Radiation Safety Considerations for the Authorized User when Operationalizing Lutetium-177 in the Urology Clinic - Robert Brookland
October 13, 2023
Phillip Koo converses with Robert Brookland about the intricacies of implementing a PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) program. Dr. Brookland, who serves as both the radiation safety officer and the authorized user, elaborates on the pivotal role of an authorized user in patient selection, treatment monitoring, and patient counseling. He also discusses the importance of experience with radiopharmaceuticals for becoming an authorized user. Shifting focus to radiation safety, Dr. Brookland emphasizes a team approach, involving physics consultants and adhering to state and national guidelines to ensure the safety of patients, staff, and the community. He provides detailed counseling strategies for patients, including precautions related to urinary elimination and proximity to others. Lastly, Dr. Brookland shares his positive experience with PLUVICTO's safety profile, noting minimal side effects.
Biographies:
Robert Brookland, MD, Radiation Oncology, Chesapeake Urology
Phillip J. Koo, MD, Division Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Arizona
Biographies:
Robert Brookland, MD, Radiation Oncology, Chesapeake Urology
Phillip J. Koo, MD, Division Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Arizona
Read the Full Video Transcript
Phillip Koo: Hi, this is Phillip Koo. We're continuing our discussion looking at how to operationalize and integrate a PLUVICTO program into a large urology group practice. We're continuing our discussion focusing on the authorized user and the radiation safety considerations. And we have with us Dr. Rob Brookland, who's a radiation oncologist here at Chesapeake Urology, and also serves as the authorized user and the radiation safety officer for this program. So thank you very much for joining us.
Robert Brookland: Pleasure to be with you.
Phillip Koo: So can you talk to us and the readers about what the authorized user means, what their role is, and how pivotal it is to a PLUVICTO program?
Robert Brookland: The critical issue in administering this type of sophisticated treatment is to have the appropriate selection of patients and someone who's authorized to administer that treatment. And so that's where folks like me come in because not everybody's going to be an appropriate candidate for that. And as with any significant medical therapy, you need to be able to monitor the delivery of the treatment, effects of the treatment, manage any side effects, and be able to counsel patients. So that's where the authorized user comes in.
Phillip Koo: And for you as a radiation oncologist who's been practicing for a while, were there any special certifications or anything that you needed to do in order to be an AU for this type of treatment?
Robert Brookland: Certainly their experience using radiopharmaceuticals is important, and in the training of nuclear medicine physicians and radiation oncologists have in their training the experience of administering radioactive substances, it comes in many forms. And these liquid radiopharmaceuticals that are administered are continually evolving from what our limited arsenal was several decades ago to the really more transformational drugs and medicines that we're currently using.
Phillip Koo: So you serve a unique dual role here where you're the authorized user and also serve as the radiation safety officer. Can you talk about the role of radiation safety officer in a PLUVICTO program?
Robert Brookland: So to be frank, at our program, there's more than just me involved in radiation safety. We have physics consultants who help us as well. There are certain requirements that the state has and there's the national guidelines and societies that recommend how to keep our patients safe and also the community safe, the caregivers safe. So we need to make sure that the environment is safe for staff. We have to make sure that it's safe, of course, for the patient, but others around the patient. And so there are monitoring requirements. There is making sure that the materials are being handled safely, the reception when the drugs are shipped in, how that's stored, the handling of it, how after treatment it's stored, the surveying to make sure that the space is not radioactive, the counseling that's given to the patients. It's all part of the radiation safety requirements.
Phillip Koo: I think that's a great point that even though the radiation safety officer might be designated as one person, it really is a team of individuals or a team of lots of people that really make sure it happens correctly. So let's shift gears a little and talk a little bit about the clinical aspects with regards to Lutetium-177 PSMA. It's a new drug, it's a novel drug. How do you counsel your patients with regards to the mechanism of action and just what it does and how it works?
Robert Brookland: Well, one of the important things to understand about PLUVICTO is that while much of the drug is going to be absorbed appropriately in areas in the body, some of the medicine is going to be eliminated from the body. And a prime route of elimination is through the urinary system. This means that the urine is going to be radioactive. So we have counseling for our patients considerations when in the restroom. For example, I instruct my patients to sit rather than stand when using the restroom to cut down on splashing. Also, if there's any leakage, I counsel them on what to do with the underwear, for example. Or if they were using pads, if there's any leakage onto those areas, what to do with that material. You can't just throw it in the wash. So we counsel them on how to safeguard that material. We talk about the half-life of Lutetium 177, which is 6.6 days.
And from a radiation safety standpoint, for something to be non-radioactive or non-concerning, you multiply the half-life times 10. So that's two months. So if you've got some soilage, you need to put that stuff away for the better part of two months. So we talk about that. We also talk about their proximity to other people because most of the medicine is in their body. And yes, there's this relatively rapid decay of the radioactivity. Nevertheless, for the first two or three days, we don't want our patients sleeping in bed with their partners. We talk about safety considerations as it relates to sexual activity for a week and just keeping safe distances. And like any radioactive material, the dose falls off dramatically with distance, it's what we call the inverse square law. So the further away someone gets from another, the vastly reduced doses and exposure other individuals would get. So we talk about safe distances. We talk about not sharing the same bed for three days, let's say, and limiting sexual activity initially. So these are important considerations as well.
Phillip Koo: I think those considerations, it's interesting how they vary and I think it really reflects the fact that different states have different regulations and it gets quite complicated, but it's always nice to be able to refer to some local resources to help make those decisions.
Robert Brookland: Yes, I think always in setting up a program, you need to understand what the local requirements are as well as the national requirements, which in fact may be under reevaluation. So different clinics are going to use different strategies for ensuring that the radiation safety issues are respected even before the patients are discharged. And that can vary in each, I think site is going to take into consideration the local considerations before determining what's the right way of preparing their space and protecting their staff. It will vary.
Phillip Koo: So as the authorized user and as a practice that's participated in trials and now offering this drug commercially, side effects are a topic that often comes up. Sort of what's your experience been with the side effects and any advice you have to those people looking to get into this space on how to prepare and manage some of these adverse events.
Robert Brookland: We've been very fortunate. It's been a very favorable safety profile. It's one of the things that makes it nice to use this medication. Very few of our patients actually have concerning side effects. You can see lowering blood counts. You can see nausea or vomiting or diarrhea or dry mouth or dry eye. These are some of the possible side effects that you might see. I've been impressed at how few, the number of complaints that I've seen from patients have been, and I've been using this even before it was clinically available on clinical trials. I've been working with Lutetium-177 for many years.
Phillip Koo: Well, thank you very much for sharing your experience with us, and we look forward to learning more about what you guys do here at Chesapeake.
Robert Brookland: It was a pleasure speaking with you.
Phillip Koo: Hi, this is Phillip Koo. We're continuing our discussion looking at how to operationalize and integrate a PLUVICTO program into a large urology group practice. We're continuing our discussion focusing on the authorized user and the radiation safety considerations. And we have with us Dr. Rob Brookland, who's a radiation oncologist here at Chesapeake Urology, and also serves as the authorized user and the radiation safety officer for this program. So thank you very much for joining us.
Robert Brookland: Pleasure to be with you.
Phillip Koo: So can you talk to us and the readers about what the authorized user means, what their role is, and how pivotal it is to a PLUVICTO program?
Robert Brookland: The critical issue in administering this type of sophisticated treatment is to have the appropriate selection of patients and someone who's authorized to administer that treatment. And so that's where folks like me come in because not everybody's going to be an appropriate candidate for that. And as with any significant medical therapy, you need to be able to monitor the delivery of the treatment, effects of the treatment, manage any side effects, and be able to counsel patients. So that's where the authorized user comes in.
Phillip Koo: And for you as a radiation oncologist who's been practicing for a while, were there any special certifications or anything that you needed to do in order to be an AU for this type of treatment?
Robert Brookland: Certainly their experience using radiopharmaceuticals is important, and in the training of nuclear medicine physicians and radiation oncologists have in their training the experience of administering radioactive substances, it comes in many forms. And these liquid radiopharmaceuticals that are administered are continually evolving from what our limited arsenal was several decades ago to the really more transformational drugs and medicines that we're currently using.
Phillip Koo: So you serve a unique dual role here where you're the authorized user and also serve as the radiation safety officer. Can you talk about the role of radiation safety officer in a PLUVICTO program?
Robert Brookland: So to be frank, at our program, there's more than just me involved in radiation safety. We have physics consultants who help us as well. There are certain requirements that the state has and there's the national guidelines and societies that recommend how to keep our patients safe and also the community safe, the caregivers safe. So we need to make sure that the environment is safe for staff. We have to make sure that it's safe, of course, for the patient, but others around the patient. And so there are monitoring requirements. There is making sure that the materials are being handled safely, the reception when the drugs are shipped in, how that's stored, the handling of it, how after treatment it's stored, the surveying to make sure that the space is not radioactive, the counseling that's given to the patients. It's all part of the radiation safety requirements.
Phillip Koo: I think that's a great point that even though the radiation safety officer might be designated as one person, it really is a team of individuals or a team of lots of people that really make sure it happens correctly. So let's shift gears a little and talk a little bit about the clinical aspects with regards to Lutetium-177 PSMA. It's a new drug, it's a novel drug. How do you counsel your patients with regards to the mechanism of action and just what it does and how it works?
Robert Brookland: Well, one of the important things to understand about PLUVICTO is that while much of the drug is going to be absorbed appropriately in areas in the body, some of the medicine is going to be eliminated from the body. And a prime route of elimination is through the urinary system. This means that the urine is going to be radioactive. So we have counseling for our patients considerations when in the restroom. For example, I instruct my patients to sit rather than stand when using the restroom to cut down on splashing. Also, if there's any leakage, I counsel them on what to do with the underwear, for example. Or if they were using pads, if there's any leakage onto those areas, what to do with that material. You can't just throw it in the wash. So we counsel them on how to safeguard that material. We talk about the half-life of Lutetium 177, which is 6.6 days.
And from a radiation safety standpoint, for something to be non-radioactive or non-concerning, you multiply the half-life times 10. So that's two months. So if you've got some soilage, you need to put that stuff away for the better part of two months. So we talk about that. We also talk about their proximity to other people because most of the medicine is in their body. And yes, there's this relatively rapid decay of the radioactivity. Nevertheless, for the first two or three days, we don't want our patients sleeping in bed with their partners. We talk about safety considerations as it relates to sexual activity for a week and just keeping safe distances. And like any radioactive material, the dose falls off dramatically with distance, it's what we call the inverse square law. So the further away someone gets from another, the vastly reduced doses and exposure other individuals would get. So we talk about safe distances. We talk about not sharing the same bed for three days, let's say, and limiting sexual activity initially. So these are important considerations as well.
Phillip Koo: I think those considerations, it's interesting how they vary and I think it really reflects the fact that different states have different regulations and it gets quite complicated, but it's always nice to be able to refer to some local resources to help make those decisions.
Robert Brookland: Yes, I think always in setting up a program, you need to understand what the local requirements are as well as the national requirements, which in fact may be under reevaluation. So different clinics are going to use different strategies for ensuring that the radiation safety issues are respected even before the patients are discharged. And that can vary in each, I think site is going to take into consideration the local considerations before determining what's the right way of preparing their space and protecting their staff. It will vary.
Phillip Koo: So as the authorized user and as a practice that's participated in trials and now offering this drug commercially, side effects are a topic that often comes up. Sort of what's your experience been with the side effects and any advice you have to those people looking to get into this space on how to prepare and manage some of these adverse events.
Robert Brookland: We've been very fortunate. It's been a very favorable safety profile. It's one of the things that makes it nice to use this medication. Very few of our patients actually have concerning side effects. You can see lowering blood counts. You can see nausea or vomiting or diarrhea or dry mouth or dry eye. These are some of the possible side effects that you might see. I've been impressed at how few, the number of complaints that I've seen from patients have been, and I've been using this even before it was clinically available on clinical trials. I've been working with Lutetium-177 for many years.
Phillip Koo: Well, thank you very much for sharing your experience with us, and we look forward to learning more about what you guys do here at Chesapeake.
Robert Brookland: It was a pleasure speaking with you.