Challenge #25 : My patient received the wrong treatment or the wrong dose, What should I do?

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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to look at a new topic. There’s been an error in the administration of medication. What can we do about it? So, you’re a clinical research fellow and you find out there was an error in the administration of the treatment. What I would like to tell you first is that you should always refer to your protocol to determine whether there is such an error and discuss it with your project leader. Here, in this video, I am going to give you a basis for reflection, but it is with your project manager that you must see how to react.

Having said that, it was a warning with your project manager but also with the doctor. Now, we will see in detail the various errors that could occur. So, it could be on a rather small error. For example, maximum 10%. It all depends on the study and the drug. 10% can have a big impact. It all depends. But a small error. But if in this case, we may be in a minor deviation.  In that case, you can have the case where you have a major deviation, where the dose is really much higher than expected. And then you can also have the case where there’s an outright error in the treatment given. That is, for example, the treatment was administered when it was not the right one to be administered. Finally, there was a huge error in the treatment. So, in that case, what you have to do first is to go see the investigator, tell him what you have found to see in terms of safety what should be done for the patient. So this discussion can take place between the investigator, the medical monitor, the doctor who specializes in the product under study, who works on the studies, and the project leader. It’s a collegial discussion about what should be done.

Maybe there will be immediate actions to be taken in terms of security or maybe there is no specific action to be taken, but it must be done with all these people and your role is to pass on the information as quickly as possible to the investigator, but also to the project leader and the team’s doctor or medical monitor. It will have to be analysed. First of all, we’ll look at the security aspect, then we’ll see how we can prevent this from happening again. So, to prevent this from happening again, we’re going to have to analyze. The error may be due to a number of situations, it may be the fact that a document has been incorrectly completed. So, how can this be avoided?  It could be related to the fact that a machine was incorrectly calibrated. How can we avoid this? It could be the fact that a person starts working on the study without being trained. How can we ensure in the future that the people who interact in the study, especially for example pharmacy assistants, who have a big role to play when preparing chemotherapy, for example, we must ensure that these people are properly trained in the study, because if they make a mistake on the preparation, it can be problematic. So they need to know. If there is a specificity in the preparation, they have to know about that specificity. That’s it, or there may be a flaw in the quality control.

Since, in general, during the preparation of drugs, quality control must be carried out on procedures that are carried out in pharmacies. Has quality control been carried out in the context of the transmission of medicines, the administration of medicines? You need to check these points. The doctor in all cases must be retrained about the protocol and the administration of treatments. I think you have to inform the doctor, the project manager, the medical monitor, find solutions and then of course always document. The documentation is done in the report, in the follow-up letter, by email. All of this must be kept and filed as part of the study and the communications that are made between medical monitor and the investigator, possibly to the project manager, must also be kept as proof of what happened.

I hope this video has helped you. If you want to know more about the research, you should go to the link here, the clinical research blog. If you liked this video, please put I like and you can comment, it will be my pleasure. I’ll get back to you. If you want to know more about Pharmaspecific, our CRO you can go on the link. You should also know that Pharmaspecific has created a white paper to help you better understand clinical research and you can download it at the bottom of the video. It is a summary of our experience in clinical research. So the experience of our team. That’s it, so feel free to get it back. Thank you, see you soon.

Bye. Bye, guys.