In an August 3rd story in the USA Today. Rita Rubin writes about a Pew Charitable Trust Prescription Project Poll that surveyed the trust of the average domestic US voter in prescription medications.According to the Pew Poll, more than three out of four voters are confident that prescription drugs made in the US are free from contamination, while fewer than one in 10 feel confident about medications made in India or China.
This is troubling as Ms Rubin writes, because:
Unbeknownst to many Americans, an estimated 80% of the substances used to make or package drugs sold here are made in other countries, says Allan Coukell, a pharmacist who directs the medical safety portfolio for the Pew Health Group. And a growing proportion come from India or China. In 2007, 68% of ingredients of drugs sold worldwide came from India or China, vs. 49% in 2004.
Also in the USA Today article:
· Monitoring far-flung plants presents a logistical challenge to the Food and Drug Administration, Coukell says. "They clearly don't have the people or the resources they need to oversee manufacturing the way it exists today."
· In 2007 and 2008, more than 100 patients in the USA died after taking heparin made with a contaminated active ingredient from China.
· Complicating matters is the FDA's inability to order recalls of batches of drugs that might pose a risk, Coukell says. (The FDA can withdraw approval of a drug, taking it off the U.S. market entirely.)
· Even so, drug recalls soared 400% from 2008 to 2009, which saw a record 1,742, according to the Drug Safety and Accountability Act of 2010, to be introduced today by Sen. Michael Bennet, D-Colo. Bennet's bill would empower the FDA to order recalls of unsafe batches of drugs.
· According to the Pew random nationwide survey of 802 registered voters, 55% say the government should do more to ensure the safety of drugs made in other countries, and nearly nine in 10 back legislation to implement new drug safety measures.
· In an interview, Bennet said McNeil Consumer Healthcare's recall this year of more than 130 million bottles of over-the-counter children's medicines fueled his concerns. Referring to his daughters, ages 10, 9 and 6, he said, "I want to make sure any pharmaceuticals they're ingesting are safe."
· In 2007 and 2008, more than 100 patients in the USA died after taking heparin made with a contaminated active ingredient from China.
· Complicating matters is the FDA's inability to order recalls of batches of drugs that might pose a risk, Coukell says. (The FDA can withdraw approval of a drug, taking it off the U.S. market entirely.)
· Even so, drug recalls soared 400% from 2008 to 2009, which saw a record 1,742, according to the Drug Safety and Accountability Act of 2010, to be introduced today by Sen. Michael Bennet, D-Colo. Bennet's bill would empower the FDA to order recalls of unsafe batches of drugs.
· According to the Pew random nationwide survey of 802 registered voters, 55% say the government should do more to ensure the safety of drugs made in other countries, and nearly nine in 10 back legislation to implement new drug safety measures.
· In an interview, Bennet said McNeil Consumer Healthcare's recall this year of more than 130 million bottles of over-the-counter children's medicines fueled his concerns. Referring to his daughters, ages 10, 9 and 6, he said, "I want to make sure any pharmaceuticals they're ingesting are safe."
Clearly consumers understand the potential issue of globally sourced drugs but are not informed as to the extent that the drugs that they take every day are manufactured or contain raw materials from countries with suspect or under regulated industry.
It is vital that members of the domestic pharmaceutical supply chain and domestic regulatory agencies deploy solutions and technologies to test the safety and efficacy of drugs and consumer goods produced overseas.
To learn more about authentication solutions that can protect consumers against fraudulent, substandard, adulterated or counterfeit medications, visit: http://www.xstreamsystems.net/.
To see the entire USA Today article, visit: http://www.usatoday.com/news/health/2010-08-03-recall03_ST_N.htm.
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