ABSTRACT

This chapter provides to some of the loopholes that are inevitably present in a process as complex as the pharmaceutical industry supply chain. The exceptional complexity of the pharmaceutical supply chain creates a variety of threats to patient safety. The intermediary products or chemical precursors to the active pharmaceutical ingredient (API) are often made in low-cost manufacturing countries such as India, China and Korea. The API itself is usually manufactured in a country that provides significant incentives through tax, capital relief programmes or low cost of labour. The majority of packed goods supplied to the dispensing pharmacist are controlled through a few major full-line wholesalers who are licensed and regulated. In addition to the risk that a distributor will mishandle a product, or that a fraudster will alter or substitute it, patients are also at risk from dispensing and administration errors.