ABC News: FDA Looking into Tylenol Arthritis Pain Caplets Recall

ABC World News is reporting that the US Food and Drug Administration is investigating the process of the recall and the way that it has been communicated to consumers.

November, Tylenol posted a small recall on its website. Twelve days ago, all six million bottles were recalled. However, it wasn't until a nationwide FDA medical alert just this Monday that most people learned the bottles had been recalled.

In an analysis piece aired on ABC World News, ABC’s Senior Medical Editor Richard Besser, MD, advised consumers what actions to take if they have the recalled Tylenol. Dr. Besser explained that consumers who have the Tylenol arthritis caplets in the Easy Cap bottles should get rid of them by safely disposing them in their trash.

On Wednesday, the deputy commissioner of the FDA, Joshua M. Sharfstein, MD, said the agency is "looking into...the case," additional stating "a system that relies on the consumer to either visit websites or to sign up for multiple web blogs or email alerts, I don't think is the way we want to alert consumers about recalls."

Tylenol Pain Caplets Recalled Due to Trace Chemical Which Causes Nausea and Vomiting

The Associated Press and other major media outlets are reporting that Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

The FDA released a statement on their website that Johnson & Johnson is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Johnson & Johnson had previously recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pan, vomiting and diarrhea.

Johnson & Johnson is saying that the odor results from trace amounts of a chemical called 2, 4, 6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

For more information on the recall visit the Tylenol website: http://www.tylenol.com/.

This recall, based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

PETN Explosives Are Visible to EDXRD Technology

As everyone breathes a sigh of relief over the near miss that happened on Christmas Day in Detroit on Northwest # 253, it brings to mind the issues over current screening technologies used in security applications and their ability to efficiently detect various threats that we currently face from terrorist around the globe.

While nothing is fool proof, it is apparent that most of the x-ray technologies in place are based solely on image density screening and cannot adequately differentiate between common everyday items and significant threats. With current x-ray screening an image of a block of plastic explosive (i.e. C4), which is roughly the same density as chocolate or cheese, would be nearly identical to these common food items and almost impossible for a TSA Operator to properly distinguish without a thorough secondary inspection.

There are however alternatives to the current technologies, many that have been tested or used periodically in Homeland Security applications, that may be one of the solutions to consider as we begin to face a seemingly renewed and more sophisticated terrorist threat.

EDXRD or Energy Dispersive X-Ray Diffraction, is one such alternative that bears a looking at as our threats become more sophisticated and resolute.

EDXRD utilizes x-ray beams to screen crystalline materials, penetrating a container like luggage, while giving the operator molecular spectra of the material instead of an image and a clear cut way to distinguish real threats and common items. The EDXRD spectrum is essentially a fingerprint which can be automatically “matched” against a known library of threats and the operator notified immediately.

PETN, a crystalline based material that was used by the suspected terrorist is a perfect example of a material that EDXRD would detect. PETN comes in a substance form as a powder. The powder would show up as any other powdered material in a current magnetometer used in airports around the globe. EDXRD would be able to differentiate its molecular spectra fingerprint and recognize the threat in real time as it was being passed through the system.

EDXRD technology is currently in use within the pharmaceutical supply chain as a way to detect fraudulent, adulterated and counterfeit medications inside the material’s unit-of-sale container without destroying or degrading the products and has proven extremely accurate and reliable.

As we continue to face new and more dangerous threats it is important for both industry, regulators and government officials that we need to stretch our technology as the solution to these clear and present dangers.

To learn more about EDXRD technology and its current applications, visit: www.xstreamsystems.net.

UK Gets Tough with Bogus Drug Website Operators

Those operating bogus online pharmacies could face stiffer penalties, up to 12 years jail time under a new law developed by Britain’s Medical and Healthcare Products Regulatory Agency (MHRA).

Specific criminal sentences for counterfeiting medicines are to be introduced in the UK. Convicted individuals would face a maximum penalty of 10-12 years' imprisonment, the agency has announced. Individuals could be found guilty of either supplying or offering to supply counterfeit medicines.

Stronger enforcement is in answer to the increase of counterfeit medicines in the United Kingdom. Earlier this year a British newspaper survey indicated that one out of four general practitioners believes they have treated a victim of counterfeit drugs.

To view the entire article visit: http://www.healthcarerepublic.com/news/975201/Bogus-drug-website-operators-face-12-year-jail-sentences/.

Pharmaceutical Commerce: FDA Counterfeit Drug Investigations Reach New High in 2009

In the December 23rd online edition of Pharmaceutical Commerce, they reported on the FDA’s statistics on Counterfeit Drug Investigations. It is believed that the number of investigations is an indicator of the increase in counterfeit drug activity and represents a fraction of the overall activity within the United States. The entire online posting appears below:

At the HDMA Track & Trace Seminar (National Harbor, MD, Nov. 30-Dec. 1), David Dorsey, Acting Deputy Administrator for Policy at FDA, revealed the FY 2009 (which ended last September) figure for counterfeit-drug investigations opened by FDA’s Office of Criminal Investigations: a new record of 65.

FDA cautions that this count is not a direct measure of the volume of counterfeit activity—but on the other hand, where there’s smoke there’s fire. Dorsey also said that the agency is working toward its mandated March 2010 deadline for making recommendations on a “serial numeric identifier” program for drug tracking, as specified in the FDA Amendments Act of 2007.

Meanwhile, newer legislation, such as the Buyer-Matheson bill from the 2008 session (H.R. 5389) is expected to be re-introduced in the current Congress. That bill would mandate a national track-and-trace system to prevent counterfeiting and diversion.

Visit Pharmaceutical Commerce and read the story online at: www.pharmaceuticalcommerce.com/frontEnd/1339-counterfeit_drugs_FDA_Office_of_Criminal_Investigations_OCI.html

XStream Systems Presents Quad Layer of Protection against Counterfeit Drugs

With an invitation from Pfizer Inc.. and Dr. Mohammed Abuelkhair, Head, Pharma/Medicine and Medical Products Regulation Section – Health Authority Abu Dhabi, XStream Systems had the opportunity to present at the joint Regional Conference on Fighting Counterfeit Medicines in Dubai December 15 and 16, 2009.

Representing XStream Systems were Brian Mayo, President and CTO, Patricia Earl, Vice President Business Development and Simon Irish, XStream Systems’ Director.

XStream Systems representatives had an opportunity to interact with officials from the Ministries of Health, Police, and Customs representing governments of the Middle East and North Africa region.

On the second day of the conference XStream Systems’ President formally presented the company’s vision of the “Quad-Layer Approach” that integrates molecular screening, serialization, sealants and pedigree. He shared with the attendees that this was an all-encompassing system that will deliver a seamless method of counterfeit control and product integrity assurance, and, in this regard discussed XStream Systems’ on-going collaboration with the Kodak Security Solutions and use of the Traceless System for Anti-Counterfeiting.

To view entire article visit: www.xstreamsystems.net.

Ministry Plans Ban on Re-export of Medicines

The UAE is taking measures to combat counterfeit drugs. One of those measures is to ban re-exportation of medication.

An article published this week in Khaleej Times quotes prominent industry and regulatory leaders on the scope of the counterfeit drug trade in the Middle East, the challenges, and current initiatives to combat it.

Below are some key fact listed in the article:

The scope of the counterfeit drug trade and seizures in the Middle East

• Nearly one per cent of the fake medicines detected in the European Union comes from the UAE, said Dr Amin Al Amiri, CEO, Medical Practice and License at the UAE Health Ministry


• During the first five months of 2008, Dubai Customs seized and destroyed 293 tonnes of counterfeit medical products.


• During 2006-2008, the UAE ranked sixth in the region with 36 numbers of raids in which counterfeit medicines were seized. Israel topped the list of 10 countries with 162 raids. “Four other incidents in the UAE discovered goods that were being diverted to another country,” said Ashley How, regional director for Pharmaceutical Security Institute.


• In 2008, $3.1 million worth of Pfizer counterfeit drugs were seized in the region. “It is not only expensive drugs that are duplicated but even common ones such as Ponstan,” said Steve Allen, Pfizer’s senior director for 
Global Security. “This is because people would prefer buying a drug from a known company rather than an unknown,” he said, adding that 30 of the company’s well known drugs including Viagra, Ponstan, Xanax and weight loss drug Lipitor had 
been copied.

Dependence on imports are a challenge

• The expanded volume of imported medical products and medicinal ingredients is a challenge for the country, said Dr Mohammed Abu Elkhair, Head of Pharma/Medicine and Medical Products Regulation Section, Health Authority of Abu Dhabi.


• Only 20 per cent of the medicines needed in the UAE are manufactured locally, thus increasing a chance of counterfeit trade. “Only increased penalties as proposed in the law can help curb the trade,” he said.


• Quoting a recently held study in Abu Dhabi, Dr Elkhair said only 40-50 per cent of the registered medicines are available in the country.

Current Initiatives

• The UAE will soon end re-exporting of medicinal drugs from its ports to curb a growing regional trade in counterfeit products, according to a senior health official.


• The Health Ministry has also increased raids and inspections and toughened punishments against violators. “Two doctors have recently been blacklisted GCC-wide while in 2008 we closed two factories. This year, 35 pharmacies have been shut down for selling fake drugs,” said Dr Amin Al Amiri.


• Other measures taken by the ministry include quality control analysis, inclusion of new technologies to identify fake medicines, tougher imports control, and advertisement control.

To view the article in its entirety, visit: www.khaleejtimes.com.

The National: Tighter Controls on Fake Drugs Sought

The Regional Conference on Fighting Counterfeit Medicines recently held in Dubai, examined the issue and solutions to fighting counterfeit medications. The conference, sponsored by Pfizer, attracted representatives from 15 countries.

XStream Systems President and Chief Technology Officer, Brian Mayo presented XStream’s revolutionary material screening technology at the conference.

Reported by Mitya Underwood and published by The National the following are some excerpts from the article:

• The UAE must tighten its border controls and increase co-operation between enforcement agencies if it hopes to turn back the rising tide of counterfeit drugs, officials said yesterday.


• The Ministry of Health said it would work with customs and free zone officials to stop fake medicines and medical equipment from entering the country or passing through its ports.


• Dr Amin al Amiri, the chief executive of medical practices and licensing, said the ministry would ask customs officials to stop clearance for medicines and equipment until it had approval for each consignment.


• Speaking at the Regional Conference on Fighting Counterfeit Medicines, Dr al Amari said the ministry hoped to reduce the UAE’s role in the global trafficking of illegal products. He declined to say how much counterfeit material was coming into or passing through the country.


• Figures from the European Commission’s Taxation and Customs Union recently showed that the UAE was the origin of almost nine per cent of all counterfeit medicines seized at European borders in 2008. The UAE was the third largest importer after India and Syria.


• Dr al Amiri said in addition to increased inspections and raids, a federal pharmaceutical law would be introduced to tighten penalties and introduce jail terms and larger fines.


• Dr Mohammed Abuelkhair, the head of drugs and medical products registration at the Health Authority-Abu Dhabi, said the law should deter pharmacies from knowingly stocking counterfeit drugs and stop importers from targeting the UAE market.

To read the entire article, visit: http://www.thenational.ae/apps/pbcs.dll/article?AID=/20091216/NATIONAL/712159821/1010

Six Chinese Sentenced to Death for Selling Fake Drugs Labeled “Made in India”

Six Chinese traders who exported fake anti-malaria drugs to Africa Labeled as “Made in India” have been sentenced to death. Chinese officials have offered apologies to India, but no further information on the traders’ identities was given.

The issue became a major controversy last June when Nigeria's National Agency for Food and Drug Administration and Control said it had seized a large consignment of spurious anti-malaria drugs worth $210,000.

Indian officials had received complaints that drugs exported from China but mislabeled as manufactured in India were being exported to South Africa, Ghana, Ivory Coast and other parts of Africa.

To view the entire article visit: timesofindia.indiatimes.com.

November 2009 Pharmaceutical Cargo Theft Report

Freightwatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released its November 2009 cargo theft report.

There have been 64 cargo theft events for the month of November. There were three documented incidents of pharmaceutical theft which included H1N1 Vaccines, OTC Medications and Infant Formula.

Two months ago FreightWatch noted that cargo theft incidents are occurring from terminal and carrier lots, as well as public access parking lots. This trend has continued through November, where almost 45% of known theft locations were in terminal or carrier lots, in lieu of truck stops (approximately 20%), which are traditionally where cargo theft is known to occur in the highest amounts volume

These trends coincides with intelligence reports and activity that show cargo thieves are becoming more organized and proactive in targeting specific loads or products, conducting surveillance and stealing the loads at their first opportunity.

Members of the pharmaceutical supply chain should be aware of the incidents of pharmaceutical cargo thefts and the overall safety and security implications. XStream Systems encourages manufacturers, distributors and dispensers to utilize a variety of tools and solutions including EDXRD screening to secure, authenticate and verify that the inventories and products within their control are authenticate and safe. Nefarious sources of supply are known to infiltrate the legitimate supply chain with fraudulent, adulterated and counterfeit medications which impact the safety, security and efficacy of supply to healthcare consumers.

To see the November 2009 report, visit Freightwatch International’s site at: www.freightwatchintl.com.

To learn more about XStream Systems supply chain security solution visit our site at: www.xstreamsystems.net.

Washington Post: US Crackdown Targets Counterfeit Drugs

Fake medicines are a growing enterprise. In a November 20th article in the Washington Post they give out excellent statistics and report on an international law enforcement effort, code named Pangea that we have blogged about several times recently.

Operation Pangea conducted organized raids on five continents to combat counterfeit drugs.

In the U.S. the crackdown uncovered 700 alleged packages of fake or suspicious prescription drugs including Viagra, Vicodin, and Claritin, and shut down 90 alleged rogue online pharmacies. The international operation took down 72 Web sites, seized nearly 1,000 packages and found more than 167,000 suspected illicit and counterfeit pills. Some may have as much as three times more of an active ingredient than is typically prescribed; others may be placebos.

According to the National Association of Chain Drug Stores, a trade group, Americans spent $254 billion on prescription drugs last year, up 1.8 percent from 2007.

The increase of internet pharmacies has given rise to rogue pharmacies posing as legitimate sites. One site under federal investigation for selling erectile dysfunction medications like Viagra and Cialis states that it is headquartered in Canada, has a warehouse in India and is licensed to sell in the U.S. through Minnesota. However, the website is registered in China and is hosted in Russia.

These sites are very hard to track and the Food and Drug Administration discourages consumers from purchasing medication online except through Verified Internet Pharmacy Practice (VIPP) pharmacies, which are certified by the National Association of Boards of Pharmacy (NABAP). The National Association of Boards of Pharmacy maintains a list of roughly 4,000 online pharmacies it says are questionable.

The global crackdown involved a half a dozen U.S. agencies and 24 countries in a week long intensive sweep. "For the criminals, at least," said Richard Halverson, unit chief at the National Intellectual Property Rights Coordination Center, "we're telling them that everybody's looking."

To view the entire article visit: http://www.washingtonpost.com/wp-dyn/content/article/2009/11/20/AR2009112002772.html.

CBI Probes Bulk Drugs Imported from China

The office of the Drugs Controller General of India (DCGI) is investigating bulk pharmaceutical ingredients imported in from China. The DCGI has handed over 4 cases of “alleged” unregistered bulk drugs to the Central Bureau of Investigation (CBI) with an additional 3 cases to follow.

The Directorate of Revenue Intelligence was alerted after the apex drug regulator noticed that such unregistered drugs accounted for almost half of the country’s recent bulk drugs import.

According to official sources, CBI has been asked to inquire into the import of drugs such as Roxithromycin ($81.5 per kg), Progesterone ($187.5 per kg) and Cimetidine ($14.5 per kg) by Gujarat-based Envee Drugs Pvt Ltd, and Mumbai-based firms J B Khokhani & Co and Sheetal Pharmaceuticals, respectively.

Samples of all three consignments are being tested for quality at Central Drugs Laboratory, Kolkata. The fourth case has been registered against Mumbai-based C J Shah & Co.

The products showed discrepancies in labeling, packaging and documentation. The documentation names Chinese manufacturers that have denied the products were sourced from them.

Many of the cases are labeled as chemicals, which do not undergo the same inspection as raw materials used in pharmaceuticals. This is of particular concern as these bulk drugs are used by local manufacturers to make the final medicine for domestic as well as export purposes.

The Indian drug industry is highly dependent on Chinese bulk drugs. “There is an urgent need to ensure the quality and authenticity of these drugs,” said a senior government official. India imported Rs 6,700 crore ($USD 144.23 Million) worth of mostly bulk drugs in 2007-08.

To view more on the investigation visit: www.business-standard.com.