Multiple definitive diagnoses without signs/symptoms Multiple diagnoses (only possible option) Multiple provisional diagnoses without signs/symptoms Multiple provisional diagnoses (only possible option) Multiple definitive diagnoses with signs/symptoms Preferred: Multiple diagnoses only Alternate: Diagnoses and signs/symptoms Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 3 Multiple provisional diagnoses with signs/symptoms Preferred: Multiple provisional diagnoses and signs/symptoms Alternate: Signs/symptoms only Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 4 EXAMPLES Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnoea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnoea Hypotension Laryngospasm 2 Possible myocardial infarction with chest pain, dyspnoea, diaphoresis Myocardial infarction Chest pain Dyspnoea Diaphoresis Chest pain Dyspnoea Diaphoresis 3 Pulmonary embolism, myocardial infarction, and congestive heart failure with chest pain, cyanosis, shortness of breath, and blood pressure decreased Pulmonary embolism Myocardial infarction Congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased
4 Chest pain, cyanosis, shortness of breath, and blood pressure decreased. Differential diagnosis includes pulmonary embolism, myocardial infarction, and congestive heart failure. Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased Chest pain Cyanosis Shortness of breath Blood pressure decreased Always include signs/ symptoms not associated with diagnosis Myocardial infarction, chest pain, dyspnoea, diaphoresis, ECG changes and jaundice Myocardial infarction Jaundice (note that jaundice is not typically associated with myocardial infarction) Death and Other Patient Outcomes Death, disability, and hospitalisation are considered outcomes in the context of safety reporting and not usually considered ARs/AEs. Outcomes are typically recorded in a separate manner (data field) from AR/AE information. A term for the outcome should be selected if it is the only information reported or provides significant clinical information. (For reports of suicide and self-harm, see Section 3.3). Death with ARs/AEs Death is an outcome and not usually considered an AR/AE. If ARs/AEs are reported along with death, select terms for the ARs/AEs. Record the fatal outcome in an appropriate data field. Example Reported LLT Selected Comment Death due to myocardial infarction Myocardial infarction Record death as an outcome Constipation, ruptured bowel, peritonitis, sepsis; patient died Constipation Perforated bowel Peritonitis Sepsis
Example Reported LLT Selected Comment Elevated potassium, K 7.0 mmol/L, and hyperkalaemia Hyperkalaemia It is not necessary to select LLT Potassium increased Investigation results not consistent with diagnosis When investigation results are reported with a diagnosis, select a term for the diagnosis and also select terms for any investigation results that are not consistent with the diagnosis. Example Reported LLT Selected Comment Alopecia, rash, and elevated potassium 7.0 mmol/L Alopecia Rash Potassium increased Elevated potassium is not consistent with the diagnoses of alopecia and rash. Terms for all concepts should be selected. Grouped investigation result terms Select a term for each investigation result as reported; do not “lump” together separate investigation results under an inclusive term unless reported as such. Example Reported LLT Selected Comment Abnormalities of liver function tests Abnormal liver function tests Increased alkaline phosphatase, increased SGPT, increased SGOT and elevated LDH Alkaline phosphatase increased SGPT increased SGOT increased LDH increased Select four individual terms for the investigation results. A single term such as LLT Liver function tests abnormal should not be selected Investigation terms without qualifiers Terms in SOC Investigations without qualifiers may be used to record test names when entering diagnostic test data in the ICH E2B electronic transmission standard. Example Information/Reported (Verbatim) LLT Selected for Test Name Comment
Cardiac output measured Cardiac output Haemoglobin 7.5 g/dL Haemoglobin LLT Haemoglobin decreased should not be selected as it is both a test name and a result* * MedDRA is used only for test names, not test results, in the E2B data elements for Results of Tests and Procedures Medication Errors, Accidental Exposures and Occupational Exposures Medication errors 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. Appendix B of the MedDRA Introductory Guide contains descriptions of the interpretation and use of certain medication error terms (e.g., “Dispensing error”). Reports of medication errors may or may not include information about clinical consequences. Medication errors reported with clinical consequences If a medication error is reported with clinical consequences, select terms for both the medication error and the clinical consequences. Example 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
contact Occupational exposures For the purposes of term selection and analysis of MedDRA-coded data, occupational exposure encompasses the “chronic” exposure to an agent (including therapeutic products) during the normal course of one’s occupation, and could include additional scenarios in specific regulatory regions. For example, occupational exposure may additionally relate to a more acute, accidental form of exposure that occurs in the context of one’s occupation. In these regions, occupational exposure for healthcare workers could be of particular interest. Example Reported LLT Selected Comment Physical therapist developed a photosensitivity rash on hands after exposure to an pain relief cream that she applied to a patient Occupational exposure to drug Exposure via skin contact Photosensitive rash Pathologist chronically exposed to formaldehyde developed nasopharyngeal carcinoma Occupational exposure to toxic agent Nasopharyngeal carcinoma Exposure to formaldehyde is a known risk factor for this type of malignancy Nurse splashed injectable drug in her own eye resulting in excessive tearing Inadvertent exposure to drug Excess tears An additional term for occupational exposure – e.g., LLT Occupational exposure to drug – could also be selected, if applicable to regional requirements Misuse, Abuse and Addiction The concepts of misuse, abuse and addiction are closely related and can pose challenges for term selection since the terms may overlap to some extent; the specific circumstances of each case/reported event may help in consideration for term selection of these concepts. Medical judgment and regional regulatory considerations need to be applied. It may also be useful to consider these concepts as shown in the table below: Concept Intentional? By Whom? Therapeutic Use? Additional Sections in this Document containing
Ventricular tachycardia due to malfunction of device Device malfunction Ventricular tachycardia Partial denture fractured leading to tooth pain Dental prosthesis breakage Tooth pain Device-related event reported without clinical consequences If a device-related event is reported in the absence of clinical consequences, select the appropriate term. Example Reported LLT Selected Medical device breakage Device breakage My patch is leaking on my arm Leaking patch Drug Interactions This term includes reactions between drugs and other drugs, food, devices and alcohol. In this document, “drug” includes biologic products. Labelled drug interactions may be medication errors (see Section 3.15.1.3). Reporter specifically states an interaction Select an interaction term and additional term(s) for any reported medical event. Example Reported LLT Selected Torsade de pointes with suspected drug interaction Drug interaction Torsade de pointes Patient drank cranberry juice which interacted with anticoagulant drug causing an INR increase Food interaction INR increased Reporter does not specifically state an interaction Two products may be used together, but if the reporter does not specifically state that an interaction has occurred, select terms only for the medical events reported. Example Reported LLT Selected Patient was started on an anti-seizure medication and a heart medication and developed syncope Syncope Patient was already on an anti-seizure Anticonvulsant drug level increased
Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Daisuke Inoue Miki Ohta Daisuke Sato Yasuko Inokuma Kiyomi Ueno Pharmaceutical Research and Manufacturers of America Milbhor D’Silva 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 Former members of the ICH Points to Consider Working Group 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 Alison Bennett; Heather Morrison; Polina Ostrovsky; Michelle Séguin; Heather Sutcliffe; Bill Wilson Japanese Maintenance Organization Osamu Handa; Akemi Ishikawa; Yasuo Sakurai; Yuki Tada; Reiji Tezuka Japan Pharmaceutical Takayoshi Ichikawa; Akemi Ishikawa;