BETHESDA, MD 27 March 2013—Labels on newly manufactured heparin products will prominently state the number of units of drug in the entire container once revisions to the United States Pharmacopeia monographs for heparin lock flush solution and heparin sodium injection go into effect on May 1.
This change, although intended to prevent medication errors, may initially present difficulties for health care professionals, FDA and the United States Pharmacopeial Convention (USP) have warned.
New and old in coexistence. According to FDA, manufacturers of Heparin Lock Flush Solution, USP, and Heparin Sodium Injection, USP, will have to use labels that "clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter."
The label on a 10-mL vial of heparin sodium 5,000 units/mL, in one example provided by FDA, will foremost state "50,000 USP units per 10 mL" followed closely by "(5,000 USP units per mL)."
As a result of this type of language on labels, health care professionals will no longer have to calculate the total amount of heparin in a container holding more than 1 mL, USP and FDA said.
Health care professionals may already have seen the new style of label on heparin products. FDA said in early March that it allowed manufacturers to ship heparin products with the new style of label before May 1.
As for products with the old style of label, FDA said those shipped before May 1 remain usable until their expiration dates.
Safety. To protect patients while both styles of label are in use, USP suggests that pharmacies and hospitals
Consider separating heparin products with the old style of label from those with the new style and exhausting the supplies of the former before using the latter,
Emphasize to practitioners that they should always look at the label on a heparin vial before doing anything with it, and
Establish protocols, policies, and procedures, such as an independent double-check process, that highlight the change to labels on heparin containers.
Patricia C. Kienle, director of accreditation and medication safety at Cardinal Health Pharmacy Solutions, said now is "a great time for people to do a mini failure mode and effects analysis, an FMEA."
Doing that type of analysis, she explained, gives people the opportunity to look for heparin products everywhere in the health care organization.
"They may be surprised" at what they find, Kienle said.
Procedural areas tied to the hospital likely have heparin products, she said. But so may a health system’s clinics, offices, and remote procedural areas. And don’t forget the dialysis areas.
"Often, dialysis [services] are contract services," Kienle said. "And often, heparin is brought in by those contract services to be used in dialysis centers. And often, pharmacy isn’t aware of that."
An FMEA of heparin products also presents the opportunity to ensure that the policies concerning high-alert medications are being followed, she said.
There is also the matter of size and strength.
"When I see people who have 10,000-unit/mL [vials] or have larger than 1-mL-vial sizes of heparin," Kienle said, "it strikes a chord with me that, maybe, they haven’t looked at that whole safety perspective."
Allen J. Vaida, executive vice president of the Institute for Safe Medication Practices, said his group for years has wanted hospitals to assess whether any area other than pharmacy truly needs to have heparin vials.
Take, for example, the patient care units.
If the pharmacy provides all first doses of heparin infusion, prepares all bolus doses of heparin, and stocks the units with standard premixed heparin solutions, Vaida said, then the nurses don’t need ready access to heparin vials.
"Use this as an opportunity and see if you can basically pull some product from the nursing units and [elsewhere] that maybe didn’t have to be up there in the first place," he said.
Vaida said hospitals should also assess how their computerized prescriber-order-entry system, electronic medication administration record, and automated dispensing cabinets display heparin products onscreen.
Always a problem. Kienle said heparin products, even when all labels prominently state the entire strength in a container, will remain problematic from a safety standpoint.
"There’s a lot of confusion with any drug that has a lot of zeros and/or has a ‘u’ for unit in their labeling," she said.
Nonetheless, she said the new style of label is an improvement and will be particularly helpful in emphasizing that a small vial is not always a unit dose vial.
Vaida said USP’s decision to change the labeling section in the two heparin monographs corrects an oversight.
His group in 2002 told the USP Safe Medication Use Expert Committee about a variety of medication errors that had occurred because manufacturers’ labels did not prominently state the total amount of drug in a container. The eventual result, Vaida said, was a requirement for injectable drug products other than insulin to have a label prominently stating the total amount of drug in the container.
What was not realized until more recently, however, was that the heparin monographs contained overriding labeling requirements that prevented a label from stating the total strength in the container, he said.
Bona E. Benjamin, director of medication-use quality improvement at ASHP, agreed with USP’s decision to have the labels on heparin containers state the total amount of drug.
The total content of a drug container is an important piece of information, she said.
This change to the labels, she added, should reduce the risk of heparin errors.