Adverse Drug Event Reporting Practice Test

A 27-year-old female (60 kg) is started on isotretinoin 40 mg by mouth twice daily for severe acne through a risk management program. Current medications: combined oral contraceptive (ethinyl estradiol/norgestimate) 1 tablet by mouth daily, multivitamin 1 tablet by mouth daily. Allergies: none known. Medical history: acne vulgaris. Baseline labs: aspartate aminotransferase 28 units/L (normal), alanine aminotransferase 30 units/L (normal), triglycerides 180 mg/dL (high; normal <150 mg/dL), serum pregnancy test negative. Which monitoring parameter is critical for this patient on isotretinoin?

A 34-year-old male (86 kg) calls the pharmacy 30 minutes after taking his first dose of amoxicillin/clavulanate 875/125 mg by mouth twice daily for sinusitis. He reports new generalized hives, lip swelling, and tightness in his throat. Current medications: none. Allergies: seasonal allergies only. Medical history: none. No labs available. What is the most important step in reporting this adverse drug reaction?