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/.

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/.