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Effectiveness of a Multi-Component Intervention on Dispensing Practices at Private Pharmacies in Vietnam and Thailand: A Randomized Controlled Trial

Chalker J, Ratanawijitrasin S, Chuc NTK, Petzold M and Tomson G

Karolinska Institutet, Sweden; Management Sciences for Health ( MSH); Chulalongkorn University, Thailand; Hanoi Medical University,

Vietnam; Nordic School of Public Health, SwedenProblem Statement: Private pharmacies are the first line of health care in many

communities, commonly selling antibiotics in too small doses and prescription-only drugs such as steroids without medical supervision.

Objectives: To study the effectiveness of a multi-faceted intervention on the dispensing practices of drug sellers within Hanoi and Bangkok.

Design: A randomized, controlled trial.Setting: Private pharmacies in Hanoi and BangkokStudy Population: 34 intervention private pharmacies in Hanoi and 39 in Bangkok and an

equal number of controls were randomly selected and assigned. In Hanoi, 28 intervention and 27 control pharmacies completed the study, as did 34 intervention and 35 control pharmacies in Bangkok

Intervention: Three three-month interventions were implemented sequentially with four months in between: enforcement of regulations with local inspectors visiting to emphasize the importance of prescription-only medicine legislation; education, performed face-to-face in Hanoi and by a large group in Bangkok; and peer review, voluntary in Bangkok and effectively compulsory in Hanoi.

Outcome Measures: Behaviour was assessed by five simulated client visits per pharmacy per dispensing practice, at baseline and a month or more after each intervention. Whether the requested antibiotic or steroid was dispensed and whether relevant questions were asked and advice given were recorded.

Results: In Hanoi, significant improvements compared to controls was shown after the educational intervention, reducing the dispensing of illegal steroids (29% v 62%) and low dose antibiotics (69% v 90%), sustained by means of the peer review (17% v 57% steroids and 71% v 95% antibiotics), and in fewer dispensers asking no questions and giving no advice (11% v 30% steroids and 51% v 81% antibiotics). The only significant improvement in Bangkok was the reduction in illegally dispensing steroids (25% v 44%) after the regulatory intervention which was not sustained. In Bangkok, fewer of those in the group who volunteered for the peer review asked no questions and gave no advice for low-dose antibiotics requests after the peer review (58% v 81%).

Conclusions: A multi-component intervention can have a profound effect in changing dispensers’ behaviour, but the effect is dependent on the context and the method of implementation. Possible reasons for differences between the cities are discussed.

Abstract

Background Drug sellers are becoming the first line of

PHC in many communities Dispensing Practices are often both bad

and illegal Few attempts to change but evidence

shows multifaceted interventions best No comparison of effectiveness of

multifaceted interventions in different environments

Study AimTo study the effectiveness of a multi-faceted intervention on dispensing practices of drug sellers in Hanoi and Bangkok on two critical behaviors: :

Selling antibiotics in small doses without prescription (which is particularly dangerous for the spread of antimicrobial resistance)

Selling prescription only drugs (steroids) without prescription

Study Design: Randomized Controlled Trial

Monitoring by Simulated Client Visits, 5 visits per pharmacy for each tracer condition. 4 times: Baseline & after each intervention. The Clients asked for:1) A small dose of an antibioitic2) Steroids for a bad back

Interv- Interv- Interv-ention ention ention

1 2 3

Inter- Regulat-vention SCM ory SCM Educat- SCM Peer SCMPharm - Enforce- ional Influ-

acies ment enceDec-97 Aug-98 Nov-98 Jan-99 May-99 Aug-99 Dec-99

Control Pharm - SCM SCM SCM SCM

acies

PHARMACIES SAMPLE

SCM = Simulated Client Method

Interventions1: Enforcement of Regulations Focusing on dispensing of prescription only drugs Hanoi: 2 visits giving a summary of px only regulations

with a letter from the Provincial Health BureauBangkok: Checked steroids & steroid pxs, Gave a

warning of violation of the regulations and gave instruction to the seller on the respective regulations

2: EducationHanoi: Academic detailing: 2 visits, 45 mins each by 2

people one visit steroids, and one antibiotics Questions, advice and treatment (QAT) stressed with

written and verbal info.Bangkok: Owners and counter attendants invited to 2 day

workshops; included steroids, and antibiotic requests. 9 shops who did not attend were visited twice- for 2-

hour academic detailing one steroids, and one antibiotics

3: Peer Influence Hanoi: Hanoi divided 5 area groups with 5-6 PPS. Built on

QAT. 5 meetings per group. Collected and reported cases. All pharmacies attended

Bangkok: All intervention PPs staff invited to a meeting "Techniques to increase the revenue of drugstore". Setting up of peer groups discussed. Sent out minutes and invited for peer groups. Groups set own agendas, with some guidance. 16/34 did NOT attend.

Sampling Private Pharmacies (PP) for intervention (int) and control (cont)

groups

4 area types

2 districts in each

Int / cont

39 cont39 int

35 cont34 int

Bangkok

789 PPs

641 fit criteria

34 pairs

34 cont34 int

27 cont28 int

Hanoi

Difference Int & Control (%)

P-value

Hanoi Received requested Antibiotics

Baseline 2 0.1625 Post Regulatory 0 0.7389

Post educational -21 0.0471 Post peer review -24 0.0125

Ask no Questions gave no Advice Baseline -3 0.6027

Post Regulatory 0 0.9597 Post educational -26 0.0025 Post peer review -30 0.0028

Bangkok Received requested Antibiotics

Baseline 1 0.8925 Post Regulatory -9 0.3770

Post educational -3 0.4795 Post peer review -4 0.5525

Ask no Questions gave no Advice Baseline -4 0.4165

Post Regulatory -2 0.5526 Post educational 0 0.9447 Post peer review -9 0.1927

Antibiotic Results

Difference Int & Control (%)

P-value

Hanoi Received requested steroids

Baseline 7 0.2930 Post Regulatory -4 0.5456

Post educational -33 0.0011 Post peer review -40 <.0001

Ask no Questions gave no Advice Baseline 8 0.2488

Post Regulatory 6 0.2919 Post educational -24 0.0032 Post peer review -19 0.0014

Bangkok Received requested steroids

Baseline 3 0.6815 Post Regulatory -19 0.0240

Post educational -16 0.1151 Post peer review -18 0.0639

Ask no Questions gave no Advice Baseline 4 0.6176

Post Regulatory -7 0.2818 Post educational -3 0.6518 Post peer review 0 0.9610

Steroid Results

Results In Hanoi, significant improvement

compared to control was seen for the dispensing of antibiotics and steroids as well as a reduction in those not asking relevant questions or giving advice

In Bangkok there were no significant changes by the end of the intervention package

The importance of individually tailoring interventions to the locations and societies in which they will be implemented through formative research has been shown.

Methodological considerations-1

Caution is needed in interpreting the difference in effectiveness between cities (inter-city) . Contextual factors are as likely as the details of the implementation to explain the difference in effectiveness in Hanoi and Bangkok.

Caution is needed in interpreting longitudinal trends. as the consistency of simulated client reporting varies

This does not affect the validity of the intra-city interpretation between intervention and control groups

The interventions were performed one after the other, so there is no possibility of isolating the effect of each individual intervention.

Methodological considerations -2The randomized controlled trial (RCT) is

a robust design to judge intra city effect

RCTs are the cornerstone of clinical medicine for assessing the efficacy of medication or clinical intervention because of the minimizing of bias.

The RCT can also be used for assessing the effectiveness in specific real life situations

There are problems with RCTs RCTs are expensive, the results are

rarely produced within two years. Therefore the results are not useful for steering the design of the intervention

To avoid bias it is necessary to standardize the content and format of the delivery of an intervention and with complex behavioural interventions it is difficult to reproduce them exactly

Methodological considerations 3We know Multi faceted interventions are

most likely to be effective. It is the very nature of multi faceted interventions to be contextualized. This reduces their external validity

So in our work the contextualization, all compromise the external validity and may be the reason for the difference between the results in Hanoi and Bangkok

In Hanoi, the success of the multi-intervention package gives important evidence showing that these drug-seller practices are changeable

The interventions are adapted to the opportunities of the environment and the goal is therefore to find whether the intervention works in that setting

Conclusion and recommendations

This study show that improvements are possible to achieve in the private sectors. However even with improvements major problems remain.

Isolated multi faceted interventions are not generalisable, leave problems of scaling up and will not solve the problems of antimicrobial resistance.

The successes of interventions depend on place. The search for the interventions that will universally work is therefore illusory. The art and science of developing specific strategies relevant to specific locations is needed.

Both indicators and interventions have to focus on chosen key problems.

If information from monitoring such indicators is produced in a timely manner, the data can be used to iteratively develop the intervention.