Draft Guidance Outlines Recommendations for Products Containing Heparin
To reduce dosing errors that have resulted in deaths and patient adverse events, the FDA is providing manufacturers with labeling and safety testing recommendations for medical devices and combination products containing the blood thinner heparin.
Patient safety organizations such as the Institute for Safe Medication Practices have maintained that confusing labels on heparin vials were responsible for inadvertent medication errors. And as a July 9 draft guidance notes, heparin products span a wide range of doses and concentrations based on the indication and the intended patient population.
Following high-profile incidents involving heparin overdoses — including actor Dennis Quaid’s newborns receiving 1,000 times the prescribed dose — the U.S. Pharmacopeial Convention revised its labeling expectations for the drug in 2012.
Heparin vials now must display the strength per vial, followed by the strength per milliliter. The draft guidance provides examples of this labeling format and recommends that this information be provided in the instructions for use. In addition, the labels must identify the organ and animal species from which the product is derived. The draft guidance also provides labeling expectations for heparin-bonded products.
In terms of safety testing, the FDA urges manufacturers to follow the 2013 guidance document, Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality. Manufacturers also should verify and document that the drug product has been tested to the current USP monograph, as well as manufactured and tested consistent with existing FDA guidance.
Premarket submissions should document compliance with heparin safety testing and include the following information:
- Heparin source-tissue and species, e.g., porcine intestinal mucosa;
- Confirmation of the species origin; and
- Name, address and contact information of the heparin active pharmaceutical ingredient manufacturer, as well as that of any repacker or distributor that handled the product prior to receipt.
Another topic addressed in the draft guidance is heparin containing oversulfated chondroitin sulfate. In 2008, heparin contaminated with this substance from a Chinese plant was linked to adverse events. The FDA says that between Jan. 1 and May 14, 2008, 11 deaths and 86 nonfatal adverse events were reported in patients using heparin-containing combination products.
Both the FDA and USP have testing recommendations for OSCS. In their premarket submissions, manufacturers should demonstrate conformance with testing parameters from the 2013 guidance on monitoring the quality of crude heparin and show that the testing methods used can detect low levels of OSCS.
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