USP Building Database of Fake & Substandard Meds

USP is building a database of counterfeit medicines to support international drug procurement organizations, such as WHO, and the timely sharing of information between national regulators.

In a November 16th article in the In-PharmaTechnologist, Nick Taylor reports on the development of a new database that is due to launch early next year by the US Pharmacopeia (USP).

USP’s database will allow regulators and organizations the ability to monitor counterfeit and substandard drugs and to support more informed enforcement actions and procurement-related decisions.

According to Mr. Taylor’s article:

• Speaking to in-PharmaTechnologist at AAPS 2010 Patrick Lukulay, director of the promoting the quality of medicines (PQM) initiative at USP, outlined how timely sharing of information can support enforcement actions.

• Lukulay said the database could have supported a more effective response to counterfeit medicines that spread to Mali after first being seized in Ghana. Using the database regulators in Mali would have been aware of the products, which had the same batch numbers as the products seized in Ghana, and acted accordingly.

• Having created the architecture the USP is now inputting information about counterfeit or substandard drugs into the database. Listed on the database will be the name of the product, the country it was seized in, what was wrong with it and other descriptors, said Lukulay. If countries agree the database will be shared with the public.

• The benefits of sharing information also underpin the USP's creation of a 'virtual forum'. This will allow users to pose questions, share alerts and discuss best practices among a network of people involved with ensuring the quality of medicines.

Secure Pharma Chain, supports all efforts to share information in fighting the deadly crime of adulterated, fraudulent, substandard and counterfeit drugs.

All members of the pharmaceutical supply chain must use all tools including technologies, solutions and cooperative intelligence databases to interdict these dangerous products

It is critical that each member of the supply chain bear the responsibility of securing their inventories in order to protect their business brand and ultimately the health care consumer.

To read the entire story, visit: http://www.in-pharmatechnologist.com/Processing-QC/USP-building-database-of-fake-substandard-meds

To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/

Healthcare Fraud Costing EU €56bn a Year

In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

Euractiv.com posted a story about a study stating that €56 billion is lost to healthcare fraud each year in the EU.

In the October 6th post, Euractiv.com claims that experts say conflicts of interest in the pharmaceutical sector mean that the true extent of expenditure being directed away from patients remains unknown.

The study by The European Healthcare Fraud and Corruption Network (EHFCN) was done to determine “the burden healthcare fraud places on society and facilitate the exchange of best practice on its detection.”

The research was conducted in the countries of Belgium, France, the Netherlands, Northern Ireland, Norway, Poland, Slovenia and Scotland and was presented at the EHFCN conference in Brussels in September.

According to the EHFCN report:

• The vast number of parties involved in the healthcare sector and the subsequent potential complexity of fraud schemes means that special fraud detectors - professionals already working in health care - have to be employed in order to carry out investigations into bills, patient notes and medication receipts.

• Trade in counterfeit medicines has exploded and it is now estimated that global counterfeit drug sales will reach €60 billion this year. In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

• Low quality treatment - including from unqualified practitioners, forged receipts and sickness certificates, price cartels and the provision of counterfeit medicines - were identified as contributing to a phenomenon difficult to measure but ringing alarm bells at a time when austerity measures are being undertaken across the EU.

• 4,188 instances of suspected fraud were identified in the study, which was carried out in seven member states. The Netherlands and Belgium - working under a 'pay for service' system where doctors have an incentive to provide as much treatment as possible - hold the highest rates.

Hopefully this study will bring awareness to government, industry leaders and consumers to the negative impact that fraudulent, adulterated, sub-standard and counterfeit drugs have on health care and populations as a whole.

Secure Pharma Chain believes that it is important that all members of the pharmaceutical supply chain take proactive measures to deploy solutions to protect their inventories and provide themselves with a competitive edge as consumers begin to understand the potential risks of counterfeit and fraudulent medications.

To read the entire Euractiv.com story, visit: http://www.euractiv.com/en/health/healthcare-fraud-costing-eu-56bn-a-year-news-498480

To learn about pharmaceutical anti-counterfeiting technologies, visit: www.xstreamsystems.net.

Pharmaceutical Technology: New Treaty to Curb Counterfeit Drugs

Stephanie Sutton in a July 15th report in the electronic newsletter of Pharmaceutical Technology writes about a Council of Europe (CoE) Medcrime Treaty that is hoped will curb the lucrative global trade in counterfeit medications.

According to Ms. Sutton's story, the treaty is the first global convention against counterfeit pharmaceuticals and encourages cooperation among law enforcement agencies, customs, health professionals, and the judiciary.

“This treaty offers a comprehensive approach to tackling a crime that threatens public health and public healthcare systems,” said a spokesman, according to a news briefing from CoE.

“Counterfeit medicines are more lucrative than heroin. It is a vile crime to fraudulently provide patients with products that don’t work.”

Ms. Sutton writes:

· CoE has been long concerned about the absence of harmonized international legislation, nondeterrent sanctions, and the involvement of cross-border criminal organizations. Experts also believe the trend toward self-treatment has “flooded the Internet with medicines produced without any controls, tests or authorisation,” according to the news briefing.

· Another significant worry is the growing incidence of counterfeit medicines in supply chains. The healthcare systems of developing countries are particularly vulnerable to the mass entry of counterfeits; however, CoE believes that fake anticoagulation drugs may already have been taken by patients in the UK. Adultered antibiotics, cancer treatments, antipsychotic drugs, cholesterol-lowering treatments, and erectile dysfunction may also be present in Europe.

· According to CoE, counterfeiters are attracted by the potential for huge profits (i.e., economically motivated adulteration) coupled with low detection rates and comparative light penalties. The treaty will introduce tougher sanctions and help to ensure more effective pursuit of counterfeit manufacturers across international borders.

· The Medicrime Treaty will be opened for signatures later this year at a conference in Istanbul, which will be attended by representatives from more than 40 countries.

Secure Pharma Chain is encouraged by this step by the CoE to gain a more global, regulatory mandate to combat this deadly criminal act.

This treaty along with enhanced technologies and supply chain solutions are critical in eradicating the danger of bogus drugs to consumers around the globe.

To read the entire Pharmaceutical Technology story and see the text of the Medcrime Treaty, visit: http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=678874

Voice of America Editorial: Warning! Counterfeit Medicines

In the November 18th online edition of Voice of America (VOANews.com), an editorial describing the issue of counterfeit medications in developing countries and USAID new program to combat this issue was posted. The complete editorial appears below:

"Substandard and counterfeit medicines represent a threat to public health worldwide but pose a particular problem in developing countries, where lack of financial, technical and other resources make it difficult to protect the drug supply chains," said United States Agency for International Development, or USAID, Acting Assistant Administrator for Global Health, Gloria Steele.

That is why USAID is launching a new program to combat this menace over the next five years. The USAID program will be conducted jointly with the U.S. Pharmacopeial Convention, or USP, a non-profit, non-governmental scientific organization that sets globally recognized standards for medicines and health care products.

The Promoting the Quality of Medicines, or PQM, Program, a $35 million cooperative agreement, will help improve the quality, safety and efficacy of medicines in countries around the world. These medicines are critical for the treatment of serious disease such as AIDS, tuberculosis, and malaria, and essential to USAID's priority health programs.

"Such medicines undermine decades of investments in public health," said USAID Acting Assistant Administrator Steele. "Without good quality, safe medicines to treat such diseases as malaria and tuberculosis, the impact of other health initiatives is severely weakened if not negated completely. The PQM Program focuses on this critical aspect of combating these diseases."

"The lives of patients are put in serious jeopardy when they take substandard or counterfeit drugs," said Dr. Roger L. William, chief executive officer of USP. He noted that these dangerous substances "contribute to the development of drug-resistant strains of infectious diseases. Such strains are a leading challenge in the fight against malaria, HIV/AIDs and tuberculosis."

Building on a 10-year USAID-USP partnership in this arena that assists health officials and others in 28 countries around the world, the program will increase efforts to address the significant public health challenge posed by substandard or counterfeit medicines.

Specifically, the program will help countries strengthen their medicines regulatory bodies; increase the supply of good-quality medicines; reduce the availability of counterfeit and substandard medicines; and conduct global advocacy to raise awareness of the dangers of substandard and counterfeit drugs.

The PQM Program builds on the work of USAID and USP over the past decade through a predecessor program, the Drug Quality and Information [DQI] Program. The new program will expand on these and other activities in Asia, Eastern Europe, Latin America, and sub-Saharan Africa. The United States is committed to working with its international partners to combat the growing global threat posed by counterfeit and substandard medicines.

XStream Systems endorses USAID’s efforts and recommends the use of technology such as material screening as an efficient and robust solution to this issue.

To view the editorial online visit: www.voanews.com/uspolicy/2009-11-17-voa1.cfm.
To learn more about XStream Systems, visit our website at http://www.xstreamsystems.net/.

Weekend News Highlights International Epidemic of Counterfeit Medications

XStream Systems found an op-ed article in the New York Times regarding the health epidemic in the third world regarding poor quality and counterfeit medications and a story reported by Bloomberg News about the seizure of millions in counterfeit malaria, HIV and tuberculosis drugs in SE Asia.

The phenomenon of counterfeit, adulterated and contaminated pharmaceuticals continues to grow and flourish as our global economy declines.

Until technology solutions such as XStream’s XT250 become ubiquitous, this malady will continue to proliferate and impact those beyond the third world.

Op-ed: More needs to be done to ensure safety, quality of drugs in the developing world.

In an op-ed in the New York Times (11/15, A21), Roger Bate, author, director of the health advocacy group Africa Fighting Malaria, and resident fellow at the American Enterprise Institute, wrote that, "if aid organizations are serious about combating the spread of deadly diseases in the developing world, they must do more to ensure the safety and quality of drugs."

According to Bate, the importations of counterfeit medicines "are only part of the problem." Bate explained that in order "deal with the scarcity of drugs, many poor governments have turned to local production." Still, "local producers often make low-quality" medicines. "Many poor countries," he wrote, "lack the regulatory structure needed to monitor safety and effectiveness. Some do not even have laws against selling substandard drugs, and none have sophisticated agencies like the" Food and Drug Administration (FDA).

Bate concluded that aid organizations must first "give technical and financial support to governments' sincere efforts to maintain strict drug inspection standards." Second, they should "always refuse to subsidize any low-quality drugs." And finally, organizations need to "insist that only brand-name and generic products approved by stringent drug agencies like the FDA be distributed."


Interpol seizes more than $6.65 million of counterfeit medicines in Southeast Asia.

Bloomberg News (11/17, Bennett) reports, "Interpol seized more than $6.65 million of counterfeit medicines against malaria, HIV, and tuberculosis in Southeast Asia and made 27 arrests, disrupting the region's fake drug trade for the second time in three years."

According to Aline Plancon, an officer involved in the "five-month investigation called Operation Storm," officials "seized more than 16 million pills, including fake antibiotics for pneumonia and child-related illnesses." Operation Storm "involved almost 200 raids" conducted across "Cambodia, China, Laos, Myanmar, Singapore, Thailand, and Vietnam."

Health officials were particularly concerned by "copies of a class of malaria drugs called artemisinins." Fake "artemisinin-based treatments containing small amounts of the medicine are helping the parasite responsible for malaria to evade authentic drugs in patients near Cambodia's border with Thailand, a recent study showed."