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| Weekly Update | January 18, 2010 |
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USAID Fights Fake Drugs and Helps Countries Find the Fakes
USAID raised the counterfeit drug alarm to Congress in a report including data on pervasive fake anti-malarials and the success of medicine quality control assistance to 20 nations. USAID is successfully fighting the impact of substandard medicines in developing countries through drug authenticity training and technical assistance.
USAID has raised awareness on the impact of substandard medicines on the quality of health care in developing countries and is developing tools to improve quality assurance because "health systems with inadequate regulatory capacity are ill-equipped to control the entry of counterfeit and substandard medicines and products into the marketplace....Access to poor-quality medicines can contribute to the emergence of drug resistance and an increased need for second-line medicines, which can add to the cost and potential duration of treatment."
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 | | Indian Women looking at Medicine by USAID via Flickr |
In its report, USAID estimated that 30% of the world's population lacks regular access to medicine, and that the proportion is greater than 50% in the poorest areas of Africa and Asia.
"Unfortunately, many developing countries lack the capacity to protect their citizens in this way, much less to protect them from unscrupulous drug manufacturers and vendors. What should be a matter of trust is more like a tragic game of chance with devastating odds," said Dr. Maria A. Miralles, USAID's Senior Pharmaceutical Management Advisor.
To this end, USAID has also been supporting the development of a tool to enable regulatory authorities to evaluate their quality assurance systems in more than 20 nations, leading to recalls of substandard and counterfeit medicines and closure of illicit pharmacies. Monitoring is currently conducted largely through more than 100 sentinel sites that can perform product quality testing with measurable results. One sentinel site in Ghana detected a counterfeit antimalarial drug which lacked any active ingredient. It was promptly removed from pharmacies by the Foods and Drug Board, preventing further harm to malaria patients using the fake drug.
Public health NGOS who provide healthcare have a responsibility to insure that safe, authentic drugs in proper doses are available for treatment, believes Miralles. For example, in order to ensure quality products for multi-drug resistant tuberculosis patients, "USAID has been providing technical assistance to selected manufacturers to be able to meet internationally recognized Good Manufacturing Practices and for the preparation of dossiers for tuberculosis drugs for submission to WHO [for qualification purposes]," she explained.
USAID has helped countries establish and strengthen post-marketing surveillance systems to sample and test medicine in Latin America, Africa, and Southeast Asia. Post-marketing surveillance data was successful in curbing a regional anticounterfeit operation in Southeast Asia that led to the withdrawal of $6.7 million worth of sub-standard medicines.
But USAID has still more work to do as fake medicines continue to be a problem in many countries. A World Health Organization and U.S. Pharmacopeia Drug Quality study documented quality control failure rates of antimalarials provided by the public, private and informal sectors at 44% for Senegal, 30% for Madagascar and 20% for Uganda, states the report. "The sale of counterfeit, altered, and poor- quality malaria drugs is particularly acute in developing countries due to the limited regulatory capacity of country health systems and their inability to control the entry of antimalarials into the marketplace."
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Top News
Worldwide Rogue Pharmacy Spam Drops According to experts, spam declined worldwide last October following the closure of Spamit, a Russian affiliate program that paid spammers to promote "Canadian Pharmacy" brand rogue pharmacies. However, the software used to operate Spamit is now focusing on installing spyware and adware onto vulnerable computers. Investigative reporter, Brian Krebs, reports that M86 Security Labs measured Spam from February until the end of 2010 and that after Spamit closed in October, spam volume dropped precipitously and held to less than half the average of the previous seven months. Spamit promoted rogue pharmacies branded "Canadian Pharmacy" predominantly for American victims, but also used "European Pharmacy" and "United Pharmacy" to hook European and British online drug purchasers. (Partnership for Safe Medicines, January 17, 2010; Link here) |
World News
China: Online Sales of Fake Drugs Targeted
The online sales of fake drugs have become the target of an intellectual property rights violation crackdown in China. Said State Food and Drug Administration (SFDA) deputy director Bian Zhenjia, "We've noticed a proliferation of such illegal activities in cyberspace in recent years and have decided to prioritize combating them." Beijing Drug Administration spokesman Yuan Lin said online channels posed new challenges to anti-counterfeiting efforts. Dubious Web ads have duped members of the public with false information about drugs and medical equipment said to be able to cure chronic or untreatable diseases, such as kidney problems, cardiovascular diseases or cancer. Last month the administration shut down five production lines and destroyed 60 illegal bases that had sold fake drugs via express delivery companies. The producers posted false ads online, using the names of renowned pharmaceutical companies, hospitals and research institutes. (People Daily, January 19, 2011; Link here)
Philippines: Ten Percent of Drugs Sold are Fake
Filipino lawmakers are seeking strong anti-counterfeiting legislation after a national report announced that one of every ten drugs is fake. Cagayan de Oro Rep. Rufus Rodriguez and Abante Mindanao party-list Maximo Rodriguez filed House Resolution 742 to start an inquiry by the Committee on Health after reviewing a report by The Filipino Coalition Against Fake Medicines (SAMAHAN) identifying 10% of all medicines in the Philippines as fake, reports the Philippine Journal. The Filipino Coalition Against Fake Medicines, Samahan Laban sa Pekeng Gamot, is a public and private sector group committed to educating Filipinos about the dangers of fake drugs. This follows on the heels of a large fake drug bust in December, when the National Bureau of Investigation seized more than P25 million in fake medications during a sting operation. (Partnership for Safe Medicines, January 10, 2011; Link here)
Nigeria: Pharmacies Selling Fake Antibiotics Shut Down
The National Agency for Food and Drug Administration and Control (NAFDAC) has shut down numerous pharmacies selling fake drugs in Benue state.
Agents are continuing to use a portable optical analyzer that uses Raman spectroscopy to identify fake medicine even through plastic wrapping, said The Director of The NAFDAC Ports Inspections Directorate, Mr Segiru Momodu, in the Nigerian Tribune. Counterfeit antibiotics, anti-malarials, and anti-fungals were found. Counterfeit antibiotics that contain small, non-therapeutic amounts of active ingredients contribute to the development of antibiotic resistant strains of bacteria. Also found among the pharmacy stores was oral rehydration salt, donated by the United Nations Children's Fund (UNICEF), intended for free use at public clinics, not for sale at private pharmacies. (Parternship for Safe Medicines, January 18, 2010; Link here)
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About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
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