Example Reported LLT Selected Sterile lumbar puncture kit received in Product sterile packaging disrupted broken packaging (sterility compromised) Product quality issue vs. medication error It is important to distinguish between a product quality issue and a medication error. Product quality issues are defined as abnormalities that may be introduced during the manufacturing/labelling, packaging, shipping, handling or storage of the products. They may occur with or without clinical consequences. Medication errors are defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. Explanations of the interpretations of product quality issue terms are found in the MedDRA Introductory Guide (Appendix B, MedDRA Concept Descriptions). Example Reported LLT Selected Comment Pharmacist dispensing Wrong label placed Drug A inadvertently Medication error on medication attached a product label for during dispensing Drug B The drug store clerk noted that the wrong product Product label Product quality issue label was attached to some on wrong product bottles in a shipment of mouthwash Product quality issue and medication error. The mother administered Product dropper If underdose is reported in an underdose of antibiotic calibration unreadable the context of a medication because the lines on the Accidental underdose error, the more specific LLT dropper were illegible Accidental underdose can be selected.
Example Reported LLT Selected Sterile lumbar puncture kit received in broken packaging (sterility compromised) Product sterile packaging disrupted Product quality issue vs. medication error It is important to distinguish between a product quality issue and a medication error. Product quality issues are defined as abnormalities that may be introduced during the manufacturing/labelling, packaging, shipping, handling or storage of the products. They may occur with or without clinical consequences. Medication errors are defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. Explanations of the interpretations of product quality issue terms are found in the MedDRA Introductory Guide (Appendix B, MedDRA Concept Descriptions). 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 illegible 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.