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.

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

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

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 n 46 n 46 Difference means (Post-Pre) Active Regular p-value 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 low- income setting.