The effect of outlet location on regulatory visits and quality compliance at private- sector retail drug outlets in Tanzania: A Cross-Sectional Study

Abstract

Background Private-sector medicine retail outlets play a crucial role in delivering essential medicines to populations in Low- and Middle-Income Countries (LMICs), especially for rural areas. However, regulatory compliance and inspection of these outlets, crucial for ensuring quality, pose significant challenges, especially in remote regions. This study investigates relationships between outlet location, regulatory compliance and inspection frequency in Tanzania. Specifically, two hypotheses are tested: that private-sector medicine retail outlet in remote locations will be (a) less likely to comply with quality standards, and (b) less likely to receive timely regulatory inspection visits, than those closer to regional centres and roads. Methods 158 private-sector medicine outlets (69 pharmacies and 89 Accredited Drug Dispensing Outlets (ADDOs)) were surveyed across four regions in Tanzania. Data were collected on location (using GPS coordinates), outlet characteristics, facilities and reported frequency of inspections. Bivariate and multivariate statistical analyses were performed to test the two hypotheses. Results Overall, fewer than 10% of outlets surveyed were fully compliant with the criteria measured. Pharmacies (predominantly located in urban areas) demonstrated levels of higher compliance than ADDOs (predominantly found in rural areas). Controlling for the pharmacy/ADDO distinction, outlets closer to regional capitals exhibited better compliance on two criteria (cleanliness and staff presentation). 59.5% of outlets reported having received at least once regulatory inspection in the preceding 12 months, which pharmacies more likely to have been inspected than ADDOs (81.2% versus 42.7% respectively). Conclusion The poor levels of regulatory compliance observed are worrying, given the reliance of Tanzania’s population on private-sector medicine retail outlets. The poorer levels of compliance observed in ADDOs (compared with pharmacies), and in outlets located further from regional capitals, suggests a double disadvantage for rural communities when it comes to accessing medicines from quality-assured outlets. Increasing the frequency of regulatory visits may be part of the answer, but further investment is needed to build capacity of outlets serving rural communities.