@Risk

The US Pharmacopeial Convention (USP) has proposed a set of recommended best practices to help the pharmaceutical industry improve supply chain integrity and reduce risks of counterfeit or mishandled medicines.

Improvements like these are long overdue. As I reported last spring, research from PwC concluded that many pharmaceutical supply chains have suffered from what amounts to benign neglect. As a result, they are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations.

Sure, in today’s global economy relationships between suppliers and other business entities are often opaque and difficult to track, but clearly, it’s time for the pharmaceutical industry to step up to better ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited and are transported to their intended destination with their quality intact.

Too many companies have discovered the hard way that “willful blindness” only increases their culpability in the eyes of Federal agents, regulators who now are cracking down on businesses that aren’t compliant with the Foreign Corrupt Practices Act (FCPA).

Don’t take that kind of risk. Resolve that this is the year to start better managing your multiple supplier master databases as you monitor and mitigate supplier risk in a global operating arena.

“There is incentive for all players in the pharmaceutical industry—large and small companies, regulators and standards-setting bodies—to come to some agreement on hotbutton issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity,” said Praveen Tyle, Ph.D., chief science officer for USP.

USP’s proposed standard covers four main areas: (more…)

Recent drug shortages in the US underscore the complexities, interdependencies and volatility of modern global supplier networks.

According to an IMS Institute for Healthcare Informatics study released last week, most of the 168 products on the drug shortage lists compiled by the US Food and Drug Administration and American Society of Health-System Pharmacists have only one or two manufacturers. Thirteen companies have stopped supplying products on the shortages lists within the past two years. As Murray Aitken, executive director, IMS Institute for Healthcare Informatics, points out, this leaves a growing number of products open to possible production disruptions that cannot be offset rapidly by other manufacturers.

“Patients throughout the US, including hundreds of thousands being treated for cancer, may be at risk of treatment disruption due to drug shortages,” Aitken said. “Understanding the nature of these medicines, their suppliers and the supply volume dynamics – and focusing sharply on the market and supply chains that are most impacted – are essential to formulating meaningful solutions to this complex, and often misunderstood, issue.”

The new study, Drug Shortages: A Closer Look at Products, Suppliers and Volume Volatility, also found that: (more…)

New research from OpSec Security, Inc. reveals that counterfeiting has expanded beyond high cost health and beauty products, such as luxury fragrances, into everyday personal care items, such as toothpaste, shampoo and nail polish.

Obviously, these fake goods extract an enormous economic toll, pose a threat to brand reputation and present a serious risk to consumer safety, as well.

OpSec used its proprietary internet monitoring platform to identify listings of health and beauty products on business-to-business (B2B) trade boards and business-to-consumer (B2C) trading platforms within the following categories: mascara, nail polish, shampoo, razors, men’s cologne and women’s perfume. By monitoring the key Suspicious Behavior Indicators characteristic of dubious sellers, OpSec found that: (more…)

Pharmaceutical companies are facing increasing pressure to update their supply chains.

For some, it’s going to be an uphill battle.

A new report from PwC US concludes that many pharmaceutical supply chains have suffered from what amounts to benign neglect. Now, they are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations.

Essentially, the pharma supply chain needs to adopt a new consumer-oriented focus. As a result, PwC says we can expect the pharma supplier network to become: (more…)

The European Parliament has approved a new law to help prevent fake drugs from entering the supply chain. The legislation introduces new safety regulations, traceability measures and sanctions against counterfeiters.

The problem of counterfeit drugs is a growing concern throughout the world. Researchers estimate that 1 percent of medicinal products sold to the European public through the legal supply chain are now fake. In other parts of the world, more than 30 percent of the medicines on sale can be fake, and counterfeiters appear to be increasingly targeting innovative and life-saving drugs.

An article at PharmaTimes outlines provisions of the new EU legislation. For instance, the new regulations require that: (more…)