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Effects of introducing RDTs in drug shops:
Findings from a randomised trial in Uganda
Anthony Mbonye, Pascal Magnussen, Eleanor Hutchinson,
Kristian Hansen, Sham Lal & Siân Clarke
Ministry of Health, Uganda; University of Copenhagen, Denmark;
London School of Hygiene & Tropical Medicine, UK
Answering key questions on malaria drug delivery 1
2
Malaria diagnosis in Uganda
 2010 WHO recommendation – universal access to diagnostic testing, to
encompass all treatment providers, wherever possible
 Rapid diagnostic tests (RDTs) were introduced in public health facilities
in Uganda in 2010
 Up to 80% of malaria cases are treated in the private sector
 Two-arm trial to compare feasibility and impact of using RDTs vs current
practice (presumptive treatment of fever) in 65 registered drug shops
 Improved targeting of ACTs as primary endpoint:
Impact and cost-effectiveness of the intervention on proportion of patients
receiving appropriate ACT treatment [with microscopy as gold standard]
3
What is a registered drug shop?
• Registered with Ministry of Health, licensed
to sell Class C drugs, including antimalarials,
but not antibiotics or injections
• Most located in or around trading centres
(rural and built-up areas)
• Typically comprise 1-2 rooms with 1-2 staff
• Most have appearance of pharmacies, with
drugs displayed on shelves or in glass cabinets
• Drug shop vendors smartly dressed, some with
white coats
• Subject to periodic inspection by District
Assistant Drug Inspector
• Licence renewed annually for a fee
4
Intervention Design and Outcomes
5
What did the intervention include?
RDT training
based on WHO
generic RDT
training materials
Trial findings:
RDT adherence and targeting of ACTs
Answering key questions on malaria drug delivery 6
7
Reduced number of ACT treatments
Arm
Total
consults
Reported treatment
% ACT
Tx data
missingCoartem
Rectal
artesunate
No ACT
Presumptive 6845 6732 49 16 98% 48
RDT arm 8672 5085 57 3177 59% 353
Within intervention shops:
RDT pos client 4924 4814 44 49 98% 17
RDT neg client 3488 42 7 3117 1% 322
No RDT result* 260 229 6 11 88% 14
• Reported adherence to treatment guidelines was high
• Only 1% of clients with an RDT-negative result were treated with an ACT
• Use of RDTs in registered drug shop reduced sales of ACTs by approx 40%
* Refused, test invalid, not done, result missing
8
Primary endpoint definition
Appropriately
targeted ACT
treatment
=
Positive bloodslide
given ACT
Negative bloodslide
not given ACT+
Total consultations for fever
Can RDT testing in drug shops improve the correct targeting
of ACTs?
 Treatment decisions recorded by vendors
In RDT intervention arm: treatment decision informed by results of RDT test
In control arm: treatment decision based signs and symptoms alone
 Treatment decisions were validated by later expert microscopy on a
bloodslide collected by the vendor at the time of consultation
9
Improved targeting of ACTs
Control group RDT group
Use of RDTs in drug shops: significant increase in proportion of ACT treatment
decisions that were consistent with “true” malaria status [microscopy], p<0.001
33% appropriate 75% appropriatevs.
10
Cost-effectiveness of RDTs
Cost per additional appropriately treated client if presumptive diagnosis
was replaced by RDTs in drug shops:
Health sector perspective: 0.55 US$
Societal perspective: 3.83 US$
 Due to the low costs, the introduction of RDTs can be considered a cost-
effective intervention from a health sector perspective
 Extra costs of supplying RDTs were only partially offset by a reduction in the
consumption of ACTs
 Higher costs from a societal perspective was largely explained by higher
out-of-pocket expenditure on drugs by clients treated at drug shops offering
RDT compared to clients treated at drug shops with presumptive diagnosis
Qualitative Evaluation
Answering key questions on malaria drug delivery 11
Aim: To understand more about the processes involved
with the introduction of RDTs at drug shops
12
Support for RDTs in drug shops
Research participants were broadly supportive of the introduction of RDTs
into drug shops:
• Community members liked RDTs because they allow
them to “know the truth about their illness” and stated
that they sought out drug shop vendors who could test
for malaria and recommended drug shops who carried
out RDTs to other community members.
• Drug shop vendors reported that they liked to use RDTs
and that the availability of RDTs in their shops increases
the number of clients, their profitability, their status and
diagnostic skills.
• Government health-workers were generally in favour of
drug shops using RDTs - as long as vendors were well
trained, properly supervised and their practice was
limited by knowing when to refer patients who they
were unable to manage.
its not that we studied
much but the patients
themselves know that
we are real health
workers, they no longer
know us as people only
selling drugs. Now they
know that we also test
what.. even blood.
So for us we no longer
accept to have our
children given treatment
before having their blood
taken off, because I see
now that it is very cheap
13
Effect on reputation of shops
……there are those
(project supervisors)
who usually come here
now. If they come and
they do not disturb him
and they do not close
his drug shop, we also
get encouraged to
remain supporting that
facility
The businesses are up to date and have life in them. You can’t spend a day
without working. Even this one (the patient) who hadn’t come for testing
gets to know that this health provider knows what he is doing. Even if he/she
had come with another ailment. After he had developed trust in the DSV he
brings his children and they get tested and you treat them. Whenever he gets
any ailment, he comes because he has confidence in you.
They [patients] see that
we are really health
workers. This has a way
it puts life in us and we
feel big, ehhe [yes] and
you see yourself
becoming big.
• Patients were pleased diagnosis was available in drug shops,
and felt reassured by the training and supervision of providers
with otherwise uncertain credentials
• Vendors welcomed the opportunity to demonstrate a new skill
and a status more akin to a qualified health worker
• Together, the views of drug shop vendors revealed that the
intervention had a profound effect on how drug shops were
perceived and used, highlighting the need to consider wider
effects of RDT training interventions in the private sector
14
Summary of findings
From the project
 RDTs are likely to be popular in the private
retail sector
 Clients are willing to buy RDTs at subsidised
prices, and trained drug shop vendors can
use RDTs and comply with results
 RDT training in drug shops can improve
targeting of ACTs to malaria patients, and
reduce overuse of these drugs
 Training to perform tests can also change
the reputation of drug shops
 RDTs are likely to be financially viable for
drug shops: profit from enhanced
reputation, increased clientele and sale of
other medicine to RDT-negative clients
 Referral from shops is uncommon and faces
multiple challenges
For programme managers
 It is feasible to collaborate with the private
retail sector to improve malaria treatment
 There may be multiple benefits to drug shop
vendors in being part of an RDT training
programme
 Visible government involvement may help
promote compliance with guidelines
 Introduction of RDTs could increase
popularity of drug shops and affect where
patients seek care
 RDT use may give a false impression of
vendors’ other skills, and could expose
patients to less desirable practices.
 RDTs should only be introduced within
broader accreditation programmes aiming
to improve standard of care in private retail
sector. Effective regulation by authorities is
also needed
15
Further information
www.actconsortium.org/RDTdrugshops
 Training manuals
 Job aids
 Published reports
 Evidence brief

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Effects of introducing RDTs in drug shops: Findings from a randomised trial in Uganda

  • 1. Effects of introducing RDTs in drug shops: Findings from a randomised trial in Uganda Anthony Mbonye, Pascal Magnussen, Eleanor Hutchinson, Kristian Hansen, Sham Lal & Siân Clarke Ministry of Health, Uganda; University of Copenhagen, Denmark; London School of Hygiene & Tropical Medicine, UK Answering key questions on malaria drug delivery 1
  • 2. 2 Malaria diagnosis in Uganda  2010 WHO recommendation – universal access to diagnostic testing, to encompass all treatment providers, wherever possible  Rapid diagnostic tests (RDTs) were introduced in public health facilities in Uganda in 2010  Up to 80% of malaria cases are treated in the private sector  Two-arm trial to compare feasibility and impact of using RDTs vs current practice (presumptive treatment of fever) in 65 registered drug shops  Improved targeting of ACTs as primary endpoint: Impact and cost-effectiveness of the intervention on proportion of patients receiving appropriate ACT treatment [with microscopy as gold standard]
  • 3. 3 What is a registered drug shop? • Registered with Ministry of Health, licensed to sell Class C drugs, including antimalarials, but not antibiotics or injections • Most located in or around trading centres (rural and built-up areas) • Typically comprise 1-2 rooms with 1-2 staff • Most have appearance of pharmacies, with drugs displayed on shelves or in glass cabinets • Drug shop vendors smartly dressed, some with white coats • Subject to periodic inspection by District Assistant Drug Inspector • Licence renewed annually for a fee
  • 5. 5 What did the intervention include? RDT training based on WHO generic RDT training materials
  • 6. Trial findings: RDT adherence and targeting of ACTs Answering key questions on malaria drug delivery 6
  • 7. 7 Reduced number of ACT treatments Arm Total consults Reported treatment % ACT Tx data missingCoartem Rectal artesunate No ACT Presumptive 6845 6732 49 16 98% 48 RDT arm 8672 5085 57 3177 59% 353 Within intervention shops: RDT pos client 4924 4814 44 49 98% 17 RDT neg client 3488 42 7 3117 1% 322 No RDT result* 260 229 6 11 88% 14 • Reported adherence to treatment guidelines was high • Only 1% of clients with an RDT-negative result were treated with an ACT • Use of RDTs in registered drug shop reduced sales of ACTs by approx 40% * Refused, test invalid, not done, result missing
  • 8. 8 Primary endpoint definition Appropriately targeted ACT treatment = Positive bloodslide given ACT Negative bloodslide not given ACT+ Total consultations for fever Can RDT testing in drug shops improve the correct targeting of ACTs?  Treatment decisions recorded by vendors In RDT intervention arm: treatment decision informed by results of RDT test In control arm: treatment decision based signs and symptoms alone  Treatment decisions were validated by later expert microscopy on a bloodslide collected by the vendor at the time of consultation
  • 9. 9 Improved targeting of ACTs Control group RDT group Use of RDTs in drug shops: significant increase in proportion of ACT treatment decisions that were consistent with “true” malaria status [microscopy], p<0.001 33% appropriate 75% appropriatevs.
  • 10. 10 Cost-effectiveness of RDTs Cost per additional appropriately treated client if presumptive diagnosis was replaced by RDTs in drug shops: Health sector perspective: 0.55 US$ Societal perspective: 3.83 US$  Due to the low costs, the introduction of RDTs can be considered a cost- effective intervention from a health sector perspective  Extra costs of supplying RDTs were only partially offset by a reduction in the consumption of ACTs  Higher costs from a societal perspective was largely explained by higher out-of-pocket expenditure on drugs by clients treated at drug shops offering RDT compared to clients treated at drug shops with presumptive diagnosis
  • 11. Qualitative Evaluation Answering key questions on malaria drug delivery 11 Aim: To understand more about the processes involved with the introduction of RDTs at drug shops
  • 12. 12 Support for RDTs in drug shops Research participants were broadly supportive of the introduction of RDTs into drug shops: • Community members liked RDTs because they allow them to “know the truth about their illness” and stated that they sought out drug shop vendors who could test for malaria and recommended drug shops who carried out RDTs to other community members. • Drug shop vendors reported that they liked to use RDTs and that the availability of RDTs in their shops increases the number of clients, their profitability, their status and diagnostic skills. • Government health-workers were generally in favour of drug shops using RDTs - as long as vendors were well trained, properly supervised and their practice was limited by knowing when to refer patients who they were unable to manage. its not that we studied much but the patients themselves know that we are real health workers, they no longer know us as people only selling drugs. Now they know that we also test what.. even blood. So for us we no longer accept to have our children given treatment before having their blood taken off, because I see now that it is very cheap
  • 13. 13 Effect on reputation of shops ……there are those (project supervisors) who usually come here now. If they come and they do not disturb him and they do not close his drug shop, we also get encouraged to remain supporting that facility The businesses are up to date and have life in them. You can’t spend a day without working. Even this one (the patient) who hadn’t come for testing gets to know that this health provider knows what he is doing. Even if he/she had come with another ailment. After he had developed trust in the DSV he brings his children and they get tested and you treat them. Whenever he gets any ailment, he comes because he has confidence in you. They [patients] see that we are really health workers. This has a way it puts life in us and we feel big, ehhe [yes] and you see yourself becoming big. • Patients were pleased diagnosis was available in drug shops, and felt reassured by the training and supervision of providers with otherwise uncertain credentials • Vendors welcomed the opportunity to demonstrate a new skill and a status more akin to a qualified health worker • Together, the views of drug shop vendors revealed that the intervention had a profound effect on how drug shops were perceived and used, highlighting the need to consider wider effects of RDT training interventions in the private sector
  • 14. 14 Summary of findings From the project  RDTs are likely to be popular in the private retail sector  Clients are willing to buy RDTs at subsidised prices, and trained drug shop vendors can use RDTs and comply with results  RDT training in drug shops can improve targeting of ACTs to malaria patients, and reduce overuse of these drugs  Training to perform tests can also change the reputation of drug shops  RDTs are likely to be financially viable for drug shops: profit from enhanced reputation, increased clientele and sale of other medicine to RDT-negative clients  Referral from shops is uncommon and faces multiple challenges For programme managers  It is feasible to collaborate with the private retail sector to improve malaria treatment  There may be multiple benefits to drug shop vendors in being part of an RDT training programme  Visible government involvement may help promote compliance with guidelines  Introduction of RDTs could increase popularity of drug shops and affect where patients seek care  RDT use may give a false impression of vendors’ other skills, and could expose patients to less desirable practices.  RDTs should only be introduced within broader accreditation programmes aiming to improve standard of care in private retail sector. Effective regulation by authorities is also needed
  • 15. 15 Further information www.actconsortium.org/RDTdrugshops  Training manuals  Job aids  Published reports  Evidence brief

Editor's Notes

  • #13: In all three groups, FGD participants were broadly supportive of the introduction of RDTs into drug shops. DSVs reported that they liked to RDTs and that the availability of RDTs in their shops increases business, their status and diagnostic skills. DSVs in the control arm were on the whole more suspicious about using RDTs and were concerned that there were a large number of fake RDTs that they thought were on the market. The popularity of RDTs and their ability to pull in extra clientele, however, was reflected in the fact that some DSVs in the control arm had purchased RDTs on the open market to sell in their shops. Further, DSVs in both arms of the study liked taking blood for the blood slides, and felt that this in and of itself raised their status in the community. Community members stated that they sought drug shop vendors who could test for malaria and recommended DSVs who carried out RDTs to other community members. Felt that it reduced costs of illness episodes (treated for the illness that they had), helped the DSV to know the “truth about the illness”. Government health-workers were generally in favour of DSVs using RDTs as long as DSVs were well trained, properly supervised and their practice was limited by knowing when to refer patients who they were unable to manage. DSVs in the control arm were on the whole more suspicious about using RDTs and were concerned that there were a large number of fake RDTs that they thought were on the market. The popularity of RDTs and their ability to pull in extra clientele, however, was reflected in the fact that some DSVs in the control arm had purchased RDTs on the open market to sell in their shops. Further, DSVs in both arms of the study liked taking blood for the blood slides, and felt that this in and of itself raised their status in the community.