Challenge # 17: Monitoring at the pharmacy, what to check?

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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to talk about a new topic. What to look for when you’re being monitored at the pharmacy?

Indeed, when you do monitoring at the pharmacy, you have two types of checks to do with the investigator, and then there is also a part that often takes place at the pharmacy. There may also be other monitoring. Monitoring in the radiology department, especially in clinical studies with oncology treatments, and then there is also a visit to the hospital’s analysis laboratory. There we will talk about the visit to the pharmacy. You will first have to look at the overall accounting. There are treatments that are going to be sent by the pharmaceutical laboratory, and you have to make sure that the treatments sent have arrived. You will verify this by means of acknowledgements of receipt that will be signed by the pharmacist and then sent back to confirm that the treatments have been received. Then you will verify that the treatments sent have been received thanks to the acknowledgement of receipt but also by checking the contents of this acknowledgement of receipt against the bottles that have been received or the boxes of treatments that have been received. The second thing to do is the accounting per patient. Here you will look at the treatments that have been consumed by the patients. The patient received a prescription from the investigator, a prescription for the clinical study.

Did he take the treatments required for the study and according to the protocol requirements? So you’re going to check that information. You will also verify whether the patient was compliant in taking these treatments. You can verify this by looking at the number of tablets in the bottles compared to the number of days the patient should have taken the treatments. Sometimes it can be complicated to check for compliance because some patients do not bring back the bottles or bring back some bottles and do not bring back any. However, the investigator must be made to understand that it is absolutely necessary for the patient to bring back the vials and that they must train the patient on this subject. The investigator and his or her clinical trial technician must be well trained in this prerequisite. There’s something you have to be very careful about. It’s when there are vials that are prepared for chemotherapy in oncology. There may be cases of chemotherapy. So we’re looking at treatment and chemotherapy, and in that case you’re going to have to do a dilution of the treatment. We’re going to have to prepare the treatment. This preparation is done by pharmacy assistants and you have to make sure that the preparation is done correctly by reviewing the chemotherapy preparation sheets. This is a very important point and can sometimes be overlooked by some ARCs.  In addition, pharmacy technicians can provide their CVs as part of the study since they are preparing for the chemotherapy treatments in the study. You should ask the pharmacist in charge of these pharmacies for the CVs of all staff involved in your study. In particular, the CVs of those who prepare the chemotherapy treatments. They must also complete the delegation log, i.e. the pharmacy task delegation form. Either the pharmacy’s, you make a specific document for the pharmacy, or the investigator’s, but that complicates things because you have to transport the form from the investigator’s department to the pharmacy on a regular basis. So the best thing is to have a log delegation specific to the pharmacy. You need to look at whether there will be enough treatments throughout the study. So at each monitoring visit, you have to make sure that the number of patients who are going to be included or who are included will be sufficient. For this you will make a balance. In some studies, this balance is automatically done by IVRS, a system that allows for the inclusion of patients, but it depends on the study. Sometimes it’s not done automatically. So you have to make sure that there are enough treatments for the next patients. The pharmacist has to check that, but it is your role to do that. You also have to check the temperature of the treatments, at what temperature are the treatments and if there are temperature excursions.  For example, you may have treatments in the room or treatments in the refrigerator or treatments in the freezer. It’s quite rare, but hey, it may be possible. So, you need to make sure that the treatments are kept at the temperature required by the protocol and that if temperature excursions occur, the treatments are properly quarantined until it is confirmed that you can remove the quarantined treatments. The temperature must be taken continuously. If it is taken manually, a thermometer with a minimum and maximum is required and the temperature must be taken daily by hand. What is the purpose of a thermometer with a minimum and maximum. It is used to find out if the treatment would have had a temperature excursion during the day. Because if you only take the temperature once during the day, it is possible that the rest of the time the temperature might have changed and evolved into an excursion. So, it has to be checked with a thermometer with a minimum and a maximum. You have the possibility to do this check. On the other hand, you have to check the qualification of the people participating in the study at the pharmacy level, both the pharmacist and also the pharmacy assistants.  You must therefore have their CVs and have them on the log delegation. Last thing, you have to check the calibration and maintenance of refrigerators. You have to make sure that the maintenance is done once a year at a minimum and that the temperature sensor of the refrigerator is well calibrated. The calibration must be done at least once a year. Indeed, imagine that treatments are in a refrigerator and that the refrigerator is not calibrated, that the refrigerator’s probe is not calibrated. This means that the temperature announced by the refrigerator is not correct. So you need to do this check. You also need to make sure that the refrigerator is connected to the security PC, the central security station of the hospital because if an alarm goes off someone has to be able to intervene quickly and it is thanks to the connection to this security PC that you can have this possibility. That’s all I had to tell you about monitoring at the pharmacy. I hope it helped you. If you liked this program, please put I like at the bottom of the video. The Clinical Research Blog is a blog where you can get a lot of research information. Feel free to visit it. The address is here and if you want to know more about Pharmaspecific, our CRO specialized in clinical research, you can find out more by going to this address.

I also wanted to tell you that Pharmaspecific has written a guide to help you better understand clinical trials as a CRO and as a project manager. So I encourage you to download this guide. It’s at the bottom of the video. That’s it, thank you for following us and see you soon!

Goodbye.