Weak links: Instabilities and areas for improvement in the drug supply chain

Abstract

ObjectiveTo evaluate the current pharmaceutical supply chain, from both a regulatory and market perspective, to identify instabilities as well as propose methods to ensure consistent drug quality and access. Data sourcesData sources include publicly available Food and Drug Administration (FDA) databases. SummaryRecent recalls of important drugs such as angiotensin receptor blockers, heparin, epinephrine, and acyclovir highlight the importance of ensuring access to essential medications. However, the current drug supply chain has multiple weaknesses from both regulatory and market perspectives. A lack of adequate inspection and quality standards means that quality issues often go unfound, but when they are found, disruptions to the supply chain are amplified by a dependence on India and China for active pharmaceutical ingredients. The mutual recognition agreement, India Pilot Program, and increased number of FDA foreign inspectors were steps in the right direction, but more must be done to ensure access. ConclusionEnsuring drug quality and access is not possible without first providing greater transparency into the drug supply chain. This allows both health care consumers and the FDA to respond to drug quality issues. Additionally, extra steps including broadening the scope of the mutual recognition agreement, encouraging increased self-regulation in China and India, and mandating unannounced inspections of foreign manufacturers may help in providing a more stable supply chain.