Drug Authentication Evolves to Use Molecular Screening to Combat Fake Drugs

Life Science Leader, a magazine for key executives in the life science industry, recently published an article "Molecular Screening: It's Time to Stop Thinking Outside the Box with Counterfeit Drugs" by Brian Mayo, President and CTO of XStream Systems.

In the article, Mr. Mayo discusses the advancement of analytical methods as they have moved from the lab setting to the next generation of authentication by allowing screening of the product itself throughout the pharmaceutical supply chain.

By putting this non-destructive screening method in the hands of non-scientific personnel the industry has evolved it’s protection services from merely deterrents for diversion and counterfeit drugs to real authentication of the product “inside the box”.

It’s so simple and it makes sense that we spend so much money and time developing the drugs themselves – shouldn’t our authentication be centered on them as well.

To view more on molecular screening technology, please visit www.xstreamsystems.net

To view more on Life Science Leader…

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.

Caraco: FDA to Eventually Allow Manufacturing Operations

The Associated Press and several major news outlets reported that Caraco Pharmaceutical Laboratories announced on Tuesday that it has agreed to a series of measures with the FDA that will allow the company to resume manufacturing operations.

As reported on Secure Pharma Chain Blog, Caraco has had their manufacturing operations halted by the FDA after they found repeated violations of manufacturing standards and seized inventories. Recalls have been made on certain Caraco products that were found to have manufacturing defects, including oversized tablets and possible formulation errors.

The manufacturing restrictions will be in place until regulators give written notification of compliance with the agreement measures and regulations. Caraco will continue to distribute FDA-approved products manufactured by third parties.

XStream endorses the concept that all members of the pharmaceutical supply chain utilize material screening process in all points of the process; raw materials, production, quality assurance, packaging, distribution and dispensing in order to protect the supply chain and the consumer.

To learn more about XStream’s revolutionary material screening technology visit: www.xstreamsystems.net.

Law Enforcement Examiner: Operation CYBERx

In yet another fascinating article from Jim Kouri at the Law Enforcement Examiner, the September 23, 2009 issue spotlights a recent DEA-led investigation targeting the e-trafficking of drugs within the United States.

The investigation, which is part of a larger initiative named Operation CYBERx was conducted by the DEA and other law enforcement agencies. This collaboration targeted internet pharmaceutical drug traffickers, operating within the United States that pose as legitimate pharmacies which in fact are peddling dangerous narcotics and prescription drugs, many of which are counterfeit.

Here are some of the highlights from the article:

• Recognizing that criminals are facilitating more drug-related crimes through the use of 21st century technology, the DEA, along with their law enforcement counterparts recently arrested 18 people for allegedly selling pharmaceutical drugs illegally over the Internet. Those arrested include the ringleaders of more than 4,600 rogue Internet pharmacy websites.


• The alleged drug dealers who operated these rogue internet pharmacies received prescription orders for controlled substances over the Internet, which were then shipped to the doors of many US citizens — sometimes without any prescription needed. These alleged criminal pharmaceutical drug traffickers averaged more than $50,000 a day in profits from their illegal Internet based enterprise.


• Operation CYBERx is part of the DEA's "Virtual Enforcement Initiative (VEI)." This new DEA cyber initiative acknowledges that criminals in the drug trade are embracing the use of state-or-the-art technology to peddle their narcotics and dangerous drugs into US communities, all with an air of respectability.


• DEA Administrator Karen P. Tandy said, "Operation CYBERx puts out of business alleged cyber criminals who [are] selling powerful narcotics without legitimate prescriptions to anyone with a computer and cash. These high-tech drug dealers were fueling addictions by selling the very drugs intended to prevent and treat ailments — not inflict them. Just as important, this Operation makes more Americans aware that buying prescription drugs from these rogue websites is illegal and dangerous."


• The VEI concept was realized last April when DEA led Operation "Cyber Chase," which resulted in more than 20 arrests in eight US cities and four foreign countries; shutting down an organization that ran over 200 web sites illegally selling what were identified as pharmaceutical drugs. This year-long investigation targeted international Internet pharmaceutical traffickers operating in the United States, India, Asia, Europe and the Caribbean. These e-traffickers also distributed drugs world-wide using rogue Internet pharmacies.

XStream Systems endorses the efforts of the DEA in cracking down on the illegal trafficking of prescription drugs and narcotics. This effort highlights the vulnerabilities of the pharmaceutical supply chain in the 21st century and XStream encourages all members of the supply chain to utilize material screening to verify, authenticate and protect their inventories. XStream also encourages health care consumers to only buy prescriptions from licensed, known pharmacies within your area and always use health care professionals (physicians, pharmacists) when taking medications.

To read Mr. Kouri’s Law Enforcement Examiner article in full, follow the following link: http://www.examiner.com/examiner/x-2684-Law-Enforcement-Examiner~y2009m9d23-Health-care-crime-Combating-rogue-Internet-pharmacy-operations

To learn more about XStream Systems visit us at: http://www.xstreamsystems.net/.

Chinese Heparin Producers Get Warning Over Falsified Information

FDA issues letters to two more Chinese manufacturers regarding tainted Heparin

It reads like a bad sequel as more companies have been named in the tainted heparin scandal…

Two Chinese companies have been issued warnings from the FDA for falsifying information on Heparin. Shanghai No. 1 Biochemical & Pharmaceutical said they were manufacturing heparin, when in fact they were purchasing it from two outside companies. One supplier is no longer producing the medicinal product.

The other supplier, Qingdao Jiulong Biopharmaceuticals was also given a warning letter. Jiulong was found to have produced 19 lots of heparin contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), a substance implicated in the U.S. deaths last year. The FDA further faulted them for not investigating how the substance got into the blood thinner and for exporting medicinal products without regulatory approval.

This warning letter was in response to the FDA’s inspection of Jiulong in August 2008. Jiulong told investigators that they did not ship directly to the United States. However, during inspections at U.S. facilities purchase orders were discovered indicating that the plant had been shipping heparin sodium to the U.S. since 2005. FDA also stated that in the past, the firm supplied heparin to Amphastar Pharmaceuticals Inc., a California company that supplies pre-filled syringes.

This story illustrates why analytical screening should be conducted throughout the supply chain – to ensure the quality of: those products supplied to your company, those products you supply to others, and ultimately the finished product consumed by the patient.