Evidence-based Approach for Applying Risk Management Principles to Monitor the Quality of Pharmaceutical Products

Abstract

Background: ĐĐŽƌĚŝŶŐ ƚŽ t,K ƌĞƉŽƌƚƐ͕ ůŽǁ ƋƵĂůŝƚLJ ŵĞĚŝĐŝŶĞƐ ƌĞƉƌĞƐĞŶƚ ĂďŽƵƚ ϭϬй ŽĨ ƚŚĞ global pharmaceutical market of ǁŚŝĐŚ ĂďŽƵƚ ϰϬй ǁĞƌĞ ƐƵďƐƚĂŶĚĂƌĚmedicines. Most of the studies of quality of medicines recommend development of additional innovative techniques to control the existence of substandard medicines in the market. In Sudan, the system applied to detect substandard and/or counterfeit medicines is not effective enough. A round ϵй ŽĨ ƉŚĂƌŵĂĐĞƵƟĐĂů ƉƌŽĚƵĐƚƐ ĂƌĞ ƌĞƉŽƌƚĞĚ ƚŽ ďĞ ƐƵďƐƚĂŶĚĂƌĚ ŵĞĚŝĐŝŶĞƐ͘ ƐƚƌŽŶŐ ƉŽƐƚ marketing surveillance system would be a more powerful tool for detecting substandard and/or counterfeit medicines and showing a true picture of the situation in Sudan. Strengthening the system by applying risk-based model for supporting the decisions is proven to be useful and possible approach. Setting: This study was conducted in Khartoum city, Sudan. Objectives: this research aimed at developing risk-based quality monitoring scheme or model for pharmaceutical products. The model should help medicines regulatory authorities in resource limited settings to improve surveillance systems. The research will provide a practical model for the expanding the existing surveillance system for quality check of pharmaceuticals currently adopted in Sudan. Methods: different methods were used to build this model. These include health professionals’ survey targeting the pharmacists and physicians and chemical ĂŶĂůLJƐŝƐ ŽĨ ϯϬ ŵĞĚŝĐŝŶĞƐ͘ ĂƐĞĚ ŽŶ ƚŚĞ ŽƵƚĐŽŵĞƐ ŽĨ ƚŚĞƐĞ ƐƵďstudies, further experiments were conducted that include bioequivalence study of Glibenclamide products, microbiological sensitivity test on Amoxicillin; biological assay of three Ceftriaxone products and modeling process of data generated. Results: A model has been successfully formulated and adopted to improve the surveillance system. This model is Please purchase PDFcamp Printer on http://www.verypdf.com/ to remove this watermark. PageͳͶ unique and it was the first time to develop such tool globally to help in indicating critical information about the quality of medicines and associated hazard factors to its quality. The model was designed as large and complex computerized system using Microsoft excel program. A sample from the outcomes of the model was printed and attached in annex ŶƵŵďĞƌ ϵ ĨŽƌ ƌĞĨĞƌĞŶĐĞ͘ dŚĞ ŵŽĚĞů ǁĂƐ ƚĞƐƚĞĚ ĨŽƌ ŝƚƐ ƵƐĞĨƵůŶĞƐƐ ĂŶĚ ĞīĞĐƟǀĞŶĞƐƐ ĂŶĚ ƚŚĞ results obtained showed potential applications of the system in improving the system. This would include its use in the selection technique of products for inclusion in post-marketing quality monitoring. It can also be applied to increase the detection rate of low quality products. Using the developed model, the chance to detect substandard and/or counterfeit productƐ ǁŝůů ďĞ ŝŶĐƌĞĂƐĞĚ ďLJ ĂďŽƵƚ ϯϬй͘ Conclusion: the outcome of this proposed approach will enable the authorities to expand the input measures of its surveillance system beyond quality to consider also the efficacy of medicines.