Product administration errors/issues Dose omission As per the MedDRA Concept Description, dose omission is failure to ‘the administer an ordered dose to a patient before the next scheduled dose, if any. This excludes patients who refuse to take a medication, a clinical decision (e.g., contraindication), or other reasons not to administer (e.g., patient sent for test). For the purposes of retrieval and analysis, in general, a dose omission should be considered to be a suspected medication error. There may be scenarios where doses are missed which are not considered medication errors and therefore a term such as LLT Therapy interrupted should be used to help to distinguish these. LLT Therapy interrupted / PT Therapy cessation is included in HLT Therapeutic procedures NEC and is not a medication error concept. Scenario Medication LLT Comment error? Health provider was Yes Drug dose omission This is an example of unable to mix the contents a product quality issue of the two syringes leading to a Syringe because the plunger was medication error and this resulted in leakage where the two syringes were connected. The defective plunger resulted in the dose not being given. Patient was not the Yes Drug dose omission In this scenario, a dose of the drug, as the preparation leads nurse accidentally to a medication error Inappropriate administered the diluent to reconstitution technique a patient instead of using (PT Product preparation the diluent to reconstitute error) the vial containing the active ingredient Drug administration error Missed dose Unknown Missed dose (PT Drug dose omission) Patient couldn’t take No Temporary interruption This event is neither medication for a week of therapy intentional nor a because the pharmacy medication error. Use was out of the medication LLT Temporary Product availability issue interruption of therapy and capture that external factors
Product administration errors/issues Dose omission As per the MedDRA Concept Description, dose omission is ‘the failure to administer an ordered dose to a patient before the next scheduled dose, if any. This excludes patients who refuse to take a medication, a clinical decision (e.g., contraindication), or other reasons not to administer (e.g., patient sent for test). For the purposes of retrieval and analysis, in general, a dose omission should be considered to be a suspected medication error. There may be scenarios where doses are missed which are not considered medication errors and therefore a term such as LLT Therapy interrupted should be used to help to distinguish these. LLT Therapy interrupted / PT Therapy cessation is included in HLT Therapeutic procedures NEC and is not a medication error concept. Scenario Medication error? LLT Comment Health provider was unable to mix the contents of the two syringes because the plunger was and this resulted in leakage where the two syringes were connected. The defective plunger resulted in the dose not being given. Yes Drug dose omission Syringe This is an example of a product quality issue leading to a medication error Patient was not the dose of the drug, as the nurse accidentally administered the diluent to a patient instead of using the diluent to reconstitute the vial containing the active ingredient Yes Drug dose omission Inappropriate reconstitution technique (PT Product preparation error) Drug administration error In this scenario, a preparation leads to a medication error Missed dose Unknown Missed dose (PT Drug dose omission) Patient couldn’t take medication for a week because the pharmacy was out of the medication No Temporary interruption of therapy Product availability issue This event is neither intentional nor a medication error. Use LLT Temporary interruption of therapy and capture that external factors
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