Conference Attendees Share Concerns About Counterfeits

This month, XStream Systems’ Sales Team had the opportunity to discuss counterfeiting issues with pharmaceutical executives from pharmacy providers, manufacturers and pharmaceutical wholesalers at two industry conferences.

In an effort to ascertain industry thought leaders viewpoint on risk liability and current available anti-counterfeiting technologies, a voluntary survey was conducted. Though the survey was conducted on a relatively small statistical sampling, it represents an excellent cross section and a diverse variety of pharmacy experts from national entities, regional players, large corporations and small entrepreneurs.

The following are specific excerpts from the surveys:

• 2/3 of respondents consider the greatest vulnerability of the U.S. pharmaceutical supply chain is with pharmaceuticals from foreign countries, internet sales and loosely regulated suppliers.



• Nearly 75% of distributors and pharmacy providers who responded use some process of pharmaceutical supply security including pedigree tracking, sensor based technologies (RFID, barcodes, etc.), visual inspection, weight inspections and materials analysis but their methods are not uniform. All respondents who do use some procedure ultimately use a variety of processes because collectively they seem uncertain that the methods they have in place can properly protect their inventories from fraudulent or counterfeit products.



• 75% of all respondents were aware of drug identification and authentication system technology but 50% were not familiar with a specific technology or a particular solution.



• 75% of respondents are concerned about counterfeit drugs impacting medication safety to their distributors/providers/patients.

• 75% of respondents are concerned over their financial liability of counterfeit drugs within their inventories.



• 75% of respondents are concerned about their professional reputation being ruined if they were to have counterfeit pharmaceutical in their inventories.

• 2/3 of respondents expressed concern over the issue of counterfeit drugs within the supply chain.



• 75% of the respondents were concerned that their current methods and processes for supply security were not enough to protect their inventories.



• 50% of respondents fear a catastrophic counterfeit event within the U.S. pharmaceutical supply chain in 2009.

A complete report will available shortly on XStream Systems' website at http://www.xstreamsystems.net/

KV Pharmaceutical Issues Recalls on Dozens of Products

2008 was a rough year for KV Pharmaceuticals, and 2009 is starting off even worse.

Plagued with recalls in 2008 (a total of five), they now start off 2009 by suspending manufacturing and issuing a voluntary recall of all of their products for two of their subsidiaries, Ethex Corporation and Ther-Rx Corporation.

So what spurred this action that is being touted as one of the largest generic recalls in history? The recalls started with an FDA inspection in December 2008. The recalls are being done because the products manufactured did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

Previous recalls in 2008 were due to oversized tablets delivering higher than labeled doses. At least one of those items has a pending litigation from a patient in Texas. Judy Goodman took Morphine Sulfate ER tablets (manufactured by Ethex) from June 2007 until she died on April 10 from drug toxicity. In June 2008, Frank Goodman received an "Urgent Drug Recall" notice informing the family that "her tablets may be over-sized and to contact her physician." The family has filed suit against Ethex Corporation and KV Pharmaceutical.

Along with lack of oversight during the manufacturing process, it also begs the question as to what kind of process is in place for quality control in general before any manufacturers send their products out into the various pharmaceutical supply chains.

XStream Systems is encouraging all members of the pharmaceutical supply chain to utilize authentication technologies in their business processes including manufacturing, quality control, distribution and dispensing.

XStream’s XT250 system enables all within the pharmaceutical supply chain to authenticate and verify the medication inside its sealed, unit-of-sale container and is nondestructive. These technologies detect counterfeit, adulterated, fraudulent and substandard materials.

By all members of the supply chain utilizing cost effective authentication technologies, these recalls and unfortunate deaths may have been avoided altogether.

For a listing of drugs being recalled please view the FDA notices:

Ethex
For complete recall listing: http://www.fda.gov/oc/po/firmrecalls/ethex01_09.html

Ther-Rx Corporation
For complete recall listing: http://www.fda.gov/oc/po/firmrecalls/therrx01_09.html


Previous Recalls
ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet (12/23/08)


ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets (11/07/08)

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (10/15/08)

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets NDC #58177-320-04 & 58177-330-04 Lot Numbers listed below (6/13/08)

ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets (6/9/08)

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?