How to handle heparin shortage with supply chain issues in China

If the heparin shortage goes critical, there are some steps that could mitigate the harm, as one group outlined.
“Manufacturing disturbances and an outbreak of African swine fever in China are threatening to cause a severe heparin shortage globally, particularly in the USA, which currently relies solely on porcine-derived heparin,” Cian McCarthy, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues wrote in a viewpoint in The Lancet.

Cow-derived heparin was taken off the U.S. market after the bovine spongiform encephalopathy (“mad cow disease”) outbreak in the 1990s. Now it’s all porcine — 80% from China, where an ongoing outbreak of African swine fever has killed up to 40% of pigs whose intestines supply the heparin.
“[P]hysicians, hospital administrators, manufacturers, regulators, and the community at large should prepare for alternative anticoagulant strategies and secure safe and more durable long-term anticoagulant options,” the authors recommended.
Even though the FDA said in October that there wasn’t a U.S. heparin manufacturing or distribution issue, premixed unfractionated heparin (UFH) is in short supply and heparin flushes for line care and prefilled syringes “could progress to shortage if sources are not optimised.”
Some institutions have started “moving beyond conservation to implement alternative anticoagulation strategies.”
McCarthy’s group proposed a tiered response for temporary shortage:

First would be to triage use of unfractionated heparin in particular, using fondaparinux (Arixtra) or direct oral anticoagulants in appropriately selected patients and low molecular weight heparin or direct thrombin inhibitors for acute coronary syndromes. Parenteral direct thrombin inhibitors like bivalirudin (Angiomax) are pricier but could be used when close titration of anticoagulation is needed, as with cardiopulmonary bypass.
“If the heparin shortage were to progress to a critical status, UFH might be prioritised for only urgent or emergency cardiac surgeries,” McCarthy and colleagues wrote.
At a hospital level, action plans and pathways can have a big impact, they noted. “We have introduced a venous thromboembolism prophylaxis pathway at our institutions, which provides guidance for alternatives to using 5000 unit/mL heparin vials and has resulted in an 84% reduction in use.”
Conservation efforts could include only spiking heparin bags once ready to use and keeping heparin out of contact isolation rooms until needed, as well as encouraging multidose vials in procedural rooms and aseptically capping IV UFH bags if stopped for a procedure.
Manufacturers and regulators have a role as well in mitigating and preventing shortage, McCarthy’s group wrote.

McCarthy disclosed no relevant relationships with industry, although co-authors had extensive disclosures.

• Primary Source

  The Lancet

  Source Reference: McCarthy CP, et al “Running thin: implications of a heparin shortage” Lancet 2020; DOI:10.1016/ S0140-6736(19)33135-6.

https://www.medpagetoday.com/cardiology/acutecoronarysyndrome/84550