Quality Defects in Pharmaceutical Products Marketed in Cuba

Abstract

Introduction: Quality defects in pharmaceutical products are varied and of diverse causes; according to the risk to human health they are classified as class I, II and III.

Objective: To characterize the quality defects of pharmaceutical products reported to the National Regulatory Authority and to evaluate their possible association with the presence of health risk.

Methods: An observational, descriptive, cross-sectional and retrospective study of quality defects reported in the period from 2009 to 2021 was conducted. The odds ratio was used to evaluate the association between the presence of health risk and each of the quality defects.

Results: The most reported defects were changes in organoleptic characteristics and mixtures, with a predominance of sterile dosage forms and oral solids. The 47.8% of the reports came from drugstores, with a higher incidence of nationally produced drugs and class II health risks. An association was found between quality defects and the likelihood for causing health risk.

Conclusions: Quality defects showed similar characteristics to those reported in the international context.