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 3.2.2 Death as the only reported information If the only information reported is death, select the most specific death term available. Circumstances of death should not be inferred but recorded only if stated by the reporter. Death terms in MedDRA are linked to HLGT Fatal outcomes. Example Reported LLT Selected Patient was found dead Found dead Patient died in childbirth Maternal death during childbirth The autopsy report stated that the cause of death was natural Death from natural causes 3.2.3 Death terms that add important clinical information Death terms that add important clinical information should be selected along with any reported ARs/AEs. Example Reported LLT Selected Patient experienced a rash and had sudden cardiac death Rash Sudden cardiac death 3.2.4 Other patient outcomes (non-fatal) Hospitalization, disability and other patient outcomes are not generally considered ARs/AEs.
Pregnancy (no adverse effect) Pregnancy No adverse effect Select LLT No adverse effect (in addition to LLT Pregnancy) if no adverse event has occurred. (See Section 3.21) Pregnancy (outcome unknown) Pregnancy Select LLT Pregnancy only if neither outcome nor occurrence of AE is known Pregnant patient receiving medication experienced adverse event Example Reported LLT Selected Comment Pregnant patient receiving drug X experienced a pruritic rash Maternal exposure during pregnancy Pruritic rash LLT Pregnancy can be selected for medical history, concomitant medical condition 3.10.2 Events in the child or fetus Select terms for both the type of exposure and any adverse event(s). Example Setting/Patient Reported LLT Selected Fetus with AE; exposed in utero; mother took product Pregnant woman taking drug X; fetal tachycardia noted on routine examination Drug exposure in utero Fetal tachycardia Baby with AE; exposed in utero; father took product Baby born with cleft palate; father had been taking drug X at time of conception Paternal drug exposure before pregnancy Cleft palate Newborn with AE; exposed to product via breast milk Mother exposed to drug X; nursing newborn experienced vomiting Drug exposure via breast milk Vomiting neonatal
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 3.14.4 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 3.14.5 Investigation terms without qualifiers Terms in SOC Investigations without qualifiers may be used to record test names when entering diagnostic test data. Example Information/Reported (Verbatim) LLT Selected for Test Name Comment
3.15.1.2 Medication errors and potential medication errors reported without clinical consequences 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 other route No adverse effect See Section 3.21 Patient was dispensed the wrong drug. The error was detected prior to patient administration Intercepted drug dispensing error Pharmacist notices that the names of two drugs are similar and is concerned that this may result in a medication error Circumstance or information capable of leading to medication error LLT Drug name confusion could be an optional additional term to select (for tracking purposes). Note: this example is a potential medication error Drug inadvertently administered. The error was noticed soon afterwards. Drug administration error 3.15.1.3 Medication errors in the context of labeled interactions
Abuse Yes Patient/consumer No 3.16.2 Addiction Yes Patient/consumer No 3.16.3 Medication error No Patient/consumer or healthcare provider Yes 3.15 Off label use Yes Healthcare provider Yes 3.27 3.16.1 Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional and inappropriate use of a product – over-the-counter or prescription – other than as prescribed or not in accordance with the authorized product information. Example Reported LLT Selected Patient deliberately ingested the topical medication Intentional use by incorrect route Patient deliberately took the medication for two days longer than instructed on the product label Intentional use beyond labeled duration 3.16.2 Abuse For the purposes of term selection and analysis of MedDRA-coded data, abuse is the intentional, non-therapeutic use of a product – over-the counter or prescription – for a perceived reward or desired non-therapeutic effect including, but not limited to, “getting high”. Abuse may occur with a single use, sporadic use or persistent use of the product. Example Reported LLT Selected Athlete used anabolic steroid preparation to enhance performance Steroid abuse Patient occasionally uses opioid product to get high Opioid abuse, episodic use
Patient had decreased effect from drug A Drug effect decreased Patient had prolonged effect from drug A Drug effect prolonged 3.24 – Social Circumstances 3.24.1 Use of terms in this SOC Terms in SOC Social circumstances represent social factors and may be suitable to record social and medical history data. Such terms are not generally suitable for recording ARs/AEs; however, in certain instances, terms in SOC Social circumstances are the only available terms for recording ARs/AEs or may add valuable clinical information. Example Reported LLT Selected Patient’s ability to drive was impaired Impaired driving ability Terms in SOC Social circumstances are not multi-axial and, unlike terms in other “disorder” SOCs in MedDRA (e.g., SOC Gastrointestinal disorders), they generally refer to a person, not to a medical condition. Be aware of the impact that terms in SOC Social circumstances may have on data retrieval, analysis and reporting as illustrated in the table below: Term in SOC Social circumstances (“person”) Similar term in “Disorder” SOC (“condition”) Alcoholic Alcoholism Drug abuser Drug abuse Drug addict Drug addiction Glue sniffer Glue sniffing Smoker Nicotine dependence Note that “abuse” terms not associated with drugs/substances are in this SOC*, regardless of whether they refer to the person or to the condition, as illustrated in the table below: LLT PT Child abuse Child abuse Child abuser
Example Reported LLT Selected Comment Used off label Off label use Off label use in paediatric patients Drug use in unapproved population Refers to a population of patients Drug X given to a 10 year old boy; the drug is not indicated for use below 18 years Adult product administered to child LLT Adult product administered to child is linked to PT Off label use 3.27.2 Off label use when reported with an AR/AE If an AR/AE occurs as a result of off label use, the preferred option is to select LLT Off label use, or other appropriate LLTs linked to PT Off label use, and a term for the medical condition in addition to a term for the AR/AE. Alternatively, select a term for the medical condition and a term for the AR/AE. Example Reported LLT Selected Preferred Option Patient was administered a drug off label for pulmonary hypertension and suffered a stroke Off label use Stroke Pulmonary hypertension Stroke Pulmonary hypertension 3.28 – Product Quality Issues It is important to recognize product quality issues as they may have implications for patient safety. They may be reported in the context of adverse events or as part of a product quality monitoring system.
European Communities Maria Luisa Casini European Federation of Pharmaceutical Industries Associations Hilary Vass* Christina Winter† Health Canada Alison Bennett Lynn Macdonald Japanese Maintenance Organization Osamu Handa Kazuyuki Sekiguchi Reiji Tezuka Japan Pharmaceutical Manufacturers Association Yo Tanaka MedDRA MSSO Judy Harrison Patricia Mozzicato Ministry of Health, Labour and Welfare Shinichi Okamura Makiko Isozaki Hideyuki Kondou Shinichi Watanabe Pharmaceutical Research and Manufacturers of America Anna-Lisa Kleckner JoAnn Medbery US Food and Drug Administration John (Jake) Kelsey* Sonja Brajovic * Current co-Rapporteurs † Former Rapporteur 4.3.2 Former members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Dolores Montero Carmen Kreft-Jais Morell David