Pharmacovigilance (PV)
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Hello – we have a potential SUSAR to report by next Friday and are trying to interpret a piece of advice which is proving a challenge.
The event relates to IMPs and Radiotherapy. The event is related but expected to the IMPs, but the site have stated that there has been an interaction between the IMP and the Radiotherapy which has been given by external beam. The event is not expected to the Radiotherapy.
The advice we currently have is;
“where there is a reasonable possibility the event has been caused by an interaction between the IMP(s), and the event is unexpected to radiotherapy, then it must be reported as a SUSAR. The guidance from the MHRA is, “If it was a drug-drug interaction there may be a possibility to submit this event as a SUSAR as in the scenario where there is possible interaction between the IMP and radiotherapy. In this case you would enter both the IMP and the radiotherapy drug(s) as suspect drugs upon submission.” In this case, it needs to be clear if the radiotherapy is given as a drug (where it is inserted into the patient, e.g., in brachytherapy), or it is an external beam which wouldn’t be classed as a drug.”
Our query is with regard to the final sentence – as to the precise meaning;
1) SUSARs only need to be reported where the radiotherapy has been given as a drug – brachytherapy
or
2) SUSARs need to be reported in all cases for this type of event – but, it needs to be made clear how the drug was administered in the report.
Hopefully, others have faced the same issue and can enlighten us?
With many thanks, Cathy
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