Government Seizes Contaminated Heparin STILL in the US Supply Chain?

In a news report, the Federal Agents seized contaminated Heparin a full seven months following the recall. Read the full story.

It seems shocking that after confirmed deaths of over 250 people that this type of product would still be in the domestic supply chain. “I think that this is an illustration of how many gaps that remain in the process and the system that leaves the US consumer at risk,” stated Alan Clock, SVP of XStream Systems. “Those within the supply chain that believe that they are not vulnerable or that the burden of product safety lay elsewhere are in for a rude awakening when not if the next counterfeit or adulterated products hit their warehouse or store shelves.”

To learn more about XStream Systems revolutionary materials analysis solution to counterfeit, contaminated or adulterated products please visit us at www.xstreamsystems.net.

How do Recalls Affect Consumer Loyalty?

A new study release by Deloitte shows that safety issues costs companies millions of revenue dollars. The study shows that when consumers hear of product safety and/or quality issues, more than half of them switch products for nine months or more, increasing the likelihood that they would discontinue the brand use entirely.

Modern consumers are less tolerant of recalls and over 49 percent are extremely concerned with product safety. Those population segments with the greatest concern are women (53%) and seniors (56% of those over the age of 55).

In addition, recent recalls from China have left the public with a distrust of items manufactured there. Over 73 percent stated they were extremely apprehensive about items manufactured in China.

To see how loyalty is affected, just look at last year’s recall issue where thousands of pets died from tainted products resulting in the largest recall of pet food in US history. Today, pet owners, even in this economic downturn, are reluctant to change to a cheaper pet food. ….

A recent article by the associated press stated “That's because many pet owners, who upgraded their kibble after contaminated pet food killed or sickened thousands of animals last year are leery of switching back…..”

So what can companies do to assure their customers that their products are safe? Consumers want safety information on the package, on the company website, and from the government. Furthermore, testing materials for consumer safety is a necessity.

Build and they shall come – But, test and assure and they will stay.

What Measures Can Ensure the Integrity of Purchased Pharmaceuticals?

The integrity of our pharmaceutical supply chain is being questioned! Diversion, counterfeited products and adulterated ingredients have left consumers, regulators, and dispensers clamoring for more stringent anti-counterfeiting methods. Furthermore, the recent heparin recalls have emphasized the need for protection not only of the finished product, but also of the raw materials used in the production of medications.

In the May issue of Pharmacy Times, James C. McAllister, a health-systems consultant, addresses the security responsibilities of all players within the supply chain to combat these threats.

Mr. McAllister states, “Solving this dilemma will be challenging. Collaboration of pharmacists, manufacturers, wholesalers, and distributors, as well as regulatory agencies at the state and national level, should begin expeditiously.”

He moves forward to suggest that manufacturers bear all recall costs and financial responsibility for the quality of their drugs. For distributors and manufacturers, he asks that the FDA levy heavy economic sanctions on those selling substandard drugs. His proposal is a wake up call to the risks that are present – Those who risk our health – Risk their wealth.

Which begs the question - How do your anti-counterfeiting methods measure up?

FDA Links 100 Deaths to Heparin Since 2007

Late yesterday, the FDA announced publicly that over 100 patients within the United States have died while taking the blood thinning medication Heparin since January 2007.

The FDA found that over 62 of the deaths are the result of allergic reactions to contaminated batches of Heparin, which is significantly higher than their previous estimate of 19 deaths. Many of these deaths were not reported when they occurred, but are only now being reported to the FDA.

Allergic reactions to heparin are rare with only 3 deaths reported in 2006. However these increased in 2007, jumping dramatically to 8 in November, 12 in December, 16 in January, and 11 in February. FDA has posted the month to month mortality statistics on their website.

The presumed cause of the increased reactions is the adulterated compound the FDA discovered in the recalled products, whose ingredients were imported from China (See: Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin).

China is a major supplier of raw heparin, which is derived from pig intestines. Recent decreases in swine population, due to blue ear disease, have caused Chinese plants to turn to smaller wholesalers for their own supply. Chondroitin-Sulfate is less expensive than its genuine heparin counterpart, which may explain why it was incorporated in the raw heparin.

In answer to this major threat, recalls have expanded to seven countries: U.S., Germany, Japan, Denmark, France, Italy, and Australia. Furthermore, the FDA has upgraded the pharmaceutical testing of imported Heparin.

Heparin Contamination and Recalls

We at XStream Systems have been monitoring the Heparin contamination and recall situation very closely. Each day we are uncovering more stories on the who, what, when, where, and why.

Aside from the precautionary recalls of the product from the market, and the normal spin on the topic by the media, there really is a problem with a number of the lots of medication.

Adding to recent stories on other contaminated products, China is again accused in this case. Here is a link to a summary of the heparin situation so far. This article points out that China is waking up to the issue.

Sadly, the number of U.S. deaths is up to 19.

Outsourcing: The Whole is Only as Good as the Sum of Its Parts!

One of the little known facts about the pharmaceutical industry is how much of its manufacturing is outsourced. Over 80% of the pharmaceutical ingredients used in the manufacture of US drugs are outsourced to foreign countries, with a majority of these ingredients coming from China and India.

Understandably, with the current news on the contamination of heparin in the US supply and the role the Chinese supplier played in this case being questioned, quality control has become a major concern. Since the whole is only as good as the sum of the individual pieces, should we not be questioning the quality and safety of all outsourced materials?

Timely testing of these ingredients should greatly reduce quality issues, adverse reactions and recalls. After all, diligence in safety of what goes in to our bodies cannot be overstated!