The FDA had violated its own policy: Adverse drug reactions from defective heparin

Baxter International announced recently that it is recalling virtually all its heparin products. Baxter makes and sells more than 500,000 multi-dose vials of heparin in the U.S. each month. Heparin is used to prevent blood from clotting during dialysis and some common forms of heart surgery.

More than 400 adverse reactions have already been reported in the US from the use of heparin, including up to 21 deaths. Investigators are trying to identify the root cause, which seems related to the practices of small Chinese suppliers of crude heparin.

To make heparin, workers collect and cook the mucous membrane from the intestines of slaughtered pigs, producing crude heparin. Major producers refine that and sell it to Baxter and others, which make the finished product for use in hospitals.

Blue ear pig disease has swept through China, depleting stocks, and leading some farmers to sell sick pigs. This led companies to switch to using small, often unsanitary and unregulated village workshops as less expensive suppliers. As much as 70% of China’s crude heparin now comes from such small factories in poor villages.

The FDA had admitted this month that it had violated its own policy by failing to inspect Changzhou SPL, located west of Shanghai, before the factory began shipping crude heparin, an ingredient of the medicine heparin, in 2004. The Chinese government does not inspect such factories.

Advice to heart surgery and dialysis patients: Ascertain, or ask your patient advocate to ascertain, the source of the heparin you will receive. A sufficient supply is available from safer suppliers.

Browse for related stories in the index at the very bottom of this page.

Thanks to Walt Bogdanich and David Barboza for the two source articles in last week's NY Times.

The Machine was the Perp, Part 2: A drug dispensing error

Earlier
I described what happened after nurses opened the drug drawer of a mis-stocked automated dispensing machine and gave adult doses of Heparin to three newborns.

That hospital unit usually only received doses of Heparin for newborns, and the vials of adult and baby doses are of similar size and color. If the hospital had consistently used vials of a distinct size or color for babies or youths, the errors would have been far less likely. The pharmacy technician would not have stocked the drug wrongly, and the nurses would not have given it to the babies.

Safeguards like this distinctive repackaging are a form of error-proofing ("pokayoke," in Japanese)--an effort to make errors impossible, or at least highly unlikely. Of course, such distinctive packaging costs hospitals time and money. Since the powerful blood-thinner Heparin is known as a hazardous medication, it's probably money well-spent.

Advice to patients and advocates: Be especially vigilant when hazardous medications are being given.

Advice to pharmacy directors: Repackage hazardous medications to consistently distinguish adult from infant doses with distinctive colors or vial sizes.

Read Nurse Mary Bylone's blog posting for more.

The Machine Was the Perp: Wrong drug errors

Most American hospitals place automated drug dispensing cabinets on the patient floors, to enable nurses to give drugs to patients more promptly. Usually this is a good thing, but the convenience comes with an awful high hidden price.

The families of six premature babies, and hospital staff, have learned that grim lesson. The babies were being cared for in the neonatal intensive care unit of an Indiana hospital. The NICU was equipped with an automated drug dispensing machine--imagine a candy machine that requires a nurse's password instead of money to activate. A pharmacy technician had stocked it with the ADULT doses of heparin, a powerful blood-thinner meant to prevent blood clots that could clog intravenous tubes. Then, over time, as nurses opened the cabinet's drawer to get heparin for their preemie patients, they took the adult heparin, and gave it to six different preemies. Three of the babies died and three remain in critical condition.

Advice to hospital pharmacy directors: Store hazardous medications in the pharmacy, not in the automated dispensing machines, to prevent multiple errors.

Advice to parents: Check the label of each dose of medication your family member receives. In choosing a hospital, ascertain whether hazardous medications are stored in automated dispensing machines. A patient advocate may be useful for this purpose.

Read another of our stories about a drug error lawsuit, or read more about this one in "Family of 3rd preemie to die of overdose speaks" and "Drug Error Triple Tragedy in Indiana."