Pharmacist dispensing Wrong label placed Drug A inadvertently on medication Medication error attached a product label during dispensing for Drug B The drug store clerk noted that the wrong product Product label was attached to Product quality issue on wrong product some bottles in a shipment of mouthwash The mother administered insufficient amount of Product dropper Product quality prescribed antibiotic calibration unreadable and medication error because the on the Insufficient dosage dropper were hard to read Was changed as follows (note change to the third example): Example Reported LLT Selected Comment Pharmacist dispensing Wrong label placed Drug A inadvertently on medication Medication error attached a product label during dispensing for Drug B The drug store clerk noted that the wrong product Product label label was attached to Product quality issue on wrong product some bottles in a shipment of mouthwash Product quality issue and medication error. The mother administered If underdose is Product dropper an underdose of antibiotic reported in the context calibration unreadable because the lines on the of a medication error, Accidental underdose dropper were hard to read the more specific LLT Accidental underdose can be selected. 4.3.1 Current members of the ICH Points to Consider Working Group The table of current members was replaced and updated as follows: Affiliation Member Maria Luisa Casini
Pharmacist dispensing Drug A inadvertently attached a product label for Drug B Wrong label placed on medication during dispensing Medication error The drug store clerk noted that the wrong product label was attached to some bottles in a shipment of mouthwash Product on wrong product Product quality issue The mother administered insufficient amount of prescribed antibiotic because the on the dropper were hard to read Product dropper calibration unreadable Insufficient dosage Product quality and medication error Was changed as follows (note change to the third example): Example Reported LLT Selected Comment Pharmacist dispensing Drug A inadvertently attached a product label for Drug B Wrong label placed on medication during dispensing Medication error The drug store clerk noted that the wrong product label was attached to some bottles in a shipment of mouthwash Product label on wrong product Product quality issue The mother administered an underdose of antibiotic because the lines on the dropper were hard to read Product dropper calibration unreadable Accidental underdose Product quality issue and medication error. If underdose is reported in the context of a medication error, the more specific LLT Accidental underdose can be selected. 4.3.1 Current members of the ICH Points to Consider Working Group The table of current members was replaced and updated as follows: Affiliation Member Maria Luisa Casini
termselptc_r4.9soc_mar2015.docx