Counterfeit threat intensifies

A worldwide flood of counterfeit and unsafe medications is seeping into the United States and other developed countries via the Internet and porous borders, threatening public health and the security of the pharmaceutical supply chain. In response, federal drug safety overseers and such drug manufacturers as Pfizer are working to shore up the integrity of drug supplies and stop production of fake and adulterated pharmaceuticals at their source.

According to Peter Pitts, director of the Center for Medicine in the Public Interest, global drug counterfeiting is growing at 12% to 16% a year, and in 2010 generated as much as $75 billion in worldwide revenues. In some third-world countries, counterfeit medicines now account for as much as half the total drug supply, the World Health Organization reported.

“It is shocking to realize that in some parts of the world, somewhere between 30% and 50% of drugs to treat serious diseases are actually counterfeit,” said Food and Drug Administration commissioner Margaret Hamburg, who added that the problem “is growing every day.”

Americans also are at risk. “Even in countries generally considered ‘safe’ — such as Canada, the United States and [much] of the European Union, counterfeit medicines have entered the legitimate supply chain, including counterfeit Lipitor, Norvasc, Viagra, Zithromax and Celebrex,” Pfizer noted. “During 2010, authorities from 53 countries seized almost 8.4 million tablets, capsules and vials of counterfeit Pfizer medicines.”

The FDA estimated the number of drug products made outside the United States but consumed domestically doubled from 2001 to 2008. As much as 40% of finished drugs are now manufactured abroad, according to the agency, and 80% of active ingredients and bulk chemicals in U.S. drugs come from other countries.

“Increasingly, the United States relies on drug manufacturing in developing countries — mainly China and India,” Pew Charitable Trusts noted in a July report. “Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution and the existence of criminal actors willing to capitalize on supply chain weaknesses have created the potential for counterfeit or substandard medicines to enter the system and reach patients.”

U.S. pharmacy buyers should be selective of sources, said Patrick Ford, senior director for Pfizer Global Security. “The further you go down the food chain in the secondary wholesale market, [the] greater risk of discovering a counterfeit,” he told DSN. “But if you can buy directly from an authorized distributor of a manufacturer, you can be pretty sure you’re not getting a counterfeit.”

Ford’s recommendation: “Know who your supplier is. And be familiar with the packaging.”

Although “the incidence of counterfeits in the legitimate supply chain is very rare,” he added, drug counterfeiters are taking full advantage of the Internet to circumvent U.S. Customs and Border Protection and FDA oversight. Patients who buy pharmaceuticals through a website not certified by the National Association of Boards of Pharmacy’s Verified Internet Pharmacy Practice Site program “run a very high risk of getting a counterfeit,” Ford asserted.

In a recent analysis of 8,000 rogue websites, NABP concluded that 96% of them were out of compliance with U.S. pharmacy laws, and 85% didn’t require a valid prescription.

Among the most notorious incidences of adulterated drugs in recent times are those involving the blood thinner heparin. Beginning in 2007, as many as 149 U.S. patients undergoing dialysis suffered severe allergic reactions to doses of contaminated heparin produced in China.

The FDA has adopted a global strategy for assuring the safety of the U.S. supply chain. That includes creation of an office to oversee import safety, with stepped-up powers to interdict incoming drug shipments into the United States, collaborate with regulatory agencies in other countries and order recalls of unsafe products. The agency also is calling on manufacturers to improve their own screenings of raw materials produced outside the United States — and has begun ranking more than 1,000 active drug ingredients to assess their “respective risk of economically motivated adulteration,” according to Hamburg.

Congress also has stepped in with legislation, including the Drug Safety and Accountability Act of 2010 and the FDA Globalization Act. The issue also will be a priority this fall for the Senate Health, Education, Labor and Pensions Committee, promised its chairman, Sen. Tom Harkin of Iowa.

The move in many states to adopt drug pedigree laws also could help button up the supply chain and improve safety.

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