Lake Forest, IL: Recent issues surrounding heparin contamination and problems with heparin syringes have illustrated that there is no alternative to heparin for things such as catheter locking. According to a recent blog post appearing at Lynn Hadaway Associates Inc., an enterprise that provides infusion therapy performance consulting, there remain numerous issues with heparin as a catheter locking solution.
However, there is a complete lack of alternative solutions that carry approval by the US Food and Drug Administration (FDA). So heparin is it. What's more, there are more companies getting into the heparin business.Hospira Inc., described on its web site as a global pharmaceutical and medication delivery company based in Illinois, was approved for heparin by the FDA in September of this year.
According to the Hadaway blog post of November 2, the goal with regard to heparin flushing protocol is to "avoid having the dose of heparin lock solution produce any effect on the patient's coagulation values. This means that the lowest concentration of heparin should be used."
However, what is the impact of the new USP standards for heparin products? The latter batches of updated heparin, produced to help stem a repeat of previous contamination issues, shipped starting October 8, and differ from previous batches in that the updated USP protocols will result in decreased potency, according to a communiqué by the FDA.
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To that end Hospira, according to its website, is promising an enhanced label design that uses vibrant label colors inherent with each strength, a simplified text with increased font for dosing information, and differentiated warning labels.
Recent changes to USP standards, which align more closely with those of the World Health Organization, were implemented to prevent the tragic deaths and health issues that plagued the heparin industry in recent years due to contamination. But the changes need to be well communicated if future adverse reactions are to be avoided.