If the infection is identified, select a second term for the specific infection; if appropriate, a product quality issue term can also be selected (See Section 3.28). Note also that this section number has changed from 3.16 to 3.17. Also in this section, an additional LLT was added to the Example table: Example Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal infection with Burkholderia cepacia. Cultures of unopened containers of the nasal spray grew B. cepacia Transmission of an infectious agent via a medicinal product Burkholderia cepacia infection As follows (LLT Product contamination bacterial was Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal infection with Burkholderia cepacia. Cultures of unopened containers of the nasal spray grew B. cepacia Transmission of an infectious agent via a medicinal product Product contamination bacterial Burkholderia cepacia infection Finally, the last paragraph in this section: Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via medicinal product but this could be implied by other data within the case. In this instance, select LLT Suspected transmission of an infectious agent via a medicinal product. The same LLT should be used in the E2B field for the sender’s diagnosis (B.5.3). Was changed as follows (note substitution of the word “report” for “case” and deletion of the last sentence): Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via medicinal product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via a medicinal product.
Addition of two new examples (fourth and fifth examples in the table) Note also that this section number has changed from 3.17 to 3.18. 3.18.1 Overdose reported with clinical consequences In the Example table, the order of the LLTs in the “LLT Selected” column has been changed so that the first LLT (LLT Overdose) reflects the topic of this section. (See “Throughout document”, point no. 6 above). Note also that this section number has changed from 3.17.1 to 3.18.1. 3.19.2 Device-related event reported without clinical consequences An additional (third) example was added to the Example table: Example Reported LLT Selected Medical device breakage Device breakage My patch is leaking on my arm Leaking patch As follows: Example Reported LLT Selected Medical device breakage Device breakage My is leaking on my arm Leaking patch My patch is not sticking to my skin Medicinal patch adhesion issue Note also that this section number has changed from 3.18.2 to 3.19.2. 3.22 – Unexpected Therapeutic Effect
A third example was added to the Example table as follows: Reported LLT Selected Consumer noted that the toothpaste they had purchased had a mouldy odour Subsequent investigation of the product lot number revealed that the toothpaste was a counterfeit product Product counterfeit Product odour abnormal Note also that this section number has changed from 3.27.1 to 3.28.1. 3.28.3 Product quality vs. medication error A minor edit was made to the third paragraph of this section by inserting the word “the” before the phrase “control of the healthcare professional…” Note also that this section number has changed from 3.27.3 to 3.28.3. . 4.3.1 Current members of the ICH Points to Consider Working Designation of the current and former Rapporteurs: Affiliation Member European Federation of Pharmaceutical Industries Associations Hilary Vass** Christina Winter* US Food and Drug Administration John (Jake) Kelsey* * Current co-Rapporteurs ** Acting Rapporteur for June 2010 meeting of Working Group Was changed as follows: Affiliation Member Hilary Vass*