FDA Investigating Deaths of Heparin Patients

Two patients have died from adverse reactions to heparin at Beebe Medical Center in Delaware. Another patient hospitalized at Beebe is also experiencing the same adverse reaction. The deaths are being investigated by the Food and Drug Administrations (FDA) and Baxter Healthcare, who supplied the blood thinner to facility. It is uncertain what caused the reaction. Unlike last year’s recall in which patients developed low blood pressure, these patients developed intracranial bleeding.

Baxter stated that the active ingredient in the product was obtained from Pfizer and not bulk suppliers in China. Pfizer commented that while they do source heparin raw materials from China, they believe that the lot number in question was purchased domestically.

This reaction seems to be an isolated case and has not been reported as any other facilities.

The Delaware hospital where both patients died emphasized that it's not sure heparin caused the deaths. "We are not pointing fingers at Baxter," a Beebe Medical Center spokesman stated. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves."

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.

RFID Not Embraced by Pharma Industry as Anti-Counterfeiting Measure

A report put out by IDTechEx states that less than 1% of the RFID market was used by the Pharmaceutical Market. The global market share for RFID was $5.56 billion up 6% over last year but only 10 million tags were used in the pharmaceutical industry.

So why wouldn’t the pharma industry embrace it after 7 years of a highly intense campaign for its adoption as an anti-counterfeiting tool? The answer comes in its use.

It is primarily an inventory management security tool. You will see RFID tags on items at your local Wal-Mart. You will see them on all your computer software and that new video game that just came out, but not necessarily on Grandma’s medicine.

The truth is -RFID is very helpful at managing your inventory. It will tell you how much you have on stock. Some tags will even beep at the door if someone tries to make off with it without paying. It does help against shoplifting and employee theft. But it does not tell you what is inside. You are still only verifying the package.

To view the article discussing the report visit www.SecuringPharma.com.

IDTechEx is a knowledge based company specializing in RFID smart labels, smart packaging and Radio Frequency Identification RFID. The company gives strictly independent marketing, technical and business advice and services on these subjects.

US Drug makers Express Concern with USA Trading Partner Countries

The US Trade Representative (USTR) released its 2009 Special 301 Report on Friday May 1, 2009. According to the report, US drug makers have expressed concern over the policies of a number of USA’s trading partners - including Canada, France, Germany, Italy, Japan, New Zealand and Taiwan in regards to global intellectual property protection.

“In this time of economic uncertainty, we need to redouble our efforts to work with all of our trading partners – even our closest allies and neighbors such as Canada – to enhance protection and enforcement of intellectual property rights in the context of a rules-based trading system,” said the USTR, Ambassador Ron Kirk.

The USTR Priority Watch List for 2009 names countries requiring particular scrutiny - Algeria, Argentina, Canada, Chile, France, Germany, India, Indonesia, Israel, Italy, Japan, New Zealand, Pakistan, Taiwan, Thailand and Venezuela. Canada was added to list for the first time this year, due to “increasing concern about the continuing need for copyright reform, as well as continuing concern about weak border enforcement.”

Brazil, China, India, Indonesia and Russia are listed as areas where the manufacture of counterfeit drugs is rampant.

Indonesia joins the list for its counterfeit manufacturing, its counterfeit drug trade and the introduction last year’s law on the operation of foreign pharmaceutical companies that raises “significant market access concerns;”

China is also listed due to its regulatory lapse in the enforcement of active pharmaceutical ingredients (API) – since often these ingredients are not declared as a bulk chemical intended for use in pharmaceuticals by API makers to avoid regulatory oversight.

To read a recap on the USTR Report visit Pharma Times.

It is understandable that China’s lack of regulatory control for APIs would be of particular concern to the US since China provides 40% of the APIs for drugs. The impact of this danger was felt dramatically last year when an adulterated substance added by a Chinese supplier resulted in the heparin recall and almost 100 deaths in the United States.

XStream's XT250 System Verifies WHO Figure for Counterfeit Drugs in U.S.

Based on XStream Systems' usage data from end user XT250 systems, they can verify that the World Health Organization’s (WHO) estimate of 1% of the United States pharmaceutical supply chain being counterfeit, is accurate.

XStream System’s XT250 Materials Identification System verifies and authenticates materials within its sealed, unit of sale container. The standalone system is currently deployed in several pharmaceutical distribution companies that distribute pharmaceuticals throughout the United States.

“Based on our macro look at the data from the end user, we can confirm that the WHO estimates are reasonably accurate”, stated Alan Clock, Senior Vice President at XStream. “Our system is the only technology that can accurately authenticate pharmaceuticals within the supply chain without destroying the product or packaging so we have excellent visibility on what is going on literally inside the supply chain .”

“The XT250 is the only materials analysis technology that can keep up with the tremendous flow of drugs throughout the supply chain. We are seeing data that suggest between 0.67% and 1.4% of receivables and returns within these pharmaceutical distributor end users are likely counterfeit products or fraudulent medications,” explained Mr. Clock.

From the data, XStream is learning that authentication rejection/failure rates vary between pharmaceutical products, and even within a given pharmaceutical product the rejection rates can vary significantly over time. In some cases isolated bottles have been rejected, while in other cases entire lots have been rejected. “You can’t predict when the counterfeits will show up,” said Mr. Clock.

XStream’s data validates that the members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should be using authentication technology more and taking steps to screen as many pharmaceuticals as possible, as often as possible. Currently many regulatory officials have been advocating more frequent inspections at foreign manufacturing facilities as the primary solution to the problem of poor manufacturing and counterfeit medications in the supply chain. While inspections are needed, given the sheer quantity of places to inspect and global nature of these sites, inspectors have little chance of catching counterfeits. In addition, XStream’s data suggests that counterfeits are inserted at a multitude of sources all along the supply chain. The point of production is not the primary starting point for fake medications. Verification and authentication at each point along the supply chain is the most effective way to detect and interdict fraudulent and counterfeit pharmaceuticals.

“The good news is that the United States is one of the last of the developed countries to see an increase in counterfeit medications. The United Kingdom has already seen an increase in the last three years and it stands to reason it will not be long till we see significant increases domestically as well. Because of this impending proliferation, the XT250 is essential for the protection of the consumer since it is one of the only tools available which can act as a roadblock to counterfeiters.”, said Mr. Clock.

China's Bad Medicine and Its Impact on the US

The Wall Street Journal features an informative editorial by Roger Bate in today's issue on the counterfeiting drug trade in China. Roger Bate is an expert on counterfeit drugs and is the author of the book “Making a Killing: The Deadly Implications of the Counterfeit Drug Trade.”

Mr. Bates discusses the scope of the problem in China and what the Chinese government can do to combat the issue. The black market is a huge enterprise in China employing as many as 5 million Chinese citizens in the counterfeit market. This is an alarming fact seeing as China is the fourth largest pharmaceutical exporter and supplies 40% of the global supply of active pharmaceutical ingredients (API).

The scope of Chinese counterfeiting has been felt globally as shown in these most recent incidents cited by Mr. Bates: In the United Kingdom in March of this year, Chinese counterfeit pharmaceuticals amounting to $745,000 were seized. In January of this year, two people died and nine were hospitalized due to counterfeit diabetes drugs in Xinjiang province. Last year hundreds suffered adverse reactions and at least 95 died due to a chemical ingredient that is believe to have been deliberately adulterated by Chinese suppliers.

In his paper “The Problems and Potential of China’s Pharmaceutical Industry” Bates further discusses the problem and why the world should be concerned. He states:

“With more Americans opting to procure drugs directly from overseas, often by purchasing over the Internet, understanding the causes of the counterfeit and substandard problem in China—and what can be done to combat it—has never been more important.”

To combat counterfeit drugs, he stresses the importance of collecting reliable information and coordinating consistent unbiased regulatory enforcement.

To view the editorial visit the Wall Street journal at www.wsj.com.

To view the paper "The Problems and Potential of China’s Pharmaceutical Industry” by Roger Bates and Karen Porter, visit the American Enterprise Institute for Public Research at: www.aei.org

Egypt Seizes Large Amount Of Suspected Fake Drugs

Reported by Dow Jones last week: Egyptian authorities seized a large amount of suspected counterfeit drugs from a warehouse in Egypt and have one of the key individuals responsible in custody.

The seizure of counterfeit drugs used to treat conditions such as diabetes and cancer were part of Egypt’s crackdown on the distribution of spurious medicines, which is on the increase in the region. The head of Egypt's anti-fraud General Mustafa Amr stated to Dow Jones reporters that the counterfeit drugs found in the raid had originated in China and arrived in Egypt after passing through Syria. The individual arrested was a Jordanian residing in Egypt.

A Pfizer spokesman stated that they had been informed of the raid and added that 21,000 pills of suspected fake Dostinex were seized in the raids. The brand drug Dostinex is manufactured by Pfizer for the treatment of hyperprolactinaemia, which is the presence of abnormally high levels of the hormone prolactin in the blood.

Note: According to the Organisation for Economic Co-operation and Development (OECD), 7% of all counterfeit pharmaceuticals distributed globally are thought to originate in Egypt.