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

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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]

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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

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Intervention Design and Outcomes

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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

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Reduced number of ACT treatments

Arm Total consults

Reported treatment% ACT Tx data

missingCoartem Rectal artesunate No ACT

Presumptive 6845 6732 49 16 98% 48RDT arm 8672 5085 57 3177 59% 353Within intervention shops:RDT pos client 4924 4814 44 49 98% 17RDT neg client 3488 42 7 3117 1% 322No 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

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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 testIn 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

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Improved targeting of ACTsControl 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.

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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

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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

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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

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Summary of findingsFrom 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

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Further information

www.actconsortium.org/RDTdrugshops

Training manuals Job aids Published reports Evidence brief