Meningitis outbreak highlights supply chain management risks

Oct 25, 2012

A fungal meningitis outbreak linked to steroid shots has caused hundreds to fall ill and is related to the deaths of dozens of people. The contaminated injections have shown up across the country, and many who received them fear becoming sick as a result. This highly-publicized story draws pharmaceutical manufacturing into the spotlight, and raises concerns about how producers can ensure their ingredients are safe and their products perform as intended. In this case it has to be asked could a vendor management system complete with supply chain assessment prevented this tragedy?

Pharmaceutical supply chain is vast

Companies that manufacture drugs often have complex global supply chains. Some rely on ingredients sourced from Asia, manufacture in Europe, and distribute the medicine in the U.S. Others are slightly more direct and source components from other countries before producing the drugs at home and shipping them out to pharmacies and hospitals.

When supply chains are this large, it can be hard to keep track of what is going on where, let alone ensure every ingredient coming from overseas is safe and approved by the FDA. Foreign suppliers are required to comply with strength, quality, and purity requirements, but it's up to the Food and Drug Administration to ensure those standards are met. That can be difficult to enforce, especially when there are so many drugs and ingredients coming into the country. Supplier management software allow employing organizations to qualify their supply chain against rigorous standards then continue to monitor their performance over time.

Large supply chain means more risk

According to Pew Health Group, this global sourcing and manufacturing is only increasing, and it's hard to monitor foreign suppliers or manufacturers. The source revealed that 80 percent of active ingredients and chemicals used in U.S. drugs are shipped from other countries, and 40 percent of all drugs are manufactured overseas. The amount of prescriptions made outside the U.S. doubled from 2001 to 2008. While it may be cost effective for companies to have their drugs manufactured overseas, it can put consumers at risk and jeopardize a company's reputation. While the FDA inspects domestic drug manufacturers every 2 to 3 years, it looks over foreign sites roughly every 9 years, according to Pew Health Group.

Keeping track of supply chain safety

It's critical to ensure ingredient suppliers, manufacturers, and others involved in the drug-making process are reliable and use approved safety measures when dealing with medication. If a supplier isn't thoroughly vetted, a company risks losing its credibility, facing massive recalls, and missing out on profits. By investigating a supplier in advance, a business can avoid serious consequences and keep consumers safe.