Degradation And What It Means To The Supply Chain - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Degradation And What It Means To The Supply Chain

Pharmaceutical Technology Europe

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.

When it comes to discussions about supply chain vulnerabilities, counterfeit drugs are front and centre for good reason. According to estimates from The World Health Organisation, up to 30% of drugs sold in Africa, Asia and Latin America are fake and the International Policy Network reports that more than 700000 people die each year from counterfeit malaria and tuberculosis drugs alone (1). Counterfeits also impact pharmaceutical companies, which are losing as much as $75 billion in business each year (2).

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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology Europe,
Click here