Hello Risk Management Community,
I am working with an integral combination product, a prefilled, single-use pen intended to administer a monoclonal antibody. To be used by both HCPs but also to be self-injected by patients.
I am struggling with the hazard analysis because hazardous situations and associated harms related to the pen are pretty straight forward but I am not at all sure how to identify and incorporate the hazards related to the mAb.
Isn't the administration of the wrong dosage of the mAb almost always the hazardous situation (either under- or overdosage)? If so, I am not sure how to specify the resulting harm. Do I associate the hazardous situation with the adverse effects of the mAb? Do I proceeed the same way as with the hazards related to the pen? My problem is that administration of the wrong dosage can be linked to many different reasons and at the same time linked to many different adverse effects but none of this would be possible if there is no misuse of the pen.
Therefore how do I calculate the probability of harm for the mAb?
If anyone has an example of an analysis of such a product, I am interested in purchasing it. I guess any prefilled pen could help me as the rationale will be the same (??)
My main challenge is that I cannot get my head around the differentiation of the pen-associated VS the mAb-associated hazards (e.g., you cannot overdose the medicine if you are using the pen correctly, therefore how does a hazard directly from the mAb may arise?)
Any help will be much appreciated
I am working with an integral combination product, a prefilled, single-use pen intended to administer a monoclonal antibody. To be used by both HCPs but also to be self-injected by patients.
I am struggling with the hazard analysis because hazardous situations and associated harms related to the pen are pretty straight forward but I am not at all sure how to identify and incorporate the hazards related to the mAb.
Isn't the administration of the wrong dosage of the mAb almost always the hazardous situation (either under- or overdosage)? If so, I am not sure how to specify the resulting harm. Do I associate the hazardous situation with the adverse effects of the mAb? Do I proceeed the same way as with the hazards related to the pen? My problem is that administration of the wrong dosage can be linked to many different reasons and at the same time linked to many different adverse effects but none of this would be possible if there is no misuse of the pen.
Therefore how do I calculate the probability of harm for the mAb?
If anyone has an example of an analysis of such a product, I am interested in purchasing it. I guess any prefilled pen could help me as the rationale will be the same (??)
My main challenge is that I cannot get my head around the differentiation of the pen-associated VS the mAb-associated hazards (e.g., you cannot overdose the medicine if you are using the pen correctly, therefore how does a hazard directly from the mAb may arise?)
Any help will be much appreciated
