Regulatory Compliance of Community Drug Retail Outlets in Ambo Town, West Showa, Oromia Region, Ethiopia
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Date
2020-09
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Addis Abeba University
Abstract
Introduction: If standards for pharmaceutical premises exist in a country, it should define the
minimum requirements to operate a drug retail outlet as the regulation. Food, Medicine and
Healthcare Administration and Control Authority of Ethiopia (FMHACA) prepared private drug
retail outlets model directive based on proclamation 661/2009. The directive states about the
requirements for qualifications of the technical personnel and the adequacy of the premises,
processes and equipment in order to grant a license for providing the drug retail outlet services.
This study aimed in assessing the regulatory compliance of the community drug retail outlets in
Ambo Town based on the minimum standard set by EFMHACA.
Method: A descriptive cross-sectional survey on all community drug retail outlets in Ambo
Town was conducted from April to May 2019. Checklist based observation and measuring,
record review and semi- structured interview guide questionnaire were used for data collection.
Results: The response rate was 25(92.6%) for the retails; 6(24%) pharmacies and 19 (76%) drug
stores. The total area of the premises varies from 30m
2
to 56.5m
2
for Pharmacies and 22.75m
to
56.0m
2
for drugstores. Majority (92%) of retails have functional refrigerator, but only 15(60%)has functional refrigerator thermometer. Only 10(40%) retails have Stock card and/or Bin cards;
even 4(40%) didn’t have for all products and 6(60%)of retails didn’t register stock movements
on time. Only 12(48%) of the retails were kept the prescription with/out registration either
separately or not. Only 13(52%) of the licensed professionals were available at the date of visit.
In 15(60%) of the retails there was accumulation of expired drugs, stored from 3 months up to 11
years.
Conclusions: Based on this study, we conclude that; majority of the drug retail outlets do not
satisfy the minimum requirements set by the regulatory authority of the country. The concerned
regulatory bodies also do not strictly monitor the requirements, irrespective of their allegation on
the products stocked and the service provided by the DROs. We also recommend the concerned
stakeholders to improve or prevent the non compliances of DROs through stringent regulatory
action, follow up inspection, training and accountability rule.
2
Description
Keywords
Drug Retail Outlets