilisation data and the overall doctor response rate was 90.1%. A total of 766 patients was enrolled in the study, of which 728 were analysable for safety and efficacy. More than half the patients prescribed isotretinoin were women, of whom only 48.25% were practising some form of contraception. The mean overall dosage prescribed was 0.64 mg/kg/day and the mean overall duration of therapy prescribed was 15.5 weeks. The mean dose and duration of therapy prescribed by dermatologists was significantly higher than that prescribed by general practitioners. Potentially dangerous drug interactions involving the concomitant use of isotretinoin with tetracyclines, vitamin A and oral contraceptives together with antibiotics were noted. Mucocutaneous drying effects were the most common adverse events and the incidence of these effects decreased with continuation of therapy. The known effectiveness of the drug was confirmed by the results of the study.
Smart
A J
AJ
Department of Pharmacology, University of Cape Town.
Walters
L
L
D000152:Acne Vulgaris / Q000188:drug therapy / Q000378:metabolism; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics; D002648:Child; D015331:Cohort Studies; D003276:Contraceptives, Oral / Q000493:pharmacokinetics; D004347:Drug Interactions; D005260:Female; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods; D013019:South Africa; D014801:Vitamin A / Q000493:pharmacokinetics
D000900:Anti-Bacterial Agents; D003276:Contraceptives, Oral; D014801:Vitamin A; D015474:Isotretinoin