Regulatory Practice>Rems Requirement Practice Test

A 17-year-old female presents with severe nodular acne unresponsive to oral antibiotics and topical retinoids. The dermatologist plans to start isotretinoin and discusses risks, including severe birth defects. The patient reports regular menses, is sexually active, and currently uses a copper IUD. She does not smoke or drink alcohol and denies depression. The prescriber explains that the medication is available only through a restricted program and that specific steps must be completed before and during therapy. The community pharmacy is enrolled to dispense this medication and asks what requirements must be met before filling the first prescription and for subsequent monthly refills.

A 23-year-old woman with severe nodular acne refractory to oral antibiotics is beginning isotretinoin therapy. She has regular menses, is sexually active with a male partner, and admits to inconsistent condom use. Baseline hepatic panel and fasting lipids are within normal limits. The dermatologist reviewed risks of teratogenicity and instructed the patient to use effective contraception. The pharmacy is registered with the iPLEDGE program, and the patient has created her account. The prescriber asks the pharmacist to confirm the key steps needed before the first fill and subsequent refills under the REMS requirements.