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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.
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 overprescribing 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
Background
• In Lao PDR, 2,000 new private
pharmacies established in a few years
after 1986. 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.
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%
Study design
The design is a randomized
controlled trial
7 Active districts 7 Regular districts
Base-line data collection, June 1997
Intervention
____________
Post-intervention data collection
February 1999
Methods
 Inspection of pharmacies
using the developed
indicators
 Structured interviews with
drug sellers
 Semi-structured exit
interviews with customers
 Inspection of drugs bought
Indicators
• Facility specific indicators
- Order in the pharmacy
- Availability of Essential Drugs
- Essential materials for
dispensing
• Dispensing indicators
- Information
- Labelling
- Mixing drugs
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
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
Results
Pre
Post p-value
n 92 n 92
Pharmacy indicators (mean scores)
Order
5.76 6.86 0.0001
EssentialDrugs
6.03 6.40 0.1131
Materials
5.16 6.92 0.0001
Dispensing indicators (proportions)
Information
0.41 0.51 0.0008
Labelling
0.53 0.48 0.0001
Mixing
0.26 0.09 0.5592
Results
Difference means (Post-Pre)
Active Regular p-value
n 46 n 46
Pharmacy indicators
Order
1.03 1.17 0.1175
EssentialDrugs
0.58 0.17 0.0969
Materials
2.04 1.48 0.0241
Dispensing indicators
Information
0.29 0.01 0.1066
Labelling
0.00 -0.06 0.9306
Mixing
-0.04 -0.14 0.5223
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 lowincome setting.