- The U.S. Food and Drug Administration is implementing stricter standards for the use of heparin and glycerin due to recent contamination incidents.
- The newly introduced standards have been put together by the US Pharmacopeia Convention, aiming to ensure public health safety.
- Previous incidents, such as patient reactions to heparin treatments and glycerin contamination, have inspired these changes.
- Starting from August, the manufacturers and importers of heparin will have to follow the new standard to verify their products before these can be marketed in the U.S.
- The standard for glycerin has been enhanced to exclude ethylene glycol or diethylene glycol and manufacturers will now have to test for these chemicals in all the glycerin that comes into their facilities.
In order to prevent unauthentic and tainted medications from being accessible to consumers in America, the U.S. Food and Drug Administration has decided to implement stricter standards for the use of heparin and glycerin. These are two commonly used drugs which have been at the core of recent contamination incidents.
Creation of the New Standards
The newly introduced standards have been put together by the US Pharmacopeia Convention. This is a non-profit health entity that designs public standards for prescription drugs, over-the-counter medicines and other healthcare products produced or sold in the United States.
“These are continuing changes in well-established guidelines for heparin and glycerin, specifically those that could possibly be contaminated with toxins such as ethylene glycol and diethylene glycol,” Dr. Darrell R. Abernethy, USP Chief Science Officer, stated. “The purpose of these changes is to ensure public health safety.”
Incidences Leading to the Changes
Starting from late 2007, there were several serious reactions reported from patients who received heparin treatments, a type of blood thinner, particularly patients undergoing kidney dialysis. Roughly 200 individuals lost their lives due to these reactions, according to Abernethy.
“Most likely, the heparin from China was contaminated intentionally and is the cause of these reactions. The contamination was executed so remarkably well that it went undetected by our existing standards,” he added.
The adulterated heparin from China was found to be mixed with over-sulfated chondroitin sulfate, a product derived from the dietary supplement chondroitin, which closely mimics the blood-thinning properties of heparin.
Permanent Changes to Heparin and Glycerin Guidelines
The USP made necessary changes to the standard to prevent the adulterated heparin from entering the United States. As a first measure, the USP administered an immediate “quick fix” to address the problem arising from China.
From August, there will be a standard change that will be permanent in nature. After this change, manufacturers and importers of heparin will have to follow the new standard to verify their products before these can be marketed in the United States. The new standard will include a detailed chemical identification of heparin, which pinpoints the chemicals in the heparin more accurately than before.
Possible Dangers of Glycerin
Glycerin is a chemical used to sweeten various products such as toothpaste and pancake syrup, whereas ethylene glycol and diethylene glycol are poisonous chemicals. The incidence of using ethylene glycol, an antifreeze ingredient, as a cost-effective substitute for glycerin dates back to 1937. More than 107 people were reported to have died in the United States due to ethylene glycol being used as a liquid base for an antibiotic.
In recent times, there have been instances of ethylene glycol or diethylene glycol contamination found in toothpaste imported from China in the United States. The most recent case was in November, when 34 Nigerian children died after being administered a tainted teething drug.
In light of these events, the FDA requested the USP to enhance the standard for glycerin to exclude ethylene glycol or diethylene glycol. Prior to these changes, manufacturers were only required to sporadically test their products for these chemicals. However, manufacturers will now have to test for these chemicals in all the glycerin that comes into their facilities. This new standard will come into effect in May.
Enforcement of the New Standards
“The stance taken by the FDA to enforce these standards for heparin and glycerin should prevent these impurities from happening again”, Abernethy stated.
Dr. David L. Katz, director of the Yale University School of Medicine’s Prevention Research Center, shared his thoughts and he wasn’t convinced that these new standards will keep all adulterated drugs or other products from being imported into the country. Perfect defenses against tainted or adulterated drugs could be achieved, but would come with costs few would be willing to pay. It would demand intensive inspections, strict quality control measures and massively expensive surveillance efforts to allow only good products in while filtering out the bad ones effectively.
“Though the increased quality standards and closer scrutiny for heparin and glycerin will not perfectly shield against drug adulteration, they certainly move us in the right direction,” says Katz.
For additional information on drug safety, please visit U.S. Food and Drug Administration.