Cardiac output measured Cardiac output LLT Haemoglobin decreased should not be Haemoglobin 7.5 g/dL Haemoglobin 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 administered wrong drug and experienced Hypotension hypotension Because of similar sounding It is important to select Drug name confusion drug names, the wrong drug terms for all medication Wrong drug dispensed was dispensed; as a result, error concepts, i.e., do Wrong drug administered the patient took the wrong not subtract information Rash drug and experienced a rash If an overdose is Insulin was given using the reported in the context wrong syringe resulting in the Wrong device used of a medication error, administration of an Accidental overdose the more specific term overdose. The patient Hypoglycaemia LLT Accidental developed hypoglycaemia. overdose can be
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
9491-1900_termselptc_r4_11_mar2016_rl.docx