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/

USAID: Substandard and Counterfeit Drugs Found By Cooperative Aid Program

Fake Medications in Use in Public Hospital, Many Other Sites

In a press release from the U.S. Agency for International Development (USAID), they announced that substandard and counterfeit versions of thirteen key anti-malarial medicines were uncovered in multiple locations across Ghana by the Medicines Quality Monitoring surveillance program.

Set up by the Ghana Food and Drugs Board (FDB) in collaboration with the U.S. Pharmacopeial Convention (USP) and the U.S. Agency for International Development (USAID), the program samples anti-malarials across the public and private sectors.

The program was established in 2008 and is implemented by USP's Promoting the Quality of Medicines (PQM) initiative. USP is a scientific nonprofit organization that develops globally recognized standards for the quality of medicines. Through the PQM program, USP works in developing countries to help verify and improve the quality of medications intended to treat life-threatening neglected diseases such as malaria, HIV/AIDS and tuberculosis.

"Few people fully realize the devastation that distribution of substandard or counterfeit medications can wreak on vulnerable populations," said Stephen Opuni, M.D., chief executive officer of the FDB. "In this case some of the drugs discovered contained no active pharmaceutical ingredient, while others failed to meet required quality standards. This causes great harm in two ways: the individual patients taking the drugs get no relief, and drug-resistant strains of malaria may grow stronger. In addition, people lose confidence in the efficacy of medicines and may be reluctant to seek medical help when they need it. I'm very pleased with the outcomes we're seeing from the Medicines Quality Monitoring program."

In 2009 the same program uncovered a counterfeit version of Novartis' Coartem®, another widely used anti-malarial. In that case, an alert citizen notified the authorities after suspecting the drug he bought might be fake.

"Last year's seizure of counterfeit drugs showed the importance of public education," said Patrick Lukulay, Ph.D., director of the PQM program. "In the current case, rigorous surveillance worked very well. The fact that the fake and poor quality drugs were so widespread—found in many areas across Ghana, and in many types of outlets—underscores the need not only for continuing surveillance but also for active enforcement of anti-counterfeiting laws."

The discovery of the counterfeits—tragically, in use at a government-run hospital and private clinic, and being distributed through many pharmacies—has resulted in a nationwide recall of all thirteen drugs, including publicizing the names of the outlets where they were found.

This is intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers. Manufacturers of some of the recalled medications will be required to meet with the FDB for required regulatory sanctions.

Noted Dr. Lukulay, "It's important to keep in mind that all these fake and substandard medicines were found just in one round of post-market surveillance, just of anti-malarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations."

The American people, through the U.S. Agency for International Development, have provided economic and humanitarian assistance worldwide for nearly 50 years.

Secure Pharma Chain agrees with the conclusions of enhanced public education, more rigorous enforcement of laws and official collaborations between public and private standards as essential in combating this lethal crime.

The members of the global pharmaceutical supply chain (manufacturers, distributors and dispensers) need to take the lead on defeating this crime. Waiting for agencies and regulations is not an option, proactive deployment of solutions and technologies designed to interdict and protect inventories from fraudulent, adulterated, sub-standard and counterfeit medications by the commercial interests seemingly is the most effective and efficient way to eradicate this deadly epidemic.

To read the USAID press release, visit: http://www.prnewswire.com/news-releases/substandard-and-counterfeit-antimalarial-drugs-in-ghana-discovered-by-cooperative-program-of-usp-ghana-food-and-drugs-board-106891733.html

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

Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.