Drug Safety Matters

#37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa

• Uppsala Monitoring Centre

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Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new routes have been introduced to facilitate reporting for patients and healthcare professionals, including email, WhatsApp and the Med Safety smartphone app. Henry Zakumumpa is a researcher at Makerere University in Kampala, Uganda. He has recently performed a qualitative study to learn more about drivers and obstacles for quality in adverse event reporting from patients and healthcare professionals in Uganda. He joins the Drug Safety Matters studio to help us get a more nuanced picture of challenges and opportunities around the issue.
 
 

Tune in to find out:

  • Why are HIV patients in Uganda reluctant to report adverse events to their healthcare providers?
  • What are the challenges with reporting via WhatsApp?
  • How can regulators and PV centres foster better quality in incoming adverse event reports?

 

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Fredrik Brounéus:

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. I'm Fredrik Brouneus and today I'm looking forward to learning more about drivers of data quality in the reporting of adverse drug reactions. We often talk about the challenge of under-reporting and the large proportion of adverse events that never reach the ears or desks of pharmacovigilance assessors, but the quality of reports is also crucially important, and this is why today's guest, Henry Zakumumpa, at Makerere University in Uganda, decided to explore drivers of data quality in the reporting of adverse drug reactions. He did this in a recent qualitative study where he and colleagues interviewed healthcare professionals and patients at HIV clinics in Uganda. Henry now joins us online from Kampala to tell us about the results from the study and what we can do to improve data quality in the reporting of adverse drug reactions from healthcare professionals and patients. Welcome back to Drug Safety Matters, Henry. We're so glad to have you on the show again, and this time joining us from Uganda.

Henry Zakumumpa:

Yes, absolutely. It's a pleasure to join Drug Safety Matters again and it was a pleasure to be in Uppsala a few days ago.

Fredrik Brounéus:

That's right, you were in Uppsala a few days ago for the ISOP Mid-year Conference, but we didn't manage to meet up then. So it's been three years now since we last had the pleasure of having you on the show, and that was back in April 2022. And the topic then was the safety of HIV medications, and HIV medication safety is also part of today's discussion, but from a slightly different angle. But before we go into that, I was wondering if you could tell us a little about your research at large. What are your key research interests and what drives you as a researcher?

Henry Zakumumpa:

Thank you, Fredrik, for this question. Well, what really drives me is the overwhelming HIV epidemic in Uganda. Uganda has one of the highest populations of people living with HIV AIDS. So we have a huge HIV burden and I've lost people to HIV. My cousin's sisters and my maternal aunt died out of HIV. So I have devoted myself to doing all I can to contribute solutions towards responding to HIV epidemic in Uganda.

Fredrik Brounéus:

Yes, and what got you into pharmacovigilance, because that's quite a special field as well.

Henry Zakumumpa:

That's a good question actually, but what happened is, what attracted me to pharmacovigilance was I think it was 2019. Uganda at the time was rolling out a newer HIV dolutegravir, or DTG, and patients were being transitioned from efavirenz, the older HIV drug. So everybody was saying DTG is the way to go. So they were enrolling people on DTG but then, although it was a superior drug, we got so many complaints from patients. Patients were complaining around hyperglycemia, erectile dysfunction. So I was reading so many letters from patients in newspapers asking for guidance and saying all this new drug, since I started it, I'm getting problems.

Henry Zakumumpa:

I kind of piqued interest, you know, and I happen to be working closer with them, with somebody the Minister of Health in Uganda who's in charge of HIV treatment, and she was sharing with me the challenges. They were receiving a lot of reports around problems with DTG, but they had no research, they had no data and the National Pharmacovigilance Center was saying we don't have reports, we don't have ADR reports. But the patients were really feeling the impact of this drug and the side effects and the adverse events. So that's how I got interested. You know, and fortunately around that same time Uppsala Monitoring Centre was supporting the Consortium for Advanced Research Training in Africa which funded my PhD. It was supporting researchers who are interested in pharmacovigilance research. So naturally I got in touch with the National Pharmacovigilance Center in Uganda so they supported our bid and we successfully got that research grant. So that's how I was launched into pharmacovigilance. So it was out of the problem. Really it was not that I trained as a specialist in this area.

Fredrik Brounéus:

So actually, the topic that we are talking about today around the spontaneous adverse events reporting – that's actually what got you into pharmacovigilance from the beginning, looking at what patients were describing from their new HIV medications, and so this is, in many ways, the backbone of pharmacovigilance systems, the spontaneous reporting, and we often talk about the fundamental challenge of underreporting and the low proportion of events being reported. Do you think it would be fair to say that the quality of reports is an equally big challenge?

Henry Zakumumpa:

You know, that's a fantastic question, Fredrik. You're absolutely right. Of course, Uganda and many countries in Africa have underreporting, and I've seen studies which suggest that only 10% of adverse drug reactions are actually reported to the authorities. So in Uganda, we have that problem as well. However, what has happened in Uganda is we have benefited from so many interventions around piloting new reporting routes, such as the Med Safety app, which I participated in rolling out, reporting via WhatsApp. They even accept email ADR reports.

Henry Zakumumpa:

But when I engaged with the National Pharmacovigilance Center in Uganda, they told us Henry, okay, now, initially we had a problem of under-reporting, but now the volume of reports has increased, which is positive. However, the quality is now a challenge. There's no dosage of the person, when did the onset of the symptoms begin? And so all the details are sometimes missing or you find like a significant number of ADR reports cannot be used for analysis. So that's actually why we launched into this research in the first place, because the NPC in Uganda thought this was a research problem they had and they wanted to understand from the perspective of the health workers, from the perspective of the patients: what are your problems? Why are you giving us incomplete reports? Hence this research which we conducted.

Fredrik Brounéus:

And that research is actually what we're going to focus on here today. This recent study of yours, where you and colleagues at the College of Health Sciences at Makerere University and the National Pharmacovigilance Center at the National Drug Authority, both in Kampala, Uganda, where you explored drivers and obstacles of data quality in adverse events reporting. You've already mentioned that it was a qualitative study, but I was wondering if you could go a little deeper into that.

Henry Zakumumpa:

Okay, okay, thank you. So first of all, as I mentioned earlier on, this study was commissioned by the National Drug Authority or the National Pharmacovigilance Center in Uganda, and it was a research priority. They wanted to understand why we're getting reports that are incomplete, that do not help us to analyze and therefore take regulatory decision-making. So this was a qualitative study, meaning we conducted in-depth interviews with HIV clinicians, we conducted focus group discussions with patients, people who are living with HIV, AIDS. So what we did is we went to 12 HIV clinics across Uganda. So we made sure that the clinics we selected were kind of regionally representative. We got northern Uganda, southern Uganda, eastern Uganda, and also, with a certain level, we had a regional referral hospital at the various levels of service delivery. So we tried to have a really representative sample.

Fredrik Brounéus:

So what did you find out with regards to obstacles and drivers?

Henry Zakumumpa:

Actually this study, in my opinion, revealed many novel things, many new interesting things that we didn't know. For example, we found that patients first of all deliberately under-report because they want to remain on effective HIV therapies. There's this super HIV drug called dolutegravir and patients believe this drug is effective in viral load suppression and so they have seen from their friends. When they report side effects they say I have the erectile dysfunction, I have hypoglycemia, I have nausea, I have insomnia.

Henry Zakumumpa:

Then the clinicians tend to kind of revert them to the old HIV drug and the patient thought that this leads to kind of getting a medication that is not effective. So they deliberately under-report the severity of the ADRs they are suffering. So they don't give all the full extent of the ADRs because they know when they give you the full details of how they are being impacted, how their vision is affected, how they can't sleep at night, then definitely, naturally, you'll say no, we have to take you back to a efavirenz, we have to take you to atanazavir, another HIV drug. So patients are kind of tolerating the adverse drug reactions of DTG because they believe or they perceive this drug to be very effective, to be very effective and from their judgment, they would rather suffer the ADRs you know, than lose an effective regimen, an effective medication.

Fredrik Brounéus:

That must be so important feedback for healthcare professionals to know that this is what patients are fearing.

Henry Zakumumpa:

Yeah, yeah, I think it was. That's number one. Number two, we found that there's a high level of herbal use, especially among HIV patients who are 50 years or older. Now, when they become older, also because of the medication itself, actually, it also leads to NCDs non-communicable diseases like diabetes, hypertension. And now in Uganda HIV treatment is free to the user. The government provides treatment for HIV, partly because also the US government used to support Uganda government to provide treatment free of care. Now we have a challenge of these NCDs, or non-communicable diseases like hypertension. So, although the government claims to offer treatment, patients tell us actually the hospitals don't have the drugs, they're not available. So when they go to a government hospital they might tell them we are out of stock. Please go to a private pharmacy and buy, and many of our people are very poor. So what they do then is they revert to natural remedies. You know, because Africans had these herbal medicines for a long time and they were using them. Of course there are challenges with that, but now many people are taking these drugs. So the clinician has told us Henry, now this person tells you they have these problems, they have insomnia, they have neuropsychiatric problems, but when you ask them what other drugs are you taking? They say "no other drugs". Are you taking herbs? Yes, I'm taking herbs. Then they have a challenge doing causality assessment linking DTG to this problem. So when they're filling these reports, that's another challenge on how to overcome it. Then the other challenge we found was that now, because Uganda has a high HIV burden, hiv clinics in Uganda are congested. There are long waiting times, there is a heavy workload. So the Uganda government and even the American government, because they were supporting it for a long time they devised new approaches to HIV service delivery and these are called differentiated service delivery models. So if you are virally suppressed, in their judgment, you don't need to come to the facility every month for a review because you're virally suppressed. In their judgment, you don't need to come to the facility every month for review because you're very suppressed. So what they say for you we're going to give you a six-month supply of HIV medication. You only come back at least twice a year. So you go to the community or somebody can pick drugs on your behalf.

Henry Zakumumpa:

The aim was to first of all reduce the burden of care on patients, to reduce transport and time spent at facilities and also to decongest the health system. We found that now, when it comes to reporting adverse drug reactions, now this arrangement is problematic because patients come back and then after six months they have been enduring these adverse reactions and we even found some actually die. For example, if you have hyperglycemia and it's uncontrolled for three months, I mean it can lead to death. So they told us, now this is a major problem. Although it was meant to ease the life of patients when it comes to adverse drug reaction reporting, now it's becoming a problem. Because now, when a patient comes after six months, they are telling you about this ADR they suffered, but then recalling events becomes problematic Because when you ask them, when did it begin, what symptom did you get, what drugs were you taking at the time, what other symptoms did you have, and then a patient can only give you bits and bits of information, so they don't give you a full picture that helps you to determine which other ADR is this. You know, do a causality assessment.

Henry Zakumumpa:

Besides patients, we also found that healthcare professionals also are part of the problem. Actually, first of all, the health workers I talked to said they don't have incentive to report. They said they have been reporting. They don't get feedback from the National Pharmacovigilance Center. They told us that reporting is inconsequential. Whether you report ADRs or not, there's no feedback, first of all. Number two, you don't get any guidance on how to manage the patient. Basically, it's inconsequential from their perspective. That's why qualitative research is good, because you understand somebody's psychology, somebody's understanding. That also affects the amount of information they provide on ADR reports, the seriousness with which they take ADR reports, the amount of detail they give in ADR report. So it's like a formality. So they will say oh, this person came here, he had erectile dysfunction. It was for two weeks. So they will skip so many parts of the ADR report and just submit it. Because in their mind, whether they report or not, nothing's going to happen, all right? So health workers have developed kind of complacency.

Henry Zakumumpa:

Now that's also another point. They have kind of – we have submitted this paper for publication and we have called it a professional urgency, where the health worker now says ah, we know what DTG causes. I no longer have to report to the National Pharmacovigilance Center. If a patient comes to me, tells me he has hyperglycemia, I know that's DTG. If he tells me he has erectile dysfunction, I think probably that's DTG. If he tells me he has insomnia, he can't sleep, that's DTG. So what they told us? The clinicians no longer even bother to report to the National Pharmacovigilance Center, you know. So that's a huge problem. They said what I do I manage the patient on my own; I either remove him from DTG, I take him to efavirenz, you know, or I take another clinical decision. So I don't have to bother myself giving a well-detailed report to the NPC, because I know the NPC will not guide me, it will not take any action. So also this situation where health workers manage these ADRs on their own is also, I think, a huge challenge. All right, a huge challenge.

Henry Zakumumpa:

Then also we found some health system issues around laboratory infrastructure, even inputs, basic inputs for reagents to conduct studies, even basic things like liver function tests, glucometers for testing blood sugar. They are not available. For example, if a patient says they have frequent urination at night, I am wasting away. I don't know whether it's because of DTG. The clinician cannot even do a simple test for blood sugar because they lack glucometers, they lack basic test kits.

Henry Zakumumpa:

You know, if you go in rural Uganda, these are real, real problems. They're real, real problems for a a condition. So he may have a hunch that this is hyperglycemia, but they cannot even write it on the ADR report because he has not taken the mandatory three blood glucose fasting, blood glucose tests you know to be able to do to say authoritatively that this is hyperglycemia or diabetes, whatever it is. So we found that there are issues to these issues of under-reporting, incomplete information or inaccurate information, an interaction between patient-based factors, health workforce factors, health system factors. So it's really a complex thing. It's not just a one-factor thing. There's an interaction in the factors that contribute to incomplete documentation of ADRs.

Fredrik Brounéus:

Yes, that struck me as I was reading your paper just the complexity of the challenges, the combination of some material challenges, communicative challenges and also another challenge that you mentioned that clinicians may also hesitate to report events out of fear that it may be due to a medication error, so someone would perhaps point their finger at them.

Henry Zakumumpa:

Oh yeah, oh yeah, they say when they report, they kind of invite scrutiny in their clinical decision making. So they think when they report then they will say oh, did you give the patient the right dosage? Did you guide them properly on how to take these drugs, for example? I'll give you an example: DTG is supposed to be taken in the morning, not at night.

Henry Zakumumpa:

Some of the ADRs of insomnia are because patients are taking the drug at night, contrary to instructions, and so if you report, for example, insomnia, they will ask you did you tell the patient that they have to take this drug in the morning? And then there's an anti-TB drug called isoniazid. You're supposed to put another additional drug to avoid the very toxic effects of the drug, I think, called pyridoxine. There's a drug you have to add on, but at the beginning clinicians were not providing that additional drug. So there was drug toxicity of TB drugs, you know. So now you see, if a patient, if a health worker reports that, then they think that they are going to bring into question their own competence as clinicians. So it's an unfortunate situation.

Fredrik Brounéus:

I was also interested to see that in the paper you say that the majority of healthcare professionals in your study, they preferred to report via the WhatsApp route that you mentioned, but currently paper-based forms are still the dominant reporting route. Is that right?

Henry Zakumumpa:

Yes, absolutely. That's a good question. Now, according to recent, I think, studies in Uganda that I've seen published, data shows that paper-based ADR forms are the dominant reporting tool. Okay, so that's number one. Now, what we did?

Henry Zakumumpa:

We asked them what they preferred, what route, what platform they used, what they preferred to report, and the majority of them said WhatsApp. All right, and, as I said, I've been involved in the rollout of Med Safety app and I know these interventions are ongoing. So, and what I asked them, why do you prefer WhatsApp? They said one: you know WhatsApp allows them to report in the way they want to report. There's a convenience, you know, to give the level of detail they want.

Henry Zakumumpa:

Number two, which is, I think, underestimated, is that they said also, they are able to take a photo of the symptom, you know, of the ADR, so they can. For example, if a patient has jaundice or whatever it is, they can take a picture. You know, if they have a wasting, they can take a picture. You know, if they have a wasting, they can take a picture and share it on WhatsApp. All right. So number two is, most, most medical doctors have smartphones, actually, and many of them can afford internet, so they always have WhatsApp. At least the WhatsApp is not very expensive to, even if internet charges are very expensive in Uganda. So they prefer to use WhatsApp. But they told me principle reason one is it's convenient, fast, quick and also they know that their report has been received, because when you send a WhatsApp it can show you what time it has been delivered and that has been received. So that's why they preferred WhatsApp, which again was an interesting finding, but we need more research to understand that.

Fredrik Brounéus:

I'm quite curious about this WhatsApp reporting. So how does it work? Is it just free text reporting from the clinician's side, or is it possible to have some kind of questions or prompts or forms that they fill in?

Henry Zakumumpa:

That's a good question. Again, now, that's why I said that the NPC in Uganda has increased the volume of reports received. Now the WhatsApp is unstructured. People report like the way I send a WhatsApp to my girlfriend or to my boss or whatever, so you report in your own language, in your own. Again, that's what they prefer, which doesn't help so much when it comes to analysis.

Henry Zakumumpa:

Now, you see, that means now you have sent to the NPC in Kampala in Uganda, the capital, and then a data analyst has to clean the data and kind of feed, enter it into a database to make it analyzable. You see, again, that's why we are going into this issue of data quality. Okay, the reports are coming in, but analyzing them is a challenge. Now, all right, so, although they're like WhatsApp, you receive so many WhatsApp, but you have to make the data analyzable. So you have to move from the data you have received to making it usable, to cleaning it and making it intelligible so that you can analyze it. Yeah, so those are some of the challenges of WhatsApp.

Fredrik Brounéus:

That is a very interesting point you raised there.

Fredrik Brounéus:

I think that just there is a balance there, um, in getting a lot of information but with perhaps less structure or quality as well. It demands a lot more work from the assessor, or having more structured, strict information, but getting less of it, because it demands more from the reporter and I would be very curious to to know how, when it comes to the completeness of a WhatsApp report, how that compares to the completeness of the paper forms.

Henry Zakumumpa:

Yeah, now in Uganda they require a lot of detail. It's very, very elaborate. One: they have to give patient details, age, gender or sex. You know, what condition they're suffering from. Then you have to give details on the drug – what's the batch number, who's the manufacturer, expiry date. Even the reporter themselves have to give details: I'm a clinician, I'm based in this hospital in this district of Uganda. So it's very elaborate and some of the health workers think the detail is too much. They think it's too much, they should reduce on the detail. Of course that's from their perspective, because they have heavy workloads. But again, from the perspective of the pharmacovigilance center, they need data that can help them do causality assessment, that can help them analyze and link ADRs to drugs. So their standards are, of course, higher. You know so it's a question of perspective. You know, yeah, so, but it's very clear what we have to an ADR report has to have details on the patient, on the drug itself and the person reporting.

Fredrik Brounéus:

Is it possible for patients as well to report side effects in Uganda?

Henry Zakumumpa:

Absolutely, absolutely. I participated in the rollout of the Med Safety app and I published a paper, I think together with a colleague of mine in Drug Safety, on the rollout. The Med Safety app has been rolled out and piloted in some hospitals across Uganda and some patients have already uploaded it or downloaded it on their smartphones, so they have it. So patients have now been empowered to report. Also, I've been involved in a study where we had the peer support model, where we are supporting peers to help the patients report and we train them on how to use the Med Safety app. So the patients have now been kind of engaged, have been trained on how to use the Med Safety app, on how to report and how to train their fellow patients to report using the Med Safety app. So patients do actually report.

Henry Zakumumpa:

But also, number two is that the National Pharmacovigilance Center, which we call the National Drug Authority in Uganda, has hotlines, hotlines for reporting side effects by anybody in the public. And if you go to a hospital, you go to some private pharmacies, there's always a hotline. It's advertised, there's always a poster NDA. Please, if you have a side effect, please send us an SMS, a text message to this number, call this hotline. So, even patients can report. Even caregivers can report. If your father is on hypertension medication or cancer medication and he has very severe adverse drug reactions, you can report to the National Drug Authority. So even patients have been empowered to report, although I would say overall almost 80% of the reports in Uganda are from healthcare professionals, so it's still much health worker dominated, although there are interventions to increase uptake by patients in reporting.

Fredrik Brounéus:

How have Ugandan authorities gone about marketing this patient side effect reporting? You mentioned posters at clinics and have there been other public campaigns or efforts to spread the word?

Henry Zakumumpa:

First of all I would say number one is there's little funding going to pharmacovigilance. That's number one. Even the National Pharmacovigilance Centre, the budget they have, is insufficient to meet their responsibility in the country, all right, or what they need to do. So Uganda government does not invest enough in pharmacovigilance, in engaging patients, in reporting, in training health workers. So even the NPC itself has is under the budget, is small for doing the mandate it has as a regulatory authority which is part of the problem actually.

Fredrik Brounéus:

Yeah, so, departing from your research and your experiences, with limited resources, what do you think are the most important interventions or actions that a regulator or PV center could do to foster or improve data quality and data quantity for incoming reports?

Henry Zakumumpa:

Okay, thank you for that question. Actually, number one is the clinicians told us that, Henry, what the way the government can help us is first of all, to increase the national guidance on likely adverse drug reactions. And they gave me an example. When they're rolling out DTG, this super HIV drug, they're telling me they were just dropping boxes of medicine. You know, they just drop drugs and they tell you you have to give, each patient has to take one tablet a day and that's it. They didn't tell them that patients can get hyperglycemia, that they can get insomnia if they take this drug at night. So national guidance has to improve, all right. And then number two: health worker.

Henry Zakumumpa:

I think health workers need to be trained, they need to be sensitized, especially nurses, midwives, because in Uganda, unfortunately, we don't have enough doctors in the front line of HIV service delivery. So you have a lot of nurses, midwives, who are giving HIV care, who don't have extensive clinical training. You know, in fact, when I was doing this research, one nurse told me: Henry, I didn't know that they need this ADR report to do analysis and to make a decision at the National Pharmacovigilance Center. I didn't know that. So I was just filling a form, I didn't know, you know they didn't understand there is an input in a process to make a decision, you know. So training of health workers, especially mid-cadre, the nurses and midwives who are very important in uganda.

Henry Zakumumpa:

80 percent of the health workforce in uganda are nurses. So we need to focus on the mid-cadre, even in their training at the tertiary level, in their institutions of learning, to train them in pharmacovigilance. Then even patients need to be told, you know, they need to report and they should stop tolerating adverse drug reactions. They can be toxic, they can be fatal, you know. So, anyway, there are many. And then also we have to invest in laboratory systems, in basic things – liver function tests, glucometers for testing, blood sugar test kits, basic things. We need to improve our supply chain for medical supplies across the country.

Fredrik Brounéus:

I wanted to ask also, Henry, a dramatic change from when you wrote the paper is the financial terms for receiving HIV treatment in Uganda due to recent termination of foreign funding programs. And you write in the paper that the United States PEPFAR has enabled the rolling out HIV treatment to over 1.4 million Ugandans. And also you mentioned that the reason for many people to take traditional herbal medicines, for instance for diabetes or high blood pressure, instead of prescribed medicines, is that they cannot afford the conventional medicines. And I just wanted to ask what will happen now?

Henry Zakumumpa:

Excellent question and very timely indeed. Now, Uganda has been very heavily dependent on the US government especially, even other donors, because the global fund is funded even by European countries like the UK, France and other countries. But the US has been funding, I think, up to almost 70% of HIV spending in Uganda. So when the new administration, the US government, came into place, they had different priorities and they abruptly stopped HIV aid. So there have been devastating impacts.

Henry Zakumumpa:

It has caused confusion, it has already resulted in disruptions in service delivery. Well, medicines are being given. Now that's okay. Antiretrovirals are still available.

Henry Zakumumpa:

But you know, HIV care is a complex disease to manage. Now, like community outreach, where you go to people's households to ensure they are adhering. Those who are not coming to the clinics for review, you tell them, please come for review. People who give you psychosocial support to strengthen your adherence. All those who are not under the Uganda government payroll, so they've been funded by the Americans. Those are no longer in position. We had HIV prevention interventions like PrEP, which is a pre-exposure prophylaxis, where, for example, sex workers who take this PrEP don't get HIV even if they expose the virus. Now all this stopped because it was American-funded. Services for gay community, lgbt community has also now stopped because the US government was funding what are called drop-in centers, special health facilities, which are friendly, which don't discriminate, which don't judge them.

Henry Zakumumpa:

So now my prediction is HIV is going to reemerge as a public health threat again. So unfortunately this loss in funding is really going to have major impacts and right now it appears as though we are managing. But my research has already shown that after around three years that's when you really know the full impact. That's when you see community transmission going up, drug-resistant TB rising, you know deaths happening. So it will take time to know the true impact of loss of aid.

Henry Zakumumpa:

So now the Uganda government has come in with some strategies.

Henry Zakumumpa:

One, they have said they are going to – because HIV clinics were kind of standalone, because they were American-funded, because they were paying additional health workforce – now they have said ideally the HIV clinic should be integrated with general health services. That's number one. All right, so the Uganda government is going to replace some of the funding for especially antiretrovirus, which is a positive thing.

Henry Zakumumpa:

So the president has even said publicly that the Uganda government, we are going to do all we can to replace the money the US government has been investing in procuring antivirus, so which is positive. Then also, we had an idea of a levy or a tax on soft drinks like soda in Uganda, which had been planned about 10 years ago but it was never implemented. It was called an AIDS Trust Fund. That also is going to be kick-started, revived to make sure that there's more domestic reliance for the national HIV response, and they are trying also to improve national health insurance, private health insurance, and also to see if the private sector can contribute to bridging the financing gap. So there are a number of strategies, but it's still a problem that we need to really fully grapple with.

Fredrik Brounéus:

We're nearing the end of the interview now and I wanted to ask what's up next on your research agenda?

Fredrik Brounéus:

What studies are you planning to go into now?

Henry Zakumumpa:

Actually, so that's a good question. Now, before I did this study, I engaged, had meetings several meetings with the National Pharmacovigilance Center in Uganda, with people like Helen Ndagije, who is really a champion in pharmacovigilance, and they have a lot of research questions. Actually, they had so many research questions we were only able, because of funding, to deal with one of data quality. So I'll give you just a few examples of the questions that were not answered yet. One, they were talking about the potential role of AI, right, and they wanted us to do research, both within the NDA, within healthcare professionals, and they really have a lot of hope in the potential of AI to help with causality assessments, data analysis, big data, machine learning. So we didn't do that research.

Henry Zakumumpa:

We're also looking at how to synchronize these multiple reporting tools of Med Safety app, WhatsApp, email, to find a way of kind of synergies you know, because right now they're standalone and they're not speaking to each other to see how to manage that, all right. Also, we need to do research on designing the new ADR forms, because there's been feedback saying it's too detailed, the space is not enough, we'll take this one out, I want this one. So the preferences of healthcare professionals, which again hasn't been done, and the NPC doesn't have funding to do that, unfortunately. So there's several questions, several questions. The thing, of course, to do is to source for funding in Uganda and abroad as well.

Fredrik Brounéus:

I'm already looking forward to having you back in the studio, Henry. Those are very interesting questions you have there. Given the, let's say, unlimited resources, do you have a dream study or a dream research project?

Henry Zakumumpa:

I think I have a dream research project. For me, I think that my research has shown me that patient-led reporting actually is ideally what we should push for. For me, I think we need more research and working with patients on how they can report, train them how to recognize adverse drug reactions and how they can report easily, how they can be confident, how they can have peers supporting them. So for me, my research would be on how to strengthen the patient-led reporting of ADRs Because, even given the UMC funding I got for my study on DTG, I found that actually patients come up with more novel ADRs than health workers.

Henry Zakumumpa:

I'll give you an example: we found that DTG causes sexual dysfunction, which was a novel finding. Now, before I talked to the patients, I had been all over Uganda northern Uganda, eastern Uganda thanks to funding from UMC, talking to clinicians. Nobody had ever mentioned that there's a problem of sexual dysfunction that is causing low libido, it's causing marriage split-ups, but when you talk to the patients, they give you new, unheard-of problems, you know. So that's why I personally think that I'll do more research around patient-led interventions to enhance reporting of ADRs. So for me, that's my dream project.

Fredrik Brounéus:

Thank you so much, Henry. This has been a very inspiring interview. Thank you for your time and, as always, I learned a lot.

Henry Zakumumpa:

Okay, all right, and thank you Fredrik.

Fredrik Brounéus:

That's all for now, but if you'd like to learn more about Henry's work, we've put together some links for you in the episode show notes. Apart from the Drug Safety Matters podcast, we have our pharmacovigilance magazine, Uppsala Reports. Visit uppsalareports. org to stay up to date with news, research and trends in the field, and don't forget to subscribe to the newsletter for the latest articles. If you have any comments or suggestions for the podcast or the magazine, please feel free to reach out on Facebook, LinkedIn, Blues ky or X. You can also visit our website to learn more about what we do to promote safer use of medicines and vaccines for everyone, everywhere. If you like the podcast, please subscribe to make sure you won't miss an episode and spread the word so other listeners can find us too. For Drug Safety Matters, I'm Fredrik Brouneus. Thanks for listening.

People on this episode

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Alexandra Coutinho

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Federica Santoro

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Fredrik Brounéus

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