Redispensing of Medication: World’s First Sensor-Controlled Program

The following edited, excerpted interview by the ELPRO Leading Minds Network features Dr. Charlotte Bekker and Lisa-Marie Smale, PharmD, detailing their extensive research on their redispensing of medications initiative at Radboud University Medical Center utilizing ELPRO LIBERO ITS electronic indicators to monitor temperature and manage the stability budget of the medication.

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Martin Davis –Moderator:
Hi everyone and welcome to this special interview of the Leading Minds Network powered by ELPRO. I'm pleased to have with us on our interview today Dr. Charlotte Bekker and Lisa-Marie Smale. Tell us a little bit about your role, what you're doing, and then we can talk about your project.

Lisa-Marie Smale:
My name is Lisa-Marie, and I'm a pharmacist from the Netherlands and I'm investigating medication waste. I started this in 2020 under the supervision of Charlotte. We are focusing on expensive drugs and how to prevent waste by redispensing unused drugs of good quality.

Martin Davis - Moderator:
Lisa-Marie, thank you. Charlotte.

Charlotte Bekker:
My name is Charlotte Bekker and I am a biomedical scientist by background. I work as a researcher at the Radboud University Medical Center. I lead multiple projects on waste reduction, sustainable pharmaceutical care, medication adherence, and optimized dosing of expensive drugs. Today we are talking about a topic that is close to my heart. I did my Ph.D. in this field and now we have a very nice research team, including Lisa-Marie, working on this topic to see whether we can also re-issue expensive drugs.

Martin Davis - Moderator:
That's great. Very, very interesting topic. So let's start by having you tell us a little bit about the project. What were you trying to accomplish when you first set out to do this?

Charlotte Bekker:
We aim to reduce medication waste that occurs at the patient level. What we see is that a lot of patients, when they use their medications, they switch at therapy. They could go to another dosage, they could go to another drug, or they discontinue the therapy early and many medications remain unused. At this moment, we collect them in the pharmacy and then we dispose of them in an environmentally friendly way.
Back when we started, we were first exploring the extent of this problem. We asked, “Do we face a problem here?” We saw that many good quality products are wasted. We asked ourselves, could we not work towards a more secular system and give the medications that we currently wasted a new purpose. Can we not take them back into the pharmacy and give them to patients. So that's how we started this project.

Lisa-Marie Smale:
I think the most important and innovative part of our project is that we assure the medication quality upon re-dispensing. In order to do this, we have a special quality control process in place in the pharmacies.

Martin Davis - Moderator:
All right. So Lisa-Marie, can you walk us through that process?

Lisa-Marie Smale: ((INSERT VIDEO--VIDEO VO BELOW))
To show the quality of medication that remains unused by patients, we dispense the medication in a particular way to our patients. First, we put the medication in a special bag that includes a patient flyer with information. Secondly, we use a LIBERO ITS temperature indicator, which you can easily activate by breaking the label. We put that temperature indicator inside of the bag as well. Then we seal the bag. The bag consists of a special seal that shows any attempt of opening to prevent any tampering of the medication.
The flyer includes information for patients. For example, that they can only open the sealed bag when they initiate the medication. If they have any leftover medication they return it to the pharmacy, and the pharmacists will verify the quality of the medication by looking at three quality criteria. First, the sealed bag must be unopened. Secondly, the medication must have a remaining shelf life of at least six months. Last, with the temperature indicator, we verify the medication was stored according to the product label claim.
If all these quality criteria are met, we can then redispense the medication to another patient that participates in the project and needs the same prescription instead of throwing the medication away like Charlotte just mentioned.

Martin Davis - Moderator:
Very good. Thank you for that walkthrough. Let's move on to the next question. Tell me a little bit about the rationale. Why did you decide to do this particular project?

Charlotte Bekker:
So, the question of “why” relates to the research that we did before we actually started this project. We have been working on this for seven years and what we see with this medication waste problem is that-- at least in the Netherlands--we dispose of more than a hundred million Euro of “own-use” medications each year. This leads to a huge financial loss and we are facing limited healthcare budgets. So, we need to think about where can we save money, but also where can we do better for the environment. Those are two domains where we hope to show benefit. On one side, we reduce medication waste and it leads to cost savings. On the other hand, that we can reduce the environmental pollution because we do not need to dispose of these medications.

Lisa-Marie Smale:
Yeah. I totally agree with that, and I want to add something as well. The environmental burden of medication is of course associated with incorrect disposal. As Charlotte just described, people are not aware that it [medicine] has to be disposed of as chemical waste. It often ends up as household garbage, or is flushed through the drain or toilet. That directly pollutes the environment and leads to great disturbances of the ecosystems. Then if you think about it again, there are also carbon emissions associated with the production and distribution of the drugs that go unused, so there we can also do better. That is why this project was initiated.

Martin Davis - Moderator:
Interesting. Okay. Thank you for that. So how did you gain support for the project?

Charlotte Bekker:
Over the past years, we have had quite a lot of discussion. When we talk about support for this project, it depends on financial support. However, the success of the project also depends on patient and stakeholder support. So when we think about re-dispensing, what I would like to highlight is that we are the first worldwide who are evaluating this process as part of normal patient care. Some donation schemes in place collect unused medicines from health facilities, for instance. However, they dispense it to people who cannot afford normal healthcare. Also to uninsured people.

When we think about redispensing, what I would like to highlight is that we are the first worldwide who are evaluating this process as part of normal patient care.

Dr. Charlotte Bekker

What we do here in the Netherlands is that we include it as part of usual care. So we collect it from patients in the home setting, we dispense it, and re-dispense it to another patient in a home setting. After this quality control--and this is totally new--it's quite an easy solution. However, it has not been evaluated or implemented anywhere yet, mostly because of the quality concerns. This is a long answer, but when we started, we were also looking into the patient perspective because the patient has a big role in this process. The patient needs to accept the re-dispensed medication; they need to trust the medication.

Martin Davis - Moderator:
Sure.

Charlotte Bekker:
So I think the patient's support is very important. Aside from that, we also needed the support from the healthcare provider. For instance, is the pharmacist willing to guarantee the quality of the returned products? Is it feasible on a national level? Can we have stakeholder support from the Ministry of Health, the health insurance companies, and so on? Every stakeholder in the pharmaceutical supply chain is involved in some way and they need to be supportive of this idea.
We had a lot of discussions and also a lot of research looking into their views, their concerns and their preferences in order to optimize the program that Lisa-Marie is currently running. In the end, based on the data we collected, we were able to get some funding for this larger project to use the temperature device monitoring system. This program is part of usual care.

Martin Davis - Moderator:
That sounds like a phenomenal effort to get all of those stakeholders involved. I'm sure there were challenges along the way. Lisa-Marie, can you share with us some of those challenges?

Lisa-Marie Smale:
Of course. We were quite surprised that all the stakeholders were willing to think along with us because medication waste was such a frustration for almost everyone. So there were not a lot of challenges there, but there were some operational challenges. The most important drawback relates to political regulations here in the Netherlands. We follow European law, which includes the EU Falsified Medicines Directive (FMD). This directive prevents falsified medications in the pharmaceutical chain by labeling and tracing medication through the entire chain.
We extract the medication back from the chain by dispensing it through the first patient, and then we have to put it back in the chain because we want to re-dispense it to a second patient and that intersects with this falsified medicine directive. So that was quite a challenge for us.

Charlotte Bekker:
Yes. I would like to add something to that. So, we have to do our due diligence on the operational logistical level. Over the past seven years, we have been working on this. In the beginning, I experienced quite a bit of resistant on an international level. Let's say in other countries, whether they were open to this idea to implement this also as part of usual care. I think in the Netherlands we were, or we are, quite open to innovation and out of the box thinking, and over the past years, as you probably have experienced as well, is that sustainability is a huge topic of debate, and we see many things going on. We see a lot of mind-changing and behavioral change as well.
And that was very good for us. It enabled us to make this project even bigger. When I look at an international level, I think a lot can be learned from us or I hope that also other countries will follow our initiative.

Martin Davis - Moderator:
Yes. Very good. So what about the logistical challenges? Talk to us about the European regulations, the quality criteria, and those types of things.

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Lisa-Marie Smale:
Oh, yes, of course. So how did we proceed with the Falsified Medicine Directive? We contacted our policymakers in the Netherlands. We collaborated with all stakeholders and the stakeholders at the Radboud board. And that really helped us along. We spoke with policymakers, payers, the pharmaceutical industry, but also to professional associations. Of course, as researchers, we were involved in this board and we discussed a lot of the problems that we faced. In collaboration with the Dutch government, we came up with an exception to the FMD for our research project. We're still investigating the opportunities, and how to proceed with this as regular care after the research has been ended. So it's an ongoing process. This board was also involved in quality criteria, but Charlotte can tell a little bit more about that.

Charlotte Bekker:
From the quality criteria perspective, the biggest initial challenge was how to guarantee the quality of medications that patients have stored at home. In addition, it is the main reason why many countries do not allow the re-dispensing of unused medications. I think one of the most important factors is the storage temperature. We had many discussions with health care professionals to see how we can guarantee the storage temperature. With the right technological solutions like ELPRO LIBERO ITS as a temperature-monitoring device, we can easily monitor storage conditions, which allows us to see whether we can take the medication back in stock and give it to another patient.

With the right technological solutions like the ELPRO LIBERO ITS as a temperature-monitoring device, you can easily monitor storage conditions...
Dr. Charlotte Bekker

We wanted to do this in the most convenient way. We are currently running a large-scale project in oncology care. In our hospital alone, we have around 1,500 patients. We have this project running in multiple hospitals. So we have around 1,000 patients participating in our study for 12 months. On average, patients get a new medication package each month. Therefore, we need a lot of temperature monitoring devices. They need to be cheap, but they need to give us the guarantee that we can monitor storage quality and storage temperature adequately.
We were considering disposable temperature devices versus reusable temperature devices. We know it is difficult to get those temperature devices returned to the pharmacy. From a sustainability perspective, the challenges we discussed were reduction of medication waste and not causing more waste with disposable temperature devices.

Martin Davis - Moderator:
Sure. Okay. Let's talk about the approach in searching for a solution. You talk about your collaboration with the Ministry of Health and, and some of the challenges that you faced in terms of your criteria.

Lisa-Marie Smale:
Yes, I would like to highlight two operational challenges. As Charlotte mentioned, not all patients are participating in our program. So we have to work with a “double stock” and that was quite a logistic challenge. We asked patients to give permission to participate in the redispensing program and about half of these patients participated. That means that only these patients can receive re-dispensed medication. For these patients a separate dispensing process, and a separate (medication) stock, has to be in place. Therefore, we needed a second administration system.
As a pharmacy, another very important challenge for us is that we do not want to profit from redispensing. So when we re-dispense the medication that has already been paid for, we reimburse this money to the organization that bates the price of the medication in the first place. However, that can get quite complicated.

Martin Davis - Moderator:
Okay. Charlotte, anything to add?

Charlotte Bekker:
Regarding your first question about rule of the Ministry of Health, when we started they were more observative. A lot of the initiatives started bottom up. Along the way, when we showed more evidence in support of this idea, they became more active to make our project succeed. They discussed it during parliament sessions and, as Lisa-Marie explained, we are still facing legal barriers with the European law. However, they have allowed us to work on this research project in the meantime, to show some evidence. Sometimes you need to think out of the box and follow paths that are not the regular paths. That's how innovation and new processes start. I think we were very lucky that they were willing to give us this opportunity, knowing that we are facing this European legal barrier, and we can still work on this on the national level. Because they also see that we need to tackle this problem of medication waste and to make health care more sustainable.

Martin Davis - Moderator:
What was the timeline for this project? Was this happening during the COVID-19 pandemic?

Lisa-Marie Smale:
Yeah. Definitely. We started with this project the beginning of 2021, so the restrictions were still in place.

Martin Davis - Moderator:
So, were there any particular challenges in that regard, conducting the study, or was it just following the safety protocol that your country has put into place.

Lisa-Marie Smale:
We followed along with COVID restrictions, but it was a little bit harder to include the amount of patients that we aimed to include. Although oncology care was trying to go along as planned, of course, it was still less than before. So that was kind of a drawback, and we're still including patients at the moment for that reason. For us, patients are the key because they have to be willing to participate in a redispensing program for it to work. Therefore, we put a lot of effort in obtaining patient support, working with patient representatives, interviewing oncology patients about their willingness to participate in the redispensing program and determining any underlying factors. That helped out, designing our programs to cater to patient needs.

Martin Davis - Moderator:
Was there reluctance among the patients, or did you find most were willing to participate in the project?

Lisa-Marie Smale:
Patients were quite motivated to participate in the project because they can see that oncology care is so expensive. They also wanted a more sustainable system in terms of costs and the environment. They insisted on a good quality of their medication, which makes a lot of sense when having cancer. Of course, they need good treatments! The redispensing program cannot alter the quality of the medications. So therefore the quality restrictions were really important for us.

Martin Davis - Moderator:
That's great. Okay. So let's talk specifically about the temperature monitoring device that you used, the LIBERO ITS that helped you maintain the temperature control, obviously the monitoring, the stability budget, and then also the reporting. Can you elaborate on that a little bit?

Lisa-Marie Smale:
I would like to highlight that the medication we use is already packaged in blisters. So it's already protected from influences of light and humanity. Therefore we needed the solution to verify the temperature in which they were stored. We only include a medication that has to be stored at room temperature in our studies. Usually that goes well, but of course, you want to guarantee the quality, as I explained. So therefore, we needed a temperature-monitoring device. For several reasons, we chose the ELPRO LIBERO ITS for that purpose. First, it's quite small, lightweight and convenient for patients because they don't have to carry it along. Secondly, the read out options are quite easy. You can, push the button and then they will blink a light, which is either green or orange. So within the pharmacy practice, we can easily read out the temperature indicators and it doesn't take much time.
For the research, we can access a full read out and that provides information on the maximum/minimum temperature. Also, how much time the medication was stored between certain temperatures. That can be quite interesting for our research. It is also interesting to see how patients stored their medication. So, that was quite an advantage as well. Lastly, liked Charlotte explained, the battery life of the ELPRO LIBERO ITS, is four years. So that makes it possible to reduce waste by reusing the temperature device as well, if possible. That was quite a “pro,” for us to be as sustainable as possible.

Martin Davis - Moderator:
Okay. Charlotte, anything to add to that?

Charlotte Bekker:
Yeah. We looked at many devices to determine whether they fulfilled our requirements. We also wanted to have a device that was already validated. We saw many devices being used, or being developed, that could not provide a full validation report. When we are talking about patient safety we wanted to be sure that the company was able to give us the assurance that the device was validated and it actually measures what it's intend to measure in an accurate manner. I think with ELPRO, when we look at your experience and all the products that you offer, we were fairly confident that we would have this data and the reporting you were able to provide. So your device was, for us, very helpful and convincing.

Lisa-Marie Smale:
Because ELPRO was able to provide the calibration certificates, we did not need to validate the temperature indicators. We did perform small experiments just for the sake of it, exposing the loggers to different circumstances, to validate the use of them and that worked out really well. We’ve been using them for patients now since the beginning of 2021.

Martin Davis - Moderator:
Okay. So let's talk a little bit about the results. We've talked about the challenges, the processes, and the procedures that you had to go through to get your research in place. So let's talk about the numbers a little bit. Can you quantify some of the results?

Lisa-Marie Smale:
Yeah, definitely. Maybe it is good to state that Radboud University Medical Center is not the only hospital participating. So, we have four Dutch hospitals participating in this project. Right now almost 1,000 oncology patients are included in the redispensing program. I can say that we save more and more returned medication every week--sometimes even up to 10 packages a week. You have to realize that every package is worth about 3,000 euros on average. That's quite a lot of money. The most expensive medication package was worth 14,000 euros, we were really happy that we could approve the quality of that package, that it was still good, and we didn't have to dispose of it. We are investigating the cost savings we can make and we are aiming to re-dispense medication worth 500,000 euros in this project. I can give you a little teaser: we are almost halfway there, so that is quite an accomplishment already!

Martin Davis - Moderator:
Wow. Congratulations on that. That is awesome. So what are the plans after the trials have concluded?

Lisa-Marie Smale:
For medication redispensing, if they are successful for oncology care, we believe that it should become standard of care. So therefore, we are collaborating with all the stakeholders in place. We hope that the cost savings we can obtain within this project will incentivize policymakers to think about and organize this within the current healthcare system. To accelerate this process, we should not look only at cost savings, but also at the environmental footprint.
We're also investigating the implementation of medication redispensing to realize this for the entire country. After that, maybe the entire world?

Martin Davis - Moderator:
This study included primarily oncology medication, correct? Are you looking at other types of medication or other groups of medications that it would be appropriate for as well?

Charlotte Bekker:
No, not yet. We chose oncology patients. It's quite a large patient group. They have a lot of treatment changes when they experience side effects, for instance, or inefficacy. When they switch to another drug, the old one remains new, unused. So there's also quite a lot of waste and the drugs are expensive, but it works more like a proof of concept study. Therefore, we chose the oncology field. When we show the benefits, we hope that we can implement it for any expensive drug therapy. What would be even better, but I don't think we are there yet, is that we can also implement it for lower priced medications. There, the volume of medication waste is quite substantial.
So, not only the expensive therapies, but also for local therapies, I think that will be great. At least we can implement it for the expensive therapies, hopefully in one, two years, and then maybe in five or 10 years for the locals therapies. So, it becomes a normal practice, like when you return your batteries for proper disposal. You also do it for your medication, those returned medications that are still of good quality, they will be redispensed through another patient.

Martin Davis - Moderator:
Very interesting. Do you have any recommendations for others who might be interested in heading similar trials or looking into this further? Patients are, and stakeholders were, key to process. How important is it for everybody to get onboard?

Charlotte Bekker:
I think on one side it's very important to get to know your stakeholders in force in your process: involve them in a working group. If it doesn't work out right away, continue to think about sustainable solutions and what you can do. Start very small, maybe just locally in your hospital or in your ward or department, and find some support there. Then you can build your group and see whether you can perhaps attract national stakeholders like the health authorities. There are multiple strategies. Just continue. If you believe in the idea at one point you will get there.

Lisa-Marie Smale:
I can only agree with Charlotte. I think if you have a vision--and we do--we believe that you should follow it and we believe that no medication of good quality should go to waste.

Martin Davis - Moderator:
Okay. It's been great to have you all in the interview today. It's been my pleasure to talk with you about this project and we wish you well with your future endeavors in it. You're obviously making an impact on the lives of a lot of people by providing affordable health care and making medications more effective and more affordable. So good luck to you both. We hope to have a follow-up interview in the future to see how things are going as you progress with your research and your project. Thank you very much for your time today.

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