PHARMACEUTICAL SUPPLY CHAINS IN THE NEWS, FOR THE WRONG REASONS

Economic adulteration in the supply chain killed and injured people in 2007 - 8

THE HEPARIN TRAGEDY

In 2007/8, pharmaceutical supply chains became the subject of global debate among key stakeholders, but for the wrong reasons.

A tragic event occurred that shocked the world into realizing that pharmaceutical supply chains had the potential to kill and maim unsuspecting patients.

A blood thinning agent, heparin, had been adulterated [weakened or lessened in purity by the addition of a foreign or inferior substance or element] due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material.

The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). The full account of this has been documented in the report: After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, authored by PEW Health Group.

This is an extract from the PEW HEALTH GROUP summary:

“In late 2007, US health officials began receiving reports of unexpected allergic-type reactions in patients undergoing dialysis. The reactions were linked to a widely used blood thinner—heparin—and specifically to an adulterant that had been introduced during manufacture of the drug in China.”

It goes on to say:

“…drug manufacturing and distribution has become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers, and distributors.”

“Increasingly, the United States relies on drug manufacturing in developing countries—mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution, and the existence of criminal actors willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients. As evidenced by the adulteration of heparin and other case studies outlined in this report, these rare but potentially serious events can have grave consequences.”

In June, 2010, I was asked to present on the topic of supply chain security and pedigree at the US FDA/Xavier Health co-sponsored Global Outsourcing Conference.

U.S. FDA/XAVIER HEALTH GLOBAL OUTSOURCING CONFERENCE, JUNE 2010

This was a purpose-driven conference bringing contract manufacturers together with drug license holders, in search of answers and solutions.

Outsourcing and offshore sourcing were considered key issues that should be addressed, and presentations focussed accordingly.

One of the presentations was from Kathleen Culver, U.S. FDA Cincinnati District, titled FDA Issues for Inspections of Contract Sites, linked here.

Kathleen was an awesome storyteller, captivating the audience with her horror stories of things she had found during her inspections of contract sites. Paraphrasing Kathleen’s observations and conclusions as best I can, it would be that the relationships between companies submitting applications to market drugs, and the contractors manufacturing products on their behalf, is often dysfunctional, sometimes non-existent.

From the work that I do, I can confidently say it remains the same today, if not even more wanting of proper connectedness.

HEPARIN COULD STILL HAPPEN TODAY

Subsequently, Governments, Regulatory Authorities, industry trade associations and other concerned stakeholders have been collaborating globally to raise standards in supply-chains for medicines and healthcare products.

EU Legislation was passed in 2011, with the Falsified Medicines Directive (FMD), and major changes to Good Manufacturing and Distribution Practice (GMDP) introduced.

In the US, the Drug Quality and Security Act (DQSA) 2013 and the Drug Supply Chain Security Act (DSCSA) 2017 were passed…

…but in spite of all this frenetic activity, it would not prevent adulteration of materials in the upstream supply chain happening today. The safety features demanded in the legislation only apply to finished, packaged, products. Bad actors could still substitute adulterated materials for the real thing, for economic advantage.

WHAT DOES THIS MEAN FOR SARS-COV-2 INJECTIONS?

With supply chains under huge pressure to scale-up manufacture on the injections, and the consequent dramatic spike in demand for raw and starting materials, extreme caution is required from all actors in the supply chain, to ensure there are no grey areas for criminals to exploit.