Tag:patient safety

According to a report recently released by the Government Accountability Office, over 2,000 foreign drug manufacturers subject to inspection by the U.S. Food and Drug Administration may never have been visited by agency inspectors.

This lack of oversight poses serious safety concerns for American patients, which are further compounded by the fact that a quarter (714) of these foreign drug manufacturers are from China. A recent article in the New York Times reported that pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators. (1)

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A Congress out of touch with American consumers is considering making it easier to import drugs from other countries into the US. Yet according to recent data, internet drug sales from Canada have dropped 80 percent over the last 3 years. Growing concerns over the safety of mail-order drug imports and better access to drug benefits through programs like Medicare part D have caused many of the larger Canadian mail order pharmacies to close their doors.

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According to a story published in the Washington Post on June 17, 2007, “ Companies based in India were bit players in the American drug market 10 years ago, selling just eight generic drugs here. Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by American consumers are made by Indian manufacturers. Five years ago, Chinese drug-makers exported about $300 million worth of products to the United States. Eager to meet Americans' demand for lower-cost medicines, they, too, have expanded rapidly. Last year, they sold more than $675 million in pharmaceutical ingredients and products in the U.S. market.”

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Patients need to have confidence in the quality, safety and effectiveness of their medicines. In developed countries, governments enact laws and regulations that provide stringent safeguards for drug approval, manufacturing, labelling and distribution.

Despite the obvious importance of such safeguards, some American lawmakers continue to promote the importation of cheap drugs by enabling foreign suppliers to evade the stringent oversight that protects America’s drug supply chain. One of the largest “Canadian” mail order pharmacies has been found to be shipping products from other countries to avoid the oversight of both American and Canadian regulators.

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Drug utilization in Canada increased 37 percent from 228 million prescriptions in 1995 to nearly 313 million prescriptions in 2001 . As Canada’s population ages this trend is likely to continue as more Canadians will rely on medicines to manage and treat chronic conditions. With increased drug utilization, one would expect the potential for adverse effects from prescription drug use to increase. Yet, the percentage of hospital stays in Canada attributable to the adverse effects of medical agents has remained relatively constant from 1995 to 2001 accounting for only approximately 0.6 percent of all hospitalizations annually.

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Counterfeit medicines are a growing threat to public health in Peru, according to a recent study published in the Pan American Journal of Public Health1. Since 2005, the prevalence of counterfeit medicines has increased annually by an average of 45 per cent.

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Confusion in the EU over whether or not some ‘generic’ drugs intended for the developing world are in violation of intellectual property laws have led to numerous delays and seizures at ports and airports around the region.   Most recently a shipment of 1.74mn tablets of a generic antiplatelet drug—a drug that reduces the risk of strokes and heart attacks due to blood clots—en route to Venezuela from India was seized by French custom’s officials on suspicion of patent infringement.  Just one month prior French agents seized another shipment of 740,000 tablets of the heart medicine Clopidogrel—Plavix—, again originating from India.  It has been reported that there have been at least 18 seizures of Indian drugs shipments in the EU this year.

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Review and approval of new drugs takes significantly longer in Canada compared to the United States. A new study published in the Annals of Pharmacotherapy compares new drug approval times in Canada and the United States and examines whether faster, more efficient reviews have an impact on drug safety.

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The Medicare Modernization Act passed by Congress in 2003, contained a provision that would permit the importation of prescription drugs into the U.S. if the Department of Health and Human Services (HHS) certified that drugs imported from Canada posed no additional risk to public health and safety and that such imports provided significant cost savings to American consumers. H.H.S. released the results of its study of these issues on December 21, 2004.

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During the past year a handful of states including Minnesota, Wisconsin and New Hampshire have sanctioned websites to facilitate the importation of prescription drugs for their residents. In order to assure the safety and quality of foreign drug supplies, some states have imposed certain conditions on selected internet drug sellers.

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