Eli Lilly Loses $75M in Warehouse Burglary

In an update to a blog posted to Securing Pharma Chain Blog, more details are becoming public in the reported burglary of a drug warehouse in Enfield, Connecticut on early Sunday morning.

The warehouse, operated by Eli Lilly & Company, lost approximately $75 million dollars in prescription drugs after thieves scaled a wall onto the roof of the building and rappelled inside.

The thieves made off with enough drugs to fill at least one tractor trailer and apparently were loading pallets of product into waiting vehicles at the site's loading dock for over an hour.

The suspects disabled phone lines, back up security systems and access programs as they made their way into the building. Apparently they were aided in their efforts by a strong rainstorm, the leading edge of a nor’easter, which help conceal much of their activity.

The stolen drugs are described by a Lilly spokesperson as “a mixture of pharmaceutical products” including Prozac, Cymbalta and Zyprexa. No narcotics or pain medications were stored in this warehouse.

Federal authorities have been brought into the investigation to assist State and Local law enforcement.

The theft is being described as the work of a well planned, sophisticated and organized criminal group.

The issue of pharmaceutical theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

To learn more about solutions to protect the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

Five Businessmen Charged with Multi-Million Dollar Bogus Medicine Scheme

Five business men appeared in the City of London Magistrates' Court accused of multi-million pound pharmaceutical plot involving bogus Chinese-manufactured life-saving drugs.

The charges were brought forth after a two-year investigation conducted by Medicines and Health Care Products Regulatory Agency, Britain’s regulatory equivalent of the Food and Drug Administration in the United States.

One of the accused is Ian Harding, a 57 year old businessman from Bradford on Avon. He is charged with conspiring with others to defraud pharmaceutical wholesalers, pharmacists, the public and brand pharmaceutical companies by distributing counterfeit medicines. He is accused of selling bogus life saving medications portrayed as the brand names Casodex, Plavix and Zyprexa. Casodex is used to treat prostate cancer; Plavix is a drug prescribed to prevent blood clots to the heart and Zyprexa is an anti-psychotic drug.

Between 2005 and 2007 Harding allegedly acquired and sold counterfeit drugs through Consolidated Medical Supplies Ltd. This caused a massive recall forcing suspicious product to be pulled from pharmacists’ shelves, resulting in huge losses to the pharmaceutical industry.

Harding and his fellow defendants were sent for trial to Southwark Crown Court and will appear for a plea and directions hearing on December 15.

To view the entire article visit The Bath Chronicle at: www.thisisbath.co.uk.

SafeMeds Weekly: Counterfeit Drug Sentencing Less Than Adequate

In an opinion piece posted on SafeMeds Weekly on August 10, 2009, Marvin D. Shepherd, PhD discusses the issue of light sentencing given to those convicted of counterfeiting medications around the globe. Dr. Shepherd asserts that inadequate sentencing “undermines the seriousness and true threat that counterfeit drugs pose to society and public health.”

Dr. Shepherd sites several examples:

• After nearly two years under investigation, the final sentence for running an international multi-million pound counterfeit medication operation was issued in the United Kingdom. The first four convictions were made in September 2007 and on July 6, the final member of the operation received a 12 month sentence, suspended for two years, for masterminding an industrial scale conspiracy of supplying counterfeit drugs between 2002 and 2005. In total, the seven convicted members of this international counterfeit drug ring received a combined 17.5 years imprisonment-an average of 2.5 years for each participant-for their part in the U.K. distribution arm of a global ring operating from China, India and Pakistan, extending to the Caribbean and the United States.


• In March 2009, an Arizona couple received at most eight years imprisonment for running an illegal drug business netting more than $2.5 million from 2004 to 2006. In comparison, convicted members of an illegal recreational drug ring would receive mandatory minimum sentences starting at 20 years up to life imprisonment for distribution in the United States.

In this article Dr. Shepherd questions the logic of not holding those responsible for the distribution and sale of counterfeit drugs to the same severity to those who commit similar offenses with illicit drugs. Basically he believes that until this is done the individuals and organizations responsible for this very real threat will continue to flourish.

XStream Systems favors stricter and more stringent enforcement and criminal penalties across the globe for those convicted of manufacturing, distributing or selling counterfeit or adulterated medications. XStream also encourages those within the pharmaceutical supply chain to screen and test their inventories with solutions such as XStream’s XT250 which allows the user to test and authenticate product inside its sealed container without destroying product or opening the container. The XT250 is designed to be deployed and used within the supply chain onsite and does not require technical resources to operate.

To read the opinion piece and to learn more about SafeMeds Weekly, visit their site at www.safemedicines.org.

To learn more about XStream Systems, XT250, visit us at 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)

Pharmaceutical Returns: The Weak Link in the US Rx Supply Chain

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

As many within domestic regulatory agencies and pharmaceutical industry leaders ponder the battles against counterfeit medications and the many solutions available to combat this global scourge, most have over looked probably the most obvious and weakest link in the overall supply chain, returns.

Pharmaceutical returns, although a small percentage of the overall transactions of the supply chain, account for a significant amount of fraud and counterfeit activities. Most major wholesale pharmaceutical distributors average less than 1% of their monthly gross sales revenues in returns however given the size of their transactions and revenues; this is still a multi-billion dollar weak link that cannot be ignored.

In addition, product transfers within a given distributor, entity or dispenser also are part of this weak link. It is not unusual for a single bottle of pills to be transferred a dozen or more times before a product reaches the dispenser.

Returns are also a necessary component of any supply chain; it is unlikely that restricting the process altogether is a reasonable solution given the enormity of the cost and the thin profit margins of most of the members of the pharmaceutical supply chain.

Most current anti-counterfeiting solutions are capturing the transaction (pedigree) or utilize a sensor based technology on the packaging (RFID) and are totally ineffective in tracking the validity of the product once it has left a secure chain of custody and is returned back into a distributors inventory.

In a time of economic tough times it is far too easy and far too profitable for a pharmaceutical provider or dispenser to fraudulently extract good product, replace all or some of it with inexpensive fillers and then re-seal the bottle. At best a pharmacist can double his profitability on a bottle of pharmaceuticals by replacing good product with harmless fillers, minimally he can re-coup margin lost to unprofitable reimbursement by replacing some pills from a bottle to cover his losses.

Although all pharmaceutical wholesalers require some sort of statement from the provider stating that the product they are returning is the original product that was purchased, sophisticated providers realize that the distributor has very little chance in identifying the adulterated products in its returns as most are tracking hundreds of thousands of bottles that flow through their receiving and returns departments daily. These healthcare professionals must rationalize that their fraud will ultimately be realized in a future transaction by a dispensing pharmacist when they go to fill a prescription and realize that the product in the sealed container is filler and not the actual medication. Even though a pharmacist will be dispensing the medication, it seems likely that too high of a percentage of this fraudulent product will make its way to the consumer and will impact their health adversely.

To date, the majority of the counterfeit materials that XStream’s Authentication solution is discovering at our distributor end users are primarily products that have been fraudulently tampered/adulterated and somehow brought back into the pharmaceutical supply chain inventory via a return goods or transfer process.

XStream encourages all within the pharmaceutical supply chain to protect their inventories by validating their inventories and using an authentication solution to identify the product. The only way that the pharmaceutical supply chain can protect itself is for its members to authenticate its inventories especially when it is processing returns.

If you are a member of the pharmaceutical supply chain or an end user consumer it is important that you are aware of and insist that the partners that you trade with as it relates to pharmaceuticals utilize an authentication technology to protect their inventories and fill in the holes that potentially will impact your health.

Are Lawmakers Finally Showing Concern Over Counterfeit Medications and Bioterrorism?

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

Drug Store News reported that US Lawmakers and Analysts are finally beginning to question the globalization of the pharmaceutical supply chain, namely the disproportionate amount of manufacturing and raw materials that are produced overseas in countries like China and India.

With the rapid rise of counterfeit medications and food products in these countries within their own population it seems likely that the US domestic pharmaceutical supply will also see a significant rise in reported and unreported incidents of counterfeit medications and the rise in likelihood of bioterrorist threats.

Without the use of a variety of anti-counterfeiting methods and solutions, the US consumer will be at greater risk in 2009 than ever before.

XStream continues to work with agencies, regulators and industry thought leaders to introduce its authentication technology as a solution to safeguarding supply chain inventories. Its technology allows the manufacturer, distributor and dispenser the ability to authenticate the product within its sealed, unit-of-sale container.

The full Drug Store News article is available here:

http://www.drugstorenews.com/story.aspx?id=91433

LAWMAKERS CONCERNED INTERNATIONAL DRUG MANUFACTURING PRESENTS RISK OF COUNTERFEITS

By Alaric Dearment

New York (Jan. 20)Concern has arisen about the manufacturing of ingredients for drugs in other countries, especially antibiotics like penicillin, according to published reports.

Drug manufacturing has mostly moved to countries such as India and China, but some lawmakers and analysts have said it increases the risks of counterfeits and bioterrorism.

Already, more than 200 Americans have experienced dangerous drug reactions since November 2007 after taking counterfeit versions of the blood-thinning drug heparin manufactured in China containing a toxic chemical that merely mimics heparin. Last November, the Food and Drug Administration confiscated 11 lots of counterfeit heparin from a company based in Cincinnati.