requirements. An organisation should be consistent in the option that they choose to use and document that option in internal coding guidelines. 3.3.2 If self-injury is reported An additional (third) example was added to the Example table: Example Reported LLT Selected Comment Self slashing Self inflicted laceration LLT Self inflicted laceration is linked to PT Intentional self-injury Cut her own wrists Cut wrists in a suicide attempt Suicide attempt In addition, LLT Self inflicted laceration can be selected As follows: Example Reported LLT Selected Comment Self slashing Self inflicted laceration LLT Self inflicted laceration is linked to PT Intentional self-injury Cut her own wrists Cut wrists in a suicide attempt Suicide attempt In addition, LLT Self inflicted laceration can be selected Took an overdose in an attempt to commit suicide Intentional overdose Suicide attempt If overdose is reported in the context of suicide or a suicide attempt, the more specific LLT Intentional overdose can be selected (See also Section 3.18) 3.11 Congenital Terms
Patient was administered wrong drug and experienced hypotension Wrong drug administered Hypotension Because of similar sounding drug names, the patient took the wrong drug and experienced a rash Drug name confusion Wrong drug administered Rash 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) 3.15.1.1 Medication errors and potential medication errors reported without clinical consequences The Example table: Reported LLT Selected Comment Medication was given intravenously instead of intramuscularly Intramuscular formulation administered by other route Medication was 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 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 LLT Drug name confusion be an optional additional term to select (for tracking purposes). Note: this example is a potential medication error Drug inadvertently administered. The error Drug administration
was noticed soon afterwards. Was changed as follows (note changes to the third and fourth examples): Reported LLT Selected Comment Medication was given intravenously instead of intramuscularly Intramuscular formulation administered by route Medication was given intravenously instead of intramuscularly without sequelae Intramuscular formulation administered by other route No adverse effect See Section 3.21 The pharmacist selected the wrong drug strength but the error was detected prior to dispensing to the patient Intercepted wrong drug strength selected LLT Intercepted drug strength selected links to PT 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 Drug name confusion Circumstance or information capable of leading to medication error Note: this example is a potential medication error and LLT Drug name confusion provides additional information about the nature of the 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 labelled interactions There were several changes made to this sub-section of the document to accommodate new examples of medication monitoring errors in addition to the existing examples of medication errors occurring in the context of labelled interactions. The sub-section name:
Patient became pregnant whilst taking an antifungal drug and an oral contraceptive Labelled drug-drug interaction medication error Pregnancy on oral contraceptive Interaction must be stated in product data sheet (See also Section 3.20) Patient drank grapefruit juice whilst taking a calcium channel blocker Labelled drug-food interaction medication error Product is labelled for grapefruit juice interaction Patient with renal failure is prescribed a drug that is contraindicated in renal failure Labelled drug-disease interaction medication error Patient is administered a sulfonamide-based drug Documented hypersensitivity to administered drug Medical file clearly indicates patient has a sulfa allergy Was changed as follows (in the fourth example, note the addition of the event of wheezing and the addition of a reference to the Concept Description): Example Reported LLT Selected Comment Patient became pregnant whilst taking an antifungal drug and an oral contraceptive Labelled drug-drug interaction medication Pregnancy on oral contraceptive Interaction must be stated in product data sheet (See also Section 3.20) Patient grapefruit juice whilst taking a calcium channel blocker Labelled drug-food interaction medication error Product is labelled for grapefruit juice interaction Patient with renal failure is prescribed a drug that is contraindicated in renal failure Labelled drug-disease interaction medication error Patient with known sulfa allergy is administered a sulfonamide-based drug and experienced wheezing Documented hypersensitivity to administered drug Wheezing See Concept Description in Appendix B of the MedDRA Introductory Guide 3.16.4 Drug diversion The wording in this section: