Reported LLT Selected Comment Patient was administered wrong drug and experienced hypotension Wrong drug administered Hypotension Because of similar sounding drug names, the wrong drug was dispensed; as a result, the patient took the wrong drug and experienced a rash Drug name confusion Wrong drug dispensed Wrong drug administered Rash It is important to select terms for all medication error concepts, i.e., do not subtract information Insulin was given using the wrong syringe resulting in the administration of an overdose. The patient developed hypoglycaemia. Wrong device used Accidental overdose Hypoglycaemia If an overdose is reported in the context of a medication error, the more specific term LLT Accidental overdose can be selected (see also Section 3.18) 3.15.1.2 Medication errors and potential medication errors reported without clinical consequences The wording and Example tables in this section: Medication errors without clinical consequences are not ARs/AEs. However, it is important to record the occurrence or potential occurrence of a medication error. Select a term that is closest to the description of medication error reported. Also, if specifically reported that no adverse effect has occurred, it is acceptable to select LLT No adverse effect. In instances where the medication did not reach the patient, it is acceptable to select LLT Drug not taken in context of intercepted medication error. Example Reported LLT Selected Comment Medication was given intravenously instead of intramuscularly Intramuscular formulation administered by other route Medication was given intravenously instead of intramuscularly without sequelae Intramuscular formulation administered by route No adverse effect See Section 3.21 The pharmacist selected the wrong drug strength Intercepted wrong drug strength selected LLT Intercepted wrong drug strength selected
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
Commission of the European Communities Kavita Chadda European Federation of Pharmaceutical Industries and Associations Hilary Vass* Christina Winter† Health Canada Alison Bennett Polina Ostrovsky Lynn Macdonald Japanese Maintenance Organization Yutaka Nagao Kazuyuki Sekiguchi Mitsuru Takano Reiji Tezuka Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Yuhei Fukuta Miki Ohta Daisuke Sato Makiko Isozaki Kiyomi Ueno Pharmaceutical Research and Manufacturers of America Milbhor D’Silva Medbery US Food and Drug Administration Sonja Brajovic# Christopher Breder Ministry of Food and Drug Safety, Korea YuBin Lee Kyung-Eun Yoon World Health Organization Daisuke Tanaka * Current Rapporteur # Regulatory Chair † Former Rapporteur 4.3.2 Former members of the ICH Points to Consider Working Group
The table of former members was replaced and updated as follows: Affiliation Member Commission of the European Communities Dolores Montero; Carmen Kreft-Jais; Morell David; Sarah Vaughan European Federation of Pharmaceutical Industries and Associations Barry Hammond†; Reinhard Fescharek† Health Canada Heather Morrison; Michelle Séguin; Heather Sutcliffe; Bill Wilson Japanese Maintenance Organization Handa; Akemi Ishikawa; Yasuo Sakurai; Yuki Tada Japan Pharmaceutical Manufacturers Association Takayoshi Ichikawa; Akemi Ishikawa; Satoru Mori; Yasuo Sakurai; Kunikazu Yokoi MedDRA MSSO JoAnn Medbery; Patricia Mozzicato Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Tamaki Fushimi; Wakako Horiki; Sonoko Ishihara; Kazuhiro Kemmotsu; Tatsuo Chie Kojima; Emiko Kondo; Hideyuki Kondou; Kemji Kuramochi; Tetsuya Kusakabe; Kaori Nomura; Izumi Oba; Shinichi Okamura; Yoshihiko Sano; Nogusa Takahara; Kenichi Tamiya; Daisuke Tanaka; Shinichi Watanabe; Takashi Yasukawa; Go Yamamoto; Manabu Yamamoto; Nobuhiro Yamamoto Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Kleckner; Susan M. Lorenski; Margaret M. Westland† US Food and Drug Administration Miles Braun; Andrea Feight; John (Jake) Kelsey†; Brad Leissa; Toni Piazza-Hepp † Former Rapporteur