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Impact of Government Regulation on Pharmacy Practice in Laos: A Randomized Trial

This randomized trial evaluates the effectiveness of government regulation on private pharmacy practice in Laos, focusing on the improvement of quality and effectiveness of pharmacy services. The study collects data on indicators such as facility specific indicators, dispensing indicators, and pharmacy indicators. The results show that government regulations have positively influenced the quality of private pharmacy practice in this low-income country.

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Impact of Government Regulation on Pharmacy Practice in Laos: A Randomized Trial

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  1. PRIVATE PHARMACY PRACTICE AND REGULATION- A RANDOMIZED TRIAL IN LAO PDR

  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 • Little has been known about the effect of regulation on the quality and effectiveness of pharmacy services

  3. Background • In Lao PDR, 2,000 new private pharmacies established in a few years after 1986 • High self-medication • Non-prescription drugs including antibiotics • Widespread irrational drug use, and counterfeiting • Weakness of regulation of private pharmacies • National Drug Policy (NDP) endorsement in 1993 • Regulation of private pharmacies in Savannakhet province began 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 7 Active districts 7 Regular districts Base-line data collection, June 1997 Intervention No Intervention Post-intervention data collection February 1999

  6. Study population/ sample Study population 214 Active 56 Study sample 115 Regular 59 9 dropouts at baseline data collection Active 52 106 Regular 54 14 dropouts at post- intervention data collection Regular 46 Active 46 92

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

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

  9. Intervention • Four inspections per pharmacy annually • Information to drug sellers • Regulation documents to pharmacies • Sanctions for violations • Intensified supervision and training for district drug inspectors • An injection of USD 1,000

  10. Differences between the regular and active intervention packages during the study period “Active” intervention package in the 7 active districts “Regular” intervention package in the 7 regular districts • 2 inspections/pharmacy/year • Information • Distribution of regulatory • documents • Sanctions • Additional intervention • 2 more inspections • More information • More regulation documents • More enforcement • 2 inspections/pharmacy/year • Information • Distribution of regulatory • documents • Sanctions • No additional intervention Through Supervision and training for district inspectors Additional fund of USD 1,000 No supervision and no training for district inspectors No additional fund

  11. 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

  12. Results (continued) Pre Post p-value n 92 n 92 Pharmacy indicators (mean scores) Order 5.76 6.86 0.0001 Essential Drugs 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

  13. Results (continued) 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

  14. Conclusions • The quality of private pharmacy practice was improved after 1½years 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.

  15. Further research • Knowledge and practice of drug sellers in management of diseases important for public health • The quality of drug information given by drug sellers to customers to improve Rational Use of Drugs.

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