Examining the Quality of Medicines at Kenyan Healt

Authors: Francis Wafula Amy Dolinger Benjamin Daniels Njeri Mwaura Guadalupe Bedoya Khama Rogo Ana Goicoechea Jishnu Das Bernard Olayo

Publish Date: 2016/11/25

Volume: 4, Issue: 1, Pages: 53-63

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Abstract

Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact Although problems of substandard and falsified medicines have been documented in low and middleincome countries reliable information on quality is rarely availableThe study used standardized patients or mystery clients people recruited from the local community and trained to pose as real patients to collect medicine samples after presenting a prespecified condition The patients presented four standardized conditions to 42 blinded facilities in Nairobi Kenya resulting in 166 patient–clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies The medicine samples obtained thus resemble those that would be given to real patientsSixty samples were selected from the 300 and sent for analysis at the Kenya National Quality Control Laboratory Of these ten 17 did not comply with monograph specifications three ibuprofen two cetirizine two amoxicillin/clavulanic acid combinations and one each for prednisone salbutamol and zinc Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina There was no association between medicine quality and ownership size or location of the facilitiesThe study shows that the standardized patient model can provide insights into multiple dimensions of care thus helping to link primary care encounters with medicine quality Furthermore it makes it possible to obtain medicines from blinded sellers thus minimizing the risk of obtaining biased samplesBy having standardized patients go through the full processes of care at the health facilities and collect medicine samples at the end it is possible to link the pharmaceutical quality of the medicines given to the other dimensions of care including correctness of diagnosis and proper selection of treatment Medicine providers are also less likely to give biased samples for analysisThere is widespread recognition that promoting access to medicines is not sufficient on its own and that mechanisms must be put in place to guarantee compliance to acceptable quality standards However such mechanisms can only exist in markets where information on the quality of medicines exists with proper mechanisms for enforcing compliance to standards 1 2 This information is not as widely available as it should be in lowincome countries where complaints of substandard and falsified medicines are common and where regulatory enforcement may be weak 3 4 More recent evidence suggests that the problem may be worsening in middle and higherincome countries as well 5 Worse still there has been little effort to describe the causes and broader impact of poor quality medicines 6

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