Drug Safety Responsibility-For Whom Does the Finger Point?

This blog posting first appeared in Secure Pharma Chain in May 2008.

This posting still remains relevant today as the issue of poor quality, fraudulent, adulterated and counterfeit medications continues to proliferate in pharmaceutical supply chains around the globe-and the regulatory ability to meet this threat remains woefully inadequate.

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw. In reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply.

Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.Now it is the consumer who is doing the pointing and he or she is pointing at us all!

To learn more about supply chain authenticity testing, visit: http://www.xstreamsystems.net/.

Report Notes Rise in Adverse Drug Events, Patient Deaths

As reported by Shawn Rhea in Modern Healthcare, the Food and Drug Administration has announced that adverse drug events increased by 25% in 2008 compared with 2007. This data came from a new QuarterWatch report from the Institute for Safe Medication Practices, a Philadelphia-based not-for-profit dedicated to the prevention of medical errors.

• The increase was the largest over a one-year period since the FDA began collecting data in 1998.


• According to researchers, the FDA received reports of nearly 100,800 cases of serious injury related to drug use in 2008 compared with 80,600 in 2007. Those numbers included a 56% increase in patient deaths—from 9,700 in 2007 to 15,200 in 2008.


• The ISMP credited the surge in reported events to both the FDA's efforts to better identify adverse drug events and a slew of recalls on generic drugs such as heparin vials, and morphine and digoxin tablets during 2008.

As blogged about repeatedly in Secure Pharma Chain Blog it has been predicted that this increase is consistent with the increase in instances of counterfeit, adulterated and fraudulent medications within the domestic pharmaceutical supply chain. Although industry and regulatory authorities continue to use Track and Trace technologies to combat this issue, it is apparent that additional solutions are needed to protect the healthcare consumer.

Material screening by using EDXRD, allows the members of the pharmaceutical supply chain to verify and authenticate the medications inside of its unit-of-sale container without degrading or destroying the material inside the package. This solution can be used at all areas of the supply chain from raw materials, to production, packaging, distribution and dispensing and will authenticate both the medication and protect against medication errors.

To learn more about EDXRD technology as a solution to counterfeit, adulterated and fraudulent medications, visit: www.xstreamsystems.net.

XStream Systems Stories and News for the Week of November 28, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the safety of our supply chain. Recent incidents such as the adulteration of heparin and the discovery of melamine in baby formula have heightened consumer’s awareness of safety risks to our food and drug supply.

U.S. pays millions for unapproved drugs
The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s.

Republican Lawmaker Asks GAO to Review FDA Handling of Heparin
The FDA may not have used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities, according to a Republican congressman. “Based on the available information … there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths,” Rep. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, says in a letter to the Government Accountability Office (GAO).

FDA Finds Melamine Traces In U.S. Infant Formula
Bloomberg News reported that the industrial chemical melamine was found in U.S. infant formula in trace amounts that pose no health concern, according to FDA. Since September, some 50,000 children in China were sickened by melamine-tainted milk and several died.

We at XStream Systems believe that molecular pharmaceutical authentication will play a major role in the coming years to protect us from contaminated, adulterated and counterfeit products. To learn more about how this can be done, please visit www.xstreamsytems.net.

Baxter CEO Says Heparin Purposely Tainted

Yesterday on Capitol Hill, a house subcommittee heard testimony on the recent issue of contaminated Heparin. Robert Parkinson, CEO of Baxter testified that the company believes the heparin was deliberately tainted.

Most heart wrenching, was when the family’s victims told their stories on how the tainted Heparin has destroyed their lives.

Leroy Hubely, was in tears as he explained how his wife Bonney died in December 2007 and then a month later his son, Randy died under the same circumstances. Only after the recall of Heparin, did he learn from his local dialysis center that tainted heparin, and not some cruel twist of fate, led to both of their deaths.

His daughter-in-law Collen Hubely, a dialysis nurse, testified: “As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naive. I never thought the life saving medication we were relying on might be contaminated. If citizens are truly going to ever to feel safe in this country going to the hospital, a doctor, taking your daily medication; we have a responsibility to be make sure that everything that is given is free from contamination.”

Families demanded more stringent policies and testing to protect consumers from dangerous materials hidden in our medications.

Opinion: Heparin Deaths Just the Start

Unfortunately the recent FDA announcement of over 100 deaths due to contaminated Heparin, is just the start of a health care epidemic within the United States.

As with other consumable products that are now produced globally, the United States Pharmaceutical Supply Chain is now more vulnerable than ever.

In 2008 nearly every pharmaceutical manufacturer has doubled their overseas production. Additionally over 80% of all raw materials used in the production of pharmaceutical products is produced overseas

We here in the United States have been relatively protected from exposure to contaminated, adulterated and counterfeit medications that has been a scourge for the rest of the world for many years.

In 2006 it was estimated that the US Pharmaceutical Supply Chain had only 1% of its channel impacted by contaminated, adulterated or counterfeit medications. This still meant that one in nine citizens had at least one of its prescriptions filled with bogus medication.

Globally this statistic in 2006 was that nearly 10% of medications or one in ten within the Global Pharmaceutical Supply Chain were fake and potentially lethal.

* Expect the percentage of the United States Supply Chain of fake medications to rapidly grow in 2008 with the rise of more Heparin-like incidents. Most likely the United State's Pharmaceutical Supply Chain will begin to mirror the Global Supply Chain statisically.
* Expect to hear stories in the media with dozens, hundreds or even thousands in the Untied States made ill or even die because there are no effective measures in place to authenticate the validity of the medications within the Supply Chain. No longer will the stories of hundreds of people dying because of contaminated or fake medications be exclusive to underdeveloped areas of Africa and Asia.

Even though the technology is currently proven and readily available to authenticate the molecular structure of medications within a sealed bottle, the regulatory, manufacturing, distribution and dispensing members of the Pharmaceutical Supply Chain are hesitant or unwilling to deploy effective measures and appropriate technology to protect the United States consumer.

Fortunately the solution and technology is available today to prevent these impending health care disasters due to fake and contaminated medications. Now all we have to do is convince the members of the supply chain and the regulatory agencies to put it in place.

Just check out our website at www.xstreamsystems.net to see the solution.