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.

FDA: Supplier Audits, Qualification Needed to Protect Supply Chain

At the Parenteral Drug Association-FDA 2009 Joint Regulatory Conference the FDA was on record stating that manufacturers should secure their supply chains through testing and anticipate risks to head off issues like the recent contamination of imported ingredients.

Steven Wolfgang, FDA Consumer Safety Officer is quoted as saying, “ the FDA is looking more closely at quality management systems as a first step toward that goal.”

This reinforces XStream’s position that material screening should be done throughout the supply chain to verify and authenticate materials from raw materials, to production, through distribution and to the point of dispense. Material screening is the most effect way to make certain that the product is protected and maintains it effectiveness to the consumer.

XStream’s XT250 solution allows the entire supply chain to quickly screen products, within the supply chain, inside it unit-of-sale container without degradation or the destruction of the material.

To view more about the FDA statement, follow this link: http://www.fdanews.com/newsletter/article?articleId=120738&issueId=13038

To learn more about XStream’s XT250 system, visit: www.xstreamsystems.net.

Freightwatch International: July 2009 Pharma Cargo Thefts

FreightWatch International (USA), an international logistics security company, whose expertise is in identifying threats and vulnerabilities to high-value supply and distribution chains, publishes a monthly Cargo Theft Report that contains some very interesting statistics and observations.

The July 2009 Cargo Theft Report is available on-line and outlines statistics and vulnerabilities of various supply chains, specifically reporting on pharmaceutical cargo theft incidents. In the July 2009 Report they list four Pharma cargo theft incidents worth tens of millions of dollars:

• July 4th in Breezewood, Pennsylvania a cargo theft of pharmaceutical healthcare products worth $262,000.


• July 9th in Forest Park, Georgia a cargo theft of pharmaceuticals worth in excess of $10,000,000.


• July 29th in Plainville, Connecticut a cargo theft of pharmaceutical products of an unreported value.


• July 30th in Effingham, Illinois a cargo theft of baby formula products of an unreported value.

XStream Systems encourages all within the pharmaceutical supply chain to verify and authenticate the products that they receive from all sources. XStream System’s solution of non-destructive screening of products within their sealed unit of sale containers protects inventories from nefarious sources of supply.

To view the entire July 2009 report visit Freightwatch’s website at: www.freightwatchusa.com

Bi-Annual Cargo Theft Report: Value of Pharmaceutical Cargo Theft Has Skyrocketed in the First Half of 2009

FreightWatch International (USA), an international logistics security company, whose expertise is in identifying threats and vulnerabilities to high-value supply and distribution chains, publishes a Bi-Annual Cargo Theft Report that contains some very interesting statistics and observations.

The Bi-Annual Cargo Theft Report is available on-line and outlines statistics and vulnerabilities of various supply chains, specifically reporting on pharmaceutical cargo theft incidents.

As you read through the Cargo Theft Report it is striking how sophisticated and prevalent cargo theft has become. Additionally as it relates to the domestic pharmaceutical supply chain it is illuminating on how cargo theft can impact the amount of fraudulent, counterfeit and adulterated medications within our medication supply.

The following are some striking statistics from January to June 2009 as it relates to the pharmaceutical cargo theft incidents:

• The first six months of 2009 has seen a decrease in cargo theft incidents involving pharmaceuticals from 25 reported incidents in 2008 to 14 incidents in 2009. However, the total value of pharmaceutical products lost as a result of cargo theft has skyrocketed in the first half of 2009.


• From January to June 2009 over $73,000,000 in pharmaceutical products has been stolen. One loss was valued at $37 million, which was subsequently recovered, however, not after the chain of custody was broken for a short period of time.


• The average pharmaceutical loss for the first six months in 2009 is $6,712,500 per theft, a tremendous increase from 2008’s six month average of $704,685 per theft.

Both in 2008 and 2009, the vast majority of pharmaceutical thefts occurred on the East and South Eastern U.S., particularly along major interstate highways as well as in Florida.

The statistics and relevance of this Report supports XStream Systems’ assertion that it is important that pharmaceutical inventories be screened through a level of material verification that is available via our XT250 and its revolutionary EDXRD technology. This exciting technology allows the XT250 to authenticate pharmaceuticals inside their unit of sale containers without destroying or degrading the medication inside.

With so many millions lost each month in cargo theft and presumably re-introduced into the supply chain at various points, it is critical that the provider and consumer are assured that the medications they are taking are safe and effective.

To learn more about FreightWatch’s services or to view the entire Bi-Annual Cargo Theft Report January-June 2009, visit their website at www.freightwatchusa.com.

Drug Companies Need to Improve Their Screening for Quality and Counterfeits

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

Recent massive recalls on generic drugs imported from overseas contract manufacturers are making significant reverberations within the pharmaceutical industry and making the case for more stringent screening of drugs both in finished form and in raw materials.

Manufacturers in the past have seemingly been immune to this level of public scrutiny because it has often been perceived that their products are at their most pristine at the point of manufacture however with the continued proliferation of contract manufacture of product and raw material sourcing from companies located in lesser developed countries the need for more robust screening from point of manufacture through the supply chain seems obvious.

These global recalls are not just happening to the smaller generic companies that contract their manufacturing overseas but also the generic divisions of big Pharma companies are feeling the sting of substandard product within their brand.

Although the liability to the stakeholders of these impacted companies is great, the impact and consequence to the consumers of these inferior medications should remain paramount. For those in the know within the pharmaceutical supply chain, the message and actions seem clear.

XStream Systems supports the concept of screening products throughout the pharmaceutical supply chain from raw materials, to the point of manufacture, packaging, throughout the supply chain and finally at the point of dispensing to the patient.

The level of screening required is important as well, realize that all of the poor quality recently recalled product in question were passed or would have been passed on to the consumer through the process of pedigree, serialization, bar codes and RFID tags.

End-to-end screening does not have to be costly, overly time consuming or onerous to the various members of the supply chain. Current technologies exist to rapidly screen raw materials at the point of production while XStream’s XT250 has a robust solution of analytical testing of products within the sealed container in the supply chain. At the point of dispense there are a variety of technologies available currently which test for product quality and medication errors before they reach the consumer. We at XStream believe that the most effective way of protecting the product is to employ a variety of solutions at each link of the supply chain.

As the world continues to move to a global economy and the pieces of the pharmaceutical supply chain scatter beyond borders a watchful eye towards quality and security are in the interest to all of those who either make a business of or consume pharmaceuticals.