K-V Pharmaceutical May Not Resume Sales Until 4th Quarter

K-V Pharmaceuticals announced last week that it will not resume sales until October 2010 at the earliest and may have to cut operations to stay in business.

K-V stopped all manufacturing and shipping in January 2009 after a series of product recalls and has closed its generic drug unit Ethex.

K-V pleaded guilty in February to charges it failed to inform regulators about manufacturing problems that caused some of its pills to be too large, which could have lead to accidental overdoses.

The K-V saga is a cautionary tale of a company who has suffered from a lack of product quality control, testing and verification. Had authentication technologies been in place at the point of manufacture, distribution or dispense the issue of manufacturing difficulties would have been discovered prior to the dispensing of the drug to any consumer.

XStream Systems encourages the entire pharmaceutical supply chain to employ authentication and verification technologies from end to end to protect inventories and consumers.

Turkish Serialization Plan Delayed Yet Again

In a SecuringPharma.com online article written by Phil Taylor and Keribar Duman they document yet another delay in Turkey’s efforts to adopt a nationwide serialization coding system for pharmaceutical products.

According to the article, the further delay is a result of pharmacies still not having implemented the necessary technology for the process to begin.

Turkish authorities have pushed for the serialization due to widespread fraud in the reimbursement of medications, which is thought to cost the government over $150 million a year and as a deterrent to counterfeit and illegal drugs.

This is the third official delay of the ITS (Ilac Takip Sistemi) system. It was first set to launch on January 1, 2009, then July 1, 2009 and now the latest implementation date was at the start of 2010.

The ITS system was to employ a 2D datamatrix coding to medications that are either produced or imported into Turkey. According to the article the lack of implementation is the “ability and willingness in some cases-of pharmacies to implement and use the system for reading the codes”.

The Turkish Pharmacists Association has been instrumental in pushing authorities for extensions for the regulatory mandate and are on record as saying that issues with the ITS system make the process unworkable.

The inability of Turkey to implement this process in a timely and efficient manner exemplify the issue of a regulatory authority mandating a single approach to fraud, adulteration and counterfeit within a pharmaceutical supply chain. A serialized approach is totally dependent upon an entire system and process adopting an end to end “daisy chain” which is expensive and cumbersome to implement and maintain and relies on total compliance to become effective. Without 100% cooperation the process loses nearly its entire effectiveness and value.

Secure Pharma Chain Blog and XStream Systems; endorse a layered approach of material authentication, pedigree, overt and covert marker technology and ultimately serialization as the most effective way to efficiently, economically and effectively protect an entire supply chain. A multiple technology solution does not require absolute compliance to make it effective and valuable. In a layered technology approach, each solution provides specific protection which overlaps without creating added costs or onerous mandates.

To read Taylor and Duman’s article, visit: http://www.securingpharma.com/40/articles/366.php.

To learn more about efficient pharmaceutical supply chain technologies, visit: http://www.xstreamsystems.net/.

Using EDXRD to Look Inside the Box for Pharmaceutical Safety

By: Alan Clock, Senior Vice President, XStream Systems

Until recently the only true way to test quality and identify fraudulent medications was through laboratory analytical methods. The inadequacies of these solutions are obvious. They are expensive and cumbersome, and usually require sending to an outsourced laboratory.

Additionally, laboratory testing requires highly trained personnel and typically destroys the product. The testing method generally requires that the tester be cognizant of a potential problem in order to properly focus the analysis.

Unfortunately, in this day and age, by the time the suspicious product gets to a laboratory environment, it has most likely already been in the supply chain for some time all the while placing consumers at risk. Furthermore, following laboratory testing, the only element of certitude is the exact product that was tested, but does not reveal any information about other similar products in the supply chain.
The best way to effectively purge the pharmaceutical supply chain of poor quality, fraudulent or counterfeit medications is to look inside the box to screen, verify and authenticate the product inside its package.

Ideally, a quality control and anti-counterfeit solution for the pharmaceutical supply chain should not require any alterations to the product or the package. The model remedy would allow packaged drugs to remain intact and be returned to the supply chain.

The perfect solution would be readily deployable with placement of the solution at strategic points within the supply chain or deployed throughout without onerous costs or extensive implementation.

This type of innovative technology would provide a level of confidence that public safety is ensured. Bottom line . . . it checks to see what is inside the box.
The One new technology which fits the definition of the ideal solution in this challenge within the supply chain is known as Energy Dispersive X-Ray Diffraction (EDXRD). This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product and ultimately minimizes the need for Track and Trace technologies as the only robust solution.

EDXRD transforms the process from looking at the outside of the box with Track and Trace to looking inside the box with Molecular Screening. Ultimately, this truly provides all of the members of the supply chain, from manufacturer to consumer, the confidence to know that the medications in their inventories or that they are taking are safe and efficacious.

EDXRD was first proposed in the 1960's as a simple and high speed way to analyze remotely the crystalline structure of material within a container. EDXRD uses high powered X-Ray beams, thus generating very high penetration power. EDXRD was first tested as a detection tool in the late 1980's, for detection of explosives hidden within luggage/packages by Philips Medical Systems. EDXRD instruments function by matching the diffraction pattern obtained by the instrument with a library of patterns previously obtained for comparison. The EDXRD diffracted spectral patterns of crystalline substances are markedly different, even to an untrained eye. Much like a human fingerprint, although there may be a few features that are common to both patterns, they are nonetheless very different. In current iterations of the technology, which is fitted with a computer-based detection device, the system relies on a mathematical algorithm to extract a unique feature set from the pattern and use them to identify the material giving rise to that pattern.

In general, the EDXRD methods are highly material specific, since the diffraction patterns of crystalline materials are unique. As it relates to pharmaceuticals, the signature of diffracted aspirin is very different from ibuprofen, acetaminophen, codeine, etc. Equally important is the fact that the diffracted patterns of the excipients specific to the unique recipe of the formulation are unique and one can determine differences in manufacturer, packaging, dosage, etc. For example, acetaminophen, 325mg from one vendor, will differ from acetaminophen 325mg from another vendor unless they follow the exact same recipe, density, pill configuration and utilize the exact same packaging.

This material sensitivity of EDXRD has two important ramifications - high detection/verification rates and low false alarm rates. Under ideal conditions (i.e. - low absorption and high test mass), the detection rate is close to 100% and the false alarm rate is 0.1% or lower. In addition because it uses high powered X-Ray, EDXRD technology can penetrate through nearly all plastics, cardboard, wood and metals in order to screen the material.

XStream Systems has succeeded in its mission of taking EDXRD through its evolution to a robust Molecular Screening tool. XStream has conceptualized and architected the world’s first countertop EDXRD machine, the XT250 Material Identification System. This machine made a historically complex technology easy to operate for the average end user. The XT250 system is now fully deployed in drug wholesalers, pharmaceutical manufacturers and pharmaceutical reverse logistics companies. The system is designed to be used either in a standalone or integrated capacity anywhere along the supply chain; the deployment can be in a warehouse setting and operated by a non-technical warehouse worker.

EDXRD’s first intended use is in the pharmaceutical industry where the XT250 material identification system detects fraudulent, adulterated or counterfeit drugs. The system also enhances quality in the manufacturing processes and provides consumer protection to the end user. With its superior X-Ray penetrating power, fast results and scalability, EDXRD can verify and detect materials in both small and large packages. Also, due to the vast flexibility of the technology, EDXRD will be well suited for many other markets.

In subsequent versions, now in development, EDXRD technology will incorporate high speed and larger capacity. These improved systems will increase the scale and capabilities of the technology and allow for high levels of integration within all stages of supply chains from manufacturing all the way through, including dispensing.

In summary, EDXRD provides a near perfect what you see is what you get (WYSIWYG) environment for the pharmaceutical industry. While Track and Trace technologies like RFID, Serialization, Taggants and Pedigree’s are important elements in supply chain security, EDXRD is the ultimate “completer” for patient safety and supply chain integrity. With an aggressive Molecular Screening Program which is offered by XStream Systems, each member of the pharmaceutical supply chain can minimize risk to the consumer, severely undermine liability risks of all members of the pharmaceutical supply chain, and thwart nefarious criminal enterprises that prey on the healthcare of others.

To learn more about XStream’s EDXRD technology, visit us at: www.xstreamsystems.net.

Counterfeit Drugs: An International Safety Problem

In the current economic crisis, it seems counterfeits and knock-offs are on the rise. In the case of counterfeit or adulterated drugs, this causes a real safety issue. If the medication does not contain the correct amount of the active pharmaceutical ingredient (API), it may not be effective or may cause undesirable and sometimes very dangerous adverse reactions. Also any inexpensive substituted filler ingredients that the counterfeiters may use, are used for appearance only and can turn what was meant to be a remedy for the patient into a poison.

We at XStream Systems encourage all throughout the pharmaceutical distribution cycle to screen their products through molecular pharmaceutical authentication. By ensuring that the products that pass through your hands are genuine, you are doing your part to protect the public health.

COMBATING THE SPREAD OF FAKE DRUGS

In the June 28, 2009 Online Issue Daily Policy Digest, the National Center for Policy Analysis highlights a very relevant policy document titled, "Keeping It Real: Combating the Spread of Fake Drugs in Poor Countries" by Julian Harris, Philip Stevens and Julian Morris of the International Policy Network.

XStream endorses the primary assertion that one of the most effective ways in combating this international problem is for the private sector of the pharmaceutical supply chain to take advantage of its innovative capacity to experiment with various technological solutions that enable it to protect the identity of its products. Members of the pharmaceutical supply chain need to utilize a variety of technologies, like XStream’s XT250 solution which allows the end user to verify and authenticate medications inside its sealed manufacturer’s unit of sale container without destroying or degrading the material.

The text of the Daily Policy Digest review on "Keeping It Real":

Counterfeit and substandard drugs are a serious and growing problem around the world -- especially in less developed countries. These fake drugs pose three direct threats to patients: failure to provide effective treatment; adulteration with toxic chemicals, often leading to death or injury; and if a drug contains some active ingredient but too little to kill all the disease agents, it can lead to the emergence of drug resistant strains of disease.

These problems are caused in large part by a combination of defective legal systems and government-imposed distortions of the pharmaceuticals market, say researchers at the International Policy Network:

Poor countries tend to have highly inefficient, slow and expensive legal systems, which makes it very difficult for people to be assured of the quality of the medicines they purchase.

Lack of enforceable trademarks and civil liability are instances of a wider problem; in such an environment, legal decisions tend to be arbitrary and designed to benefit the elite.

Price control measures, like tariffs, on imported medicines are very common in poor countries and drive up the price of high quality medicines creating opportunities for suppliers of fakes, who can then more easily undercut them.

Tariffs can also lead to unnecessary delays in ports, where improper storage conditions can cause drugs degrade.

However, bolstering the rule of law is a long term process in many countries. In the short-term, the private sector should take advantage of its innovative capacity to experiment with various technological solutions that enable it to protect the identity of its products. Governments, meanwhile, should reduce those interventions which undermine the supply of quality drugs, such as taxes, tariffs, price controls and other arbitrary regulations, say researchers.

Source: Julian Harris, Philip Stevens and Julian Morris, "Keeping it Real: Combating the spread of fake drugs in poor," International Policy Network, 2009.

The National Center for Policy Analysis (NCPA) is a nonprofit, nonpartisan public policy research organization, established in 1983. The NCPA's goal is to develop and promote private alternatives to government regulation and control, solving problems by relying on the strength of the competitive, entrepreneurial private sector.

To read the entire piece by Harris, Stevens and Morris, follow the link below:
http://policynetwork.net/uploaded/pdf/keeping_it_real_2009.pdf

Cargo Theft: A Major Rx Supply Chain Issue

The June 23, 2008 issue of Drug Topics contains an article about the ever increasing issue of cargo theft and its impact on the drug supply chain.

Given the high dollar value of pharmaceutical shipments, shipments of all types of medications lead the list of targets for transit thieves.

Much of the article is based on a presentation at a National Boards of Pharmacy meeting by FBI Special Agent Ryan Toole. The article states, “….in 2005 there were reported thefts of $14 million worth of Lipitor (atorvastatin, Pfizer) and Viagra (sildenafil citrate, Pfizer), and $29 million worth of Novartis products. However, Toole said, there's a long list of types of drugs stolen, including those for acid reflux, cancer, depression, hypertension, stroke, and many other conditions.”

Obviously once these products are stolen, these medications often make their way back into legitimate channels via non-legitimate enterprises in a variety of formats. The major concern is what happens to the product once it is in the hands of the thieves. Once in the hands of a thief, the products and their containers can be altered, contaminated, diluted or diverted. It is, however, certain that at some point these products will ultimately find their way to the hands of a consumer in a format that may not be safe for consumption.

These types of thefts make the case for an authentication technology that can verify the molecular structure of the material inside the sealed container such as the XStream Systems’ XT250™ Material Identification System. Operating in conjunction with Track and Trace processes or as a standalone technology, the XT250 protects the inventories within each step in the supply chain from receiving products that have been highjacked and altered.

View the article in full at this link to Drug Topics.