Quality of Drugs Based on Ferrous Sulfate Dispensed in a Basic Health and Commercial Pharmacy in a City in the Amazon Region

Abstract

Background: For the WHO, anemia is a serious public health problem, with an emphasis on deprivation anemia, which has socioeconomic conditions as determining factors for its development. Among nutritional anemias, the most relevant is iron deficiency, whose main form of prevention and treatment is supplementation with ferrous sulfate dispensed in the public health system, with the need to periodically check whether the drug has the quality required by regulatory health agencies. Thus, the objective of this study was to analyze the quality of the ferrous sulfate medication, from the same laboratory, and dispensed in a basic health unit (BHU) and a commercial pharmacy (CF). Materials and Methods: An analytical, qualitative and quantitative study of ferrous sulfate heptahydrate (25 mg/mL in 100 mL syrup), carried out on 20 BHU and 10 from CF, both from the same laboratory, but in different batches. Samples were subjected to organoleptic analysis and verification of iron content, pH, volume and density. Data were compared with values recommended by the Brazilian pharmacopoeia 5th edition. Results: Three batches were evaluated: 4659 of from the CF; 4574 from the BHU1, and 4576 from the BHU2, stored in accordance with RDC 304/19 of ANVISA. All showed compliance with some organoleptic characteristics; and stable values in pH (3.61 - CF; 3.67 - BHU1; 3.65 - BHU2), density (1.079 - CF; 1.088 - BHU1; 1.086 - BHU2) and individual volume (not less than 95% of the declared value). However, it was not possible to detect the odor of herbs; the average volume of batch BHU1 was below the declared value, and the iron content of both BHUs was above the maximum value of pharmacopoeia standards. Conclusion: Samples did not show full compliance with the physical and chemical parameters evaluated, suggesting deviation in the quality of the medication.