The drug Heparin has been in the news quite a bit this year, unfortunately for all of the wrong reasons. Patient deaths, accusations of non-authorized substitution of ingredients during the manufacturing process and nationwide shortages have kept this product in the public eye. What’s wrong with Heparin?

First of all, what the heck is Heparin? Heparin is an anticoagulant that is used to treat blood clots primarily in the lungs or legs, although it is also used to prevent clots after surgery, during kidney dialysis, or when collecting blood samples. It works by preventing the conversion of prothrombin to thrombin and fibrinogen to fibrin, which are the final steps in the clotting process.

A couple of years ago, we became familiar with the dangers of Heparin through the tragic medication errors at Methodist Hospital in Indianapolis, where infants were given thousand-fold overdoses of the drug, resulting in their deaths. The errors were due, in part, to similar labeling on the various strengths of Heparin, and at that time manufacturing processes were called into question.

More recently, there have been additional deaths, and several allergic reactions, linked to a contaminant found in some batches of Heparin manufactured in China. The contaminant, identified as an altered form of chondroitin sulfate, has raised questions regarding our entire pharmaceutical delivery process.

Most of us are familiar with chondroitin sulfate, a supplement made from animal cartilage used to treat joint pain. It is found on any drug or grocery store shelf in Greensburg, and in its over-the-counter form, chondroitin has no anticlotting activity. However, when chemically altered into what is known as oversulfated chondroitin sulfate, it mimics the actions of Heparin. The base compound, chondroitin sulfate, is very abundant and inexpensive, and modifying the material into oversulfated chondroitin sulfate is not an expensive process. Obviously, whether this contaminant was intentionally introduced into the Heparin or not, doing so would drastically reduce the cost of producing a vial of what is being sold as Heparin.

In China, a drug manufacturer often purchases products from other companies, called consolidators, that gather crude material, in this case Heparin, from workshops that derive the Heparin from pig intestines. These workshops are often family operations that manufacturer their product in a completely unregulated environment.

As we have witnessed with the lead paint on children’s toys and the contaminated pet food over the last few years, there is often a price to pay for outsourcing to the lowest bidder. Competition is a good thing, and if a product can be manufactured with the same quality for a lower cost, most of us would reward that manufacturer with our business. Unfortunately, under extreme pressure to reduce costs, shortcuts will be a constant temptation.

Since outsourcing is a reality, and since up to 80 percent of ingredients used in the manufacture of pharmaceuticals sold in the United States come from outside our borders, concern regarding safety standards used in the process is certainly valid and appropriate. The Food and Drug Administration may have already taken a first step to address these concerns, when they announced in March the creation of eight full-time, permanent FDA positions at US diplomatic posts in China. In addition, there will be five additional Chinese FDA employees placed at the US Embassy in Beijing and the US consulates in Shanghai and Guangzhou, in an ongoing effort to assure safety in Chinese manufacturing processes.

As of now, both Baxter Healthcare, the American supplier of Heparin, and the Chinese company that provided the raw ingredients to Baxter, have denied any knowledge of contamination or an intentional substitution of ingredients.

With more and more products coming from outside the United States, where many of our manufacturing standards and regulations do not apply, it is important for consumers to involve themselves in the process. While most drug wholesalers are reputable and have performed due diligence to assure the products are manufactured to correct standards, it is important to note that many over-the-counter medications now have toll-free numbers, or websites, available on the label of the product. Become an educated consumer and call the manufacturers. Ask where the product originated, what methods are in place to assure safety, and find out what other products are supplied by the same company. If enough people take the time to show they are concerned, manufacturers will usually respond to meet the need, especially when that need is patient safety.

Remember, in the end, the government standards and regulations we often lament are there to protect us all.