Medical Products Quality and Public Health
Newton PN., Caillet C.
Poor-quality medical products, including medicines, vaccines, biologics, and diagnostics, threaten the benefits of improvements in healthcare. The problem is more severe in many poor-resource tropical countries where pharmaceutical regulation and inspection are limited. Poor-quality medical products include those falsified, or substandard, including degraded. Few objective data on their prevalence exist, but surveys suggest that an alarming proportion of medical products in much of the tropical world are of poor quality. Their use may lead to severe complications not just for the individual but also for the community and affect the faith of patients in essential medicines and in health systems and cause economic damage. Subtherapeutic amounts of the active pharmaceutical ingredient(s) and presence of wrong active ingredient(s) will impair patient outcome and may engender the emergence and spread of resistance to anti-infectives, putting affordable treatments at risk. Medicines with excessive amounts of active ingredient(s) or containing wrong harmful ingredient(s) may induce adverse drug reactions. Different techniques have been developed, each with advantages and limitations, to detect poor-quality medicines at different levels of the pharmaceutical supply chain in a timely manner. Innovative handheld spectrometry devices offer hope to empower medicines inspectors to optimize post-marketing surveillance of medicine quality in the community. Investment in financial and human national medicines regulatory authority capacity and action, and allied stakeholders such as purchasers and distributors, along with enhanced appropriate data sharing are essential for improving the global medical products supply.