May 28, 2025 • 38 mins
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?
Want to know more?
- Listen to Henry talk about the safety of HIV medications in this 2022 episode of Drug Safety Matters.
- Visit this CARTA (Consortium for Advanced Research Training in Africa) profile page to learn more about Henry’s research.
- Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews (British Journal of Clinical Pharmacology, 2023)
- Improving adverse drug event reporting by healthcare professionals (Cochrane Database Systematic Review, 2024)
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About UMC
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Fredrik Brounéus (00:11):
Welcome to Drug Safety Matters, a podcast
by Uppsala Monitoring Center,where we explore current issues
in pharmacovigilance and patientsafety.
I'm Fredrik Brouneus and todayI'm looking forward to learning
more about drivers of dataquality in the reporting of
adverse drug reactions.
We often talk about thechallenge of under-reporting and
the large proportion of adverseevents that never reach the
(00:32):
ears or desks ofpharmacovigilance assessors, but
the quality of reports is alsocrucially important, and this is
why today's guest, HenryZakumumpa, at Makerere
University in Uganda, decided toexplore drivers of data quality
in the reporting of adversedrug reactions.
He did this in a recentqualitative study where he and
(01:00):
colleagues interviewedhealthcare professionals and
patients at HIV clinics inUganda.
Henry now joins us online fromKampala to tell us about the
results from the study and whatwe can do to improve data
quality in the reporting ofadverse drug reactions from
healthcare professionals andpatients.
Welcome back to Drug SafetyMatters, Henry.
We're so glad to have you onthe show again, and this time
(01:21):
joining us from Uganda.
Henry Zakumumpa (01:24):
Yes, absolutely .
It's a pleasure to join DrugSafety Matters again and it was
a pleasure to be in Uppsala afew days ago.
Fredrik Brounéus (01:32):
That's right, you were in Uppsala a few days
ago for the ISOP Mid-yearConference, but we didn't manage
to meet up then.
So it's been three years nowsince we last had the pleasure
of having you on the show, andthat was back in April 2022.
And the topic then was thesafety of HIV medications, and
(01:54):
HIV medication safety is alsopart of today's discussion, but
from a slightly different angle.
But before we go into that, Iwas wondering if you could tell
us a little about your researchat large.
What are your key researchinterests and what drives you as
a researcher?
Henry Zakumumpa (02:13):
Thank you, Fredrik, for this question.
Well, what really drives me isthe overwhelming HIV epidemic in
Uganda.
Uganda has one of the highestpopulations of people living
with HIV AIDS.
So we have a huge HIV burdenand I've lost people to HIV.
My cousin's sisters and mymaternal aunt died out of HIV.
So I have devoted myself todoing all I can to contribute
(02:39):
solutions towards responding toHIV epidemic in Uganda.
Fredrik Brounéus (02:44):
Yes, and what got you into pharmacovigilance,
because that's quite a specialfield as well.
Henry Zakumumpa (02:52):
That's a good question actually, but what
happened is, what attracted meto pharmacovigilance was I think
it was 2019.
Uganda at the time was rollingout a newer HIV dolutegravir,
or DTG, and patients were beingtransitioned from efavirenz, the
older HIV drug.
So everybody was saying DTG isthe way to go.
(03:13):
So they were enrolling peopleon DTG but then, although it was
a superior drug, we got so manycomplaints from patients.
Patients were complainingaround hyperglycemia, erectile
dysfunction.
So I was reading so manyletters from patients in
newspapers asking for guidanceand saying all this new drug,
since I started it, I'm gettingproblems.
(03:35):
I kind of piqued interest, youknow, and I happen to be working
closer with them, with somebodythe Minister of Health in
Uganda who's in charge of HIVtreatment, and she was sharing
with me the challenges.
They were receiving a lot ofreports around problems with DTG
, but they had no research, theyhad no data and the National
Pharmacovigilance Center wassaying we don't have reports, we
(03:58):
don't have ADR reports.
But the patients were reallyfeeling the impact of this drug
and the side effects and theadverse events.
So that's how I got interested.
You know, and fortunatelyaround that same time Uppsala
Monitoring Centre was supportingthe Consortium for Advanced
Research Training in Africawhich funded my PhD.
It was supporting researcherswho are interested in
(04:19):
pharmacovigilance research.
So naturally I got in touchwith the National
Pharmacovigilance Center inUganda so they supported our bid
and we successfully got thatresearch grant.
So that's how I was launchedinto pharmacovigilance.
So it was out of the problem.
Really it was not that Itrained as a specialist in this
area.
Fredrik Brounéus (04:37):
So actually, the topic that we are talking
about today around thespontaneous adverse events
reporting – that's actually whatgot you into pharmacovigilance
from the beginning, looking atwhat patients were describing
from their new HIV medications,and so this is, in many ways,
the backbone ofpharmacovigilance systems, the
(05:01):
spontaneous reporting, and weoften talk about the fundamental
challenge of underreporting andthe low proportion of events
being reported.
Do you think it would be fairto say that the quality of
reports is an equally bigchallenge?
Henry Zakumumpa (05:21):
You know, that's a fantastic question,
Fredrik.
You're absolutely right.
Of course, Uganda and manycountries in Africa have
underreporting, and I've seenstudies which suggest that only
10% of adverse drug reactionsare actually reported to the
authorities.
So in Uganda, we have thatproblem as well.
However, what has happened inUganda is we have benefited from
so many interventions aroundpiloting new reporting routes,
(05:45):
such as the Med Safety app,which I participated in rolling
out, reporting via WhatsApp.
They even accept email ADRreports.
But when I engaged with theNational Pharmacovigilance
Center in Uganda, they told usHenry, 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 achallenge.
(06:07):
There's no dosage of theperson, when did the onset of
the symptoms begin?
And so all the details aresometimes missing or you find
like a significant number of ADRreports cannot be used for
analysis.
So that's actually why welaunched into this research in
the first place, because the NPCin Uganda thought this was a
(06:27):
research problem they had andthey wanted to understand from
the perspective of the healthworkers, from the perspective of
the patients (06:34):
what are your problems?
Why are you giving usincomplete reports?
Hence this research which weconducted.
Fredrik Brounéus (06:42):
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 atMakerere University and the
National PharmacovigilanceCenter at the National Drug
Authority, both in Kampala,Uganda, where you explored
(07:03):
drivers and obstacles of dataquality in adverse events
reporting.
You've already mentioned thatit was a qualitative study, but
I was wondering if you could goa little deeper into that.
Henry Zakumumpa (07:17):
Okay, okay, thank you.
So first of all, as I mentionedearlier on, this study was
commissioned by the NationalDrug Authority or the National
Pharmacovigilance Center inUganda, and it was a research
priority.
They wanted to understand whywe're getting reports that are
incomplete, that do not help usto analyze and therefore take
(07:37):
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 12HIV clinics across Uganda.
So we made sure that theclinics we selected were kind of
(07:59):
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 levelsof service delivery.
So we tried to have a reallyrepresentative sample.
Fredrik Brounéus (08:13):
So what did you find out with regards to
obstacles and drivers?
Henry Zakumumpa (08:20):
Actually this study, in my opinion, revealed
many novel things, many newinteresting things that we
didn't know.
For example, we found thatpatients first of all
deliberately under-reportbecause they want to remain on
effective HIV therapies.
There's this super HIV drugcalled dolutegravir and patients
(08:41):
believe this drug is effectivein viral load suppression and so
they have seen from theirfriends.
When they report side effectsthey say I have the erectile
dysfunction, I have hypoglycemia, I have nausea, I have insomnia
.
Then the clinicians tend to kindof revert them to the old HIV
(09:01):
drug and the patient thoughtthat this leads to kind of
getting a medication that is noteffective.
So they deliberatelyunder-report the severity of the
ADRs they are suffering.
So they don't give all the fullextent of the ADRs because they
know when they give you thefull details of how they are
being impacted, how their visionis affected, how they can't
(09:23):
sleep at night, then definitely,naturally, you'll say no, we
have to take you back to aefavirenz, we have to take you
to atanazavir, another HIV drug.
So patients are kind oftolerating the adverse drug
reactions of DTG because theybelieve or they perceive this
drug to be very effective, to bevery effective and from their
judgment, they would rathersuffer the ADRs you know, than
(09:48):
lose an effective regimen, aneffective medication.
Fredrik Brounéus (09:54):
That must be so important feedback for
healthcare professionals to knowthat this is what patients are
fearing.
Henry Zakumumpa (09:59):
Yeah, yeah, I think it was.
That's number one.
Number two, we found thatthere's a high level of herbal
use, especially among HIVpatients who are 50 years or
older.
Now, when they become older,also because of the medication
itself, actually, it also leadsto NCDs non-communicable
diseases like diabetes,hypertension.
(10:20):
And now in Uganda HIV treatmentis free to the user.
The government providestreatment for HIV, partly
because also the US governmentused to support Uganda
government to provide treatmentfree of care.
Now we have a challenge ofthese NCDs, or non-communicable
diseases like hypertension.
So, although the governmentclaims to offer treatment,
(10:44):
patients tell us actually thehospitals don't have the drugs,
they're not available.
So when they go to a governmenthospital they might tell them
we are out of stock.
Please go to a private pharmacyand buy, and many of our people
are very poor.
So what they do then is theyrevert to natural remedies.
You know, because Africans hadthese herbal medicines for a
long time and they were usingthem.
(11:04):
Of course there are challengeswith that, but now many people
are taking these drugs.
So the clinician has told usHenry, now this person tells you
they have these problems, theyhave insomnia, they have
neuropsychiatric problems, butwhen 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 challengedoing causality assessment
(11:27):
linking DTG to this problem.
So when they're filling thesereports, that's another
challenge on how to overcome it.
Then the other challenge wefound 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 andeven the American government,
(11:49):
because they were supporting itfor a long time they devised new
approaches to HIV servicedelivery and these are called
differentiated service deliverymodels.
So if you are virallysuppressed, in their judgment,
you don't need to come to thefacility every month for a
review because you're virallysuppressed.
In their judgment, you don'tneed to come to the facility
every month for review becauseyou're very suppressed.
So what they say for you we'regoing to give you a six-month
(12:09):
supply of HIV medication.
You only come back at leasttwice a year.
So you go to the community orsomebody can pick drugs on your
behalf.
The aim was to first of allreduce the burden of care on
patients, to reduce transportand time spent at facilities and
also to decongest the healthsystem.
We found that now, when itcomes to reporting adverse drug
(12:31):
reactions, now this arrangementis problematic because patients
come back and then after sixmonths they have been enduring
these adverse reactions and weeven found some actually die.
For example, if you havehyperglycemia and it's
uncontrolled for three months, Imean it can lead to death.
(12:55):
So they told us, now this is amajor problem.
Although it was meant to easethe life of patients when it
comes to adverse drug reactionreporting, now it's becoming a
problem.
Because now, when a patientcomes after six months, they are
telling you about this ADR theysuffered, but then recalling
events becomes problematicBecause when you ask them, when
(13:18):
did it begin, what symptom didyou get, what drugs were you
taking at the time, what othersymptoms did you have, and then
a patient can only give you bitsand bits of information, so
they don't give you a fullpicture that helps you to
determine which other ADR isthis.
You know, do a causalityassessment.
Besides patients, we also foundthat healthcare professionals
(13:40):
also are part of the problem.
Actually, first of all, thehealth workers I talked to said
they don't have incentive toreport.
They said they have beenreporting.
They don't get feedback fromthe National Pharmacovigilance
Center.
They told us that reporting isinconsequential.
Whether you report ADRs or not,there's no feedback, first of
all.
Number two, you don't get anyguidance on how to manage the
(14:03):
patient.
Basically, it's inconsequentialfrom their perspective.
That's why qualitative researchis good, because you understand
somebody's psychology,somebody's understanding.
That also affects the amount ofinformation they provide on ADR
reports, the seriousness withwhich they take ADR reports, the
amount of detail they give inADR report.
(14:26):
So it's like a formality.
So they will say oh, thisperson came here, he had
erectile dysfunction.
It was for two weeks.
So they will skip so many partsof the ADR report and just
submit it.
Because in their mind, whetherthey report or not, nothing's
going to happen, all right?
So health workers havedeveloped kind of complacency.
Now that's also another point.
They have kind of – we havesubmitted this paper for
(14:49):
publication and we have calledit a professional urgency, where
the health worker now says ah,we know what DTG causes.
I no longer have to report tothe National Pharmacovigilance
Center.
If a patient comes to me, tellsme he has hyperglycemia, I know
that's DTG.
If he tells me he has erectiledysfunction, I think probably
that's DTG.
If he tells me he has insomnia,he can't sleep, that's DTG.
(15:09):
So what they told us?
The clinicians no longer evenbother to report to the National
Pharmacovigilance Center, youknow.
So that's a huge problem.
They said what I do I managethe patient on my own; I either
remove him from DTG, I take himto efavirenz, you know, or I
take another clinical decision.
So I don't have to bothermyself giving a well-detailed
(15:31):
report to the NPC, because Iknow the NPC will not guide me,
it will not take any action.
So also this situation wherehealth workers manage these ADRs
on their own is also, I think,a huge challenge.
All right, a huge challenge.
Then also we found some healthsystem issues around laboratory
infrastructure, even inputs,basic inputs for reagents to
(15:55):
conduct studies, even basicthings like liver function tests
, glucometers for testing bloodsugar.
They are not available.
For example, if a patient saysthey have frequent urination at
night, I am wasting away.
I don't know whether it'sbecause of DTG.
The clinician cannot even do asimple test for blood sugar
(16:17):
because they lack glucometers,they lack basic test kits.
You know, if you go in ruralUganda, these are real, real
problems.
They're real, real problems fora a condition.
So he may have a hunch thatthis is hyperglycemia, but they
cannot even write it on the ADRreport because he has not taken
the mandatory three bloodglucose fasting, blood glucose
(16:38):
tests you know to be able to doto say authoritatively that this
is hyperglycemia or diabetes,whatever it is.
So we found that there areissues to these issues of
under-reporting, incompleteinformation or inaccurate
information, an interactionbetween patient-based factors,
(17:00):
health workforce factors, healthsystem factors.
So it's really a complex thing.
It's not just a one-factorthing.
There's an interaction in thefactors that contribute to
incomplete documentation of ADRs.
Fredrik Brounéus (17:14):
Yes, that struck me as I was reading your
paper just the complexity of thechallenges, the combination of
some material challenges,communicative challenges and
also another challenge that youmentioned that clinicians may
also hesitate to report eventsout of fear that it may be due
(17:38):
to a medication error, sosomeone would perhaps point
their finger at them.
Henry Zakumumpa (17:44):
Oh yeah, oh yeah, they say when they report,
they kind of invite scrutiny intheir clinical decision making.
So they think when they reportthen they will say oh, did you
give the patient the rightdosage?
Did you guide them properly onhow to take these drugs, for
example?
I'll give you an example (17:59):
DTG is supposed to be taken in the
morning, not at night.
Some of the ADRs of insomnia arebecause patients are taking the
drug at night, contrary toinstructions, and so if you
report, for example, insomnia,they will ask you did you tell
the patient that they have totake this drug in the morning?
(18:21):
And then there's an anti-TBdrug called isoniazid.
You're supposed to put anotheradditional drug to avoid the
very toxic effects of the drug,I think, called pyridoxine.
There's a drug you have to addon, but at the beginning
clinicians were not providingthat additional drug.
(18:43):
So there was drug toxicity ofTB drugs, you know.
So now you see, if a patient,if a health worker reports that,
then they think that they aregoing to bring into question
their own competence asclinicians.
So it's an unfortunatesituation.
Fredrik Brounéus (19:01):
I was also interested to see that in the
paper you say that the majorityof healthcare professionals in
your study, they preferred toreport via the WhatsApp route
that you mentioned, butcurrently paper-based forms are
still the dominant reportingroute.
(19:23):
Is that right?
Henry Zakumumpa (19:25):
Yes, absolutely .
That's a good question.
Now, according to recent, Ithink, studies in Uganda that
I've seen published, data showsthat paper-based ADR forms are
the dominant reporting tool.
Okay, so that's number one.
Now, what we did?
We asked them what theypreferred, what route, what
platform they used, what theypreferred to report, and the
(19:46):
majority of them said WhatsApp.
All right, and, as I said, I'vebeen involved in the rollout of
Med Safety app and I know theseinterventions are ongoing.
So, and what I asked them, whydo you prefer WhatsApp?
They said one (19:59):
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.
Number two, which is, I think,underestimated, is that they
said also, they are able to takea photo of the symptom, you
know, of the ADR, so they can.
For example, if a patient hasjaundice or whatever it is, they
(20:24):
can take a picture.
You know, if they have awasting, they can take a picture
.
You know, if they have awasting, they can take a picture
and share it on WhatsApp.
All right.
So number two is, most, mostmedical doctors have smartphones
, actually, and many of them canafford internet, so they always
have WhatsApp.
At least the WhatsApp is notvery expensive to, even if
(20:45):
internet charges are veryexpensive in Uganda.
So they prefer to use WhatsApp.
But they told me principlereason one is it's convenient,
fast, quick and also they knowthat their report has been
received, because when you senda WhatsApp it can show you what
time it has been delivered andthat has been received.
So that's why they preferredWhatsApp, which again was an
(21:06):
interesting finding, but we needmore research to understand
that.
Fredrik Brounéus (21:11):
I'm quite curious about this WhatsApp
reporting.
So how does it work?
Is it just free text reportingfrom the clinician's side, or is
it possible to have some kindof questions or prompts or forms
that they fill in?
Henry Zakumumpa (21:27):
That's a good question.
Again, now, that's why I saidthat the NPC in Uganda has
increased the volume of reportsreceived.
Now the WhatsApp isunstructured.
People report like the way Isend a WhatsApp to my girlfriend
or to my boss or whatever, soyou report in your own language,
(21:48):
in your own.
Again, that's what they prefer,which doesn't help so much when
it comes to analysis.
Now, you see, that means now youhave sent to the NPC in Kampala
in Uganda, the capital, andthen 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 weare going into this issue of
(22:09):
data quality.
Okay, the reports are coming in, but analyzing them is a
challenge.
Now, all right, so, althoughthey're like WhatsApp, you
receive so many WhatsApp, butyou have to make the data
analyzable.
So you have to move from thedata you have received to making
it usable, to cleaning it andmaking it intelligible so that
you can analyze it.
Yeah, so those are some of thechallenges of WhatsApp.
Fredrik Brounéus (22:33):
That is a very interesting point you raised
there.
I think that just there is abalance there, um, in getting a
lot of information but withperhaps less structure or
quality as well.
It demands a lot more work fromthe assessor, or having more
structured, strict information,but getting less of it, because
(22:56):
it demands more from thereporter and I would be very
curious to to know how, when itcomes to the completeness of a
WhatsApp report, how thatcompares to the completeness of
the paper forms.
Henry Zakumumpa (23:12):
Yeah, now in Uganda they require a lot of
detail.
It's very, very elaborate.
One (23:16):
they have to give patient details, age, gender or sex.
You know, what conditionthey're suffering from.
Then you have to give detailson the drug – what's the batch
number, who's the manufacturer,expiry date.
Even the reporter themselveshave to give details: I'm a
clinician, I'm based in thishospital in this district of
(23:37):
Uganda.
So it's very elaborate and someof the health workers think the
detail is too much.
They think it's too much, theyshould reduce on the detail.
Of course that's from theirperspective, because they have
heavy workloads.
But again, from the perspectiveof the pharmacovigilance center
(23:57):
, they need data that can helpthem do causality assessment,
that can help them analyze andlink ADRs to drugs.
So their standards are, ofcourse, higher.
You know so it's a question ofperspective.
You know, yeah, so, but it'svery clear what we have to an
ADR report has to have detailson the patient, on the drug
(24:18):
itself and the person reporting.
Fredrik Brounéus (24:21):
Is it possible for patients as well to report
side effects in Uganda?
Henry Zakumumpa (24:26):
Absolutely, absolutely.
I participated in the rolloutof the Med Safety app and I
published a paper, I thinktogether with a colleague of
mine in Drug Safety, on therollout.
The Med Safety app has beenrolled out and piloted in some
hospitals across Uganda and somepatients have already uploaded
(24:48):
it or downloaded it on theirsmartphones, so they have it.
So patients have now beenempowered to report.
Also, I've been involved in astudy where we had the peer
support model, where we aresupporting peers to help the
patients report and we trainthem on how to use the Med
Safety app.
So the patients have now beenkind of engaged, have been
(25:09):
trained on how to use the MedSafety app, on how to report and
how to train their fellowpatients to report using the Med
Safety app.
So patients do actually report.
But also, number two is that theNational Pharmacovigilance
Center, which we call theNational Drug Authority in
Uganda, has hotlines, hotlinesfor reporting side effects by
(25:31):
anybody in the public.
And if you go to a hospital,you go to some private
pharmacies, there's always ahotline.
It's advertised, there's alwaysa poster NDA.
Please, if you have a sideeffect, 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 onhypertension medication or
(25:52):
cancer medication and he hasvery severe adverse drug
reactions, you can report to theNational Drug Authority.
So even patients have beenempowered to report, although I
would say overall almost 80% ofthe reports in Uganda are from
healthcare professionals, soit's still much health worker
dominated, although there areinterventions to increase uptake
(26:14):
by patients in reporting.
Fredrik Brounéus (26:17):
How have Ugandan authorities gone about
marketing this patient sideeffect reporting?
You mentioned posters atclinics and have there been
other public campaigns orefforts to spread the word?
Henry Zakumumpa (26:34):
First of all I would say number one is there's
little funding going topharmacovigilance.
That's number one.
Even the NationalPharmacovigilance Centre, the
budget they have, isinsufficient to meet their
responsibility in the country,all right, or what they need to
do.
So Uganda government does notinvest enough in
pharmacovigilance, in engagingpatients, in reporting, in
(26:54):
training health workers.
So even the NPC itself has isunder the budget, is small for
doing the mandate it has as aregulatory authority which is
part of the problem actually.
Fredrik Brounéus (27:07):
Yeah, so, departing from your research and
your experiences, with limitedresources, what do you think are
the most importantinterventions or actions that a
regulator or PV center could doto foster or improve data
quality and data quantity forincoming reports?
Henry Zakumumpa (27:29):
Okay, thank you for that question.
Actually, number one is theclinicians told us that, Henry,
what the way the government canhelp us is first of all, to
increase the national guidanceon 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 justdropping boxes of medicine.
(27:50):
You know, they just drop drugsand they tell you you have to
give, each patient has to takeone tablet a day and that's it.
They didn't tell them thatpatients can get hyperglycemia,
that they can get insomnia ifthey take this drug at night.
So national guidance has toimprove, all right.
And then number two (28:07):
health worker.
I think health workers need tobe trained, they need to be
sensitized, especially nurses,midwives, because in Uganda,
unfortunately, we don't haveenough doctors in the front line
of HIV service delivery.
So you have a lot of nurses,midwives, who are giving HIV
(28:27):
care, who don't have extensiveclinical training.
You know, in fact, when I wasdoing this research, one nurse
told me (28:33):
Henry, I didn't know that they need this ADR report
to do analysis and to make adecision at the National
Pharmacovigilance Center.
I didn't know that.
So I was just filling a form, Ididn't know, you know they
didn't understand there is aninput in a process to make a
decision, you know.
So training of health workers,especially mid-cadre, the nurses
(28:54):
and midwives who are veryimportant in uganda.
80 percent of the healthworkforce in uganda are nurses.
So we need to focus on themid-cadre, even in their
training at the tertiary level,in their institutions of
learning, to train them inpharmacovigilance.
Then even patients need to betold, you know, they need to
report and they should stoptolerating adverse drug
(29:15):
reactions.
They can be toxic, they can befatal, you know.
So, anyway, there are many.
And then also we have to investin laboratory systems, in basic
things – liver function tests,glucometers for testing, blood
sugar test kits, basic things.
We need to improve our supplychain for medical supplies
(29:39):
across the country.
Fredrik Brounéus (29:40):
I wanted to ask also, Henry, a dramatic
change from when you wrote thepaper is the financial terms for
receiving HIV treatment inUganda due to recent termination
of foreign funding programs.
And you write in the paper thatthe United States PEPFAR has
enabled the rolling out HIVtreatment to over 1.4 million
(30:05):
Ugandans.
And also you mentioned that thereason for many people to take
traditional herbal medicines,for instance for diabetes or
high blood pressure, instead ofprescribed medicines, is that
they cannot afford theconventional medicines.
And I just wanted to ask whatwill happen now?
Henry Zakumumpa (30:25):
Excellent question and very timely indeed.
Now, Uganda has been veryheavily dependent on the US
government especially, evenother donors, because the global
fund is funded even by Europeancountries like the UK, France
and other countries.
But the US has been funding, Ithink, up to almost 70% of HIV
spending in Uganda.
So when the new administration,the US government, came into
(30:48):
place, they had differentpriorities and they abruptly
stopped HIV aid.
So there have been devastatingimpacts.
It has caused confusion, it hasalready resulted in disruptions
in service delivery.
Well, medicines are being given.
Now that's okay.
Antiretrovirals are stillavailable.
(31:09):
But you know, HIV care is acomplex disease to manage.
Now, like community outreach,where you go to people's
households to ensure they areadhering.
Those who are not coming to theclinics for review, you tell
them, please come for review.
People who give youpsychosocial support to
strengthen your adherence.
All those who are not under theUganda government payroll, so
(31:30):
they've been funded by theAmericans.
Those are no longer in position.
We had HIV preventioninterventions like PrEP, which
is a pre-exposure prophylaxis,where, for example, sex workers
who take this PrEP don't get HIVeven if they expose the virus.
Now all this stopped because itwas American-funded.
(31:50):
Services for gay community,lgbt community has also now
stopped because the USgovernment was funding what are
called drop-in centers, specialhealth facilities, which are
friendly, which don'tdiscriminate, which don't judge
them.
So now my prediction is HIV isgoing to reemerge as a public
health threat again.
(32:11):
So unfortunately this loss infunding is really going to have
major impacts and right now itappears as though we are
managing.
But my research has alreadyshown that after around three
years that's when you reallyknow the full impact.
That's when you see communitytransmission going up,
drug-resistant TB rising, youknow deaths happening.
(32:32):
So it will take time to knowthe true impact of loss of aid.
So now the Uganda government hascome in with some strategies.
One, they have said they aregoing to – because HIV clinics
were kind of standalone, becausethey were American-funded,
because they were payingadditional health workforce –
now they have said ideally theHIV clinic should be integrated
(32:54):
with general health services.
That's number one.
All right, so the Ugandagovernment is going to replace
some of the funding forespecially antiretrovirus, which
is a positive thing.
So the president has even saidpublicly that the Uganda
government, we are going to doall we can to replace the money
the US government has beeninvesting in procuring antivirus
, so which is positive.
(33:15):
Then also, we had an idea of alevy or a tax on soft drinks
like soda in Uganda, which hadbeen planned about 10 years ago
but it was never implemented.
It was called an AIDS TrustFund.
That also is going to bekick-started, revived to make
sure that there's more domesticreliance for the national HIV
(33:37):
response, and they are tryingalso to improve national health
insurance, private healthinsurance, and also to see if
the private sector cancontribute to bridging the
financing gap.
So there are a number ofstrategies, but it's still a
problem that we need to reallyfully grapple with.
Fredrik Brounéus (34:00):
We're nearing the end of the interview now and
I wanted to ask what's up nexton your research agenda?
What studies are you planning togo into now?
Henry Zakumumpa (34:15):
Actually, so that's a good question.
Now, before I did this study, Iengaged, had meetings several
meetings with the NationalPharmacovigilance Center in
Uganda, with people like HelenNdagije, who is really a
champion in pharmacovigilance,and they have a lot of research
questions.
Actually, they had so manyresearch questions we were only
able, because of funding, todeal with one of data quality.
(34:36):
So I'll give you just a fewexamples of the questions that
were not answered yet.
One, they were talking aboutthe potential role of AI, right,
and they wanted us to doresearch, both within the NDA,
within healthcare professionals,and they really have a lot of
hope in the potential of AI tohelp with causality assessments,
(34:56):
data analysis, big data,machine learning.
So we didn't do that research.
We're also looking at how tosynchronize these multiple
reporting tools of Med Safetyapp, WhatsApp, email, to find a
way of kind of synergies youknow, because right now they're
standalone and they're notspeaking to each other to see
(35:17):
how to manage that, all right.
Also, we need to do research ondesigning the new ADR forms,
because there's been feedbacksaying it's too detailed, the
space is not enough, we'll takethis one out, I want this one.
So the preferences ofhealthcare professionals, which
again hasn't been done, and theNPC doesn't have funding to do
(35:37):
that, unfortunately.
So there's several questions,several questions.
The thing, of course, to do isto source for funding in Uganda
and abroad as well.
Fredrik Brounéus (35:47):
I'm already looking forward to having you
back in the studio, Henry.
Those are very interestingquestions you have there.
Given the, let's say, unlimitedresources, do you have a dream
study or a dream researchproject?
Henry Zakumumpa (36:02):
I think I have a dream research project.
For me, I think that myresearch has shown me that
patient-led reporting actuallyis ideally what we should push
for.
For me, I think we need moreresearch and working with
patients on how they can report,train them how to recognize
adverse drug reactions and howthey can report easily, how they
(36:25):
can be confident, how they canhave peers supporting them.
So for me, my research would beon how to strengthen the
patient-led reporting of ADRsBecause, even given the UMC
funding I got for my study onDTG, I found that actually
patients come up with more novelADRs than health workers.
I'll give you an example (36:48):
we found that DTG causes sexual
dysfunction, which was a novelfinding.
Now, before I talked to thepatients, I had been all over
Uganda northern Uganda, easternUganda thanks to funding from
UMC, talking to clinicians.
Nobody had ever mentioned thatthere's a problem of sexual
dysfunction that is causing lowlibido, it's causing marriage
(37:13):
split-ups, but when you talk tothe patients, they give you new,
unheard-of problems, you know.
So that's why I personallythink that I'll do more research
around patient-ledinterventions to enhance
reporting of ADRs.
So for me, that's my dreamproject.
Fredrik Brounéus (37:30):
Thank you so much, Henry.
This has been a very inspiringinterview.
Thank you for your time and, asalways, I learned a lot.
Henry Zakumumpa (37:39):
Okay, all right , and thank you Fredrik.
Fredrik Brounéus (37:45):
That's all for now, but if you'd like to learn
more about Henry's work, we'veput together some links for you
in the episode show notes.
Apart from the Drug SafetyMatters podcast, we have our
pharmacovigilance magazine,Uppsala Reports.
Visit uppsalareports.
org to stay up to date with news, research and trends in the
(38:05):
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If you have any comments orsuggestions for the podcast or
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You can also visit our websiteto learn more about what we do
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(38:26):
If you like the podcast, pleasesubscribe to make sure you
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find us too.
For Drug Safety Matters, I'mFredrik Brouneus.
Thanks for listening.
Welcome to Drug Safety Matters, a podcast
by Uppsala Monitoring Center,where we explore current issues
in pharmacovigilance and patientsafety.
I'm Fredrik Brouneus and todayI'm looking forward to learning
more about drivers of dataquality in the reporting of
adverse drug reactions.
We often talk about thechallenge of under-reporting and
the large proportion of adverseevents that never reach the
(00:32):
ears or desks ofpharmacovigilance assessors, but
the quality of reports is alsocrucially important, and this is
why today's guest, HenryZakumumpa, at Makerere
University in Uganda, decided toexplore drivers of data quality
in the reporting of adversedrug reactions.
He did this in a recentqualitative study where he and
(01:00):
colleagues interviewedhealthcare professionals and
patients at HIV clinics inUganda.
Henry now joins us online fromKampala to tell us about the
results from the study and whatwe can do to improve data
quality in the reporting ofadverse drug reactions from
healthcare professionals andpatients.
Welcome back to Drug SafetyMatters, Henry.
We're so glad to have you onthe show again, and this time
(01:21):
joining us from Uganda.
Henry Zakumumpa (01:24):
Yes, absolutely .
It's a pleasure to join DrugSafety Matters again and it was
a pleasure to be in Uppsala afew days ago.
Fredrik Brounéus (01:32):
That's right, you were in Uppsala a few days
ago for the ISOP Mid-yearConference, but we didn't manage
to meet up then.
So it's been three years nowsince we last had the pleasure
of having you on the show, andthat was back in April 2022.
And the topic then was thesafety of HIV medications, and
(01:54):
HIV medication safety is alsopart of today's discussion, but
from a slightly different angle.
But before we go into that, Iwas wondering if you could tell
us a little about your researchat large.
What are your key researchinterests and what drives you as
a researcher?
Henry Zakumumpa (02:13):
Thank you, Fredrik, for this question.
Well, what really drives me isthe overwhelming HIV epidemic in
Uganda.
Uganda has one of the highestpopulations of people living
with HIV AIDS.
So we have a huge HIV burdenand I've lost people to HIV.
My cousin's sisters and mymaternal aunt died out of HIV.
So I have devoted myself todoing all I can to contribute
(02:39):
solutions towards responding toHIV epidemic in Uganda.
Fredrik Brounéus (02:44):
Yes, and what got you into pharmacovigilance,
because that's quite a specialfield as well.
Henry Zakumumpa (02:52):
That's a good question actually, but what
happened is, what attracted meto pharmacovigilance was I think
it was 2019.
Uganda at the time was rollingout a newer HIV dolutegravir,
or DTG, and patients were beingtransitioned from efavirenz, the
older HIV drug.
So everybody was saying DTG isthe way to go.
(03:13):
So they were enrolling peopleon DTG but then, although it was
a superior drug, we got so manycomplaints from patients.
Patients were complainingaround hyperglycemia, erectile
dysfunction.
So I was reading so manyletters from patients in
newspapers asking for guidanceand saying all this new drug,
since I started it, I'm gettingproblems.
(03:35):
I kind of piqued interest, youknow, and I happen to be working
closer with them, with somebodythe Minister of Health in
Uganda who's in charge of HIVtreatment, and she was sharing
with me the challenges.
They were receiving a lot ofreports around problems with DTG
, but they had no research, theyhad no data and the National
Pharmacovigilance Center wassaying we don't have reports, we
(03:58):
don't have ADR reports.
But the patients were reallyfeeling the impact of this drug
and the side effects and theadverse events.
So that's how I got interested.
You know, and fortunatelyaround that same time Uppsala
Monitoring Centre was supportingthe Consortium for Advanced
Research Training in Africawhich funded my PhD.
It was supporting researcherswho are interested in
(04:19):
pharmacovigilance research.
So naturally I got in touchwith the National
Pharmacovigilance Center inUganda so they supported our bid
and we successfully got thatresearch grant.
So that's how I was launchedinto pharmacovigilance.
So it was out of the problem.
Really it was not that Itrained as a specialist in this
area.
Fredrik Brounéus (04:37):
So actually, the topic that we are talking
about today around thespontaneous adverse events
reporting – that's actually whatgot you into pharmacovigilance
from the beginning, looking atwhat patients were describing
from their new HIV medications,and so this is, in many ways,
the backbone ofpharmacovigilance systems, the
(05:01):
spontaneous reporting, and weoften talk about the fundamental
challenge of underreporting andthe low proportion of events
being reported.
Do you think it would be fairto say that the quality of
reports is an equally bigchallenge?
Henry Zakumumpa (05:21):
You know, that's a fantastic question,
Fredrik.
You're absolutely right.
Of course, Uganda and manycountries in Africa have
underreporting, and I've seenstudies which suggest that only
10% of adverse drug reactionsare actually reported to the
authorities.
So in Uganda, we have thatproblem as well.
However, what has happened inUganda is we have benefited from
so many interventions aroundpiloting new reporting routes,
(05:45):
such as the Med Safety app,which I participated in rolling
out, reporting via WhatsApp.
They even accept email ADRreports.
But when I engaged with theNational Pharmacovigilance
Center in Uganda, they told usHenry, 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 achallenge.
(06:07):
There's no dosage of theperson, when did the onset of
the symptoms begin?
And so all the details aresometimes missing or you find
like a significant number of ADRreports cannot be used for
analysis.
So that's actually why welaunched into this research in
the first place, because the NPCin Uganda thought this was a
(06:27):
research problem they had andthey wanted to understand from
the perspective of the healthworkers, from the perspective of
the patients (06:34):
what are your problems?
Why are you giving usincomplete reports?
Hence this research which weconducted.
Fredrik Brounéus (06:42):
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 atMakerere University and the
National PharmacovigilanceCenter at the National Drug
Authority, both in Kampala,Uganda, where you explored
(07:03):
drivers and obstacles of dataquality in adverse events
reporting.
You've already mentioned thatit was a qualitative study, but
I was wondering if you could goa little deeper into that.
Henry Zakumumpa (07:17):
Okay, okay, thank you.
So first of all, as I mentionedearlier on, this study was
commissioned by the NationalDrug Authority or the National
Pharmacovigilance Center inUganda, and it was a research
priority.
They wanted to understand whywe're getting reports that are
incomplete, that do not help usto analyze and therefore take
(07:37):
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 12HIV clinics across Uganda.
So we made sure that theclinics we selected were kind of
(07:59):
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 levelsof service delivery.
So we tried to have a reallyrepresentative sample.
Fredrik Brounéus (08:13):
So what did you find out with regards to
obstacles and drivers?
Henry Zakumumpa (08:20):
Actually this study, in my opinion, revealed
many novel things, many newinteresting things that we
didn't know.
For example, we found thatpatients first of all
deliberately under-reportbecause they want to remain on
effective HIV therapies.
There's this super HIV drugcalled dolutegravir and patients
(08:41):
believe this drug is effectivein viral load suppression and so
they have seen from theirfriends.
When they report side effectsthey say I have the erectile
dysfunction, I have hypoglycemia, I have nausea, I have insomnia
.
Then the clinicians tend to kindof revert them to the old HIV
(09:01):
drug and the patient thoughtthat this leads to kind of
getting a medication that is noteffective.
So they deliberatelyunder-report the severity of the
ADRs they are suffering.
So they don't give all the fullextent of the ADRs because they
know when they give you thefull details of how they are
being impacted, how their visionis affected, how they can't
(09:23):
sleep at night, then definitely,naturally, you'll say no, we
have to take you back to aefavirenz, we have to take you
to atanazavir, another HIV drug.
So patients are kind oftolerating the adverse drug
reactions of DTG because theybelieve or they perceive this
drug to be very effective, to bevery effective and from their
judgment, they would rathersuffer the ADRs you know, than
(09:48):
lose an effective regimen, aneffective medication.
Fredrik Brounéus (09:54):
That must be so important feedback for
healthcare professionals to knowthat this is what patients are
fearing.
Henry Zakumumpa (09:59):
Yeah, yeah, I think it was.
That's number one.
Number two, we found thatthere's a high level of herbal
use, especially among HIVpatients who are 50 years or
older.
Now, when they become older,also because of the medication
itself, actually, it also leadsto NCDs non-communicable
diseases like diabetes,hypertension.
(10:20):
And now in Uganda HIV treatmentis free to the user.
The government providestreatment for HIV, partly
because also the US governmentused to support Uganda
government to provide treatmentfree of care.
Now we have a challenge ofthese NCDs, or non-communicable
diseases like hypertension.
So, although the governmentclaims to offer treatment,
(10:44):
patients tell us actually thehospitals don't have the drugs,
they're not available.
So when they go to a governmenthospital they might tell them
we are out of stock.
Please go to a private pharmacyand buy, and many of our people
are very poor.
So what they do then is theyrevert to natural remedies.
You know, because Africans hadthese herbal medicines for a
long time and they were usingthem.
(11:04):
Of course there are challengeswith that, but now many people
are taking these drugs.
So the clinician has told usHenry, now this person tells you
they have these problems, theyhave insomnia, they have
neuropsychiatric problems, butwhen 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 challengedoing causality assessment
(11:27):
linking DTG to this problem.
So when they're filling thesereports, that's another
challenge on how to overcome it.
Then the other challenge wefound 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 andeven the American government,
(11:49):
because they were supporting itfor a long time they devised new
approaches to HIV servicedelivery and these are called
differentiated service deliverymodels.
So if you are virallysuppressed, in their judgment,
you don't need to come to thefacility every month for a
review because you're virallysuppressed.
In their judgment, you don'tneed to come to the facility
every month for review becauseyou're very suppressed.
So what they say for you we'regoing to give you a six-month
(12:09):
supply of HIV medication.
You only come back at leasttwice a year.
So you go to the community orsomebody can pick drugs on your
behalf.
The aim was to first of allreduce the burden of care on
patients, to reduce transportand time spent at facilities and
also to decongest the healthsystem.
We found that now, when itcomes to reporting adverse drug
(12:31):
reactions, now this arrangementis problematic because patients
come back and then after sixmonths they have been enduring
these adverse reactions and weeven found some actually die.
For example, if you havehyperglycemia and it's
uncontrolled for three months, Imean it can lead to death.
(12:55):
So they told us, now this is amajor problem.
Although it was meant to easethe life of patients when it
comes to adverse drug reactionreporting, now it's becoming a
problem.
Because now, when a patientcomes after six months, they are
telling you about this ADR theysuffered, but then recalling
events becomes problematicBecause when you ask them, when
(13:18):
did it begin, what symptom didyou get, what drugs were you
taking at the time, what othersymptoms did you have, and then
a patient can only give you bitsand bits of information, so
they don't give you a fullpicture that helps you to
determine which other ADR isthis.
You know, do a causalityassessment.
Besides patients, we also foundthat healthcare professionals
(13:40):
also are part of the problem.
Actually, first of all, thehealth workers I talked to said
they don't have incentive toreport.
They said they have beenreporting.
They don't get feedback fromthe National Pharmacovigilance
Center.
They told us that reporting isinconsequential.
Whether you report ADRs or not,there's no feedback, first of
all.
Number two, you don't get anyguidance on how to manage the
(14:03):
patient.
Basically, it's inconsequentialfrom their perspective.
That's why qualitative researchis good, because you understand
somebody's psychology,somebody's understanding.
That also affects the amount ofinformation they provide on ADR
reports, the seriousness withwhich they take ADR reports, the
amount of detail they give inADR report.
(14:26):
So it's like a formality.
So they will say oh, thisperson came here, he had
erectile dysfunction.
It was for two weeks.
So they will skip so many partsof the ADR report and just
submit it.
Because in their mind, whetherthey report or not, nothing's
going to happen, all right?
So health workers havedeveloped kind of complacency.
Now that's also another point.
They have kind of – we havesubmitted this paper for
(14:49):
publication and we have calledit a professional urgency, where
the health worker now says ah,we know what DTG causes.
I no longer have to report tothe National Pharmacovigilance
Center.
If a patient comes to me, tellsme he has hyperglycemia, I know
that's DTG.
If he tells me he has erectiledysfunction, I think probably
that's DTG.
If he tells me he has insomnia,he can't sleep, that's DTG.
(15:09):
So what they told us?
The clinicians no longer evenbother to report to the National
Pharmacovigilance Center, youknow.
So that's a huge problem.
They said what I do I managethe patient on my own; I either
remove him from DTG, I take himto efavirenz, you know, or I
take another clinical decision.
So I don't have to bothermyself giving a well-detailed
(15:31):
report to the NPC, because Iknow the NPC will not guide me,
it will not take any action.
So also this situation wherehealth workers manage these ADRs
on their own is also, I think,a huge challenge.
All right, a huge challenge.
Then also we found some healthsystem issues around laboratory
infrastructure, even inputs,basic inputs for reagents to
(15:55):
conduct studies, even basicthings like liver function tests
, glucometers for testing bloodsugar.
They are not available.
For example, if a patient saysthey have frequent urination at
night, I am wasting away.
I don't know whether it'sbecause of DTG.
The clinician cannot even do asimple test for blood sugar
(16:17):
because they lack glucometers,they lack basic test kits.
You know, if you go in ruralUganda, these are real, real
problems.
They're real, real problems fora a condition.
So he may have a hunch thatthis is hyperglycemia, but they
cannot even write it on the ADRreport because he has not taken
the mandatory three bloodglucose fasting, blood glucose
(16:38):
tests you know to be able to doto say authoritatively that this
is hyperglycemia or diabetes,whatever it is.
So we found that there areissues to these issues of
under-reporting, incompleteinformation or inaccurate
information, an interactionbetween patient-based factors,
(17:00):
health workforce factors, healthsystem factors.
So it's really a complex thing.
It's not just a one-factorthing.
There's an interaction in thefactors that contribute to
incomplete documentation of ADRs.
Fredrik Brounéus (17:14):
Yes, that struck me as I was reading your
paper just the complexity of thechallenges, the combination of
some material challenges,communicative challenges and
also another challenge that youmentioned that clinicians may
also hesitate to report eventsout of fear that it may be due
(17:38):
to a medication error, sosomeone would perhaps point
their finger at them.
Henry Zakumumpa (17:44):
Oh yeah, oh yeah, they say when they report,
they kind of invite scrutiny intheir clinical decision making.
So they think when they reportthen they will say oh, did you
give the patient the rightdosage?
Did you guide them properly onhow to take these drugs, for
example?
I'll give you an example (17:59):
DTG is supposed to be taken in the
morning, not at night.
Some of the ADRs of insomnia arebecause patients are taking the
drug at night, contrary toinstructions, and so if you
report, for example, insomnia,they will ask you did you tell
the patient that they have totake this drug in the morning?
(18:21):
And then there's an anti-TBdrug called isoniazid.
You're supposed to put anotheradditional drug to avoid the
very toxic effects of the drug,I think, called pyridoxine.
There's a drug you have to addon, but at the beginning
clinicians were not providingthat additional drug.
(18:43):
So there was drug toxicity ofTB drugs, you know.
So now you see, if a patient,if a health worker reports that,
then they think that they aregoing to bring into question
their own competence asclinicians.
So it's an unfortunatesituation.
Fredrik Brounéus (19:01):
I was also interested to see that in the
paper you say that the majorityof healthcare professionals in
your study, they preferred toreport via the WhatsApp route
that you mentioned, butcurrently paper-based forms are
still the dominant reportingroute.
(19:23):
Is that right?
Henry Zakumumpa (19:25):
Yes, absolutely .
That's a good question.
Now, according to recent, Ithink, studies in Uganda that
I've seen published, data showsthat paper-based ADR forms are
the dominant reporting tool.
Okay, so that's number one.
Now, what we did?
We asked them what theypreferred, what route, what
platform they used, what theypreferred to report, and the
(19:46):
majority of them said WhatsApp.
All right, and, as I said, I'vebeen involved in the rollout of
Med Safety app and I know theseinterventions are ongoing.
So, and what I asked them, whydo you prefer WhatsApp?
They said one (19:59):
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.
Number two, which is, I think,underestimated, is that they
said also, they are able to takea photo of the symptom, you
know, of the ADR, so they can.
For example, if a patient hasjaundice or whatever it is, they
(20:24):
can take a picture.
You know, if they have awasting, they can take a picture
.
You know, if they have awasting, they can take a picture
and share it on WhatsApp.
All right.
So number two is, most, mostmedical doctors have smartphones
, actually, and many of them canafford internet, so they always
have WhatsApp.
At least the WhatsApp is notvery expensive to, even if
(20:45):
internet charges are veryexpensive in Uganda.
So they prefer to use WhatsApp.
But they told me principlereason one is it's convenient,
fast, quick and also they knowthat their report has been
received, because when you senda WhatsApp it can show you what
time it has been delivered andthat has been received.
So that's why they preferredWhatsApp, which again was an
(21:06):
interesting finding, but we needmore research to understand
that.
Fredrik Brounéus (21:11):
I'm quite curious about this WhatsApp
reporting.
So how does it work?
Is it just free text reportingfrom the clinician's side, or is
it possible to have some kindof questions or prompts or forms
that they fill in?
Henry Zakumumpa (21:27):
That's a good question.
Again, now, that's why I saidthat the NPC in Uganda has
increased the volume of reportsreceived.
Now the WhatsApp isunstructured.
People report like the way Isend a WhatsApp to my girlfriend
or to my boss or whatever, soyou report in your own language,
(21:48):
in your own.
Again, that's what they prefer,which doesn't help so much when
it comes to analysis.
Now, you see, that means now youhave sent to the NPC in Kampala
in Uganda, the capital, andthen 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 weare going into this issue of
(22:09):
data quality.
Okay, the reports are coming in, but analyzing them is a
challenge.
Now, all right, so, althoughthey're like WhatsApp, you
receive so many WhatsApp, butyou have to make the data
analyzable.
So you have to move from thedata you have received to making
it usable, to cleaning it andmaking it intelligible so that
you can analyze it.
Yeah, so those are some of thechallenges of WhatsApp.
Fredrik Brounéus (22:33):
That is a very interesting point you raised
there.
I think that just there is abalance there, um, in getting a
lot of information but withperhaps less structure or
quality as well.
It demands a lot more work fromthe assessor, or having more
structured, strict information,but getting less of it, because
(22:56):
it demands more from thereporter and I would be very
curious to to know how, when itcomes to the completeness of a
WhatsApp report, how thatcompares to the completeness of
the paper forms.
Henry Zakumumpa (23:12):
Yeah, now in Uganda they require a lot of
detail.
It's very, very elaborate.
One (23:16):
they have to give patient details, age, gender or sex.
You know, what conditionthey're suffering from.
Then you have to give detailson the drug – what's the batch
number, who's the manufacturer,expiry date.
Even the reporter themselveshave to give details: I'm a
clinician, I'm based in thishospital in this district of
(23:37):
Uganda.
So it's very elaborate and someof the health workers think the
detail is too much.
They think it's too much, theyshould reduce on the detail.
Of course that's from theirperspective, because they have
heavy workloads.
But again, from the perspectiveof the pharmacovigilance center
(23:57):
, they need data that can helpthem do causality assessment,
that can help them analyze andlink ADRs to drugs.
So their standards are, ofcourse, higher.
You know so it's a question ofperspective.
You know, yeah, so, but it'svery clear what we have to an
ADR report has to have detailson the patient, on the drug
(24:18):
itself and the person reporting.
Fredrik Brounéus (24:21):
Is it possible for patients as well to report
side effects in Uganda?
Henry Zakumumpa (24:26):
Absolutely, absolutely.
I participated in the rolloutof the Med Safety app and I
published a paper, I thinktogether with a colleague of
mine in Drug Safety, on therollout.
The Med Safety app has beenrolled out and piloted in some
hospitals across Uganda and somepatients have already uploaded
(24:48):
it or downloaded it on theirsmartphones, so they have it.
So patients have now beenempowered to report.
Also, I've been involved in astudy where we had the peer
support model, where we aresupporting peers to help the
patients report and we trainthem on how to use the Med
Safety app.
So the patients have now beenkind of engaged, have been
(25:09):
trained on how to use the MedSafety app, on how to report and
how to train their fellowpatients to report using the Med
Safety app.
So patients do actually report.
But also, number two is that theNational Pharmacovigilance
Center, which we call theNational Drug Authority in
Uganda, has hotlines, hotlinesfor reporting side effects by
(25:31):
anybody in the public.
And if you go to a hospital,you go to some private
pharmacies, there's always ahotline.
It's advertised, there's alwaysa poster NDA.
Please, if you have a sideeffect, 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 onhypertension medication or
(25:52):
cancer medication and he hasvery severe adverse drug
reactions, you can report to theNational Drug Authority.
So even patients have beenempowered to report, although I
would say overall almost 80% ofthe reports in Uganda are from
healthcare professionals, soit's still much health worker
dominated, although there areinterventions to increase uptake
(26:14):
by patients in reporting.
Fredrik Brounéus (26:17):
How have Ugandan authorities gone about
marketing this patient sideeffect reporting?
You mentioned posters atclinics and have there been
other public campaigns orefforts to spread the word?
Henry Zakumumpa (26:34):
First of all I would say number one is there's
little funding going topharmacovigilance.
That's number one.
Even the NationalPharmacovigilance Centre, the
budget they have, isinsufficient to meet their
responsibility in the country,all right, or what they need to
do.
So Uganda government does notinvest enough in
pharmacovigilance, in engagingpatients, in reporting, in
(26:54):
training health workers.
So even the NPC itself has isunder the budget, is small for
doing the mandate it has as aregulatory authority which is
part of the problem actually.
Fredrik Brounéus (27:07):
Yeah, so, departing from your research and
your experiences, with limitedresources, what do you think are
the most importantinterventions or actions that a
regulator or PV center could doto foster or improve data
quality and data quantity forincoming reports?
Henry Zakumumpa (27:29):
Okay, thank you for that question.
Actually, number one is theclinicians told us that, Henry,
what the way the government canhelp us is first of all, to
increase the national guidanceon 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 justdropping boxes of medicine.
(27:50):
You know, they just drop drugsand they tell you you have to
give, each patient has to takeone tablet a day and that's it.
They didn't tell them thatpatients can get hyperglycemia,
that they can get insomnia ifthey take this drug at night.
So national guidance has toimprove, all right.
And then number two (28:07):
health worker.
I think health workers need tobe trained, they need to be
sensitized, especially nurses,midwives, because in Uganda,
unfortunately, we don't haveenough doctors in the front line
of HIV service delivery.
So you have a lot of nurses,midwives, who are giving HIV
(28:27):
care, who don't have extensiveclinical training.
You know, in fact, when I wasdoing this research, one nurse
told me (28:33):
Henry, I didn't know that they need this ADR report
to do analysis and to make adecision at the National
Pharmacovigilance Center.
I didn't know that.
So I was just filling a form, Ididn't know, you know they
didn't understand there is aninput in a process to make a
decision, you know.
So training of health workers,especially mid-cadre, the nurses
(28:54):
and midwives who are veryimportant in uganda.
80 percent of the healthworkforce in uganda are nurses.
So we need to focus on themid-cadre, even in their
training at the tertiary level,in their institutions of
learning, to train them inpharmacovigilance.
Then even patients need to betold, you know, they need to
report and they should stoptolerating adverse drug
(29:15):
reactions.
They can be toxic, they can befatal, you know.
So, anyway, there are many.
And then also we have to investin laboratory systems, in basic
things – liver function tests,glucometers for testing, blood
sugar test kits, basic things.
We need to improve our supplychain for medical supplies
(29:39):
across the country.
Fredrik Brounéus (29:40):
I wanted to ask also, Henry, a dramatic
change from when you wrote thepaper is the financial terms for
receiving HIV treatment inUganda due to recent termination
of foreign funding programs.
And you write in the paper thatthe United States PEPFAR has
enabled the rolling out HIVtreatment to over 1.4 million
(30:05):
Ugandans.
And also you mentioned that thereason for many people to take
traditional herbal medicines,for instance for diabetes or
high blood pressure, instead ofprescribed medicines, is that
they cannot afford theconventional medicines.
And I just wanted to ask whatwill happen now?
Henry Zakumumpa (30:25):
Excellent question and very timely indeed.
Now, Uganda has been veryheavily dependent on the US
government especially, evenother donors, because the global
fund is funded even by Europeancountries like the UK, France
and other countries.
But the US has been funding, Ithink, up to almost 70% of HIV
spending in Uganda.
So when the new administration,the US government, came into
(30:48):
place, they had differentpriorities and they abruptly
stopped HIV aid.
So there have been devastatingimpacts.
It has caused confusion, it hasalready resulted in disruptions
in service delivery.
Well, medicines are being given.
Now that's okay.
Antiretrovirals are stillavailable.
(31:09):
But you know, HIV care is acomplex disease to manage.
Now, like community outreach,where you go to people's
households to ensure they areadhering.
Those who are not coming to theclinics for review, you tell
them, please come for review.
People who give youpsychosocial support to
strengthen your adherence.
All those who are not under theUganda government payroll, so
(31:30):
they've been funded by theAmericans.
Those are no longer in position.
We had HIV preventioninterventions like PrEP, which
is a pre-exposure prophylaxis,where, for example, sex workers
who take this PrEP don't get HIVeven if they expose the virus.
Now all this stopped because itwas American-funded.
(31:50):
Services for gay community,lgbt community has also now
stopped because the USgovernment was funding what are
called drop-in centers, specialhealth facilities, which are
friendly, which don'tdiscriminate, which don't judge
them.
So now my prediction is HIV isgoing to reemerge as a public
health threat again.
(32:11):
So unfortunately this loss infunding is really going to have
major impacts and right now itappears as though we are
managing.
But my research has alreadyshown that after around three
years that's when you reallyknow the full impact.
That's when you see communitytransmission going up,
drug-resistant TB rising, youknow deaths happening.
(32:32):
So it will take time to knowthe true impact of loss of aid.
So now the Uganda government hascome in with some strategies.
One, they have said they aregoing to – because HIV clinics
were kind of standalone, becausethey were American-funded,
because they were payingadditional health workforce –
now they have said ideally theHIV clinic should be integrated
(32:54):
with general health services.
That's number one.
All right, so the Ugandagovernment is going to replace
some of the funding forespecially antiretrovirus, which
is a positive thing.
So the president has even saidpublicly that the Uganda
government, we are going to doall we can to replace the money
the US government has beeninvesting in procuring antivirus
, so which is positive.
(33:15):
Then also, we had an idea of alevy or a tax on soft drinks
like soda in Uganda, which hadbeen planned about 10 years ago
but it was never implemented.
It was called an AIDS TrustFund.
That also is going to bekick-started, revived to make
sure that there's more domesticreliance for the national HIV
(33:37):
response, and they are tryingalso to improve national health
insurance, private healthinsurance, and also to see if
the private sector cancontribute to bridging the
financing gap.
So there are a number ofstrategies, but it's still a
problem that we need to reallyfully grapple with.
Fredrik Brounéus (34:00):
We're nearing the end of the interview now and
I wanted to ask what's up nexton your research agenda?
What studies are you planning togo into now?
Henry Zakumumpa (34:15):
Actually, so that's a good question.
Now, before I did this study, Iengaged, had meetings several
meetings with the NationalPharmacovigilance Center in
Uganda, with people like HelenNdagije, who is really a
champion in pharmacovigilance,and they have a lot of research
questions.
Actually, they had so manyresearch questions we were only
able, because of funding, todeal with one of data quality.
(34:36):
So I'll give you just a fewexamples of the questions that
were not answered yet.
One, they were talking aboutthe potential role of AI, right,
and they wanted us to doresearch, both within the NDA,
within healthcare professionals,and they really have a lot of
hope in the potential of AI tohelp with causality assessments,
(34:56):
data analysis, big data,machine learning.
So we didn't do that research.
We're also looking at how tosynchronize these multiple
reporting tools of Med Safetyapp, WhatsApp, email, to find a
way of kind of synergies youknow, because right now they're
standalone and they're notspeaking to each other to see
(35:17):
how to manage that, all right.
Also, we need to do research ondesigning the new ADR forms,
because there's been feedbacksaying it's too detailed, the
space is not enough, we'll takethis one out, I want this one.
So the preferences ofhealthcare professionals, which
again hasn't been done, and theNPC doesn't have funding to do
(35:37):
that, unfortunately.
So there's several questions,several questions.
The thing, of course, to do isto source for funding in Uganda
and abroad as well.
Fredrik Brounéus (35:47):
I'm already looking forward to having you
back in the studio, Henry.
Those are very interestingquestions you have there.
Given the, let's say, unlimitedresources, do you have a dream
study or a dream researchproject?
Henry Zakumumpa (36:02):
I think I have a dream research project.
For me, I think that myresearch has shown me that
patient-led reporting actuallyis ideally what we should push
for.
For me, I think we need moreresearch and working with
patients on how they can report,train them how to recognize
adverse drug reactions and howthey can report easily, how they
(36:25):
can be confident, how they canhave peers supporting them.
So for me, my research would beon how to strengthen the
patient-led reporting of ADRsBecause, even given the UMC
funding I got for my study onDTG, I found that actually
patients come up with more novelADRs than health workers.
I'll give you an example (36:48):
we found that DTG causes sexual
dysfunction, which was a novelfinding.
Now, before I talked to thepatients, I had been all over
Uganda northern Uganda, easternUganda thanks to funding from
UMC, talking to clinicians.
Nobody had ever mentioned thatthere's a problem of sexual
dysfunction that is causing lowlibido, it's causing marriage
(37:13):
split-ups, but when you talk tothe patients, they give you new,
unheard-of problems, you know.
So that's why I personallythink that I'll do more research
around patient-ledinterventions to enhance
reporting of ADRs.
So for me, that's my dreamproject.
Fredrik Brounéus (37:30):
Thank you so much, Henry.
This has been a very inspiringinterview.
Thank you for your time and, asalways, I learned a lot.
Henry Zakumumpa (37:39):
Okay, all right , and thank you Fredrik.
Fredrik Brounéus (37:45):
That's all for now, but if you'd like to learn
more about Henry's work, we'veput together some links for you
in the episode show notes.
Apart from the Drug SafetyMatters podcast, we have our
pharmacovigilance magazine,Uppsala Reports.
Visit uppsalareports.
org to stay up to date with news, research and trends in the
(38:05):
field, and don't forget tosubscribe to the newsletter for
the latest articles.
If you have any comments orsuggestions for the podcast or
the magazine, please feel freeto reach out on Facebook,
LinkedIn, Blues ky or X.
You can also visit our websiteto learn more about what we do
to promote safer use ofmedicines and vaccines for
everyone, everywhere.
(38:26):
If you like the podcast, pleasesubscribe to make sure you
won't miss an episode and spreadthe word so other listeners can
find us too.
For Drug Safety Matters, I'mFredrik Brouneus.
Thanks for listening.
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