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Does a missed dose need reporting as an adverse event for PSURs? If, for example, the SPC states that the medication should be given every week but the dose was missed due to non compliance or product complaint, would this information be needed for PSURs?
A missed dose with no evidence of an adverse event does not need to be recorded in the safety database. There will be always be instances of a missed dose of a medication and there may be a number of data sources within the company that contains information on missed doses in the absence of an adverse event. At the time of the PSUR it is recommended that those data sources are reviewed to determine if there are any specific trends in the reason for missed doses and if relevant to the benefi-risk assessment information should be provided in the PSUR (now known as PBRER=periodic benefit risk evaluation report) under section "3.9 information from other clinical trials and sources". Particular attention should be paid on the importance of compliance with dosing regimens that are critical to adhere to for certain medicinal products as the impact of missed dose on the benefit-risk profile for these products is likely to be more significant
Dear Colleagues.. Do we have to report missed dose if there is no adverse event associated?
For example, for infusion drug if the patient has Q4 Week dosing but due to scheduling issues or other non clinical issues patient is scheduled +/- few days.
Is this considered misuse or off label use even if this is not consistent for each time and is due to non clinical reasons like no appointments available, no ride available for patient to come to clinic on that specific day, patient having other restrictions or conflicts in their calendar?