Regulatory Compliance Of Community Drug Retail Outlets In Ambo Town West Showa Oromia Region Ethiopia

Introduction: If standards for pharmaceutical premises exist in a country, it should define thernminimum requirements to operate a drug retail outlet as the regulation. Food, Medicine andrnHealthcare Administration and Control Authority of Ethiopia (FMHACA) prepared private drugrnretail outlets model directive based on proclamation 661/2009. The directive states about thernrequirements for qualifications of the technical personnel and the adequacy of the premises,rnprocesses and equipment in order to grant a license for providing the drug retail outlet services.rnThis study aimed in assessing the regulatory compliance of the community drug retail outlets inrnAmbo Town based on the minimum standard set by EFMHACA.rnMethod: A descriptive cross-sectional survey on all community drug retail outlets in AmbornTown was conducted from April to May 2019. Checklist based observation and measuring,rnrecord review and semi- structured interview guide questionnaire were used for data collection.rnResults: The response rate was 25(92.6%) for the retails; 6(24%) pharmacies and 19 (76%) drugrnstores. The total area of the premises varies from 30mrn2rnto 56.5mrn2rnfor Pharmacies and 22.75mrntorn56.0mrn2rnfor 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;rneven 4(40%) didn’t have for all products and 6(60%)of retails didn’t register stock movementsrnon time. Only 12(48%) of the retails were kept the prescription with/out registration eitherrnseparately or not. Only 13(52%) of the licensed professionals were available at the date of visit.rnIn 15(60%) of the retails there was accumulation of expired drugs, stored from 3 months up to 11rnyears.rnConclusions: Based on this study, we conclude that; majority of the drug retail outlets do notrnsatisfy the minimum requirements set by the regulatory authority of the country. The concernedrnregulatory bodies also do not strictly monitor the requirements, irrespective of their allegation onrnthe products stocked and the service provided by the DROs. We also recommend the concernedrnstakeholders to improve or prevent the non compliances of DROs through stringent regulatoryrnaction, follow up inspection, training and accountability rule.rn2

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