Product degradation is often overlooked compared with other supply chain issues. but if left unchecked can lead to the market entry of substandard medicines, whether through ignorance or gross negligence.
However, there is another serious threat to the supply chain that is often overlooked: pharmaceutical degradation. Degradation, as with counterfeiting, enables substandard drugs to fall into the hands of patients and is most prevalent in developing countries where inadequate storage facilities are commonplace and proper regulatory oversight is often lacking. Unlike counterfeiting, however, degradation is not solely the result of malicious activity and can stem from a variety of issues. There is no effective method for monitoring what occurs between point A and point B in the supply chain, but the main contributors tend to be humidity, temperature and expiration.Humidity and temperature
In developing countries, materials often degrade because of shifts in temperature and humidity. This can occur during transport; for instance, storage containers offloaded at the port of entry may sit in the tropical sun for an extended period of time while waiting to clear customs.
The transportation phase is not the only culprit. Following delivery, pharmaceuticals are frequently stored in warehouses that lack a suitable air conditioning system. The US Centers for Disease Control and Prevention estimate that 17–37% of providers expose vaccines to improper storage temperatures (3), which can diminish the levels of a drug's active ingredient or alter the excipient matrix and, ultimately, hinder its effectiveness.
The concept of monitoring expiration dates seems fairly rudimentary. However, drugs that have passed their expiration date still frequently make it into the supply chain. This could happen as a result of ignorance, with the retailer being unaware that the expiration date had passed before delivery. The more common reason, however, is gross negligence where retailers repackage and re-label pharmaceuticals before putting them back into the supply chain. This is most prevalent in countries lacking sufficient regulation and where drugs are often sold at markets. To a lesser degree, repackaged drugs are also an issue in Europe because of parallel trade, where drug repackaging is legal. In these instances, there is no way to know how old a product is unless it is properly tested.