1. Syhakhang L, Stenson B, Stålsby LC, Eriksson B, Tomson G
PRIVATE PHARMACY PRACTICE AND REGULATION - A RANDOMIZED TRIAL IN LAO PDR
Syhakhang L, Stenson B, Stålsby LC, Eriksson B, Tomson G
Ministry of Health, Lao PDR, International Health Care Research (IHCAR), Karolinska Institutet, Sweden
Problem statement: Little has been known about the effect of regulation on thequality
and effectiveness of pharmacy services. Most published reviews of intervention
research are from industrialized countries and there is a lack of studies on the
relationship between regulatory factors and pharmacy behaviour.
Objective: To assess the effectiveness of government regulation of private pharmacy
practice in a low-income country.
Design: Randomised controlled trial.
Setting and Population: A sample of 115 private pharmacies out of the total 214
licensed private pharmacies in the Savannakhet province was randomly selected from
all 14 districts of the province. The 14 districts were matched in pairs according to the
general socioeconomic criteria such as income level and literacy. Thereafter, each
district in a pair was assigned to either active or regular intervention by random
selection.
Interventions: The intervention comprised inspections of the pharmacies, providing
the pharmacies with information on regulations, distributing documents to drug sellers,
and imposing sanctions for violations. The intervention was implemented at two
intensify levels, active and regular intervention.
Outcome Measures: Indicator scores (0-10) for pharmacy indicators: order, essential
drugs, and essential materials; indicator scores for dispensing indicators (proportions):
information, labelling and mixing.
Results: There was an overall improvement in indicator scores from initially low
level. The improvements were particularly marked by increases in the availability of
essential materials for dispensing (34%) and in order in the pharmacy (19%).
Information given to customers increased from 35% to 51%, and the mixing of
different drugs in the same package went down from 17% to 9% of the contacts. The
pharmacies in the active intervention districts showed greater improvements for four of
the six indicators, although there were statistically significant, compared with the
regular intervention, for only the essential material indicator.
Conclusions: The regulatory activities have been important for promoting
improvements in quality of services. It appeared feasible as well as effective to
regulate private pharmacy practice in this particular low-income setting.
Study funded: Swedish International Development and Cooperation Agency; Swedish
Agency for Research Cooperation with Developing Countries.

2. Background Pharmaceuticals make up half or more of health care costs
Pharmacies often function as outpatient clinics and have a considerable public health responsibility
Problems of quality as reliance on profit from drug sales contributes to over-prescribing and polypharmacy may be compounded
Little is known about the effect of regulation on the quality and effectiveness of pharmacy services
Lack of studies on the relationship between regulatory factors and pharmacy behaviour

3. Background
In Lao PDR, 2,000 new private pharmacies established in a few years after Main problems were:
High self-medication
Non-prescription drugs including antibiotics
Widespread irrational drug use, and counterfeiting
Weakness of regulation of private pharmacies
The Lao National Drug Policy (NDP) was endorsed in 1993
Regulation of private pharmacies in Savannakhet province began with the second phase of the NDP development programme in 1996.

4. Objective & setting Objective:
To assess the effectiveness of government regulation of private pharmacy practice in a low-income country.
Setting and population:
214 licensed private pharmacies in 14 districts of Savannakhet province
115 private pharmacies as study sample
Base-line data collection reached 92%
Post- intervention reached 80%

5. Study design
The design is a randomized controlled trial

6. Methods Inspection of pharmacies using the developed indicators
Structured interviews with drug sellers
Semi-structured exit interviews with customers
Inspection of drugs bought

7. Indicators Facility specific indicators - Order in the pharmacy
- Availability of Essential Drugs
- Essential materials for dispensing
Dispensing indicators
- Information
- Labelling
- Mixing drugs

8. Intervention Ensuring four inspections annually
Providing information to drug sellers
Distributing regulation documents to pharmacies
Imposing sanctions for violations
Through:
Intensified supervision and training for district drug inspectors
An injection of USD 1,000

9. Results
Only small and not statistically significant differences existed between the active and regular intervention districts before the intervention
The differences of the means of these indicators from pre- to post-intervention differed statistically significant between the active and regular intervention districts only for one indicator (essential materials)
Positive differences in all indicator scores from the pre- to post-intervention period between the active and regular intervention districts, except for labelling in the regular intervention districts

10. Results Pre Post p-value n 92 n 92 Pharmacy indicators (mean scores)
Order
EssentialDrugs
Materials
Dispensing indicators (proportions)
Information
Labelling
Mixing

11. Results n 46 n 46 Difference means (Post-Pre) Active Regular p-value
Pharmacy indicators
Order
EssentialDrugs
Materials
Dispensing indicators
Information
Labelling
Mixing

12. Conclusions
The quality of private pharmacy practice was improved after 1½ years intervention
Government regulations are likely to be an important cause of this positive development
It appeared feasible and effective to regulate private pharmacy practice in this low- income setting.