Labelled drug-drug Patient became pregnant Interaction must be interaction medication whilst taking an antifungal stated in product data error drug and an oral sheet (See also Pregnancy on oral contraceptive Section 3.20) contraceptive Patient drank grapefruit Labelled drug-food Product is labelled for juice whilst taking a interaction grapefruit juice calcium channel blocker medication error interaction Patient with renal failure is Labelled drug-disease prescribed a drug that is interaction contraindicated in renal medication error failure Documented Medical file clearly Patient is administered a hypersensitivity to indicates patient has a sulfonamide-based drug administered drug sulfa allergy Was changed as follows (in the fourth example, note the addition of the event of wheezing and the addition of a reference to the Concept Description): Example Reported LLT Selected Comment Patient became pregnant Labelled drug-drug Interaction must be whilst taking an antifungal interaction medication stated in product data drug and an oral Pregnancy on oral sheet (See also contraceptive contraceptive Section 3.20) Patient grapefruit juice Labelled drug-food Product is labelled for whilst taking a calcium interaction grapefruit juice channel blocker medication error interaction Patient with renal failure is Labelled drug-disease prescribed a drug that is interaction contraindicated in renal medication error failure See Concept Patient with known sulfa Documented Description in allergy is administered a hypersensitivity to Appendix B of the sulfonamide-based drug administered drug MedDRA Introductory and experienced wheezing Wheezing Guide 3.16.4 Drug diversion The wording in this section:
Patient became pregnant whilst taking an antifungal drug and an oral contraceptive Labelled drug-drug interaction medication error Pregnancy on oral contraceptive Interaction must be stated in product data sheet (See also Section 3.20) Patient drank grapefruit juice whilst taking a calcium channel blocker Labelled drug-food interaction medication error Product is labelled for grapefruit juice interaction Patient with renal failure is prescribed a drug that is contraindicated in renal failure Labelled drug-disease interaction medication error Patient is administered a sulfonamide-based drug Documented hypersensitivity to administered drug Medical file clearly indicates patient has a sulfa allergy Was changed as follows (in the fourth example, note the addition of the event of wheezing and the addition of a reference to the Concept Description): Example Reported LLT Selected Comment Patient became pregnant whilst taking an antifungal drug and an oral contraceptive Labelled drug-drug interaction medication Pregnancy on oral contraceptive Interaction must be stated in product data sheet (See also Section 3.20) Patient grapefruit juice whilst taking a calcium channel blocker Labelled drug-food interaction medication error Product is labelled for grapefruit juice interaction Patient with renal failure is prescribed a drug that is contraindicated in renal failure Labelled drug-disease interaction medication error Patient with known sulfa allergy is administered a sulfonamide-based drug and experienced wheezing Documented hypersensitivity to administered drug Wheezing See Concept Description in Appendix B of the MedDRA Introductory Guide 3.16.4 Drug diversion The wording in this section:
TermSelPTC_R4.8SoC_sep2014.docx