Quality of the combined oral contraceptive pill (0.15mg levonorgestrel and 0.03mg ethinylestradiol) in the private retail pharmacies of Nyeri Town, Kenya. Results from a postmarket quality study

Abstract

Background: The effectiveness of the combined oral contraceptive pill as a family planning method is dependent on its quality. The quality of medicines on the healthcare market is established through postmarket quality studies. Methods: The quality of the combined oral contraceptive pill was established through the collection of samples from 17 (62%) private retail pharmacies in the Nyeri town of Kenya. Their quality was then determined through the assay of content of levonorgestrel and ethinylestradiol and the levonorgestrel dissolution test at the National Quality Control Laboratory. Findings: 13 of the 17 pharmacies were licensed with the Pharmacy and Poisons Board while 4 were unlicensed. Femiplan® was available in all the 17 pharmacies while Microgynon® was available in only 4 pharmacies. 17 samples of Femiplan® and 4 samples of Microgynon® were collected. None of the samples was counterfeit or falsely labeled. All the samples passed the assay of content of levonorgestrel and ethinylestradiol and the levonorgestrel dissolution test. Conclusion: Notwithstanding the fact this study provides a snapshot in time, it is reasonable to conclude that the combined oral contraceptive pill (0.15mg levonorgestrel and 0.03mg ethinylestradiol) in the Nyeri town of Kenya private retail pharmacies is of the right quality with respect to the quality tests of assay of content of levonorgestrel and ethinylestradiol and the levonorgestrel dissolution test.